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Indaptus Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update NEW YORK (

Key Takeaway: Indaptus Therapeutics announced its third-quarter 2023 financial results, revealing progress in its clinical trials, particularly the INDP-D101 trial of Decoy20 for treating solid tumors. The company reported that all patients in the first cohort maintained stable disease and that immune activation was evident. They have begun dosing in the second cohort at a lower dose and expect results to guide Phase 2 dosing decisions. Financially, R&D expenses increased compared to the previous year, and the company is managing its cash position as it anticipates ongoing operating needs into the second quarter of 2024.

Market Sentiment Analysis

POSITIVE FACTORS

  • All four patients in the first trial cohort maintained stable disease.
  • Evidence of immune activation observed in study participants.
  • First patient of the second cohort has been dosed, indicating progress.
  • Appointment of a new Chief Medical Officer is expected to enhance development.

CONCERNS & RISKS

  • Three patients in the first cohort presented with progressive disease.
  • R&D expenses have increased year-over-year, indicating financial pressure.
  • Cash and cash equivalents decreased significantly since December 2022.
  • Dependence on current cash runway to support operations until mid-2024.

Full Press Release Details

Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update
YORK (November 6, 2023) - Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the "Company") today
announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.
continue to be encouraged by early results from our first cohort of patients in the INDP-D101 trial evaluating Decoy20 for the treatment
of solid tumors. As we recently reported and presented at the Society for Immunology in Cancer (SITC) conference, all four first cohort
patients have maintained stable disease since receiving their single dose and presented evidence of immune activation, along with short-lived
adverse events consistent with Decoy20's mechanism of action, and we look forward to continuing to track them. In the meantime,
we have already dosed our first patient in the second cohort, for which we have titrated the dose down in anticipation of a similar response.
We continue to expect to have the second cohort completed by early 2024, which would provide guidance for the selection for the recommended
Phase 2 dose for subsequent multi-dosing and combination studies, which are also planned for 2024," said Jeffrey Meckler, Chief
Executive Officer of Indaptus. "We are also fortunate to be receiving the benefit of our appointment of industry veteran, Roger
Waltzman, M.D., as our Chief Medical Officer, who has already proven valuable even in this short period. We anticipate continuing to
benefit from his expertise as we move forward with our Phase 1 trial and further develop the Decoy platform. In the meantime, we are
prudently managing our cash position."
Corporate Highlights:
Top line data from the INDP-D101 trial of lead compound Decoy20 was presented at the Society of Immunotherapy in Cancer on November 4, 2023. In addition to the safety data and immune-response reported previously, the Company reported that all four patients had achieved and continue to maintain stable disease, three of whom presented with progressive disease.
The Company announced the initiation and first dosing of the second cohort of its INDP-D101 trial, which will be administered at a lower dose and is expected to bring the Company closer to determination of the recommended Phase 2 dose for the multi-dosing part of the trial.
Roger Waltzman, M.D. was appointed the Chief Medical Officer of Indaptus, effective August 7, 2023.
Highlights for the Third Quarter Ended September 30, 2023
and development expenses for the three months ended September 30, 2023 were approximately $2.2 million, an increase of approximately
$0.6 million compared with approximately $1.6 million in the three months ended September 30, 2022. Research and development expenses
for the nine months ended September 30, 2023 were approximately $5.6 million, an increase of approximately $1.2 million compared with
approximately $4.4 million in the nine months ended September 30, 2022. The increase in each of the three- and nine-month periods was
primarily due to the Phase 1 clinical trial and activities related to the expansion of our pipeline.
and administrative expenses for the three months ended September 30, 2023 were approximately $2.0 million, an increase of approximately
$0.1 million compared with approximately $1.9 million in the three months ended September 30, 2022. General and administrative expenses
for the nine months ended September 30, 2023 were approximately $6.6 million, an increase of approximately $0.2 million compared with
approximately $6.4 million in the nine months ended September 30, 2022. This increase in the nine-month period was primarily due to legal
fees, payroll and related expenses, recruitment costs and other professional fees, which were partially offset by a decrease in directors'
and officers' insurance expenses.
per share for the three months ended September 30, 2023 was approximately $0.47 compared with approximately $0.42 for the three months
ended September 30, 2022. Loss per share for the nine months ended September 30, 2023 was approximately $1.36 compared with approximately
$1.29 per share for the nine months ended September 30, 2022.
of September 30, 2023, the Company had cash and cash equivalents of approximately $16.0 million as compared to $26.4 million as of December
31, 2022. The Company expects that its current cash and cash equivalents will support its ongoing operating activities into the second
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.
cash used in operating activities was approximately $10.8 million for the nine months ended September 30, 2023, compared with net cash
used in operating activities of approximately $10.9 million for the nine months ended September 30, 2022.
cash provided by investing activities was approximately $17.1 million for the nine months ended September 30, 2023, which was a result
of the maturity of $24.0 million in marketable securities, offset by net investment of approximately $6.9 million in marketable securities.
Net cash used in investing activities was approximately $21.5 million for the nine months ended September 30, 2022, which was primarily
related to net investment in marketable securities in the amount of approximately $23.7 million, offset by approximately $0.2 million
from the proceeds received for assets held for sale and by $2.0 million from the maturity of marketable securities.
was no net cash provided by or used in financing activities in the nine months ended September 30, 2023 and 2022.
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 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.
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 timing of the enrollment of the second cohort of
patients in the Phase 1 trial, and our expectations regarding the recommended Phase 2 doses for subsequent multi-dosing and combination
studies and related timing; 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, 2023 to be filed
with the SEC, our most recent Annual Report on Form 10-K filed with the SEC on March 17, 2023, 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.
Condensed Consolidated Balance Sheets

Frequently Asked Questions

What are the latest results from the INDP-D101 trial?

All four patients in the first cohort have maintained stable disease after treatment.

Who is the new Chief Medical Officer at Indaptus?

Roger Waltzman, M.D., was appointed as Chief Medical Officer on August 7, 2023.

What was Indaptus' cash position at the end of Q3 2023?

Indaptus had approximately $16.0 million in cash and cash equivalents.

What is Decoy20's mechanism of action?

Decoy20 activates immune responses with minimal adverse effects.

When will the second cohort of the INDP-D101 trial be completed?

The second cohort is expected to be completed by early 2024.

Last updated: Nov 6, 2023