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Indaptus Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update NEW YORK (

Key Takeaway: Indaptus Therapeutics reported its financial results for Q2 2024, highlighting advancements in its Phase 1 clinical trial for Decoy20. The company completed a $3 million offering to support ongoing operations and is gearing up to increase patient dosing in the trial. CEO Michael Newman noted positive early results from the trial and continued engagement in significant oncology conferences. Despite an increase in expenses and a slight rise in loss per share, Indaptus remains optimistic about its future prospects.

Market Sentiment Analysis

POSITIVE FACTORS

  • Indaptus Therapeutics is advancing its clinical trials, particularly with Decoy20, showing well-tolerated results.
  • The company successfully completed a $3 million offering to enhance its funding for further development.
  • CEO Michael Newman was recognized for his contributions by being named chair of a prominent summit.

CONCERNS & RISKS

  • The company's loss per share has slightly increased from the previous year.
  • Clinical trial expenses have risen, which may impact financial sustainability.

Full Press Release Details

Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update
YORK (August 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 second quarter ended June 30, 2024, and provided a corporate update.
Meckler, Indaptus Therapeutics' Chief Executive Officer, commented, "During the second quarter we had multiple opportunities
to share our findings regarding our Phase 1 clinical trial to date, and to demonstrate the unique approach that our Decoy platform offers.
These included impactful conferences such as the American Association for Cancer Research (AACR) annual meeting and the American Society
of Clinical Oncology (ASCO) annual meeting, which are considered among the top annual oncology conferences. Further, our founder was
once again recognized by the industry when he was named chair of the STING & TLR-Targeted Therapies Summit. We are encouraged by
the results we have reported, along with the data we are seeing as we continue the multi-dose stage of the Phase 1 clinical trial. As
Decoy20 continues to be well-tolerated in our Phase 1 clinical trial, we expect to progress to dosing multiple patients simultaneously.
This will increase the data we receive and, as a result, is expected to accelerate the progress of the trial. We look forward to demonstrating
continued impactful outcomes in the second half of the year."
Completed a $3 million registered direct offering and concurrent private placement on August 8, 2024, for net proceeds of approximately $2.5 million
Advancing clinical trial from single to weekly doses of Decoy20, the company completed one month of weekly dosing in three patients at the 3 x 10^7 Decoy20 dose
Completed a single dose cohort at the higher dose of 7 x 10^7 Decoy20 and intend to initiate weekly dosing later this year
Presented poster outlining data from 3 x 10^7 and 7 x 10^7 dose at the ASCO annual meeting on June 1, 2024, in Chicago
Presented poster outlining new mechanism of action data for Decoy platform at the AACR annual meeting in April 2024
Founder and Chief Scientific Officer, Michael Newman, Ph.D. presented additional data on the Company's lead product candidate, Decoy20, at the 5 th Annual STING & TLR-Targeted Therapies Summit in San Diego on June 19-20, 2024, where he was also named chair of the Summit
Highlights for the Second Quarter Ended June 30, 2024
and development expenses for the three months ended June 30, 2024, were approximately $1.7 million, an increase of approximately $0.2
million compared with approximately $1.5 million in the three months ended June 30, 2023. The increase for the three-month period was
primarily due to payroll and related expenses and stock-based compensation. Research and development expenses for the six months ended
June 30, 2024, were approximately $3.3 million, a decrease of approximately $0.1 million compared with approximately $3.4 million in
the six months ended June 30, 2023. The decrease for the six-month period was primarily due to a decrease of approximately $0.5 million
in our manufacturing processes of Decoy20 that were conducted in 2023 and was offset by an increase of approximately $0.4 million in
our Phase 1 clinical trial and in payroll and related expenses.
and administrative expenses for the three months ended June 30, 2024, were approximately $2.4 million, an increase of approximately $0.4
million compared with approximately $2.0 million in the three months ended June 30, 2023. The increase was primarily due to payroll and
related expenses, legal fees and investor relations expenses. General and administrative expenses for the six months ended June 30, 2024,
were approximately $4.7 million, an increase of approximately $0.1 million compared with approximately $4.6 million in the six months
ended June 30, 2023. The increase for the six-month period was primarily due to payroll and related expenses and stock-based compensation.
per share for the three months ended June 30, 2024, was approximately $0.47 compared with approximately $0.39 for the three months ended
June 30, 2023. Loss per share for the six months ended June 30, 2024, was approximately $0.92 compared with approximately $0.89 per share
for the six months ended June 30, 2023.
of June 30, 2024, the Company had cash and cash equivalents of approximately $7.3 million and on August 8, 2024, the Company raised $3.0
million in a registered direct offering of 1,643,837 shares of common stock at a purchase price of $1.825 per share and a concurrent
private placement, in which the Company also issued to the purchasers in the offering unregistered warrants to purchase 1,643,837 shares
of common stock. The warrants have an exercise price of $1.70 per share, are immediately exercisable, and will expire five years from
the date of issuance. The total net proceeds of the registered direct offering and the private placement were approximately $2.5 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 $6.4 million for the six months ended June 30, 2024, compared with net cash used
in operating activities of approximately $7.1 million for the six months ended June 30, 2023. The decrease of approximately $0.7 million
in net cash used was primarily attributable to a settlement fee that was paid in February 2023.
was no net cash provided by or used in investing activities in the six months ended June 30, 2024. Net cash provided by investing activities
was approximately $10.1 million for the six months ended June 30, 2023, which was related to the maturity of $17.0 million in marketable
securities, offset by net investment of approximately $6.9 million in marketable securities.
cash provided by financing activities for the six months ended June 30, 2024, was approximately $0.4 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 six months ended June 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. 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
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 and expected immune responses as we dose more patients
in the multi-dosing part of the trial; 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 June 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

Frequently Asked Questions

What financial updates did Indaptus announce for Q2 2024?

Indaptus reported a $2.5 million net gain from a $3 million direct offering.

Where did Indaptus present its Phase 1 trial data?

The data was presented at the AACR and ASCO annual meetings.

What is the Decoy20 treatment related to?

Decoy20 is part of a Phase 1 clinical trial for treating cancer.

Who is the chair of the STING & TLR-Targeted Therapies Summit?

Indaptus' founder, Michael Newman, Ph.D., is the chair of the Summit.

How much cash did Indaptus have at the end of June 2024?

Indaptus had approximately $7.3 million in cash and cash equivalents.

Last updated: Aug 12, 2024