Full Press Release Details
Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update
YORK (November 12, 2024) - 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.
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."
Highlights for the Third Quarter Ended September 30, 2024
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.
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.
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.
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.
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.
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.
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.
Indaptus Therapeutics
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.
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 data from 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,