Indaptus Therapeutics Provides Clinical Update

Rhea-AI Summary

Indaptus Therapeutics (Nasdaq: INDP) provided updates on its INDP-D101 clinical trial evaluating Decoy20. A patient receiving Decoy20 monotherapy achieved a Partial Response with reduced liver metastases in urothelial cancer, though the response was not sustained. The company has also initiated combination therapy with tislelizumab, dosing 7 patients in the initial safety cohort.

Of the first three evaluable combination therapy patients, one showed stable disease while two experienced disease progression. Additionally, Indaptus raised $5.7 million through convertible promissory notes and warrants, which were later converted into common stock and pre-funded warrants in July 2025.

Positive

• None.

Negative

• Partial Response was not sustained, with disease progression at next imaging
• Two out of three evaluable combination therapy patients showed disease progression
• Dilution from conversion of promissory notes into common stock and warrants

Insights

Oncology Clinical Trial Specialist

Indaptus reports mixed clinical results: one partial response with Decoy20 but followed by progression; combination therapy showing initial safety data.

The clinical update from Indaptus Therapeutics provides moderate yet mixed signals for its Decoy20 platform. The monotherapy portion of the INDP-D101 trial has shown a partial response in one patient with urothelial cancer and liver metastases - an important signal of potential efficacy. However, this response was short-lived, with disease progression observed at the next imaging assessment. The patient had previously received anti-PD-1 therapy, making any response in this pretreated population noteworthy, yet the transient nature tempers enthusiasm.

In the combination therapy cohort with tislelizumab (BeOne's anti-PD-1 antibody), initial safety profiles appear consistent with expectations for both agents. Among the first three evaluable patients, one achieved stable disease while two experienced disease progression. This 33% disease control rate is preliminary but modest for an early-phase oncology trial.

The company has completed monotherapy evaluation and advanced to combination therapy, dosing seven patients in the initial safety cohort. This progression through trial phases demonstrates operational execution but doesn't yet provide definitive efficacy signals. For context, urothelial cancers with liver metastases typically have poor prognoses with limited treatment options, making even temporary responses potentially meaningful for heavily pretreated patients. The investigator's assessment of clinical benefit over four months provides some encouragement despite the eventual progression. Additional patient data expected "in the coming weeks" will be critical for better understanding Decoy20's potential.

Biotech Investment Analyst

Indaptus' financial position has improved with the $5.7 million raised through convertible promissory notes and accompanying warrants. The subsequent conversion of these notes into common stock and pre-funded warrants in July 2025 has strengthened the company's balance sheet, potentially extending its operational runway. This financing is particularly important for clinical-stage biotechs like Indaptus that typically burn cash while advancing their pipeline.

The mixed clinical signals create an interesting risk-reward profile. The single partial response in a pretreated patient demonstrates proof-of-concept for Decoy20's mechanism, but the short duration and limited sample size prevent drawing broader conclusions. The market will likely view these results cautiously - encouraging enough to maintain interest but insufficient to dramatically change valuation perspectives.

For a small biotech, the partnership with BeOne for tislelizumab adds credibility and enables combination approaches that have become standard in immuno-oncology. However, with only one stable disease and two progressions in the first combination cohort, the preliminary efficacy signal remains modest. The promised additional data later this year represents a significant near-term catalyst that could substantially impact company valuation, either positively or negatively.

Management's emphasis on "disciplined execution" suggests an awareness of cash conservation needs, appropriate for a company at this development stage. The progression from monotherapy to combination studies demonstrates pipeline advancement despite the mixed efficacy signals. Investors should focus on the upcoming combination therapy data as the next critical inflection point for evaluating Decoy20's potential.

Decoy20 monotherapy induces Partial Response in patient with urothelial cancer and liver metastases

Decoy20 combination with PD-1 inhibitor, tislelizumab, demonstrates safety profiles consistent with each agent

NEW YORK, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announces recent updates for the ongoing INDP-D101 clinical trial.

“We currently have completed the monotherapy portion of our trial and have initiated seven patients in our initial cohort of combination therapy with tislelizumab, BeOne’s anti PD-1 monoclonal antibody. We are encouraged to report a patient in our monotherapy study who previously received an anti-PD-1 therapy had a clear reduction in size of liver metastases, consistent with a Partial Response. Unfortunately, there was evidence of disease progression at the next scheduled imaging, and the patient discontinued the study,” said Dr. Roger Waltzman, Chief Medical Officer. “However, the investigator believes the therapy provided clinical benefit for the patient over that 4-month period.

“Additionally, we have dosed 7 patients in the combination therapy initial safety cohort. Of the first three evaluable patients, one patient had stable disease at the first assessment, and the other two patients had disease progression. We continue to dose additional patients and will report their results in the coming weeks,” concluded Dr. Waltzman.

Jeffrey Meckler, Indaptus Therapeutics Chief Executive Officer, commented, “We continue to progress our Decoy platform in the clinic to better understand this potential breakthrough therapy in combination with BeOne’s tislelizumab.

“On the financial front, we raised approximately $5.7 million in gross proceeds through the sale of convertible promissory notes and accompanying warrants. In July 2025, the notes were converted into common stock and pre-funded warrants, which strengthens our balance sheet. We remain focused on disciplined execution and look forward to sharing initial combination trial data later this year,” added Mr. Meckler.

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, the sufficiency of our cash and cash equivalents to fund our ongoing activities and our expectations and plans regarding our Phase 1 clinical trial of Decoy20 and our combination study and the anticipated effects of our product candidates, including Decoy20. 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 most recent Annual Report on Form 10-K filed with the SEC on March 13, 2025, 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

FAQ

What results did Indaptus Therapeutics (INDP) report for Decoy20 monotherapy in urothelial cancer?

A patient treated with Decoy20 monotherapy achieved a Partial Response with reduced liver metastases, though the response lasted only 4 months before disease progression occurred.

How many patients has Indaptus (INDP) treated in the Decoy20-tislelizumab combination therapy trial?

Indaptus has dosed 7 patients in the initial combination therapy safety cohort, with three patients evaluable so far showing one stable disease and two disease progressions.

What financing did Indaptus Therapeutics secure in 2025?

Indaptus raised $5.7 million in gross proceeds through convertible promissory notes and warrants, which were converted into common stock and pre-funded warrants in July 2025.

What is the current status of INDP's INDP-D101 clinical trial?

The trial has completed its monotherapy portion and is now in the combination therapy phase with tislelizumab, with initial combination trial data expected later in 2025.

What were the safety results of Decoy20 combination therapy with tislelizumab?

The combination of Decoy20 with tislelizumab demonstrated safety profiles consistent with each individual agent.