Indaptus Therapeutics(INDP) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights Introduction and CEO Commentary 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] - 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] Key Corporate and Clinical Milestones 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] - Raised $5.7 million in gross proceeds via private placement of convertible notes and warrants, which converted to equity in July[4] - 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] Financial Summary for Q2 2025 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 Operating Expenses 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 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] General and Administrative Expenses 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] Net Loss and Loss Per Share 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 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 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] Cash Flows from Operating Activities 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] Cash Flows from Financing Activities 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] Corporate Information and Future Outlook About Indaptus Therapeutics 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] - 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] - 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] 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] Forward-Looking Statements 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] - 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] - The company undertakes no obligation to update or revise forward-looking statements except as required by applicable law[12] Unaudited Condensed Consolidated Financial Statements Balance Sheets 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 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 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]