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 third quarter ended September
30, 2024, and provided a corporate update.
Jeffrey Meckler, Indaptus Therapeutics’ Chief
Executive Officer, commented, “The recent announcement highlighting
our clinical supply agreement with BeiGene is an important
milestone, representing a significant step forward in our clinical
development as we plan the first clinical trial combining BeiGene's
anti-PD-1 antibody, tislelizumab, with Indaptus’ Decoy20 product
candidate for cancer treatment. PD-1 inhibitors have proven
meaningful in treating multiple cancer types, and we are optimistic
that we can improve patient outcomes by broadly and safely
stimulating the immune system to enhance the effectiveness of
currently approved treatments. We have also progressed our Phase 1
clinical trial to now allow for unrestricted enrollment of patients
in weekly administration at the lower Decoy20 dose, which will
enable us to gather more safety and efficacy data, which is
important for assessing the full potential of Decoy20. Those data
will guide how we initiate the combination trial next year. To
date, Decoy20 continues to be well tolerated and we are anxiously
awaiting further outcomes, which we will report as the trial
progresses. We continue to carefully manage our resources and will
provide status updates as they develop.”
Key recent
highlights:
- Announced clinical supply agreement
with BeiGene to evaluate novel cancer treatment combinations for
the treatment of patients with advanced solid tumors
- Initiated unrestricted enrollment
of patients in Indaptus’ Phase 1 clinical trial of Decoy20 allowing
for weekly dosing based on encouraging safety data
- Announced that Dr. Michael Newman,
Founder and Chief Scientific Officer, has published his
groundbreaking research in the peer-reviewed journal, Frontiers in
Immunology. The article was titled, "Invention and Characterization
of a Systemically Administered, Attenuated and Killed
Bacteria-Based Multiple Immune Receptor Agonist for Antitumor
Immunotherapy"
- Completed a $3 million registered
direct offering and concurrent private placement on August 8, 2024
(the “August 2024 Offering”), for net proceeds of approximately
$2.5 million
- Participated in Lumanity webinar
regarding the future of innate immunity in cancer
immunotherapy
Financial Highlights for
the Third
Quarter Ended
September 30,
2024
Research and development expenses for the three
months ended September 30, 2024, were approximately $1.5 million, a
decrease of approximately $0.7 million compared with approximately
$2.2 million in the three months ended September 30, 2023. The
decrease for the three-month period was primarily due to the
development of our manufacturing processes of Decoy20 that were
conducted in the three months ended September 30, 2023. Research
and development expenses for the nine months ended September 30,
2024, were approximately $4.8 million, a decrease of approximately
$0.8 million compared with approximately $5.6 million in the nine
months ended September 30, 2023. The decrease for the nine-month
period was primarily due to a decrease of approximately $1.1
million in the development of our manufacturing processes of
Decoy20 that were conducted in 2023 and was offset by an increase
of approximately $0.3 million in our Phase 1 clinical trial and in
payroll and related expenses.
General and administrative expenses for the
three months ended September 30, 2024, were approximately $1.7
million, a decrease of approximately $0.3 million compared with
approximately $2.0 million in the three months ended September 30,
2023. The decrease was primarily due to stock-based compensation,
legal fees and recruitment costs. General and administrative
expenses for the nine months ended September 30, 2024, were
approximately $6.4 million, a decrease of approximately $0.2
million compared with approximately $6.6 million in the nine months
ended September 30, 2023. The decrease for the nine-month period
was primarily due to a decrease of approximately $0.7 million in
legal fees, payroll and related expenses, recruitment costs and
directors’ and officers’ insurance expenses, and was offset by an
increase of approximately $0.5 million in investor relations and
business development expenses.
Loss per share for the three months ended
September 30, 2024, was approximately $0.32 compared with
approximately $0.47 for the three months ended September 30, 2023.
Loss per share for the nine months ended September 30, 2024, was
approximately $1.23 compared with approximately $1.36 per share for
the nine months ended September 30, 2023.
As of September 30, 2024, the Company had cash
and cash equivalents of approximately $7.4 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 into the
first quarter of 2025. 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
approximately $8.9 million for the nine months ended September 30,
2024, compared with net cash used in operating activities of
approximately $10.8 million for the nine months ended September 30,
2023. The decrease resulted primarily from a decrease in our
research and development activities and general and administrative
expenses and by net changes in operating asset and liability
items.
There was no net cash provided by or used in
investing activities in the nine months ended September 30, 2024.
Net cash provided by investing activities was approximately $17.1
million for the nine months ended September 30, 2023, which was
related to the maturity of $24.0 million in marketable securities,
offset by net investment of approximately $6.9 million in
marketable securities.
Net cash provided by financing activities for
the nine months ended September 30, 2024, was approximately $2.9
million, which was provided by the issuance and sale of our common
stock under the ATM Agreement and the issuance and sale of our
common stock and warrants in the August 2024 Offering. There was no
net cash provided by or used in financing activities in the nine
months ended September 30, 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 candidate, with
associated “cold” to “hot” tumor inflammation signature transition.
The Decoy platform has also been shown to induce activation,
polarization or maturation of human macrophages, dendritic, NK,
NKT, CD4 T and CD8 T cells in vitro. 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 candidate.
Indaptus’ Decoy product candidates have also produced meaningful
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 clinical supply agreement
with BeiGene; our plans to advance clinical evaluation of the
combination of BeiGene’s anti-PD-1 antibody, tislelizumab, with
Decoy20; our ability to gather more safety and efficacy datafrom
our Phase 1 clinical trial; our plans to seek FDA approval and to
initiate a combination trial, and the timing 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 September 30, 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 IRLouie
Tomalouie@coreir.com
Media Contact:Cuttlefish CommunicationsShira
Derasmoshira@cuttlefishpr.com917-280-2497
INDAPTUS THERAPEUTICS, INC.Unaudited Condensed Consolidated
Balance Sheets |
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
7,380,686 |
|
|
$ |
13,362,053 |
|
Prepaid expenses and other
current assets |
|
|
248,737 |
|
|
|
633,156 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
7,629,423 |
|
|
|
13,995,209 |
|
|
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
- |
|
|
|
735 |
|
Right-of-use asset |
|
|
105,655 |
|
|
|
173,206 |
|
Other assets |
|
|
504,728 |
|
|
|
754,728 |
|
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
|
610,383 |
|
|
|
928,669 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
8,239,806 |
|
|
$ |
14,923,878 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and other
current liabilities |
|
$ |
2,128,491 |
|
|
$ |
2,672,327 |
|
Operating lease liability,
current portion |
|
|
103,982 |
|
|
|
101,705 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
2,232,473 |
|
|
|
2,774,032 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Operating lease liability, net
of current portion |
|
|
4,007 |
|
|
|
73,348 |
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities |
|
|
4,007 |
|
|
|
73,348 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
2,236,480 |
|
|
|
2,847,380 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock: $0.01 par value,
200,000,000 shares authorized as of September 30, 2024 and December
31, 2023; 10,196,884 shares issued and outstanding as of September
30, 2024 and 8,401,047 shares issued and outstanding as of December
31, 2023 |
|
|
101,969 |
|
|
|
84,011 |
|
Additional paid in
capital |
|
|
62,209,493 |
|
|
|
57,409,643 |
|
Accumulated deficit |
|
|
(56,308,136 |
) |
|
|
(45,417,156 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
6,003,326 |
|
|
|
12,076,498 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
8,239,806 |
|
|
$ |
14,923,878 |
|
|
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated Statements of Operations
and Comprehensive Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,466,037 |
|
|
$ |
2,226,688 |
|
|
$ |
4,771,152 |
|
|
$ |
5,587,073 |
|
General and administrative |
|
|
1,676,020 |
|
|
|
2,021,724 |
|
|
|
6,423,029 |
|
|
|
6,611,767 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
3,142,057 |
|
|
|
4,248,412 |
|
|
|
11,194,181 |
|
|
|
12,198,840 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(3,142,057 |
) |
|
|
(4,248,412 |
) |
|
|
(11,194,181 |
) |
|
|
(12,198,840 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
73,021 |
|
|
|
326,024 |
|
|
|
303,201 |
|
|
|
778,149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,069,036 |
) |
|
$ |
(3,922,388 |
) |
|
$ |
(10,890,980 |
) |
|
$ |
(11,420,691 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders per share of common stock, basic and diluted |
|
$ |
(0.32 |
) |
|
$ |
(0.47 |
) |
|
$ |
(1.23 |
) |
|
$ |
(1.36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares used in calculating net loss per share, basic and
diluted |
|
|
9,510,447 |
|
|
|
8,401,047 |
|
|
|
8,832,630 |
|
|
|
8,401,047 |
|
Net loss |
|
$ |
(3,069,036 |
) |
|
$ |
(3,922,388 |
) |
|
$ |
(10,890,980 |
) |
|
$ |
(11,420,691 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification adjustment for interest earned on marketable
securities included in net loss |
|
|
- |
|
|
|
(140,567 |
) |
|
|
- |
|
|
|
(430,993 |
) |
Change in unrealized gain on marketable securities |
|
|
- |
|
|
|
6,412 |
|
|
|
- |
|
|
|
334,559 |
|
Comprehensive loss |
|
$ |
(3,069,036 |
) |
|
$ |
(4,056,543 |
) |
|
$ |
(10,890,980 |
) |
|
$ |
(11,517,125 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated Statements of Cash
Flows |
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months Ended |
|
|
|
September 30, |
|
|
|
2024 |
|
|
2023 |
|
Cash flows from operating
activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(10,890,980 |
) |
|
$ |
(11,420,691 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
735 |
|
|
|
964 |
|
Stock-based compensation |
|
|
2,001,727 |
|
|
|
2,220,413 |
|
Interest earned on marketable securities |
|
|
- |
|
|
|
(430,993 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current and non- current assets |
|
|
634,419 |
|
|
|
(84,568 |
) |
Accounts payable and other current liabilities |
|
|
(673,829 |
) |
|
|
(1,088,785 |
) |
Operating lease right-of-use asset and liability, net |
|
|
487 |
|
|
|
290 |
|
Net cash used in operating activities |
|
|
(8,927,441 |
) |
|
|
(10,803,370 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities: |
|
|
|
|
|
|
|
|
Maturity of marketable securities |
|
|
- |
|
|
|
24,000,000 |
|
Purchase of marketable securities |
|
|
- |
|
|
|
(6,859,432 |
) |
Net cash provided by investing activities |
|
|
- |
|
|
|
17,140,568 |
|
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities: |
|
|
|
|
|
|
|
|
Proceeds from issuance of shares of common stock and warrants |
|
|
3,375,590 |
|
|
|
- |
|
Issuance costs |
|
|
(429,516 |
) |
|
|
- |
|
Net cash provided by financing activities |
|
|
2,946,074 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in
cash and cash equivalents |
|
|
(5,981,367 |
) |
|
|
6,337,198 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
beginning of period |
|
|
13,362,053 |
|
|
|
9,626,800 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
end of period |
|
$ |
7,380,686 |
|
|
$ |
15,963,998 |
|
|
|
|
|
|
|
|
|
|
Noncash investing and
financing activities |
|
|
|
|
|
|
|
|
Transaction costs in accounts payable and other current
liabilities |
|
$ |
129,993 |
|
|
$ |
- |
|
Change in unrealized gain/loss on marketable securities |
|
$ |
- |
|
|
$ |
(96,434 |
) |
ASC 842 lease renewal option exercise |
|
$ |
- |
|
|
$ |
236,506 |
|
Reclassification of security deposit |
|
$ |
- |
|
|
$ |
16,477 |
|
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