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 Points - Indaptus Therapeutics, Inc. announced the sale of approximately $2.3 million in convertible promissory notes and warrants, aiming to raise up to $5 million in total gross proceeds [1][4] - The notes carry an interest rate of 6% per year and will mature on July 28, 2026, with conversion terms linked to a reverse stock split and a maximum conversion price of $0.40 [2] - Warrants will be issued to purchase 200% of the conversion shares, with an exercise price equal to the conversion price of the notes and a term of five years [3] Financial Use - The net proceeds from the offering will be utilized 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 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]

Financial Performance - For the three months ended March 31, 2025, the company reported a net loss of approximately $4.5 million, compared to a net loss of $3.8 million for the same period in 2024, representing an increase of 18.9%[19] - The net loss for Q1 2025 was $4.53 million, representing a 19.1% increase from a net loss of $3.81 million in Q1 2024[74] - The net loss per share for Q1 2025 was $(0.32), a decrease of 28.9% compared to $(0.45) in Q1 2024[74] Operating Expenses - Total operating expenses for the first quarter of 2025 were $4.57 million, up from $3.94 million in the first quarter of 2024, reflecting a year-over-year increase of 16.0%[19] - General and administrative expenses for Q1 2025 were approximately $1.76 million, a decrease of 25.1% from $2.35 million in Q1 2024, mainly due to reduced payroll and legal fees[78] - Total stock-based compensation expense for the three months ended March 31, 2025, was $240,891, a decrease of 69.0% compared to $774,691 for the same period in 2024[43] Research and Development - Research and development expenses increased significantly to $2.81 million in Q1 2025, compared to $1.59 million in Q1 2024, marking a rise of 76.7%[19] - Research and development expenses for Q1 2025 were approximately $2.81 million, an increase of 76.7% compared to $1.59 million in Q1 2024, primarily due to costs associated with the Phase 1 clinical trial[77] Cash and Liquidity - The company's cash and cash equivalents decreased to $3.89 million as of March 31, 2025, down from $5.79 million at the end of 2024, a decline of 32.8%[17] - The company had an accumulated deficit of approximately $65.0 million as of March 31, 2025, up from $60.4 million at the end of 2024[27] - The company anticipates needing additional capital to fund ongoing activities beyond the second quarter of 2025, with potential financing through equity or debt, which may lead to substantial dilution for stockholders[86] Financing Activities - The Company completed a private placement offering on January 16, 2025, raising approximately $2.0 million after expenses by issuing 2,109,383 shares of common stock[46] - A private placement in January 2025 raised approximately $2.25 million through the sale of 2,109,383 shares and warrants[82] - A registered direct offering in November 2024 generated gross proceeds of approximately $2.135 million from the sale of 1,817,017 shares and warrants[83] - In August 2024, the company completed a registered direct offering, selling 1,643,837 shares of common stock and issuing unregistered warrants, resulting in gross proceeds of approximately $3.0 million[84] Assets and Liabilities - As of March 31, 2025, the company had total assets of $5.41 million, down from $7.34 million at the end of 2024, a decrease of 26.3%[17] - Accounts payable and other current liabilities decreased to $2,552,379 as of March 31, 2025, down from $3,309,717 as of December 31, 2024, reflecting a 22.8% reduction[41] Future Outlook - The company plans to secure additional capital through collaborations, strategic alliances, or public/private financing to fund ongoing activities beyond Q2 2025[27] - Future capital requirements will depend on various factors, including the success of clinical trials and the ability to secure financing under acceptable terms[92] - Operating expenses are expected to continue increasing, particularly with ramping up clinical development activities and hiring additional personnel[90] Clinical Development - As of May 13, 2025, the company had enrolled 13 participants in the single-dose study and 32 participants in the weekly dosing study of Decoy20[62] - The company initiated a Phase 1 Combination Study of Decoy20 with Tislelizumab in March 2025, following a clinical supply agreement with BeOne Medicines[63] Cost Management - The company began implementing a cost-reduction plan in May 2025, focusing on essential activities and reducing non-essential expenses[91] - The total future payments for operating lease obligations as of March 31, 2025, were approximately $0.06 million due in the next twelve months[94] - The company has no off-balance sheet arrangements as defined under SEC rules[95]

Financial Performance - The net loss for Q1 2025 was $4.5 million, compared to a net loss of $3.8 million in Q1 2024, with a loss per share of $0.32 versus $0.45 in the prior year[4][17]. - General and administrative expenses decreased to $1.8 million in Q1 2025 from $2.4 million in Q1 2024, mainly due to reduced payroll and legal fees[4]. - 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[6]. Research and Development - Research and development expenses for Q1 2025 were $2.8 million, up from $1.6 million in Q1 2024, primarily due to a $1.5 million increase related to the Phase 1 clinical trial[3]. - The company initiated a Phase 1b/2 combination study of Decoy20 with the PD-1 checkpoint inhibitor Tislelizumab, focusing on safety and early anti-tumor activity signals[2][10]. - A total of 32 patients have been enrolled in the Decoy20 weekly dosing trial, which has shown a favorable safety profile and early signs of clinical benefit[2]. Capital and Assets - 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[5]. - The total assets as of March 31, 2025, were $5.4 million, down from $7.3 million at the end of 2024, reflecting a decrease in cash and cash equivalents[15]. - Net cash provided by financing activities was $3.2 million in Q1 2025, significantly higher than $0.3 million in Q1 2024, attributed to the issuance of common stock and warrants[8]. Intellectual Property - The company expanded its intellectual property portfolio with new patents granted in China, Japan, and Israel for its Decoy platform[2][10].

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, Inc. is a clinical-stage biotechnology company focused on developing innovative treatments for cancer and viral infections, specifically through its product Decoy20 [1][5] - The company has enrolled over 20 patients in the weekly dosing cohort of its Phase 1 trial for Decoy20, achieving a significant milestone [2] - Initial findings indicate that Decoy20 at a dosage of 30 million cells is well-tolerated, showing a favorable safety profile and early signs of clinical benefit, including stable disease in some patients [2] - Decoy20 treatment has resulted in short-term increases in key immune system biomarkers, indicating activation of the body's defenses against cancer [2][3] - The treatment also promotes broad immune cell trafficking, suggesting active mobilization of immune cells from bone marrow to tissues, which is a critical pharmacodynamic marker [3][4] - The company is exploring the combination of Decoy20 with BeiGene's PD-1 checkpoint inhibitor, tislelizumab, in a new arm of its Phase 1b/2 clinical trial to assess safety and preliminary anti-tumor activity [4] Company Overview - Indaptus Therapeutics leverages over a century of immunotherapy advancements, focusing on activating both innate and adaptive immune responses through a multi-targeted approach [6] - The Decoy platform utilizes non-pathogenic Gram-negative bacteria to produce immune system-activating signals, aiming to enhance the effectiveness of existing cancer treatments [6] - Pre-clinical studies have shown that Decoy product candidates can eradicate tumors and produce significant activity against chronic viral infections like hepatitis B and HIV [6]