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]

Financial Performance - Net loss for the nine months ended September 30, 2025, was $12,736,466, compared to a net loss of $10,890,980 for the same period in 2024, indicating an increase in losses of approximately 16.9%[20] - Net loss for the three months ended September 30, 2025, was $2,975,117, slightly down from $3,069,036 in the same period of 2024, indicating a reduction of 3.1%[70] - For the nine-month period ended September 30, 2025, the Company incurred a net loss of approximately $12.7 million and had an accumulated deficit of approximately $73.2 million[30] - Net cash used in operating activities for the nine months ended September 30, 2025 was approximately $11.6 million, compared to $8.9 million in the same period of 2024[110] - 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 in the same period of 2024[111] Assets and Liabilities - Total assets decreased to $6,840,052 as of September 30, 2025, down from $7,338,756 as of December 31, 2024, representing a decline of approximately 6.8%[17] - Total current liabilities decreased to $2,234,325 as of September 30, 2025, compared to $3,393,881 as of December 31, 2024, a reduction of about 34.2%[17] - Total accounts payable and other current liabilities as of September 30, 2025, amounted to approximately $2.23 million, down from $3.31 million as of December 31, 2024[51] - Total prepaid expenses and other current assets as of September 30, 2025, were approximately $613,354, a decrease from $831,577 as of December 31, 2024[50] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $6,495,677, up from $4,771,152 in 2024, reflecting a growth of about 36.1%[20] - Research and development expenses for Q3 2025 were approximately $1.52 million, an increase of 3.5% from $1.47 million in Q3 2024, primarily due to higher clinical trial costs[95] - The company expects research and development expenses to increase substantially as clinical development activities ramp up[87] - The company is focused on developing a novel, multi-targeted product aimed at enhancing cancer immunotherapy for patients with unresectable or metastatic solid tumors and lymphomas[28] Financing Activities - The company issued 75,335 shares of common stock and warrants, netting $1,986,744 during the nine months ended September 30, 2025[22] - The Company raised net proceeds of approximately $1.75 million under the Standby Equity Purchase Agreement during the nine-month period ended September 30, 2025[30] - In June 2025, the Company raised total gross proceeds of approximately $5.7 million through the issuance of convertible notes[30] - The company completed a private placement offering in January 2025, raising approximately $2.0 million from the sale of 75,335 shares of common stock and warrants[57] - The company completed a private placement in June 2025, raising approximately $5.7 million through the issuance of convertible notes and warrants[104] Stock and Equity - Stock-based compensation for the nine months ended September 30, 2025, was $572,268, compared to $2,001,727 for the same period in 2024, showing a decrease of approximately 71.5%[24] - The weighted average number of shares used in calculating net loss per share, basic and diluted, was 689,174 for the nine months ended September 30, 2025, compared to 315,451 for the same period in 2024, an increase of about 118.5%[20] - The company executed a 1-for-28 reverse stock split on June 26, 2025, reducing outstanding common stock from 16,946,528 shares to 604,963 shares[32] - As of September 30, 2025, the company had 104,396 outstanding stock options with a weighted average exercise price of $125.59[53] - The company granted 3,301 stock options during the nine months ended September 30, 2025, with a weighted average fair value of $8.14 per share[54] Operational Insights - The company operates in one business segment focused on developing a novel anti-cancer and anti-viral immunotherapy[68] - General and administrative expenses for the three months ended September 30, 2025, were $1,130,764, a decrease of 32.6% compared to $1,676,020 in the same period of 2024[70] - General and administrative expenses for the nine months ended September 30, 2025 were approximately $5.2 million, a decrease of 19.3% from $6.4 million in the same period of 2024[101] - Total operating expenses for Q3 2025 were approximately $2.65 million, down 15.7% from $3.14 million in Q3 2024[94] Concerns and Risks - There is substantial doubt about the Company's ability to continue as a going concern due to ongoing losses and cash utilization[31] - Economic conditions such as inflation and interest rates may negatively impact the company's ability to access capital, affecting both short-term and long-term liquidity[84] - The company is currently not aware of any legal proceedings or claims that would significantly affect its business or financial position[128] - There have been no material changes to risk factors from those disclosed in the previous filings[129] Compliance and Governance - The management evaluated the effectiveness of disclosure controls and procedures as of September 30, 2025, concluding they were effective at the reasonable assurance level[124] - There were no changes in internal control over financial reporting that materially affected the company during the quarter ended September 30, 2025[125] - The company has filed various exhibits related to its corporate governance and financial reporting[134]

Financial Performance - Loss per share for Q3 2025 was approximately $2.98, compared to approximately $9.04 for Q3 2024[6] - The net loss for the nine months ended September 30, 2025, was $12,736,466, compared to a net loss of $10,890,980 for the same period in 2024, representing an increase in loss of approximately 16.9%[18] - The net loss per share for the three months ended September 30, 2025, was $(2.98), compared to $(9.04) for the same period in 2024, showing a decrease in loss per share of about 67.0%[16] Cash Flow and Liquidity - Cash and cash equivalents as of September 30, 2025, were approximately $5.8 million, expected to support operations into Q1 2026[7] - Cash and cash equivalents at the end of the period on September 30, 2025, were $5,825,639, a decrease from $7,380,686 at the end of the same period in 2024, reflecting a decline of approximately 21.1%[18] - Net cash used in operating activities for the nine months ended September 30, 2025, was approximately $11.6 million, an increase of about $2.7 million from $8.9 million in the same period of 2024[8] - Net cash used in operating activities for the nine months ended September 30, 2025, was $(11,632,743), compared to $(8,927,441) for the same period in 2024, indicating an increase in cash outflow of about 30.3%[18] - Net cash provided by financing activities for the nine months ended September 30, 2025, was approximately $11.7 million, compared to $2.9 million in the same period of 2024[9] - The company raised approximately $2.3 million in September 2025 through its at-the-market facility[2] - Proceeds from the issuance of convertible promissory notes amounted to $5,714,800 during the nine months ended September 30, 2025, with no such proceeds reported in the same period in 2024[18] Expenses - 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[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[4] - The ongoing Phase 1 study saw an increase of $2.6 million in research and development expenses for the nine months ended September 30, 2025[3] - Research and development expenses for the three months ended September 30, 2025, were $1,517,723, compared to $1,466,037 for the same period in 2024, reflecting an increase of approximately 3.5%[16] - Total operating expenses for the nine months ended September 30, 2025, were $11,677,809, compared to $11,194,181 for the same period in 2024, indicating an increase of about 4.3%[16] - The company reported stock-based compensation of $572,268 for the nine months ended September 30, 2025, compared to $2,001,727 for the same period in 2024, indicating a decrease of approximately 71.4%[18] Assets and Equity - Total assets as of September 30, 2025, were approximately $6.84 million, down from $7.34 million as of December 31, 2024[14] - Total stockholders' equity as of September 30, 2025, was approximately $4.61 million, an increase from $3.94 million as of December 31, 2024[14] Convertible Promissory Notes - The change in fair value of convertible promissory notes resulted in a loss of $(1,153,421) for the nine months ended September 30, 2025, with no such loss reported in the same period in 2024[18] - The weighted average number of shares used in calculating net loss per share for the nine months ended September 30, 2025, was 689,174, compared to 315,451 for the same period in 2024, reflecting an increase of approximately 118.5%[16]

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 - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - SHF Holdings, Inc. (SHFS) increased by 150% to $8.17 - Lithium Americas Corp. (LAC) rose by 69% to $5.18 - Aqua Metals, Inc. (AQMS) gained 50% reaching $6.11 - CleanCore Solutions, Inc. (ZONE) up by 44% at $2.87 - Cyclerion Therapeutics, Inc. (CYCN) increased by 33% to $4.03 - Twin Vee Powercats Co. (VEEE) rose by 17% to $2.92 - Solidion Technology, Inc. (STI) up by 11% at $5.09 - China Pharma Holdings, Inc. (CPHI) increased by 11% to $2.18 - Stardust Power Inc. (SDST) rose by 10% to $3.04 - Aligos Therapeutics, Inc. (ALGS) increased by 7% to $11.03 [3] Premarket Losers - Aytu BioPharma, Inc. (AYTU) decreased by 15% to $2.11 - Professional Diversity Network, Inc. (IPDN) down by 13% to $4.10 - STRATA Skin Sciences, Inc. (SSKN) fell by 10% to $2.31 - Cohu, Inc. (COHU) decreased by 9% to $20.68 - Super League Enterprise, Inc. (SLE) down by 9% to $7.74 - CTW Cayman (CTW) fell by 9% to $2.29 - Fitell Corporation (FTEL) decreased by 8% to $7.70 - Soluna Holdings, Inc. (SLNH) down by 8% to $2.16 - StableX Technologies, Inc. (SBLX) decreased by 5% to $5.22 - Indaptus Therapeutics, Inc. (INDP) down by 5% to $2.95 [4]

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]

As filed with the Securities and Exchange Commission on September 3, 2025. Registration No. 333-289984 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 INDAPTUS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Copies of all communications, including communications sent to agent for service, should be sent to: Gary Emmanuel, Esq. Greenberg Traurig LLP One Vanderbilt Avenue New Y ...

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 ...