New trial arm to evaluate safety, dosing and preliminary anti-tumor activity of the combination therapy in advanced solid tumorsNEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, announces that the first patient has been dosed in the expansion arm of its Phase 1b/2 clinical trial evaluating Decoy20 in combination with BeOne’s (formerly known as Beigene) PD-1 c ...

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].

NEW YORK, May 08, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, announces that its Founder and Chief Scientific Officer, Michael Newman, Ph.D., will serve as an Expert Speaker and Chair of Day 2 at the 6th Annual Cytokine-Based Drug Development Summit taking place May 15-16, 2025 in Boston. Dr. Newman will deliver a presentation titled “Pulsed Cytokine Delivery for Anti-Tum ...

NEW YORK, March 25, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company pioneering innovative therapies for cancer and viral infections, announces that its chief medical officer, Roger Waltzman, M.D., M.B.A. will be moderating a panel at the annual CMO360 Summit, being held April 7-8 in Boston. Dr. Waltzman’s panel, titled “Ensuring Effective and Efficient Trials Through Clinical Operations” will be Monday, April 7th from 4:05PM – 4:35PM ET. Jeffrey Me ...

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]

NEW YORK, March 18, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (NASDAQ:INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, today announced that it has advanced to a new expansion arm of its Phase 1b/2 clinical trial of Decoy20. This expansion will evaluate the combination of Decoy20 with BeiGene's PD-1 checkpoint inhibitor, tislelizumab, with a focus on safety, dose optimization, and early signs of anti-tumor activity. Jeffrey Mec ...

Financial Performance - The company reported a loss per share of $1.61 for the fiscal year 2024, compared to $1.83 for the fiscal year 2023[8]. - Net loss narrowed from $15,423,471 in 2023 to $15,022,027 in 2024, representing a decrease of about 2.6%[21]. - Net loss per share improved from $(1.83) in 2023 to $(1.61) in 2024, reflecting a 12.0% enhancement[21]. - Comprehensive loss decreased from $15,519,905 in 2023 to $15,022,027 in 2024, a reduction of approximately 3.2%[21]. Research and Development - Research and development expenses for Q4 2024 were $2.5 million, up from $2.0 million in Q4 2023, primarily due to a $0.7 million increase in Phase 1 clinical trial expenses[4]. - Total research and development expenses for the fiscal year 2024 were $7.2 million, a decrease from $7.6 million in 2023, mainly due to a $1.3 million reduction in manufacturing process development costs[4]. - The company achieved a key clinical milestone by enrolling over 20 patients in the weekly dosing cohort of the Phase 1 trial of Decoy20[6]. - A clinical supply agreement was established with BeiGene to evaluate Decoy20 in combination with tislelizumab, with trial initiation expected in 2025[6]. - The company plans to increase trial sites to accelerate patient enrollment and expects to provide further clinical updates throughout 2025[15]. - Indaptus secured new patents in China, Japan, and Israel for Decoy bacteria compositions, enhancing its intellectual property position[6]. Cash and Cash Equivalents - As of December 31, 2024, cash and cash equivalents were $5.8 million, down from $13.4 million at the end of 2023, with a private placement in January 2025 generating net proceeds of $2.0 million[9]. - Cash and cash equivalents decreased from $13,362,053 at the beginning of the year to $5,786,753 at the end of the year, a decline of approximately 56.7%[23]. Operating Expenses - General and administrative expenses for Q4 2024 were $1.7 million, down from $2.2 million in Q4 2023, attributed to lower stock-based compensation and legal fees[5]. - Total operating expenses decreased from $16,378,474 in 2023 to $15,365,751 in 2024, a reduction of approximately 6.2%[21]. - Stock-based compensation decreased from $2,965,938 in 2023 to $2,305,849 in 2024, a decline of about 22.2%[23]. Cash Flow - Net cash used in operating activities for the fiscal year 2024 was $12.3 million, an improvement from $13.4 million in 2023[10]. - Net cash used in operating activities reduced from $13,405,315 in 2023 to $12,323,188 in 2024, a decrease of about 8.1%[23]. - Proceeds from the issuance of shares of common stock and warrants amounted to $5,510,591 in 2024, with issuance costs of $762,703[23]. Shareholder Information - The weighted average number of shares used in calculating net loss per share increased from 8,401,047 in 2023 to 9,355,710 in 2024, an increase of approximately 11.4%[21].

Clinical Development - The company is developing a novel anti-cancer and anti-viral immunotherapy, Decoy20, which has shown broad anti-tumor and anti-viral activity in preclinical models [27]. - In August 2023, the first cohort of four patients in the Phase 1 clinical trial experienced transient adverse events, with one patient showing dose-limiting toxicity of grade 3 bradycardia [29]. - The second cohort of the Phase 1 clinical trial began in September 2023, with a reduced dose of 3 x 10^7 Decoy20, and similar adverse events were observed [30]. - As of October 2024, the company completed one month of weekly dosing at the 3 x 10^7 Decoy20 dose, with over 20 patients enrolled showing early signs of potential benefits [32]. - The Phase 1 clinical trial for Decoy20, initiated in December 2022, aims to assess safety, tolerability, and pharmacokinetics in patients with advanced solid tumors, with the primary endpoint focused on adverse events [61]. - As of March 12, 2025, over 20 patients have been enrolled in the weekly dosing of Decoy20, with early signs of potential benefits observed in some patients [62]. - The company entered into a clinical supply agreement with BeiGene to advance the clinical evaluation of Decoy20 in combination with BeiGene's tislelizumab for treating advanced solid tumors, with the Combination Study expected to begin in 2025 [45]. - A clinical supply agreement was entered into with BeiGene in October 2024 to evaluate Decoy20 in combination with BeiGene's anti-PD-1 antibody for advanced solid tumors, with plans to seek FDA approval in 2025 [33]. Financial Performance - For the year ended December 31, 2024, the company reported a net loss of approximately $15.0 million and an accumulated deficit of approximately $60.4 million [127]. - As of December 31, 2024, the company had approximately $5.8 million in cash and used $12.3 million of cash in operations during the twelve months ended December 31, 2024 [129]. - The company has incurred significant operating losses in every reporting period since inception and does not expect to become profitable in the near future [126]. - The company may need to increase capital resources through equity and/or debt financings to fund its operating expenses and capital expenditure requirements [129]. - The company raised approximately $6.4 million in August, November 2024, and January 2025, net of offering expenses, and has a Standby Equity Purchase Agreement allowing for the sale of up to $20 million of common stock [140]. Regulatory Environment - The FDA requires extensive preclinical laboratory tests, animal studies, and formulation studies before human clinical studies can begin [70]. - An IND must be submitted to the FDA, which becomes effective 30 days after receipt unless a clinical hold is placed [71]. - Clinical trials are divided into three phases, with Phase 1 focusing on safety and dosage, Phase 2 on preliminary efficacy, and Phase 3 on statistically significant evidence of clinical efficacy [80]. - The FDA aims to review standard applications within ten months and priority reviews within six months after acceptance [81]. - Approval of an NDA or BLA is contingent upon satisfactory inspections of manufacturing facilities and compliance with cGMP requirements [82]. - The FDA may issue an approval letter or a Complete Response Letter (CRL) detailing deficiencies in the NDA or BLA [83]. - Expedited development programs, such as fast track and breakthrough therapy designations, are available for qualifying product candidates [85][86]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to manage known or potential serious risks associated with a product [84]. - The FDA may grant accelerated approval for product candidates that show effects on surrogate endpoints likely to predict clinical benefits, contingent on confirmatory studies [88]. - The FDA requires ongoing compliance with regulations post-approval, including record-keeping and reporting of adverse experiences [92]. - The FDA may withdraw approval if regulatory compliance is not maintained, which could lead to product recalls or fines [93]. Intellectual Property - The company has developed 34 issued or granted patents related to its patented treatment methods for non-pathogenic, Gram-negative bacteria [37]. - The company owns 58 granted patents and has 11 pending patent applications related to cancer and infectious diseases, with expiration dates between 2033 and 2043 [114]. - The company intends to submit patent applications for each new product and technology developed, although the patent outlook is generally uncertain [115]. Market and Competition - The company faces intense competition from larger biopharmaceutical and biotechnology companies, particularly in the field of cancer immunotherapies [109]. - The company is heavily reliant on the success of its lead product candidate, Decoy20, which is still in the clinical trial phase and has not yet received regulatory approval [142]. - The potential market opportunity for the company's product candidates is difficult to estimate and may be smaller than anticipated, affecting revenue and profitability [189]. - The company lacks a sales and marketing organization, which may hinder its ability to generate significant revenues if product candidates are approved [204]. - The company faces significant competition in seeking collaboration agreements for the development and commercialization of product candidates [201]. Operational Risks - The company has identified conditions that raise substantial doubt regarding its ability to continue as a going concern due to ongoing losses and cash flow challenges [129]. - The company may face significant delays or limitations in research programs and product development if additional financing is not available on satisfactory terms [135]. - Clinical trials are subject to delays due to various factors, including regulatory approvals and recruitment challenges, which could increase costs and affect timelines [149]. - The company may face challenges in patient enrollment for clinical trials, which could delay development and increase costs [166]. - The company relies on third-party organizations for conducting preclinical studies and clinical trials, which poses risks if these parties do not meet their obligations [190]. - The company must comply with extensive regulatory requirements, including cGMP and GCP, to ensure the reliability of clinical trial data [191]. - Relationships with CROs and other third parties are critical, and any termination or failure to perform could materially impact clinical development timelines [194]. Manufacturing and Supply Chain - The company relies on third-party manufacturers for the production of its product candidates during clinical development, which increases the risk of insufficient quantities or unacceptable costs [195]. - There are no long-term commitments or supply agreements with third-party manufacturers, raising the risk of delays in obtaining sufficient quantities of product candidates [197]. - The company does not have arrangements for redundant supply or a second source for all required raw materials, which could materially impact its financial position if manufacturers fail to perform [199]. - Manufacturing processes are complex and highly regulated, with risks including contamination and equipment failure that could disrupt supply and increase costs [224]. - Adverse developments in manufacturing operations may result in shipment delays, inventory shortages, and potential product recalls [225]. Healthcare Reform and Pricing - Recent and future healthcare reform measures may increase the difficulty and cost of obtaining marketing approval and affect pricing strategies [215]. - The company anticipates that new healthcare reform measures may lead to additional reductions in Medicare funding and increased downward pressure on product pricing [220]. - Legislative changes at the state level may impose price controls and reimbursement constraints, potentially harming the company's business and financial condition [219]. - Coverage and reimbursement for products can differ significantly among third-party payors, making the process time-consuming and costly [212]. - International operations are subject to extensive governmental price controls, which may restrict the pricing and revenue generation of the company's products [213].

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]