NEW YORK, Dec. 29, 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 it has entered into a $6 million securities purchase agreement with investor, David E. Lazar, for the purchase of non-voting convertible preferred stock of the Company. Mr. Lazar has been appointed Indaptus’ Co-Chief Executive Officer and Chairman of the Board. Jef ...

Core Insights - Indaptus Therapeutics, a clinical stage biotechnology company, is focused on innovative treatments for cancer and viral infections, and will present at the 3rd Donor Selection & Cell Source Summit in San Diego [1][4] Company Overview - Indaptus Therapeutics is leveraging over a century of immunotherapy advancements, utilizing a patented Decoy platform that activates both innate and adaptive immune responses through a multi-targeted approach [5] - The Decoy platform consists of non-pathogenic, Gram-negative bacteria designed to activate immune pathways safely via intravenous administration, showing promise in treating various cancers and viral infections [5] Research and Development - Dr. Michael Newman will present research on the Decoy bacterial platform, which aims to address donor cell variability in allogeneic immune cell cancer therapy [2][4] - The lead candidate, Decoy20, utilizes killed bacteria to induce a broad immune response, potentially enhancing the quality and consistency of allogeneic immune cell products [3][4] - Preclinical data indicates that Decoy bacteria can activate key immune cell types, suggesting their potential to improve the potency and reproducibility of donor-derived cell therapies [4] Industry Context - The Donor Selection & Cell Source Summit aims to tackle challenges in donor screening and cell sourcing within the expanding allogeneic cell therapy market, bringing together industry and academic leaders [4]

Core Viewpoint - Indaptus Therapeutics, Inc. reported its financial results for Q3 2025, highlighting ongoing clinical trials and financial performance, including a recent capital raise of approximately $2.3 million to strengthen its balance sheet [1][2]. Financial Highlights - Research and development expenses for Q3 2025 were approximately $1.52 million, an increase of about $50,000 from $1.47 million in Q3 2024, primarily due to a $0.35 million increase in the ongoing Phase 1 study [3]. - For the nine months ended September 30, 2025, research and development expenses totaled approximately $6.5 million, up by $1.7 million from $4.8 million in the same period in 2024, mainly due to a $2.6 million increase in the Phase 1 study [3]. - General and administrative expenses for Q3 2025 were approximately $1.1 million, a decrease of about $0.6 million from $1.7 million in Q3 2024, primarily due to a reduction in stock-based compensation and payroll-related expenses [4]. - Loss per share for Q3 2025 was approximately $2.98, compared to approximately $9.04 for Q3 2024, indicating a significant reduction in losses [5]. - As of September 30, 2025, the company had cash and cash equivalents of approximately $5.8 million, which is expected to support operations into Q1 2026 [6][7]. Operational Updates - The company completed the Safety Lead-In cohort, dosing six evaluable participants with the combination of Decoy20 and tislelizumab, with three participants achieving stable disease at the first assessment [2]. - Enrollment for the trial has been paused pending further efficacy evaluations of remaining participants and to assess future development options [2]. - The company raised approximately $2.3 million in September 2025 through its at-the-market facility, enhancing its financial position [2]. Cash Flow and Financing Activities - Net cash used in operating activities for the nine months ended September 30, 2025, was approximately $11.6 million, compared to $8.9 million for the same period in 2024, primarily due to increased research and development activities [8]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was approximately $11.7 million, significantly higher than $2.9 million for the same period in 2024 [9].

Core Insights - Indaptus Therapeutics has reported updates on the ongoing INDP-D101 clinical trial, highlighting the potential of Decoy20 in treating urothelial cancer with liver metastases [1][2] - The company has completed the monotherapy portion of the trial and initiated combination therapy with PD-1 inhibitor tislelizumab, with initial results showing a patient achieving a Partial Response [2][3] - Financially, Indaptus raised approximately $5.7 million through the sale of convertible promissory notes, which were converted into common stock, enhancing the company's balance sheet [5] Clinical Trial Updates - The monotherapy portion of the trial has been completed, and seven patients have been initiated in the combination therapy cohort with tislelizumab [2] - One patient in the monotherapy study showed a reduction in liver metastases size, indicating a Partial Response, although disease progression was noted in subsequent imaging [2] - In the initial safety cohort of the combination therapy, one out of three evaluable patients had stable disease, while the other two experienced disease progression [3] Financial Developments - Indaptus raised approximately $5.7 million in gross proceeds through convertible promissory notes and accompanying warrants, which were converted into common stock in July 2025 [5] - The company emphasizes a focus on disciplined execution and anticipates sharing initial combination trial data later in the year [5] Company Overview - Indaptus Therapeutics is a clinical-stage biotechnology company focused on innovative cancer and viral infection treatments, utilizing a Decoy platform based on immune system activation [6] - The Decoy technology aims to activate both innate and adaptive immune responses through a multi-targeted approach, showing promise in pre-clinical studies against various cancers and viral infections [6]

Core Insights - Indaptus Therapeutics, Inc. will present a corporate overview at the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025 [1] - The presentation is scheduled for September 8, 2025, at 3:30 PM ET, and will be accessible via a live webcast [2] Company Overview - Indaptus Therapeutics focuses on immunotherapy, utilizing a multi-targeted approach to activate both innate and adaptive immune responses [3] - The company's patented technology involves non-pathogenic Gram-negative bacteria that produce multiple immune system-activating signals, designed for safe intravenous administration [3] - Decoy product candidates have shown efficacy against various cancers and chronic viral infections in pre-clinical models, demonstrating significant single-agent activity [3] - The Decoy platform has been effective in combination with other therapies, leading to tumor eradication and the induction of immunological memory [3] - IND-enabling studies indicate that intravenous administration of Decoy product candidates does not induce significant cytokine release syndromes, suggesting a favorable safety profile [3]

As filed with the Securities and Exchange Commission on September 2, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 INDAPTUS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-3158720 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 3 Columbus Ci ...

Core Insights - Indaptus Therapeutics has initiated a Phase 1b/2 combination trial for Decoy20 with the PD-1 inhibitor tislelizumab, marking a significant clinical milestone for the company [2][7] - The company raised approximately $5.7 million through the sale of convertible promissory notes, which has strengthened its balance sheet to support ongoing clinical development [2][8] - Indaptus plans to share initial data from the combination trial later this year, reflecting its commitment to advancing immunotherapy options for patients [11][12] Financial Highlights - Research and development expenses for Q2 2025 were approximately $2.2 million, up from $1.7 million in Q2 2024, primarily due to increased costs associated with the ongoing Phase 1 study [4] - General and administrative expenses for Q2 2025 were approximately $2.3 million, a slight decrease from $2.4 million in Q2 2024, attributed to reduced stock-based compensation and related expenses [5] - Loss per share for Q2 2025 was approximately $9.09, compared to $13.16 in Q2 2024, indicating an improvement in financial performance [6][20] Cash Flow and Liquidity - As of June 30, 2025, the company had cash and cash equivalents of approximately $6.2 million, an increase from $5.8 million at the end of 2024, which is expected to support operations into Q4 2025 [8] - Net cash used in operating activities for the first half of 2025 was approximately $9.1 million, up from $6.4 million in the same period of 2024, primarily due to increased research and development activities [9] - Net cash provided by financing activities for the first half of 2025 was approximately $9.4 million, significantly higher than $0.4 million in the first half of 2024, reflecting successful capital raising efforts [10] Clinical Development - The first patient has been dosed in the Phase 1b/2 study evaluating the combination of Decoy20 and tislelizumab, which aims to provide new treatment options for patients unresponsive to existing therapies [2][7] - Indaptus' Decoy platform is designed to activate both innate and adaptive immune responses, showing promise in preclinical studies for various cancers and viral infections [12]

Core Points - Indaptus Therapeutics, Inc. has raised a total of $5.7 million through the sale of convertible promissory notes and accompanying warrants [1][2] - The notes have a 6% annual interest rate and will mature on July 28, 2026, with conversion into common stock at a price equal to 80% of the average Nasdaq closing price for the five trading days prior to conversion, capped at $11.20 [2] - Warrants to purchase 200% of the conversion shares will be issued upon conversion, with an exercise price equal to the conversion price and a term of five years [3] - The net proceeds from the offering will be used for research and development activities, including funding a Phase 1b/2 clinical trial, as well as for working capital and general corporate purposes [4]

Core Points - Indaptus Therapeutics, Inc. has announced a one-for-twenty-eight reverse stock split of its common stock, effective after trading closes on June 26, 2025 [1] - The reverse stock split aims to increase the per share price and bid price to regain compliance with Nasdaq listing requirements and attract institutional investors [1] - Following the split, the number of outstanding shares will decrease from approximately 16 million to about 572 thousand [3] Stockholder Impact - Every 28 shares will be converted into one share, with adjustments made to the exercise price and number of shares for outstanding options and warrants [2] - No fractional shares will be issued; instead, stockholders will receive cash payments for any fractional shares based on the adjusted closing price on June 26, 2025 [3] - Registered stockholders in book-entry form do not need to take action, while those with physical certificates will receive instructions for exchanging them [4] Additional Information - More details about the reverse stock split can be found in the definitive proxy statement filed with the SEC on April 28, 2025 [5]

Core Insights - Indaptus Therapeutics has initiated a Phase 1b/2 clinical trial to evaluate the safety, dosing, and preliminary anti-tumor activity of Decoy20 in combination with tislelizumab for patients with advanced solid tumors [1][2] - The trial aims to assess the effectiveness of this combination therapy in patients who have previously been treated with checkpoint inhibitors or have tumors that are typically unresponsive to such therapies [1][7] Company Overview - Indaptus Therapeutics is focused on developing innovative therapies that leverage the immune system to combat cancer and viral infections, utilizing a patented Decoy platform that activates both innate and adaptive immune responses [6][5] - The Decoy platform is based on non-pathogenic Gram-negative bacteria that produce multiple immune system-activating signals, designed to be administered safely via intravenous injection [6] Clinical Trial Details - The trial has already dosed over 25 patients with Decoy20 at a dosage of 30 million cells, with treatment being well tolerated and side effects mostly mild or moderate [7] - The combination therapy is expected to enhance immune responses in patients who have not responded to prior treatments, potentially leading to improved outcomes [2][4] Mechanism of Action - PD-1 inhibitors like tislelizumab work by blocking the PD-1 receptor on T cells, which helps restore the immune system's ability to fight cancer [4] - The combination of Decoy20 with PD-1 inhibitors is hypothesized to provide a more powerful and sustained anti-tumor response by activating both innate and adaptive immune cells [4][8] Preclinical Evidence - Preclinical studies have shown that Decoy product candidates can induce significant anti-tumor activity and have produced promising results against various cancers in combination with checkpoint inhibitors [6][8] - The Decoy platform has also demonstrated efficacy against chronic viral infections such as hepatitis B and HIV in preclinical models [8]