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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended SEPTEMBER 30, 2023
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ________ to ________
Commission
File Number: 001-40738
RENOVORX,
INC.
(Exact
Name of Registrant as Specified in its Charter)
Delaware |
|
27-1448452 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
No.) |
|
|
|
4546
El Camino Real, Suite B1 |
|
|
Los
Altos, California |
|
94022 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(650)
284-4433
(Registrant’s
telephone number, including area code)
N/A
(Former name, former address
and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.0001 per share |
|
RNXT |
|
Nasdaq
Capital Market |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,
or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐ |
Accelerated
filer ☐ |
Non-accelerated
filer ☒ |
Smaller
reporting company ☒ |
Emerging
growth company ☒ |
|
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of November 8, 2023, the registrant had 10,693,580 shares of common stock, $0.0001 par value per share, outstanding.
Table
of Contents
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q, or Quarterly Report, and the information incorporated herein by reference, particularly in the sections
captioned “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,”
contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act,
and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, that are based on our management’s beliefs
and assumptions and on information currently available to our management. Forward-looking statements are inherently subject to risks
and uncertainties, some of which cannot be predicted or quantified. All statements other than present and historical facts and conditions
contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business
strategy, plans and our objectives for future operations, are forward-looking statements. In some cases, you can identify forward-looking
statements by terminology such as “anticipate,” “believe,” “can,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “might,” “objective,”
“ongoing,” “plan,” “potential,” “predict,” “project,” “should,”
“will,” or “would,” or the negative of these terms or other comparable terminology. Actual events or results
may differ from those expressed in these forward-looking statements, and these differences may be material and adverse. Forward-looking
statements include, but are not limited to, statements about:
|
● |
the
sufficiency of our existing cash, cash equivalents, and investments to fund our future operating expenses and capital expenditure
requirements and our ability to operate as a going concern; |
|
|
|
|
● |
our
estimates regarding expenses, future revenue, anticipated capital requirements to fund our future operating expenses, and our need
for additional financing; |
|
|
|
|
● |
our
financial performance; |
|
|
|
|
● |
our
anticipated use of our existing cash, cash equivalents, and investments; |
|
|
|
|
● |
the
ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; |
|
|
|
|
● |
the
progress and focus of our current and future clinical trials, and the timing of reporting of data from those trials; |
|
|
|
|
● |
our
continued reliance on third parties to conduct clinical trials of our product candidates, and for the manufacture of our product
candidates; |
|
|
|
|
● |
the
beneficial characteristics, safety, efficacy, and therapeutic effects of our product candidates; |
|
|
|
|
● |
our
ability to advance product candidates into and successfully complete clinical trials; |
|
|
|
|
● |
our
ability to further develop and expand our therapy platform, both to use different chemotherapeutic agents and to include new indications; |
|
|
|
|
● |
expectations
relating to the timing of the provision of updates on, data readouts for, and completion of our clinical trials; |
|
|
|
|
● |
our
ability to obtain and maintain regulatory approval of our product candidates and the timing or likelihood of regulatory filings and
approvals, including our expectation to seek special designations, such as orphan drug designation, for our product candidates for
various diseases; |
|
|
|
|
● |
existing
regulations and regulatory developments in the United States and other jurisdictions; |
|
● |
our
plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and our potential
and ability to successfully commercialize our product candidates and generate revenue; |
|
|
|
|
● |
the
implementation of our strategic plans for our business and product candidates; |
|
|
|
|
● |
the
expected potential benefits of strategic collaborations with third parties and our ability to attract collaborators with relevant
and complementary expertise; |
|
|
|
|
● |
our
estimates of the number of patients in the United States who suffer from the diseases we target, and enrollment timing and projections
for our clinical trials; |
|
|
|
|
● |
our
estimates of potential market opportunities and our ability to successfully realize these opportunities; |
|
|
|
|
● |
the
success of competing therapies that are or may become available; |
|
|
|
|
● |
developments
relating to our competitors and our industry, including competing product candidates and therapies; |
|
|
|
|
● |
our
plans relating to the further development and manufacturing of our product candidates, including for additional indications which
we may pursue; |
|
|
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our
plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available; |
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● |
the
scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform and product
candidates; |
|
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● |
our
ability to successfully negotiate and enter into agreements with distribution, strategic and corporate partners; |
|
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● |
our
potential and ability to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if
approved; |
|
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● |
our
ability to retain the continued service of our key personnel and to identify, hire, and then retain additional qualified personnel; |
|
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● |
our
expectations regarding the impact of the ongoing COVID-19 pandemic and geopolitical events on our business; and |
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● |
our ability to comply with the continued listing standards of The Nasdaq
Stock Market LLC (“Nasdaq”) or the continued listing of our securities on Nasdaq. |
We
have based the forward-looking statements contained in this Quarterly Report primarily on our current expectations and projections about
future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy
and financial needs. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, assumptions
and other factors described in the section titled “Risk Factors” and elsewhere in this Quarterly Report. These risks are
not exhaustive. Other sections of this Quarterly Report include additional factors that could adversely affect our business and financial
performance. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time
to time and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements
contained in this Quarterly Report. We cannot assure you that the results, events and circumstances reflected in the forward-looking
statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the
forward-looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these
statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time
frame or at all.
In
addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These
statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information
forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to
indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements
are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. The forward-looking statements made in
this Quarterly Report relate only to events as of the date on which such statements are made. We undertake no obligation to update any
forward-looking statements after the date of this Quarterly Report or to conform such statements to actual results or revised expectations,
except as required by law. Unless the context otherwise indicates, “RenovoRx,” the “Company,” “we,”
“our,” and “us” refer to RenovoRx, Inc., a Delaware corporation.
Part
I – FINANCIAL INFORMATION
Item
1. Financial Statements
RenovoRx,
Inc.
Condensed
Balance Sheets
(Unaudited)
(in
thousands, except share and per share amounts)
| |
September 30,
2023 | | |
December 31,
2022 | |
| |
| | |
| |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash
equivalents | |
$ | 3,226 | | |
$ | 4,391 | |
Short-term marketable securities | |
| - | | |
| 2,049 | |
Prepaid expenses and other
current assets | |
| 252 | | |
| 825 | |
Deferred
offering costs | |
| 41 | | |
| - | |
Total
assets | |
$ | 3,519 | | |
$ | 7,265 | |
| |
| | | |
| | |
Liabilities and Stockholders’
Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 350 | | |
$ | 534 | |
Accrued
expenses | |
| 1,255 | | |
| 568 | |
Total current liabilities | |
| 1,605 | | |
| 1,102 | |
Common warrant liability | |
| 1,908 | | |
| - | |
Total
liabilities | |
| 3,513 | | |
| 1,102 | |
Commitments and contingencies | |
| - | | |
| - | |
Stockholders’ equity: | |
| | | |
| | |
Convertible preferred stock, $0.0001 par
value; 15,000,000 shares authorized as of September 30, 2023, and December 31, 2022, respectively; no shares issued and outstanding
at September 30, 2023, and December 31, 2022 | |
| - | | |
| - | |
Common stock, $0.0001 par value, 250,000,000
shares authorized at September 30, 2023, and December 31, 2022; 10,693,080 and 9,097,701 shares issued and outstanding as of September
30, 2023, and December 31, 2022, respectively | |
| 1 | | |
| 1 | |
Additional paid-in capital | |
| 38,183 | | |
| 37,318 | |
Accumulated other comprehensive
income | |
| - | | |
| 17 | |
Accumulated
deficit | |
| (38,178 | ) | |
| (31,173 | ) |
Total
stockholders’ equity | |
| 6 | | |
| 6,163 | |
Total
liabilities and stockholders’ equity | |
$ | 3,519 | | |
$ | 7,265 | |
The
accompanying notes are an integral part of these condensed interim financial statements.
RenovoRx,
Inc.
Condensed
Statements of Operations and Comprehensive Loss
(Unaudited)
(in
thousands, except share and per share amounts)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months
Ended | | |
Nine Months
Ended | |
| |
September
30, | | |
September
30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and
development | |
$ | 1,629 | | |
$ | 846 | | |
$ | 4,892 | | |
$ | 3,525 | |
General
and administrative | |
| 1,354 | | |
| 1,315 | | |
| 4,727 | | |
| 4,255 | |
Total
operating expenses | |
| 2,983 | | |
| 2,161 | | |
| 9,619 | | |
| 7,780 | |
Loss from operations | |
| (2,983 | ) | |
| (2,161 | ) | |
| (9,619 | ) | |
| (7,780 | ) |
Other income/(expenses), net: | |
| | | |
| | | |
| | | |
| | |
Interest and dividend income | |
| 43 | | |
| 22 | | |
| 97 | | |
| 43 | |
Other income, net | |
| - | | |
| 3 | | |
| - | | |
| 4 | |
Change in fair value of
common warrant liability | |
| 1,519 | | |
| - | | |
| 3,092 | | |
| - | |
Transaction
costs allocated to common warrant liability | |
| - | | |
| - | | |
| (575 | ) | |
| - | |
Total
other income/(expenses), net | |
| 1,562 | | |
| 25 | | |
| 2,614 | | |
| 47 | |
Net loss | |
| (1,421 | ) | |
| (2,136 | ) | |
| (7,005 | ) | |
| (7,733 | ) |
Other comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
Unrealized
gain on marketable securities | |
| - | | |
| 17 | | |
| - | | |
| 13 | |
Comprehensive loss | |
$ | (1,421 | ) | |
$ | (2,119 | ) | |
$ | (7,005 | ) | |
$ | (7,720 | ) |
Net loss per share,
basic and diluted | |
$ | (0.13 | ) | |
$ | (0.24 | ) | |
$ | (0.69 | ) | |
$ | (0.86 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average shares
of common stock outstanding, basic and diluted | |
| 10,693,080 | | |
| 9,067,509 | | |
| 10,154,914 | | |
| 9,039,308 | |
The
accompanying notes are an integral part of these condensed interim financial statements.
RenovoRx,
Inc.
Condensed
Statements of Convertible Preferred Stock and Stockholders’ Equity
(Unaudited)
(in
thousands, except share amounts)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Income | | |
Deficit | | |
Equity | |
| |
Convertible
Preferred Stock | | |
Common
Stock | | |
Additional Paid-
In | | |
Accumulated
Other Comprehensive | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Income | | |
Deficit | | |
Equity | |
Balance — December 31,
2022 | |
| - | | |
$ | - | | |
| 9,097,701 | | |
$ | 1 | | |
$ | 37,318 | | |
$ | 17 | | |
$ | (31,173 | ) | |
$ | 6,163 | |
Issuance of common stock upon exercise of stock
options | |
| - | | |
| - | | |
| 3,547 | | |
| - | | |
| 6 | | |
| - | | |
| - | | |
| 6 | |
Issuance of restricted stock awards | |
| - | | |
| - | | |
| 30,000 | | |
| - | | |
| 117 | | |
| - | | |
| - | | |
| 117 | |
Stock-based compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 244 | | |
| - | | |
| - | | |
| 244 | |
Other comprehensive loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (17 | ) | |
| - | | |
| (17 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,257 | ) | |
| (3,257 | ) |
Balance — March 31, 2023 | |
| - | | |
| - | | |
| 9,131,248 | | |
| 1 | | |
| 37,685 | | |
| - | | |
| (34,430 | ) | |
| 3,256 | |
Issuance of common stock upon the registered
direct offering | |
| - | | |
| - | | |
| 1,000,000 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Issuance and exercise of pre-funded common
warrants upon the registered direct offering | |
| - | | |
| - | | |
| 557,632 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Issuance of common stock upon exercise of stock
options | |
| - | | |
| - | | |
| 4,200 | | |
| - | | |
| 2 | | |
| - | | |
| - | | |
| 2 | |
Stock-based compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 257 | | |
| - | | |
| - | | |
| 257 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,327 | ) | |
| (2,327 | ) |
Balance — June 30, 2023 | |
| - | | |
| - | | |
| 10,693,080 | | |
| 1 | | |
| 37,944 | | |
| - | | |
| (36,757 | ) | |
| 1,188 | |
Stock-based compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 239 | | |
| - | | |
| - | | |
| 239 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,421 | ) | |
| (1,421 | ) |
Balance —
September 30, 2023 | |
| - | | |
$ | - | | |
| 10,693,080 | | |
$ | 1 | | |
$ | 38,183 | | |
$ | - | | |
$ | (38,178 | ) | |
$ | 6 | |
The
accompanying notes are an integral part of these condensed interim financial statements.
RenovoRx,
Inc.
Condensed
Statements of Convertible Preferred Stock and Stockholders’ Equity
(Unaudited)
(in
thousands, except share amounts)
| |
Convertible
Preferred Stock | | |
Common
Stock | | |
Additional Paid-In | | |
Accumulated
Other Comprehensive | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Loss | | |
Deficit | | |
Equity | |
Balance — December 31,
2021 | |
| - | | |
$ | - | | |
| 8,933,989 | | |
$ | 1 | | |
$ | 36,632 | | |
$ | - | | |
$ | (21,284 | ) | |
$ | 15,349 | |
Issuance of common stock upon exercise of stock
options | |
| - | | |
| - | | |
| 91,816 | | |
| - | | |
| 26 | | |
| - | | |
| - | | |
| 26 | |
Issuance of restricted stock awards | |
| - | | |
| - | | |
| 3,500 | | |
| — | | |
| 14 | | |
| - | | |
| - | | |
| 14 | |
Stock-based compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 154 | | |
| - | | |
| - | | |
| 154 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,003 | ) | |
| (3,003 | ) |
Balance — March 31, 2022 | |
| - | | |
| - | | |
| 9,029,305 | | |
| 1 | | |
| 36,826 | | |
| - | | |
| (24,287 | ) | |
| 12,540 | |
Issuance of common stock upon exercise of stock
options | |
| - | | |
| - | | |
| 37,558 | | |
| - | | |
| 9 | | |
| - | | |
| - | | |
| 9 | |
Stock-based compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 169 | | |
| - | | |
| - | | |
| 169 | |
Other comprehensive loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4 | ) | |
| - | | |
| (4 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,594 | ) | |
| (2,594 | ) |
Balance — June 30, 2022 | |
| - | | |
| - | | |
| 9,066,863 | | |
| 1 | | |
| 37,004 | | |
| (4 | ) | |
| (26,881 | ) | |
| 10,120 | |
Balance, value | |
| - | | |
$ | - | | |
| 9,066,863 | | |
$ | 1 | | |
$ | 37,004 | | |
$ | (4 | ) | |
$ | (26,881 | ) | |
$ | 10,120 | |
Issuance of common stock upon exercise of stock
options | |
| - | | |
| - | | |
| 5,400 | | |
| - | | |
| 4 | | |
| - | | |
| - | | |
| 4 | |
Stock-based compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 143 | | |
| - | | |
| - | | |
| 143 | |
Other comprehensive loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 17 | | |
| - | | |
| 17 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,136 | ) | |
| (2,136 | ) |
Balance —
September 30, 2022 | |
| - | | |
$ | - | | |
| 9,072,263 | | |
$ | 1 | | |
$ | 37,151 | | |
$ | 13 | | |
$ | (29,017 | ) | |
$ | 8,148 | |
Balance, value | |
| - | | |
$ | - | | |
| 9,072,263 | | |
$ | 1 | | |
$ | 37,151 | | |
$ | 13 | | |
$ | (29,017 | ) | |
$ | 8,148 | |
The
accompanying notes are an integral part of these condensed interim financial statements.
RenovoRx,
Inc.
Condensed
Statements of Cash Flows
(Unaudited)
(in
thousands)
| |
2023 | | |
2022 | |
| |
Nine
Months Ended September 30, | |
| |
2023 | | |
2022 | |
Operating activities: | |
| | | |
| | |
Net loss | |
$ | (7,005 | ) | |
$ | (7,733 | ) |
Adjustments to reconcile net loss to net cash
used in operating activities: | |
| | | |
| | |
Stock-based compensation
expense | |
| 857 | | |
| 480 | |
Amortization on leasehold
improvement | |
| - | | |
| 6 | |
Unrealized gain on change
in fair value of common warrants classified as a liability | |
| (3,485 | ) | |
| - | |
Loss on financing common
stock and common warrants | |
| 393 | | |
| - | |
Changes in operating assets
and liabilities: | |
| | | |
| | |
Prepaid expenses and other
current assets | |
| 573 | | |
| (47 | ) |
Deferred offering costs | |
| (41 | ) | |
| - | |
Accounts payable | |
| (184 | ) | |
| 13 | |
Accrued
expenses | |
| 687 | | |
| 151 | |
Net cash used in operating
activities | |
| (8,205 | ) | |
| (7,130 | ) |
| |
| | | |
| | |
Investing activities: | |
| | | |
| | |
Proceeds from maturities of marketable securities | |
| - | | |
| 2,992 | |
Proceeds from sale of
investments | |
| 2,032 | | |
| - | |
Net cash provided by
(used in) investing activities | |
| 2,032 | | |
| (5,008 | ) |
| |
| | | |
| | |
Financing activities: | |
| | | |
| | |
Proceeds from common stock and pre-funded common
warrants | |
| 5,000 | | |
| - | |
Proceeds from exercise
of stock options | |
| 8 | | |
| 39 | |
Net cash provided by
financing activities | |
| 5,008 | | |
| 39 | |
Decrease in cash and cash equivalents | |
| (1,165 | ) | |
| (12,099 | ) |
Cash and cash equivalents,
beginning of period | |
| 4,391 | | |
| 15,192 | |
Cash and cash equivalents, end of period | |
$ | 3,226 | | |
$ | 3,093 | |
| |
| | | |
| | |
Supplemental of non-cash
financing activities: | |
| | | |
| | |
Fair value of common
warrant classified as a liability | |
$ | 1,908 | | |
| - | |
The
accompanying notes are an integral part of these condensed interim financial statements.
RenovoRx,
Inc.
Notes
to the Unaudited Condensed Interim Financial Statements
1.
Business and Principal Activities
Description
of Business
RenovoRx,
Inc. (the “Company”) was incorporated in the state of Delaware in December 2012 and operates from its headquarters in
Los Altos, California. The Company is a clinical-stage biopharmaceutical company developing proprietary targeted combination
therapies for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. The
Company’s proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure precise therapeutic
delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus systemic (intravenous (IV)
therapy). The Company’s unique approach is under a clinical trial investigation for targeted treatment with the potential for increased safety, tolerance, and
improved efficacy. The Company’s Phase III lead product candidate, RenovoGem™, a novel oncology drug-device combination
product, is being investigated under a US Investigational New Drug (“IND”) that is regulated by Food and Drug
Administration Code of Federal Regulation (“FDA 21 CFR 312’) pathway. RenovoGem is currently being evaluated for the
treatment of locally advanced pancreatic cancer (“LAPC”) by the Center for Drug Evaluation and Research (the drug
division of the FDA).
Initial
Public Offering
On
August 25, 2021, the Company’s Registration Statement on Form S-1 (File No. 333-258071) relating to its initial public offering
(“IPO”) was declared effective and its shares of common stock began trading on the Nasdaq Capital Market on August 26, 2021.
In connection with the IPO, the Company issued and sold an aggregate of 1,850,000 units at a price of $9.00 per unit. Each unit consisted
of (a) one share of common stock and (b) one warrant to purchase one share of common stock at an exercise price equal to $10.80 per share,
which is exercisable for a period of five years after the issuance date. The underwriters exercised their over-allotment option to purchase
277,500 common stock warrants on August 30, 2021. In connection with the IPO, the underwriters were issued a five-year warrant, exercisable
on or after February 25, 2022, to purchase up to 198,875 shares of the Company’s common stock at an exercise price of $10.80.
The
Company received aggregate gross proceeds of $16.7 million from the IPO, paid underwriting discounts and commissions of $1.3 million
and incurred other expenses of $0.8 million, resulting in net offering proceeds of $14.6 million. Immediately prior to the closing of
the IPO, all shares of convertible preferred stock then outstanding were converted into 3,535,469 shares of common stock after giving
effect to the reverse stock split. In addition, all of the outstanding 2020 and 2021 Convertible Notes, representing principal and accrued
but unpaid interest of $5.3 million, converted at a 20% and 12.5% discount to the IPO price, respectively, into an aggregate of 708,820
units. Each unit consisted of (a) one share of common stock and (b) one five-year warrant to purchase one share of common stock at an
exercise price equal to $10.80 per share.
Reverse
Stock Split
On
August 5, 2021, the Company effected a 1-for-5 reverse stock split of its issued and outstanding preferred stock and common stock. The
number of authorized shares and the par values of the common stock and convertible preferred stock were not adjusted as a result of the
reverse stock split. Adjustments corresponding to the reverse stock split were made to the ratio at which the Company’s convertible
preferred stock converted into the Company’s common stock. Accordingly, all share and per share amounts related to the common stock,
stock options, warrants and restricted stock awards for all periods presented in the accompanying financial statements and notes thereto
have been retroactively adjusted.
Liquidity
and Capital Resources
Since
inception, and through September 30, 2023, the Company has raised estimated gross proceeds of $39.8 million through private
placements of convertible preferred stock, convertible debt securities, the issuance of securities in the IPO, and the exercise of
warrants and common stock options. As of September 30, 2023, the Company had cash and cash equivalents of $3.2 million.
The
Company has incurred significant losses and negative cash flows from operations since its inception. For the nine months ended September
30, 2023, the Company reported a net loss of $7.0 million and an accumulated deficit of $38.2 million. It does not anticipate generating
positive cash flows from operations in the foreseeable future. The Company expects to continue incurring significant losses until it
obtains regulatory approval for RenovoGem™, its first product candidate. However, regulatory approval is not guaranteed and may
never be obtained.
To
address its capital needs, the Company believes it will be able to raise additional capital through debt financings, private or public
equity financings, license agreements, collaborative agreements or other arrangements with other companies, or other financing sources.
Nevertheless, there is no assurance that such financing will be available or will be at terms acceptable to the Company. The inability
to raise capital as and when needed could negatively impact the Company’s liquidity, financial condition and its ability to pursue
its business strategy. The Company will need to generate significant revenue to achieve profitability, and it may never do so.
The
Company has filed an omnibus shelf registration statement on Form S-3 that provides for the aggregate offerings of up to $50.0 million
of the Company’s securities subject to various limitations, including limited sales in any twelve-month period while the Company
is subject to the “baby-shelf” rules. The Company has also filed a registration statement on Form S-1 to register the cash
exercise of the Company’s outstanding IPO, underwriter and private warrants. Cash exercise of the outstanding warrants is only
expected to occur when the trading price of the Company’s common stock is in excess of the $10.80 per share exercise price of the
outstanding warrants.
On
March 30, 2023, the Company entered into a securities purchase agreement (“Securities Purchase Agreement”) with a certain
institutional investor (“Purchaser”). Pursuant to the Securities Purchase Agreement, the Company agreed to sell in a
registered direct offering (the “Registered Direct Offering”) 1,000,000 shares (“Shares”) of the Company’s
common stock, par value $0.0001 (“Common Stock”), and purchase contracts issued as pre-funded warrants (“Pre-Funded
Warrants”) to purchase up to 557,632 shares of Common Stock, which Pre-Funded Warrants were issued to the extent that the Purchaser
determined, in its sole discretion, that such Purchaser would beneficially own in excess of 4.99% (or at the Purchaser’s election,
9.99%). The Pre-Funded Warrants have an exercise price of $0.0001 per share and are immediately exercisable and can be exercised at
any time after their original issuance until such Pre-Funded Warrants are exercised in full. Each Share was sold at an offering
price of $3.21, and each Pre-Funded Warrant was sold at an offering price of $3.2099 (equal to the purchase price per Share minus
the exercise price of the Pre-Funded Warrant). Additionally, in a concurrent private placement (together with the Registered Direct Offering,
the “March 2023 Offering”), the Company issued to Purchaser unregistered warrants to purchase up to 1,947,040 shares
of its Common Stock (the “Common Warrants”). Each Common Warrant has an exercise price of $3.21 per share, is exercisable
at any time after their original issuance, and expires five and a half years from the original issuance date. The aggregate gross proceeds
from the March 2023 Offering were approximately $5 million before deducting placement fees and other offering expenses.
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern and has reviewed the
relevant conditions and events surrounding its ability to continue as a going concern including among others: historical losses, projected
future results, negative cash flows from operations, including cash requirements for the upcoming year, funding capacity, net working
capital, total stockholders’ equity and future access to capital. Based upon this review and the Company’s current financial
condition and operating plans as of September 30, 2023, the Company has concluded that substantial doubt exists as to the Company’s
ability to operate as a going concern.
2.
Summary of Significant Accounting Policies
Basis
of Presentation and Unaudited Condensed Interim Financial Information
The
accompanying unaudited condensed interim financial statements have been prepared in accordance with accounting principles generally accepted
in the United States of America (“GAAP”) and applicable rules and regulations of the Securities and Exchange Commission or
(“SEC”) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information
normally included in unaudited condensed interim financial statements prepared in accordance with GAAP have been condensed or omitted.
The unaudited condensed interim financial statements have been prepared on the same basis as the annual financial statements and, in
the opinion of management, reflect all adjustments, which include only normal, recurring adjustments that are necessary to present fairly
the Company’s results for the interim periods presented. The condensed balance sheet as of December 31, 2022, is derived from the
Company’s audited financial statements. The results of operations for the three and nine months ended September 30, 2023, are not
necessarily indicative of the results to be expected for the year ending December 31, 2023, or for any other future annual or interim
period. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards
Codification (“ASC”) and as amended by Accounting Standards Update (“ASU”) of the Financial Accounting Standards
Board (“FASB”).
The
accompanying unaudited condensed interim financial statements should be read in conjunction with the audited financial statements and
the related notes thereto for the year ended December 31, 2022, which are included in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2022, filed with the SEC on March 31, 2023.
Summary
of Significant Accounting Policies
There
have been no material changes to the significant accounting policies during the nine months ended September 30, 2023 from those previously
disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
In
April 2023, the Company completed a financing under its March 2023 Offering issuing common stock, pre-funded common warrants and common
warrants. The Company has applied the following accounting policies as it relates to such offering.
Pre-Funded
Common Warrants and Common Warrants
The
Company evaluated the Pre-Funded Common Warrants and Common Warrants issued in connection with the March 2023 registered direct financing
in accordance with ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity, and concluded that
the Pre-Funded Common Warrants qualify for equity classification, while a provision in the Common Warrants precluded it from being accounted
for as components of equity. As the Common Warrants met the definition of a derivative instrument, the Company recorded the Common Warrants
as a liability on the condensed balance sheets and measured at fair value at inception and at each reporting date in accordance with
ASC 820, Fair Value Measurement, with changes in fair value recognized in the Condensed Statements of Operations and Comprehensive
Loss in the period of change. As the initial fair value of the Common Warrants exceeded the total proceeds of the March 2023 Offering,
no value was recorded for the Common Stock and Pre-funded Common Warrants.
Direct
Offering Costs
Direct
offering costs consist principally of placement fees and other expenses, including other professional expenses incurred. The aggregate
direct offering costs incurred from the March 2023 Offering were approximately $575,000 and were allocated solely to the Common Warrants
and subsequently expensed in the accompanying Condensed Statements of Operations and Comprehensive Loss.
Emerging
Growth Company and Smaller Reporting Company Status
The
Company is an emerging growth company (“EGC”) as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS
Act”) and may take advantage of reduced reporting requirements that are otherwise applicable to public companies. Section 107 of
the JOBS Act exempts emerging growth companies from complying with new or revised financial accounting standards until private companies
are required to comply with those standards. The Company has elected to use the extended transition period for complying with new or
revised accounting standards.
The
Company is also a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act. If the Company is a smaller
reporting company at the time the Company cease to be an emerging growth company, the Company may continue to rely on exemptions from
certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company the Company
may choose to present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K and, like
emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
From
time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of
the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not
have a material impact on the Company’s financial position or results of operations upon adoption.
Recent
Accounting Pronouncement
Recently
Adopted Accounting Pronouncement
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326). The guidance represents a significant
change in the accounting for credit losses model by requiring immediate recognition of management’s estimates of current expected
credit losses (CECL). Under the prior model, losses were recognized only as they were incurred. The Company has determined that it has
met the criteria of a smaller reporting company (“SRC”) as of November 15, 2019. As such, ASU 2019-10, Financial Instruments
—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) —Effective Dates amended
the effective date for the Company to be for reporting periods beginning after December 15, 2022. The Company adopted ASU 2016-13 on
January 1, 2023 and the adoption had no significant impact to the Company’s financial statements.
Recently
Accounting Pronouncement Not Yet Adopted
In
August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) (ASU 2020-06): Accounting for Convertible Instruments and
Contracts in an Entity, which simplifies the accounting for certain financial instruments with characteristics of liabilities and
equity, including convertible instruments and contracts on an entity’s own equity. The updated guidance is effective on a prospective
basis for annual reporting periods beginning after December 15, 2023 and for interim periods within those periods. Early adoption is
permitted. The Company has not yet determined the impact that this new standard will have on its financial position and results of operations.
3.
Fair Value Measurements
As
of September 30, 2023, and December 31, 2022, the Company held $0.1 million and $4.3 million, respectively, in a money market account.
The
following tables summarize the Company’s financial assets and liabilities, measured at fair value on a recurring basis by level
within the fair value hierarchy, as of September 30, 2023, and December 31, 2022 (in thousands):
Schedule of Assets Measured at Fair Value on Recurring Basis
| |
Fair
Value Measurements at September 30, 2023 using: | |
Assets | |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Cash equivalents: | |
| | | |
| | | |
| | | |
| | |
Schwab U.S.
Treasury Money Fund – Ultra Shares | |
$ | 2,712 | | |
$ | - | | |
$ | - | | |
$ | 2,712 | |
Money
market funds | |
| 108 | | |
| - | | |
| - | | |
| 108 | |
| |
$ | 2,820 | | |
$ | - | | |
$ | - | | |
$ | 2,820 | |
Liabilities | |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Common
warrant liability | |
$ | - | | |
$ | - | | |
$ | 1,908 | | |
$ | 1,908 | |
| |
$ | - | | |
$ | - | | |
$ | 1,908 | | |
$ | 1,908 | |
| |
Fair
Value Measurements at December 31, 2022 using: | |
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Cash equivalents: | |
| | | |
| | | |
| | | |
| | |
Money market
funds | |
$ | 4,300 | | |
$ | - | | |
$ | - | | |
$ | 4,300 | |
Available-for-sale securities: | |
| | | |
| | | |
| | | |
| | |
U.S.
Treasury bills | |
| 2,049 | | |
| - | | |
| - | | |
| 2,049 | |
| |
$ | 6,349 | | |
$ | - | | |
$ | - | | |
$ | 6,349 | |
There
were no transfers between Level 1, Level 2 or Level 3 during the periods presented. The Company had no other financial assets or liabilities
that were required to be measured at fair value on a recurring basis.
Assumptions
Used in Determining Fair Value of Warrants
With
the Common Warrants, in the event of certain fundamental transactions involving the Company, the warrant holders may require the Company
to make a payment based on a Black-Scholes valuation, using specified inputs. Therefore, the Common Warrants were accounted for as liabilities.
The
Company recorded the fair value of the Common Warrants upon issuance using the Black-Scholes valuation model. It is also required to
revalue the Common Warrants at each reporting date, with any changes in fair value recorded on our statement of operations. The valuation
of the Common Warrants is considered under Level 3 of the fair value hierarchy and influenced by the fair value of the underlying Common
Stock of the Company.
A
summary of the Black Scholes pricing model assumptions used to record the fair value of the Common Warrants is as follows:
Schedule of Assumptions to Record Fair Value of Warrants
| |
September
30, 2023 |
|
Expected volatility | |
110% –
117 |
% |
Expected term (years) | |
1.01 – 5.01 |
|
Risk-free interest rate | |
4.60% – 5.46 |
% |
Dividend rate | |
– |
|
Changes
om Level 3 Liabilities Measured at Fair Value on a Recurring Basis
The
following table reflects the change in the Company’s Level 3 common warrant liability for the nine months ended September 30, 2023
(in thousands):
Schedule
of Level 3 Liabilities Measured at Fair Value on a Recurring Basis
| |
| | |
Fair value as of December 31, 2022 | |
$ | - | |
Common warrants issued in connection
with private placement | |
| 5,393 | |
Change in fair value | |
| (3,485 | ) |
Fair value as of September 30, 2023 | |
$ | 1,908 | |
4.
Short-Term Marketable Securities
There
were no short-term marketable securities as of September 30, 2023. The tables summarize the Company’s short-term marketable securities
as of December 31, 2022 (in thousands):
Schedule of Short-Term Marketable Securities
| |
Amortized Cost
Basis | | |
Gross Unrealized Gains | | |
Gross Unrealized Losses | | |
Fair
Value | |
U.S.
Treasury bills | |
$ | 2,032 | | |
$ | 17 | | |
$ | - | | |
$ | 2,049 | |
| |
$ | 2,032 | | |
$ | 17 | | |
$ | - | | |
$ | 2,049 | |
5.
Accrued Expenses
The
components of accrued expenses as of September 30, 2023, and December 31, 2022 are as follows (in thousands):
Schedule of Accrued Expenses
| |
September
30, 2023 | | |
December
31, 2022 | |
Clinical trial | |
$ | 519 | | |
$ | 88 | |
Employee benefits | |
| 525 | | |
| 475 | |
Other | |
| 211 | | |
| 5 | |
Total accrued expenses | |
$ | 1,255 | | |
$ | 568 | |
6.
Commitments and Contingencies
Legal
Proceedings
From
time to time, the Company may become involved in legal proceedings arising in the ordinary course of business.
The
Company was not subject to any material legal proceedings during the nine months ended September 30, 2023, and no material legal proceedings
are subsequently outstanding or pending.
Guarantees
and Indemnification
In
the ordinary course of business, the Company enters into agreements that may include indemnification provisions. As permitted under Delaware
law and in accordance with its bylaws, the Company indemnifies its officers and directors for certain events or occurrences while the
officer or director is or was serving in such capacity. The Company is also party to indemnification agreements with its officers and
directors. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future
payments that the Company could be required to make under these provisions is not determinable. The Company has never incurred material
costs to defend lawsuits or settle claims related to these indemnification provisions. The Company is not currently aware of any indemnification
claims. Accordingly, the Company has not recorded any liabilities for these indemnification rights and agreements as of September 30,
2023.
Operating
Leases
The
Company leases its headquarters in Los Altos, California under a month-to-month operating lease agreement. Rent
expenses were $18,000 for both the
three months ended September 30, 2023, and 2022. Rent expenses were $55,000 and
$54,000 for the nine months ended
September 30, 2023, and 2022, respectively.
7.
Equity Incentive Plan - Stock-Based Compensation Expense and Common Warrants
2021
Omnibus Equity Incentive Plan
On
July 19, 2021, the Company’s Board of Directors adopted the RenovoRx, Inc. 2021 Omnibus Equity Incentive Plan (the “2021
Plan”). The 2021 Plan, which became effective immediately prior to the closing of the IPO, initially reserved 2,185,832 shares
of common stock, which included 10,832 shares of common shares reserved but unissued under the Amended and Restated 2013 Equity Incentive
Plan (the “2013 Plan”). The Company’s 2013 Plan was terminated immediately prior to the closing of the IPO; however,
shares subject to awards granted under the 2013 Plan will continue to be governed by the 2013 Plan. In accordance with the terms of the
2021 Plan, on January 1, 2023, the number of shares reserved and available for issuance increased by 272,931 shares.
A
summary of the stock option activity for the nine months ended September 30, 2023 is as follows:
Summary of Stock Option Award Activity
| |
Number
of Stock Options | | |
Weighted-
Average Exercise Price | | |
Weighted-
Average Remaining Contractual Life | | |
Aggregate
Intrinsic Value | |
Outstanding
as of December 31, 2022 | |
| 1,399,252 | | |
$ | 2.40 | | |
| 7.79 | | |
$ | 928 | |
Granted | |
| 420,351 | | |
$ | 3.10 | | |
| - | | |
$ | - | |
Exercised | |
| (7,747 | ) | |
$ | 0.97 | | |
| - | | |
$ | - | |
Forfeited | |
| (51,255 | ) | |
$ | 3.12 | | |
| - | | |
$ | - | |
Expired | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
Outstanding
as of September 30, 2023 | |
| 1,760,601 | | |
$ | 2.55 | | |
| 7.59 | | |
$ | 346 | |
Exercisable
as of September 30, 2023 | |
| 985,350 | | |
$ | 2.13 | | |
| 6.42 | | |
$ | 346 | |
Vested
and expected to vest as of September 30, 2023 | |
| 1,760,601 | | |
$ | 2.55 | | |
| 7.59 | | |
$ | 346 | |
As
of September 30, 2023, there was $1.8 million of unrecognized stock-based compensation expense related to options granted but not yet
amortized, which will be recognized over a weighted-average period of approximately 2.95 years.
For
the nine months ended September 30, 2023, and 2022, the Company utilized the Black-Scholes option-pricing model for estimating the fair
value of the stock option granted. The Company estimated the fair value of each option grant on the grant date using the Black-Scholes
option pricing model with the following weighted-average assumptions:
Summary
of Weighted-Average Assumptions Used to Calculate Fair Value of Stock Options Granted
| |
| Nine
Months Ended September 30, | |
| |
| 2023 | | |
| 2022 | |
Expected volatility | |
| 99.49%
– 106.69 | % | |
| 101.54%
– 102.96 | % |
Expected term (years) | |
| 6.02
– 10.0 | | |
| 5.27
– 6.08 | |
Risk-free interest rate | |
| 3.40%
– 4.28 | % | |
| 1.93%
– 1.95 | % |
Dividend rate | |
| – | % | |
| – | % |
During
the three months ended September 30, 2023, and 2022, the Company recognized $239,000 and $143,000, respectively, in stock-based compensation
expense from stock option grants. During the nine months ended September 30, 2023, and 2022, the Company recognized $857,000 and $480,000,
respectively, in stock-based compensation expense from stock option grants. The compensation expense is allocated on a departmental basis,
based on the classification of the option holder. No income tax benefits have been recognized in the condensed statements of operations
and comprehensive loss for stock-based compensation arrangements.
The
following table summarizes the components of stock-based compensation expense recognized in the Company’s Condensed Statements
of Operations and Comprehensive Loss during the three and nine months ended September 30, 2023, and 2022 (in thousands):
Schedule of Stock Based Compensation Expense
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months
Ended | | |
Nine Months
Ended | |
| |
September
30, | | |
September
30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 46 | | |
$ | 27 | | |
$ | 155 | | |
$ | 109 | |
General and administrative | |
| 193 | | |
| 116 | | |
| 702 | | |
| 371 | |
Total stock-based compensation
expense | |
$ | 239 | | |
$ | 143 | | |
$ | 857 | | |
$ | 480 | |
Restricted
Stock
In
March 2023, the Board approved the issuance of 30,000 shares of restricted stock to an entity as consideration for a commercial contract,
vested immediately, in a private placement. The shares were issued outside the 2021 Plan and the Company recognized $117,000 of stock-based
compensation expense for the restricted stock.
Common
Warrants
In
August 2021, in connection with the IPO, the Company issued warrants to purchase 3,035,195 shares of the Company’s common stock.
Warrants to purchase 198,875 shares of the Company’s common stock expire on August 25, 2026 and warrants to purchase 2,588,120
shares of the Company’s common stock expire on August 31, 2026.
On
April 3, 2023, in connection with the March 2023 Offering, the Company issued 557,632 Pre-Funded Warrants and 1,947,040 Common Warrants
to purchase the Company’s Common Stock. The Pre-Funded Warrants were exercised in June 2023 and the Common Warrants expire on October
3, 2028.
The
following is a summary of the common stock warrant activity during the nine months ended September 30, 2023.
Schedule
of Common Stock Warrant Activity
| |
Shares
Issuable Upon Exercise of Outstanding Warrants | | |
Weighted-
Average Exercise Price | | |
Weighted-
Average Remaining Contractual Life | | |
Aggregate
Intrinsic Value (In thousands) | |
Outstanding
as of December 31, 2022 | |
| 2,786,995 | | |
$ | 10.80 | | |
| 3.67 | | |
$ | 30,100 | |
Issued | |
| 2,504,672 | | |
$ | 3.21 | | |
| 5.00 | | |
$ | - | |
Exercised | |
| (557,632 | ) | |
$ | 3.21 | | |
| - | | |
$ | - | |
Expired | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
Outstanding
as of September 30, 2023 | |
| 4,734,035 | | |
$ | 7.68 | | |
| 3.51 | | |
$ | 36,350 | |
8.
Income Taxes
The
Company had no income tax expense for the three and nine months ended September 30, 2023, and 2022. During the three and nine months
ended September 30, 2023, and 2022, the Company had a net operating loss (“NOL”) for each period that generated deferred
tax assets for NOL carryforwards. Deferred income tax assets and liabilities are recognized for temporary differences between the financial
statements and income tax carrying values using tax rates in effect for the years such differences are expected to reverse. Due to uncertainties
surrounding our ability to generate future taxable income and consequently realize such deferred income tax assets, the Company has determined
that it is more likely than not that these deferred tax assets will not be realized. Accordingly, the Company has established a full
valuation allowance against its deferred tax assets as of September 30, 2023.
The
Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense.
For the three and nine months ended September 30, 2023, and 2022, the Company had no accrued interest or penalties related to uncertain
tax positions.
9.
Net Loss Per Share
Basic
and diluted net loss per common share was calculated as follows (in thousands except per share amounts):
Schedule of Computation of Basic and Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months
Ended | | |
Nine Months
Ended | |
| |
September
30, | | |
September
30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (1,421 | ) | |
$ | (2,136 | ) | |
$ | (7,005 | ) | |
$ | (7,733 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted average shares
used in computing net loss per share – basic and diluted | |
| 10,693,080 | | |
| 9,067,509 | | |
| 10,154,914 | | |
| 9,039,308 | |
Net loss per share –
basic and diluted | |
$ | (0.13 | ) | |
$ | (0.24 | ) | |
$ | (0.69 | ) | |
$ | (0.86 | ) |
For
the three and nine months ended September 30, 2023, and 2022, the Company had a net loss and as such, all outstanding shares of potentially
dilutive securities were excluded from the calculation of diluted net loss per share as the inclusion would be anti-dilutive.
Potentially
dilutive securities not included in the computation of diluted net loss per share because to do so would be antidilutive are as follows
(in common stock equivalent shares):
Schedule of Potentially Anti Dilutive Securities
| |
2023 | | |
2022 | |
| |
As
of September 30, | |
| |
2023 | | |
2022 | |
Options
to purchase common stock | |
| 453,346 | | |
| 484,518 | |
Total | |
| 453,346 | | |
| 484,518 | |
10.
Related Party Transactions
In
January 2018, the Company entered into a consulting agreement with one of the Company’s co-founders, Dr. Ramtin Agah, pursuant
to which Dr. Agah provides consulting services as the Company’s Chief Medical Officer by overseeing Company-sponsored clinical
trials. The agreement, which was amended on September 1, 2019, and November 11, 2021, respectively, continues in force for as long as
Dr. Agah is providing consulting services and may be terminated by either party on 30 days’ notice. In connection with his services,
Dr. Agah was awarded various equity awards as the Company has previously disclosed. In December 2018, Dr. Agah’s agreement was
amended to provide that he would receive cash compensation of $4,000 per month for certain proctoring services, and in September 2019,
his compensation was increased to $10,000 per month to compensate for additional services he was providing. In November 2021, we entered
into a third amendment to the Consulting Agreement with Dr. Agah which provides for a monthly consulting fee of $21,667.67, based on
Dr. Agah spending no less than 24 hours per week on Company matters. Dr. Agah’s monthly consulting fee was increased to $25,000,
effective January 1, 2023. The Company may, in its discretion, proportionally adjust the monthly consulting fee if Dr. Agah’s time
commitment decreases. The amendment also provides for Dr. Agah’s eligibility for an annual target cash incentive bonus equal to
35% of his annualized base consulting fee. In November 2021, we entered into a Change in Control and Severance Agreement with Dr. Agah.
For the three months ending September 30, 2023, and 2022, consulting fees paid to Dr. Agah were $76,000 and $72,000, respectively. For
the nine months ending September 30, 2023, and 2022, consulting fees paid to Dr. Agah were $319,000 and $217,000, respectively. In addition,
the Board approved a discretionary bonus of $91,000, paid in February 2023, to Dr. Agah in recognition of the Company’s and individual
performance during the year ended December 31, 2022.
Item
2: Management’s Discussion and Analysis of Financial Condition and Results of Operations
Unless
the context otherwise requires, all references in this section to the “Company,” “we,” “us,” or “our”
refer to RenovoRx, Inc. You should read the following discussion and analysis of our financial condition and results of operations in
conjunction with our unaudited interim condensed financial statements and related notes included elsewhere in this Quarterly Report on
Form 10-Q, our management’s discussion and analysis of financial condition and results of operations for the year ended December
31, 2022, included in our Annual Report on Form 10-K that was filed with the SEC on March 31, 2023 (the “Annual Report”),
and our final prospectus, dated August 25, 2021, filed with the SEC pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended
(the “Securities Act”).
This
discussion contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities
Exchange Act of 1934, as amended, that reflect our plans, estimates, and beliefs that involve risks and uncertainties, including those
described in the section titled “Forward Looking Statements.” Our actual results and the timing of selected events could
differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited
to, those identified below and those set forth under the section titled “Risk Factors” included elsewhere in this Quarterly
Report and in the Annual Report.
Overview
We are a clinical-stage biopharmaceutical company developing proprietary targeted combination therapies for high unmet medical need
with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. Our proprietary TAMP therapy platform is
designed to ensure precise therapeutic delivery to directly target the tumor while potentially minimizing a therapy’s
toxicities versus systemic (intravenous (IV) therapy). Our unique approach to targeted treatment is under a clinical trial
investigation with the potential for increased safety, tolerance, and improved efficacy. Our Phase III clinical lead product
candidate, RenovoGem, a novel oncology drug-device combination product, is being investigated under a US IND that is regulated by
FDA 21 CFR 312 pathway. RenovoGem is currently being evaluated for the treatment of LAPC by the Center for Drug Evaluation and
Research (the drug division of FDA.) RenovoGem is currently in a Phase III clinical trial (TIGeR-PaC) for the treatment of LAPC and
is not available for commercial sale. The first of two interim analyses was completed in March 2023, and the Data Monitoring
Committee recommended a continuation of the study. The study is prespecified to provide a primary endpoint of a 6-month overall
survival benefit and secondary endpoints including reduced adverse events versus standard of care. RenovoGem will also be evaluated
as a potential therapy in bile duct cancer, with a Phase III clinical trial expected to be launched in late 2023 with other
potential future pipeline indication opportunities including non-small cell lung cancer, uterine tumors, glioblastoma, and sarcoma.
RenovoGem received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market
exclusivity upon a New Drug Application (“NDA”) approval. Additionally, a recent collaboration began with Imugene
further validates TAMP and will expand use of RenovoRx’s delivery platform beyond chemotherapy to immunotherapy. We are
committed to developing transformative therapies for improved quality of life and extended life in cancer patients.
Pursuing the development of our therapy platform requires that we raise
additional capital, and we currently have enough capital to operate into February 2024. Failure to obtain additional capital on acceptable
terms, or at all, would result in a material and adverse impact on our operations. As a result, there is substantial doubt about our ability
to operate as a going concern.
Systemic
(IV gemcitabine and nab-paclitaxel) chemotherapy is currently the standard of care for pancreatic cancer treatment. However, the
standard of care is known to cause debilitating side effects for patients diagnosed with this disease. Unlike other tumors with
extensive blood supply, pancreatic tumors have poor blood supply so systemic chemotherapy may not reach the tumor. Thus, the
standard of care may be less effective in treating this type of cancer because the blood vessels are critical for transporting
systemic administration of chemotherapy to the tumor.
Our Phase III TIGeR-PaC clinical trial is an
ongoing randomized multi-center study using RenovoRx’s innovative therapy platform, TAMP, to evaluate RenovoRx’s first
product candidate, RenovoGem. The study is evaluating trans-arterial delivery, a form of intra-arterial administration, of an
FDA-approved chemotherapy, gemcitabine, to treat LAPC following stereotactic body radiation therapy (“SBRT”). The study
is comparing treatment of gemcitabine with TAMP versus systemic IV administration of gemcitabine and nab-paclitaxel. The study has a
primary endpoint of overall survival and several secondary endpoints, including quality of life for patients diagnosed with LAPC.
The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction systemic chemotherapy
and SBRT. Final analysis will be conducted after 86 protocol-specified events have occurred in the SBRT population with two interim
analyses. The first analysis at 30% of the specified events was completed in March 2023 and the second analysis will be performed at 60% of the specified events (deaths) is expected to occur in late-2024.
In
December 2021, we amended the protocol for the TIGeR-PaC Phase III clinical trial to only allow for SBRT during the induction phase of
the study (prior to randomization). We had previously permitted both SBRT and intensity-modulated radiation therapy (“IMRT”).
Patients receiving IMRT must complete 25 radiation treatments in combination with oral chemotherapy during the induction phase of the
study, which takes between 35 and 56 days to complete. In comparison, patients receiving SBRT during the induction phase are only required
to complete 5 treatments, over 5 consecutive days, and do not receive oral chemotherapy. The decision to modify the study population
was based on the observation in the Phase III TIGeR-PaC study that IMRT patients had a higher dropout rate during the induction phase
of the study due to the high frequency of hospital visits and side effects from the required concurrent chemotherapy. As part of the
pre-randomization, induction phase change made to the protocol, we initiated a review of the statistical considerations for the study
and in June 2022, submitted a modified Statistical Analysis Plan (the “Modified SAP”) to FDA. As part of the Modified SAP,
we now plan to (i) analyze only patients receiving SBRT, consistent with the protocol change made in December 2021, (ii) include a second
interim analysis, (iii) change the total number of SBRT patients randomized in the study to 114 (a reduction from the original 200 patients)
with a total of 86 deaths from SBRT patients, including all deaths from SBRT patients enrolled in the study before the submission of
the Modified SAP, and (iv) repower the study from 90% to 80%, which is commonly used in clinical trials. In August 2023, we received comments from the FDA on the Modified SAP,
which we responded to in September 2023. Based on the FDA’s feedback, we plan to submit the revised SAP and a protocol amendment
to reflect the changes in the statistical analysis for the study. We have not discussed the protocol amendment
or the Modified SAP with the FDA, and we cannot provide any assurance that the FDA will not raise any objections or disagree with our protocol amendments, including
our proposed SAP or how we interpret the data. The first planned
interim analysis was triggered when 30%, or 26 of 86, of the total number of deaths occurred (and announced in March 2023), and the second
interim analysis at 60%, or 52 of 86, of the total number of deaths have occurred and is estimated to be late-2024. Given that the timing
of the interim analysis is predicated on a specific number of deaths, it is difficult to predict the exact timing of the interim analysis
or when we will be able to complete the study. As of October 26, 2023, the Phase III TIGeR-PaC trial has randomized 59 SBRT patients
out of 114 total needed under the Modified SAP. At this rate, we anticipate that all patients will be enrolled and randomized in 2024,
with the final study readout in 2025.
We
are also planning to evaluate RenovoGem in a second indication in a Phase III trial in extrahepatic (or outside the liver) cholangiocarcinoma
(or eCCA), cancer that occurs in the bile ducts that lead out of the liver and join with the gallbladder. After significant input from
key opinion leaders across the spectrum of relevant medical specialties and feedback from the FDA, we submitted the protocol for a Phase
III eCCA clinical trial to FDA, and after receiving feedback, we are finalizing the protocol and also including incorporating a recently
approved drug, durvalumab into the study protocol with guidance from the Steering Committee. We have also secured FDA Orphan Drug Designation
for RenovoGem for the treatment of cholangiocarcinoma, which would provide us with seven years of orphan exclusivity to market RenovoGem
for our eCCA indication upon NDA approval, provided we are the first sponsor to obtain FDA approval for intra-arterial gemcitabine for
the eCCA indication.
We
intend to explore applications of our TAMP platform in additional indications, locally advanced lung cancer, locally advanced uterine
cancer, and glioblastoma. We have completed and presented data on a lung cancer application in preclinical studies, and additional preclinical
experiments in lung cancer may be conducted.
We
are using gemcitabine in our initial anti-cancer product candidate, RenovoGem. However, multiple small molecule therapeutics are compatible
with our TAMP platform. We intend to opportunistically develop additional anti-cancer product candidates using small molecule therapeutics
in combination with our therapy platform.
Since
our inception, we have devoted substantially all of our efforts to developing our cancer therapy platform and product candidates, raising
capital and organizing and staffing our Company. To date, we have financed our operations primarily through issuance of convertible preferred
stock with net proceeds of $11.8 million, convertible notes with net proceeds of $5.0 million, and a loan of $140,000 pursuant to the
Paycheck Protection Program (“PPP”) under the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”),
which was forgiven in February 2021. In August 2021, we completed our IPO with aggregate gross proceeds of $16.7 million. We paid underwriting
discounts and commissions of $1.3 million, and incurred expenses of $0.8 million in connection with the offering. As a result, the net
offering proceeds to us, after deducting underwriting discounts and commissions and offering expenses were $14.6 million.
We
have incurred significant operating losses and generated negative cash flows from operations since our inception. As of September 30,
2023, we had cash and cash equivalents of $3.2 million. For the three and nine months ended September 30, 2023, we reported net losses
of $1.4 million and $7.0 million, respectively. As of September 30, 2023, we had an accumulated deficit of $38.2 million. We expect to
continue to incur significant expenses, increasing operating losses and negative cash flows from operations in 2023 and for the foreseeable
future. We do not expect to generate revenues from product sales unless and until we successfully complete development and obtain regulatory
approval for one or more product candidates. We expect that our expenses will increase in connection with our ongoing research and development
activities.
In
addition to the variables described above, if and when any of our product candidates successfully complete development, we will incur
substantial additional costs associated with establishing a sales, marketing, medical affairs and distribution infrastructure to commercialize
products for which we may obtain marketing approval, regulatory filings, marketing approval, and post-marketing requirements, in addition
to other commercial costs. We cannot reasonably estimate these costs at this time.
Due
to our recurring operating losses and the expectation that we will continue to incur net losses in the future, we will be required to
raise additional capital to complete the development and commercialization of our product candidates. We have historically financed our
operations primarily through private sales of our equity, debt financing and the sale of common stock and warrants in our initial public
offering, or IPO. To raise additional capital, we may seek to sell additional equity and/or debt securities, obtain a credit facility
or other loan or enter into collaborations, licenses or other similar arrangements, which we may not be able to do on favorable terms,
or at all. For example, we have filed an omnibus shelf registration statement on Form S-3 that provides for aggregate offerings of up
to $50 million of the Company’s securities subject to various limitations, including limited sales in any twelve-month period while
we are subject to the “baby-shelf” rules. On April 3, 2023, we completed a registered direct offering under our shelf registration
statement on Form S-3 for the purchase and sale of 1,557,632 shares of common stock (or pre-funded common stock warrants) at a purchase
price of $3.21 per share of common stock (or pre-funded common stock warrants) to a certain institutional investor (the “Registered
Direct Offering”). Additionally, in a concurrent private placement, we issued to the investor unregistered warrants to purchase
up to 1,947,040 shares of common stock (together with the Registered Direct Offering, the “March 2023 Offering”). The aggregate
gross proceeds from the March 2023 Offering were approximately $5 million before deducting placement fees and other offering expenses.
We
also have filed a registration statement on Form S-1 to register the cash exercise of our outstanding warrants, with such cash exercise
only expected to occur when the trading price of our common stock is in excess of the $10.80 per share exercise price of our outstanding
warrants. Our ability to obtain additional financing will be subject to a number of factors, including market conditions, fluctuations
in interest rates, our operating performance and investor sentiment. If we are unable to raise additional capital when required or on
acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of our product
candidates, restrict or cease our operations or obtain funds by entering into agreements on unfavorable terms. Failure to obtain additional
capital on acceptable terms, or at all, would result in a material and adverse impact on our operations. As a result, there is substantial
doubt about our ability to operate as a going concern.
On August 21, 2023, we received a notice from Nasdaq
notifying us that, as of August 18, 2023, the Company was not in compliance with the minimum stockholders’ equity requirement for
continued listing on The Nasdaq Capital Market, under Listing Rule 5550(b)(1), because the Company’s stockholders’ equity
of $1,188,000 as reported in the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2023 was below the required
minimum of $2.5 million (the “Equity Requirement”), and because, as of June 30, 2023, the Company did not meet the alternative
compliance standards, relating to the market value of listed securities of $35 million or net income from continuing operations of $500,000
in the most recently completed fiscal year.
In accordance with the Nasdaq
Listing Rules 5810(c)(2)(C), we were provided 45 calendar days from August 21, 2023, or until October 5, 2023, to submit a plan to regain
compliance with the Equity Requirement (the “Compliance Plan”). We submitted the Compliance Plan to Nasdaq on October 5, 2023.
On October 31, 2023, the Company received formal notice that the Listing Qualifications Staff (the “Staff”) had granted the
Company’s request for continued listing on Nasdaq pursuant to an extension, ultimately through February 19, 2024, to evidence full
compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $2.5 million stockholders’
equity requirement set forth in Nasdaq Listing Rule 5550(b)(2).
The
Company is diligently working to provide timely evidence compliance with the terms of the Staff’s decision; however, there can
be no assurance that the Company will be able to do so. In the event the Company does not evidence full compliance with the Nasdaq
listing criteria by February 19, 2024, the Staff must issue a delist determination, which would be stayed upon the Company’s
timely request for a hearing before the Nasdaq Hearings Panel (the “Panel”). The Company’s request for a hearing
would stay any further action by the Staff at least pending a hearing, the subsequent issuance of a decision by the Panel, and the
expiration of any additional extension the Panel may grant to the Company as a result of the hearing.
Our
financial statements as of September 30, 2023 have been prepared on a going concern basis and do not include any adjustments that may
result from the outcome of this uncertainty. Based on our operating plans, we do not expect that our current cash and cash equivalents
as of September 30, 2023, will be sufficient to fund our operating, investing and financing cash flow needs, assuming our programs advance
as currently contemplated.
As
a result, we will require significant additional funding to support our continuing operations. Until such time, if ever, as we can generate
substantial product revenue, we expect to finance our cash needs through private or public equity financings, debt financings and collaborations,
licenses or other similar arrangements. We currently have no credit facility or committed sources of capital. To the extent that we raise
additional capital through the future sale of equity or debt, the ownership interests of our stockholders will be diluted, and the terms
of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders.
If we raise additional funds through the issuance of debt securities, these securities could contain covenants that would restrict our
operations. We may require additional capital beyond our currently anticipated amounts and additional capital may not be available on
reasonable terms, or at all. If we raise additional funds through collaboration arrangements or other strategic transactions in the future,
we may have to relinquish valuable rights to our technologies or future revenue streams or grant licenses on terms that may not be favorable
to us. If we are unable to raise additional funds through private or public equity financings or debt financings when needed, we may
be required to delay, limit, reduce development or future commercialization efforts, and we may be unable to continue as a going concern.
If we are unable to continue as a going concern, we might have to liquidate our assets and the value we receive for our assets in liquidation
or dissolution could be significantly lower than the values reflected in our financial statements, and our shareholders may lose their
entire investment in our common stock.
Impact
of COVID-19
The
ongoing COVID-19 global and national health emergency has caused significant disruption in the international and U.S. economies and financial
markets. The continued spread of COVID-19, and its variants, has caused illness, quarantines, cancellation of events and travel, business
and school shutdowns, reduction in business activity and financial transactions, labor shortages, supply chain interruptions and overall
economic and financial market instability.
In
response to public health directives and orders and to help minimize the risk of the virus to employees, we have taken precautionary
measures, including implementing hybrid work policies for certain employees. The ongoing COVID-19 global pandemic also has negatively
affected, and we expect will continue to negatively affect, our clinical studies. For example, we have faced challenges in conducting
our clinical trials, including recruiting subjects and accommodating patient visits. Additionally, our service providers and their operations
may be disrupted, temporarily closed or experience worker or supply shortages, which could result in additional disruptions or delays
in shipments of purchased materials or the continued development of our product candidates. To date, we have not suffered material supply
chain disruptions.
Although
the public health emergency declaration related to COVID-19 ended on May 11, 2023, the extent of COVID-19’s effect on our operational
and financial performance will depend in large part on future developments, which cannot be predicted and are out of our control. As
the COVID-19 global pandemic continues to evolve, it could result in significant long-term disruption of global financial markets, including
a period of a rising rate of inflation, reducing our ability to raise additional capital when needed and on acceptable terms, if at all,
which could negatively affect our liquidity. The extent to which the COVID-19 pandemic impacts our clinical development and regulatory
efforts will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the duration of
the continued outbreak, new travel restrictions, quarantines and social distancing requirements in the United States and other countries,
business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain
and treat the virus. We will continue to monitor the COVID-19 situation closely.
Components
of Our Results of Operations
Revenue
We
have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products for several years,
if at all. If our development efforts for our current or future product candidates are successful and result in marketing approval or
collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or
payments from collaboration or license agreements.
Operating
Expenses
Research
and Development
Research
and development expenses consist of costs related to the research and development of our platform technology. Clinical trial costs are
a significant component of research and development expenses and include costs associated with third-party contractors and consultants.
We outsource a substantial portion of our clinical trial activities, utilizing the service of third-party clinical trial sites and contract
research organizations to assist us with the execution of our clinical trials. In addition, we have FDA 510(k) clearance for the RenovoCath
delivery device, which comprises part of the RenovoGem product. Accordingly, we are able to charge our clinical trial sites for the RenovoCath
delivery device. To date, payments from clinical trial sites in consideration for RenovoCath delivery devices have been adequate to cover
our direct manufacturing costs. Any payments we receive from clinical trial sites as consideration for use of RenovoCath delivery devices
offset our research and development expenses. We expect our research and development expenses to increase for the foreseeable future
as we continue the development of our product candidates and enroll subjects in our ongoing Phase III clinical trial, initiate new clinical
trials and pursue regulatory approval of our product candidates. It is difficult to predict with any certainty the duration and costs
of completing our current or future clinical trials of our product candidates or if, when or to what extent we will achieve regulatory
approval and generate revenue from the commercialization and sale of our product candidates. The duration, costs and timing of clinical
trials and other development of our product candidates will depend on a variety of factors, including uncertainties in clinical trial
enrollment, timing and extent of future clinical trials, development of new product candidates and significant and changing government
regulation. We may never succeed in achieving regulatory approval for any of our product candidates.
Our
research and development expenses include:
|
● |
expenses
incurred under agreements with clinical trial sites, contract research organizations, and consultants that are involved in conducting
our clinical trials; |
|
|
|
|
● |
costs
of acquiring and developing clinical trial materials; |
|
|
|
|
● |
personnel
costs, including salaries, benefits, bonuses, and stock-based compensation for employees engaged in preclinical and clinical research
and development; |
|
|
|
|
● |
costs
related to compliance with regulatory requirements; |
|
|
|
|
● |
third-party
vendor costs related to manufacturing materials and testing; |
|
|
|
|
● |
costs
related to preclinical studies and pilot testing; |
|
|
|
|
● |
travel
expenses; and |
|
|
|
|
● |
allocated
general and administrative expenses which includes facilities and other indirect administrative expenses to support research and
development activities. |
Research
and development costs are expensed as incurred. Costs for certain development activities, such as clinical trials and preclinical studies,
are recognized based on evaluation of progress to completion of specific tasks using data such as subject enrollment, clinical site activations
or information provided to us by third party vendors.
General
and Administrative
General
and administrative expenses consist of salaries, benefits, and stock-based compensation for personnel in executive, finance and administrative
functions. They also include professional services costs related to accounting, tax, audit, legal, intellectual property, and other matters,
as well as consulting expenses, conferences, travel costs, and allocated expenses for rent, insurance, and general overhead. Operating
as a public company entails additional expenses, including compliance costs with the SEC rules and regulations, Nasdaq listing standards,
and increased expenditures in insurance, professional services, and investor relations. As a result, we anticipate a rise in general
and administrative expenses in the foreseeable future. General and administrative expenses are expensed as incurred.
Other
Income, Net
Interest
and Dividend Income
We
earn interest income from the cash deposited in our short-term marketable securities and money market accounts. We earn dividend income
from a money fund that invests exclusively in securities backed by the U.S. government.
Change
in Fair Value of Common Warrant Liability
The
gain or loss reported from the change in fair value of the common warrant liability.
Transaction
Costs Allocated to Common Warrant Liability
Direct
offering costs incurred in our March 2023 Offering and consists principally of agency placement fees and other expenses, including other
professional expenses.
Income
Tax Expense
We
account for income taxes using the asset and liability method. Under this method, deferred income tax assets and liabilities are recorded
based on the estimated future tax effects of differences between the financial statement and income tax basis of existing assets and
liabilities. Deferred income tax assets and liabilities are recorded net and classified as noncurrent on the balance sheets. A valuation
allowance is provided against our deferred income tax assets when their realization is more likely than not.
We
are subject to income taxes in the federal and state jurisdictions. Tax regulations within each jurisdiction are subject to the interpretation
of the related tax laws and regulations and require significant judgment to apply. In accordance with the authoritative guidance on accounting
for uncertainty in income taxes, we recognize tax liabilities for uncertain tax positions when it is more likely than not that a tax
position will not be sustained upon examination and settlement with various taxing authorities. Liabilities for uncertain tax positions
are measured based upon the largest amount of benefit that is more-likely-than-not (greater than 50%) of being realized upon settlement.
Our policy is to recognize interest and/or penalties related to income tax matters in income tax expense.
On
March 27, 2020, the CARES Act was enacted. The CARES Act includes several significant provisions for corporations, including the usage
of net operating losses, interest deductions and payroll benefits. Corporate taxpayers may carryback net operating losses, or NOLs, originating
during 2018 through 2020 for up to five years.
Results
of Operations
The
following table summarizes our results of operations for the periods indicated (in thousands):
| |
Three Months Ended
September 30, | | |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Statements of Operations
Data: | |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and
development | |
$ | 1,629 | | |
$ | 846 | | |
$ | 4,892 | | |
$ | 3,525 | |
General
and administrative | |
| 1,354 | | |
| 1,315 | | |
| 4,727 | | |
| 4,255 | |
Total
operating expenses | |
| 2,983 | | |
| 2,161 | | |
| 9,619 | | |
| 7,780 | |
Loss from operations | |
| (2,983 | ) | |
| (2,161 | ) | |
| (9,619 | ) | |
| (7,780 | ) |
Other income/(expense), net | |
| | | |
| | | |
| | | |
| | |
Interest and dividend income | |
| 43 | | |
| 22 | | |
| 97 | | |
| 43 | |
Other income, net | |
| - | | |
| 3 | | |
| - | | |
| 4 | |
Change in fair value of
common warrant liability | |
| 1,519 | | |
| - | | |
| 3,092 | | |
| - | |
Transaction
costs allocated to warrant liability | |
| - | | |
| - | | |
| (575 | ) | |
| - | |
Total
other income/(expense), net | |
| 1,562 | | |
| 25 | | |
| 2,614 | | |
| 47 | |
Net loss | |
$ | (1,421 | ) | |
$ | (2,136 | ) | |
$ | (7,005 | ) | |
$ | (7,733 | ) |
Comparison
of the Three Months Ended September 30, 2023, and 2022
The
following table summarizes the significant components of our results of operations for the periods presented (in thousands, except percentages):
| |
Three Months Ended
September 30, | | |
Increase
/ (Decrease) | |
| |
2023 | | |
2022 | | |
$ | | |
% | |
| |
(unaudited) | | |
| | |
| |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and
development | |
$ | 1,629 | | |
$ | 846 | | |
$ | 783 | | |
| 93 | % |
General
and administrative | |
| 1,354 | | |
| 1,315 | | |
| 39 | | |
| 3 | % |
Total
operating expenses | |
| 2,983 | | |
| 2,161 | | |
| 822 | | |
| 38 | % |
Loss from operations | |
| (2,983 | ) | |
| (2,161 | ) | |
| (822 | ) | |
| (38 | )% |
Other income/(expense), net | |
| | | |
| | | |
| | | |
| | |
Interest and dividend income | |
| 43 | | |
| 22 | | |
| 21 | | |
| 95 | % |
Other income (expense),
net | |
| - | | |
| 3 | | |
| (3 | ) | |
| (100 | )% |
Change in fair value of
common warrant liability | |
| 1519 | | |
| - | | |
| 1,519 | | |
| n/a | |
Transaction
costs allocated to warrant liabilities | |
| - | | |
| - | | |
| - | | |
| n/a | |
Total
other income/(expense), net | |
| 1,562 | | |
| 25 | | |
| 1,537 | | |
| 6,148 | % |
Net loss | |
$ | (1,421 | ) | |
$ | (2,136 | ) | |
$ | 715 | | |
| 33 | % |
Research
and Development
Research
and development expenses were $1.6 million for the three months ended September 30, 2023, an increase of $0.8 million compared to
$0.8 million in the same period last year. This increase was primarily due to our ongoing Phase III clinical trial cost of $0.4
million, an increase in employee and related benefits costs of $0.3 million, partially offset by a decrease in costs associated with
a secondary manufacturer of $0.1 million. We expect the secondary manufacturer device company to commence production later this
year. Allocated general and administrative support costs for personnel, facility and office supply expenses increased by $0.2
million compared to the same period last year. We anticipate research and development expenses to increase as we continue advancing
our lead programs throughout the year.
General
and Administrative
General
and administrative expenses were $1.3 million for the three months ended September 30, 2023, remaining flat compared to the same
period last year. Higher employee and related benefits costs due to increased headcount of $0.3 million were partially offset by
$0.1 million decrease in directors’ and officers’ liability insurance expense including allocated general and
administrative costs of $0.2 million compared to the same period last year. We anticipate general and administrative expenses to
continue increasing throughout the year as we progress with our lead program.
Other
Income/(Expense), Net
Other
income/(expense), net was $1.6 million for the three months ended September 30, 2023, compared to nil in the same prior period. The
increase was primarily due to a $1.5 million change in the fair value of the common warrant liability due to a decrease in our
common stock price during the period.
Comparison
of the Nine Months Ended September 30, 2023, and 2022
The
following table summarizes the significant components of our results of operations for the periods presented (in thousands, except percentages):
| |
Nine Months Ended
September 30, | | |
Increase
/ (Decrease) | |
| |
2023 | | |
2022 | | |
$ | | |
% | |
| |
(unaudited) | | |
| | |
| |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and
development | |
$ | 4,892 | | |
$ | 3,525 | | |
$ | 1,367 | | |
| 39 | % |
General
and administrative | |
| 4,727 | | |
| 4,255 | | |
| 472 | | |
| 11 | % |
Total
operating expenses | |
| 9,619 | | |
| 7,780 | | |
| 1,839 | | |
| 24 | % |
Loss from operations | |
| (9,619 | ) | |
| (7,780 | ) | |
| (1,839 | ) | |
| (24 | )% |
Other income/(expense), net | |
| | | |
| | | |
| | | |
| | |
Interest income and dividend
income | |
| 97 | | |
| 43 | | |
| 54 | | |
| 126 | % |
Other income, net | |
| - | | |
| 4 | | |
| (4 | ) | |
| (100 | )% |
Change in fair value of
common warrant liability | |
| 3,092 | | |
| - | | |
| 3,092 | | |
| n/a | |
Transaction
costs allocated to warrant liabilities | |
| (575 | ) | |
| - | | |
| (575 | ) | |
| n/a | |
Total
other/(expense), net | |
| 2,614 | | |
| 47 | | |
| 2,567 | | |
| 5,462 | % |
Net
loss | |
$ | (7,005 | ) | |
$ | (7,733 | ) | |
$ | 728 | | |
| 9 | % |
Research
and Development
Research
and development expenses totaled $4.9 million for the nine months ended September 30, 2023, an increase of $1.4 million, compared to
$3.5 million for the prior year period. This increase is due to our ongoing Phase III clinical trial cost of $0.8 million, an increase
of employee and related benefits costs of $0.4 million, partially offset by a decrease in costs associated
with a secondary manufacturer of $0.4 million. We expect the secondary manufacturer device company to commence production later this
year. Allocated general and administrative support costs for personnel, facility and office supply expenses increased by $0.5 million
compared to the same period last year. We anticipate research and development expenses to increase as we continue advancing our lead programs throughout
the year.
General
and Administrative
General
and administrative expenses were $4.7 million for the nine months ended September 30, 2023, an increase of $0.5 million compared to $4.2
million for the prior year period. The increase was due to an increase in employee and related benefits costs of $0.7 million, an increase
in stock-based compensation expense of $0.3 million and an increase in professional and consulting fees of $0.2 million compared to the
same period last year. This increase was offset by a decrease in directors’ and officers’ liability insurance expense of
$0.2 million and a decrease of $0.5 million in the allocation of general administrative expenses to research and development. It is
anticipated that general and administrative expenses will continue to increase during the fiscal year.
Other
Income/(Expense), Net
Other
income/(expense), net was $2.6 million for the nine months ended September 30, 2023, compared to nil in the same prior period. The
increase was primarily due to a $3.1 million change in the fair value of the common warrant liability due to a decrease in our
common stock price during the period. This increase was offset by $0.6 million of transaction costs allocated to common warrant
liability.
Liquidity
and Capital Resources
For
the nine months ended September 30, 2023, we incurred a net loss of $7.0 million. As of September 30, 2023, our accumulated deficit stood
at $38.2 million. We anticipate incurring further losses and increasing operating expenses in future periods. Since our inception, our
primary sources of liquidity have been the sale and issuance of convertible preferred stock, convertible notes, and common stock, including
our IPO and the March 2023 Offering, as well as from the exercise of warrants.
As
of September 30, 2023 and December 31, 2022, we had $3.2 million and $6.4 million in cash and cash equivalents and short-term marketable
securities, respectively. During the nine months ended September 30, 2023, we used $8.2 million of cash in operations. Our primary requirements
for liquidity have been to fund our clinical trial activities and general corporate and working capital needs. In August 2021, we successfully
completed our IPO, receiving aggregate gross proceeds of $16.7 million. We paid underwriting discounts and commissions of $1.3 million,
and we also incurred expenses of $0.8 million in connection with the offering. After deducting underwriting discounts, commissions and
offering expenses, the net proceeds to us amounted to $14.6 million. Furthermore, in February 2021, we received notification from Silicon
Valley Bank confirming the complete forgiveness and cancellation of our PPP loan of $140,000 by the U.S. Small Business Administration.
We
filed an omnibus shelf registration statement on Form S-3 that provides for the aggregate offerings of up to $50 million of our securities
subject to various limitations, including limited sales in any twelve-month period while we are subject to the “baby-shelf”
rules. We have also filed a registration statement on Form S-1 to register the cash exercise of the Company’s outstanding IPO,
underwriter and private warrants. Cash exercise of the outstanding warrants is only expected to occur when the trading price of the Company’s
common stock is in excess of the $10.80 per share exercise price of the outstanding warrants.
On
April 3, 2023, we completed the Registered Direct Offering under our shelf registration statement on Form S-3 for the purchase and sale
of 1,557,632 shares of Common Stock (or Pre-funded Common Warrants) at a purchase price of $3.21 per share of Common Stock (or Pre-Funded
Common Warrants) to a certain institutional investor. Additionally, in a concurrent private placement, we issued to the investor Common
Warrants to purchase up to 1,947,040 shares of its Common Stock. The aggregate gross proceeds from the March 2023 Offering were $5.0
million, and the net offering proceeds were $4.4 million after deducting placement agent fees and placement agent’s expenses of
$0.4 million and other professional expenses of $0.2 million.
Based
on our operational plans, we do not expect our current cash and cash equivalents to be sufficient to fund our operating, investing and
financing cash flow needs for at least the next twelve months, assuming the progress of our programs as currently envisioned. Based upon
this review and the Company’s current financial condition, the Company has concluded that substantial doubt exists as to the Company’s
ability to continue as a going concern. We believe we will be able to raise additional capital through debt financing, private or public
equity financing, license agreements, collaborative agreements or other arrangements with other companies, or other sources of financing.
There can be no assurance that such financing will be available or will be at terms acceptable to us. If we are unable to raise capital
when needed or on attractive terms, we would be forced to delay, reduce or eliminate our clinical trials or other operations. If any
of these events occur, our ability to achieve our operational goals would be adversely affected. Our future capital requirements and
the adequacy of available funds will depend on many factors, including those described in the section titled “Risk Factors.”
Depending on the severity and direct impact of these factors on us, we may be unable to secure additional financing to meet our operating
requirements on commercially acceptable terms favorable to us, or at all.
Sources
of Liquidity
Since
our inception, we have not generated any revenue from product sales, and we have incurred significant operating losses and negative cash
flows from our operations. We do not have any products that have achieved regulatory marketing approval and we do not expect to generate
revenue from sales of any product candidates for several years, if ever.
We
have financed our operations primarily through the issuance and sale of convertible preferred stock and convertible debt, the public
offerings of our common stock, as well as from the exercise of warrants. Through the date of this report, we have raised estimated gross
proceeds of $39.8 million of gross proceeds from private placements of our equity and convertible debt securities, the issuance of securities
in our IPO and the exercise of warrants and common stock options. This amount also includes a loan under the PPP, which was forgiven
in February 2021. We have also raised aggregate net proceeds of $19 million from the initial public offering and the March 2023 Offering
of our common stock.
Cash
Flows
Our
primary uses of cash are to fund our operations including research and development and general and administrative expenses. We will continue
to incur operating losses in the future and expect that our research and development and general and administrative expenses will continue
to increase as we continue our research and development efforts with respect to clinical development of our product candidates, further
develop our therapy platform and ensure that we are complying with the requirements of being a public company. The cash used to fund
operating expenses is impacted by the timing of when we pay expenses, as reflected in the change in our outstanding accounts payable
and accrued expenses.
The
following table summarizes our cash flows for the period indicated (in thousands):
| |
Nine Months Ended
September 30, | |
| |
2023 | | |
2022 | |
Net
cash provided by (used in): | |
| | | |
| | |
Operating
activities | |
$ | (8,205 | ) | |
$ | (7,130 | ) |
Investing
activities | |
| 2,032 | | |
| (5,008 | ) |
Financing
activities | |
| 5,008 | | |
| 39 | |
Decrease
in cash and cash equivalents | |
$ | (1,165 | ) | |
$ | (12,099 | ) |
Net
Cash Used in Operating Activities
Cash
used in operating activities for the nine months ended September 30, 2023, reflected a net loss of $7.0 million and non-cash charges
of $2.2 million, offset by a net change in our operating assets and liabilities of $1.0 million.
Cash
used in operating activities for the nine months ended September 30, 2022, reflected a net loss of $7.7 million, offset by a net change
in our operating assets and liabilities of $0.1 million, and non-cash charges of $0.5 million.
Cash
Provided by (Used in) Investing Activities
Cash
provided by investing activities for the nine months ended September 30, 2023, consisted of $2.0 million from the sale of investments.
Cash
used in investing activities for the nine months ended September 30, 2022, consisted of $8.0 million from the purchase U.S. Treasury
bills, partially offset by $3.0 million from the maturities of marketable securities.
Cash
Provided by Financing Activities
Net
cash provided by financing activities for the nine months ended September 30, 2023 was $5.0 million, consisting primarily of proceeds
from common stock and pre-funded common warrants.
Net
cash provided by financing activities for the nine months ended September 30, 2022 consisted of proceeds from the exercise of stock options.
Contractual
Obligations and Other Commitments
There
have been no significant changes in our contractual obligations or other commitments as of September 30, 2023.
Critical
Accounting Policies and Significant Judgments and Estimates
The
accompanying management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited
condensed interim financial statements and the related disclosures, which have been prepared in accordance with accounting principles
generally accepted in the United States or GAAP. The preparation of these unaudited condensed interim financial statements requires us
to make estimates, assumptions and judgments that affect the reported amounts in our unaudited condensed interim financial statements
and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable
under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities
that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
To the extent that there are material differences between these estimates and actual results, our future financial statement presentation,
financial condition, results of operations and cash flows will be affected. Our critical accounting policies and estimates are detailed
in our Annual Report on Form 10-K for the year ended December 31, 2022.
There
have been no significant changes to our critical accounting policies or significant judgments and estimates for the nine months ended
September 30, 2023, from those previously disclosed in our Annual Report.
The Company closed its March 2023 Offering on April
3, 2023 by issuing common stock and warrants. The Company has applied the following accounting policies as it relates to the March 2023
offering:
Pre-Funded
Common Warrants and Common Warrants
We
evaluated the Pre-Funded Common Warrants and Common Warrants issued in connection with the March 2023 registered direct financing in
accordance with ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity, and concluded that the Pre-Funded
Common Warrants qualify for equity classification, while a provision in the Common Warrants precluded it from being accounted for as
components of equity. As the Common Warrants met the definition of a derivative instrument, we recorded the Common Warrants as a liability
on the condensed balance sheets and measured at fair value at inception and at each reporting date in accordance with ASC 820, Fair
Value Measurement, with changes in fair value recognized in the Condensed Statements of Operations and Comprehensive Loss in the
period of change. As the initial fair value of the Common Warrants exceeded the total proceeds of the March 2023 Offering, no value was
recorded for the Common Stock and Pre-funded Common Warrants.
Direct
Offering Costs
Direct
offering costs consist principally of placement fees and other expenses, including other professional expenses incurred. The aggregate
direct offering costs incurred from the March 2023 Offering were approximately $575,000 and were allocated solely to the Common Warrants
and subsequently expensed in the accompanying Condensed Statements of Operations and Comprehensive Loss.
Emerging
Growth Company and Smaller Reporting Company Status
We
are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act (“JOBS Act”). Under the
JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. We have elected
this exemption to delay adopting new or revised accounting standards. We will remain an emerging growth company until the earlier of
(1) December 31, 2026, (2) the last day of the fiscal year in which we have total annual gross revenues of at least $1.07 billion, (3)
the date on which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, or (4)
the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. An emerging
growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements
that are otherwise generally applicable to public companies. As an emerging growth company,
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we
may present only two years of audited financial statements, plus unaudited interim condensed financial statements for any interim
period, and related Management’s Discussion and Analysis of Financial Condition and Results of Operations; |
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we
may avail ourselves of the exemption from the requirement to obtain an attestation and report from our auditors on the assessment
of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act; |
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we
may provide reduced disclosure about our executive compensation arrangements; and |
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we
do not require stockholder non-binding advisory votes on executive compensation or golden parachute arrangements. |
We
have elected to take advantage of certain reduced disclosure obligations in this Quarterly Report on Form 10-Q and may elect to take
advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our stockholders
may be different than you might receive from other public reporting.
We
are also a “smaller reporting company,” meaning that the market value of our stock held by non-affiliates plus the proposed
aggregate amount of gross proceeds to us as a result of this offering is less than $700.0 million and our annual revenue is less than
$100.0 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (1) the market
value of our stock held by nonaffiliates is less than $250.0 million or (2) our annual revenue is less than $100.0 million during the
most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million. If we are a
smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure
requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present
only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, like emerging growth companies,
smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Recently
Issued and Adopted Accounting Pronouncements
There
were no new accounting pronouncements that were issued or became effective since the issuance of our Annual Report on Form 10-K for the
year ended December 31, 2022 that had, or are expected to have, a material impact on our unaudited condensed balance sheets, unaudited
condensed statement of operations or unaudited condensed statement of cash flows.
Off-Balance
Sheet Arrangements
During
the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements, as defined in the rules and regulations
of the SEC.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
The
disclosures in this section are not required because we qualify as a smaller reporting company under federal securities laws.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Under
the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial and Accounting
Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and
15d-15(e) under the Exchange Act) as of the end of the fiscal quarter ended September 30, 2023. Based on this evaluation, our Chief Executive
Officer and Chief Financial and Accounting Officer have concluded that, during the period covered by this Quarterly Report, our disclosure
controls and procedures were not effective due to our previously identified material weaknesses in internal control over financial reporting.
As a result, we have performed additional analysis as deemed necessary to ensure that our financial statements were prepared in accordance
with U.S. GAAP. Accordingly, notwithstanding the identified material weaknesses, management, including our Chief Executive Officer and
Chief Financial and Accounting Officer, believes the financial statements included in this Quarterly Report on Form 10-Q are fairly presented,
in all material respects, in accordance with U.S. GAAP.
We
maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in our Exchange
Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and
that such information is accumulated, communicated and discussed with our management, including our Chief Executive Officer and Chief
Financial Officer, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure.
Management recognizes that controls and procedures, no matter how well designed and operated, can only provide reasonable, not absolute,
assurance the desired control objectives will be met. In reaching a reasonable level of assurance, management has weighed the cost of
contemplated controls against their intended benefits. The design of any system of controls is based on management’s assumptions
about the likelihood of future events. We cannot assure you that our controls will achieve their stated goals under all possible conditions.
Changes in future conditions may render our controls inadequate or may cause our degree of compliance with them to deteriorate. Because
of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Previously
Identified Material Weakness and Plans to Remediate
In
preparation for our IPO, we identified a material weakness in our internal control over financial reporting related to our control environment.
Specifically, we have determined that we have not maintained adequate formal accounting policies, processes and controls related to complex
transactions as a result of a lack of finance and accounting staff with the appropriate GAAP technical expertise needed to identify,
evaluate and account for complex and non-routine transactions. We also determined that we have not maintained sufficient staffing or
written policies and procedures for accounting and financial reporting, which contributed to the lack of a formalized process or controls
for management’s timely review and approval of financial information. More specifically, we have determined that our financial
statement close process includes significant control gaps mainly driven by the small size of our accounting and finance staff and, as
a result, a significant lack of appropriate segregation of duties. A material weakness is a deficiency, or combination of significant
deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement
of our annual or interim financial statements will not be prevented or detected and corrected on a timely basis.
We
are in the process of implementing a number of measures to address the material weaknesses that has been identified including: (i) engaging
additional accounting and financial reporting personnel with U.S. GAAP, and SEC reporting experience, (ii) developing, communicating
and implementing an accounting policy manual for our accounting and financial reporting personnel for recurring transactions and period-end
closing processes, and (iii) establishing effective monitoring and oversight controls for non-recurring and complex transactions to ensure
the accuracy and completeness of our financial statements and related disclosures.
These
additional resources and procedures are designed to enable us to broaden the scope and quality of our internal review of underlying information
related to financial reporting and to formalize and enhance our internal control procedures. With the oversight of senior management
and our Audit Committee, we have begun taking steps and plan to take additional measures to remediate the underlying causes of the material
weaknesses.
We
intend to complete the implementation of our remediation plan during 2024. Although we believe that our remediation plan will improve
our internal control over financial reporting, additional time may be required to fully implement it and to make conclusions regarding
the effectiveness of our internal control over financial reporting. Our management will closely monitor and modify, as appropriate, the
remediation plan to eliminate the identified material weakness.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
during the quarter ended September 30, 2023 that materially affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
Limitations
on the Effectiveness of Controls
In
designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how
well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design
of disclosure controls and procedures must reflect the fact that there are resource constraints, and that management is required to apply
judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Part
II – OTHER INFORMATION
Item
1. Legal Proceedings
From
time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently a party
to any material legal proceedings. Regardless of the outcome, litigation can have an adverse impact on us due to defense and settlement
costs, diversion of management resources, negative publicity, reputational harm and other factors.
Item
1A. Risk Factors
An
investment in our securities involves a high degree of risk. You should carefully consider the risks described below, as well as the
other information in this Quarterly Report on Form 10-Q, including our unaudited interim condensed financial statements and the related
notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,”
and in our other public filings in evaluating our business. The occurrence of any of the events or developments described below could
harm our business, financial condition, results of operations, growth prospects or stock price. In such an event, the market price of
our common stock could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known
to us or that we currently deem immaterial may also impair our business operations and the market price of our common stock.
Risk
Factors Summary
Investing
in shares of our common stock involves a high degree of risk because our business is subject to numerous risks and uncertainties, including
those outside of our control, that could cause our actual results to be harmed. The principal factors and uncertainties that make investing
in shares of our common stock risky and impact our ability to execute on our business strategy include risks regarding the following,
among others:
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We
are a clinical stage biopharmaceutical company, have a limited operating history and have no drug/device combination products approved
for commercial sale, which makes it difficult to evaluate our current business and predict our future success and viability. |
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We
have incurred significant net losses in each period since inception, and we expect to continue to incur net losses for the foreseeable
future. |
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We
will need to raise substantial additional capital to develop and commercialize RenovoGem, and our failure to obtain funding when
needed may force us to delay, reduce or eliminate our product development programs or collaboration efforts. As a result, there is
substantial doubt about our ability to operate as a going concern and we estimate that our current capital resources will be sufficient
to fund our operating expenses and capital expenditure requirements through February 2024. |
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Our
product candidates’ commercial viability remains subject to current and future preclinical studies, clinical trials, regulatory
approvals, and the risks generally inherent in the development of a pharmaceutical product candidate. If we are unable to successfully
advance or develop our product candidates, our business will be materially harmed. |
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If
we do not achieve our projected development goals in the timeframes we announce and expect, our stock price may decline. |
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Our
product candidates may exhibit undesirable side effects when used alone or in combination with other approved pharmaceutical products
or investigational new drugs, which may delay or preclude further development or regulatory approval or limit their use if approved. |
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If
the results of preclinical studies or clinical trials for our product candidates are negative, we could be delayed or precluded from
the further development or commercialization of our product candidates, which could materially harm our business. |
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If
we are unable to satisfy regulatory requirements, we may not be able to commercialize our product candidates. |
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If
our product candidates are unable to compete effectively with marketed drugs targeting similar indications as our product candidates,
our commercial opportunity will be reduced or eliminated. |
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We
may delay or terminate the development of our product candidates at any time if we believe the perceived market or commercial opportunity
does not justify further investment, which could materially harm our business. |
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Our
future success depends on our ability to retain our key personnel and to attract, retain, and motivate qualified personnel, especially
in light of an acute workforce shortage and hyper-competitive compensation environment. |
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If
we are unable to protect our intellectual property effectively, we may be unable to prevent third parties from using our technologies,
which would impair our competitive advantage. |
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The
patents issued to us may not be broad enough to provide any meaningful protection, one or more of our competitors may develop more
effective technologies, designs, or methods without infringing our intellectual property rights and one or more of our competitors
may design around our proprietary technologies. |
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The
market price of our common stock may be volatile and fluctuate substantially, which could
result in substantial losses for our investors.
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If
we fail to regain compliance with the applicable Nasdaq continued listing requirement, our common stock may be delisted from Nasdaq. |
In
addition, we face other risks and uncertainties that may materially affect our business prospects, financial condition, and results of
operations. You should consider the risks discussed in “Risk Factors” and in our other public filings before investing in
our securities.
Risks
Related to Our Business, Financial Condition and Capital Requirements
We
are a clinical stage biopharmaceutical company, have a limited operating history and have no drug/device combination products approved
for commercial sale, which makes it difficult to evaluate our current business and predict our future success and viability.
We
are a clinical stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects.
While RenovoCath, a drug delivery medical device, has been separately cleared by the FDA for the isolation of blood flow and delivery
of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system, and for temporary vessel
occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion, we are focused on developing
and commercializing drug product candidates in combination with our delivery platform technology. We have no drug/device combination
products approved for commercial sale and have not generated any revenue from product sales. We are developing a novel therapy platform,
which is an unproven and highly uncertain undertaking and involves a substantial degree of risk. Our first product candidate, RenovoGem,
is a drug/device combination product consisting of intra-arterial gemcitabine and RenovoCath. The FDA has determined that RenovoGem will
be regulated as, and if approved we expect will be reimbursed as, a new oncology drug product. To date, we have not obtained marketing
approval for any drug/device combination product candidates, manufactured a commercial scale product or arranged for a third-party to
do so on our behalf, or conducted sales and marketing activities necessary for successful product commercialization. Our limited operating
history as a company makes any assessment of our future success and viability subject to significant uncertainty. As a result, it may
be more difficult for investors to accurately predict our likelihood of success and viability than it could be if we had a longer operating
history.
We
will encounter expenses, difficulties, complications, delays, and other known and unknown factors and risks frequently experienced by
clinical stage biopharmaceutical companies in rapidly evolving fields. We also may need to transition from a company with a research
and clinical development focus to a company capable of supporting commercial activities. We have not yet demonstrated an ability to successfully
overcome such risks and difficulties, or to make such a transition. If we do not adequately address these risks and difficulties or successfully
make such a transition, our business will suffer.
We
have incurred significant net losses in each period since inception, and we expect to continue to incur net losses for the foreseeable
future.
We
are a clinical stage company and have incurred significant losses since our formation. As of September 30, 2023, we have an accumulated
deficit of approximately $38.2 million. For the nine months ended September 30, 2023, we had a net loss of approximately $7.0 million.
For the fiscal years ended December 31, 2022, and 2021, we had net losses of approximately $9.9 million and $6.3 million, respectively.
To date, we have experienced negative cash flow from the development of our product candidate, RenovoGem, our platform technology, TAMP,
and our RenovoCath delivery system. We have not generated any revenue from operations, and we expect to incur substantial net losses
for the foreseeable future as we seek to further develop and commercialize RenovoGem and expand our pipeline of product candidates. Because
of the numerous risks and uncertainties associated with developing and commercializing RenovoGem, we are unable to predict the extent
of any future losses or when we will attain profitability, if ever. Investors in our common stock must carefully consider the substantial
challenges, risks and uncertainties inherent in the attempted development and commercialization of RenovoGem. We may never successfully
commercialize RenovoGem, and our business may not be successful.
Our
product candidates will require substantial additional development time and resources before we will be able to receive regulatory approvals,
if any, and, if approved, to begin generating revenue from product sales. As a result, we expect that will be several years, if ever,
before we receive approval to commercialize a product and generate revenue from product sales. Even if we succeed in receiving marketing
approval for and commercializing one or more of our product candidates, we expect that we will continue to incur substantial expenses
and increasing operating losses in the foreseeable future. The amount of our future net losses will depend, in part, on the level of
our future expenditure and revenue. Moreover, our net losses may fluctuate significantly from quarter to quarter and year to year, such
that a period-to-period comparison of our results of operations may not be a good indication of our future performance. If we are unable
to generate significant revenue from RenovoGem or attain profitability, we will not be able to sustain operations.
We
anticipate that our expenses will increase substantially if and as we:
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continue
our research and discovery activities; |
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continue
the development of our proprietary technology platform; |
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progress
our current and any future product candidates through preclinical and clinical development; |
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initiate
and conduct additional preclinical, clinical, or other studies for our product candidates; |
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work
with our contract manufacturing organizations to manufacture RenovoCath and our other product candidates for our clinical trials; |
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change
or add additional contract manufacturers or suppliers; |
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seek
regulatory approvals and marketing authorizations for our product candidates; |
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establish
sales, marketing, and distribution infrastructure to commercialize any products for which we obtain approval; |
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take
steps to seek protection of our intellectual property and defend our intellectual property against challenges from third parties; |
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obtain,
expand, maintain, protect, and enforce our intellectual property portfolio; |
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pursue
any licensing or collaboration opportunities; |
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attract,
hire, and retain key and qualified personnel including clinical, scientific, management, and administrative personnel; |
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provide
additional internal infrastructure to support our continued research and development operations and any planned commercialization
efforts in the future; |
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experience
any delays or encounter other issues related to our operations; |
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implement
operations, financial, and management information systems; |
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meet
the requirements and demands of being a public company; and |
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defend
against any product liability claims or other lawsuits related to our products. |
Our
prior operating losses and expected future net losses have had and will continue to have an adverse effect on our stockholders’
equity, working capital, and our ability to fund our development efforts and achieve and maintain profitability. In any particular period,
our operating results could be below the expectations of securities analysts or investors, or such analysts or investors could perceive
these results to be negative, which could have a substantial adverse effect on the price of our common stock.
We
will need to raise substantial additional capital to develop and commercialize RenovoGem, and our failure to obtain funding when needed
may force us to delay, reduce or eliminate our product development programs or collaboration efforts. If we do not obtain adequate and
timely funding, we may not be able to continue as a going concern.
As
of September 30, 2023, we had cash and cash equivalents of $3.2 million. Due to our recurring operating losses and the expectation that
we will continue to incur net losses in the future, we will be required to raise additional capital to complete the development and commercialization
of our product candidates. We have historically financed our operations primarily through private sales of our equity, debt financing
and the sale of common stock and warrants in our initial public offering, or IPO. To raise additional capital, we may seek to sell additional
equity and/or debt securities, obtain a credit facility or other loan or enter into collaborations, licenses or other similar arrangements,
which we may not be able to do on favorable terms, or at all. For example, we have filed an omnibus shelf registration statement on Form
S-3 that provides for aggregate offerings of up to $50 million of the Company’s securities subject to various limitations, including
limited sales in any twelve-month period while we are subject to the “baby-shelf” rules. On April 3, 2023, we completed the
Registered Direct Offering under our shelf registration statement on Form S-3 for the purchase and sale of 1,557,632 shares of the Company’s
common stock (or pre-funded common stock warrants) at a purchase price of $3.21 per share of common stock (or pre-funded common stock
warrants) to a certain institutional investor. Additionally, in a concurrent private placement, we issued to the investor unregistered
warrants to purchase up to 1,947,040 shares of our common stock. The aggregate gross proceeds from the March 2023 Offering were approximately
$5 million before deducting placement fees and other offering expenses. We also have filed a registration statement on Form S-1 to register
the cash exercise of our outstanding warrants, with such cash exercise only expected to occur when the trading price of our common stock
is in excess of the $10.80 per share exercise price of our outstanding warrants. Our ability to obtain additional financing will be subject
to a number of factors, including market conditions, fluctuations in interest rates, our operating performance and investor sentiment.
If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or
discontinue the development and/or commercialization of our product candidates, restrict or cease our operations or obtain funds by entering
into agreements on unfavorable terms. Failure to obtain additional capital on acceptable terms, or at all, would result in a material
and adverse impact on our operations. As a result, there is substantial doubt about our ability to operate as a going concern and we
estimate that our current capital resources will be sufficient to fund our operating expenses and capital expenditure requirements through
February 2024.
Our
financial statements as of September 30, 2023 have been prepared on a going concern basis and do not include any adjustments that may
result from the outcome of this uncertainty. If we fail to raise additional working capital, or do so on commercially unfavorable terms,
it would materially and adversely affect our business, prospects, financial condition and results of operations, and we may be unable
to continue as a going concern. As a result, there is substantial doubt about our ability to operate as a going concern. If we seek additional
financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going
concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms,
if at all. If we are unable to continue as a going concern, we might have to liquidate our assets and the value we receive for our assets
in liquidation or dissolution could be significantly lower than the values reflected in our financial statements, and our shareholders
may lose their entire investment in our ordinary shares.
Risks
Related to the Discovery, Development, and Commercialization of Our Product Candidates
Our
product candidates’ commercial viability remains subject to current and future preclinical studies, clinical trials, regulatory
approvals, and the risks generally inherent in the development of a pharmaceutical product candidate. If we are unable to successfully
advance or develop our product candidate, our business will be materially harmed.
In
the near-term, failure to successfully advance the development of any of our product candidates may have a material adverse effect on
us. To date, we have not successfully developed or commercially marketed, distributed, or sold any product candidate. The success of
our business depends primarily upon our ability to successfully advance the development of our current and future product candidates
through preclinical studies and clinical trials, have the product candidates approved for sale by the FDA or regulatory authorities in
other countries, and ultimately have the product candidates successfully commercialized by us or a commercial partner. We cannot assure
you that the results of our ongoing preclinical studies or clinical trials will support or justify the continued development of our product
candidates, or that we will receive regulatory approval from the FDA, or similar regulatory authorities in other countries, to advance
the development of our product candidates.
Our
product candidates must satisfy rigorous regulatory standards of safety and efficacy before we can advance or complete their clinical
development, or before they can be approved for sale. To satisfy these standards, we must engage in expensive and lengthy preclinical
studies and clinical trials, develop acceptable manufacturing processes, and obtain regulatory approval. Despite these efforts, the FDA
could delay, limit or deny approval of a product candidate for many reasons, including because the FDA:
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not deem our product candidate to be safe and effective; |
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determines
that the product candidate does not have an acceptable benefit-risk profile; |
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may
not agree that the data collected from preclinical studies and clinical trials are acceptable or sufficient to support the submission
of an NDA or other submission or to obtain regulatory approval, and may impose requirements for additional preclinical studies or
clinical trials; |
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may
determine that adverse events experienced by participants in our clinical trials represent an unacceptable level of risk; |
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may
determine that population studied in the clinical trial may not be sufficiently broad or representative to assure safety in the full
population for which we seek approval; |
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may
disagree regarding the formulation, labeling and/or the specifications; |
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may
not approve the manufacturing processes associated with our product candidate or may determine that a manufacturing facility does
not have an acceptable compliance status; |
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may
conclude there are CMC issues that preclude approval of the NDA; |
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may
conclude that the drug substance or drug product manufacturing process is not in a state of control or does not meet cGMP or all
the regulatory requirements; |
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may
conclude that the medical device manufacturing process for the drug/device combination product candidate is not in a state of control
or does not meet all the regulatory requirements; |
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may
change approval policies or adopt new regulations; or |
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may
not file a submission due to, among other reasons, the content or formatting of the submission. |
If
we experience delays in obtaining approval or if we fail to obtain approval of RenovoGem, our commercial prospects will be harmed and
our ability to generate revenues will be materially impaired which would adversely affect our business, prospects, financial condition
and results of operations.
We
cannot assure you that the results of late-stage clinical trials will be favorable enough to support the continued development of our
product candidates. A number of companies in the pharmaceutical and biopharmaceutical industries have experienced significant delays,
setbacks and failures in all stages of development, including late-stage clinical trials, even after achieving promising results in preclinical
testing or early-stage clinical trials. Accordingly, results from completed preclinical studies and early-stage clinical trials of our
product candidates may not be predictive of the results we may obtain in later-stage trials. Furthermore, even if the data collected
from preclinical studies and clinical trials involving our product candidates demonstrate a favorable safety and efficacy profile, such
results may not be sufficient to support the submission of an NDA to obtain regulatory approval from the FDA in the U.S., or other similar
regulatory agencies in other jurisdictions, which is required to market and sell the product. Even if we are successful in obtaining
approval in one jurisdiction, we may not be successful in obtaining approval in any other jurisdictions. If we are unable to obtain approval
for our product candidates in multiple jurisdictions, our business, financial condition, results of operations and our growth prospects
could be negatively affected.
Our
product candidates will require significant additional research and development efforts, the commitment of substantial financial resources,
and regulatory approvals prior to advancing into further clinical development or being commercialized by us or collaborators. Additionally,
changes in regulations as part of a response to the COVID-19 pandemic, including the effects of recent variants, may require us to change
the ways in which our clinical trials are conducted, or to discontinue clinical trials altogether, or which may result in unexpected
costs. We cannot assure you that our product candidates will successfully progress through the drug development process or will result
in commercially viable products. We do not expect our product candidates to be commercialized by us or collaborators for at least several
years.
If
we do not achieve our projected development goals in the timeframes we announce and expect, our stock price may decline.
From
time to time, we estimate the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product
development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of scientific
studies and clinical trials and the submission of regulatory filings. From time to time, we may publicly announce the expected timing
of some of these milestones. All of these milestones are and will be based on numerous assumptions. The actual timing of these milestones
can vary dramatically compared to our estimates, in some cases for reasons beyond our control. If we do not meet these milestones as
publicly announced, our stock price may decline.
Our
product candidates may exhibit undesirable side effects when used alone or in combination with other approved pharmaceutical products
or investigational new drugs, which may delay or preclude further development or regulatory approval or limit their use if approved.
Throughout
the drug development process, we must continually demonstrate the efficacy, safety and tolerability of our product candidates to obtain
regulatory approval to further advance clinical development or to market them. Even if our product candidates demonstrate clinical efficacy,
any unacceptable, adverse side effects or toxicities, when administered alone or in the presence of other pharmaceutical products, which
can arise at any stage of development, may outweigh the potential benefits. In preclinical studies and clinical trials we have conducted
to date, each of our product candidate’s tolerability profile is based on studies and trials that have involved a small number
of subjects or patients over a limited period of time. We may observe adverse or significant adverse events or drug-drug interactions
in future preclinical studies or clinical trial candidates, which could result in the delay or termination of development, prevent regulatory
approval, or limit market acceptance if ultimately approved.
If
the results of preclinical studies or clinical trials for our product candidates, including those that are subject to existing or future
license or collaboration agreements, are unfavorable or delayed, we could be delayed or precluded from the further development or commercialization
of our product candidates, which could materially harm our business.
To
further advance the development of, and ultimately receive regulatory approval to sell, our product candidates, we must conduct extensive
preclinical studies and clinical trials to demonstrate their safety and efficacy to the satisfaction of the FDA or similar regulatory
authorities in other countries, as the case may be. Preclinical studies and clinical trials are expensive, complex, can take many years
to complete, and have highly uncertain outcomes. Delays, setbacks, or failures can occur at any time, or in any phase of preclinical
or clinical testing, and can result from concerns about safety or toxicity, a lack of demonstrated efficacy or superior efficacy over
other similar products that have been approved for sale or are in more advanced stages of development, poor study or trial design, and
issues related to the formulation or manufacturing process of the materials used to conduct the trials. The results of prior preclinical
studies or clinical trials are not necessarily predictive of the results we may observe in later stage clinical trials. In many cases,
product candidates in clinical development may fail to show desired safety, efficacy or tolerability characteristics despite having favorably
demonstrated such characteristics in preclinical studies or earlier stage clinical trials.
In
addition, we may experience numerous unforeseen events during, or as a result of, preclinical studies and the clinical trial process,
which could delay or impede our ability to advance the development of, receive regulatory approval for, or commercialize our product
candidate, including, but not limited to:
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communications
with the FDA, or similar regulatory authorities in different countries, regarding the scope or design of a trial or trials; |
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regulatory
authorities, including an Institutional Review Board (“IRB”) or Ethical Committee (“EC”), not authorizing
us to commence or conduct a clinical trial at a prospective trial site; |
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enrollment
in our clinical trials being delayed, or proceeding at a slower pace than we expected, because our clinical trial sites have staffing
shortages or are unable to recruit/retain qualified staff, or we have difficulty recruiting patients, including as a result of competing
clinical trials, or participants dropping out of our clinical trials at a higher rate than we anticipated; |
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our
third-party contractors, upon whom we rely for conducting preclinical studies, clinical trials and manufacturing of our trial materials,
may fail to comply with regulatory requirements, fail to meet their contractual obligations to us in a timely manner, or terminate
their relationship with us; |
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having
to suspend or ultimately terminate our clinical trials if participants are being exposed to unacceptable health or safety risks; |
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IRBs,
ECs, or regulators requiring that we hold, suspend or terminate our preclinical studies and clinical trials for various reasons,
including non-compliance with regulatory requirements or due to the effects of the COVID-19 pandemic, including the effects of recent
variants; and |
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the
supply or quality of drug material or the supply of our RenovoCath delivery system necessary to conduct our preclinical studies or
clinical trials being insufficient, inadequate or unavailable. |
Even
if the data collected from preclinical studies or clinical trials involving our product candidates demonstrate a favorable safety and
efficacy profile, such results may not be sufficient to support the submission of an NDA to obtain regulatory approval from the FDA in
the U.S., or other similar foreign regulatory authorities in foreign jurisdictions, which is required to market and sell the product.
We
may be required to perform additional or unanticipated clinical trials to obtain approval or be subject to additional post-marketing
testing requirements to maintain regulatory approval. In addition, regulatory authorities may withdraw their approval of a product or
impose restrictions on our distribution, such as in the form of a Risk Evaluation and Mitigation Strategy, or REMS. The failure to obtain
timely regulatory approval of product candidates, any product marketing limitations or a product withdrawal would materially and adversely
affect our business, results of operations and financial condition.
Interim,
preliminary or topline data from our clinical trials that we announce or publish from time to time may change as more patient data become
available and are subject to audit and verification procedures that could result in material changes in the final data.
From
time to time, we may publish interim, preliminary or topline data from clinical trials. Interim data from clinical trials that we may
complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and
more patient data becomes available. Preliminary or topline data also remain subject to audit and verification procedures that may result
in the final data being materially different from the preliminary or topline data previously published. As a result, interim, preliminary
and topline data should be viewed with caution until the final data are available. Adverse differences between interim, preliminary or
topline data and final data could significantly harm our reputation and business prospects. Moreover, preliminary, interim and topline
data are subject to the risk that one or more of the clinical outcomes may materially change as more patient data become available when
patients mature on study, patient enrollment continues or as other ongoing or future clinical trials with a product candidate further
develop. Past results of clinical trials may not be predictive of future results. In addition, the information we choose to publicly
disclose regarding a particular study or clinical trial is based on what is typically more extensive information, and you or others may
not agree with what we determine is the material or otherwise appropriate information to include in our disclosure. Any information we
determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise
regarding a particular product candidate or our business. Similarly, even if we are able to complete our planned and ongoing preclinical
studies and clinical trials of our product candidates according to our current development timeline, the positive results from such preclinical
studies and clinical trials of our product candidates may not be replicated in subsequent preclinical studies or clinical trial results.
If third party vendors upon whom we intend to
rely on to conduct our preclinical studies or clinical trials do not perform or fail to comply with strict regulations, these studies
or trials of our product candidate may be delayed, terminated, or fail, or we could incur significant additional expenses, which could
materially harm our business.
We
have limited resources dedicated to designing, conducting, and managing preclinical studies and clinical trials. We intend to rely on
third parties, including clinical research organizations, consultants, and principal investigators, to assist us in designing, managing,
monitoring and conducting our preclinical studies and clinical trials. We intend to rely on these vendors and individuals to perform
many facets of the drug development process, including certain preclinical studies, the recruitment of sites and patients for participation
in our clinical trials, maintenance of good relations with the clinical sites, and ensuring that these sites are conducting our trials
in compliance with the trial protocol, including safety monitoring and applicable regulations. If these third parties fail to perform
satisfactorily, do not adequately fulfill their obligations under the terms of our agreements with them, or terminate their relationship
with us, we may not be able to enter into alternative arrangements without undue delay or additional expenditures, and therefore the
preclinical studies and clinical trials of our product candidate may be delayed or prove unsuccessful. For example, the investigators
we currently use for our clinical trials are not our employees and we cannot control the amount or timing of resources that they devote
to our programs. If these investigators fail to devote sufficient time and resources to our clinical trial, fail to enroll patients as
rapidly as expected, or otherwise do not perform in a satisfactory manner, we may make elect to close such clinical trial site, which
may increase our expenses, require additional attention from our clinical team and delay our clinical trial timeline and regulatory approval.
Further, the FDA, or other similar foreign regulatory authorities, may inspect some of the clinical sites participating in our clinical
trials in the U.S., or our third-party vendors’ sites, to determine if our clinical trials are being conducted according to good
clinical practice, or GCP. If we or the FDA determine that our third-party vendors are not in compliance with, or have not conducted
our clinical trials according to, applicable regulations we may be forced to delay, repeat, or terminate such clinical trials. Additionally,
certain third parties with whom we engage or may engage for preclinical studies or clinical studies may have to adjust their operations
or limit their capacity in light of the effects of the COVID-19 pandemic, including the effects of recent variants.
We
have limited capacity for recruiting and managing clinical trials, which could impair our timing to initiate or complete clinical trials
of our product candidate and materially harm our business.
We
have limited capacity to recruit and manage the clinical trials necessary to obtain FDA approval or approval by other regulatory authorities.
By contrast, larger pharmaceutical and biopharmaceutical companies often have substantial staff with extensive experience in conducting
clinical trials with multiple product candidates across multiple indications. In addition, they may have greater financial resources
to compete for the same clinical investigators and patients that we are attempting to recruit for our clinical trials. If potential competitors
are successful in completing drug development for their product candidates and obtain approval from the FDA, they could limit the demand
to participate in clinical trials of our product candidates. As a result, we may be at a competitive disadvantage that could delay the
initiation, recruitment, timing, and completion of our clinical trials, as well as obtaining regulatory approvals, if at all, for our
product candidates.
We,
and our collaborators, if any, must comply with extensive government regulations in order to advance our product candidates through the
development process and ultimately obtain and maintain marketing approval for our products in the U.S. and abroad.
The
product candidates that we, or our collaborators, are developing or may develop require regulatory approval to advance through clinical
development and to ultimately be marketed and sold and are subject to extensive and rigorous domestic and foreign government regulation.
In the U.S., the FDA regulates, among other things, the development, testing, manufacture, safety, efficacy, record-keeping, labeling,
storage, approval, advertising, promotion, sale, and distribution of pharmaceutical and biopharmaceutical products. Our product candidates
are also subject to similar regulation by foreign governments to the extent we seek to develop or market them in those countries. We,
or our collaborators, must provide the FDA and foreign regulatory authorities, if applicable, with preclinical and clinical data, as
well as data supporting an acceptable manufacturing process, that appropriately demonstrate each of our product candidate’s safety
and efficacy before it can be approved for the targeted indications. Our product candidates have not been approved for sale in the U.S.
or any foreign market, and we cannot predict whether we or our collaborators will obtain regulatory approval for any product candidates
we are developing or plan to develop. The regulatory review and approval process can take many years, is dependent upon the type, complexity,
novelty of, and medical need for the product candidate, requires the expenditure of substantial resources, and involves post-marketing
surveillance and vigilance and potentially post-marketing studies or Phase IV clinical trials. In addition, we or our collaborators may
encounter delays in, or fail to gain, regulatory approval for any of our product candidates based upon additional governmental regulation
resulting from future legislative, administrative action or changes in the FDA’s or other similar foreign regulatory authorities’
policy or interpretation during the period of product development. Delays or failures in obtaining regulatory approval to advance any
of our product candidates through clinical development, and ultimately to commercialize them, may:
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impact our ability to raise sufficient capital, if at all, to fund the development of our product candidates; |
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adversely
affect our ability to further develop or commercialize our product candidates; |
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diminish
any competitive advantages that we or our collaborators may have or attain; or |
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adversely
affect the receipt of potential milestone payments and royalties from collaborators, if any, from the sale of our products or product
revenues in the future. |
Furthermore,
any regulatory approvals, if granted, may later be withdrawn. If we or our collaborators fail to comply with applicable regulatory requirements
at any time, or if post-approval safety concerns arise, we or our collaborators may be subject to restrictions or a number of actions,
including:
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delays,
suspension, or termination of clinical trials related to our product candidates; |
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refusal
by regulatory authorities to review pending applications or supplements to approved applications; |
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product
recalls or seizures; |
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suspension
of manufacturing; |
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withdrawals
of previously approved marketing applications; or |
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fines,
civil penalties, and criminal prosecutions. |
Additionally,
at any time we or our collaborators may voluntarily suspend or terminate the preclinical or clinical development of a product candidate
or withdraw any approved product from the market if we believe that it may pose an unacceptable safety risk to patients, or if the product
candidate or approved product no longer meets our business objectives. The ability to develop or market a pharmaceutical product outside
of the U.S. is contingent upon receiving appropriate authorization from the respective foreign regulatory authorities. Foreign regulatory
approval processes typically include many, if not all, of the risks and requirements associated with the FDA regulatory process for drug
development and may include additional risks. Additionally, results acceptable to support approval in one jurisdiction may be deemed
inadequate by another regulatory authority to support regulatory approval in that other jurisdiction.
Clinical
trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive
of future trial results.
Our
product candidates may not prove to be safe and efficacious in clinical trials and may not meet all the applicable regulatory requirements
needed to receive regulatory approval. To receive regulatory approval for the commercialization of our product candidates, we must conduct,
at our own expense, extensive preclinical testing and clinical trials to demonstrate safety and efficacy of our product candidate for
the intended indication of use. Clinical testing is expensive, can take many years to complete, if at all, and its outcome is uncertain.
Failure can occur at any time during the clinical trial process.
The
results of preclinical studies and early clinical trials of new drugs do not necessarily predict the results of later-stage clinical
trials. The design of our clinical trials is based on many assumptions about the expected effects of our product candidate, and if those
assumptions are incorrect, they may not produce statistically significant results. Preliminary results may not be confirmed on full analysis
of the detailed results of a clinical trial. Product candidates in later stages of clinical development may fail to show safety and efficacy
sufficient to support intended use claims despite having progressed through earlier clinical testing. The data collected from clinical
trials of our product candidates may not be sufficient to support the filing of an NDA or to obtain regulatory approval in the United
States or elsewhere. Because of the uncertainties associated with drug development and regulatory approvals, we cannot determine if or
when we will have an approved product for commercialization or achieve sales or profits.
Delays
in clinical testing could result in increased costs to us and delay our ability to generate revenue.
We
may experience delays in clinical testing of our product candidates. We do not know whether planned clinical trials will begin on
time, will need to be redesigned or will be completed on schedule, if at all, especially in light of the effects of the COVID-19
pandemic, including the effects of recent variants. From time to time, based on our experience with a clinical trial, we may amend
the clinical trial protocol to address any issues that we observe as the trial is progressing, including in response to COVID-19
related factors or other factors impacting safety and the data collected, or we may be required to make certain changes in response
to issues raised by the FDA, IRB, other regulatory authorities, investigators or clinical sites. Protocol amendments are subject to
IRB and regulatory approval before we implement material changes, can result in additional costs, require additional data or
participants, and may negatively impact the timelines for the trial. For example, in December 2021, we amended the protocol for our
Phase III clinical trial to only allow SBRT patients during the induction phase of the study, as we observed a higher drop-out rate
for patients on IMRT. As part of this change, we initiated a review of the statistical considerations for the study and in June
2022, submitted a Modified SAP to the FDA. We submitted a protocol amendment to the FDA in the second half of 2022 to reflect the
changes in the Modified SAP. Under the modified Phase III clinical trial protocol and the Modified SAP, we plan to (i) analyze only
patients receiving SBRT, consistent with the protocol change made in December 2021, (ii) include a second interim analysis, (iii)
change the total number of SBRT patients randomized in the study to 114 (a reduction from the original 200 patients), with a total
of 86 deaths from SBRT patients, including all deaths from SBRT patients enrolled in the study before the submission of the Modified
SAP, and (iv) repower the study from 90% to 80%, which is commonly used in clinical trials. In August 2023, we received comments
from the FDA on the Modified SAP, which we responded to in September 2023 . Based on the FDA’s feedback, we plan to
submit the revised SAP and a protocol amendment to reflect the changes in the statistical analysis for the study. Such amendment and
Modified SAP are subject to IRB and regulatory review that may result in additional costs and may negatively impact the timelines
for the trial. We cannot provide assurance that the FDA will not raise any objections or disagree with our protocol amendments,
including our proposed SAP or how we interpret the data. We can provide no assurance on the timing of any of our interim analyses or
when we will complete our Phase III study, if at all, or the outcome of the study. Disclosure of findings from our interim analyses
before the completion of the trial may also impact the enrollment or retention of patients in our ongoing clinical trial. The
changes in our study protocol may limit the clinical trial sites that can participate in our study, impact enrollment, and delay
regulatory approval. We may be required to expand the size of our study, increase the power level, or make other changes that can
delay our clinical timelines and delay regulatory approval. Further, to the extent protocol amendments impact the data needed to
support our proposed indication, the indication that is ultimately approved by the FDA or other regulatory authorities may be
narrower than the indication initially sought. The FDA and other regulatory authorities may also impose other restrictions in our
proposed labeling, which could have a material adverse effect on the prospects of our product candidates, if approved, and our
business.
Clinical
trials can be delayed for a variety of reasons, including pandemics, delays in obtaining regulatory approval to commence a clinical trial,
in securing clinical trial agreements with prospective sites with acceptable terms, in obtaining IRB approval to conduct a clinical trial
at a prospective site, in recruiting patients to participate in a clinical trial or in obtaining sufficient supplies of clinical trial
materials, including RenovoCath. Many factors affect patient enrollment, including the size of the patient population, the proximity
of patients to clinical sites, the eligibility criteria for the clinical trial, the existing body of safety and efficacy data with respect
to the study drug, competing clinical trials, new drugs approved for the conditions we are investigating, clinicians’ and patients’
perceptions of the potential advantages and side effects of the product candidates being studied in relation to other available therapies
and product candidates, and health epidemics such as the COVID-19 pandemic. Clinical investigators will need to decide whether to offer
their patients enrollment in clinical trials of our product candidate versus treating these patients with commercially available drugs
that have established safety and efficacy profiles. Any delays in completing our clinical trials will increase our costs, slow down our
product development, timeliness and approval process, and delay our ability to generate revenue.
The regulatory approval processes of the FDA
and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain
regulatory approval for our product candidates, our business will be substantially harmed.
The
time required to obtain approval by the FDA and comparable foreign authorities is unpredictable, but it typically takes many years following
the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities.
In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the
course of a product candidate’s clinical development and may vary among jurisdictions. We have not obtained regulatory approval
for any product candidate, and it is possible that any of our existing product candidates, or any product candidate we may seek to develop
in the future, may never obtain regulatory approval.
Our
product candidates could fail to receive regulatory approval for many reasons, including the following:
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the
FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials; |
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we
may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate
is safe and effective for its proposed indication; |
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the
results of clinical trials may not meet the level of statistical significance required for approval by the FDA or comparable foreign
regulatory authorities; |
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the
FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical
trials; |
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the
data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or other
submission or to obtain regulatory approval in the United States or elsewhere; |
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the
FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers
with which we contract for clinical and commercial supplies; or |
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the
approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering
our clinical data insufficient for approval. |
This
lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory
approval to market our product candidates, which would significantly harm our business, results of operations, prospects and our underlying
stock price.
In
addition, even if we were to obtain approval, regulatory authorities may approve our product candidates for fewer or more limited indications
than we request, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product
candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that
product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for any of our product candidates.
We
have not previously submitted an NDA to the FDA, nor similar drug approval filings to comparable foreign authorities, for our product
candidates, and we cannot be certain that our product candidates will be successful in clinical trials or receive regulatory approval.
Further, our product candidates may not receive regulatory approval even if they are successful in clinical trials. If we do not receive
regulatory approvals for our product candidates, we may not be able to continue our operations. Even if we successfully obtain regulatory
approvals to market one or more of our product candidates, our revenues will be dependent on many factors including the size of the markets
in the territories for which we gain regulatory approval and have commercial rights. If the markets for patients that we are targeting
for our product candidates are not as significant as we estimate, we may not generate significant revenues from sales of such products,
if approved.
We
plan to seek regulatory approval and to commercialize our product candidates, directly or with collaborators in the United States, the
European Union, and other foreign countries which we have not yet identified. While the scope of regulatory approval is similar in other
countries, to obtain separate regulatory approval in many other countries we must comply with numerous and varying regulatory requirements
of such countries regarding the safety and efficacy, among other things, of clinical trials and commercial sales, pricing, and distribution
of our product candidates, and we cannot predict success in these jurisdictions.
We
may be required to suspend or discontinue clinical trials due to unexpected side effects or other safety risks that could preclude approval
of our product candidates.
Our
clinical trials may be suspended at any time for a number of reasons. For example, we may voluntarily suspend or terminate our clinical
trials if at any time we believe that they present an unacceptable risk to the clinical trial patients. In addition, the FDA or other
regulatory agencies may order the temporary or permanent discontinuation of our clinical trials at any time if they believe that the
clinical trials are not being conducted in accordance with applicable regulatory requirements or that they present an unacceptable safety
risk to the clinical trial patients.
Administering
our product candidates to humans may produce undesirable side effects. These adverse side effects could interrupt, delay or halt clinical
trials of our product candidates and could result in the FDA or other regulatory authorities denying further development or approval
of any of our product candidates for any or all targeted indications. Ultimately, our product candidates may prove to be unsafe for human
use. Moreover, we could be subject to significant liability if any volunteer or patient suffers, or appears to suffer, adverse health
effects as a result of participating in our clinical trials. Prosecution, enforcement actions, damages or adverse media coverage related
to such events, if any, will likely result in a materially significant diversion of management’s attention and resources and significant
defense costs and other professional fees. As a general matter, such events could damage our reputation, brand, international activities,
business, prospects, operating results and financial condition.
If
we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties
and our business, operations and financial condition could be adversely affected.
Our
business operations and activities may be directly or indirectly subject to various federal and state fraud and abuse laws, including,
without limitation, the federal Anti-Kickback Statute and the federal False Claims Act. The product candidates that we are developing
are highly regulated, and there can be no assurance that the regulatory environment in which we operate will not change significantly
and adversely in the future. If we begin commercializing any products cleared or approved by the FDA in the United States, our exposure
under such laws will increase significantly, and our costs associated with compliance with such laws are also likely to increase. Our
current and future arrangements with healthcare professionals, clinical investigators, CROs, third-party payors and customers may expose
us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements
and relationships through which we market, sell and distribute our products for which we obtain marketing approval. In addition, we may
be subject to laws of the federal government and state governments in which we conduct our business relating to privacy, data protection
and data security with respect to patient information.
As
a developer of drug/device combination products and a proprietary drug delivery device, certain federal and state healthcare laws and
regulations pertaining to fraud and abuse, false claims, transparency and patients’ privacy rights are and will be applicable to
our business. We could be subject to healthcare fraud and abuse laws, transparency and privacy laws of both the federal government and
the states in which we conduct our business and private “qui tam” actions brought by individual whistleblowers on behalf
of the federal or state governments. The scope and enforcement of each of the laws applicable to our business and products are uncertain
and subject to rapid change in the current environment of healthcare reform. The laws include:
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the
federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing
remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or
ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid
programs; |
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federal
false claims laws which prohibit, among other things, individuals, or entities from knowingly presenting, or causing to be presented,
claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent, and which may apply to entities
like us which provide coding and billing information to customers; |
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the
federal Health Insurance Portability and Accountability Act of 1996, which prohibits executing a scheme to defraud any healthcare
benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to
the privacy, security and transmission of individually identifiable health information; |
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the
federal Open Payments program under the Physician Payments Sunshine Act, created under Section 6002 of the ACA and its implementing
regulations, which requires certain manufacturers of covered drugs, devices, biologics and medical supplies for which payment is
available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) and applicable group
purchasing organizations to report annually to CMS information related to payments or other transfers of value made in the previous
year to covered recipients, including physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors),
certain non-physician healthcare professionals (such as physician assistants and nurse practitioners, among others), and teaching
hospitals, and information regarding ownership and investment interests held by physicians (as defined above) and their immediate
family members; |
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the
federal Food, Drug, and Cosmetic Act, which among other things, strictly regulates drug manufacturing and product marketing, prohibits
manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples; |
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federal
consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm
consumers; |
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federal
government drug price reporting laws, changed by the ACA to, among other things, increase the minimum Medicaid rebates owed by most
manufacturers under the Medicaid Drug Rebate Program and offer such rebates to additional populations, that require us to calculate
and report complex pricing metrics to government programs, where such reported prices may be used in the calculation of reimbursement
or discounts on our marketed drugs (participation in these programs and compliance with the applicable requirements may subject us
to potentially significant discounts on our product candidates, increased infrastructure costs, and potentially limit our ability
to offer certain marketplace discounts); |
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the
Foreign Corrupt Practices Act, a United States law which regulates certain financial relationships with foreign government officials
(which could include, for example, certain medical professionals); |
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analogous
state and foreign laws and regulations, including: state anti-kickback and false claims laws which may apply to our business practices,
including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or
services reimbursed by state governmental and non-governmental third-party payors, including private insurers; state laws that require
pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance
guidance promulgated by the federal government; state laws that require drug manufacturers to track gifts and other remuneration
and items of value provided to healthcare professionals and entities; state and local laws that require the registration of pharmaceutical
sales representatives; and state laws that require drug manufacturers to report information relating to pricing and marketing information;
and |
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state
and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each
other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts. |
Efforts
to ensure that our business arrangements with third parties will comply with applicable healthcare laws may involve substantial costs.
It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes,
regulations or case law involving applicable fraud and abuse or other healthcare laws. If our operations are found to be in violation
of any of the laws described above or any governmental regulations that apply to us, we may be subject to greater liabilities, penalties,
including civil and criminal penalties, damages, fines, and the curtailment or restructuring of our operations. Any penalties, damages,
fines, curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results.
Although compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be
entirely eliminated. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to
incur significant legal expenses and divert management’s attention from the operation of our business.
If
any of the physicians or other providers or entities with whom we expect to do business, is found not to be in compliance with applicable
laws, it may be subject to significant criminal, civil or administrative sanctions, including exclusions from participation in government
healthcare programs, which could also materially affect our business.
We
are also subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering
laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets.
We can face criminal liability and other serious consequences for violations which can harm our business. Anti-corruption laws are interpreted
broadly and prohibit companies and their employees, agents, contractors, and other partners from authorizing, promising, offering, or
providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector. We may
engage third parties for clinical trials outside of the United States, to sell our products abroad once we enter a commercialization
phase, or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. We may have direct or indirect
interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations.
We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other partners, even if
we do not explicitly authorize or have actual knowledge of such activities. Any violation of the laws and regulations described above
may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax
reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.
If
we are unable to satisfy regulatory requirements, we may not be able to commercialize our product candidates.
We
need FDA approval prior to marketing our product candidates in the United States. This approval process is lengthy and subject to extensive
governmental regulations and given the unpredictability of the results of clinical trials, our failure to obtain regulatory approval
from the FDA to market any of our product candidates would significantly harm our business, results of operations and prospects. Any
delay or failure in seeking or obtaining required approvals from the FDA to market any of our product candidates would have a material
and adverse effect on our ability to sell our product candidates in the United States and to generate revenue from any such candidates
we are developing and for which we are seeking approval.
The
FDA’s review and approval process, including among other things, evaluation of preclinical studies and clinical trials of a product
candidate as well as the manufacturing process and facility, is lengthy, expensive, and uncertain. To receive approval, we must, among
other things, demonstrate with substantial evidence from well-designed and well-controlled preclinical testing and clinical trials that
the product candidates are both safe and effective for each indication for which approval is sought. Satisfaction of these requirements
typically takes several years, and the time needed to satisfy them may vary substantially, based on the type, complexity and novelty
of the pharmaceutical product. We cannot predict if or when we will submit an NDA for approval for any of our product candidates currently
under development. Any approvals we may obtain may not cover all of the clinical indications for which we are seeking approval or may
contain significant limitations on the conditions of use.
The
FDA has substantial discretion in the NDA review process and may either refuse to file our NDA for substantive review or may decide that
our data is insufficient to support approval of our product candidates for the claimed intended uses. Following any regulatory approval
of our product candidates, we will be subject to continuing regulatory obligations such as safety reporting, required and additional
post marketing obligations, and regulatory oversight of promotion and marketing. Even if we receive regulatory approvals for any of our
product candidates, the FDA may subsequently seek to withdraw approval of our NDA if we determine that new data or a reevaluation of
existing data show the product is unsafe for use under the conditions of use upon the basis of which the NDA was approved, or based on
new evidence of adverse effects or adverse clinical experience, or upon other new information. If the FDA does not file or approve our
NDA or withdraws approval of our NDA, the FDA may require that we conduct additional clinical trials, preclinical or manufacturing studies
and submit that data before it reconsiders our application. Depending on the extent of these or any other requested studies, approval
of any applications that we submit may be delayed by several years, may require us to expend more resources than we have available, or
may never be obtained at all. In addition, we have obtained FDA clearance for our RenovoCath delivery system, which is subject to FDA
medical device regulations, including the Quality System Regulation. In the event adverse events arise with respect to the RenovoCath
delivery system, the FDA could revoke its clearance which would have a material adverse effect on our business.
We
will also be subject to a wide variety of foreign regulations governing the development, manufacture, and marketing of our products to
the extent we seek regulatory approval to develop and market any of our product candidates in a foreign jurisdiction. As of the date
hereof we have not identified any foreign jurisdictions which we intend to seek approval from. Whether or not FDA approval has been obtained,
approval of a product candidate by the comparable regulatory authorities of foreign countries must still be obtained prior to marketing
the product candidate in those countries. The approval process varies, and the time needed to secure approval in any region such as the
European Union or in a country with an independent review procedure may be longer or shorter than that required for FDA approval. We
cannot assure you that clinical trials conducted in one country will be accepted by other countries or that an approval in one country
or region will result in approval elsewhere.
Even
after approval, we are subject to extensive regulations. The regulations to which we are subject are complex and have tended to become
more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher
than anticipated costs or lower than anticipated sales. The FDA and foreign counterparts enforce these regulatory requirements through,
among other means, periodic unannounced inspections and periodic reviews of public marketing and promotion materials. We do not know
whether we will be found compliant in connection with any future FDA or foreign counterparts’ inspections or reviews. Failure to
comply with applicable regulations could jeopardize our ability to sell our products and result in enforcement actions such as: warning
letters; untitled letters; fines; injunctions; civil penalties; termination of distribution; recalls or seizures of products; delays
in the introduction of products into the market; total or partial suspension of production; refusal to grant future clearances, approvals,
or certifications; withdrawals or suspensions of current approvals or certifications, resulting in prohibitions on sales of our products;
and in the most serious cases, criminal penalties.
We
have received Orphan Drug Designation for RenovoGem for two rare diseases: pancreatic cancer and cholangiocarcinoma. We may seek Orphan
Drug Designation for future product candidates, but we may be unable to obtain such designation or to maintain the benefits associated
with Orphan Drug Designation, including market exclusivity, which may cause our revenue, if any, to be reduced.
To
date, we have secured FDA Orphan Drug Designation for RenovoGem in two rare diseases: pancreatic cancer and cholangiocarcinoma. Although
we may seek Orphan Drug Designation for some or all of our other product candidates, we may never receive such designations. Under the
Orphan Drug Act, the FDA may designate a drug product as an orphan drug if it is intended to treat a rare disease or condition, defined
as a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States
where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. Orphan
Drug Designation must be requested before submitting an NDA. In the United States, Orphan Drug Designation entitles a party to financial
incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and application fee waivers. After the
FDA grants Orphan Drug Designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA.
In
addition, if a drug product receives the first FDA approval for an indication for which it has orphan designation, the drug product is
entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication
for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan
exclusivity or where the manufacturer is unable to assure sufficient product quantity for the orphan patient population. Exclusive marketing
rights in the United States may also be unavailable if we seek approval for an indication broader than the orphan designation and may
be lost if the FDA later determines that the request for designation was materially defective.
Even
if we obtain Orphan Drug Designation, we may not be the first to obtain marketing approval for any particular indication within the orphan
designation due to uncertainties associated with developing pharmaceutical products, which would have a material adverse effect on our
operations, regulatory approval and ability to commercialize our product candidate. Further, even if we obtain orphan drug exclusivity
for a product candidate, that exclusivity may not effectively protect the product from competition because different drugs with different
active moieties can be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve the same
drug with the same active moiety for the same indication or use if the FDA concludes that the later drug is clinically superior or makes
a major contribution to patient care. Orphan Drug Designation neither shortens the development time or regulatory review time of a product
candidate nor gives the product candidate any advantage in the regulatory review or approval process or entitles the product candidate
to priority review.
Further,
in Catalyst Pharms., Inc. v. Becerra, 14 F.4th 1299 (11th Cir. 2021), the court disagreed with the FDA’s longstanding position
that the orphan drug exclusivity only applies to the approved use or indication within an eligible disease. This decision created uncertainty
in the application of the orphan drug exclusivity. On January 24, 2023, the FDA published a notice in the Federal Register to clarify
that while the agency complies with the court’s order in Catalyst, the FDA intends to continue to apply its longstanding interpretation
of the regulations to matters outside of the scope of the Catalyst order – that is, the agency will continue tying the scope of
orphan-drug exclusivity to the uses or indications for which a drug is approved, which permits other sponsors to obtain approval of a
drug for new uses or indications within the same orphan designated disease or condition that have not yet been approved. It is unclear
how future litigation, legislation, agency decisions, and administrative actions will impact the scope of the orphan drug exclusivity.
If
our product candidates are unable to compete effectively with marketed drugs targeting similar indications as our product candidates,
our commercial opportunity will be reduced or eliminated.
We
face competition generally from established pharmaceutical and biotechnology companies, as well as from academic institutions, government
agencies and private and public research institutions. Many of our competitors have significantly greater financial resources and expertise
in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing
approved products than we do. Small or early-stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large, established companies. We are aware of a number of companies in Phase III clinical trials for the treatment
of LAPC including Angiodynamics, Bausch Health, FibroGen, Novocure, and SynCore Biotechnology. In addition, we are aware of a number
of companies in Phase I and Phase II clinical trials for the treatment of LAPC including one interventional company, TriSalus Lifesciences.
Our commercial opportunity will be reduced or eliminated if our competitors develop and commercialize any products that are safer, more
effective, have fewer side effects or are less expensive than our product candidates. These potential competitors compete with us in
recruiting and retaining key and qualified scientific and management personnel, establishing clinical trial sites, and patient enrollment
for clinical trials, as well as in acquiring technologies and technology licenses complementary to our programs or advantageous to our
business.
If
approved and commercialized, RenovoGem would compete with several currently approved prescription therapies for the treatment of LAPC
and cholangiocarcinoma. To our knowledge, other potential competitors are in the earlier stages of development. If potential competitors
are successful in completing drug development for their product candidates and obtain approval from the FDA, they could limit the demand
for RenovoGem.
We
expect that our ability to compete effectively will depend upon our ability to:
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successfully
identify and develop key points of product differentiation from currently available therapies; |
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successfully
and timely complete clinical trials and submit for and obtain all requisite regulatory approvals in a cost-effective manner; |
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maintain
a proprietary position for our products and manufacturing processes and other related product technology; |
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attract
and retain key and qualified personnel; |
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develop
relationships with physicians prescribing these products; and |
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build
an adequate sales and marketing infrastructure for our products, if approved. |
Because
we will be competing against significantly larger companies with established track records, we will have to demonstrate that, based on
experience, clinical data, side-effect profiles and other factors, our products, if approved, are competitive with other products. If
we are unable to compete effectively and differentiate our products from other marketed drugs, we may never generate meaningful revenue.
We
may expend our limited resources to pursue one or more product candidates or indications within our product development strategy, which
has and may continue to change over time, and fail to capitalize on product candidates or indications that may be more profitable or
for which there is a greater likelihood of success.
Because
we have limited financial and managerial resources, we intend to focus on developing product candidates for specific indications that
we identify as most likely to succeed, in terms of their potential both to gain regulatory approval and to achieve commercialization.
As a result, we may forego or delay the pursuit of opportunities with other product candidates or in other indications with greater commercial
potential. Such resource allocation and strategic decisions may cause us to fail to capitalize on viable commercial products or profitable
market opportunities. Our spending on current and future research and development programs and product candidates for specific indications
may not yield any commercially viable product candidates. If we do not accurately evaluate the commercial potential or target market
for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing, or
other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization
rights to the product candidate.
If
the manufacturers upon whom we rely fail to produce our product candidates, in the volumes that we require on a timely basis or fail
to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the development and commercialization
of our product candidates.
We
do not currently possess internal manufacturing capacity. We plan to utilize the services of cGMP manufacturers, FDA inspected contract
manufacturers, to formulate and manufacture our preclinical and clinical supplies. Any curtailment in the availability of gemcitabine,
or RenovoCath, the drug delivery device, however, could result in production or other delays with consequent adverse effects on us. In
addition, because regulatory authorities must generally approve raw material sources for pharmaceutical products, changes in raw material
suppliers may result in production delays or higher raw material costs.
We
obtain our RenovoCath delivery system from a single source, which must be manufactured in accordance with the FDA Quality System Regulation
(QSR). Gemcitabine is supplied from our clinical sites’ pharmacies and used off-label for intra-arterial use within our clinical
study. We continue to pursue supply agreements for gemcitabine and our RenovoCath delivery system. We may be required to agree to minimum
volume requirements, exclusivity arrangements or other restrictions with the contract manufacturers. We may not be able to enter into
long-term agreements on commercially reasonable terms, or at all. If we change or add manufacturers, the FDA and comparable foreign regulators
may require approval of the changes. Approval of these changes could require new testing by the manufacturer and compliance inspections
to ensure the manufacturer is conforming to all applicable laws and regulations and cGMP.
The
manufacture of pharmaceutical products, including drug/device combination products, requires significant expertise and capital investment,
including the development of an acceptable formulation to support later-stage trials for our product candidates, advanced manufacturing
techniques and process controls. Manufacturers of pharmaceutical products may encounter difficulties in production, particularly in scaling
up production and reformulating the form of any of our product candidates. For drug/device combination products, ensuring compliance
with both medical device and drug regulations exposes us to additional risks. These problems include difficulties with production costs
and yields, quality control, including stability of the product and quality assurance testing, shortages of qualified personnel, as well
as compliance with federal, state, and foreign regulations. Our contract manufacturers may also place a priority on the manufacture of
their own products, or other customers’ products. In addition, any delay or interruption in the supply of clinical trial supplies
could delay the completion of our clinical trials, increase the costs associated with conducting our clinical trials and, depending upon
the period of delay, require us to commence new clinical trials at significant additional expense or to terminate a clinical trial.
We
will be responsible for ensuring that our future contract manufacturers comply with the cGMP requirements of the FDA and other regulatory
authorities from which we seek to obtain product approval. These requirements include, among other things, quality control, quality assurance
and the maintenance of records and documentation. The approval process for NDAs includes an inspection of the manufacturer’s compliance
with cGMP requirements. We will be responsible for regularly assessing a contract manufacturer’s compliance with cGMP requirements
through record reviews and periodic audits and for ensuring that the contract manufacturer takes responsibility and corrective action
for any identified deviations. Manufacturers of our product candidates may be unable to comply with these cGMP requirements and with
other FDA and foreign regulatory requirements, if any.
While
we will oversee compliance of our contract manufacturers, ultimately, we will not have control over our manufacturers’ compliance
with these regulations and standards. A failure to comply with these requirements may result in fines and civil penalties, suspension
of production, suspension or delay in product approval, product seizure or recall, or withdrawal of product approval. If the safety of
any of our product candidates is compromised due to a manufacturers’ failure to adhere to applicable laws or for other reasons,
we may not be able to obtain regulatory approval for or successfully commercialize any of our product candidates, and we may be held
liable for any injuries sustained as a result. Any of these factors could cause a delay of clinical trials, regulatory submissions, approvals,
or commercialization of RenovoGem or other product candidates, entail higher costs or result in us being unable to effectively commercialize
any of our product candidates. Furthermore, if our manufacturers fail to deliver the required commercial quantities on a timely basis
and at commercially reasonable prices, we may be unable to meet demand for any approved products and would lose potential revenues. There
are also risks of our contract manufacturers failing to perform as agreed, terminating their relationship with us, experiencing the effects
of any strikes or other work stoppages, or not remaining in the contract manufacturing business.
Our
dependence on third-party suppliers subjects us to a number of risks that could negatively impact our ability to manufacture products
and harm our business, including:
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interruption
of supply resulting from modifications to, or discontinuation of, a supplier’s operations; |
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delays
in product shipments resulting from uncorrected defects, reliability issues, or a supplier’s failure to produce components
that consistently meet our quality specifications; |
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price
fluctuations due to a lack of long-term supply arrangements with our suppliers for key components; |
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inability
to obtain adequate supply in a timely manner or on commercially reasonable terms; |
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difficulty
identifying and qualifying alternative suppliers for components in a timely manner; |
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inability
of suppliers to comply with applicable provisions of the FDA’s QSR, cGMP regulations or other applicable laws or regulations
enforced by the FDA or state regulatory authorities and foreign regulatory authorities; |
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inability
to ensure the quality of products or components manufactured by third parties; |
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production
delays related to the evaluation and testing of products and components from alternative suppliers and corresponding regulatory qualifications; |
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delays
in delivery by our suppliers due to changes in demand from us or their other customers, or our suppliers prioritizing their other
customers over us; and |
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an
outbreak of disease or similar public health threat particularly as it may impact our supply chain. |
Although
we require that our third-party suppliers provide our manufacturing partners with components that meet our specifications and comply
with applicable provisions of the QSR, cGMP and other applicable legal and regulatory requirements in our agreements and contracts, there
is a risk that our suppliers will not always act with our best interests in mind, and they may not always supply components that meet
our requirements or supply components in a timely manner. Any interruption or delay in the supply of components or materials, or our
inability to obtain components or materials from alternate sources at acceptable prices in a timely manner, could impair our ability
to meet the demand of our customers and cause them to cancel orders or switch to competitive procedures. These events could harm our
business and our operating results.
We
may not be able to manufacture our product candidates in commercial quantities, which would prevent us from commercializing our product
candidates.
To
date, our product candidates have been manufactured in small quantities for preclinical studies and clinical trials. If any of our product
candidates are approved by the FDA or comparable regulatory authorities in other countries for commercial sale, we will need to manufacture
such product candidates in larger quantities. We may not be able to successfully increase the manufacturing capacity for our product
candidates in a timely or economic manner, or at all. A significant scale-up of manufacturing may require additional validation studies,
which the FDA must review and approve. If we are unable to successfully increase the manufacturing capacity for a product candidate,
the clinical trials as well as the regulatory approval or commercial launch of that product candidate may be delayed or there may be
a shortage in supply. Our product candidates require precise, high-quality manufacturing in accordance with cGMP. Our failure to achieve
and maintain these high-quality manufacturing standards in collaboration with our third-party manufacturers, including the incidence
of manufacturing errors, could result in patient injury or death, product recalls or withdrawals, delays or failures in product testing
or delivery, cost overruns or other problems that could harm our business, financial condition and results of operations.
Our
product candidates, if approved for sale, may not gain acceptance among physicians, patients, and the medical community, thereby limiting
our potential to generate revenues.
If
our product candidates are approved for commercial sale by the FDA or other regulatory authorities, the degree of market acceptance of
any approved product by physicians, healthcare professionals and third-party payors and our profitability and growth will depend on a
number of factors, including:
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demonstration
of safety and efficacy; |
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perceived
advantages of our product candidates over alternative treatments; |
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the
indications for which the product candidates are approved, and the labeling approved by regulatory authorities for use with the product
candidates, including any warnings, limitations or contraindications contained in a product’s approved labeling; |
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approval
of other new therapies for the same indications; |
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acceptance
by physicians and patients of the product candidate as a safe and effective treatment; |
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the
cost, safety and efficacy of treatment in relation to alternative treatments, including generic versions of the product candidates; |
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the
extent to which our product candidates are included on formularies of hospitals and managed care organizations; |
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changes
in the practice guidelines and the standard of care for the targeted indication; |
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relative
convenience and ease of administration; |
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the
prevalence and severity of any adverse side effects; |
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budget
impact of adoption of our product on relevant drug formularies and the availability, cost, and potential advantages of alternative
treatments, including less expensive generic drugs; |
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pricing,
reimbursement, and cost effectiveness, which may be subject to regulatory control; |
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effectiveness
of our or any of our partners’ sales and marketing strategies; |
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the
product labeling or product insert required by the FDA or regulatory authority in other countries; and |
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the
availability of adequate third-party insurance coverage or reimbursement. |
If
any product candidate that we develop does not provide a treatment regimen that is as beneficial as, or is perceived as being as beneficial
as, the current standard of care or otherwise does not provide patient benefit, that product candidate, if approved for commercial sale
by the FDA or other regulatory authorities, likely will not achieve market acceptance. Our ability to effectively promote and sell any
approved products will also depend on pricing and cost-effectiveness, including our ability to produce a product at a competitive price
and our ability to obtain sufficient third-party coverage or reimbursement. If any product candidate is approved but does not achieve
an adequate level of acceptance by physicians, patients and third-party payors, our ability to generate revenues from that product would
be substantially reduced. In addition, our efforts to educate the medical community and third-party payors on the benefits of our product
candidates may require significant resources, may be constrained by FDA rules and policies on product promotion, and may never be successful.
Guidelines
and recommendations published by various organizations can impact the use of our products.
Government
agencies promulgate regulations and guidelines directly applicable to us and to our product. In addition, professional societies, practice
management groups, private health and science foundations and organizations involved in various diseases from time to time may also publish
guidelines or recommendations to the healthcare and patient communities. Recommendations of government agencies or these other groups
or organizations may relate to such matters as usage, dosage, route of administration and use of concomitant therapies. Recommendations
or guidelines suggesting the reduced use of our products or the use of competitive or alternative products that are followed by patients
and healthcare providers could result in decreased use of our proposed products.
The
market for RenovoGem and our other product candidates may not be as large as we expect.
Our
estimates of the potential market opportunity for RenovoGem and our other product candidates include several key assumptions based on
our industry knowledge, industry publications, third-party research reports and other surveys, including surveys commissioned by us.
These assumptions include the size of our target populations, the prevalence and incidence of each of our target indications, the number
of patients receiving current treatment, the percentage of patients unsatisfied with the current treatments, the number of diagnosed
but untreated patients, the compliance and adherence of patients in our target populations, the number of treatment centers and prescribing
physicians and the percentage of payer acceptance. While we believe that our internal assumptions are reasonable, if any of these assumptions
proves to be inaccurate, then the actual market for our product candidates could be smaller than our estimates of our potential market
opportunity. If the actual market for any of our product candidates is smaller than we expect, our product revenue may be limited, and
it may be more difficult for us to achieve or maintain profitability.
In
the event that we need to change our third-party contract manufacturers, our preclinical studies, clinical trials or the commercialization
of our product candidates could be delayed, adversely affected or terminated, or such a change may result in significantly higher costs.
Due
to regulatory restrictions inherent in an IND or NDA, or for economic reasons, various steps in the manufacture of any of our product
candidates may need to be sole-sourced. We currently obtain our RenovoCath delivery system, subject to requirements under the QSR, from
a single supplier. In accordance with cGMP regulations and QSR, changing manufacturers may require the re-validation of manufacturing
processes and procedures, and may require further preclinical studies or clinical trials to show comparability between the materials
produced by different manufacturers, and further regulatory review and approval. Changing our current or future contract manufacturers
may be difficult for us and could be costly, which could result in our inability to manufacture our product candidate for an extended
period of time and therefore a delay in the development of any of our product candidates. While we intend to find alternative suppliers
to mitigate the risk, our efforts may not be successful. Further, to maintain our development timelines in the event of a change in our
third-party contract manufacturer, we may incur significantly higher costs to manufacture any of our product candidates.
We
currently do not have any internal drug discovery capabilities, and therefore we are dependent on identifying drugs that are off patent
or on in-licensing or acquiring development programs from third parties in order to obtain additional product candidates.
If
in the future we decide to further expand our pipeline of product candidates, we will be dependent on identifying drugs that are off
patent or on in-licensing or acquiring product candidates as we do not have significant internal discovery capabilities at this time.
We may face substantial competition from other biotechnology and pharmaceutical companies, many of which may have greater resources than
we have, in obtaining in-licensing, sponsored research or acquisition opportunities. In-licensing or acquisition opportunities may not
be available to us on terms we find acceptable, if at all. In-licensed compounds that appear promising in research or in preclinical
studies may fail to progress into further preclinical studies or clinical trials.
If
a product liability claim is successfully brought against us for uninsured liabilities, or such a claim exceeds our insurance coverage,
we could be forced to pay substantial damage awards that could materially harm our business.
The
use of any of our existing or future product candidates in clinical trials and the sale of any approved pharmaceutical products may expose
us to significant product liability claims. We have product liability insurance coverage for our proposed clinical trials; however, such
insurance coverage may be inadequate and may not protect us against any or all of the product liability claims that may be brought against
us now or in the future. We may not be able to acquire or maintain adequate product liability insurance coverage at a commercially reasonable
cost or in sufficient amounts or scope to protect us against potential losses. In the event a product liability claim is brought against
us, we may be required to pay legal and other expenses to defend the claim, as well as uncovered damage awards resulting from a claim
brought successfully against us. In the event that any of our product candidates are approved for sale by the FDA and commercialized,
we may need to substantially increase the amount of our product liability coverage. Defending any product liability claim or claims could
require us to expend significant financial and managerial resources, which could have a material adverse effect on our business.
We
may delay or terminate the development of our product candidates at any time if we believe the perceived market or commercial opportunity
does not justify further investment, which could materially harm our business.
Even
though the results of preclinical studies and clinical trials that have been conducted or may be conducted in the future may support
further development of our product candidates, we may delay, suspend or terminate the future development of a product candidate at any
time for strategic, business, financial or other reasons, including the determination or belief that the emerging profile of the product
candidate is such that it may not receive FDA approval, gain meaningful market acceptance, generate a significant return to stockholders,
or otherwise provide any competitive advantages in its intended indication or market.
Risks
Related to Our Operations
Our
future success depends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel.
We
are highly dependent on the development, regulatory, commercialization, and business development expertise of Shaun Bagai, our Chief
Executive Officer, as well as the other principal members of our management, scientific and clinical teams. Although we have employment
agreements, offer letters or consulting agreements with our executive officers, these agreements do not prevent them from terminating
their services at any time.
If
we lose one or more of our executive officers or key employees, our ability to implement our business strategy successfully could be
seriously harmed. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time
because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop
product candidates, gain regulatory approval, and commercialize new products. Competition to hire from this limited pool is intense,
and we may be unable to hire, train, retain or motivate these additional key personnel on acceptable terms given the competition among
numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition, including a recent hyper-competitive
compensation environment, for the hiring of scientific and clinical personnel from universities and research institutions. In addition,
we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development
and commercialization strategy. Our consultants and advisors may be engaged by entities other than us and may have commitments under
consulting or advisory contracts with other entities that may limit their availability to us. One such key consultant is Dr. Ramtin Agah,
our Chief Medical Officer. If we are unable to continue to attract and retain highly qualified personnel, our ability to develop and
commercialize product candidates will be limited.
We
will need to increase the size of our organization, and we may experience difficulties in managing growth.
We
are a small company with less than 10 employees. The future growth of our company will impose significant additional responsibilities
on members of management, including the need to identify, attract, retain, motivate and integrate highly skilled personnel. We may increase
the number of employees in the future depending on the progress of our development and commercialization of our product candidates. Our
future financial performance and our ability to commercialize our product candidates and to compete effectively will depend, in part,
on our ability to manage any future growth effectively. To that end, we must be able to:
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manage
our clinical studies effectively; |
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integrate
additional and future management, administrative, manufacturing, sales and marketing, and regulatory personnel; |
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maintain
sufficient administrative, accounting and management information systems and controls; and |
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hire
and train additional qualified personnel. |
There
is no guarantee that we will be able to accomplish these tasks, and our failure to accomplish any of them could materially adversely
affect our business, prospects, and financial condition.
Business
disruptions could seriously harm future revenue and financial condition and increase our costs and expenses.
Our
operations, and those of our third-party manufacturers, contract research organizations (“CROs”), and other contractors and
consultants, could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods, hurricanes, typhoons,
fires, extreme weather conditions, medical epidemics and other natural or man-made disasters or business interruptions beyond our control,
for which we are predominantly self-insured. The occurrence of any of these business disruptions could delay our clinical trials, seriously
harm our operations and financial condition and increase our costs and expenses. In addition, our ability to obtain clinical supplies
for our clinical trials and materials for our product candidates could be disrupted if the operations of these suppliers are affected
by a man-made or natural disaster or other business interruptions.
Our
corporate headquarters are located in Silicon Valley, California, an area prone to wildfires and earthquakes. These and other natural
disasters could severely disrupt our operations, and have a material adverse effect on our business, results of operations, financial
condition and prospects. If a natural disaster, power outage or other event occurred that prevented us from using all or a significant
portion of our headquarters, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers,
or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial
period of time. Any disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster
or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity
plans, which could have a material adverse effect on our business.
Catastrophic
events and man-made problems, such as terrorism, war, or climate change may disrupt our business.
A
significant natural disaster, such as an earthquake, fire, flood, hurricane, or significant power outages, water shortages and the risks
associated with climate change could have an adverse impact on our business, results of operations, and financial condition. Our employees
and executive officers are located in the San Francisco Bay Area, a region known for seismic activity, drought, and wildfires, and the
resultant air quality impacts and power outages associated with such wildfires.
In
addition, acts of terrorism, pandemics, such as the ongoing COVID-19 pandemic or another public health crisis, protests, riots, and the
increasing frequency and impact of extreme weather events on critical infrastructure in the U.S. and elsewhere have the potential to
disrupt our business and the business of our third-party suppliers, and may cause us to experience higher attrition, losses, and additional
costs to maintain or resume operations. All of the aforementioned risks may be further increased if our course of action in response
to catastrophic events proves to be inadequate. For example, if a catastrophic event occurred that prevented us from using all or a significant
portion of our facility, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers,
or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial
period of time. Any disaster recovery and business continuity plan we have in place may prove inadequate in the event of a serious disaster
or similar event and we may incur substantial expenses as a result of the limited nature of these plans, which could have a material
adverse effect on our business.
In
February 2022, armed conflict escalated between Russia and Ukraine which led to various sanctions by the U.S. and other countries against
Russia. Furthermore, ongoing war and instability in Israel and the surrounding region that commenced in October 2023 have added to global
geopolitical unrest. It is not possible to predict the broader consequences of these conflicts, which could include further sanctions,
embargoes, regional instability, prolonged periods of higher inflation, geopolitical shifts, and adverse effects on macroeconomic conditions,
currency exchange rates, and financial markets, all of which could have a material adverse effect on our business, financial condition,
and results of operations.
Security
threats to our information technology infrastructure and/or our physical buildings could expose us to liability and damage our reputation
and business.
It
is essential to our business strategy that our and our vendors, partners, clinical trial sites, and third-party providers’ technology
and network infrastructure and physical buildings remain secure and are perceived by our customers and corporate partners to be secure.
Despite our implementation of security measures, any of the internal computer systems and networks belonging to or used by us or our
employees and our third-party service providers are vulnerable to damage and disruption from computer viruses, ransomware and other malicious
code, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failure, as well as security breaches
and incidents from inadvertent or intentional actions, or from cyber-attacks by malicious third parties (including supply chain cyber-attacks,
denial-of-service attacks, social engineering and other means to affect service reliability and threaten the confidentiality, integrity
and availability of information), which may compromise system infrastructure or lead to the loss, destruction, alteration, prevention
of access to, disclosure, or dissemination of, or damage or unauthorized access to, our data (including trade secrets or other confidential
information, intellectual property, proprietary business information, and personal information) or data that is processed or maintained
on our behalf, or other assets, which could result in financial, legal, business and reputational harm to us. Any system failure, accident
or security breach or incident that causes interruptions in our own or in our third-party service providers’ operations could result
in a material disruption of our development programs or other aspects of our operations. As a result of the ongoing COVID-19 pandemic,
with many of our employees working from home from time to time and accessing our corporate network via remote devices, the potential
for such events to occur is even greater. Despite security measures, we also cannot guarantee the security of our physical buildings.
Physical building penetration or any cyber-attacks could negatively affect our reputation, damage our network infrastructure and our
ability to deploy our products and services, harm our relationship with customers and partners that are affected, and expose us to financial
liability, including the possibility of consequential damages resulting from cyber-attacks and other security threats.
Additionally,
there are a number of state, federal, and international laws protecting the privacy and security of health information and personal data.
For example, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) imposes limitations on the use and
disclosure of an individual’s healthcare information by healthcare providers, healthcare clearinghouses, and health insurance plans,
or, collectively, covered entities, and also grants individuals rights with respect to their health information. HIPAA also imposes compliance
obligations and corresponding penalties for non-compliance on individuals and entities that provide services to healthcare providers
and other covered entities. As part of the American Recovery and Reinvestment Act of 2009 (“ARRA”), the privacy and security
provisions of HIPAA were amended. ARRA also made significant increases in the penalties for improper use or disclosure of an individual’s
health information under HIPAA and extended enforcement authority to state attorneys general. As amended by ARRA and subsequently by
the final omnibus rule adopted in 2013, HIPAA also imposes notification requirements on covered entities in the event that certain health
information has been inappropriately accessed or disclosed, including notification requirements to individuals, federal regulators, and
in some cases, notification to local and national media. Notification is not required under HIPAA if the health information that is improperly
used or disclosed is deemed secured in accordance with encryption or other standards developed by the U.S. Department of Health and Human
Services. Most states have laws requiring notification of affected individuals and/or state regulators in the event of a breach of personal
information, which is a broader class of information than the health information protected by HIPAA. Many state laws impose significant
data security requirements, such as encryption or mandatory contractual terms, to ensure ongoing protection of personal information.
Activities outside of the U.S. implicate local and national data protection standards, impose additional compliance requirements, and
generate additional risks of enforcement for non-compliance. We may be required to expend significant capital and other resources to
ensure ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate
problems caused by such breaches.
We
and our third-party contract manufacturers must comply with environmental, health and safety laws and regulations, and failure to comply
with these laws and regulations could expose us to significant costs or liabilities.
We
and our third-party manufacturers are subject to numerous environmental, health and safety laws and regulations, including those governing
laboratory procedures and the use, generation, manufacture, distribution, storage, handling, treatment, remediation and disposal of hazardous
materials and wastes. Hazardous chemicals, including flammable and biological materials, are involved in certain aspects of our business,
and we cannot eliminate the risk of injury or contamination from the use, generation, manufacture, distribution, storage, handling, treatment
or disposal of hazardous materials and wastes. In the event of contamination or injury, or failure to comply with environmental, health
and safety laws and regulations, we could be held liable for any resulting damages and any such liability could exceed our assets and
resources. We could also incur significant costs associated with civil or criminal fines and penalties for failure to comply with such
laws and regulations.
Although
we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting
from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain
insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal
of biological, hazardous or radioactive materials.
Environmental,
health and safety laws and regulations are becoming increasingly more stringent. We may incur substantial costs in order to comply with
current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our
research, development or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines,
penalties or other sanctions.
Further,
with respect to the operations of our third-party contract manufacturers, it is possible that if they fail to operate in compliance with
applicable environmental, health and safety laws and regulations or properly dispose of wastes associated with our products, we could
be held liable for any resulting damages, suffer reputational harm or experience a disruption in the manufacture and supply of our product
candidates or products.
A
variety of risks associated with operating internationally could materially adversely affect our business.
Doing
business internationally involves a number of risks, including but not limited to:
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multiple,
conflicting and changing laws and regulations, such as privacy regulations, tax laws, export and import restrictions, employment
laws, regulatory requirements and other governmental approvals, permits and licenses; |
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failure
by us to obtain and maintain regulatory approvals for the use of our products in various countries; |
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additional
potentially relevant third-party patent rights; |
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complexities
and difficulties in obtaining protection and enforcing our intellectual property; |
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difficulties
in staffing and managing foreign operations; |
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complexities
associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems; |
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limits
in our ability to penetrate international markets; |
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financial
risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises
on demand and payment for our products, exposure to foreign currency exchange rate fluctuations, and a rising rate of inflation; |
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natural
disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment
of trade and other business restrictions; |
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certain
expenses including, among others, expenses for travel, translation, and insurance; and |
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regulatory
and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the
purview of the U.S. Foreign Corrupt Practices Act, its books and records provisions, or its anti-bribery provisions. |
Any
of these factors could significantly harm any current or future international operations and, consequently, our results of operations.
General
economic or business conditions may have a negative impact on our business.
Continuing
concerns over U.S. healthcare reform legislation and energy costs, geopolitical issues, fluctuations in inflation rates, market volatility,
the availability and cost of credit and government stimulus programs in the U.S. and other countries, including those related to the
COVID-19 pandemic, as well as recent and potential future disruptions in access to bank deposits or lending commitments due to bank failure,
have contributed to increased volatility and could materially and adversely affect our liquidity, our business and financial condition.
The recent closures of Silicon Valley Bank and Signature Bank and their placement into receivership with the Federal Deposit Insurance
Corporation (“FDIC”) created bank-specific and broader financial institution liquidity risk and concerns. Although the Department
of the Treasury, the Federal Reserve, and the FDIC jointly released a statement that depositors at Silicon Valley Bank and Signature
Bank would have access to their funds, even those in excess of the standard FDIC insurance limits, future adverse developments with respect
to specific financial institutions or the broader financial services industry may lead to market-wide liquidity shortages. The failure
of any bank in which we deposit our funds could reduce the amount of cash we have available for our operations or delay our ability to
access such funds. Any such failure may increase the possibility of a sustained deterioration of financial market liquidity, or illiquidity
at clearing, cash management and/or custodial financial institutions. In the event we have a commercial relationship with a bank that
has failed or is otherwise distressed, we may experience delays or other issues in meeting our financial obligations. If other banks
and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking
system and financial markets, our ability to access our cash and cash equivalents and investments may be threatened and could have a
material adverse effect on our business and financial condition.
If
the economic climate deteriorates or is poor, our business, as well as the financial condition of our suppliers and our third-party payors,
could be negatively impacted, which could materially adversely affect our business, prospects and financial condition.
Our
operations are subject to the effects of a rising rate of inflation.
The
United States has recently experienced historically high levels of inflation. If the inflation rate continues to increase, for example
due to increases in the costs of labor and supplies, it will affect our expenses, such as employee compensation and research and development
charges. Additionally, the United States is experiencing an acute workforce shortage, which in turn, has created a very competitive wage
environment that may increase the Company’s operating costs. To the extent inflation results in rising interest rates and has other
adverse effects on the market, it may adversely affect our financial condition and results of operations.
Healthcare
reform measures could adversely affect our business. The impact of recent healthcare reform legislation and other changes in the healthcare
industry and in healthcare spending on us is currently unknown and may adversely affect our business model.
Existing
regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval
of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation
or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements
or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval
that we may have obtained and we may not achieve or sustain profitability.
In
the United States and foreign jurisdictions, there have been, and continue to be, a number of legislative and regulatory changes and
proposed changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue
to be a number of initiatives at the federal and state levels in the United States that seek to reduce healthcare costs. In 2010, the
Patient Protection and Affordable Care Act (the “PPACA”) was enacted, which includes measures to significantly change the
way healthcare is financed by both governmental and private insurers. Among the provisions of the PPACA of greatest importance to the
pharmaceutical and biotechnology industry are the following:
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an
annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned
among these entities according to their market share in certain government healthcare programs; |
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implementation
of the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act”; |
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a
licensure framework for follow-on biologic products; |
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a
new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness
research, along with funding for such research; |
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establishment
of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery
models to lower Medicare and Medicaid spending, potentially including prescription drug spending; |
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an
increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the
average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs
at 100% of the AMP; |
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a
new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and
biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected; |
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extension
of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed
care organizations; |
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expansion
of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals
and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby
potentially increasing manufacturers’ Medicaid rebate liability; |
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a
new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated
prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s
outpatient drugs to be covered under Medicare Part D; and |
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expansion
of the entities eligible for discounts under the Public Health program. |
Since
its enactment, there remain judicial and Congressional challenges to certain aspects of the PPACA. For example, in June 2021 the U.S.
Supreme Court held that Texas and other challengers had no legal standing to challenge the PPACA, dismissing the case on procedural grounds
without specifically ruling on the constitutionality of the PPACA. Thus, the PPACA will remain in effect in its current form. In addition,
other legislative changes have been proposed and adopted since the PPACA was enacted. These changes include aggregate reductions to Medicare
payments to providers of up to 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013 due to subsequent legislative
amendments will remain in effect through 2032, with the exception of a temporary suspension implemented under various COVID-19 relief
legislation.
Moreover,
there has recently been heightened governmental scrutiny over the manner in which drug manufacturers set prices for their marketed products,
which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other
things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform
government program reimbursement methodologies for drug products. For example, under the American Rescue Plan Act of 2021, effective
January 1, 2024, the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs will be
eliminated. Elimination of this cap may require pharmaceutical manufacturers to pay more in rebates than it receives on the sale of products,
which could have a material impact on our business. In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes
prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including
allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties
and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all
Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare
Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Various industry stakeholders, including
certain pharmaceutical companies and industry interest groups, have initiated lawsuits against the federal government asserting that
the price negotiation provisions of the Inflation Reduction Act are unconstitutional. The impact of these judicial challenges and future
legislative, executive, and administrative actions and any agency rules on us and the pharmaceutical industry as a whole is unclear.
The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain
profitability, or commercialize our product candidates if approved. Complying with any new legislation and regulatory changes could be
time-intensive and expensive, resulting in a material adverse effect on our business.
Individual
states have become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical product
pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost
disclosure and transparency measures, and to encourage importation from other countries and bulk purchasing. Legally mandated price controls
on payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition and
prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine
what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could
reduce the ultimate demand for our products or put pressure on our product pricing, which could negatively affect our business, results
of operations, financial condition and prospects.
In
addition, given recent federal and state government initiatives directed at lowering the total cost of healthcare, Congress and state
legislatures will likely continue to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare
and Medicaid programs. While we cannot predict the full outcome of any such legislation, it may result in decreased reimbursement for
drugs and biologics, which may further exacerbate industry-wide pressure to reduce prescription drug prices. This could harm our ability
to generate revenue. Further, a number of states are considering or have recently enacted state drug price transparency and reporting
laws that could substantially increase our compliance burdens and expose us to greater liability under such state laws once we begin
commercialization.
Increases
in importation or re-importation of pharmaceutical products from foreign countries into the United States could put competitive pressure
on our ability to profitably price our products, which, in turn, could adversely affect our business, results of operations, financial
condition and prospects. We might elect not to seek approval for or market our products in foreign jurisdictions in order to minimize
the risk of re-importation, which could also reduce the revenue we generate from product sales. It is also possible that other legislative
proposals having similar effects will be adopted.
Furthermore,
regulatory authorities’ assessment of the data and results required to demonstrate safety and efficacy can change over time and
can be affected by many factors, such as the emergence of new information, including on other products, changing policies and agency
funding, staffing and leadership. We cannot be sure whether future changes to the regulatory environment will be favorable or unfavorable
to our business prospects. For example, average review times at the FDA for marketing approval applications can be affected by a variety
of factors, including budget and funding levels and statutory, regulatory and policy changes.
Reimbursement
for any approved products may be limited or unavailable, which could make it difficult for us to sell our product candidates profitably.
In
both domestic and foreign markets, sales of any of our other product candidates, if approved, will depend, in part, on the extent to
which the costs of our product candidates will be covered by third-party payors, such as government health care programs, commercial
insurance and managed health care organizations. These third-party payors decide which drugs will be covered and establish reimbursement
levels for those drugs. The containment of health care costs has become a priority of foreign and domestic governments as well as private
third-party payors. The prices of drugs have been a focus in this effort. Governments and private third-party payors have attempted to
control costs by limiting coverage and the amount of reimbursement for particular medications, which could affect our ability to sell
our product candidates profitably. Cost-control initiatives could cause us to decrease the price we might establish for product candidates,
which could result in lower than anticipated product revenues.
Reimbursement
by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product
is:
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a
covered benefit under its health plan; |
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safe,
effective and medically necessary; |
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appropriate
for the specific patient; |
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cost-effective
relative to other alternatives, including generic products; and |
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neither
experimental nor investigational. |
Adverse
pricing limitations may hinder our ability to recoup our investment in our existing and any future product candidates, even if such product
candidates obtain marketing approval.
Obtaining
coverage and reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process
that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our product candidates to
the payor. Further, there is significant uncertainty related to third-party payor coverage and reimbursement of newly approved product
candidates, including our product candidates if they are approved. We may not be able to provide data sufficient to gain acceptance with
respect to coverage and reimbursement. We cannot be sure that coverage or adequate reimbursement will be available for any of our product
candidates. Also, we cannot be sure that reimbursement amounts will not reduce the demand for, or the price of, our product candidates.
If reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize certain of
our product candidates. In addition, in the United States, third-party payors are increasingly attempting to contain health care costs
by limiting both coverage and the level of reimbursement of new product candidates. As a result, significant uncertainty exists as to
whether and how much third-party payors will reimburse patients for their use of newly approved product candidates, which in turn will
put pressure on pricing.
In
some countries, including member states of the European Union, the pricing of prescription drugs is subject to governmental control.
In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of marketing approval
for a product. In addition, there can be considerable pressure from governments and other stakeholders on prices and reimbursement levels,
including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations,
and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various European Union member
states and other countries and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce
prices. In some countries, we may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of our
product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval. Publication of discounts
by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication
and other countries. If reimbursement of our product candidates is unavailable or limited in scope or amount, or if pricing is set at
unsatisfactory levels, our business could be adversely affected.
The
outbreak of the novel coronavirus disease, COVID-19, including its most recent variants, could materially adversely impact our business,
results of operations and financial condition, including our clinical trials.
The
COVID-19 pandemic, and government responses have created disruption in global supply chains and adversely impacting many industries.
The pandemic could have a continued material adverse impact on economic and market conditions. We continue to monitor the impact of the
COVID-19 pandemic, including its most recent variants, closely. The extent to which the COVID-19 pandemic will impact our operations
or financial results is uncertain.
The
pandemic and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce,
as worker shortages have occurred; supply chains have been disrupted; and demand for certain goods and services, such as medical services
and supplies, has spiked, while demand for other goods and services has fallen. While the extent of the impact of the COVID-19 pandemic
on our business and financial results is uncertain, a continued and prolonged public health crisis such as the COVID-19 pandemic could
have a material adverse effect on our business, financial condition and results of operations. As a result of the COVID-19 pandemic,
including its most recent variants, we may experience disruptions that could severely impact our business and clinical trials, including:
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delays
or difficulties in enrolling and retaining patients in our clinical trials; |
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delays
or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; |
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diversion
of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial
sites and hospital staff supporting the conduct of our clinical trials; |
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interruption
of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended
by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures, which
may impact the integrity of subject data and clinical study endpoints; |
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interruption
or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines; |
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interruption
of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages,
production slowdowns or stoppages and disruptions in delivery systems; |
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limitations
on employee and consulting resources that would otherwise be focused on the conduct of our clinical trials, including because of
sickness of employees, consultants or their families or the desire of employees or consultants to avoid contact with large groups
of people; |
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interruption
or delays to our outsourced clinical activities; or |
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changes
in clinical site procedures and requirements as well as regulatory requirements for conducting clinical trials during the pandemic. |
Since
March 2020, the FDA issued various COVID-19 related guidance documents, including guidance on conducting clinical trials during the pandemic
and on good manufacturing practice considerations, among others. The COVID-19 national and public health emergencies ended on May 11,
2023. The full impact of the termination of the public health emergencies on FDA and other regulatory policies and operations are unclear.
Any legal proceedings or claims against
us could be costly and time-consuming to defend and could harm our reputation regardless of the outcome.
We
may in the future become subject to legal proceedings and claims that arise in the ordinary course of business, including intellectual
property, product liability, employment, wage and hour, class action, derivative, whistleblower and other litigation claims, and governmental
and other regulatory investigations and proceedings. Such matters can be time-consuming, divert management’s attention and resources,
cause us to incur significant expenses or liability, or require us to change our business practices. In addition, the expense of litigation,
for which we are either not insured or only partially insured depending on the claim, and the timing of this expense from period to period
will be difficult to estimate, subject to change, and could adversely affect our financial condition and results of operations. Because
of the potential risks, expenses, and uncertainties of litigation, we may, from time to time, settle disputes, even where we have meritorious
claims or defenses, by agreeing to settlement agreements. Any of the foregoing could adversely affect our business, financial condition,
and results of operations.
Changes
in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
We
are or may become subject to income and non-income taxes in the United States under federal, state and local jurisdictions and in certain
foreign jurisdictions in which we operate. Tax laws, regulations and administrative practices in these jurisdictions may be subject to
significant change, with or without advance notice. For example, on January 1, 2022, a provision of the Tax Cuts and Jobs Act of 2017
went into effect that eliminates the option to deduct domestic research and development costs in the year incurred and instead requires
taxpayers to amortize such costs over five years. The Company is currently evaluating the potential impact. Also, the Inflation Reduction
Act, which introduced a 15% minimum tax on book income and a 1% excise tax on stock buybacks. Changes in tax laws (including provisions
of the recently enacted federal tax legislation titled the Inflation Reduction Act), regulations, or rulings, changes in interpretations
of existing laws and regulations, or changes in accounting principles could negatively and materially affect our financial position,
effective tax rates, cash flows, and results of operations.
Risks
Related to Intellectual Property
If
we are unable to protect our intellectual property effectively, we may be unable to prevent third parties from using our technologies,
which would impair our competitive advantage.
We
rely on patent protection as well as a combination of trademark, copyright and trade secret protection, and other contractual restrictions,
to protect our proprietary technologies, all of which provide limited protection and may not adequately protect our rights or permit
us to gain or keep any competitive advantage. We may not be successful in defending challenges made in connection with our patents and
patent applications. If we fail to protect our intellectual property, we will be unable to prevent third parties from using our technologies
and they will be able to compete more effectively against us.
The
degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations
and may not adequately protect our business or permit us to maintain our competitive advantage. For example, others may be able to make
products that are similar to our product candidates or utilize similar technology but that are not covered by the claims of the patents
that we license or may own; we, or our future licensors or collaborators, might not have been the first to file patent applications covering
certain of our or their inventions; and issued patents that we hold rights to may be held invalid or unenforceable, including as a result
of legal challenges by our competitors or other third parties.
In
addition to our patents, we rely on contractual restrictions to protect our proprietary technology. We require our employees and third
parties to sign confidentiality agreements and our employees are also required to sign agreements assigning to us all intellectual property
arising from their work for us. Nevertheless, we cannot guarantee that these measures will be effective in protecting our intellectual
property rights. Should any of these events occur, it or they could have a material adverse effect on our business, financial condition,
results of operations, and growth prospects.
If
any of our patent applications do not issue as patents in any jurisdiction, we may not be able to compete effectively.
Our
currently pending or future patent applications may not result in issued patents and any patents issued to us may be challenged, invalidated,
or held unenforceable. Changes in either the patent laws or their interpretation in the U.S. and other countries may diminish our ability
to protect our inventions, obtain, maintain, and enforce our intellectual property rights, and, more generally, could affect the value
of our intellectual property or narrow the scope of our patents with respect to our product candidates. Furthermore, we cannot be certain
that we were the first to make the invention claimed in our issued patents or pending patent applications in the U.S., or that we were
the first to file for protection of the inventions claimed in our foreign issued patents or pending patent applications.
There
are numerous recent changes to the patent laws and proposed changes to the rules of the United States Patent and Trademark Office (“USPTO”),
which may have a significant impact on our ability to protect our technology and enforce our intellectual property rights. For example,
in September 2011, the U.S. enacted sweeping changes to the U.S. patent system under the Leahy-Smith America Invents Act, including changes
that transitioned the U.S. from a “first-to-invent” system to a “first-to-file” system and alter the processes
for challenging issued patents. These changes could increase the uncertainties and costs surrounding the prosecution of our patent applications
and the enforcement or defense of our issued patents. In addition, we may become subject to interference proceedings conducted in the
patent and trademark offices of various countries to determine our entitlement to patents, and these proceedings may conclude that other
patents or patent applications have priority over our patents or patent applications.
It
is also possible that a competitor may successfully challenge our patents through various proceedings and those challenges may result
in the elimination or narrowing of our patents, and therefore reduce our patent protection. The patent prosecution process is expensive,
time-consuming, and complex, and we may not be able to file, prosecute, maintain, enforce, or license all necessary or desirable patent
applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our
research and development output in time to obtain patent protection. We may not have the right to control the preparation, filing and
prosecution of patent applications, or to maintain the rights to patents licensed to third parties. Therefore, these patents and applications
may not be prosecuted and enforced in a manner consistent with the best interests of our business. Any parties who enter into nondisclosure
or confidentiality agreements with us that have access to confidential or patentable aspects of our research and development output may
breach such agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent
protection. In addition, rights under any of our issued patents, patent applications or future patents may not provide us with commercially
meaningful protection for our products or afford us a commercial advantage against our competitors or their competitive products or processes.
If
our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest
and our business may be adversely affected.
Our
unregistered trademarks or trade names may be challenged, infringed, circumvented, or declared generic or determined to be infringing
on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition
among potential collaborators or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar
to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential
trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations
of our unregistered trademarks or trade names. Over the long term, if we are unable to successfully register our trademarks and trade
names and establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our
business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain
names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources
and could adversely impact our financial condition or results of operations.
The
patents issued to us may not be broad enough to provide any meaningful protection, one or more of our competitors may develop more effective
technologies, designs or methods without infringing our intellectual property rights and one or more of our competitors may design around
our proprietary technologies.
If
we are not able to protect our proprietary technology, trade secrets and know-how, our competitors may use our inventions to develop
competing products. Our patents may not protect us against our competitors, and patent litigation is very expensive. We may not have
sufficient cash available to pursue any patent litigation to its conclusion because we currently do not generate revenues other than
licensing, milestone and royalty income.
We
cannot rely solely on our current patents to be successful. The standards that the USPTO and foreign patent office’s use to grant
patents, and the standards that U.S. and foreign courts use to interpret patents, are not the same, are not always applied predictably
or uniformly and can change, particularly as new technologies develop. As such, the degree of patent protection obtained in the U.S.
may differ substantially from that obtained in various foreign countries.
We
cannot be certain of the level of protection, if any, that will be provided by our patents if they are challenged in court, where our
competitors may raise defenses such as invalidity, unenforceability, or possession of a valid license. In addition, the type and extent
of any patent claims that may be issued to us in the future are uncertain. Any patents that are issued may not contain claims that will
permit us to stop competitors from using similar technology.
We
may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.
Third
parties may challenge the validity, inventorship or ownership of our patents and other intellectual property rights, resulting in costly
litigation or other time-consuming and expensive proceedings, which could deprive us of valuable rights. If we become involved in any
intellectual property litigation, interference or other judicial or administrative proceedings, we will incur substantial expenses and
the attention of our technical and management personnel will be diverted. An adverse determination may subject us to significant liabilities
or require us to seek licenses that may not be available from third parties on commercially favorable terms, if at all. Further, if such
claims are proven valid, through litigation or otherwise, we may be required under applicable law to pay substantial monetary damages,
which can be tripled if the infringement is deemed willful, or be required to discontinue or significantly delay development, marketing,
selling and licensing of the affected products and intellectual property rights.
Our
competitors may have filed, and may in the future file, patent applications covering technology similar to ours. Any such patent application
may have priority over our patent applications and could further require us to obtain rights to issued patents covering such technologies.
There may be third-party patents, patent applications and other intellectual property relevant to our potential products that may block
or compete with our potential products or processes. If another party has filed a U.S. patent application on inventions similar to ours,
we may have to participate in an interference proceeding declared by the USPTO to determine priority of invention in the U.S. The costs
of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful, resulting in a loss of our U.S.
patent position with respect to such inventions. In addition, we cannot assure you that we would prevail in any of these suits or that
the damages or other remedies that we are ordered to pay, if any, would not be substantial. Claims of intellectual property infringement,
misappropriation or other violations against us may require us to enter into royalty or license agreements with third parties that may
not be available on acceptable terms, if at all. We may also be subject to injunctions against the further development and use of our
technology, which could materially adversely affect our business, prospects and financial condition.
Some
of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially
greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could materially adversely
affect our ability to raise the funds necessary to continue our operations.
Obtaining and maintaining patent protection
depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent
agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic
maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime
of the patent. In the United States, patents have a limited lifespan, and if all maintenance fees are timely paid, the natural expiration
of a patent is generally 20-years from its earliest U.S. non-provisional filing date. The USPTO and various foreign governmental patent
agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent application
process and following the issuance of a patent. While an inadvertent lapse can in many cases be cured by payment of a late fee or by
other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of
the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance
events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond
to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.
In certain circumstances, even inadvertent noncompliance events may permanently and irrevocably jeopardize patent rights. In such an
event, our competitors might be able to enter the market, which would have a material adverse effect on our business.
If
we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such
agreements, our business could be harmed.
It
may be necessary for us to use the patented or proprietary technology of third parties to commercialize our products, in which case we
would be required to obtain a license from these third parties. If we are unable to license such technology, or if we are forced to license
such technology, on unfavorable terms, our business could be materially harmed. If we are unable to obtain a necessary license, we may
be unable to develop or commercialize the affected product candidates, which could materially harm our business, and the third parties
owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation
on our part to pay royalties and/or other forms of compensation. Even if we are able to obtain a license, agreements we may enter into
in the future, if any, may not provide exclusive rights to use certain intellectual property and technology retained by the collaborator
in all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology and products in
the future. As a result, we may not be able to prevent competitors or other third parties from developing and commercializing competitive
products that utilize technology retained by such collaborators to the extent such products are not also covered by our intellectual
property. In such an event, our business, financial condition, results of operations, and growth prospects could be materially harmed.
We
rely on confidentiality agreements to protect our trade secrets. If these agreements are breached by our employees or other parties,
our trade secrets may become known to our competitors. We may also be subject to claims that our employees, consultants, or advisors
have wrongfully used or disclosed alleged trade secrets or claims asserting ownership of what we regard as our own intellectual property.
We
rely on trade secrets that we seek to protect through confidentiality agreements with our employees and other parties. If these agreements
are breached, our competitors may obtain and use our trade secrets to gain a competitive advantage over us. We may not have any remedies
against our competitors and any remedies that may be available to us may not be adequate to protect our business or compensate us for
the damaging disclosure. In addition, we may have to expend resources to protect our interests from possible infringement by others.
In
addition, although we try to ensure that our employees, consultants, and advisors do not use the proprietary information or know-how
of others in their work for us, we may be subject to claims that we or these individuals have used or disclosed intellectual property,
including trade secrets or other proprietary information, of any such individual’s current or former employer. Litigation may be
necessary to defend against these claims.
Risks
Related to Our Common Stock
An
active trading market for our common stock may not be sustained.
Prior
to the closing of our IPO in August 2021, there was no public trading market for our common stock. Although our common stock is listed
on the Nasdaq Capital Market, the market for our shares has demonstrated varying levels of trading activity. Our ability to raise capital
to continue to fund operations by selling shares of our common stock and our ability to acquire other companies or technologies by using
shares of our common stock as consideration may be impaired if an active trading market for our common stock is not sustained.
The market price of our common stock
may be volatile and fluctuate substantially, which could result in substantial losses for investors.
The
market price of our common stock is likely to be highly volatile and may be subject to wide fluctuations in response to a variety of
factors, some of which are beyond our control. These factors include the following:
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any
delay in the commencement, enrollment and ultimate completion of our clinical trials; |
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any
delay in submitting an NDA and any adverse development or perceived adverse development with respect to the FDA’s review of
that NDA; |
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failure
to successfully develop and commercialize RenovoGem; |
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inability
to obtain additional funding; |
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regulatory
or legal developments in the United States and other countries applicable to RenovoGem or any other product candidate; |
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adverse
regulatory decisions; |
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changes
in the structure of healthcare payment systems; |
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inability
to obtain adequate product supply for RenovoGem, RenovoCath or any other product candidate, or the inability to do so at acceptable
prices; |
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introduction
of new products, services or technologies by our competitors; |
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failure
to meet or exceed financial projections we provide to the public; |
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failure
to meet or exceed the estimates and projections of the investment community; |
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changes
in the market valuations of companies similar to ours; |
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market
conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts’ reports
or recommendations; |
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announcements
of significant acquisitions, strategic collaborations, joint ventures or capital commitments by us or our competitors; |
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significant
lawsuits, including patent or stockholder litigation, and disputes or other developments relating to our proprietary rights, including
patents, litigation matters and our ability to obtain patent protection for our technologies; |
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additions
or departures of key scientific or management personnel; |
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sales
of our common stock or other securities by us, our insiders or our other stockholders, including pursuant to the existing primary
and secondary shelf registration statements that we have filed with the SEC; |
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expiration
of market standoff or lock-up agreements; |
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trading
volume of our common stock; |
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fluctuations
in interest rates and inflation rates; |
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general
economic, industry and market conditions; |
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health
epidemics and outbreaks, including the COVID-19 pandemic, or other natural or man-made disasters which could significantly disrupt
our preclinical studies and clinical trials, and therefore our receipt of necessary regulatory approvals could be delayed or prevented;
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the
other factors described in this “Risk Factors” section. |
In
addition, the stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market
prices of equity securities of many companies. These fluctuations have often been unrelated or disproportionate to the operating performance
of those companies. Broad market and industry factors, as well as general economic, political, regulatory and market conditions, may
negatively affect the market price of our common stock, regardless of our actual operating performance. In particular, stock markets
have experienced extreme volatility due to the ongoing COVID-19 pandemic, including the emergence of new variants; recent inflationary
concerns; and investor concerns and uncertainty related to the impact of the pandemic on the economies of countries worldwide.
Raising
additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our
product candidates on unfavorable terms to us.
We
may seek additional capital through a variety of means, including through public or private equity, debt financings or other sources,
including up-front payments and milestone payments from strategic collaborations. For example, we have filed an omnibus shelf registration
statement on Form S-3 that provides for aggregate offerings of up to $50 million of the Company’s securities subject to various
limitations, including limited sales in any twelve-month period while we are subject to the “baby-shelf” rules. On April
3, 2023, we completed the Registered Direct Offering under our shelf registration statement on Form S-3 for the purchase and sale of
1,557,632 shares of the Company’s common stock (or pre-funded common stock warrants) at a purchase price of $3.21 per share of
common stock (or pre-funded common stock warrants) to a certain institutional investor. Additionally, in a concurrent private placement,
we issued to the investor unregistered warrants to purchase up to 1,947,040 shares of our common stock. The aggregate gross proceeds
from the March 2023 Offering were approximately $5 million before deducting placement fees and other offering expenses. We also have
filed a registration statement on Form S-1 to register the cash exercise of our outstanding warrants, with such cash exercise only expected
to occur when the trading price of our common stock is in excess of the $10.80 per share exercise price of our outstanding warrants.
To the extent that we raise additional capital through the sale of equity or convertible debt or equity securities, your ownership interest
will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. Such
financing may result in dilution to stockholders, imposition of debt covenants, increased fixed payment obligations or other restrictions
that may affect our business. If we raise additional funds through up-front payments or milestone payments pursuant to strategic collaborations
with third parties, we may have to relinquish valuable rights to our product candidates or grant licenses on terms that are not favorable
to us. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe
we have sufficient funds for our current or future operating plans.
If
we fail to regain compliance with or meet all applicable Nasdaq requirements, we could be delisted from Nasdaq, which would seriously
harm the liquidity of our stock and our ability to raise capital.
Our
common stock is listed on the Nasdaq Capital Market. In order to maintain our listing, we must meet minimum financial and other requirements,
including a minimum amount in stockholders’ equity.
On
August 21, 2023, we received a notice from Nasdaq notifying us that, as of August 18, 2023, the Company was not in compliance with the
minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market, under Listing Rule 5550(b)(1), because
the Company’s stockholders’ equity of $1,188,000 as reported in the Company’s Quarterly Report on Form 10-Q for the
period ended June 30, 2023 was below the required minimum of $2.5 million (the “Equity Requirement”), and because, as of
June 30, 2023, the Company did not meet the alternative compliance standards, relating to the market value of listed securities of $35
million or net income from continuing operations of $500,000 in the most recently completed fiscal year.
In
accordance with the Nasdaq Listing Rules 5810(c)(2)(C), we were provided 45 calendar days from August 21, 2023, or until October 5, 2023,
to submit a plan to regain compliance with the Equity Requirement (the “Compliance Plan”). We submitted the Compliance Plan
to Nasdaq on October 5, 2023. On October 31, 2023, the Company received formal notice that the Staff had granted the Company’s request
for continued listing on Nasdaq pursuant to an extension, ultimately through February 19, 2024, to evidence full compliance with all applicable criteria for continued listing
on The Nasdaq Capital Market, including the $2.5 million stockholders’ equity requirement set forth in Nasdaq Listing Rule 5550(b)(2).
The
Company is diligently working to provide timely evidence compliance with the terms of the Staff’s decision; however, there can
be no assurance that the Company will be able to do so. In the event the Company does not evidence full compliance with the Nasdaq
listing criteria by February 19, 2024, the Staff must issue a delist determination, which would be stayed upon the Company’s
timely request for a hearing before the Panel. The Company’s request for a hearing would stay any further action by the Staff
at least pending a hearing, the subsequent issuance of a decision by the Panel, and the expiration of any additional extension the
Panel may grant to the Company as a result of the hearing.
If
the Nasdaq Stock Market delists our common stock, we could face significant material adverse consequences, including:
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a
limited availability of market quotations for our securities; |
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a
determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere
to more stringent rules and possibly resulting in a reduced level of trading activity in the secondary trading market for our common
stock; |
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a
limited amount of news and analyst coverage for our Company; and |
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a
decreased ability to issue additional securities or obtain additional financing in the future. |
We
could be subject to securities class action litigation.
In
the past, securities class action and derivative litigation has often been brought against companies following a decline in the market
price of their securities or upon the occurrence of other corporate events. This risk is especially relevant for us because biotechnology
companies have experienced significant share price volatility in recent years. If we face such litigation, it could result in substantial
costs, for which we are not insured, and a diversion of management’s attention and resources, which could harm our business.
If
securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the market
price for the shares and trading volume could decline.
The
trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us
or our business. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may
provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of
our common stock could decline substantially. If one or more of the analysts who cover us downgrades our common stock or publishes inaccurate
or unfavorable research about our business, the market price for our common stock would likely decline. If one or more of these analysts
cease coverage of our Company or fail to publish reports on us regularly, we could lose visibility in the financial markets, which, in
turn, could cause the market price or trading volume for our common stock to decline.
We
do not expect to pay dividends in the foreseeable future, and you must rely on price appreciation of your shares for return on your investment.
We
have paid no cash dividends on any class of our stock to date, and we do not anticipate paying cash dividends in the near term. For the
foreseeable future, we intend to retain any earnings to finance the development and expansion of our business, and we do not anticipate
paying any cash dividends on our stock. Accordingly, investors must be prepared to rely on sales of their shares of common stock after
price appreciation to earn an investment return, which may never occur. Investors seeking cash dividends should not purchase our shares
of common stock. Any determination to pay dividends in the future will be made at the discretion of our board of directors and will depend
on our results of operations, financial condition, contractual restrictions, restrictions imposed by applicable law and other factors
our board deems relevant.
We
have incurred and will continue to incur increased costs as a result of operating as a public company, and our management has devoted
and will continue to devote substantial time to new compliance initiatives and corporate governance practices.
As
a public company, we have incurred and particularly after we no longer qualify as an emerging growth company, we will continue to incur
significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act of 2002 (“SOX”),
the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq, and other applicable securities rules
and regulations impose various requirements on U.S. reporting public companies, including the establishment and maintenance of effective
disclosure and financial controls and corporate governance practices. Our management and other personnel will need to continue to devote
a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations have increased our legal and financial
compliance costs and have made some activities more time-consuming and costly. For example, we expect that these rules and regulations
may make it more expensive for us to obtain director and officer liability insurance, which in turn could make it more difficult for
us to attract and retain qualified senior management personnel or members for our board of directors. In addition, these rules and regulations
are often subject to varying interpretations, and, as a result, their application in practice may evolve over time as new guidance is
provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs
necessitated by ongoing revisions to disclosure and governance practices.
Pursuant
to Section 404 of SOX (“Section 404”), we will be required to furnish a report by our senior management on our internal control
over financial reporting beginning with our second filing of an Annual Report on Form 10-K with the SEC.
However,
while we remain an emerging growth company, we will not be required to include an attestation report on internal control over financial
reporting issued by our independent registered public accounting firm. To prepare for eventual compliance with Section 404, once we no
longer qualify as an emerging growth company, we will be engaged in a process to document and evaluate our internal control over financial
reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially
engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting,
continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and
implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is
a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting
is effective as required by Section 404.
We
have identified material weaknesses in our internal control over financial reporting. Failure to maintain effective internal controls
could cause our investors to lose confidence in us and adversely affect the market price of our common stock. If our internal controls
are not effective, we may not be able to accurately report our financial results or prevent fraud.
Effective
internal control over financial reporting is necessary for us to provide reliable financial reports in a timely manner. In connection
with the audit of our financial statements as of and for the years ended December 31, 2022, 2021, 2020 and 2019, we identified material
weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in
internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or
interim financial statements will not be prevented or detected on a timely basis. Specifically, we determined that we lacked a sufficient
number of qualified accounting and financial reporting personnel with an appropriate level of knowledge, training and experience to address
complex accounting issues, sufficient written policies and procedures for accounting and financial reporting in accordance with U.S.
Generally Accepted Accounting Principles (“GAAP”), and adequate management review controls. In addition, we determined that
our financial statement close process includes significant control gaps mainly driven by the small size of our accounting and finance
staff and, as a result, a significant lack of appropriate segregation of duties.
The
above material weaknesses could result in a misstatement of our account balances or disclosures that would result in a material misstatement
of our annual or interim financial statements that would not be prevented or detected. To address the material weaknesses, we have implemented,
and are continuing to implement, measures designed to improve internal control over financial reporting, including expanding our accounting
and finance team to add additional qualified accounting and finance resources, which may include third party consultants, and new financial
processes. We intend to continue to take steps to remediate the material weaknesses through the hiring or engagement of additional experienced
accounting and financial reporting personnel, formalizing documentation of policies and procedures and further evolving the accounting
processes, including implementing appropriate segregation of duties. We expect to incur additional costs to remediate these weaknesses,
including personnel, consulting and other costs.
We
may not be successful in implementing these changes or in developing other internal controls, which may undermine our ability to provide
accurate, timely and reliable reports on our financial and operating results. Further, we will not be able to fully assess whether the
steps we are taking will remediate the material weakness in our internal control over financial reporting until we have completed our
implementation efforts and sufficient time passes in order to evaluate their effectiveness. In addition, until we remediate these weaknesses,
or if we identify additional material weaknesses in our internal control over financial reporting, we may not detect errors on a timely
basis and our financial statements may be materially misstated. Moreover, in the future we may engage in business transactions, such
as acquisitions, reorganizations or implementation of new information systems that could negatively affect our internal control over
financial reporting and result in material weaknesses.
If
we identify new material weaknesses in our internal control over financial reporting, if we are unable to comply with the requirements
of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we are unable to assert that our internal control over financial reporting
is effective, we may be late with the filing of our periodic reports, investors may lose confidence in the accuracy and completeness
of our financial reports, and the market price of our common stock could be negatively affected. As a result of such failures, we could
also become subject to investigations by the stock exchange on which our securities are listed, the SEC, or other regulatory authorities,
and become subject to litigation from investors and stockholders, which could harm our reputation, financial condition or divert financial
and management resources from our core business.
Our
disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
As
a public company, we maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed
by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s
rules and forms, and that such information is accumulated, communicated and discussed with our management, including our Chief Executive
Officer and Chief Financial Officer or persons performing similar functions, as appropriate, to allow timely decisions regarding required
disclosure. We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well designed and
operated, can provide only reasonable, not absolute, assurance that the desired control objectives will be met.
In
reaching a reasonable level of assurance, management has weighed the cost of contemplated controls against their intended benefits. The
design of any system of controls is based on management’s assumptions about the likelihood of future events. We cannot assure you
that our controls will achieve their stated goals under all possible conditions. Changes in future conditions may render our controls
inadequate or may cause our degree of compliance with them to deteriorate. These inherent limitations include the fact that judgments
in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented
by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly,
because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.
Under
the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial and Accounting
Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and
15d-15(e) under the Exchange Act) as of the end of the year ended December 31, 2022. Based on this evaluation, our Chief Executive Officer
and Chief Financial and Accounting Officer have concluded that, during the period covered by this Annual Report on Form 10-K, our disclosure
controls and procedures were not effective due to our previously identified material weaknesses in internal control over financial reporting.
As a result, we have performed additional analysis as deemed necessary to ensure that our financial statements were prepared in accordance
with U.S. GAAP. Accordingly, notwithstanding the identified material weaknesses, management, including our Chief Executive Officer and
Chief Financial and Accounting Officer, believes the financial statements included in this Annual Report on Form 10-K are fairly presented,
in all material respects, in accordance with U.S. GAAP.
We
are an “emerging growth company,” and the reduced reporting requirements applicable to emerging growth companies may make
our common stock less attractive to investors.
We
are an “emerging growth company,” as defined in the JOBS Act. For as long as we continue to be an emerging growth company,
we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging
growth companies, including exemption from compliance with the auditor attestation requirements of Section 404; the ability to delay
the implementation of new or revised financial accounting standards; reduced disclosure obligations regarding executive compensation;
and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any
golden parachute payments not previously approved. As a result, the information we provide stockholders will be different than the information
that is available with respect to other public companies. We will remain an emerging growth company until the earlier of (1) the last
day of the fiscal year (a) following the fifth anniversary of the closing of our IPO, (b) in which we have total annual gross revenue
of at least $1.07 billion or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock
held by non-affiliates exceeds $700 million as of the end of our prior second fiscal quarter, or (2) the date on which we have issued
more than $1.0 billion in non-convertible debt during the prior three-year period.
In
addition, under the JOBS Act, emerging growth companies may delay adopting new or revised accounting standards until such time as those
standards apply to private companies. We may elect not to avail ourselves of this exemption from new or revised accounting standards
and, therefore, may be subject to the same new or revised accounting standards as other public companies that are not emerging growth
companies.
We
cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find
our common stock less attractive as a result of these exemptions, there may be a less active trading market for our common stock and
our share price may be more volatile.
Anti-takeover
and other provisions contained in our certificate of incorporation and bylaws, as well as provisions of Delaware law, could impair a
takeover attempt and have other impacts on our corporate governance.
Our
certificate of incorporation, bylaws and Delaware law contain provisions that could have the effect of rendering more difficult, delaying
or preventing an acquisition deemed undesirable by our board of directors or otherwise impact our corporate governance. Our corporate
governance documents include provisions:
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● |
authorizing
“blank check” preferred stock, which could be issued by our board of directors without stockholder approval and may contain
voting, liquidation, dividend, and other rights superior to our common stock; |
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limiting
the liability of, and providing indemnification to, our directors and officers; |
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limiting
the ability of our stockholders to call and bring business before special meetings; |
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requiring
advance notice of stockholder proposals for business to be conducted at meetings of our stockholders and for nominations of candidates
for election to our board of directors; |
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controlling
the procedures for the conduct and scheduling of board of directors and stockholder meetings; |
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providing
our board of directors with the express power to postpone previously scheduled annual meetings and to cancel previously scheduled
special meetings; and
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providing
for a quorum comprised of stockholders representing one-third of the voting power of our outstanding shares of common stock to hold
valid annual or special meetings of our stockholders. |
These
provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management. Our reduced
quorum requirement could also lead to corporate governance changes resulting from stockholder required votes in which a minority of one-third
of our outstanding stockholders could take actions at annual or special meetings of our stockholders that impact our company as compared
to other companies in which a majority of stockholders are required for a quorum.
As
a Delaware corporation, we are also subject to provisions of Delaware law, including Section 203 of the Delaware General Corporation
law, which prevents some stockholders holding more than 15% of our outstanding common stock from engaging in certain business combinations
without approval of the holders of substantially all of our outstanding common stock.
Any
provision of our certificate of incorporation, bylaws or Delaware law that has the effect of delaying or deterring a change in control
could limit the opportunity for our stockholders to receive a premium for their shares of our common stock. These provisions and the
impact of the reduced quorum requirement could also affect the price that some investors are willing to pay for our common stock.
Our
certificate of incorporation, as amended, designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for
certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability
to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.
Our
certificate of incorporation requires that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery
of the State of Delaware will, to the fullest extent permitted by law, be the sole and exclusive forum for each of the following:
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any
derivative action or proceeding brought on our behalf; |
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any
action asserting a claim for breach of any fiduciary duty owed by any director, officer or other employee of ours to the Company
or our stockholders, creditors or other constituents; |
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any
action asserting a claim against us or any director or officer of ours arising pursuant to, or a claim against us or any of our directors
or officers, with respect to the interpretation or application of any provision of, the DGCL, our certificate of incorporation or
bylaws; or |
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any
action asserting a claim governed by the internal affairs doctrine; |
provided,
that, if and only if the Court of Chancery of the State of Delaware dismisses any of the foregoing actions for lack of subject matter
jurisdiction, any such action or actions may be brought in another state court sitting in the State of Delaware.
The
exclusive forum provision is limited to the extent permitted by law, and it will not apply to claims arising under the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or for any other federal securities laws which provide for exclusive federal
jurisdiction.
Furthermore,
Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly,
both state and federal courts have jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictions
and the threat of inconsistent or contrary rulings by different courts, among other considerations, our second amended and restated certificate
of incorporation provides that the federal district courts of the United States of America will be the exclusive forum for resolving
any complaint asserting a cause of action arising under the Securities Act. While the Delaware courts have determined that such choice
of forum provisions are facially valid, a stockholder may nevertheless seek to bring such a claim arising under the Securities Act against
us, our directors, officers, or other employees in a venue other than in the federal district courts of the United States of America.
In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our second
amended and restated certificate of incorporation.
Although
we believe this provision benefits us by providing increased consistency in the application of Delaware law in the types of lawsuits
to which it applies, this provision may limit or discourage a stockholder’s ability to bring a claim in a judicial forum that it
finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and
our directors, officers and other employees. Alternatively, if a court were to find the choice of forum provision contained in our certificate
of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action
in other jurisdictions, which could adversely affect our business and financial condition.
We
note that there is uncertainty as to whether a court would enforce the provision and that investors cannot waive compliance with the
federal securities laws and the rules and regulations thereunder. Although we believe this provision benefits us by providing increased
consistency in the application of Delaware law in the types of lawsuits to which it applies, the provision may have the effect of discouraging
lawsuits against our directors and officers.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
Unregistered
Sales of Equity Securities
None.
Use
of Proceeds from Public Offering of Common Stock
There
has been no material change in the planned use of proceeds from our IPO as described in our final prospectus filed with the SEC on August
27, 2021, pursuant to Rule 424(b)(4). We placed the funds received into an interest-bearing money market account. No payments were made
by us to directors, officers or persons owning ten percent or more of our common stock or to their associates, or to our affiliates,
other than payments in the ordinary course of business to officers for salaries and to non-employee directors pursuant to our Outside
Director Compensation Policy, as amended.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
None.
Item
5. Other Information
Not
applicable.
Item
6. Exhibits
* |
Indicates
management contract or compensatory plan. |
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† |
The
certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are deemed furnished and not
filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Registrant under
the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date
of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
RenovoRx,
Inc. |
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Date:
November 13, 2023 |
By:
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/s/
Shaun R. Bagai |
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Shaun
R. Bagai |
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Chief
Executive Officer |
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Date:
November 13, 2023 |
By:
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/s/
James M. Ahlers |
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James
M. Ahlers |
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|
Chief
Financial Officer |
Exhibit
10.4
RenovoRx,
INC.
OUTSIDE
DIRECTOR COMPENSATION POLICY
Initially
Adopted and Approved by the Board of Directors on September 30, 2021; amended and restated September 29, 2022; most recently amended
and restated September 7, 2023 (the “Restatement Date”)
RenovoRx,
Inc. (the “Company”) believes that providing cash and equity compensation to its members of the Board of Directors
(the “Board,” and members of the Board, the “Directors”) represents an effective tool to attract,
retain and reward Directors who are not employees of the Company (the “Outside Directors”). This Outside Director
Compensation Policy as amended and restated (the “Policy”) is intended to formalize the Company’s policy regarding
the compensation to its Outside Directors. Unless otherwise defined herein, capitalized terms used in this Policy will have the meaning
given to such terms in the Company’s 2021 Omnibus Equity Incentive Plan (the “Plan”), or if the Plan is no longer
in place, the meaning given to such terms or any similar terms in the equity plan then in place. Each Outside Director will be solely
responsible for any tax obligations incurred by such Outside Director as a result of the equity and cash payments such Outside Director
receives under this Policy.
This
amended and restated Policy is effective as of the Restatement Date, unless otherwise specified in specific sections of this Policy.
Annual
Cash Retainer
Each
Outside Director will be paid an annual cash retainer of $36,000. Effective January 1, 2024, the annual cash retainer shall be raised
to $40,000. There are no per-meeting attendance fees for attending Board meetings. This cash compensation will be paid quarterly in arrears
on a prorated basis to each Outside Director who has served in the relevant capacity at any point during the immediately preceding fiscal
quarter, and such payment shall be made no later than forty-five (45) days following the end of such immediately preceding fiscal quarter.
Committee
Annual Cash Retainer
Effective
as of April 12, 2022, each Outside Director who serves as the chair or a member of a committee of the Board listed below will be eligible
to earn additional annual cash fees (paid quarterly in arrears on a prorated basis to each Outside Director who has served in the relevant
capacity at any point during the immediately preceding fiscal quarter, and such payment shall be made no later than forty-five (45) days
following the end of such immediately preceding fiscal quarter) as follows:
Chair
of Audit Committee: | |
$ | 15,000 | |
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| | |
Chair
of Compensation Committee: | |
$ | 10,000 | |
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Chair
of Corporate Governance and Nominating Committee: | |
$ | 10,000 | |
| |
| | |
Non-Chair
Members of Various Committees: | |
$ | 5,000 | |
| |
| | |
Lead
Independent Director | |
$ | 5,000 | |
Effective
January 1, 2024, the Non-Chair Members of the Audit Committee annual fee shall increase to $7,500.
For
clarity, each Outside Director who serves as the chair of a committee shall receive only the additional annual cash fee as the chair
of the committee, and not the additional annual cash fee as a member of the committee. For purposes of further clarification, an Outside
Director who has served as an Outside Director, or as a member of an applicable committee (or chair thereof), as applicable, during only
a portion of the relevant Company fiscal quarter will receive a pro-rated payment of the quarterly payment of the applicable annual cash
retainer(s), calculated based on the number of days during such fiscal quarter such Outside Director has served in the relevant capacities.
Outside
Directors will be eligible to receive all types of Awards (except Incentive Stock Options) under the Plan (or the applicable equity plan
in place at the time of grant), including discretionary Awards not covered under this Policy. All grants of Awards to Outside Directors
pursuant to Section 2 of this Policy will be automatic and nondiscretionary, except as otherwise provided herein, and will be made in
accordance with the following provisions:
(a)
No Discretion. No person will have any discretion to select which Outside Directors will be granted any Awards under this Policy
or to determine the number of Shares to be covered by such Awards.
(b)
Initial Award. Subject to the following sentence and the terms of this Policy, each individual who first becomes an Outside Director
following the Restatement Date will be granted Options having a Value of $120,000 in the aggregate (an “Initial Award”),
on the date on which such individual first becomes an Outside Director, whether through election by the stockholders of the Company or
appointment by the Board to fill a vacancy. Notwithstanding the foregoing, no Initial Award granted on or after the Restatement Date
but on or prior to September 30, 2024 will cover more than 43,026 Shares (with such maximum number of Shares to be automatically proportionately
adjusted in the event of a Change in Capitalization, with any fractional Share resulting from such adjustment eliminated). Subject to
Section 11 of the Plan and Section 3 of this Policy, each Initial Award will vest and become exercisable over three years, with 1/36th
of the Initial Award vesting each month on the same day of the month as the commencement of the applicable Outside Director’s service
as an Outside Director, subject to the Outside Director continuing to be a Participant (as defined in the Plan) through such date.
(c)
Annual Award. Subject to the following sentence and the terms of this Policy, on October 1 of each year, commencing October 1,
2022, each Outside Director will be automatically granted Options having a Value of $70,000 in the aggregate (an “Annual Award”).
Notwithstanding the foregoing, no Annual Award granted on or after the Restatement Date but on or prior to September 30, 2024 will cover
more than 25,099 Shares (with such maximum number of Shares to be automatically proportionately adjusted in the event of a Change in
Capitalization, with any fractional Share resulting from such adjustment eliminated). Subject to Section 11 of the Plan and Section 3
of this Policy, 1/12th of each Annual Award will vest monthly after October 1 on the first day of each subsequent month, subject to the
applicable Outside Director continuing to be a Participant through such date.
(c)
Terms. The terms and conditions of each Initial Award or Annual Award will be as follows:
(i)
Exercise Price. The per Share exercise price for an Option granted under this Policy will be 100% of the Fair Market Value on
the grant date.
(ii)
Term. The maximum term to expiration of an Option granted under this Policy will be 10 years, subject to earlier termination as
provided in the Plan.
(d)
Value. For purposes of this Policy, “Value” means the grant date fair value as determined for the Company’s
financial reporting purposes.
In
the event of a Change in Control, each Outside Director will fully vest in his or her outstanding Company equity Awards, including any
Initial Award or Annual Award, provided that the Outside Director continues to be an Outside Director through such date.
| 4. | Annual
Compensation Limit |
In
any fiscal year, other than the fiscal year in which he or she joins the Board, no Outside Director may be paid, issued or granted compensation
(including in the form of cash or equity compensation, with cash compensation measured for this purpose at its value upon payment and
any equity compensation measured for this purpose at its Value) with an aggregate value greater than $250,000 (increased to $300,000
for an Outside Director’s first fiscal year of service). Any cash compensation paid or equity compensation award (including any
Awards) granted to an individual for his or her services as an employee, or for his or her services as a consultant (other than as an
Outside Director), will not count for purposes of the limitation under this Section 4.
Each
Outside Director’s reasonable, customary and documented travel expenses to Board or Board committee meetings will be reimbursed
by the Company.
All
provisions of the Plan not inconsistent with this Policy will apply to Awards granted to Outside Directors.
In
the event that that any extraordinary dividend or other extraordinary distribution (whether in the form of cash, Shares, other securities
or other property), recapitalization, stock split, reverse stock split, reorganization, merger, consolidation, split-up, spin-off, combination,
repurchase, or exchange of Shares or other securities of the Company, or other change in the corporate structure of the Company affecting
the Shares occurs, the Administrator, in order to prevent diminution or enlargement of the benefits or potential benefits intended to
be made available under this Policy, will adjust the number of Shares issuable pursuant to Awards granted under this Policy.
In
no event will cash compensation or expense reimbursement payments under this Policy be paid after the later of (i) 15th day of the third
month following the end of the Company’s fiscal year in which the compensation is earned or expenses are incurred, as applicable,
or (ii) 15th day of the third month following the end of the calendar year in which the compensation is earned or expenses are incurred,
as applicable, in compliance with the “short-term deferral” exception under Section 409A of the Internal Revenue Code of
1986, as amended, and the final regulations and guidance thereunder, as may be amended from time to time (together, “Section
409A”). It is the intent of this Policy that this Policy and all payments hereunder be exempt from or otherwise comply with
the requirements of Section 409A so that none of the compensation to be provided hereunder will be subject to the additional tax imposed
under Section 409A, and any ambiguities or ambiguous terms herein will be interpreted to be so exempt or comply. In no event will the
Company reimburse an Outside Director for any taxes imposed or other costs incurred as a result of Section 409A.
The
Board may amend, alter, suspend or terminate this Policy at any time and for any reason. No amendment, alteration, suspension or termination
of this Policy will materially impair the rights of an Outside Director with respect to compensation that already has been paid or awarded,
unless otherwise mutually agreed between the Outside Director and the Company. Termination of this Policy will not affect the Board’s
or the Compensation Committee’s ability to exercise the powers granted to it under the Plan with respect to Awards granted under
the Plan pursuant to this Policy prior to the date of such termination.
Exhibit 31.1
CERTIFICATION
PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Shaun R. Bagai, certify that:
1. I have reviewed this Quarterly
Report on Form 10-Q of RenovoRx, Inc.;
2. Based on my knowledge, this
report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made,
in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the
financial statements, and other financial information included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other
certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:
|
a. |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
d. |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. The registrant’s other
certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s
auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a. |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
|
|
|
b. |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 13, 2023 |
By: |
/s/ Shaun R. Bagai |
|
|
Chief Executive Officer |
Exhibit 31.2
CERTIFICATION
PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, James M. Ahlers, certify that:
1. I have reviewed this Quarterly
Report on Form 10-Q of RenovoRx, Inc.;
2. Based on my knowledge, this
report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made,
in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the
financial statements, and other financial information included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other
certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:
|
a. |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
d. |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. The registrant’s other
certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s
auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a. |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
|
|
|
b. |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 13, 2023 |
By: |
/s/ James M. Ahlers |
|
|
Chief Financial Officer |
Exhibit 32.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly
Report of RenovoRx, Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2023 as filed with the Securities
and Exchange Commission on the date hereof (the “Report”), I, Shaun R. Bagai, hereby certify, pursuant to 18 U.S.C. §1350,
as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:
|
1) |
The Report of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
|
|
|
|
2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: November 13, 2023 |
By: |
/s/ Shaun R. Bagai |
|
|
Chief Executive Officer |
Exhibit 32.2
CERTIFICATION
OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly
Report of RenovoRx, Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2023 as filed with the Securities
and Exchange Commission on the date hereof (the “Report”), I, James M. Ahlers, hereby certify, pursuant to 18 U.S.C. §1350,
as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:
|
1) |
The Report of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
|
|
|
|
2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: November 13, 2023 |
By: |
/s/ James M. Ahlers |
|
|
Chief Financial Officer |
v3.23.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Nov. 08, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Sep. 30, 2023
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-40738
|
|
Entity Registrant Name |
RENOVORX,
INC.
|
|
Entity Central Index Key |
0001574094
|
|
Entity Tax Identification Number |
27-1448452
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
4546
El Camino Real
|
|
Entity Address, Address Line Two |
Suite B1
|
|
Entity Address, City or Town |
Los
Altos
|
|
Entity Address, State or Province |
CA
|
|
Entity Address, Postal Zip Code |
94022
|
|
City Area Code |
(650)
|
|
Local Phone Number |
284-4433
|
|
Title of 12(b) Security |
Common
Stock, par value $0.0001 per share
|
|
Trading Symbol |
RNXT
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
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true
|
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true
|
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v3.23.3
Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 3,226
|
$ 4,391
|
Short-term marketable securities |
|
2,049
|
Prepaid expenses and other current assets |
252
|
825
|
Deferred offering costs |
41
|
|
Total assets |
3,519
|
7,265
|
Current liabilities: |
|
|
Accounts payable |
350
|
534
|
Accrued expenses |
1,255
|
568
|
Total current liabilities |
1,605
|
1,102
|
Common warrant liability |
1,908
|
|
Total liabilities |
3,513
|
1,102
|
Commitments and contingencies |
|
|
Stockholders’ equity: |
|
|
Convertible preferred stock, $0.0001 par value; 15,000,000 shares authorized as of September 30, 2023, and December 31, 2022, respectively; no shares issued and outstanding at September 30, 2023, and December 31, 2022 |
|
|
Common stock, $0.0001 par value, 250,000,000 shares authorized at September 30, 2023, and December 31, 2022; 10,693,080 and 9,097,701 shares issued and outstanding as of September 30, 2023, and December 31, 2022, respectively |
1
|
1
|
Additional paid-in capital |
38,183
|
37,318
|
Accumulated other comprehensive income |
|
17
|
Accumulated deficit |
(38,178)
|
(31,173)
|
Total stockholders’ equity |
6
|
6,163
|
Total liabilities and stockholders’ equity |
$ 3,519
|
$ 7,265
|
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v3.23.3
Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
250,000,000
|
250,000,000
|
Common stock, shares issued |
10,693,080
|
9,097,701
|
Common stock, shares outstanding |
10,693,080
|
9,097,701
|
Convertible Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
15,000,000
|
15,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
X |
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v3.23.3
Condensed Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Operating expenses: |
|
|
|
|
Research and development |
$ 1,629,000
|
$ 846,000
|
$ 4,892,000
|
$ 3,525,000
|
General and administrative |
1,354,000
|
1,315,000
|
4,727,000
|
4,255,000
|
Total operating expenses |
2,983,000
|
2,161,000
|
9,619,000
|
7,780,000
|
Loss from operations |
(2,983,000)
|
(2,161,000)
|
(9,619,000)
|
(7,780,000)
|
Other income/(expenses), net: |
|
|
|
|
Interest and dividend income |
43,000
|
22,000
|
97,000
|
43,000
|
Other income, net |
|
3,000
|
|
4,000
|
Change in fair value of common warrant liability |
1,519,000
|
|
3,092,000
|
|
Transaction costs allocated to common warrant liability |
|
|
(575,000)
|
|
Total other income/(expenses), net |
1,562,000
|
25,000
|
2,614,000
|
47,000
|
Net loss |
(1,421,000)
|
(2,136,000)
|
(7,005,000)
|
(7,733,000)
|
Other comprehensive loss: |
|
|
|
|
Unrealized gain on marketable securities |
|
17,000
|
|
13,000
|
Comprehensive loss |
$ (1,421,000)
|
$ (2,119,000)
|
$ (7,005,000)
|
$ (7,720,000)
|
Net loss per share, basic |
$ (0.13)
|
$ (0.24)
|
$ (0.69)
|
$ (0.86)
|
Net loss per share, diluted |
$ (0.13)
|
$ (0.24)
|
$ (0.69)
|
$ (0.86)
|
Weighted-average shares of common stock outstanding, basic |
10,693,080
|
9,067,509
|
10,154,914
|
9,039,308
|
Weighted-average shares of common stock outstanding, diluted |
10,693,080
|
9,067,509
|
10,154,914
|
9,039,308
|
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v3.23.3
Condensed Statements of Convertible Preferred Stock and Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Preferred Stock [Member]
Convertible Preferred Stock [Member]
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
AOCI Attributable to Parent [Member] |
Total |
Balance, value at Dec. 31, 2021 |
|
$ 1
|
$ 36,632
|
|
$ (21,284)
|
$ 15,349
|
Balance, shares at Dec. 31, 2021 |
|
8,933,989
|
|
|
|
|
Issuance of common stock upon exercise of stock options |
|
|
26
|
|
|
26
|
Issuance of common stock upon exercise of stock options, shares |
|
91,816
|
|
|
|
|
Issuance of restricted stock awards |
|
|
14
|
|
|
14
|
Issuance of restricted stock awards, shares |
|
3,500
|
|
|
|
|
Stock-based compensation expense |
|
|
154
|
|
|
154
|
Net loss |
|
|
|
|
(3,003)
|
(3,003)
|
Balance, value at Mar. 31, 2022 |
|
$ 1
|
36,826
|
|
(24,287)
|
12,540
|
Balance, shares at Mar. 31, 2022 |
|
9,029,305
|
|
|
|
|
Balance, value at Dec. 31, 2021 |
|
$ 1
|
36,632
|
|
(21,284)
|
15,349
|
Balance, shares at Dec. 31, 2021 |
|
8,933,989
|
|
|
|
|
Net loss |
|
|
|
|
|
(7,733)
|
Balance, value at Sep. 30, 2022 |
|
$ 1
|
37,151
|
13
|
(29,017)
|
8,148
|
Balance, shares at Sep. 30, 2022 |
|
9,072,263
|
|
|
|
|
Balance, value at Mar. 31, 2022 |
|
$ 1
|
36,826
|
|
(24,287)
|
12,540
|
Balance, shares at Mar. 31, 2022 |
|
9,029,305
|
|
|
|
|
Issuance of common stock upon exercise of stock options |
|
|
9
|
|
|
9
|
Issuance of common stock upon exercise of stock options, shares |
|
37,558
|
|
|
|
|
Stock-based compensation expense |
|
|
169
|
|
|
169
|
Other comprehensive loss |
|
|
|
(4)
|
|
(4)
|
Net loss |
|
|
|
|
(2,594)
|
(2,594)
|
Balance, value at Jun. 30, 2022 |
|
$ 1
|
37,004
|
(4)
|
(26,881)
|
10,120
|
Balance, shares at Jun. 30, 2022 |
|
9,066,863
|
|
|
|
|
Issuance of common stock upon exercise of stock options |
|
|
4
|
|
|
4
|
Issuance of common stock upon exercise of stock options, shares |
|
5,400
|
|
|
|
|
Stock-based compensation expense |
|
|
143
|
|
|
143
|
Other comprehensive loss |
|
|
|
17
|
|
17
|
Net loss |
|
|
|
|
(2,136)
|
(2,136)
|
Balance, value at Sep. 30, 2022 |
|
$ 1
|
37,151
|
13
|
(29,017)
|
8,148
|
Balance, shares at Sep. 30, 2022 |
|
9,072,263
|
|
|
|
|
Balance, value at Dec. 31, 2022 |
|
$ 1
|
37,318
|
17
|
(31,173)
|
6,163
|
Balance, shares at Dec. 31, 2022 |
|
9,097,701
|
|
|
|
|
Issuance of common stock upon exercise of stock options |
|
|
6
|
|
|
6
|
Issuance of common stock upon exercise of stock options, shares |
|
3,547
|
|
|
|
|
Issuance of restricted stock awards |
|
|
117
|
|
|
117
|
Issuance of restricted stock awards, shares |
|
30,000
|
|
|
|
|
Stock-based compensation expense |
|
|
244
|
|
|
244
|
Other comprehensive loss |
|
|
|
(17)
|
|
(17)
|
Net loss |
|
|
|
|
(3,257)
|
(3,257)
|
Balance, value at Mar. 31, 2023 |
|
$ 1
|
37,685
|
|
(34,430)
|
3,256
|
Balance, shares at Mar. 31, 2023 |
|
9,131,248
|
|
|
|
|
Balance, value at Dec. 31, 2022 |
|
$ 1
|
37,318
|
17
|
(31,173)
|
$ 6,163
|
Balance, shares at Dec. 31, 2022 |
|
9,097,701
|
|
|
|
|
Issuance of common stock upon exercise of stock options, shares |
|
|
|
|
|
7,747
|
Net loss |
|
|
|
|
|
$ (7,005)
|
Balance, value at Sep. 30, 2023 |
|
$ 1
|
38,183
|
|
(38,178)
|
6
|
Balance, shares at Sep. 30, 2023 |
|
10,693,080
|
|
|
|
|
Balance, value at Mar. 31, 2023 |
|
$ 1
|
37,685
|
|
(34,430)
|
3,256
|
Balance, shares at Mar. 31, 2023 |
|
9,131,248
|
|
|
|
|
Issuance of common stock upon exercise of stock options |
|
|
2
|
|
|
2
|
Issuance of common stock upon exercise of stock options, shares |
|
4,200
|
|
|
|
|
Stock-based compensation expense |
|
|
257
|
|
|
257
|
Net loss |
|
|
|
|
(2,327)
|
(2,327)
|
Issuance of common stock upon the registered direct offering |
|
|
|
|
|
|
Issuance of common stock upon the registered direct offering, shares |
|
1,000,000
|
|
|
|
|
Issuance and exercise of pre-funded common warrants upon the registered direct offering |
|
|
|
|
|
|
Issuance and exercise of pre-funded common warrants upon the registered direct offering, shares |
|
557,632
|
|
|
|
|
Balance, value at Jun. 30, 2023 |
|
$ 1
|
37,944
|
|
(36,757)
|
1,188
|
Balance, shares at Jun. 30, 2023 |
|
10,693,080
|
|
|
|
|
Stock-based compensation expense |
|
|
239
|
|
|
239
|
Net loss |
|
|
|
|
(1,421)
|
(1,421)
|
Balance, value at Sep. 30, 2023 |
|
$ 1
|
$ 38,183
|
|
$ (38,178)
|
$ 6
|
Balance, shares at Sep. 30, 2023 |
|
10,693,080
|
|
|
|
|
X |
- DefinitionStock issued during period shares pre funded common stock warrant exercised.
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v3.23.3
Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Operating activities: |
|
|
Net loss |
$ (7,005)
|
$ (7,733)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Stock-based compensation expense |
857
|
480
|
Amortization on leasehold improvement |
|
6
|
Unrealized gain on change in fair value of common warrants classified as a liability |
(3,485)
|
|
Loss on financing common stock and common warrants |
393
|
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other current assets |
573
|
(47)
|
Deferred offering costs |
(41)
|
|
Accounts payable |
(184)
|
13
|
Accrued expenses |
687
|
151
|
Net cash used in operating activities |
(8,205)
|
(7,130)
|
Investing activities: |
|
|
Purchases of marketable securities |
|
(8,000)
|
Proceeds from maturities of marketable securities |
|
2,992
|
Proceeds from sale of investments |
2,032
|
|
Net cash provided by (used in) investing activities |
2,032
|
(5,008)
|
Financing activities: |
|
|
Proceeds from common stock and pre-funded common warrants |
5,000
|
|
Proceeds from exercise of stock options |
8
|
39
|
Net cash provided by financing activities |
5,008
|
39
|
Decrease in cash and cash equivalents |
(1,165)
|
(12,099)
|
Cash and cash equivalents, beginning of period |
4,391
|
15,192
|
Cash and cash equivalents, end of period |
3,226
|
3,093
|
Supplemental of non-cash financing activities: |
|
|
Fair value of common warrant classified as a liability |
$ 1,908
|
|
X |
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v3.23.3
Business and Principal Activities
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Business and Principal Activities |
1.
Business and Principal Activities
Description
of Business
RenovoRx,
Inc. (the “Company”) was incorporated in the state of Delaware in December 2012 and operates from its headquarters in
Los Altos, California. The Company is a clinical-stage biopharmaceutical company developing proprietary targeted combination
therapies for high unmet medical need with a goal to improve therapeutic outcomes for cancer patients undergoing treatment. The
Company’s proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to ensure precise therapeutic
delivery to directly target the tumor while potentially minimizing a therapy’s toxicities versus systemic (intravenous (IV)
therapy). The Company’s unique approach is under a clinical trial investigation for targeted treatment with the potential for increased safety, tolerance, and
improved efficacy. The Company’s Phase III lead product candidate, RenovoGem™, a novel oncology drug-device combination
product, is being investigated under a US Investigational New Drug (“IND”) that is regulated by Food and Drug
Administration Code of Federal Regulation (“FDA 21 CFR 312’) pathway. RenovoGem is currently being evaluated for the
treatment of locally advanced pancreatic cancer (“LAPC”) by the Center for Drug Evaluation and Research (the drug
division of the FDA).
Initial
Public Offering
On
August 25, 2021, the Company’s Registration Statement on Form S-1 (File No. 333-258071) relating to its initial public offering
(“IPO”) was declared effective and its shares of common stock began trading on the Nasdaq Capital Market on August 26, 2021.
In connection with the IPO, the Company issued and sold an aggregate of 1,850,000 units at a price of $9.00 per unit. Each unit consisted
of (a) one share of common stock and (b) one warrant to purchase one share of common stock at an exercise price equal to $10.80 per share,
which is exercisable for a period of five years after the issuance date. The underwriters exercised their over-allotment option to purchase
277,500 common stock warrants on August 30, 2021. In connection with the IPO, the underwriters were issued a five-year warrant, exercisable
on or after February 25, 2022, to purchase up to 198,875 shares of the Company’s common stock at an exercise price of $10.80.
The
Company received aggregate gross proceeds of $16.7 million from the IPO, paid underwriting discounts and commissions of $1.3 million
and incurred other expenses of $0.8 million, resulting in net offering proceeds of $14.6 million. Immediately prior to the closing of
the IPO, all shares of convertible preferred stock then outstanding were converted into 3,535,469 shares of common stock after giving
effect to the reverse stock split. In addition, all of the outstanding 2020 and 2021 Convertible Notes, representing principal and accrued
but unpaid interest of $5.3 million, converted at a 20% and 12.5% discount to the IPO price, respectively, into an aggregate of 708,820
units. Each unit consisted of (a) one share of common stock and (b) one five-year warrant to purchase one share of common stock at an
exercise price equal to $10.80 per share.
Reverse
Stock Split
On
August 5, 2021, the Company effected a 1-for-5 reverse stock split of its issued and outstanding preferred stock and common stock. The
number of authorized shares and the par values of the common stock and convertible preferred stock were not adjusted as a result of the
reverse stock split. Adjustments corresponding to the reverse stock split were made to the ratio at which the Company’s convertible
preferred stock converted into the Company’s common stock. Accordingly, all share and per share amounts related to the common stock,
stock options, warrants and restricted stock awards for all periods presented in the accompanying financial statements and notes thereto
have been retroactively adjusted.
Liquidity
and Capital Resources
Since
inception, and through September 30, 2023, the Company has raised estimated gross proceeds of $39.8 million through private
placements of convertible preferred stock, convertible debt securities, the issuance of securities in the IPO, and the exercise of
warrants and common stock options. As of September 30, 2023, the Company had cash and cash equivalents of $3.2 million.
The
Company has incurred significant losses and negative cash flows from operations since its inception. For the nine months ended September
30, 2023, the Company reported a net loss of $7.0 million and an accumulated deficit of $38.2 million. It does not anticipate generating
positive cash flows from operations in the foreseeable future. The Company expects to continue incurring significant losses until it
obtains regulatory approval for RenovoGem™, its first product candidate. However, regulatory approval is not guaranteed and may
never be obtained.
To
address its capital needs, the Company believes it will be able to raise additional capital through debt financings, private or public
equity financings, license agreements, collaborative agreements or other arrangements with other companies, or other financing sources.
Nevertheless, there is no assurance that such financing will be available or will be at terms acceptable to the Company. The inability
to raise capital as and when needed could negatively impact the Company’s liquidity, financial condition and its ability to pursue
its business strategy. The Company will need to generate significant revenue to achieve profitability, and it may never do so.
The
Company has filed an omnibus shelf registration statement on Form S-3 that provides for the aggregate offerings of up to $50.0 million
of the Company’s securities subject to various limitations, including limited sales in any twelve-month period while the Company
is subject to the “baby-shelf” rules. The Company has also filed a registration statement on Form S-1 to register the cash
exercise of the Company’s outstanding IPO, underwriter and private warrants. Cash exercise of the outstanding warrants is only
expected to occur when the trading price of the Company’s common stock is in excess of the $10.80 per share exercise price of the
outstanding warrants.
On
March 30, 2023, the Company entered into a securities purchase agreement (“Securities Purchase Agreement”) with a certain
institutional investor (“Purchaser”). Pursuant to the Securities Purchase Agreement, the Company agreed to sell in a
registered direct offering (the “Registered Direct Offering”) 1,000,000 shares (“Shares”) of the Company’s
common stock, par value $0.0001 (“Common Stock”), and purchase contracts issued as pre-funded warrants (“Pre-Funded
Warrants”) to purchase up to 557,632 shares of Common Stock, which Pre-Funded Warrants were issued to the extent that the Purchaser
determined, in its sole discretion, that such Purchaser would beneficially own in excess of 4.99% (or at the Purchaser’s election,
9.99%). The Pre-Funded Warrants have an exercise price of $0.0001 per share and are immediately exercisable and can be exercised at
any time after their original issuance until such Pre-Funded Warrants are exercised in full. Each Share was sold at an offering
price of $3.21, and each Pre-Funded Warrant was sold at an offering price of $3.2099 (equal to the purchase price per Share minus
the exercise price of the Pre-Funded Warrant). Additionally, in a concurrent private placement (together with the Registered Direct Offering,
the “March 2023 Offering”), the Company issued to Purchaser unregistered warrants to purchase up to 1,947,040 shares
of its Common Stock (the “Common Warrants”). Each Common Warrant has an exercise price of $3.21 per share, is exercisable
at any time after their original issuance, and expires five and a half years from the original issuance date. The aggregate gross proceeds
from the March 2023 Offering were approximately $5 million before deducting placement fees and other offering expenses.
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern and has reviewed the
relevant conditions and events surrounding its ability to continue as a going concern including among others: historical losses, projected
future results, negative cash flows from operations, including cash requirements for the upcoming year, funding capacity, net working
capital, total stockholders’ equity and future access to capital. Based upon this review and the Company’s current financial
condition and operating plans as of September 30, 2023, the Company has concluded that substantial doubt exists as to the Company’s
ability to operate as a going concern.
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v3.23.3
Summary of Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2.
Summary of Significant Accounting Policies
Basis
of Presentation and Unaudited Condensed Interim Financial Information
The
accompanying unaudited condensed interim financial statements have been prepared in accordance with accounting principles generally accepted
in the United States of America (“GAAP”) and applicable rules and regulations of the Securities and Exchange Commission or
(“SEC”) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information
normally included in unaudited condensed interim financial statements prepared in accordance with GAAP have been condensed or omitted.
The unaudited condensed interim financial statements have been prepared on the same basis as the annual financial statements and, in
the opinion of management, reflect all adjustments, which include only normal, recurring adjustments that are necessary to present fairly
the Company’s results for the interim periods presented. The condensed balance sheet as of December 31, 2022, is derived from the
Company’s audited financial statements. The results of operations for the three and nine months ended September 30, 2023, are not
necessarily indicative of the results to be expected for the year ending December 31, 2023, or for any other future annual or interim
period. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards
Codification (“ASC”) and as amended by Accounting Standards Update (“ASU”) of the Financial Accounting Standards
Board (“FASB”).
The
accompanying unaudited condensed interim financial statements should be read in conjunction with the audited financial statements and
the related notes thereto for the year ended December 31, 2022, which are included in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2022, filed with the SEC on March 31, 2023.
Summary
of Significant Accounting Policies
There
have been no material changes to the significant accounting policies during the nine months ended September 30, 2023 from those previously
disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
In
April 2023, the Company completed a financing under its March 2023 Offering issuing common stock, pre-funded common warrants and common
warrants. The Company has applied the following accounting policies as it relates to such offering.
Pre-Funded
Common Warrants and Common Warrants
The
Company evaluated the Pre-Funded Common Warrants and Common Warrants issued in connection with the March 2023 registered direct financing
in accordance with ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity, and concluded that
the Pre-Funded Common Warrants qualify for equity classification, while a provision in the Common Warrants precluded it from being accounted
for as components of equity. As the Common Warrants met the definition of a derivative instrument, the Company recorded the Common Warrants
as a liability on the condensed balance sheets and measured at fair value at inception and at each reporting date in accordance with
ASC 820, Fair Value Measurement, with changes in fair value recognized in the Condensed Statements of Operations and Comprehensive
Loss in the period of change. As the initial fair value of the Common Warrants exceeded the total proceeds of the March 2023 Offering,
no value was recorded for the Common Stock and Pre-funded Common Warrants.
Direct
Offering Costs
Direct
offering costs consist principally of placement fees and other expenses, including other professional expenses incurred. The aggregate
direct offering costs incurred from the March 2023 Offering were approximately $575,000 and were allocated solely to the Common Warrants
and subsequently expensed in the accompanying Condensed Statements of Operations and Comprehensive Loss.
Emerging
Growth Company and Smaller Reporting Company Status
The
Company is an emerging growth company (“EGC”) as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS
Act”) and may take advantage of reduced reporting requirements that are otherwise applicable to public companies. Section 107 of
the JOBS Act exempts emerging growth companies from complying with new or revised financial accounting standards until private companies
are required to comply with those standards. The Company has elected to use the extended transition period for complying with new or
revised accounting standards.
The
Company is also a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act. If the Company is a smaller
reporting company at the time the Company cease to be an emerging growth company, the Company may continue to rely on exemptions from
certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company the Company
may choose to present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K and, like
emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
From
time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of
the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not
have a material impact on the Company’s financial position or results of operations upon adoption.
Recent
Accounting Pronouncement
Recently
Adopted Accounting Pronouncement
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326). The guidance represents a significant
change in the accounting for credit losses model by requiring immediate recognition of management’s estimates of current expected
credit losses (CECL). Under the prior model, losses were recognized only as they were incurred. The Company has determined that it has
met the criteria of a smaller reporting company (“SRC”) as of November 15, 2019. As such, ASU 2019-10, Financial Instruments
—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) —Effective Dates amended
the effective date for the Company to be for reporting periods beginning after December 15, 2022. The Company adopted ASU 2016-13 on
January 1, 2023 and the adoption had no significant impact to the Company’s financial statements.
Recently
Accounting Pronouncement Not Yet Adopted
In
August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) (ASU 2020-06): Accounting for Convertible Instruments and
Contracts in an Entity, which simplifies the accounting for certain financial instruments with characteristics of liabilities and
equity, including convertible instruments and contracts on an entity’s own equity. The updated guidance is effective on a prospective
basis for annual reporting periods beginning after December 15, 2023 and for interim periods within those periods. Early adoption is
permitted. The Company has not yet determined the impact that this new standard will have on its financial position and results of operations.
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v3.23.3
Fair Value Measurements
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
3.
Fair Value Measurements
As
of September 30, 2023, and December 31, 2022, the Company held $0.1 million and $4.3 million, respectively, in a money market account.
The
following tables summarize the Company’s financial assets and liabilities, measured at fair value on a recurring basis by level
within the fair value hierarchy, as of September 30, 2023, and December 31, 2022 (in thousands):
Schedule of Assets Measured at Fair Value on Recurring Basis
| |
Fair
Value Measurements at September 30, 2023 using: | |
Assets | |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Cash equivalents: | |
| | | |
| | | |
| | | |
| | |
Schwab U.S.
Treasury Money Fund – Ultra Shares | |
$ | 2,712 | | |
$ | - | | |
$ | - | | |
$ | 2,712 | |
Money
market funds | |
| 108 | | |
| - | | |
| - | | |
| 108 | |
| |
$ | 2,820 | | |
$ | - | | |
$ | - | | |
$ | 2,820 | |
Liabilities | |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Common
warrant liability | |
$ | - | | |
$ | - | | |
$ | 1,908 | | |
$ | 1,908 | |
| |
$ | - | | |
$ | - | | |
$ | 1,908 | | |
$ | 1,908 | |
| |
Fair
Value Measurements at December 31, 2022 using: | |
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Cash equivalents: | |
| | | |
| | | |
| | | |
| | |
Money market
funds | |
$ | 4,300 | | |
$ | - | | |
$ | - | | |
$ | 4,300 | |
Available-for-sale securities: | |
| | | |
| | | |
| | | |
| | |
U.S.
Treasury bills | |
| 2,049 | | |
| - | | |
| - | | |
| 2,049 | |
| |
$ | 6,349 | | |
$ | - | | |
$ | - | | |
$ | 6,349 | |
There
were no transfers between Level 1, Level 2 or Level 3 during the periods presented. The Company had no other financial assets or liabilities
that were required to be measured at fair value on a recurring basis.
Assumptions
Used in Determining Fair Value of Warrants
With
the Common Warrants, in the event of certain fundamental transactions involving the Company, the warrant holders may require the Company
to make a payment based on a Black-Scholes valuation, using specified inputs. Therefore, the Common Warrants were accounted for as liabilities.
The
Company recorded the fair value of the Common Warrants upon issuance using the Black-Scholes valuation model. It is also required to
revalue the Common Warrants at each reporting date, with any changes in fair value recorded on our statement of operations. The valuation
of the Common Warrants is considered under Level 3 of the fair value hierarchy and influenced by the fair value of the underlying Common
Stock of the Company.
A
summary of the Black Scholes pricing model assumptions used to record the fair value of the Common Warrants is as follows:
Schedule of Assumptions to Record Fair Value of Warrants
| |
September
30, 2023 |
|
Expected volatility | |
110% –
117 |
% |
Expected term (years) | |
1.01 – 5.01 |
|
Risk-free interest rate | |
4.60% – 5.46 |
% |
Dividend rate | |
– |
|
Changes
om Level 3 Liabilities Measured at Fair Value on a Recurring Basis
The
following table reflects the change in the Company’s Level 3 common warrant liability for the nine months ended September 30, 2023
(in thousands):
Schedule
of Level 3 Liabilities Measured at Fair Value on a Recurring Basis
| |
| | |
Fair value as of December 31, 2022 | |
$ | - | |
Common warrants issued in connection
with private placement | |
| 5,393 | |
Change in fair value | |
| (3,485 | ) |
Fair value as of September 30, 2023 | |
$ | 1,908 | |
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v3.23.3
Short-Term Marketable Securities
|
9 Months Ended |
Sep. 30, 2023 |
Investments, Debt and Equity Securities [Abstract] |
|
Short-Term Marketable Securities |
4.
Short-Term Marketable Securities
There
were no short-term marketable securities as of September 30, 2023. The tables summarize the Company’s short-term marketable securities
as of December 31, 2022 (in thousands):
Schedule of Short-Term Marketable Securities
| |
Amortized Cost
Basis | | |
Gross Unrealized Gains | | |
Gross Unrealized Losses | | |
Fair
Value | |
U.S.
Treasury bills | |
$ | 2,032 | | |
$ | 17 | | |
$ | - | | |
$ | 2,049 | |
| |
$ | 2,032 | | |
$ | 17 | | |
$ | - | | |
$ | 2,049 | |
|
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v3.23.3
Accrued Expenses
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
Accrued Expenses |
5.
Accrued Expenses
The
components of accrued expenses as of September 30, 2023, and December 31, 2022 are as follows (in thousands):
Schedule of Accrued Expenses
| |
September
30, 2023 | | |
December
31, 2022 | |
Clinical trial | |
$ | 519 | | |
$ | 88 | |
Employee benefits | |
| 525 | | |
| 475 | |
Other | |
| 211 | | |
| 5 | |
Total accrued expenses | |
$ | 1,255 | | |
$ | 568 | |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.23.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
6.
Commitments and Contingencies
Legal
Proceedings
From
time to time, the Company may become involved in legal proceedings arising in the ordinary course of business.
The
Company was not subject to any material legal proceedings during the nine months ended September 30, 2023, and no material legal proceedings
are subsequently outstanding or pending.
Guarantees
and Indemnification
In
the ordinary course of business, the Company enters into agreements that may include indemnification provisions. As permitted under Delaware
law and in accordance with its bylaws, the Company indemnifies its officers and directors for certain events or occurrences while the
officer or director is or was serving in such capacity. The Company is also party to indemnification agreements with its officers and
directors. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future
payments that the Company could be required to make under these provisions is not determinable. The Company has never incurred material
costs to defend lawsuits or settle claims related to these indemnification provisions. The Company is not currently aware of any indemnification
claims. Accordingly, the Company has not recorded any liabilities for these indemnification rights and agreements as of September 30,
2023.
Operating
Leases
The
Company leases its headquarters in Los Altos, California under a month-to-month operating lease agreement. Rent
expenses were $18,000 for both the
three months ended September 30, 2023, and 2022. Rent expenses were $55,000 and
$54,000 for the nine months ended
September 30, 2023, and 2022, respectively.
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v3.23.3
Equity Incentive Plan - Stock-Based Compensation Expense and Common Warrants
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Equity Incentive Plan - Stock-Based Compensation Expense and Common Warrants |
7.
Equity Incentive Plan - Stock-Based Compensation Expense and Common Warrants
2021
Omnibus Equity Incentive Plan
On
July 19, 2021, the Company’s Board of Directors adopted the RenovoRx, Inc. 2021 Omnibus Equity Incentive Plan (the “2021
Plan”). The 2021 Plan, which became effective immediately prior to the closing of the IPO, initially reserved 2,185,832 shares
of common stock, which included 10,832 shares of common shares reserved but unissued under the Amended and Restated 2013 Equity Incentive
Plan (the “2013 Plan”). The Company’s 2013 Plan was terminated immediately prior to the closing of the IPO; however,
shares subject to awards granted under the 2013 Plan will continue to be governed by the 2013 Plan. In accordance with the terms of the
2021 Plan, on January 1, 2023, the number of shares reserved and available for issuance increased by 272,931 shares.
A
summary of the stock option activity for the nine months ended September 30, 2023 is as follows:
Summary of Stock Option Award Activity
| |
Number
of Stock Options | | |
Weighted-
Average Exercise Price | | |
Weighted-
Average Remaining Contractual Life | | |
Aggregate
Intrinsic Value | |
Outstanding
as of December 31, 2022 | |
| 1,399,252 | | |
$ | 2.40 | | |
| 7.79 | | |
$ | 928 | |
Granted | |
| 420,351 | | |
$ | 3.10 | | |
| - | | |
$ | - | |
Exercised | |
| (7,747 | ) | |
$ | 0.97 | | |
| - | | |
$ | - | |
Forfeited | |
| (51,255 | ) | |
$ | 3.12 | | |
| - | | |
$ | - | |
Expired | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
Outstanding
as of September 30, 2023 | |
| 1,760,601 | | |
$ | 2.55 | | |
| 7.59 | | |
$ | 346 | |
Exercisable
as of September 30, 2023 | |
| 985,350 | | |
$ | 2.13 | | |
| 6.42 | | |
$ | 346 | |
Vested
and expected to vest as of September 30, 2023 | |
| 1,760,601 | | |
$ | 2.55 | | |
| 7.59 | | |
$ | 346 | |
As
of September 30, 2023, there was $1.8 million of unrecognized stock-based compensation expense related to options granted but not yet
amortized, which will be recognized over a weighted-average period of approximately 2.95 years.
For
the nine months ended September 30, 2023, and 2022, the Company utilized the Black-Scholes option-pricing model for estimating the fair
value of the stock option granted. The Company estimated the fair value of each option grant on the grant date using the Black-Scholes
option pricing model with the following weighted-average assumptions:
Summary
of Weighted-Average Assumptions Used to Calculate Fair Value of Stock Options Granted
| |
| Nine
Months Ended September 30, | |
| |
| 2023 | | |
| 2022 | |
Expected volatility | |
| 99.49%
– 106.69 | % | |
| 101.54%
– 102.96 | % |
Expected term (years) | |
| 6.02
– 10.0 | | |
| 5.27
– 6.08 | |
Risk-free interest rate | |
| 3.40%
– 4.28 | % | |
| 1.93%
– 1.95 | % |
Dividend rate | |
| – | % | |
| – | % |
During
the three months ended September 30, 2023, and 2022, the Company recognized $239,000 and $143,000, respectively, in stock-based compensation
expense from stock option grants. During the nine months ended September 30, 2023, and 2022, the Company recognized $857,000 and $480,000,
respectively, in stock-based compensation expense from stock option grants. The compensation expense is allocated on a departmental basis,
based on the classification of the option holder. No income tax benefits have been recognized in the condensed statements of operations
and comprehensive loss for stock-based compensation arrangements.
The
following table summarizes the components of stock-based compensation expense recognized in the Company’s Condensed Statements
of Operations and Comprehensive Loss during the three and nine months ended September 30, 2023, and 2022 (in thousands):
Schedule of Stock Based Compensation Expense
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months
Ended | | |
Nine Months
Ended | |
| |
September
30, | | |
September
30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 46 | | |
$ | 27 | | |
$ | 155 | | |
$ | 109 | |
General and administrative | |
| 193 | | |
| 116 | | |
| 702 | | |
| 371 | |
Total stock-based compensation
expense | |
$ | 239 | | |
$ | 143 | | |
$ | 857 | | |
$ | 480 | |
Restricted
Stock
In
March 2023, the Board approved the issuance of 30,000 shares of restricted stock to an entity as consideration for a commercial contract,
vested immediately, in a private placement. The shares were issued outside the 2021 Plan and the Company recognized $117,000 of stock-based
compensation expense for the restricted stock.
Common
Warrants
In
August 2021, in connection with the IPO, the Company issued warrants to purchase 3,035,195 shares of the Company’s common stock.
Warrants to purchase 198,875 shares of the Company’s common stock expire on August 25, 2026 and warrants to purchase 2,588,120
shares of the Company’s common stock expire on August 31, 2026.
On
April 3, 2023, in connection with the March 2023 Offering, the Company issued 557,632 Pre-Funded Warrants and 1,947,040 Common Warrants
to purchase the Company’s Common Stock. The Pre-Funded Warrants were exercised in June 2023 and the Common Warrants expire on October
3, 2028.
The
following is a summary of the common stock warrant activity during the nine months ended September 30, 2023.
Schedule
of Common Stock Warrant Activity
| |
Shares
Issuable Upon Exercise of Outstanding Warrants | | |
Weighted-
Average Exercise Price | | |
Weighted-
Average Remaining Contractual Life | | |
Aggregate
Intrinsic Value (In thousands) | |
Outstanding
as of December 31, 2022 | |
| 2,786,995 | | |
$ | 10.80 | | |
| 3.67 | | |
$ | 30,100 | |
Issued | |
| 2,504,672 | | |
$ | 3.21 | | |
| 5.00 | | |
$ | - | |
Exercised | |
| (557,632 | ) | |
$ | 3.21 | | |
| - | | |
$ | - | |
Expired | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
Outstanding
as of September 30, 2023 | |
| 4,734,035 | | |
$ | 7.68 | | |
| 3.51 | | |
$ | 36,350 | |
|
X |
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v3.23.3
Income Taxes
|
9 Months Ended |
Sep. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
8.
Income Taxes
The
Company had no income tax expense for the three and nine months ended September 30, 2023, and 2022. During the three and nine months
ended September 30, 2023, and 2022, the Company had a net operating loss (“NOL”) for each period that generated deferred
tax assets for NOL carryforwards. Deferred income tax assets and liabilities are recognized for temporary differences between the financial
statements and income tax carrying values using tax rates in effect for the years such differences are expected to reverse. Due to uncertainties
surrounding our ability to generate future taxable income and consequently realize such deferred income tax assets, the Company has determined
that it is more likely than not that these deferred tax assets will not be realized. Accordingly, the Company has established a full
valuation allowance against its deferred tax assets as of September 30, 2023.
The
Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense.
For the three and nine months ended September 30, 2023, and 2022, the Company had no accrued interest or penalties related to uncertain
tax positions.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.3
Net Loss Per Share
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
Net Loss Per Share |
9.
Net Loss Per Share
Basic
and diluted net loss per common share was calculated as follows (in thousands except per share amounts):
Schedule of Computation of Basic and Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months
Ended | | |
Nine Months
Ended | |
| |
September
30, | | |
September
30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (1,421 | ) | |
$ | (2,136 | ) | |
$ | (7,005 | ) | |
$ | (7,733 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted average shares
used in computing net loss per share – basic and diluted | |
| 10,693,080 | | |
| 9,067,509 | | |
| 10,154,914 | | |
| 9,039,308 | |
Net loss per share –
basic and diluted | |
$ | (0.13 | ) | |
$ | (0.24 | ) | |
$ | (0.69 | ) | |
$ | (0.86 | ) |
For
the three and nine months ended September 30, 2023, and 2022, the Company had a net loss and as such, all outstanding shares of potentially
dilutive securities were excluded from the calculation of diluted net loss per share as the inclusion would be anti-dilutive.
Potentially
dilutive securities not included in the computation of diluted net loss per share because to do so would be antidilutive are as follows
(in common stock equivalent shares):
Schedule of Potentially Anti Dilutive Securities
| |
2023 | | |
2022 | |
| |
As
of September 30, | |
| |
2023 | | |
2022 | |
Options
to purchase common stock | |
| 453,346 | | |
| 484,518 | |
Total | |
| 453,346 | | |
| 484,518 | |
|
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v3.23.3
Related Party Transactions
|
9 Months Ended |
Sep. 30, 2023 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
10.
Related Party Transactions
In
January 2018, the Company entered into a consulting agreement with one of the Company’s co-founders, Dr. Ramtin Agah, pursuant
to which Dr. Agah provides consulting services as the Company’s Chief Medical Officer by overseeing Company-sponsored clinical
trials. The agreement, which was amended on September 1, 2019, and November 11, 2021, respectively, continues in force for as long as
Dr. Agah is providing consulting services and may be terminated by either party on 30 days’ notice. In connection with his services,
Dr. Agah was awarded various equity awards as the Company has previously disclosed. In December 2018, Dr. Agah’s agreement was
amended to provide that he would receive cash compensation of $4,000 per month for certain proctoring services, and in September 2019,
his compensation was increased to $10,000 per month to compensate for additional services he was providing. In November 2021, we entered
into a third amendment to the Consulting Agreement with Dr. Agah which provides for a monthly consulting fee of $21,667.67, based on
Dr. Agah spending no less than 24 hours per week on Company matters. Dr. Agah’s monthly consulting fee was increased to $25,000,
effective January 1, 2023. The Company may, in its discretion, proportionally adjust the monthly consulting fee if Dr. Agah’s time
commitment decreases. The amendment also provides for Dr. Agah’s eligibility for an annual target cash incentive bonus equal to
35% of his annualized base consulting fee. In November 2021, we entered into a Change in Control and Severance Agreement with Dr. Agah.
For the three months ending September 30, 2023, and 2022, consulting fees paid to Dr. Agah were $76,000 and $72,000, respectively. For
the nine months ending September 30, 2023, and 2022, consulting fees paid to Dr. Agah were $319,000 and $217,000, respectively. In addition,
the Board approved a discretionary bonus of $91,000, paid in February 2023, to Dr. Agah in recognition of the Company’s and individual
performance during the year ended December 31, 2022.
|
X |
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v3.23.3
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation and Unaudited Condensed Interim Financial Information |
Basis
of Presentation and Unaudited Condensed Interim Financial Information
The
accompanying unaudited condensed interim financial statements have been prepared in accordance with accounting principles generally accepted
in the United States of America (“GAAP”) and applicable rules and regulations of the Securities and Exchange Commission or
(“SEC”) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information
normally included in unaudited condensed interim financial statements prepared in accordance with GAAP have been condensed or omitted.
The unaudited condensed interim financial statements have been prepared on the same basis as the annual financial statements and, in
the opinion of management, reflect all adjustments, which include only normal, recurring adjustments that are necessary to present fairly
the Company’s results for the interim periods presented. The condensed balance sheet as of December 31, 2022, is derived from the
Company’s audited financial statements. The results of operations for the three and nine months ended September 30, 2023, are not
necessarily indicative of the results to be expected for the year ending December 31, 2023, or for any other future annual or interim
period. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards
Codification (“ASC”) and as amended by Accounting Standards Update (“ASU”) of the Financial Accounting Standards
Board (“FASB”).
The
accompanying unaudited condensed interim financial statements should be read in conjunction with the audited financial statements and
the related notes thereto for the year ended December 31, 2022, which are included in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2022, filed with the SEC on March 31, 2023.
Summary
of Significant Accounting Policies
There
have been no material changes to the significant accounting policies during the nine months ended September 30, 2023 from those previously
disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
In
April 2023, the Company completed a financing under its March 2023 Offering issuing common stock, pre-funded common warrants and common
warrants. The Company has applied the following accounting policies as it relates to such offering.
Pre-Funded
Common Warrants and Common Warrants
The
Company evaluated the Pre-Funded Common Warrants and Common Warrants issued in connection with the March 2023 registered direct financing
in accordance with ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity, and concluded that
the Pre-Funded Common Warrants qualify for equity classification, while a provision in the Common Warrants precluded it from being accounted
for as components of equity. As the Common Warrants met the definition of a derivative instrument, the Company recorded the Common Warrants
as a liability on the condensed balance sheets and measured at fair value at inception and at each reporting date in accordance with
ASC 820, Fair Value Measurement, with changes in fair value recognized in the Condensed Statements of Operations and Comprehensive
Loss in the period of change. As the initial fair value of the Common Warrants exceeded the total proceeds of the March 2023 Offering,
no value was recorded for the Common Stock and Pre-funded Common Warrants.
Direct
Offering Costs
Direct
offering costs consist principally of placement fees and other expenses, including other professional expenses incurred. The aggregate
direct offering costs incurred from the March 2023 Offering were approximately $575,000 and were allocated solely to the Common Warrants
and subsequently expensed in the accompanying Condensed Statements of Operations and Comprehensive Loss.
|
Emerging Growth Company and Smaller Reporting Company Status |
Emerging
Growth Company and Smaller Reporting Company Status
The
Company is an emerging growth company (“EGC”) as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS
Act”) and may take advantage of reduced reporting requirements that are otherwise applicable to public companies. Section 107 of
the JOBS Act exempts emerging growth companies from complying with new or revised financial accounting standards until private companies
are required to comply with those standards. The Company has elected to use the extended transition period for complying with new or
revised accounting standards.
The
Company is also a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act. If the Company is a smaller
reporting company at the time the Company cease to be an emerging growth company, the Company may continue to rely on exemptions from
certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company the Company
may choose to present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K and, like
emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
From
time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of
the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not
have a material impact on the Company’s financial position or results of operations upon adoption.
|
Recent Accounting Pronouncement |
Recent
Accounting Pronouncement
Recently
Adopted Accounting Pronouncement
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326). The guidance represents a significant
change in the accounting for credit losses model by requiring immediate recognition of management’s estimates of current expected
credit losses (CECL). Under the prior model, losses were recognized only as they were incurred. The Company has determined that it has
met the criteria of a smaller reporting company (“SRC”) as of November 15, 2019. As such, ASU 2019-10, Financial Instruments
—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) —Effective Dates amended
the effective date for the Company to be for reporting periods beginning after December 15, 2022. The Company adopted ASU 2016-13 on
January 1, 2023 and the adoption had no significant impact to the Company’s financial statements.
Recently
Accounting Pronouncement Not Yet Adopted
In
August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) (ASU 2020-06): Accounting for Convertible Instruments and
Contracts in an Entity, which simplifies the accounting for certain financial instruments with characteristics of liabilities and
equity, including convertible instruments and contracts on an entity’s own equity. The updated guidance is effective on a prospective
basis for annual reporting periods beginning after December 15, 2023 and for interim periods within those periods. Early adoption is
permitted. The Company has not yet determined the impact that this new standard will have on its financial position and results of operations.
|
X |
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v3.23.3
Fair Value Measurements (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Assets Measured at Fair Value on Recurring Basis |
The
following tables summarize the Company’s financial assets and liabilities, measured at fair value on a recurring basis by level
within the fair value hierarchy, as of September 30, 2023, and December 31, 2022 (in thousands):
Schedule of Assets Measured at Fair Value on Recurring Basis
| |
Fair
Value Measurements at September 30, 2023 using: | |
Assets | |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Cash equivalents: | |
| | | |
| | | |
| | | |
| | |
Schwab U.S.
Treasury Money Fund – Ultra Shares | |
$ | 2,712 | | |
$ | - | | |
$ | - | | |
$ | 2,712 | |
Money
market funds | |
| 108 | | |
| - | | |
| - | | |
| 108 | |
| |
$ | 2,820 | | |
$ | - | | |
$ | - | | |
$ | 2,820 | |
Liabilities | |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Common
warrant liability | |
$ | - | | |
$ | - | | |
$ | 1,908 | | |
$ | 1,908 | |
| |
$ | - | | |
$ | - | | |
$ | 1,908 | | |
$ | 1,908 | |
| |
Fair
Value Measurements at December 31, 2022 using: | |
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Cash equivalents: | |
| | | |
| | | |
| | | |
| | |
Money market
funds | |
$ | 4,300 | | |
$ | - | | |
$ | - | | |
$ | 4,300 | |
Available-for-sale securities: | |
| | | |
| | | |
| | | |
| | |
U.S.
Treasury bills | |
| 2,049 | | |
| - | | |
| - | | |
| 2,049 | |
| |
$ | 6,349 | | |
$ | - | | |
$ | - | | |
$ | 6,349 | |
|
Schedule of Assumptions to Record Fair Value of Warrants |
A
summary of the Black Scholes pricing model assumptions used to record the fair value of the Common Warrants is as follows:
Schedule of Assumptions to Record Fair Value of Warrants
| |
September
30, 2023 |
|
Expected volatility | |
110% –
117 |
% |
Expected term (years) | |
1.01 – 5.01 |
|
Risk-free interest rate | |
4.60% – 5.46 |
% |
Dividend rate | |
– |
|
|
Schedule of Level 3 Liabilities Measured at Fair Value on a Recurring Basis |
The
following table reflects the change in the Company’s Level 3 common warrant liability for the nine months ended September 30, 2023
(in thousands):
Schedule
of Level 3 Liabilities Measured at Fair Value on a Recurring Basis
| |
| | |
Fair value as of December 31, 2022 | |
$ | - | |
Common warrants issued in connection
with private placement | |
| 5,393 | |
Change in fair value | |
| (3,485 | ) |
Fair value as of September 30, 2023 | |
$ | 1,908 | |
|
X |
- DefinitionTabular disclosure of input and valuation technique used to measure fair value and change in valuation approach and technique for each separate class of asset and liability measured on recurring and nonrecurring basis.
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v3.23.3
Short-Term Marketable Securities (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Investments, Debt and Equity Securities [Abstract] |
|
Schedule of Short-Term Marketable Securities |
There
were no short-term marketable securities as of September 30, 2023. The tables summarize the Company’s short-term marketable securities
as of December 31, 2022 (in thousands):
Schedule of Short-Term Marketable Securities
| |
Amortized Cost
Basis | | |
Gross Unrealized Gains | | |
Gross Unrealized Losses | | |
Fair
Value | |
U.S.
Treasury bills | |
$ | 2,032 | | |
$ | 17 | | |
$ | - | | |
$ | 2,049 | |
| |
$ | 2,032 | | |
$ | 17 | | |
$ | - | | |
$ | 2,049 | |
|
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v3.23.3
Accrued Expenses (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses |
The
components of accrued expenses as of September 30, 2023, and December 31, 2022 are as follows (in thousands):
Schedule of Accrued Expenses
| |
September
30, 2023 | | |
December
31, 2022 | |
Clinical trial | |
$ | 519 | | |
$ | 88 | |
Employee benefits | |
| 525 | | |
| 475 | |
Other | |
| 211 | | |
| 5 | |
Total accrued expenses | |
$ | 1,255 | | |
$ | 568 | |
|
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v3.23.3
Equity Incentive Plan - Stock-Based Compensation Expense and Common Warrants (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Summary of Stock Option Award Activity |
A
summary of the stock option activity for the nine months ended September 30, 2023 is as follows:
Summary of Stock Option Award Activity
| |
Number
of Stock Options | | |
Weighted-
Average Exercise Price | | |
Weighted-
Average Remaining Contractual Life | | |
Aggregate
Intrinsic Value | |
Outstanding
as of December 31, 2022 | |
| 1,399,252 | | |
$ | 2.40 | | |
| 7.79 | | |
$ | 928 | |
Granted | |
| 420,351 | | |
$ | 3.10 | | |
| - | | |
$ | - | |
Exercised | |
| (7,747 | ) | |
$ | 0.97 | | |
| - | | |
$ | - | |
Forfeited | |
| (51,255 | ) | |
$ | 3.12 | | |
| - | | |
$ | - | |
Expired | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
Outstanding
as of September 30, 2023 | |
| 1,760,601 | | |
$ | 2.55 | | |
| 7.59 | | |
$ | 346 | |
Exercisable
as of September 30, 2023 | |
| 985,350 | | |
$ | 2.13 | | |
| 6.42 | | |
$ | 346 | |
Vested
and expected to vest as of September 30, 2023 | |
| 1,760,601 | | |
$ | 2.55 | | |
| 7.59 | | |
$ | 346 | |
|
Summary of Weighted-Average Assumptions Used to Calculate Fair Value of Stock Options Granted |
For
the nine months ended September 30, 2023, and 2022, the Company utilized the Black-Scholes option-pricing model for estimating the fair
value of the stock option granted. The Company estimated the fair value of each option grant on the grant date using the Black-Scholes
option pricing model with the following weighted-average assumptions:
Summary
of Weighted-Average Assumptions Used to Calculate Fair Value of Stock Options Granted
| |
| Nine
Months Ended September 30, | |
| |
| 2023 | | |
| 2022 | |
Expected volatility | |
| 99.49%
– 106.69 | % | |
| 101.54%
– 102.96 | % |
Expected term (years) | |
| 6.02
– 10.0 | | |
| 5.27
– 6.08 | |
Risk-free interest rate | |
| 3.40%
– 4.28 | % | |
| 1.93%
– 1.95 | % |
Dividend rate | |
| – | % | |
| – | % |
|
Schedule of Stock Based Compensation Expense |
The
following table summarizes the components of stock-based compensation expense recognized in the Company’s Condensed Statements
of Operations and Comprehensive Loss during the three and nine months ended September 30, 2023, and 2022 (in thousands):
Schedule of Stock Based Compensation Expense
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months
Ended | | |
Nine Months
Ended | |
| |
September
30, | | |
September
30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 46 | | |
$ | 27 | | |
$ | 155 | | |
$ | 109 | |
General and administrative | |
| 193 | | |
| 116 | | |
| 702 | | |
| 371 | |
Total stock-based compensation
expense | |
$ | 239 | | |
$ | 143 | | |
$ | 857 | | |
$ | 480 | |
|
Schedule of Common Stock Warrant Activity |
The
following is a summary of the common stock warrant activity during the nine months ended September 30, 2023.
Schedule
of Common Stock Warrant Activity
| |
Shares
Issuable Upon Exercise of Outstanding Warrants | | |
Weighted-
Average Exercise Price | | |
Weighted-
Average Remaining Contractual Life | | |
Aggregate
Intrinsic Value (In thousands) | |
Outstanding
as of December 31, 2022 | |
| 2,786,995 | | |
$ | 10.80 | | |
| 3.67 | | |
$ | 30,100 | |
Issued | |
| 2,504,672 | | |
$ | 3.21 | | |
| 5.00 | | |
$ | - | |
Exercised | |
| (557,632 | ) | |
$ | 3.21 | | |
| - | | |
$ | - | |
Expired | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
Outstanding
as of September 30, 2023 | |
| 4,734,035 | | |
$ | 7.68 | | |
| 3.51 | | |
$ | 36,350 | |
|
X |
- DefinitionTabular disclosure of share-based payment arrangement.
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v3.23.3
Net Loss Per Share (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
Schedule of Computation of Basic and Diluted Net Loss Per Share |
Basic
and diluted net loss per common share was calculated as follows (in thousands except per share amounts):
Schedule of Computation of Basic and Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months
Ended | | |
Nine Months
Ended | |
| |
September
30, | | |
September
30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (1,421 | ) | |
$ | (2,136 | ) | |
$ | (7,005 | ) | |
$ | (7,733 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted average shares
used in computing net loss per share – basic and diluted | |
| 10,693,080 | | |
| 9,067,509 | | |
| 10,154,914 | | |
| 9,039,308 | |
Net loss per share –
basic and diluted | |
$ | (0.13 | ) | |
$ | (0.24 | ) | |
$ | (0.69 | ) | |
$ | (0.86 | ) |
|
Schedule of Potentially Anti Dilutive Securities |
Potentially
dilutive securities not included in the computation of diluted net loss per share because to do so would be antidilutive are as follows
(in common stock equivalent shares):
Schedule of Potentially Anti Dilutive Securities
| |
2023 | | |
2022 | |
| |
As
of September 30, | |
| |
2023 | | |
2022 | |
Options
to purchase common stock | |
| 453,346 | | |
| 484,518 | |
Total | |
| 453,346 | | |
| 484,518 | |
|
X |
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v3.23.3
Business and Principal Activities (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
|
|
|
3 Months Ended |
9 Months Ended |
|
Mar. 30, 2023 |
Aug. 30, 2021 |
Aug. 25, 2021 |
Aug. 05, 2021 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2022 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Over allotment option to purchase |
|
|
|
|
|
|
|
|
|
|
7,747
|
|
|
Other offering expenses |
|
|
|
|
|
|
|
|
|
|
$ 5,000
|
|
|
Reverse stock split |
|
|
|
1-for-5
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of equity |
|
|
|
|
|
|
|
|
|
|
39,800
|
|
|
Cash and cash equivalents |
|
|
|
|
$ 3,226
|
|
|
|
|
|
3,226
|
|
$ 4,391
|
Net loss |
|
|
|
|
1,421
|
$ 2,327
|
$ 3,257
|
$ 2,136
|
$ 2,594
|
$ 3,003
|
7,005
|
$ 7,733
|
|
Accumulated deficit |
|
|
|
|
$ 38,178
|
|
|
|
|
|
38,178
|
|
$ 31,173
|
Maximum possible proceeds from offerings |
|
|
|
|
|
|
|
|
|
|
$ 50,000
|
|
|
Threshold per share limit for exercise of warrants |
|
|
|
|
$ 10.80
|
|
|
|
|
|
$ 10.80
|
|
|
Common stock, par value |
|
|
|
|
$ 0.0001
|
|
|
|
|
|
$ 0.0001
|
|
$ 0.0001
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Over allotment option to purchase |
|
|
|
|
|
4,200
|
3,547
|
5,400
|
37,558
|
91,816
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares, new issues |
1,000,000
|
|
|
|
|
1,000,000
|
|
|
|
|
|
|
|
Common stock, par value |
$ 0.0001
|
|
|
|
|
|
|
|
|
|
|
|
|
Share offering price |
3.21
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-Funded Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
$ 0.0001
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares, new issues |
557,632
|
|
|
|
|
|
|
|
|
|
|
|
|
Minimum percentage of warrants to be owned |
4.99%
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant offering price per share |
$ 3.2099
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
$ 3.21
|
|
|
|
|
|
|
|
|
|
|
|
|
Prefunded warrants outstanding |
1,947,040
|
|
|
|
|
|
|
|
|
|
|
|
|
IPO [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of stock, number of shares issued in transaction |
|
|
1,850,000
|
|
|
|
|
|
|
|
|
|
|
Sale of stock, price per share |
|
|
$ 9.00
|
|
|
|
|
|
|
|
|
|
|
Other offering expenses |
|
|
$ 16,700
|
|
|
|
|
|
|
|
|
|
|
Underwriting discounts and commissions |
|
|
1,300
|
|
|
|
|
|
|
|
|
|
|
Other expenses |
|
|
800
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from intial public offering |
|
|
$ 14,600
|
|
|
|
|
|
|
|
|
|
|
Conversion of stock, shares issued |
|
|
3,535,469
|
|
|
|
|
|
|
|
|
|
|
Debt principal and accrued unpaid interest |
|
|
$ 5,300
|
|
|
|
|
|
|
|
|
|
|
Debt instrument, description |
|
|
converted at a 20% and 12.5% discount to the IPO price, respectively, into an aggregate of 708,820
units. Each unit consisted of (a) one share of common stock and (b) one five-year warrant to purchase one share of common stock at an
exercise price equal to $10.80 per share
|
|
|
|
|
|
|
|
|
|
|
IPO [Member] | Underwriter [Member] | Over-Allotment Option [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Over allotment option to purchase |
|
277,500
|
|
|
|
|
|
|
|
|
|
|
|
IPO [Member] | Underwriter [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
$ 10.80
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
198,875
|
|
|
|
|
|
|
|
|
|
|
IPO [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
$ 10.80
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise term |
|
|
5 years
|
|
|
|
|
|
|
|
|
|
|
IPO [Member] | Warrant [Member] | Underwriter [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise term |
|
|
5 years
|
|
|
|
|
|
|
|
|
|
|
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v3.23.3
Schedule of Assets Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of assets |
$ 2,820
|
$ 6,349
|
Fair value of liabilities |
1,908
|
|
US Treasury Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of assets |
2,712
|
2,049
|
Money Market Funds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of assets |
108
|
4,300
|
Common Warrant Liabilities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of liabilities |
1,908
|
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of assets |
2,820
|
6,349
|
Fair value of liabilities |
|
|
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of assets |
2,712
|
2,049
|
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of assets |
108
|
4,300
|
Fair Value, Inputs, Level 1 [Member] | Common Warrant Liabilities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of liabilities |
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of assets |
|
|
Fair value of liabilities |
|
|
Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of assets |
|
|
Fair Value, Inputs, Level 2 [Member] | Money Market Funds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of assets |
|
|
Fair Value, Inputs, Level 2 [Member] | Common Warrant Liabilities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of liabilities |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of assets |
|
|
Fair value of liabilities |
1,908
|
|
Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of assets |
|
|
Fair Value, Inputs, Level 3 [Member] | Money Market Funds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of assets |
|
|
Fair Value, Inputs, Level 3 [Member] | Common Warrant Liabilities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value of liabilities |
$ 1,908
|
|
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Schedule of Level 3 Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Change in fair value |
$ (3,485)
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Fair value as of December 31, 2022 |
|
|
Common warrants issued in connection with private placement |
5,393
|
|
Change in fair value |
(3,485)
|
|
Fair value as of September 30, 2023 |
$ 1,908
|
|
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- DefinitionAmount of expense (income) related to adjustment to fair value of warrant liability.
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9 Months Ended |
Sep. 30, 2023
USD ($)
|
Marketable Securities [Line Items] |
|
Short-term marketable securities, amortized cost basis |
$ 2,032
|
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17
|
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|
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2,049
|
US Treasury Securities [Member] |
|
Marketable Securities [Line Items] |
|
Short-term marketable securities, amortized cost basis |
2,032
|
Short-term marketable securities, unrealized gains |
17
|
Short-term marketable securities, unrealized losses |
|
Short-term marketable securities, fair value |
$ 2,049
|
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Commitments and Contingencies (Details Narrative) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Commitments and Contingencies Disclosure [Abstract] |
|
|
|
|
Lessee, Operating Lease, Description |
|
|
The
Company leases its headquarters in Los Altos, California under a month-to-month operating lease agreement.
|
|
Operating Lease, Expense |
$ 18,000
|
$ 18,000
|
$ 55,000
|
$ 54,000
|
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v3.23.3
Summary of Stock Option Award Activity (Details) - USD ($) $ / shares in Units, $ in Thousands |
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Dec. 31, 2022 |
Share-Based Payment Arrangement [Abstract] |
|
|
Number of stock options outstanding, beginning balance |
1,399,252
|
|
Weighted average exercise price outstanding, beginning balance |
$ 2.40
|
|
Weighted average remaining contractual life |
7 years 7 months 2 days
|
7 years 9 months 14 days
|
Aggregate intrinsic value outstanding, beginning balance |
$ 928
|
|
Number of stock options, granted |
420,351
|
|
Weighted average exercise price, granted |
$ 3.10
|
|
Number of stock options, exercised |
(7,747)
|
|
Weighted average exercise price, exercised |
$ 0.97
|
|
Number of stock options, forfeited |
(51,255)
|
|
Weighted average exercise price, forfeited |
$ 3.12
|
|
Number of stock options, expired |
|
|
Weighted average exercise price, expired |
|
|
Number of stock options outstanding, ending balance |
1,760,601
|
1,399,252
|
Weighted average exercise price outstanding, ending balance |
$ 2.55
|
$ 2.40
|
Aggregate intrinsic value outstanding, ending balance |
$ 346
|
$ 928
|
Number of stock options, exercisable |
985,350
|
|
Weighted average exercise price, exercisable |
$ 2.13
|
|
Weighted average remaining contractual life, exercisable |
6 years 5 months 1 day
|
|
Aggregate intrinsic value, exercisable |
$ 346
|
|
Number of stock options, vested and expected to vest |
1,760,601
|
|
Weighted average exercise price, vested and expected to vest |
$ 2.55
|
|
Weighted average remaining contractual life, vested and expected to vest |
7 years 7 months 2 days
|
|
Aggregate intrinsic value, vested and expected to vest |
$ 346
|
|
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v3.23.3
Schedule of Stock Based Compensation Expense (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 239,000
|
$ 143,000
|
$ 857,000
|
$ 480,000
|
Research and Development Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
46,000
|
27,000
|
155,000
|
109,000
|
General and Administrative Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 193,000
|
$ 116,000
|
$ 702,000
|
$ 371,000
|
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v3.23.3
Schedule of Common Stock Warrant Activity (Details) $ / shares in Units, $ in Thousands |
9 Months Ended |
Sep. 30, 2023
USD ($)
$ / shares
shares
|
Share-Based Payment Arrangement [Abstract] |
|
Warrants outstanding, beginning balance | shares |
2,786,995
|
Weighted average exercise price, beginning balance | $ / shares |
$ 10.80
|
Weighted average remaining contractual life, beginning |
3 years 8 months 1 day
|
Warrants aggregate intrinsic value, beginning balance | $ |
$ 30,100
|
Warrants outstanding, issued | shares |
2,504,672
|
Weighted average exercise price, issued | $ / shares |
$ 3.21
|
Weighted average remaining contractual life, issued |
5 years
|
Warrants aggregate intrinsic value, issued | $ |
|
Warrants outstanding, exercised | shares |
(557,632)
|
Weighted average exercise price, exercised | $ / shares |
$ 3.21
|
Warrants aggregate intrinsic value, exercised | $ |
|
Warrants outstanding, expired | shares |
|
Weighted average exercise price, expired | $ / shares |
|
Warrants outstanding, ending balance | shares |
4,734,035
|
Weighted average exercise price, ending balance | $ / shares |
$ 7.68
|
Weighted average remaining contractual life, ending |
3 years 6 months 3 days
|
Warrants aggregate intrinsic value, ending balance | $ |
$ 36,350
|
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v3.23.3
Equity Incentive Plan - Stock-Based Compensation Expense and Common Warrants (Details Narrative) - USD ($)
|
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
|
|
Apr. 03, 2023 |
Mar. 31, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Jan. 01, 2023 |
Aug. 31, 2021 |
Jul. 19, 2021 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Unrecognized stock based compensation expense |
|
|
$ 1,800,000
|
|
$ 1,800,000
|
|
|
|
|
Weighted average period of recognition |
|
|
|
|
2 years 11 months 12 days
|
|
|
|
|
Share based compensation expense |
|
|
$ 239,000
|
$ 143,000
|
$ 857,000
|
$ 480,000
|
|
|
|
Share based compensation |
|
|
|
|
$ 857,000
|
$ 480,000
|
|
|
|
Warrant, maturity date |
|
|
Oct. 03, 2028
|
|
Oct. 03, 2028
|
|
|
|
|
Common Stock Warrants [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Warrants issued |
1,947,040
|
|
|
|
|
|
|
|
|
Pre-Funded Warrants [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Pre-funded warrants issued |
557,632
|
|
|
|
|
|
|
|
|
IPO [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
|
|
|
|
|
3,035,195
|
|
Restricted Stock [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Share based compensation |
|
$ 117,000
|
|
|
|
|
|
|
|
Restricted Stock [Member] | Private Placement [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Issuance of restricted stock awards, shares |
|
30,000
|
|
|
|
|
|
|
|
Warrant One [Member] | IPO [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
|
|
|
|
|
198,875
|
|
Warrant, maturity date |
|
|
|
|
|
|
|
Aug. 25, 2026
|
|
Warrant Two [Member] | IPO [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
|
|
|
|
|
2,588,120
|
|
Warrant, maturity date |
|
|
|
|
|
|
|
Aug. 31, 2026
|
|
2021 Omnibus Equity Incentive Plan [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Number of shares reserved and available for issuance |
|
|
|
|
|
|
272,931
|
|
2,185,832
|
Amended and Restated 2013 Equity Incentive Plan [Member] |
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
|
Common shares reserved but unissued |
|
|
|
|
|
|
|
|
10,832
|
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v3.23.3
v3.23.3
Schedule of Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2022 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Earnings Per Share [Abstract] |
|
|
|
|
|
|
|
|
Net loss |
$ (1,421)
|
$ (2,327)
|
$ (3,257)
|
$ (2,136)
|
$ (2,594)
|
$ (3,003)
|
$ (7,005)
|
$ (7,733)
|
Weighted average shares used in computing net loss per share - basic |
10,693,080
|
|
|
9,067,509
|
|
|
10,154,914
|
9,039,308
|
Weighted average shares used in computing net loss per share - diluted |
10,693,080
|
|
|
9,067,509
|
|
|
10,154,914
|
9,039,308
|
Net loss per share - basic |
$ (0.13)
|
|
|
$ (0.24)
|
|
|
$ (0.69)
|
$ (0.86)
|
Net loss per share - diluted |
$ (0.13)
|
|
|
$ (0.24)
|
|
|
$ (0.69)
|
$ (0.86)
|
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v3.23.3
Related Party Transactions (Details Narrative) - Dr.Agah [Member] - USD ($)
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
|
|
|
Feb. 28, 2023 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Jan. 01, 2023 |
Nov. 30, 2021 |
Sep. 30, 2019 |
Dec. 31, 2018 |
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
Cash compensation per month |
|
|
|
|
|
$ 25,000
|
$ 21,667.67
|
|
|
Consulting Agreement [Member] |
|
|
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
|
|
Cash compensation per month |
|
|
|
|
|
|
|
$ 10,000
|
$ 4,000
|
Professional Fees |
|
$ 76,000
|
$ 72,000
|
$ 319,000
|
$ 217,000
|
|
|
|
|
Discretionary bonus |
$ 91,000
|
|
|
|
|
|
|
|
|
X |
- DefinitionCash compensation per month.
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