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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended September 30, 2023
☐ |
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from to
COMMISSION
FILE NUMBER 001-39555
GREENWICH
LIFESCIENCES, INC.
(Exact
Name of registrant as specified in its charter)
Delaware |
|
20-5473709 |
(State
or other jurisdiction
of
incorporation or organization) |
|
(I.R.S.
Employer
Identification
No.) |
|
|
|
3992
Bluebonnet Dr., Building 14, Stafford, Texas |
|
77477 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(832)
819-3232
(Registrant’s
telephone number, including area code)
Title
of each class: |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered: |
Common
Stock |
|
GLSI |
|
Nasdaq
Capital Market |
Indicate
by check mark whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act 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 and posted on its corporate Web site, if any, every Interactive Data
File required to be submitted and posted 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 and post 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 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 October 16, 2023, the issuer had 12,848,165 shares of Common Stock issued and outstanding.
GREENWICH
LIFESCIENCES, INC.
Table
of Contents
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
GREENWICH
LIFESCIENCES, INC.
CONSOLIDATED
BALANCE SHEETS
AS
OF SEPTEMBER 30, 2023 AND DECEMBER 31, 2022 (UNAUDITED)
| |
September 30, 2023 | | |
December 31, 2022 | |
Assets | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash | |
$ | 9,143,619 | | |
$ | 13,468,026 | |
Non-current assets | |
| | | |
| | |
Acquired patents, net | |
| 6,294 | | |
| 9,003 | |
Total assets | |
$ | 9,149,913 | | |
$ | 13,477,029 | |
| |
| | | |
| | |
Liabilities and stockholders’ equity | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable & accrued interest | |
$ | 230,902 | | |
$ | 220,845 | |
Unreimbursed expenses | |
| 66,385 | | |
| 42,060 | |
Total current liabilities | |
| 297,287 | | |
| 262,905 | |
Total liabilities | |
| 297,287 | | |
| 262,905 | |
| |
| | | |
| | |
Stockholders’ equity | |
| | | |
| | |
Common stock, $0.001 par value; 100,000,000 shares authorized; 12,848,165 shares issued and outstanding as of September 30, 2023 and December 31, 2022 | |
| 12,848 | | |
| 12,848 | |
Additional paid-in capital | |
| 56,457,608 | | |
| 54,674,042 | |
Accumulated deficit | |
| (47,617,830 | ) | |
| (41,472,766 | ) |
Total stockholders’ equity | |
| 8,852,626 | | |
| 13,214,124 | |
Total liabilities and stockholders’ equity | |
$ | 9,149,913 | | |
$ | 13,477,029 | |
See
accompanying notes to unaudited financial statements.
GREENWICH
LIFESCIENCES, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
FOR
THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022 (UNAUDITED)
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
Three
Months Ended
September
30, |
|
|
Nine
Months Ended
September
30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
2,158,167 |
|
|
|
1,723,493 |
|
|
|
5,365,641 |
|
|
|
4,017,564 |
|
General
and administrative |
|
|
344,758 |
|
|
|
659,568 |
|
|
|
1,126,192 |
|
|
|
1,128,007 |
|
Total
operating expenses |
|
|
2,502,925 |
|
|
|
2,383,061 |
|
|
|
6,491,833 |
|
|
|
5,145,571 |
|
Loss
from operations |
|
|
(2,502,925 |
) |
|
|
(2,383,061 |
) |
|
|
(6,491,833 |
) |
|
|
(5,145,571 |
) |
Interest
Income |
|
|
111,136 |
|
|
|
64,037 |
|
|
|
346,769 |
|
|
|
110,846 |
|
Net
loss |
|
$ |
(2,391,789 |
) |
|
$ |
(2,319,024 |
) |
|
$ |
(6,145,064 |
) |
|
$ |
(5,034,725 |
) |
Per
share information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per common share, basic and diluted |
|
$ |
(0.19 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.48 |
) |
|
$ |
(0.39 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
|
12,848,165 |
|
|
|
12,823,447 |
|
|
|
12,848,165 |
|
|
|
13,067,620 |
|
See
accompanying notes to unaudited financial statements.
GREENWICH
LIFESCIENCES, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022 (UNAUDITED)
| |
Shares | | |
Par
Amount | | |
Paid-in Capital | | |
Accumulated Deficit | | |
Stockholders’ Equity | |
| |
Common Stock | | |
Additional | | |
| | |
Total | |
| |
Shares | | |
Par
Amount | | |
Paid-in Capital | | |
Accumulated Deficit | | |
Stockholders’ Equity | |
| |
| | |
| | |
| | |
| | |
| |
Balances, December 31, 2021 | |
| 13,147,829 | | |
$ | 13,148 | | |
$ | 60,466,093 | | |
$ | (33,647,529 | ) | |
$ | 26,831,712 | |
Stock-based compensation | |
| 73,452 | | |
| 74 | | |
| 165,193 | | |
| — | | |
| 165,267 | |
Repurchase of common stock via stock buy back program, net of costs | |
| (269,828 | ) | |
| (270 | ) | |
| (5,513,441 | ) | |
| — | | |
| (5,513,711 | ) |
Net loss | |
| | | |
| | | |
| — | | |
| (1,969,628 | ) | |
| (1,969,628 | ) |
Balances, March 31, 2022 | |
| 12,951,453 | | |
| 12,952 | | |
| 55,117,845 | | |
| (35,617,157 | ) | |
| 19,513,640 | |
Stock-based compensation | |
| 73,356 | | |
| 73 | | |
| 224,430 | | |
| — | | |
| 224,503 | |
Repurchase of common stock via stock buy back program, net of costs | |
| (250,000 | ) | |
| (250 | ) | |
| (2,022,255 | ) | |
| — | | |
| (2,022,505 | ) |
Net loss | |
| | | |
| | | |
| — | | |
| (746,073 | ) | |
| (746,073 | ) |
Balances, June 30, 2022 | |
| 12,774,809 | | |
| 12,775 | | |
| 53,320,020 | | |
| (36,363,230 | ) | |
| 16,969,565 | |
Stock-based compensation | |
| 73,356 | | |
| 73 | | |
| 759,500 | | |
| — | | |
| 759,573 | |
Net loss | |
| | | |
| | | |
| — | | |
| (2,319,024 | ) | |
| (2,319,024 | ) |
Balances, September 30, 2022 | |
| 12,848,165 | | |
$ | 12,848 | | |
$ | 54,079,520 | | |
$ | (38,682,254 | ) | |
$ | 15,410,114 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balances, December 31, 2022 | |
| 12,848,165 | | |
$ | 12,848 | | |
$ | 54,674,042 | | |
$ | (41,472,766 | ) | |
$ | 13,214,124 | |
Stock-based compensation | |
| — | | |
| — | | |
| 594,522 | | |
| — | | |
| 594,522 | |
Net loss | |
| - | | |
| - | | |
| — | | |
| (2,124,902 | ) | |
| (2,124,902 | ) |
Balances, March 31, 2023 | |
| 12,848,165 | | |
| 12,848 | | |
| 55,268,564 | | |
| (43,597,668 | ) | |
| 11,683,744 | |
Stock-based compensation | |
| - | | |
| - | | |
| 594,522 | | |
| — | | |
| 594,522 | |
Net loss | |
| - | | |
| - | | |
| — | | |
| (1,628,373 | ) | |
| (1,628,373 | ) |
Balances, June 30, 2023 | |
| 12,848,165 | | |
| 12,848 | | |
| 55,863,086 | | |
| (45,226,041 | ) | |
| 10,649,893 | |
Balances | |
| 12,848,165 | | |
$ | 12,848 | | |
$ | 55,863,086 | | |
$ | (45,226,041 | ) | |
$ | 10,649,893 | |
Stock-based compensation | |
| — | | |
| — | | |
| 594,522 | | |
| — | | |
| 594,522 | |
Net loss | |
| - | | |
| - | | |
| — | | |
| (2,391,789
| ) | |
| (2,391,789
| ) |
Balances, September 30, 2023 | |
| 12,848,165 | | |
$ | 12,848 | | |
$ | 56,457,608
| | |
$ | (47,617,830
| ) | |
$ | 8,852,626
| |
Balances | |
| 12,848,165 | | |
$ | 12,848 | | |
$ | 56,457,608
| | |
$ | (47,617,830
| ) | |
$ | 8,852,626
| |
See
accompanying notes to unaudited financial statements.
GREENWICH
LIFESCIENCES, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022 (UNAUDITED)
| |
2023 | | |
2022 | |
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Operating activities: | |
| | | |
| | |
Net loss | |
$ | (6,145,064 | ) | |
$ | (5,034,725 | ) |
Adjustments required to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Amortization | |
| 2,709 | | |
| 2,709 | |
Stock-based compensation | |
| 1,783,566 | | |
| 1,149,343 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts payable | |
| 10,057 | | |
| — | |
Unreimbursed expenses (accrued) | |
| 24,325 | | |
| (147,293 | ) |
Net cash used in operating activities | |
| (4,324,407 | ) | |
| (4,029,966 | ) |
Financing activities: | |
| | | |
| | |
Repurchase of common stock via stock buy back program, net of costs | |
| — | | |
| (7,536,216 | ) |
Net cash provided by (used in) financing activities | |
| — | | |
| (7,536,216 | ) |
Net increase (decrease) in cash | |
| (4,324,407 | ) | |
| (11,566,182 | ) |
Cash, beginning of period | |
| 13,468,026 | | |
| 27,204,269 | |
Cash, end of period | |
$ | 9,143,619 | | |
$ | 15,638,087 | |
See
accompanying notes to unaudited financial statements.
GREENWICH
LIFESCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1.
Organization and Description of the Business
Greenwich
LifeSciences, Inc. (the “Company”) was incorporated in the state of Delaware in 2006 under the name Norwell, Inc. In March
2018, Norwell, Inc. changed its name to Greenwich LifeSciences, Inc. In February 2023, Greenwich LifeSciences Europe Limited was incorporated
as a wholly owned subsidiary in Ireland. The Company is developing a breast cancer immunotherapy focused on preventing the recurrence
of breast cancer following surgery.
2.
Significant Accounting Policies
Basis
of Presentation
The
accompanying unaudited interim financial statements of the Company have been prepared in accordance with accounting principles generally
accepted in the United States of America and the rules of the Securities and Exchange Commission and should be read in conjunction with
the audited financial statements and notes thereto of the Company contained elsewhere herein.
In
the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial
position and the results of operations for the interim periods presented have been reflected herein. The results of operations for the
interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements that
would substantially duplicate the disclosures contained in the audited financial statements of the Company for the years ended December
31, 2022 and 2021 as reported in the Company’s Form 10-K have been omitted.
Leases
In
February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02-Leases (Topic 842), which significantly amends
the way companies are required to account for leases. Under the updated leasing guidance, some leases that did not have to be reported
previously are now required to be presented as an asset and liability on the balance sheet. In addition, for certain leases, what was
previously classified as an operating expense must now be allocated between amortization expense and interest expense. The Company elected
to adopt this update using the modified retrospective transition method and prior periods have not been restated. The current monthly
rent is approximately $2,555. The month-to-month sub-lease is from a related party and the underlying lease expires in May of 2024. Any
right of use asset and liability is deemed to be nominal as of September 30, 2023 and December 31, 2022.
Basic
and Diluted Loss per Share
Basic
EPS is computed by dividing net loss (numerator) by the weighted average number of common shares outstanding (denominator) during the
period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method.
Diluted EPS excludes all dilutive potential shares if their effect is antidilutive. During periods of net loss, all common stock equivalents
related to 1,498,128
options and 20,174
warrants outstanding as of September 30, 2023
and 2022
are excluded from the diluted EPS calculation because they are antidilutive.
Recently
Adopted Accounting Pronouncements
In
June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-13, “Financial
Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). ASU
2016-13 requires companies to measure credit losses utilizing a methodology that reflects expected credit losses and requires a consideration
of a broader range of reasonable and supportable information to inform credit loss estimates. ASU 2016-13 is effective for fiscal years
beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted ASU 2016-13 effective January
1, 2023. The Company determined that the update applied to trade receivables, but that there was no material impact to the consolidated
financial statements from the adoption of ASU 2016-13.
3.
Related Party Transactions
Unreimbursed
expenses have been accrued and incurred by management, which total $66,385
as of September 30, 2023 and $42,060
as of December 31, 2022.
4.
Commitments and Contingencies
License
Obligation, Legal Expenses, and Manufacturing Agreements
The
Company entered into an exclusive license agreement with The Henry M. Jackson Foundation (“HJF”) in April 2009, as amended,
pursuant to which it acquired exclusive marketing rights to GP2, the Company’s product candidate. In consideration for such licensed
rights, the Company issued HJF 202,619 shares of the Company’s common stock valued at $0.267 per share, which is amortized over
15 years at $3,607 per year. Pursuant to the exclusive license agreement, the Company is required to pay an annual maintenance fee, milestone
payments and royalty payments based on sales of GP2 and to reimburse HJF for patent expenses related to GP2. The Company currently depends
on third-party contract manufacturers for all required raw materials, active pharmaceutical ingredients, and finished product candidate
for the Company’s clinical trials.
Accounts
payable includes accrued interest obligations to HJF which total $220,845 as of September 30, 2023 and December 31, 2022.
Legal
Proceedings
From
time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal
course of business. Any of these claims could subject the Company to costly legal expenses and, while management generally believes that
there will be adequate insurance to cover different liabilities at such time the Company becomes a public company and commences clinical
trials, the Company’s future insurance carriers may deny coverage or policy limits may be inadequate to fully satisfy any damage
awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the results of
operations and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s reputation
and business. The Company is currently not a party to any legal proceedings, the adverse outcome of which, in management’s opinion,
individually or in the aggregate, could have a material adverse effect on our results of operations or financial position.
5.
Stockholders’ Equity
As
of September 30, 2023, 893,181 shares of the 908,362 shares of the common stock grant, which includes an additional grant of 120 shares
issued during the vesting period due to rounding up of fractional shares, had vested at approximately $2,009,657 value and 15,181 shares
remain unvested and unrecognized at $34,157 value. There were no shares vested during the nine months ended September 30,
2023.
On
January 23, 2022, the Board of Directors authorized the Company’s management to implement a stock repurchase program for up to
$10 million of the Company’s common stock at any time. The term of the Board of Directors authorization of the repurchase program
ended on March 31, 2023. The repurchase program may be suspended or discontinued at any time and will be funded using the Company’s
working capital. As of September 30, 2023 and 2022, approximately 519,828 shares of the Company’s common stock has been repurchased
and cancelled at an aggregate purchase price, including all transactions costs, of approximately $7,536,216. There were no shares repurchased
during the nine months ended September 30, 2023.
On
January 23, 2022, the Board of Directors extended the lock-up of the shares owned by the Company’s directors, officers, and existing
pre-IPO investors to March 24, 2023 (30 months from date of the Company’s IPO) from March 24, 2022 (18 months from date of the
Company’s IPO). On November 30, 2022, the Board of Directors further extended the lock-up of the shares owned by the Company’s
directors, officers, and existing pre-IPO investors to December 31, 2023 (approximately 39 months from date of the Company’s IPO)
from March 24, 2023 (30 months from date of the Company’s IPO). During this period, current officers, directors and certain shareholders
will not be able to sell their shares of the Company’s common stock unless otherwise modified by the Board of Directors.
Warrants
At
September 30, 2023, outstanding warrants to purchase shares of common stock were as follows with an aggregate intrinsic value as of September
30, 2023 of $33,338 based on the September 29, 2023 closing share price of $8.84:
Schedule of Outstanding Warrants
Shares
Underlying |
|
|
|
|
|
|
|
Outstanding |
|
|
Exercise |
|
|
Expiration |
|
Warrants |
|
|
Price |
|
|
Date |
|
|
|
|
|
|
|
|
|
20,174 |
|
|
$ |
7.1875 |
|
|
|
September
24, 2025 |
|
20,174 |
|
|
|
|
|
|
|
|
|
Options
On
June 22, 2022, prior to the close of the Nasdaq market, 1,498,128
shares of common stock were granted to employees,
consultants, and directors issuable upon exercise of outstanding stock options under the Company’s 2019 Equity Incentive Plan at
an exercise price of $7.63
per share, which was the most recent prior closing
share price on June 21, 2022. The options had a fair value on the grant date of $9,512,356,
based on a risk-free rate of 3.2%
and an annualized volatility of 106%,
of which $3,032,062 was
expensed through September 30, 2023 and $6,480,294
will be expensed in the future if and as vesting
occurs. Vesting will be based on time of service over a four
year period and certain additional performance
milestones for senior management, primarily related to the Phase III clinical trial.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding the future
financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The
words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“intend,” “should,” “plan,” “expect,” and similar expressions, as they relate to us,
are intended to identify forward-looking statements. We have based these forward-looking statements largely on current expectations and
projections about future events and financial trends that we believe may affect our financial condition, results of operations, business
strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions.
In
addition, our business and financial performance may be affected by the factors that are discussed under “Risk Factors”
in the Annual Report on Form 10-K for the year ended December 31, 2022, filed on March 31, 2023 and updated in Item 1A below. Moreover, we operate in a very
competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for us to predict all
risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those contained in any forward-looking statements.
You
should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances
reflected in the forward-looking statements will be achieved or occur. Although we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
The
following discussion and analysis is qualified in its entirety by, and should be read in conjunction with, the more detailed information
set forth in the financial statements and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q. This discussion
should not be construed to imply that the results discussed herein will necessarily continue into the future, or that any conclusion
reached herein will necessarily be indicative of actual operating results in the future. Such discussion represents only the best present
assessment of our management.
Overview
We
are a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences
in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell
surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+),
intermediate (2+), and high (3+ or over-expressor) levels. The combination of GP2 + GM-CSF is called GLSI-100. In a completed randomized,
single-blinded, placebo-controlled, multi-center Phase IIb clinical trial led by MD Anderson Cancer Center, no recurrences were observed
in patients treated with GLSI-100 in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patients were
treated, followed, and remained disease free over the first 6 months, which is the time required to reach peak immunity and thus maximum
efficacy and protection (p = 0.0338). For the 146 patients who have been treated with GLSI-100 to date over 4 clinical trials, treatment
was well tolerated and no serious adverse events were observed related to the immunotherapy.
We
have commenced Flamingo-01, a Phase III clinical trial with Baylor College of Medicine as the global primary investigator site. Flamingo-01
is designed to evaluate the safety and efficacy of GLSI-100 in HER2/neu positive patients with residual disease or high-risk pathologic
complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment.
To
date, we have not generated any revenue and we have incurred net losses. Our net losses were approximately $7.8 million and $4.6 million
for the years ended December 31, 2022 and 2021, respectively and $6.1 million and $5.0 million for the nine months ended September 30,
2023 and 2022, respectively.
Our
net losses have resulted from costs incurred in developing the drug in our pipeline, planning and preparing for clinical trials and general
and administrative activities associated with our operations. We expect to continue to incur significant expenses and corresponding increased
operating losses for the foreseeable future as we continue to develop our pipeline. Our costs may further increase as we conduct clinical
trials and seek regulatory approval for and prepare to commercialize our product candidate. We expect to incur significant expenses to
continue to build the infrastructure necessary to support our expanded operations, clinical trials, commercialization, including manufacturing,
marketing, sales and distribution functions. We will also experience increased costs associated with operating as a public company.
Results
of Operations for the Three Months Ended September 30, 2023 and 2022
Research
and Development Expenses
Research
and development expenses increased by $434,674, or 25%, to $2,158,167 for the three months ended September 30, 2023 from $1,723,493 for
the three months ended September 30, 2022. The increase was primarily the result of an increase in clinical expenses.
General
and Administrative Expenses
General
and administrative expenses decreased by $314,810, or 48%, to $344,758 for the three months ended September 30, 2023 from $659,568 for
the three months ended September 30, 2022. The decrease was primarily the result of a decrease in compensation, financing, and corporate
expenses.
Results
of Operations for the Nine Months Ended September 30, 2023 and 2022
Research
and Development Expenses
Research and development expenses
increased by $1,348,077, or 34%, to $5,365,641 for the nine months ended September 30, 2023 from $4,017,564 for the nine months ended
September 30, 2022. The increase was primarily the result of an increase in clinical expenses.
General and Administrative Expenses
General and administrative expenses
decreased by $1,815 to $1,126,192 for the nine months ended September 30, 2023 from $1,128,007 for the nine months ended September 30,
2022.
Liquidity
and Capital Resources
Since
our inception in 2006, we have devoted most of our cash resources to research and development and general and administrative activities.
We have not yet achieved commercialization of our product and have a cumulative net loss from our operations. We will continue to incur
net losses for the foreseeable future. Our financial statements have been prepared assuming that we will continue as a going concern.
We
will require additional capital to meet our long-term operating requirements. We expect to raise additional capital through the sale
of equity and/or debt securities; however, there is no assurance that we will be successful at raising additional capital in the future.
If our plans are not achieved and/or if significant unanticipated events occur, we may have to further modify our business plan, which
may require us to raise additional capital. As of September 30, 2023 and December 31, 2022, our principal source of liquidity was our
cash, which totaled $9,143,619 and $13,468,026, respectively, and additional loans and accrued unreimbursed expenses from related parties.
Historically, our principal sources of cash have included proceeds from the sale of common stock and preferred stock and related party
loans. Our principal uses of cash have included cash used in operations. We expect that the principal uses of cash in the future will
be for continuing operations, funding of research and development, including our clinical trials, and general working capital requirements.
The Company’s existing cash resources are expected to provide sufficient funds to carry the Company’s planned operations
over the next 12 months from the date these financial statements were issued.
Cash
Flow Activities for the Nine Months Ended September 30, 2023 and 2022
We
incurred net losses of $6,145,064 and $5,034,725 during the nine month periods ended September 30, 2023 and 2022, respectively. The increase
was primarily the result of an increase in clinical expenses.
Operating
Activities
Net
cash used in operating activities was $4,324,407 for the nine months ended September 30, 2023 and $4,029,966 for the nine months ended
September 30, 2022.
Investing
Activities
We
did not use or generate cash from investing activities during the nine months ended September 30, 2023 and September 30, 2022.
Financing
Activities
We
used a total of $0 and $7,536,216 cash for the stock buy back program, net of costs, during the nine months ended September 30, 2023
and September 30, 2022, respectively.
Contractual
Obligations and Commitments
As
of September 30, 2023, we did not have any material contractual obligations, other than employment and shareholder agreements, license
for GP2 from HJF, and manufacturing and clinical trial obligations.
Off-Balance
Sheet Arrangements
As
of September 30, 2023, we did not have any off-balance sheet arrangements as described by Item 303(a)(4) of Regulation S-K.
Critical
Accounting Policies and Estimates
Our
financial statements are prepared in conformity with U.S. GAAP, which require the use of estimates, judgments and assumptions that affect
the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements, and
the reported amounts of expenses in the periods presented.
On
an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation.
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 and the reported amounts
of expenses that are not readily apparent from other sources. Actual results could differ from those estimates, particularly given the
significant social and economic disruptions and uncertainties associated with the ongoing coronavirus pandemic and the COVID-19 control
responses.
Recent
Accounting Pronouncements
In
June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-13, “Financial
Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). ASU
2016-13 requires companies to measure credit losses utilizing a methodology that reflects expected credit losses and requires a consideration
of a broader range of reasonable and supportable information to inform credit loss estimates. ASU 2016-13 is effective for fiscal years
beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted ASU 2016-13 effective January
1, 2023. The Company determined that the update applied to trade receivables, but that there was no material impact to the consolidated
financial statements from the adoption of ASU 2016-13.
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standard Board or other standard setting bodies that
the Company adopts as of the specified effective date. The Company does not believe that the impact of recently issued standards that
are not yet effective will have a material impact on the Company’s financial position or results of operations upon adoption.
JOBS
Act
On
April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take
advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended (“Securities
Act”) for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay
the adoption of certain accounting standards until those standards would otherwise apply to private companies.
We
have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying
with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act.
As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for
complying with new or revised accounting standards.
Subject
to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions,
including, without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial
reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public
Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the auditor’s
report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We
will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total
annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the
completion of our initial public offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during
the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We
are a smaller reporting company, as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to
provide the information required under this Item 3.
ITEM
4. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures
We
maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act that
are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange
Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure
controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed
by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including
our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
Our
management, with the participation of our principal executive officer and principal accounting and financial officer, has evaluated 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 period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, our principal executive officer and principal
accounting and financial officer has concluded that as of September 30, 2022, our disclosure controls and procedures were not effective
as of such date as a result of material weaknesses in our internal control over financial reporting due to inadequate segregation of
duties within account processes due to limited personnel and insufficient written policies and procedures for accounting, IT and financial
reporting and record keeping. Under the direction of our principal executive officer and principal financial and accounting officer,
we are developing a plan to remediate the material weaknesses.
Changes
in Internal Control over Financial Reporting
There
was no change in our internal control over financial reporting during our most recent fiscal quarter that materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
Limitations
on Effectiveness of Controls and Procedures
Our
disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives as specified above. Management
does not expect, however, that our disclosure controls and procedures will prevent or detect all errors and fraud. Any control system,
no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable, not absolute, assurance
that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or
fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected.
PART
II. OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
From
time to time, we may be subject to litigation and claims arising in the ordinary course of business. We are not currently a party to
any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have
a material adverse effect on our business, operating results, cash flows or financial condition.
ITEM
1A. RISK FACTORS
The
Company is updating its risk factors disclosed in its Form 10-K for the year ended December 31, 2022 as follows:
Risks
associated with out-licensing GP2 or future product candidates in foreign countries could materially adversely affect the commercialization
of our products.
We
may not be able to market products abroad if we cannot complete out-licensing transactions of GP2 or future product candidates by signing
licensing agreements with regional companies in countries where we plan to commercialize our products but where we do not have any operations.
Risks associated with out-licensing transactions of our products in foreign countries include:
| ● | failure
to obtain regulatory approval or intellectual property rights in any country which could
lead to the termination of a licensing transaction in that country; |
| | |
| ● | the
inability to obtain the issuance of patent claims or regulatory status in a foreign country
that provide periods of market exclusivity or data exclusivity prior to the entry of generic
or biosimilar forms of our products; |
| | |
| ● | the
difficulty of pursuing legal remedies to disputes or to secure monetary damages in foreign
countries; |
| | |
| ● | the
inability to repatriate income from a licensing transaction in a foreign country to the U.S.
or to other foreign countries where cash is needed; and |
| | |
| ● | the
potential to not realize or to delay development or commercialization milestone payments
due to unanticipated outcomes that prevent or delay the milestone. |
Risks
associated with operating in foreign countries could materially adversely affect our product development.
We
may conduct future clinical trials in countries outside of the U.S. Consequently, we may be subject to risks related to operating in
foreign countries. Risks associated with conducting operations in foreign countries include:
|
● |
differing
regulatory requirements for drug approvals and regulation of approved drugs in foreign countries; more stringent privacy requirements
for data to be supplied to our operations in the U.S., e.g., General Data Protection Regulation in the European Union; |
|
|
|
|
● |
difficulty
in exporting patient samples or patient data back to the U.S. to conduct research and analyze clinical trial results due to exportation
and data protection requirements; |
|
|
|
|
● |
difficulty
and costs associated with shipping drugs, clinical supplies, and patient samples in controlled temperature conditions over long distances; |
|
|
|
|
● |
unexpected
changes in tariffs, trade barriers and regulatory requirements; economic weakness, including inflation, or political instability
in particular foreign economies and markets; compliance with tax, employment, immigration and labor laws for employees living or
traveling abroad; foreign taxes, including withholding of payroll taxes; |
|
|
|
|
● |
differing
payor reimbursement regimes, governmental payors or patient self-pay systems and price controls; |
|
|
|
|
● |
foreign
currency fluctuations, which could result in increased operating expenses or reduced revenues, and other obligations incident to
doing business or operating in another country; |
|
|
|
|
● |
workforce
uncertainty in countries where labor unrest is more common than in the U.S.; |
|
|
|
|
● |
production
shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
|
|
|
|
● |
business
interruptions resulting from geopolitical actions, including war and terrorism. |
Our
future success is dependent on the regulatory approval of our product candidate.
Our
business is dependent on our ability to obtain regulatory approval for our product candidate in a timely manner. We cannot commercialize
our product candidate in the U.S. without first obtaining regulatory approval for the product from the FDA. Similarly, we cannot commercialize
our product candidate outside of the U.S. without obtaining regulatory approval from comparable foreign regulatory authorities. The FDA and foreign regulatory authorities may not allow patient data from
all countries to be used to satisfy their specific country requirements for various reasons such as concerns of varying genetics and thus
treatment responses by race or country of origin or differences in standard of care by country or regions within countries. The most recent
U.S. approved breast cancer drugs may not be approved, available, affordable, or reimbursed in all countries in the world or in countries
in which we may conduct clinical trials. Before
obtaining regulatory approvals for the commercial sale of our product candidate for a target indication, we must demonstrate with substantial
evidence gathered in preclinical studies and clinical trials, that the product candidate is safe and effective for use for that target
indication and that the manufacturing facilities, processes and controls are adequate with respect to such product candidate.
The
time required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable but typically takes many years
following the commencement of preclinical studies and 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. Additional
time may be required to do more manufacturing testing as well as to make multiple lots of commercial drug product, including the packaging
of the drug product, based on the commercial requirements of each country.
Even
if a product candidate were to successfully obtain approval from the FDA and comparable foreign regulatory authorities, any approval
might contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications,
or may be subject to burdensome post-approval clinical trial or risk management requirements. Also, any regulatory approval of our current
product candidate or any future product candidates we may pursue, once obtained, may be withdrawn.
A new EU regulatory software system
was implemented in 2023 to facilitate the submission of applications to conduct clinical trials in the EU. This new Clinical Trials Information
System (CTIS) supports the flow of information between clinical trial sponsors, EU Member States, European Economic Area countries
and the European Commission. This new unproven process for seeking approval to conduct clinical trials in EU member countries is based
on new software, is conducted without direct interaction with EU regulators, and thus may create unexpected outcomes or delays, misunderstandings
based on written interpretations and language differences, repeated submissions, protracted timelines based on staffing and EU holidays,
and limited negotiations that can only take place in writing without any voice or video discussions.
Failure
to obtain regulatory approval in international jurisdictions would prevent our product candidate from being marketed and
out-licensed abroad.
In
addition to regulations in the U.S., to market and sell our product candidate in the European Union, United Kingdom, many Asian countries
or other jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. Approval
by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority
outside the U.S. does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. The regulatory
approval process outside the U.S. generally includes all of the risks associated with obtaining FDA approval as well as risks attributable
to the satisfaction of local regulations in foreign jurisdictions. The approval procedure varies among countries and can involve additional
testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. We may not be able
to obtain approvals from regulatory authorities outside the U.S. on a timely basis, if at all. Clinical trials accepted in one country
may not be accepted by regulatory authorities in other countries. In addition, many countries outside the U.S. require that a product
be approved for reimbursement before it can be approved for sale in that country. A product candidate that has been approved for sale
in a particular country may not receive reimbursement approval in that country.
We
may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our product in any market.
If we are unable to obtain approval of any of our current product candidate or any future product candidates we may pursue by regulatory
authorities in the European Union, United Kingdom, Asia or elsewhere, the commercial prospects of that product candidate may be significantly
diminished, our business prospects could decline, we may not be able to complete out-licensing transactions, and this could materially adversely affect our business, results of operations and financial
condition.
In
the clinical trials using GP2, improper intradermal injections or poor HLA binding by GP2 may potentially jeopardize the outcome of the
trials.
GP2
is administered intradermally to patients with and without the HLA-A*02 allele. The effectiveness of GP2 is dependent upon attracting
sufficient antigen presenting cells in the patient’s intradermal space and the association of GP2 with the HLA type of a patient
to adequately train T cells to kill cancer cells, which may or may not be possible or consistent across all HLA types. It is possible
that nurses may not successfully inject GP2 in the intradermal space or that certain HLA types may form weak or no association with GP2,
potentially leading to weak or no immune response to GP2 and thus no benefit to patients with some or any HLA type.
In
the clinical trials using GP2, GM-CSF is also administered and its availability is dependent upon a third-party manufacturer, which
may or may not reliably provide GM-CSF in the U.S. or in any other country, thus potentially jeopardizing the completion of the
trials.
GP2
is administered in combination with GM-CSF which is available in a lyophilized form exclusively from one manufacturer who only has
marketing approval for sale of GM-CSF (Leukine) in the U.S, and not in any other country. We will need to export GM-CSF to any
countries in which we conduct clinical trials relying on the U.S. registration, which may not always be successful. We will continue
to be dependent on such manufacturer for our supply of GM-CSF in combination with GP2 in the ongoing GP2 trials and upon the
potential commercialization of GP2. To successfully commercialize GP2 outside of the U.S., GM-CSF will need to be available in those
countries, through a customized process that allows for individual patient use based on a doctor’s prescription or through
registration of GM-CSF in those countries. We have not entered into a supply agreement with the manufacturer for GM-CSF, and instead
rely on purchase orders to meet our supply needs. Any temporary interruptions or discontinuation of the availability of GM-CSF could
have a material adverse effect on our operations.
We are periodically involved
in various litigation and/or regulatory proceedings that, if adversely decided or settled, could materially and adversely affect our business,
financial condition, and results of operations.
We are periodically party to or
the subject of litigation, investigations, regulatory proceedings or other disputes. In general, claims made by or against us in disputes
and other legal or regulatory proceedings can be expensive and time consuming to bring or defend against, requiring us to expend significant
resources and divert the efforts and attention of our management and other personnel from our business operations. While we intend to
pursue any claims made by us, or vigorously defend against any claims brought against us, we cannot predict the outcomes of such claims.
Any failure to prevail in any claims made by us or any adverse determination against us in these legal and/or regulatory proceedings,
or even the allegations contained in such proceedings, regardless of whether they are ultimately found to be without merit, may also result
in settlements, injunctions, fines, penalties, or damages that could have a material adverse effect on our business, financial condition
and results of operations.
We
may hold cash and cash equivalents at various foreign subsidiaries and in countries outside of the US that may not be readily available
to meet cash requirements.
Currently
a majority of our cash and cash equivalents is held by our U.S. parent company, however, our foreign subsidiary may in the future hold
cash. Our U.S. parent company or our foreign subsidiary may hold cash balances outside the United States which may not be readily available,
or may not be available without an additional tax burden, to meet our domestic or foreign cash requirements. U.S. tax laws may allow
for reductions to the potential tax burden on repatriation of foreign cash; however, such actions would require us to record additional
income tax expense and remit additional taxes, which could have a material adverse effect on our results of operations, cash flows and
financial condition. In addition, foreign exchange rates may fluctuate leading to unexpected losses and inefficient utilization of cash
in countries outside of the U.S.
The
COVID-19 coronavirus could adversely impact our business in the U.S. and in other countries, including several key activities, including
clinical trial activities, manufacturing of drugs and clinical supplies, exportation of drug and supplies, and management of international
payments and cash flow that are critical to our success.
The
global outbreak of COVID-19 continues to rapidly evolve, including the emergence of new strains that could have the potential to be
as harmful as or more harmful than the original strains in 2020. As a result, businesses may close, staffing may be reduced,
including clinical staffs, and limits may be placed on travel. The extent to which COVID-19 may impact our business will depend on
future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate impact of the disease
on specific geographies, the duration of the outbreak, travel restrictions and social distancing 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 disease.
The
spread of COVID-19 throughout the world has also created global economic uncertainty, which may cause partners, suppliers and potential
customers to closely monitor their costs and reduce their spending budget. Any of the foregoing could materially adversely affect our
research and development activities, clinical trials, supply chain, financial condition and cash flows.
If
the COVID-19 outbreak continues to spread and evolve, we may need to limit operations or implement other limitations on our activities.
There is a risk that countries or regions outside the United States may be less effective at vaccinations and containing COVID-19, in
which case the risks described herein could be elevated significantly.
We
may be adversely affected by the effects of inflation and a potential recession.
Inflation has
the potential to adversely affect our liquidity, business, financial condition, and results of operations by increasing our overall cost
structure. The existence of inflation in the economy has resulted in, and may continue to result in, higher interest rates
and capital costs, shipping costs, supply shortages, increased costs of labor, weakening exchange rates, and other similar effects. As
a result of inflation, we have experienced and may continue to experience, cost increases. In addition, poor economic and market
conditions, including a potential recession, may negatively impact market sentiment, which would adversely affect our results of operations.
If we are unable to take effective measures in a timely manner to mitigate the impact of the inflation as well as a potential
recession, our business, financial condition, and results of operations could be adversely affected.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
ITEM
5. OTHER INFORMATION
None.
ITEM
6. EXHIBITS
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.
|
GREENWICH
LIFESCIENCES, INC. |
|
|
|
October
19, 2023 |
By: |
/s/
Snehal Patel |
|
|
Snehal
Patel |
|
|
Chief
Executive Officer (Principal Executive Officer and Principal Accounting and Financial Officer) |
Exhibit
31.1
Certification
of Chief Executive Officer and Principal Financial and Accounting Officer of Greenwich LifeSciences, Inc.
Pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
I,
Snehal Patel, certify that:
1. |
I have reviewed this quarterly
report on Form 10-Q of Greenwich LifeSciences, 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 15(d)-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. |
October 19, 2023 |
/s/
Snehal Patel |
|
Snehal Patel, |
|
Chief Executive Officer |
|
(Principal Executive Officer
and Principal Financial and Accounting Officer) |
Exhibit
32.1
Statement
of Chief Executive Officer and Principal Financial and Accounting Officer
Pursuant to Section 1350 of Title 18 of the United States Code
Pursuant
to Section 1350 of Title 18 of the United States Code as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned,
Snehal Patel, the Chief Executive Officer and Principal Financial and Accounting Officer of Greenwich LifeSciences, Inc. (the “Company”),
hereby certifies that based on the undersigned’s knowledge:
1. |
The
Company’s quarterly report on Form 10-Q for the period ended September 30, 2023 (the “Report”) fully complies with
the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
2. |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
October
19, 2023 |
/s/
Snehal Patel |
|
Snehal
Patel |
|
Chief
Executive Officer |
|
(Principal
Executive Officer and Principal Financial and Accounting Officer) |
v3.23.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2023 |
Oct. 16, 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 |
001-39555
|
|
Entity Registrant Name |
GREENWICH
LIFESCIENCES, INC.
|
|
Entity Central Index Key |
0001799788
|
|
Entity Tax Identification Number |
20-5473709
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
3992
Bluebonnet Dr.
|
|
Entity Address, Address Line Two |
Building 14
|
|
Entity Address, City or Town |
Stafford
|
|
Entity Address, State or Province |
TX
|
|
Entity Address, Postal Zip Code |
77477
|
|
City Area Code |
(832)
|
|
Local Phone Number |
819-3232
|
|
Title of 12(b) Security |
Common
Stock
|
|
Trading Symbol |
GLSI
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
true
|
|
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v3.23.3
Consolidated Balance Sheets (Unaudited) - USD ($)
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets |
|
|
Cash |
$ 9,143,619
|
$ 13,468,026
|
Non-current assets |
|
|
Acquired patents, net |
6,294
|
9,003
|
Total assets |
9,149,913
|
13,477,029
|
Current liabilities |
|
|
Accounts payable & accrued interest |
230,902
|
220,845
|
Unreimbursed expenses |
66,385
|
42,060
|
Total current liabilities |
297,287
|
262,905
|
Total liabilities |
297,287
|
262,905
|
Stockholders’ equity |
|
|
Common stock, $0.001 par value; 100,000,000 shares authorized; 12,848,165 shares issued and outstanding as of September 30, 2023 and December 31, 2022 |
12,848
|
12,848
|
Additional paid-in capital |
56,457,608
|
54,674,042
|
Accumulated deficit |
(47,617,830)
|
(41,472,766)
|
Total stockholders’ equity |
8,852,626
|
13,214,124
|
Total liabilities and stockholders’ equity |
$ 9,149,913
|
$ 13,477,029
|
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v3.23.3
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
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12,848,165
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v3.23.3
Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Revenue |
|
|
|
|
Operating expenses |
|
|
|
|
Research and development |
2,158,167
|
1,723,493
|
5,365,641
|
4,017,564
|
General and administrative |
344,758
|
659,568
|
1,126,192
|
1,128,007
|
Total operating expenses |
2,502,925
|
2,383,061
|
6,491,833
|
5,145,571
|
Loss from operations |
(2,502,925)
|
(2,383,061)
|
(6,491,833)
|
(5,145,571)
|
Interest Income |
111,136
|
64,037
|
346,769
|
110,846
|
Net loss |
$ (2,391,789)
|
$ (2,319,024)
|
$ (6,145,064)
|
$ (5,034,725)
|
Per share information: |
|
|
|
|
Net loss per common share, basic |
$ (0.19)
|
$ (0.18)
|
$ (0.48)
|
$ (0.39)
|
Net loss per common share, diluted |
$ (0.19)
|
$ (0.18)
|
$ (0.48)
|
$ (0.39)
|
Weighted average common shares outstanding, basic |
12,848,165
|
12,823,447
|
12,848,165
|
13,067,620
|
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12,848,165
|
12,823,447
|
12,848,165
|
13,067,620
|
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v3.23.3
Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balances at Dec. 31, 2021 |
$ 13,148
|
$ 60,466,093
|
$ (33,647,529)
|
$ 26,831,712
|
Balance, shares at Dec. 31, 2021 |
13,147,829
|
|
|
|
Stock-based compensation |
$ 74
|
165,193
|
|
165,267
|
Stock-based compensation, shares |
73,452
|
|
|
|
Repurchase of common stock via stock buy back program, net of costs |
$ (270)
|
(5,513,441)
|
|
(5,513,711)
|
Repurchase of common stock via stock buy back program, net of costs, shares |
(269,828)
|
|
|
|
Net loss |
|
|
(1,969,628)
|
(1,969,628)
|
Balances at Mar. 31, 2022 |
$ 12,952
|
55,117,845
|
(35,617,157)
|
19,513,640
|
Balance, shares at Mar. 31, 2022 |
12,951,453
|
|
|
|
Balances at Dec. 31, 2021 |
$ 13,148
|
60,466,093
|
(33,647,529)
|
26,831,712
|
Balance, shares at Dec. 31, 2021 |
13,147,829
|
|
|
|
Net loss |
|
|
|
(5,034,725)
|
Balances at Sep. 30, 2022 |
$ 12,848
|
54,079,520
|
(38,682,254)
|
15,410,114
|
Balance, shares at Sep. 30, 2022 |
12,848,165
|
|
|
|
Balances at Mar. 31, 2022 |
$ 12,952
|
55,117,845
|
(35,617,157)
|
19,513,640
|
Balance, shares at Mar. 31, 2022 |
12,951,453
|
|
|
|
Stock-based compensation |
$ 73
|
224,430
|
|
224,503
|
Stock-based compensation, shares |
73,356
|
|
|
|
Repurchase of common stock via stock buy back program, net of costs |
$ (250)
|
(2,022,255)
|
|
(2,022,505)
|
Repurchase of common stock via stock buy back program, net of costs, shares |
(250,000)
|
|
|
|
Net loss |
|
|
(746,073)
|
(746,073)
|
Balances at Jun. 30, 2022 |
$ 12,775
|
53,320,020
|
(36,363,230)
|
16,969,565
|
Balance, shares at Jun. 30, 2022 |
12,774,809
|
|
|
|
Stock-based compensation |
$ 73
|
759,500
|
|
759,573
|
Stock-based compensation, shares |
73,356
|
|
|
|
Net loss |
|
|
(2,319,024)
|
(2,319,024)
|
Balances at Sep. 30, 2022 |
$ 12,848
|
54,079,520
|
(38,682,254)
|
15,410,114
|
Balance, shares at Sep. 30, 2022 |
12,848,165
|
|
|
|
Balances at Dec. 31, 2022 |
$ 12,848
|
54,674,042
|
(41,472,766)
|
13,214,124
|
Balance, shares at Dec. 31, 2022 |
12,848,165
|
|
|
|
Stock-based compensation |
|
594,522
|
|
594,522
|
Net loss |
|
|
(2,124,902)
|
(2,124,902)
|
Balances at Mar. 31, 2023 |
$ 12,848
|
55,268,564
|
(43,597,668)
|
11,683,744
|
Balance, shares at Mar. 31, 2023 |
12,848,165
|
|
|
|
Balances at Dec. 31, 2022 |
$ 12,848
|
54,674,042
|
(41,472,766)
|
$ 13,214,124
|
Balance, shares at Dec. 31, 2022 |
12,848,165
|
|
|
|
Repurchase of common stock via stock buy back program, net of costs, shares |
|
|
|
0
|
Net loss |
|
|
|
$ (6,145,064)
|
Balances at Sep. 30, 2023 |
$ 12,848
|
56,457,608
|
(47,617,830)
|
8,852,626
|
Balance, shares at Sep. 30, 2023 |
12,848,165
|
|
|
|
Balances at Mar. 31, 2023 |
$ 12,848
|
55,268,564
|
(43,597,668)
|
11,683,744
|
Balance, shares at Mar. 31, 2023 |
12,848,165
|
|
|
|
Stock-based compensation |
|
594,522
|
|
594,522
|
Net loss |
|
|
(1,628,373)
|
(1,628,373)
|
Balances at Jun. 30, 2023 |
$ 12,848
|
55,863,086
|
(45,226,041)
|
10,649,893
|
Balance, shares at Jun. 30, 2023 |
12,848,165
|
|
|
|
Stock-based compensation |
|
594,522
|
|
594,522
|
Net loss |
|
|
(2,391,789)
|
(2,391,789)
|
Balances at Sep. 30, 2023 |
$ 12,848
|
$ 56,457,608
|
$ (47,617,830)
|
$ 8,852,626
|
Balance, shares at Sep. 30, 2023 |
12,848,165
|
|
|
|
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v3.23.3
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2022 |
Mar. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Operating activities: |
|
|
|
|
|
|
Net loss |
$ (2,391,789)
|
$ (2,124,902)
|
$ (2,319,024)
|
$ (1,969,628)
|
$ (6,145,064)
|
$ (5,034,725)
|
Adjustments required to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
Amortization |
|
|
|
|
2,709
|
2,709
|
Stock-based compensation |
|
|
|
|
1,783,566
|
1,149,343
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Accounts payable |
|
|
|
|
10,057
|
|
Unreimbursed expenses (accrued) |
|
|
|
|
24,325
|
(147,293)
|
Net cash used in operating activities |
|
|
|
|
(4,324,407)
|
(4,029,966)
|
Financing activities: |
|
|
|
|
|
|
Repurchase of common stock via stock buy back program, net of costs |
|
|
|
|
|
(7,536,216)
|
Net cash provided by (used in) financing activities |
|
|
|
|
|
(7,536,216)
|
Net increase (decrease) in cash |
|
|
|
|
(4,324,407)
|
(11,566,182)
|
Cash, beginning of period |
|
$ 13,468,026
|
|
$ 27,204,269
|
13,468,026
|
27,204,269
|
Cash, end of period |
$ 9,143,619
|
|
$ 15,638,087
|
|
$ 9,143,619
|
$ 15,638,087
|
X |
- DefinitionThe aggregate amount of recurring noncash expense charged against earnings in the period to allocate the cost of assets over their estimated remaining economic lives.
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v3.23.3
Organization and Description of the Business
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Description of the Business |
1.
Organization and Description of the Business
Greenwich
LifeSciences, Inc. (the “Company”) was incorporated in the state of Delaware in 2006 under the name Norwell, Inc. In March
2018, Norwell, Inc. changed its name to Greenwich LifeSciences, Inc. In February 2023, Greenwich LifeSciences Europe Limited was incorporated
as a wholly owned subsidiary in Ireland. The Company is developing a breast cancer immunotherapy focused on preventing the recurrence
of breast cancer following surgery.
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v3.23.3
Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Significant Accounting Policies |
2.
Significant Accounting Policies
Basis
of Presentation
The
accompanying unaudited interim financial statements of the Company have been prepared in accordance with accounting principles generally
accepted in the United States of America and the rules of the Securities and Exchange Commission and should be read in conjunction with
the audited financial statements and notes thereto of the Company contained elsewhere herein.
In
the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial
position and the results of operations for the interim periods presented have been reflected herein. The results of operations for the
interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements that
would substantially duplicate the disclosures contained in the audited financial statements of the Company for the years ended December
31, 2022 and 2021 as reported in the Company’s Form 10-K have been omitted.
Leases
In
February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02-Leases (Topic 842), which significantly amends
the way companies are required to account for leases. Under the updated leasing guidance, some leases that did not have to be reported
previously are now required to be presented as an asset and liability on the balance sheet. In addition, for certain leases, what was
previously classified as an operating expense must now be allocated between amortization expense and interest expense. The Company elected
to adopt this update using the modified retrospective transition method and prior periods have not been restated. The current monthly
rent is approximately $2,555. The month-to-month sub-lease is from a related party and the underlying lease expires in May of 2024. Any
right of use asset and liability is deemed to be nominal as of September 30, 2023 and December 31, 2022.
Basic
and Diluted Loss per Share
Basic
EPS is computed by dividing net loss (numerator) by the weighted average number of common shares outstanding (denominator) during the
period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method.
Diluted EPS excludes all dilutive potential shares if their effect is antidilutive. During periods of net loss, all common stock equivalents
related to 1,498,128
options and 20,174
warrants outstanding as of September 30, 2023
and 2022
are excluded from the diluted EPS calculation because they are antidilutive.
Recently
Adopted Accounting Pronouncements
In
June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-13, “Financial
Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). ASU
2016-13 requires companies to measure credit losses utilizing a methodology that reflects expected credit losses and requires a consideration
of a broader range of reasonable and supportable information to inform credit loss estimates. ASU 2016-13 is effective for fiscal years
beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted ASU 2016-13 effective January
1, 2023. The Company determined that the update applied to trade receivables, but that there was no material impact to the consolidated
financial statements from the adoption of ASU 2016-13.
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v3.23.3
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
4.
Commitments and Contingencies
License
Obligation, Legal Expenses, and Manufacturing Agreements
The
Company entered into an exclusive license agreement with The Henry M. Jackson Foundation (“HJF”) in April 2009, as amended,
pursuant to which it acquired exclusive marketing rights to GP2, the Company’s product candidate. In consideration for such licensed
rights, the Company issued HJF 202,619 shares of the Company’s common stock valued at $0.267 per share, which is amortized over
15 years at $3,607 per year. Pursuant to the exclusive license agreement, the Company is required to pay an annual maintenance fee, milestone
payments and royalty payments based on sales of GP2 and to reimburse HJF for patent expenses related to GP2. The Company currently depends
on third-party contract manufacturers for all required raw materials, active pharmaceutical ingredients, and finished product candidate
for the Company’s clinical trials.
Accounts
payable includes accrued interest obligations to HJF which total $220,845 as of September 30, 2023 and December 31, 2022.
Legal
Proceedings
From
time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal
course of business. Any of these claims could subject the Company to costly legal expenses and, while management generally believes that
there will be adequate insurance to cover different liabilities at such time the Company becomes a public company and commences clinical
trials, the Company’s future insurance carriers may deny coverage or policy limits may be inadequate to fully satisfy any damage
awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the results of
operations and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s reputation
and business. The Company is currently not a party to any legal proceedings, the adverse outcome of which, in management’s opinion,
individually or in the aggregate, could have a material adverse effect on our results of operations or financial position.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.3
Stockholders’ Equity
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity |
5.
Stockholders’ Equity
As
of September 30, 2023, 893,181 shares of the 908,362 shares of the common stock grant, which includes an additional grant of 120 shares
issued during the vesting period due to rounding up of fractional shares, had vested at approximately $2,009,657 value and 15,181 shares
remain unvested and unrecognized at $34,157 value. There were no shares vested during the nine months ended September 30,
2023.
On
January 23, 2022, the Board of Directors authorized the Company’s management to implement a stock repurchase program for up to
$10 million of the Company’s common stock at any time. The term of the Board of Directors authorization of the repurchase program
ended on March 31, 2023. The repurchase program may be suspended or discontinued at any time and will be funded using the Company’s
working capital. As of September 30, 2023 and 2022, approximately 519,828 shares of the Company’s common stock has been repurchased
and cancelled at an aggregate purchase price, including all transactions costs, of approximately $7,536,216. There were no shares repurchased
during the nine months ended September 30, 2023.
On
January 23, 2022, the Board of Directors extended the lock-up of the shares owned by the Company’s directors, officers, and existing
pre-IPO investors to March 24, 2023 (30 months from date of the Company’s IPO) from March 24, 2022 (18 months from date of the
Company’s IPO). On November 30, 2022, the Board of Directors further extended the lock-up of the shares owned by the Company’s
directors, officers, and existing pre-IPO investors to December 31, 2023 (approximately 39 months from date of the Company’s IPO)
from March 24, 2023 (30 months from date of the Company’s IPO). During this period, current officers, directors and certain shareholders
will not be able to sell their shares of the Company’s common stock unless otherwise modified by the Board of Directors.
Warrants
At
September 30, 2023, outstanding warrants to purchase shares of common stock were as follows with an aggregate intrinsic value as of September
30, 2023 of $33,338 based on the September 29, 2023 closing share price of $8.84:
Schedule of Outstanding Warrants
Shares
Underlying |
|
|
|
|
|
|
|
Outstanding |
|
|
Exercise |
|
|
Expiration |
|
Warrants |
|
|
Price |
|
|
Date |
|
|
|
|
|
|
|
|
|
20,174 |
|
|
$ |
7.1875 |
|
|
|
September
24, 2025 |
|
20,174 |
|
|
|
|
|
|
|
|
|
Options
On
June 22, 2022, prior to the close of the Nasdaq market, 1,498,128
shares of common stock were granted to employees,
consultants, and directors issuable upon exercise of outstanding stock options under the Company’s 2019 Equity Incentive Plan at
an exercise price of $7.63
per share, which was the most recent prior closing
share price on June 21, 2022. The options had a fair value on the grant date of $9,512,356,
based on a risk-free rate of 3.2%
and an annualized volatility of 106%,
of which $3,032,062 was
expensed through September 30, 2023 and $6,480,294
will be expensed in the future if and as vesting
occurs. Vesting will be based on time of service over a four
year period and certain additional performance
milestones for senior management, primarily related to the Phase III clinical trial.
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v3.23.3
Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
accompanying unaudited interim financial statements of the Company have been prepared in accordance with accounting principles generally
accepted in the United States of America and the rules of the Securities and Exchange Commission and should be read in conjunction with
the audited financial statements and notes thereto of the Company contained elsewhere herein.
In
the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial
position and the results of operations for the interim periods presented have been reflected herein. The results of operations for the
interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements that
would substantially duplicate the disclosures contained in the audited financial statements of the Company for the years ended December
31, 2022 and 2021 as reported in the Company’s Form 10-K have been omitted.
|
Leases |
Leases
In
February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02-Leases (Topic 842), which significantly amends
the way companies are required to account for leases. Under the updated leasing guidance, some leases that did not have to be reported
previously are now required to be presented as an asset and liability on the balance sheet. In addition, for certain leases, what was
previously classified as an operating expense must now be allocated between amortization expense and interest expense. The Company elected
to adopt this update using the modified retrospective transition method and prior periods have not been restated. The current monthly
rent is approximately $2,555. The month-to-month sub-lease is from a related party and the underlying lease expires in May of 2024. Any
right of use asset and liability is deemed to be nominal as of September 30, 2023 and December 31, 2022.
|
Basic and Diluted Loss per Share |
Basic
and Diluted Loss per Share
Basic
EPS is computed by dividing net loss (numerator) by the weighted average number of common shares outstanding (denominator) during the
period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method.
Diluted EPS excludes all dilutive potential shares if their effect is antidilutive. During periods of net loss, all common stock equivalents
related to 1,498,128
options and 20,174
warrants outstanding as of September 30, 2023
and 2022
are excluded from the diluted EPS calculation because they are antidilutive.
|
Recently Adopted Accounting Pronouncements |
Recently
Adopted Accounting Pronouncements
In
June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-13, “Financial
Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). ASU
2016-13 requires companies to measure credit losses utilizing a methodology that reflects expected credit losses and requires a consideration
of a broader range of reasonable and supportable information to inform credit loss estimates. ASU 2016-13 is effective for fiscal years
beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted ASU 2016-13 effective January
1, 2023. The Company determined that the update applied to trade receivables, but that there was no material impact to the consolidated
financial statements from the adoption of ASU 2016-13.
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v3.23.3
Stockholders’ Equity (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Schedule of Outstanding Warrants |
Schedule of Outstanding Warrants
Shares
Underlying |
|
|
|
|
|
|
|
Outstanding |
|
|
Exercise |
|
|
Expiration |
|
Warrants |
|
|
Price |
|
|
Date |
|
|
|
|
|
|
|
|
|
20,174 |
|
|
$ |
7.1875 |
|
|
|
September
24, 2025 |
|
20,174 |
|
|
|
|
|
|
|
|
|
Options
On
June 22, 2022, prior to the close of the Nasdaq market, 1,498,128
shares of common stock were granted to employees,
consultants, and directors issuable upon exercise of outstanding stock options under the Company’s 2019 Equity Incentive Plan at
an exercise price of $7.63
per share, which was the most recent prior closing
share price on June 21, 2022. The options had a fair value on the grant date of $9,512,356,
based on a risk-free rate of 3.2%
and an annualized volatility of 106%,
of which $3,032,062 was
expensed through September 30, 2023 and $6,480,294
will be expensed in the future if and as vesting
occurs. Vesting will be based on time of service over a four
year period and certain additional performance
milestones for senior management, primarily related to the Phase III clinical trial.
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v3.23.3
Significant Accounting Policies (Details Narrative) - USD ($)
|
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Operating lease, expense |
$ 2,555
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount |
1,498,128
|
1,498,128
|
Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount |
20,174
|
20,174
|
X |
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v3.23.3
v3.23.3
Commitments and Contingencies (Details Narrative) - USD ($)
|
1 Months Ended |
9 Months Ended |
|
Apr. 30, 2009 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Amortized value |
|
$ 2,709
|
$ 2,709
|
|
Accounts payable and accrued liabilities |
|
$ 220,845
|
|
$ 220,845
|
License Agreement [Member] | The Henry M. Jackson Foundation ("HJF") [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Shares issued during period common stock |
202,619
|
|
|
|
Price per share |
$ 0.267
|
|
|
|
Amortized period |
15 years
|
|
|
|
Amortized value |
$ 3,607
|
|
|
|
X |
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v3.23.3
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
|
3 Months Ended |
9 Months Ended |
|
Jun. 22, 2022 |
Jan. 23, 2022 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Number of shares vested |
|
|
|
|
893,181
|
|
Number of options granted |
1,498,128
|
|
|
|
908,362
|
|
Number of additional shares granted |
|
|
|
|
120
|
|
Share based compensation expenses in future if vesting occurs |
|
|
|
|
2,009,657
|
|
Number of unvested shares outstanding |
|
|
|
|
15,181
|
|
Unrecognized value of shares |
|
|
|
|
$ 34,157
|
|
Stock repurchase value |
|
|
$ 2,022,505
|
$ 5,513,711
|
|
|
Repurchased shares |
|
|
|
|
519,828
|
519,828
|
Repurchase amount |
|
|
|
|
$ 7,536,216
|
|
Stock repurchase number of shares |
|
|
|
|
0
|
|
Value of outstanding warrants |
|
|
|
|
$ 33,338
|
|
Closing share price |
|
|
|
|
$ 8.84
|
|
Exercise price |
$ 7.63
|
|
|
|
|
|
Stock granted |
|
|
|
|
$ 9,512,356
|
|
Risk-free interest rate |
|
|
|
|
3.20%
|
|
Voltality rate |
|
|
|
|
106.00%
|
|
Compensation expense |
|
|
|
|
$ 3,032,062
|
|
Fair value |
|
|
|
|
$ 6,480,294
|
|
Vesting term |
|
|
|
|
4 years
|
|
Maximum [Member] |
|
|
|
|
|
|
Stock repurchase value |
|
$ 10
|
|
|
|
|
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