Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the
“Company”), a clinical stage biotechnology company dedicated to
pioneering innovative cancer and viral infection treatments, today
announced financial results for the first quarter ended March 31,
2024, and provided a corporate update.
Jeffrey Meckler, Chief Executive Officer of
Indaptus, commented, “We continue to make steady progress in our
clinical development plans and are receiving regular validation for
results reported to date, both through a presentation in April at
the American Association for Cancer Research (AACR) annual meeting,
and the acceptance of further data to be presented in a poster at
the American Society of Clinical Oncology (ASCO) annual meeting,
which is considered among the top annual oncology conferences. We
are encouraged by the results we have reported, along with the
early results we are seeing as we advance our trial, and believe
they are indicative of the potential for Decoy20, and indeed our
platform as a whole. We look forward to reporting more about our
progress as it develops.”
Key recent highlights:
- Presenting poster, titled, “Preliminary results of a phase 1
study of Decoy20, an intravenous, killed, multiple immune receptor
agonist bacterial product in patients with advanced solid tumors,”
at the American Society of Clinical Oncology annual meeting on June
1, 2024, in Chicago.
- Presented poster outlining mechanism of action of Decoy
platform at the American Association for Cancer Research Annual
Meeting in April 2024.
- Reported preliminary positive results from second cohort of
Phase 1 trial and initiated multi-dose cohort in March 2024.
- Announced granting of key patent that helped to further expand
intellectual property portfolio in January 2024.
Financial Highlights for First Quarter
ended March 31, 2024
Research and development expenses for the
three-month period ended March 31, 2024, were $1.6 million, a
decrease of $0.3 million, or 15%, compared with $1.9 million in the
three-month period ended March 31, 2023. The decrease was primarily
due to the manufacturing processes of Decoy20 that were conducted
in the three months period ended March 31, 2023.
General and administrative expenses for the
three-month period ended March 31, 2024, were $2.4 million, a
decrease of $0.2 million, or 9%, compared with $2.6 million in the
three-month period ended March 31, 2023. The decrease was primarily
due to decreased legal fees, recruitment costs and directors’ and
officers’ insurance expenses, and was offset by an increase in
payroll and related expenses and investor relations expenses.
Loss per share for the three-month period ended
March 31, 2024 was $0.45, compared with $0.51 for the three-month
period ended March 31, 2023.
As of March 31, 2024, the Company had cash and
cash equivalents of $9.7 million. As of December 31, 2023, the
Company had cash and cash equivalents of $13.4 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 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 $3.9
million for the three-month period ended March 31, 2024, compared
with net cash used in operating activities of $4.9 million for the
three-month period ended March 31, 2023. The $1.0 million decrease
in net cash used was primarily attributable to a decrease in our
research and development and general and administrative expenses
and was also attributable to a settlement fee that was paid in
February 2023.
There was no net cash provided by or used in
investing activities in the three months ended March 31, 2024. Net
cash provided by investing activities was approximately $2.1
million for the three months ended March 31, 2023, which was
related to the maturity of $9.0 million in marketable securities,
offset by net investment of approximately $6.9 million in
marketable securities.
Net cash provided by financing activities for
the three months ended March 31, 2024 was approximately $0.3
million, which was provided by issuance and sale of our common
stock under the At The Market Offering Agreement. There was no net
cash provided by or used in financing activities in the three
months ended March 31, 2023.
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 Quarterly Report on Form
10-Q for the quarter ended March 31, 2024 to be filed with the SEC,
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
IR Louie Toma louie@coreir.com
Media Contact: CORE IR Jules
Abraham julesa@coreir.com
|
INDAPTUS THERAPEUTICS, INC.Unaudited Condensed Consolidated
Balance Sheets |
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
9,741,638 |
|
|
$ |
13,362,053 |
|
Prepaid expenses and other current assets |
|
551,031 |
|
|
|
633,156 |
|
|
|
|
|
|
|
|
|
Total current assets |
|
10,292,669 |
|
|
|
13,995,209 |
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
Property and equipment, net |
|
- |
|
|
|
735 |
|
Right-of-use asset |
|
151,118 |
|
|
|
173,206 |
|
Other assets |
|
504,728 |
|
|
|
754,728 |
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
655,846 |
|
|
|
928,669 |
|
|
|
|
|
|
|
|
|
Total assets |
$ |
10,948,515 |
|
|
$ |
14,923,878 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable and other current liabilities |
$ |
1,434,828 |
|
|
$ |
2,672,327 |
|
Operating lease liability, current portion |
|
102,464 |
|
|
|
101,705 |
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
1,537,292 |
|
|
|
2,774,032 |
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
Operating lease liability, net of current portion |
|
50,664 |
|
|
|
73,348 |
|
|
|
|
|
|
|
|
|
Total non-current liabilities |
|
50,664 |
|
|
|
73,348 |
|
|
|
|
|
|
|
|
|
Total liabilities |
|
1,587,956 |
|
|
|
2,847,380 |
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Common stock: $0.01 par value, 200,000,000 shares authorized as of
March 31, 2024 and December 31, 2023; 8,538,883 shares issued and
outstanding as of March 31, 2024 and 8,401,047 shares issued and
outstanding as of December 31, 2023 |
|
85,389 |
|
|
|
84,011 |
|
Additional paid in capital |
|
58,499,003 |
|
|
|
57,409,643 |
|
Accumulated deficit |
|
(49,223,833 |
) |
|
|
(45,417,156 |
) |
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
9,360,559 |
|
|
|
12,076,498 |
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
$ |
10,948,515 |
|
|
$ |
14,923,878 |
|
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated Statements of Operations
and Comprehensive Loss |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2024 |
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
1,591,142 |
|
|
$ |
1,879,900 |
|
General and administrative |
|
2,352,097 |
|
|
|
2,575,266 |
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
3,943,239 |
|
|
|
4,455,166 |
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(3,943,239 |
) |
|
|
(4,455,166 |
) |
|
|
|
|
|
|
|
|
Other income, net |
|
136,562 |
|
|
|
201,928 |
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(3,806,677 |
) |
|
$ |
(4,253,238 |
) |
|
|
|
|
|
|
|
|
Net loss available to common stockholders per share of common
stock, basic and diluted |
$ |
(0.45 |
) |
|
$ |
(0.51 |
) |
|
|
|
|
|
|
|
|
Weighted average number of shares used in calculating net loss per
share, basic and diluted |
|
8,442,364 |
|
|
|
8,401,047 |
|
Net loss |
$ |
(3,806,677 |
) |
|
$ |
(4,253,238 |
) |
Other comprehensive income: |
|
|
|
|
|
|
|
Reclassification adjustment for interest earned on marketable
securities included in net loss |
|
- |
|
|
|
(129,229 |
) |
Change in unrealized gain on marketable securities |
|
- |
|
|
|
210,252 |
|
Comprehensive loss |
$ |
(3,806,677 |
) |
|
$ |
(4,172,215 |
) |
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated Statements of Cash
Flows |
|
|
|
|
|
|
|
|
|
For the three months |
|
|
ended March 31, |
|
|
2024 |
|
|
2023 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
Net loss |
$ |
(3,806,677 |
) |
|
$ |
(4,253,238 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
Depreciation |
|
735 |
|
|
|
321 |
|
Stock-based compensation |
|
774,691 |
|
|
|
727,144 |
|
Interest earned on marketable securities |
|
- |
|
|
|
(129,229 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Prepaid expenses and other assets |
|
332,125 |
|
|
|
324,205 |
|
Accounts payable and other current liabilities |
|
(1,237,499 |
) |
|
|
(1,630,225 |
) |
Operating lease right-of-use asset and liability, net |
|
163 |
|
|
|
(1,200 |
) |
Net cash used in operating activities |
|
(3,936,462 |
) |
|
|
(4,962,222 |
) |
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
Maturity of marketable securities |
|
- |
|
|
|
9,000,000 |
|
Purchase of marketable securities |
|
- |
|
|
|
(6,859,432 |
) |
Net cash provided by investing activities |
|
- |
|
|
|
2,140,568 |
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
- |
|
Issuance of shares of common stock |
|
336,044 |
|
|
|
|
|
Issuance costs |
|
(19,997 |
) |
|
|
- |
|
Net cash provided by financing activities |
|
316,047 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
(3,620,415 |
) |
|
|
(2,821,654 |
) |
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
13,362,053 |
|
|
|
9,626,800 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
$ |
9,741,638 |
|
|
$ |
6,805,146 |
|
|
|
|
|
|
|
|
|
Noncash investing and financing activities |
|
|
|
|
|
|
|
Change in accumulated other comprehensive income |
$ |
- |
|
|
$ |
81,023 |
|
ASC 842 lease renewal option exercise |
$ |
- |
|
|
$ |
236,506 |
|
Reclassification of security deposit |
$ |
- |
|
|
$ |
16,477 |
|
|
|
|
|
|
|
|
|
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