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Indaptus Therapeutics Inc. (INDP-12.97%) has submitted its Form 10-K filing for the fiscal year ended December 31, 2024. The company is focused on developing a novel systemically-administered anti-cancer and anti-viral immunotherapy based on attenuated and killed, non-pathogenic, Gram-negative bacteria designed to activate both innate and adaptive immune responses.
The filing reports on the company's ongoing Phase 1 clinical trial for its lead candidate, Decoy20, which began in December 2022. The trial is an open-label, multi-center, dose-escalation and expansion study targeting patients with advanced solid tumors who have exhausted approved treatment options. The primary endpoints include assessing the safety and tolerability of Decoy20, determining the maximum tolerated dose, and evaluating pharmacokinetics, pharmacodynamics, and clinical activity.
In 2023, Indaptus Therapeutics initiated the Phase 1 clinical trial of Decoy20, which is designed to activate both innate and adaptive immune responses against tumors. The trial is conducted in two parts: a single-dose administration followed by continuous weekly dosing. As of March 12, 2025, more than 20 patients have been enrolled in the weekly dosing among two Decoy20 dose levels, with early signs of potential benefits observed in some patients with stable disease.
Indaptus Therapeutics has also entered into a clinical supply agreement with BeiGene Switzerland GmbH in October 2024 to evaluate Decoy20 in combination with BeiGene's anti-PD-1 antibody, tislelizumab, for treating advanced solid tumors. The company intends to seek FDA approval to initiate this Combination Study in 2025.
Indaptus has faced financial challenges, reporting a net loss of approximately $15.0 million for the year ended December 31, 2024, compared to a net loss of approximately $15.4 million for the previous year. As of December 31, 2024, the company had an accumulated deficit of approximately $60.4 million.
In order to fund its operations into the second quarter of 2025, Indaptus has raised approximately $6.3 million through registered direct offerings and private placements completed in August 2024, November 2024, and January 2025. Additionally, in February 2025, Indaptus entered into a Standby Equity Purchase Agreement with Yorkville, allowing the company to sell up to $20.0 million of its common stock over a 36-month period, subject to certain conditions.
Indaptus is a clinical-stage biotechnology company focused on developing a novel systemically-administered anti-cancer and anti-viral immunotherapy. The company is advancing its lead candidate, Decoy20, which is designed to activate both innate and adaptive immune cells using a multi-targeted package of signals that can be administered intravenously. This approach has shown broad anti-tumor and anti-viral activity in preclinical models.
The company's business strategy includes advancing the expansion portion of the Phase 1 clinical trial for Decoy20, expanding its bacterial product platform to target additional types of cancer and infectious diseases, maintaining and protecting its intellectual property portfolio, and seeking regulatory approvals for any product candidates that successfully complete clinical trials.
Indaptus is also subject to various U.S. federal, state, and foreign healthcare laws and regulations, which could increase compliance costs. The company is working to ensure that its business arrangements comply with applicable healthcare and privacy laws and regulations to avoid significant penalties, fines, or other sanctions.
The company has identified conditions and events that raise substantial doubt regarding its ability to continue as a going concern due to recurring losses and limited capital resources. Indaptus plans to obtain additional capital through collaborations, strategic alliances, or license agreements with third parties, as well as public or private debt and equity financing.
Indaptus relies on third parties for the manufacture of its product candidates during clinical development and expects to continue this reliance for the foreseeable future. This increases the risk of not having sufficient quantities of product candidates, which could delay, prevent, or impair development or potential commercialization efforts.
The company has implemented a cybersecurity risk management program to protect its critical systems and information. The program includes risk assessments, security controls, and a cybersecurity incident response plan. The Board of Directors oversees cybersecurity risks and management's implementation of the program.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Indaptus Therapeutics Inc. annual 10-K report dated March 13, 2025. To report an error, please email earnings@qz.com.