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]

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]

Core Insights - Indaptus Therapeutics reported significant progress in its clinical and research programs during Q1 2025, including the initiation of a Phase 1b/2 clinical trial expansion for Decoy20 in combination with Tislelizumab [2][3] - The company has expanded its intellectual property portfolio with new patents granted in China, Japan, and Israel for its Decoy platform [2] - Financial results indicate an increase in research and development expenses, while general and administrative expenses decreased, leading to a net loss per share improvement compared to the previous year [4][5] Financial Highlights - Research and development expenses for Q1 2025 were $2.8 million, up from $1.6 million in Q1 2024, primarily due to increased costs associated with the Phase 1 clinical trial [4] - General and administrative expenses decreased to $1.8 million in Q1 2025 from $2.4 million in Q1 2024, attributed to lower payroll and legal fees [5] - The net loss for Q1 2025 was $4.5 million, resulting in a loss per share of $0.32, compared to a loss of $3.8 million and a loss per share of $0.45 in Q1 2024 [5][16] Cash Position - As of March 31, 2025, the company had cash and cash equivalents of $3.9 million, down from $5.8 million at the end of 2024, indicating a need for additional capital to fund ongoing activities beyond Q2 2025 [6] - Net cash used in operating activities increased to $5.0 million in Q1 2025 from $3.9 million in Q1 2024, primarily due to heightened research and development activities [7][19] - Financing activities provided $3.2 million in Q1 2025, a significant increase from $0.3 million in the same period of the previous year, mainly from the issuance and sale of common stock and warrants [8][9] Clinical Developments - The company has enrolled 32 patients in the Decoy20 weekly dosing trial, which is now concluding as the focus shifts to the combination treatment with Tislelizumab [2] - Early data from the weekly dosing suggests Decoy20 is well-tolerated with a favorable safety profile and early signs of clinical benefit, including instances of stable disease [2] - Indaptus' Decoy platform is designed to activate both innate and adaptive immune responses, showing promise in pre-clinical studies against various cancers and viral infections [10]

Company Overview - Indaptus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing innovative treatments for cancer and viral infections [1][4] - The company utilizes a patented Decoy platform that activates both innate and adaptive immune responses through a multi-targeted approach [4] Key Events - Dr. Michael Newman, the Founder and Chief Scientific Officer, will serve as an Expert Speaker and Chair at the 6th Annual Cytokine-Based Drug Development Summit on May 15-16, 2025 [1][2] - Dr. Newman will present on "Pulsed Cytokine Delivery for Anti-Tumor Immunotherapy & its Impact on Toxicity & Efficacy" and lead discussions on pre-clinical models for cytokine drug development [2] Industry Recognition - The invitation for Dr. Newman to speak at the summit highlights his leadership in cytokine research and the growing recognition of Indaptus' novel approach in the industry [3] - The summit aims to bring together influential leaders to share knowledge and innovative strategies for overcoming challenges in cytokine drug development [3] Product Development - Indaptus' Decoy product candidates have shown promising results in pre-clinical studies, including activity against metastatic pancreatic and colorectal carcinomas, as well as chronic hepatitis B and HIV infections [4] - The Decoy platform has demonstrated reduced intravenous toxicity while effectively activating immune responses, leading to tumor eradication in combination with other therapies [4]

Core Insights - Indaptus Therapeutics, Inc. is a clinical-stage biotechnology company focused on innovative therapies for cancer and viral infections [1][3] - The company's chief medical officer, Dr. Roger Waltzman, will moderate a panel at the CMO360 Summit on April 7-8, 2025, discussing clinical trial management [1][2] - Indaptus' approach involves a multi-targeted package of immune system-activating signals delivered intravenously, aiming to enhance both innate and adaptive immune responses [3] Company Overview - Indaptus Therapeutics has developed a patented technology utilizing non-pathogenic Gram-negative bacteria to activate immune responses through various receptors [3] - The Decoy product candidates have shown promise in pre-clinical studies, demonstrating activity against various cancers and chronic viral infections such as hepatitis B and HIV [3] - The company emphasizes the potential for reduced intravenous toxicity while maintaining effective immune activation [3] Industry Context - The CMO360 Summit is recognized as a significant event for biotech Chief Medical Officers, facilitating networking and skill development within the industry [2] - The conference aims to advance efficient medicine development and delivery, highlighting the importance of patient diversity and access in the biotech sector [2]

Core Insights - Indaptus Therapeutics has advanced to a new expansion arm of its Phase 1b/2 clinical trial for Decoy20, evaluating its combination with BeiGene's PD-1 inhibitor, tislelizumab, focusing on safety, dose optimization, and early anti-tumor activity [1][2] Company Overview - Indaptus Therapeutics is a clinical-stage biotechnology company focused on developing innovative treatments for cancer and viral infections, leveraging a unique Decoy platform that activates the immune system [1][5] - The Decoy platform utilizes non-pathogenic Gram-negative bacteria to produce multiple immune system-activating signals, aiming to enhance both innate and adaptive immune responses [6] Clinical Trial Details - The combination trial will initially involve participants receiving one week of Decoy20 monotherapy before transitioning to the combination treatment with Decoy20 and tislelizumab [7] - The trial will begin with sequential enrollment to monitor safety, followed by unrestricted enrollment after a review by the Safety Review Committee [7] Mechanism of Action - PD-1 inhibitors like tislelizumab block the PD-1 receptor on T cells, allowing the immune system to better combat cancer cells [4] - The combination of checkpoint inhibitors with immune activators like Decoy20 is theorized to provide a more powerful and sustained anti-tumor response [4][2] Preclinical Research Findings - Preclinical studies have shown that Decoy20 can enhance the effectiveness of checkpoint inhibitors, with evidence of tumor eradication in various cancer models [6] - The Decoy platform has demonstrated single-agent activity against multiple cancers and has shown promise in combination with other therapies [6]