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]

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]

Core Insights - Indaptus Therapeutics reported significant progress in its Phase 1 trial of Decoy20, with over 20 patients enrolled in the weekly dosing cohort, indicating potential clinical benefits and a favorable safety profile [2][6][7] - The company experienced a decrease in total operating expenses for the fiscal year 2024 compared to 2023, primarily due to reduced research and development costs [4][5][21] - Indaptus has secured new patents in multiple countries and received clinical trial authorization from Health Canada, enhancing its intellectual property and operational capabilities [7][9] Financial Highlights - Research and development expenses for Q4 2024 were $2.5 million, up from $2.0 million in Q4 2023, mainly due to increased costs in the Phase 1 clinical trial [4] - Total operating expenses for the fiscal year 2024 were $15.4 million, a decrease from $16.4 million in 2023, with research and development costs dropping to $7.2 million from $7.6 million [21] - The company reported a net loss of $15.0 million for the fiscal year 2024, compared to a net loss of $15.4 million in 2023, resulting in a loss per share of $1.61, an improvement from $1.83 in the previous year [8][21] Cash Position and Financing - As of December 31, 2024, Indaptus had cash and cash equivalents of $5.8 million, down from $13.4 million at the end of 2023 [9] - The company conducted a private placement in January 2025, generating net proceeds of $2.0 million, and established a $20 million equity line of credit in February 2025 [9] - Net cash used in operating activities for the fiscal year 2024 was $12.3 million, a slight decrease from $13.4 million in 2023 [10][22] Clinical and Corporate Developments - Indaptus is advancing its Phase 1 study of Decoy20 in advanced solid tumors, with plans to initiate a combination trial with BeiGene's PD-1 inhibitor, tislelizumab, expected in 2025 [7][15] - The company presented promising pharmacokinetic and safety results for Decoy20 at major oncology conferences, further validating its clinical approach [7] - Indaptus plans to increase trial sites to accelerate patient enrollment and expects to provide further clinical updates throughout 2025 [15]