Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the
“Company”) today announced financial results for the fourth quarter
and fiscal year ended December 31, 2023 and provided a corporate
update.
Jeffrey Meckler, Chief Executive Officer of
Indaptus, commented, “We are thrilled with the progress we made in
2023, which was capped off in November when we announced that our
lead candidate, Decoy20, demonstrated a broad immune response in
patients following a single dose in the first cohort of our ongoing
phase 1 study. More recently, in March 2024, we announced positive
results from our second cohort. In close consultation with an
independent Safety Review Committee, we are now initiating a
multi-dose cohort. Our objective in this next part of the Phase 1
trial is to determine the safety of Decoy20, with multiple doses
administered to the same patient, which we believe could also
potentially enhance anti-tumor activity across various tumor types.
As we are encouraged by these initial findings and by the
anti-cancer activity we observed from multi-dosing in our
pre-clinical models, we look forward to continuing our efforts to
demonstrate safety and efficacy. We remain prudent in managing our
cash position and furthering our research in a cost effective and
efficient manner.”
Key recent
highlights:
- In March 2024, the Company
announced positive results from its second cohort of its Phase 1
trial of Decoy20, where patients continued to exhibit a broad
immune response. The results were reviewed by the Company and an
independent Safety Review Committee and based on this review, it
was recommended to proceed to the next part of the trial and enroll
patients who will receive multiple doses of Decoy20.
- In January 2024, a key patent for
the Company was approved by the European Patent Office which
relates to the Company’s platform technology, covering a
composition that can be used in the prevention or treatment of
viral infections.
- In November 2023, the Company
announced that Decoy20 demonstrated a broad immune response of more
than fifty cytokines and chemokines in patients following a single
dose in the first cohort of ongoing Phase 1 study. These data, as
well as additional human patient data, was presented at the Society
for Immunotherapy for Cancer Conference.
Financial Highlights for
Fourth Quarter and Fiscal
Year Ended December
31, 2023
Research and development expenses for the
three-month period ended December 31, 2023, were $2.0 million, an
increase of $0.1 million, or 7%, compared with $1.9 million in the
three-month period ended December 31, 2022. Research and
development expenses for the twelve-month period ended December 31,
2023, were $7.6 million, an increase of $1.3 million, or 21%,
compared with $6.3 million in the twelve-month period ended
December 31, 2022. The increase in the twelve-month period was
primarily due to increased payroll and related expenses, the Phase
1 clinical trial, and activities related to the expansion
of the Company’s pipeline.
General and administrative expenses for the
three-month periods ended December 31, 2023 and 2022, were $2.2
million. General and administrative expenses for the twelve-month
period ended December 31, 2023, were $8.8 million, an increase of
$0.2 million, or 2%, compared with $8.6 million for the
twelve-month period ended December 31, 2022. The increase in the
twelve-month period was primarily due to increased legal fees,
recruitment costs, investor relations expenses and other
professional fees, and was partially offset by a decrease in
payroll and related expenses, and directors’ and officers’
insurance expenses.
Loss per share for the twelve-month period ended
December 31, 2023 was $1.83, compared with $1.73 for the
twelve-month period ended December 31, 2022.
As of December 31, 2023, the Company had cash
and cash equivalents of $13.4 million. As of December 31, 2022, the
Company had cash and cash equivalents and marketable securities of
$26.4 million. The Company expects that its current cash and cash
equivalents will support its ongoing operating activities through
the third quarter of 2024. This cash runway guidance is based on
the Company’s current operational plans and excludes any additional
funding (including aggregate gross proceeds of $0.3 million from
sales of shares of the Company’s common stock under its ATM program
in March 2024) and any business development activities that may be
undertaken. Indaptus continues to assess all financing options that
would support its corporate strategy.
Net cash used in operating activities was $13.4
million for the twelve-month period ended December 31, 2023,
compared with net cash used in operating activities of $13.1
million for the twelve-month period ended December 31, 2022. The
$0.3 million increase in net cash used was primarily attributable
to expenses related to research and development activities in
connection with the Phase 1 clinical trial.
Net cash provided by investing activities was
$17.1 million for the twelve-month period ended December 31, 2023,
which was a result of the maturity of $24.0 million in marketable
securities, offset by purchases of $6.9 million in marketable
securities. Net cash used in investing activities was $16.4 million
for the twelve-month period ended December 31, 2022, which was
primarily related to a $29.6 million investment in marketable
securities, offset by $0.2 million from the proceeds received for
assets held for sale and by $13.0 million from the maturity of
marketable securities.
There was no net cash provided by or used in
financing activities for the twelve-month periods ended December
31, 2023 and 2022.
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than
a century of immunotherapy advances. The Company’s novel approach
is based on the hypothesis that efficient activation of both innate
and adaptive immune cells and pathways and associated anti-tumor
and anti-viral immune responses will require a multi-targeted
package of immune system-activating signals that can be
administered safely intravenously (i.v.). Indaptus’ patented
technology is composed of single strains of attenuated and killed,
non-pathogenic, Gram-negative bacteria producing a multiple
Toll-like receptor (TLR), Nucleotide oligomerization domain
(NOD)-like receptor (NLR) and Stimulator of interferon genes
(STING) agonist Decoy platform. The product candidates are designed
to have reduced i.v. toxicity, but largely uncompromised ability to
prime or activate many of the cells and pathways of innate and
adaptive immunity. Decoy product candidates represent an
antigen-agnostic technology that have produced single-agent
activity against metastatic pancreatic and orthotopic colorectal
carcinomas, single agent eradication of established
antigen-expressing breast carcinoma, as well as
combination-mediated eradication of established hepatocellular
carcinomas, pancreatic and non-Hodgkin’s lymphomas in standard
pre-clinical models, including syngeneic mouse tumors and human
tumor xenografts. In pre-clinical studies tumor eradication was
observed with Decoy product candidates in combination with
anti-PD-1 checkpoint therapy, low-dose chemotherapy, a
non-steroidal anti-inflammatory drug, or an approved, targeted
antibody. Combination-based tumor eradication in pre-clinical
models produced innate and adaptive immunological memory, involved
activation of both innate and adaptive immune cells, and was
associated with induction of innate and adaptive immune pathways in
tumors after only one i.v. dose of Decoy product, with associated
“cold” to “hot” tumor inflammation signature transition.
IND-enabling, nonclinical toxicology studies demonstrated i.v.
administration without sustained induction of hallmark biomarkers
of cytokine release syndromes, possibly due to passive targeting to
liver, spleen, and tumor, followed by rapid elimination of the
product. Indaptus’ Decoy product candidates have also produced
significant single agent activity against chronic hepatitis B virus
(HBV) and chronic human immunodeficiency virus (HIV) infections in
pre-clinical models.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act. These include statements regarding management’s
expectations, beliefs and intentions regarding, among other things:
our expectations and plans regarding our Phase 1 clinical trial of
Decoy20, including the timing and design thereof; the anticipated
effects of our product candidates, including Decoy20; the plans and
objectives of management for future operations; our research and
development activities and costs; the sufficiency of our cash and
cash equivalents to fund our ongoing activities and our cash
management strategy; and our assessment of financing options to
support our corporate strategy. Forward-looking statements can be
identified by the use of forward-looking words such as “believe”,
“expect”, “intend”, “plan”, “may”, “should”, “could”, “might”,
“seek”, “target”, “will”, “project”, “forecast”, “continue” or
“anticipate” or their negatives or variations of these words or
other comparable words or by the fact that these statements do not
relate strictly to historical matters. Because forward-looking
statements relate to matters that have not yet occurred, these
statements are inherently subject to risks and uncertainties that
could cause our actual results to differ materially from any future
results expressed or implied by the forward-looking statements.
Many factors could cause actual activities or results to differ
materially from the activities and results anticipated in
forward-looking statements, including, but not limited to the
following: our limited operating history; conditions and events
that raise substantial doubt regarding our ability to continue as
going concern; the need for, and our ability to raise, additional
capital given our lack of current cash flow; our clinical and
preclinical development, which involves a lengthy and expensive
process with an uncertain outcome; our incurrence of significant
research and development expenses and other operating expenses,
which may make it difficult for us to attain profitability; our
pursuit of a limited number of research programs, product
candidates and specific indications and failure to capitalize on
product candidates or indications that may be more profitable or
have a greater likelihood of success; our ability to obtain and
maintain regulatory approval of any product candidate; the market
acceptance of our product candidates; our reliance on third parties
to conduct our preclinical studies and clinical trials and perform
other tasks; our reliance on third parties for the manufacture of
our product candidates during clinical development; our ability to
successfully commercialize Decoy20 or any future product
candidates; our ability to obtain or maintain coverage and adequate
reimbursement for our products; the impact of legislation and
healthcare reform measures on our ability to obtain marketing
approval for and commercialize Decoy20 and any future product
candidates; product candidates of our competitors that may be
approved faster, marketed more effectively, and better tolerated
than our product candidates; our ability to adequately protect our
proprietary or licensed technology in the marketplace; the impact
of, and costs of complying with healthcare laws and regulations,
and our failure to comply with such laws and regulations;
information technology system failures, cyberattacks or
deficiencies in our cybersecurity; and unfavorable global economic
conditions. These and other important factors discussed under the
caption “Risk Factors” included in our most recent Annual Report on
Form 10-K filed with the SEC on March 13, 2024, and our other
filings with the SEC, could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release . All forward-looking statements speak
only as of the date of this press release and are expressly
qualified in their entirety by the cautionary statements included
in this press release. We undertake no obligation to update or
revise forward-looking statements to reflect events or
circumstances that arise after the date made or to reflect the
occurrence of unanticipated events, except as required by
applicable law.
Contact: investors@indaptusrx.com
Investor Relations Contact:CORE IRLouie
Tomalouie@coreir.com
Media Contact:CORE IRJules
Abrahamjulesa@coreir.com917-885-7378
|
INDAPTUS THERAPEUTICS, INC. |
|
Consolidated Balance Sheets |
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,362,053 |
|
|
$ |
9,626,800 |
|
Marketable securities |
|
|
- |
|
|
|
16,806,009 |
|
Prepaid expenses and other
current assets |
|
|
633,156 |
|
|
|
811,433 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
13,995,209 |
|
|
|
27,244,242 |
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
735 |
|
|
|
2,019 |
|
Right-of-use asset |
|
|
173,206 |
|
|
|
79,294 |
|
Other assets |
|
|
754,728 |
|
|
|
738,251 |
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
|
928,669 |
|
|
|
819,564 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
14,923,878 |
|
|
$ |
28,063,806 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and other
current liabilities |
|
$ |
2,672,327 |
|
|
$ |
3,352,847 |
|
Operating lease liability,
current portion |
|
|
101,705 |
|
|
|
80,494 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
2,774,032 |
|
|
|
3,433,341 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Operating lease liability, net
of current portion |
|
|
73,348 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities |
|
|
73,348 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
2,847,380 |
|
|
|
3,433,341 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock: $0.01 par value,
200,000,000 shares authorized as of December 31, 2023 and December
31, 2022; 8,401,047 shares issued and outstanding as of December
31, 2023 and December 31, 2022 |
|
|
84,011 |
|
|
|
84,011 |
|
Additional paid in
capital |
|
|
57,409,643 |
|
|
|
54,443,705 |
|
Accumulated deficit |
|
|
(45,417,156 |
) |
|
|
(29,993,685 |
) |
Accumulated other
comprehensive income |
|
|
- |
|
|
|
96,434 |
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
12,076,498 |
|
|
|
24,630,465 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
14,923,878 |
|
|
$ |
28,063,806 |
|
Consolidated Statements of Operations and Comprehensive
Loss |
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
7,621,707 |
|
|
$ |
6,324,657 |
|
General and administrative |
|
|
8,756,767 |
|
|
|
8,586,249 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
16,378,474 |
|
|
|
14,910,906 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(16,378,474 |
) |
|
|
(14,910,906 |
) |
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
955,003 |
|
|
|
588,108 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(15,423,471 |
) |
|
$ |
(14,322,798 |
) |
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders per share of common stock, basic and diluted |
|
$ |
(1.83 |
) |
|
$ |
(1.73 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of
shares used in calculating net loss per share, basic and
diluted |
|
|
8,401,047 |
|
|
|
8,262,119 |
|
Net loss |
|
$ |
(15,423,471 |
) |
|
$ |
(14,322,798 |
) |
Other comprehensive
income: |
|
|
|
|
|
|
|
|
Reclassification adjustment for interest earned on marketable
securities included in net loss |
|
|
(430,993 |
) |
|
|
(110,002 |
) |
Change in unrealized gain on marketable securities |
|
|
334,559 |
|
|
|
206,436 |
|
Comprehensive loss |
|
$ |
(15,519,905 |
) |
|
$ |
(14,226,364 |
) |
Consolidated Statements of Cash Flows |
|
|
|
|
|
|
|
|
|
For the year ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(15,423,471 |
) |
|
$ |
(14,322,798 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
1,284 |
|
|
|
1,781 |
|
Stock-based compensation |
|
|
2,965,938 |
|
|
|
2,957,249 |
|
Realized gain on assets held for sale |
|
|
- |
|
|
|
(24,155 |
) |
Interest earned on marketable securities |
|
|
(430,993 |
) |
|
|
(110,002 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
161,800 |
|
|
|
295,220 |
|
Accounts payable and other current liabilities |
|
|
(680,520 |
) |
|
|
(1,154,829 |
) |
Other assets |
|
|
- |
|
|
|
(721,774 |
) |
Operating lease right-of-use asset and liability, net |
|
|
647 |
|
|
|
961 |
|
Net cash used in operating activities |
|
|
(13,405,315 |
) |
|
|
(13,078,347 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities: |
|
|
|
|
|
|
|
|
Proceeds received for assets held for sale |
|
|
- |
|
|
|
172,555 |
|
Purchase of marketable securities |
|
|
(6,859,432 |
) |
|
|
(29,599,573 |
) |
Maturity of marketable securities |
|
|
24,000,000 |
|
|
|
13,000,000 |
|
Net cash provided by (used in) investing activities |
|
|
17,140,568 |
|
|
|
(16,427,018 |
) |
|
|
|
|
|
|
|
|
|
Net increase (decrease) in
cash and cash equivalents |
|
|
3,735,253 |
|
|
|
(29,505,365 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
beginning of year |
|
|
9,626,800 |
|
|
|
39,132,165 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
end of year |
|
$ |
13,362,053 |
|
|
$ |
9,626,800 |
|
|
|
|
|
|
|
|
|
|
Noncash investing and
financing activities |
|
|
|
|
|
|
|
|
ASC 842 lease renewal option exercise |
|
$ |
236,506 |
|
|
$ |
- |
|
Issuance of initial commitment shares |
|
$ |
- |
|
|
$ |
1,425 |
|
Change in accumulated other comprehensive (loss) income |
|
$ |
(96,434 |
) |
|
$ |
96,434 |
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow
disclosures |
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
1,600 |
|
|
$ |
2,400 |
|
Indaptus Therapeutics (NASDAQ:INDP)
Historical Stock Chart
From Mar 2024 to Apr 2024
Indaptus Therapeutics (NASDAQ:INDP)
Historical Stock Chart
From Apr 2023 to Apr 2024