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]

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]

[Filing Information](index=1&type=section&id=Filing%20Information) - The report is a **Quarterly Report on Form 10-Q** for the period ended **June 30, 2025**, filed by **INDAPTUS THERAPEUTICS, INC.**, a Delaware corporation[2](index=2&type=chunk) - The company's **common stock** trades on the **Nasdaq Capital Market** under the symbol **INDP**[3](index=3&type=chunk) - The registrant is classified as a **non-accelerated filer** and a **smaller reporting company**[4](index=4&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=4&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) - This **Quarterly Report** contains forward-looking statements about product development, clinical trials, market potential, business strategy, and financial condition[7](index=7&type=chunk) - These statements are predictions based on current expectations and projections, subject to known and unknown risks, uncertainties, and assumptions, and actual results may differ materially[8](index=8&type=chunk)[9](index=9&type=chunk) - The company does not plan to publicly update or revise any forward-looking statements unless required by applicable law[10](index=10&type=chunk) [Summary Risk Factors](index=4&type=section&id=SUMMARY%20RISK%20FACTORS) - The company is a clinical-stage entity with a limited operating history, is not currently profitable, and may never become profitable[12](index=12&type=chunk) - **Substantial doubt** exists regarding the company's ability to continue as a **going concern**, necessitating additional capital raises which could dilute existing shareholders[12](index=12&type=chunk)[13](index=13&type=chunk) - Clinical and preclinical development is lengthy and expensive with uncertain outcomes, and the commercial success of product candidates depends on market acceptance and adequate reimbursement[13](index=13&type=chunk) [PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Indaptus Therapeutics, Inc., including the Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Stockholders' Equity, Statements of Cash Flows, and accompanying notes, covering the periods ended June 30, 2025, and December 31, 2024 (for balance sheet) or June 30, 2024 (for income statement and cash flow) [Unaudited Condensed Consolidated Balance Sheets](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) Unaudited Condensed Consolidated Balance Sheets (Selected Data) | Metric | June 30, 2025 | December 31, 2024 | Change ($) | Change (%) | | :-------------------------------- | :------------ | :---------------- | :--------- | :--------- | | Cash and cash equivalents | $6,157,701 | $5,786,753 | $370,948 | 6.4% | | Total current assets | $6,413,058 | $6,618,330 | $(205,272) | (3.1)% | | Total assets | $6,839,207 | $7,338,756 | $(499,549) | (6.8)% | | Total current liabilities | $8,512,563 | $3,393,881 | $5,118,682 | 150.8% | | Fair value of convertible promissory notes | $6,502,503 | $- | $6,502,503 | N/A | | Total stockholders' equity (deficit) | $(1,673,356) | $3,944,875 | $(5,618,231) | (142.4)% | [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Unaudited Condensed Consolidated Statements of Operations (Selected Data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change ($) | Change (%) | | :--------------------------------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | Research and development | $2,167,114 | $1,713,973 | $453,141 | 26.4% | | General and administrative | $2,289,649 | $2,394,912 | $(105,263) | (4.4)% | | Total operating expenses | $4,456,763 | $4,108,885 | $347,878 | 8.5% | | Net loss | $(5,228,919) | $(4,015,267) | $(1,213,652) | 30.2% | | Net loss per share, basic and diluted | $(9.09) | $(13.16) | $4.07 | (30.9)% | | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :--------------------------------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | Research and development | $4,977,954 | $3,305,115 | $1,672,839 | 50.6% | | General and administrative | $4,051,368 | $4,747,009 | $(695,641) | (14.7)% | | Total operating expenses | $9,029,322 | $8,052,124 | $977,198 | 12.1% | | Net loss | $(9,761,349) | $(7,821,944) | $(1,939,405) | 24.8% | | Net loss per share, basic and diluted | $(18.09) | $(25.79) | $7.70 | (29.9)% | [Unaudited Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Total Stockholders' Equity (Deficit) | Date | Total Stockholders' Equity (Deficit) | | :------------------- | :----------------------------------- | | January 1, 2025 | $3,944,875 | | March 31, 2025 | $2,799,731 | | June 30, 2025 | $(1,673,356) | - The decrease in equity was primarily driven by a **net loss of $(9,761,349)** for the **six months ended June 30, 2025**, partially offset by approximately **$3.72 million** from the issuance of **common stock** and warrants[20](index=20&type=chunk)[23](index=23&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Unaudited Condensed Consolidated Statements of Cash Flows (Selected Data) | Cash Flow Activity (Six Months Ended June 30) | 2025 | 2024 | Change ($) | Change (%) | | :------------------------------------------ | :----------- | :----------- | :--------- | :--------- | | Net cash used in operating activities | $(9,065,316) | $(6,414,413) | $(2,650,903) | 41.3% | | Net cash provided by financing activities | $9,436,264 | $354,111 | $9,082,153 | 2564.7% | | Net increase (decrease) in cash and cash equivalents | $370,948 | $(6,060,302) | $6,431,250 | (106.1)% | | Cash and cash equivalents at end of period | $6,157,701 | $7,301,751 | $(1,144,050) | (15.7)% | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) - The company is a **biotechnology firm** focused on developing **anti-cancer and anti-viral immunotherapy**, facing risks typical of its industry, including the need for additional capital[29](index=29&type=chunk)[30](index=30&type=chunk) - The company incurred a **net loss of approximately $9.8 million** and used **$9.1 million cash in operations** for the **six months ended June 30, 2025**, resulting in an **accumulated deficit of $70.2 million**, raising **substantial doubt** about its ability to continue as a **going concern**[31](index=31&type=chunk)[32](index=32&type=chunk) - On **June 26, 2025**, the company effected a **1-for-28 reverse stock split** to regain **Nasdaq compliance**, reducing outstanding **common stock** from **16,946,528 shares** to **604,963 shares**[33](index=33&type=chunk) - In **June 2025**, the company issued **convertible promissory notes totaling approximately $5.7 million**, which automatically converted into **501,566 common shares** and **190,795 pre-funded warrants** on **July 27, 2025**, at a **conversion price of $8.3024 per share**[31](index=31&type=chunk)[58](index=58&type=chunk)[61](index=61&type=chunk) - As of **June 30, 2025**, the **fair value of the convertible notes was $6.5 million**, resulting in a **recognized increase in fair value of approximately $0.8 million** for the three and six months ended **June 30, 2025**[48](index=48&type=chunk)[64](index=64&type=chunk) - The company operates in a single business segment focused on **immunotherapy development**, with the CEO as the **chief operating decision maker**[68](index=68&type=chunk) - Subsequent to **June 30, 2025**, the conversion of the **convertible notes** into equity is expected to help the company satisfy Nasdaq's **minimum shareholders' equity requirement of $2.5 million**[71](index=71&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results for the periods presented. It covers the company's business overview, clinical development progress of Decoy20, detailed analysis of operating expenses, liquidity, and future funding requirements, emphasizing the ongoing need for capital and the associated risks [Overview](index=19&type=section&id=Overview) - **Indaptus Therapeutics** is a clinical **biotechnology company** developing **Decoy20**, a novel systemically-administered **anti-cancer and anti-viral immunotherapy**[76](index=76&type=chunk) - The **Phase 1 clinical trial** for **Decoy20** in **advanced solid tumors** has progressed through single-dose and weekly dosing, observing generally anticipated transient adverse events (e.g., **hemodynamic changes**, **transaminase elevations**, **lymphopenia**) and transient induction of over **50 biomarkers**[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk)[82](index=82&type=chunk) - The company initiated a **combination study of Decoy20 with BeOne's anti-PD-1 antibody, Tislelizumab**, in **June 2025**, building on preclinical results showing **tumor eradication synergy**[83](index=83&type=chunk) [Components of Operating Results](index=21&type=section&id=Components%20of%20Operating%20Results) - **Research and development** expenses, primarily for **CROs**, **CMOs**, and **personnel**, are expensed as incurred and are expected to increase substantially with ongoing clinical development[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk) - **General and administrative** expenses, including compensation, benefits, and **professional fees**, are expected to increase due to business growth and **public company operating costs**[90](index=90&type=chunk)[91](index=91&type=chunk) - Other income, net, primarily includes **interest earned** on **cash and cash equivalents**[92](index=92&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Operating Results Comparison (Three Months Ended June 30) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :------------------------- | :----------- | :----------- | :--------- | :--------- | | Research and development | $2,167,114 | $1,713,973 | $453,141 | 26.4% | | General and administrative | $2,289,649 | $2,394,912 | $(105,263) | (4.4)% | | Net loss | $(5,228,919) | $(4,015,267) | $(1,213,652) | 30.2% | Operating Results Comparison (Six Months Ended June 30) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :------------------------- | :----------- | :----------- | :--------- | :--------- | | Research and development | $4,977,954 | $3,305,115 | $1,672,839 | 50.6% | | General and administrative | $4,051,368 | $4,747,009 | $(695,641) | (14.7)% | | Net loss | $(9,761,349) | $(7,821,944) | $(1,939,405) | 24.8% | [Liquidity and Resources](index=24&type=section&id=Liquidity%20and%20Resources) - The company has funded operations primarily through **public and private equity offerings**[104](index=104&type=chunk) - Recent financing activities include a **$5.7 million private placement of convertible notes** (**June 2025**), **$1.75 million net** from a **Standby Equity Purchase Agreement** (**February 2025**), and **$2.25 million gross** from a **private placement of common stock and warrants** (**January 2025**)[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - As of **June 30, 2025**, **cash and cash equivalents** were **approximately $6.2 million**, expected to fund operations into the **fourth quarter of 2025**, but **substantial doubt** about the company's ability to continue as a **going concern** persists without **additional financing**[109](index=109&type=chunk) [Cash Flows](index=25&type=section&id=Cash%20Flows) - **Net cash used in operating activities** increased to **approximately $9.1 million** for the **six months ended June 30, 2025**, up from **$6.4 million** in the prior year, mainly due to higher R&D and transaction-related expenses[111](index=111&type=chunk) - **Net cash provided by financing activities** surged to **approximately $9.4 million** for the **six months ended June 30, 2025**, from **$0.4 million** in the prior year, primarily from **convertible notes** and **equity/warrant issuances**[112](index=112&type=chunk) [Funding Requirements](index=26&type=section&id=Funding%20Requirements) - **Operating expenses** are expected to continue increasing due to **clinical development** and potential **commercialization activities**[113](index=113&type=chunk) - A **cost-reduction plan** was implemented in **May 2025**, focusing on the **Combination Study**, eliminating **non-essential expenses**, and **temporary salary/board fee reductions**[114](index=114&type=chunk) - Future capital requirements are highly dependent on the scope and costs of **preclinical/clinical trials**, **regulatory approvals**, **intellectual property**, **manufacturing**, and **market conditions**, with no guarantee of securing adequate **additional financing**[115](index=115&type=chunk)[116](index=116&type=chunk) [Contractual Obligations](index=27&type=section&id=Contractual%20Obligations) - **Total minimum operating lease payments for 2025 are $34,745**, with a **present value of operating lease liability of $34,373**[66](index=66&type=chunk) - The company has no **off-balance sheet arrangements**[118](index=118&type=chunk) [Critical Accounting Policies](index=27&type=section&id=Critical%20Accounting%20Policies) - No **material changes** to **Critical Accounting Policies** from those discussed in the **2024 Annual Report on Form 10-K**[120](index=120&type=chunk) [Recently Issued Accounting Pronouncements](index=27&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) - Refer to Note 2 of the financial statements for details on **Recently Issued Accounting Pronouncements**[121](index=121&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Indaptus Therapeutics, Inc. is exempt from providing quantitative and qualitative disclosures about market risk under SEC rules - The company is a **smaller reporting company** and is not required to provide **quantitative and qualitative disclosures about market risk**[122](index=122&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the principal executive and financial officers, evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, concluding they were effective at a reasonable assurance level. No material changes in internal control over financial reporting occurred during the quarter - **Disclosure controls and procedures** were evaluated and deemed **effective at the reasonable assurance level** as of **June 30, 2025**[124](index=124&type=chunk) - No **material changes in internal control over financial reporting** occurred during the quarter ended **June 30, 2025**[125](index=125&type=chunk) [PART II. OTHER INFORMATION](index=28&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings or claims that are expected to significantly impact its business, financial position, or operating results - No pending **material legal proceedings or claims** against the company that are expected to have a **significant effect** on its **business, financial position, or operating results**[128](index=128&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Form 10-K filed on March 13, 2025 - No **material changes** to **risk factors** from those disclosed in the **Form 10-K filed on March 13, 2025**[129](index=129&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item reports that there were no unregistered sales of equity securities or use of proceeds to disclose for the period - No **unregistered sales of equity securities and use of proceeds** to report[130](index=130&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the reporting period - This item is not applicable[131](index=131&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company for the reporting period - This item is not applicable[132](index=132&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) During the three months ended June 30, 2025, no director or officer adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement - No director or officer adopted or terminated a **Rule 10b5-1 trading arrangement** or **non-Rule 10b5-1 trading arrangement** during the **three months ended June 30, 2025**[133](index=133&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including corporate organizational documents (e.g., Certificate of Incorporation, Bylaws) and certifications from executive officers - **Exhibits** include amendments to the **Certificate of Incorporation**, **Amended and Restated Bylaws**, and **certifications** from the **Principal Executive Officer** and **Principal Financial Officer**[134](index=134&type=chunk) [SIGNATURES](index=30&type=section&id=SIGNATURES) - The report is signed by **Jeffrey A. Meckler, Chief Executive Officer**, and **Nir Sassi, Chief Financial Officer**, on **August 13, 2025**[136](index=136&type=chunk)

[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) [Introduction and CEO Commentary](index=1&type=section&id=Introduction%20and%20CEO%20Commentary) Indaptus Therapeutics reported its second quarter 2025 financial results and provided a corporate update, emphasizing a significant clinical milestone with the initiation of a Phase 1b/2 combination study for Decoy20 and a strengthened balance sheet through recent financing - Indaptus Therapeutics initiated a Phase 1b/2 combination study evaluating Decoy20 with the PD-1 checkpoint inhibitor tislelizumab, marking a **major clinical inflection point**[2](index=2&type=chunk) - The company raised approximately **$5.7 million** in gross proceeds through the sale of convertible promissory notes and warrants, which converted into common stock and pre-funded warrants in July 2025, strengthening its balance sheet[2](index=2&type=chunk) [Key Corporate and Clinical Milestones](index=1&type=section&id=Key%20Corporate%20and%20Clinical%20Milestones) During Q2 2025, Indaptus achieved critical milestones including dosing the first patient in its Phase 1b/2 combination study, securing $5.7 million in financing, and enhancing executive visibility through Dr. Michael Newman's participation in an industry summit - Dosed the first patient in the Phase 1b/2 study evaluating the combination of Decoy20 and PD-1 checkpoint inhibitor tislelizumab (TEVIMBRA®)[4](index=4&type=chunk) - Raised **$5.7 million** in gross proceeds via private placement of convertible notes and warrants, which converted to equity in July[4](index=4&type=chunk) - Dr. Michael Newman, Founder and Chief Scientific Officer, was named chair and expert speaker at the Cytokine-Based Drug Development Summit, strengthening executive visibility[4](index=4&type=chunk) [Financial Summary for Q2 2025](index=1&type=section&id=Financial%20Summary%20for%20Q2%202025) The company reported increased R&D expenses, decreased G&A expenses, and a reduced net loss per share for Q2 and H1 2025, with cash and cash equivalents at $6.2 million providing a runway into Q4 2025 **Key Financials for Q2 and H1 2025 (vs. 2024)** | Metric | Q2 2025 (approx.) | Q2 2024 (approx.) | Change (YoY) | H1 2025 (approx.) | H1 2024 (approx.) | Change (YoY) | | :-------------------------------- | :---------------- | :---------------- | :----------- | :---------------- | :---------------- | :----------- | | R&D Expenses | $2.2M | $1.7M | +$0.5M | $5.0M | $3.3M | +$1.7M | | G&A Expenses | $2.3M | $2.4M | -$0.1M | $4.0M | $4.7M | -$0.7M | | Loss per Share | $(9.09) | $(13.16) | -$4.07 | $(18.09) | $(25.79) | -$7.70 | | Cash & Cash Equivalents (period end) | $6.2M (Jun 30, 2025) | N/A | N/A | $5.8M (Dec 31, 2024) | N/A | N/A | [Detailed Financial Performance](index=1&type=section&id=Detailed%20Financial%20Performance) [Operating Expenses](index=1&type=section&id=Operating%20Expenses) Total operating expenses increased year-over-year for both the three and six months ended June 30, 2025, primarily driven by higher research and development costs associated with the ongoing Phase 1 clinical study, partially offset by decreases in general and administrative expenses [Research and Development Expenses](index=1&type=section&id=Research%20and%20Development%20Expenses) R&D expenses increased significantly in Q2 and H1 2025, mainly due to increased activity in the Phase 1 study, partially offset by lower stock-based compensation and payroll **Research and Development Expenses** | Period | 2025 (approx.) | 2024 (approx.) | Change | | :----------------------- | :------------- | :------------- | :----- | | Three Months Ended Jun 30 | $2.2 million | $1.7 million | +$0.5 million | | Six Months Ended Jun 30 | $5.0 million | $3.3 million | +$1.7 million | - The increase in R&D expenses was primarily due to an increase of **$0.8 million** (Q2) and **$2.3 million** (H1) in the ongoing Phase 1 study, offset by decreases in stock-based compensation and payroll[3](index=3&type=chunk) [General and Administrative Expenses](index=2&type=section&id=General%20and%20Administrative%20Expenses) G&A expenses decreased in Q2 and H1 2025, primarily due to lower stock-based compensation, payroll, legal fees, and investor relations costs, but this was partially offset by an increase in transaction-related expenses from the convertible notes private placement **General and Administrative Expenses** | Period | 2025 (approx.) | 2024 (approx.) | Change | | :----------------------- | :------------- | :------------- | :----- | | Three Months Ended Jun 30 | $2.3 million | $2.4 million | -$0.1 million | | Six Months Ended Jun 30 | $4.0 million | $4.7 million | -$0.7 million | - The decrease in G&A expenses was primarily due to a **$0.9 million** (Q2) and **$1.5 million** (H1) reduction in stock-based compensation, payroll, legal fees, and investor relations costs, partially offset by an **$0.8 million** increase in transaction-related expenses[5](index=5&type=chunk) [Net Loss and Loss Per Share](index=2&type=section&id=Net%20Loss%20and%20Loss%20Per%20Share) Indaptus reported a reduced net loss per share for both the three and six months ended June 30, 2025, compared to the prior year, indicating an improvement in per-share performance despite an increase in overall net loss **Net Loss and Loss Per Share** | Period | Net Loss Per Share (2025) | Net Loss Per Share (2024) | Change (YoY) | | :----------------------- | :------------------------ | :------------------------ | :----------- | | Three Months Ended Jun 30 | $(9.09) | $(13.16) | -$4.07 | | Six Months Ended Jun 30 | $(18.09) | $(25.79) | -$7.70 | [Cash Flow and Liquidity](index=2&type=section&id=Cash%20Flow%20and%20Liquidity) The company's cash and cash equivalents increased slightly from December 2024 to June 2025, supported by significant financing activities, which offset increased cash usage in operating activities. The current cash runway is projected into Q4 2025 [Cash and Cash Equivalents](index=2&type=section&id=Cash%20and%20Cash%20Equivalents) As of June 30, 2025, Indaptus held approximately $6.2 million in cash and cash equivalents, an increase from $5.8 million at the end of 2024, with current funds expected to support operations into the fourth quarter of 2025 **Cash and Cash Equivalents** | Date | Amount (approx.) | | :---------------- | :--------------- | | June 30, 2025 | $6.2 million | | December 31, 2024 | $5.8 million | - The company expects its current cash and cash equivalents to support ongoing operating activities into the **fourth quarter of 2025**[7](index=7&type=chunk) [Cash Flows from Operating Activities](index=2&type=section&id=Cash%20Flows%20from%20Operating%20Activities) Net cash used in operating activities increased for the six months ended June 30, 2025, primarily due to higher research and development activities related to the Phase 1 clinical trial and increased transaction-related expenses **Net Cash Used in Operating Activities (Six Months Ended June 30)** | Year | Amount (approx.) | | :--- | :--------------- | | 2025 | $9.1 million | | 2024 | $6.4 million | | Change | +$2.7 million | - The increase in net cash used was primarily attributable to increased R&D activities for the Phase 1 clinical trial and transaction-related expenses for convertible notes[8](index=8&type=chunk) [Cash Flows from Financing Activities](index=2&type=section&id=Cash%20Flows%20from%20Financing%20Activities) Net cash provided by financing activities significantly increased for the six months ended June 30, 2025, driven by proceeds from the issuance of convertible promissory notes and common stock/warrants **Net Cash Provided by Financing Activities (Six Months Ended June 30)** | Year | Amount (approx.) | | :--- | :--------------- | | 2025 | $9.4 million | | 2024 | $0.4 million | | Change | +$9.0 million | - The substantial increase in financing cash flow was due to **$5.7 million** from convertible promissory notes and **$4.1 million** from common stock and warrants issuance in 2025[9](index=9&type=chunk) [Corporate Information and Future Outlook](index=2&type=section&id=Corporate%20Information%20and%20Future%20Outlook) [About Indaptus Therapeutics](index=2&type=section&id=About%20Indaptus%20Therapeutics) Indaptus Therapeutics is a clinical-stage biotechnology company developing novel, multi-targeted immune system-activating Decoy platform technology for cancer and viral infections, with product candidates designed to activate both innate and adaptive immunity with reduced toxicity and preclinical efficacy against various cancers and chronic viral infections - Indaptus' patented Decoy platform uses attenuated and killed Gram-negative bacteria to activate multiple Toll-like receptors (TLR), Nucleotide oligomerization domain (NOD)-like receptors (NLR), and Stimulator of interferon genes (STING) agonists[11](index=11&type=chunk) - Preclinical studies demonstrated single-agent activity against metastatic pancreatic and colorectal carcinomas, eradication of breast carcinoma, and combination-mediated eradication of hepatocellular carcinomas, pancreatic, and non-Hodgkin's lymphomas[11](index=11&type=chunk) - Decoy product candidates also showed meaningful single-agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in preclinical models[11](index=11&type=chunk) [Outlook](index=2&type=section&id=Outlook) Indaptus remains focused on disciplined execution of its clinical strategy and anticipates sharing initial combination trial data from the first patient cohort later this year - The Company expects to share initial combination trial data from the first cohort of patients later this year[10](index=10&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements regarding management's expectations for clinical trials, product candidates, and financial sufficiency, highlighting inherent risks and uncertainties that could cause actual results to differ materially from projections, with the company disclaiming any obligation to update these statements - Forward-looking statements relate to expectations regarding cash sufficiency, Phase 1 clinical trial of Decoy20, combination study, and anticipated effects of product candidates[12](index=12&type=chunk) - Statements are subject to risks and uncertainties, including limited operating history, need for additional capital, lengthy and expensive clinical development, regulatory approval, market acceptance, and reliance on third parties[12](index=12&type=chunk) - The company undertakes no obligation to update or revise forward-looking statements except as required by applicable law[12](index=12&type=chunk) [Unaudited Condensed Consolidated Financial Statements](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [Balance Sheets](index=5&type=section&id=Balance%20Sheets) The unaudited condensed consolidated balance sheets show a decrease in total assets from $7.3 million at December 31, 2024, to $6.8 million at June 30, 2025, with current liabilities significantly increasing due to convertible promissory notes, leading to a shift from stockholders' equity to a deficit **Unaudited Condensed Consolidated Balance Sheets** | Item | June 30, 2025 | December 31, 2024 | | :---------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $6,157,701 | $5,786,753 | | Total current assets | $6,413,058 | $6,618,330 | | Total assets | $6,839,207 | $7,338,756 | | Fair value of convertible promissory notes | $6,502,503 | $- | | Total current liabilities | $8,512,563 | $3,393,881 | | Total stockholders' equity (deficit) | $(1,673,356) | $3,944,875 | [Statements of Operations](index=6&type=section&id=Statements%20of%20Operations) The unaudited condensed consolidated statements of operations show an increased net loss for both the three and six months ended June 30, 2025, primarily driven by higher operating expenses and a change in the fair value of convertible promissory notes, despite a decrease in loss per share due to an increased weighted average number of shares **Unaudited Condensed Consolidated Statements of Operations** | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------ | :------------------------------ | | Research and development | $2,167,114 | $1,713,973 | $4,977,954 | $3,305,115 | | General and administrative | $2,289,649 | $2,394,912 | $4,051,368 | $4,747,009 | | Total operating expenses | $4,456,763 | $4,108,885 | $9,029,322 | $8,052,124 | | Net loss | $(5,228,919) | $(4,015,267) | $(9,761,349) | $(7,821,944) | | Net loss available to common stockholders per share | $(9.09) | $(13.16) | $(18.09) | $(25.79) | | Weighted average number of shares | 574,923 | 305,140 | 539,538 | 303,336 | [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) The unaudited condensed consolidated statements of cash flows indicate a net increase in cash and cash equivalents for the six months ended June 30, 2025, primarily driven by significant cash provided by financing activities, which more than offset the increased cash used in operating activities **Unaudited Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30)** | Item | 2025 | 2024 | | :------------------------------------------ | :----------- | :----------- | | Net loss | $(9,761,349) | $(7,821,944) | | Net cash used in operating activities | $(9,065,316) | $(6,414,413) | | Net cash provided by financing activities | $9,436,264 | $354,111 | | Net increase (decrease) in cash and cash equivalents | $370,948 | $(6,060,302) | | Cash and cash equivalents at end of period | $6,157,701 | $7,301,751 | - Cash provided by financing activities in 2025 included **$5,714,800** from convertible promissory notes and **$4,057,719** from common stock and warrants[19](index=19&type=chunk)

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 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]