Indaptus Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Rhea-AI Summary
Indaptus Therapeutics (Nasdaq: INDP) reported third quarter 2025 results and a corporate update on Nov 12, 2025. Key clinical and financing highlights include completion of a six-participant Safety Lead-In combining Decoy20 and tislelizumab, which the Safety Review Committee deemed tolerable at the current dose and schedule, while enrollment is paused pending further efficacy evaluations.
Financials: the company reported $5.8M cash at Sept 30, 2025, raised $2.3M via an at-the-market facility in Sept 2025, converted $5.7M of June 2025 promissory notes in July 2025, and expects cash to fund operations into Q1 2026.
Positive
- Completed Safety Lead-In dosing six evaluable participants
- Safety Review Committee found combination tolerable at current dose
- Raised approximately $2.3M via at-the-market facility in Sept 2025
- Net cash provided by financing was approximately $11.7M YTD
Negative
- Cash and cash equivalents of approximately $5.8M at Sept 30, 2025
- Company expects cash runway only into Q1 2026 without additional funding
- Net cash used in operating activities increased to approximately $11.6M YTD
- Nine-month loss per share of approximately $18.48
News Market Reaction 4 Alerts
On the day this news was published, INDP gained 6.25%, reflecting a notable positive market reaction. Argus tracked a peak move of +10.4% during that session. Argus tracked a trough of -4.4% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $210K to the company's valuation, bringing the market cap to $4M at that time.
Data tracked by StockTitan Argus on the day of publication.
NEW YORK, Nov. 12, 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 financial results for the third quarter ended September 30, 2025, and provides a corporate update.
Jeffrey Meckler, Indaptus Therapeutics’ Chief Executive Officer, commented, “We have completed the Safety Lead-In cohort, dosing six evaluable participants with the combination of Decoy20 and tislelizumab. Following efficacy evaluations, three participants achieved stable disease at the first assessment, two of whom remain on study, while three participants experienced disease progression. The Safety Review Committee has reviewed all available safety data from this cohort and determined that the Decoy20 and tislelizumab combination appears to be tolerable at the current dose and schedule. While this safety data may support proceeding to full enrollment, we have paused enrollment pending additional efficacy evaluations of the remaining participants and to further assess our next development options.”
“In September 2025, we raised total gross proceeds of approximately
Key Highlights:
- Completed the Safety Lead-In cohort, dosing six evaluable participants with the combination of Decoy20 and tislelizumab.
- July 2025, completed conversion of the promissory notes, that were issued in June 2025 for
$5.7 million , into common stock, pre-funded warrants and warrants. - September 2025, strengthened balance sheet with
$2.3 million raised through at-the-market facility.
Financial Highlights for the Third Quarter Ended September 30, 2025
Research and development expenses for the three months ended September 30, 2025, were approximately
General and administrative expenses for the three months ended September 30, 2025, were approximately
Loss per share for the three months ended September 30, 2025, was approximately
As of September 30, 2025 and December 31, 2024, the Company had cash and cash equivalents of approximately
Net cash used in operating activities was approximately
Net cash provided by financing activities for the nine months ended September 30, 2025, was approximately
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (NOD)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The product candidates are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy product candidates represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas, pancreatic and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy product candidates in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product candidate, with associated “cold” to “hot” tumor inflammation signature transition. The Decoy platform has also been shown to induce activation, polarization or maturation of human macrophages, dendritic, NK, NKT, CD4 T and CD8 T cells in vitro. IND-enabling, nonclinical toxicology studies demonstrated i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product candidate. Indaptus’ Decoy product candidates have also produced meaningful single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. These include statements regarding management’s expectations, beliefs and intentions regarding, among other things, the sufficiency of our cash and cash equivalents to fund our ongoing activities and our expectations and plans regarding our combination study and the anticipated effects of our product candidates, including Decoy20. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to the following: our limited operating history; conditions and events that raise substantial doubt regarding our ability to continue as going concern; the need for, and our ability to raise, additional capital given our lack of current cash flow; our clinical and preclinical development, which involves a lengthy and expensive process with an uncertain outcome; our incurrence of significant research and development expenses and other operating expenses, which may make it difficult for us to attain profitability; our pursuit of a limited number of research programs, product candidates and specific indications and failure to capitalize on product candidates or indications that may be more profitable or have a greater likelihood of success; our ability to obtain and maintain regulatory approval of any product candidate; the market acceptance of our product candidates; our reliance on third parties to conduct our preclinical studies and clinical trials and perform other tasks; our reliance on third parties for the manufacture of our product candidates during clinical development; our ability to successfully commercialize Decoy20 or any future product candidates; our ability to obtain or maintain coverage and adequate reimbursement for our products; the impact of legislation and healthcare reform measures on our ability to obtain marketing approval for and commercialize Decoy20 and any future product candidates; product candidates of our competitors that may be approved faster, marketed more effectively, and better tolerated than our product candidates; our ability to adequately protect our proprietary or licensed technology in the marketplace; the impact of, and costs of complying with healthcare laws and regulations, and our failure to comply with such laws and regulations; information technology system failures, cyberattacks or deficiencies in our cybersecurity; and unfavorable global economic conditions. These and other important factors discussed under the caption “Risk Factors” included in our most recent Annual Report on Form 10-K filed with the SEC on March 13, 2025, and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. All forward-looking statements speak only as of the date of this press release and are expressly qualified in their entirety by the cautionary statements included in this press release. We undertake no obligation to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, except as required by applicable law.
Contact: investors@indaptusrx.com
Investor Relations Contact:
CORE IR
Louie Toma
louie@coreir.com
| INDAPTUS THERAPEUTICS, INC. Unaudited Condensed Consolidated Balance Sheets | ||||||||
| September 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,825,639 | $ | 5,786,753 | ||||
| Prepaid expenses and other current assets | 613,354 | 831,577 | ||||||
| Total current assets | 6,438,993 | 6,618,330 | ||||||
| Non-current assets: | ||||||||
| Right-of-use asset | 8,487 | 82,175 | ||||||
| Other assets - deposits to third parties | 392,572 | 638,251 | ||||||
| Total non-current assets | 401,059 | 720,426 | ||||||
| Total assets | $ | 6,840,052 | $ | 7,338,756 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and other current liabilities | $ | 2,225,639 | $ | 3,309,717 | ||||
| Operating lease liability, current portion | 8,686 | 84,164 | ||||||
| Total current liabilities | 2,234,325 | 3,393,881 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock: September 30, 2025 and December 31, 2024; 1,641,920 shares issued and outstanding as of September 30, 2025 and 428,799 shares issued and outstanding as of December 31, 2024* | 16,420 | 4,288 | ||||||
| Preferred stock: September 30, 2025 and December 31, 2024; no shares issued or outstanding | - | - | ||||||
| Additional paid in capital* | 77,764,956 | 64,379,770 | ||||||
| Accumulated deficit | (73,175,649 | ) | (60,439,183 | ) | ||||
| Total stockholders’ equity | 4,605,727 | 3,944,875 | ||||||
| Total liabilities and stockholders’ equity | $ | 6,840,052 | $ | 7,338,756 | ||||
| * Retroactively restated for one-for-twenty-eight share consolidation on June 27, 2025. | ||||||||
| Unaudited Condensed Consolidated Statements of Operations | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 1,517,723 | $ | 1,466,037 | $ | 6,495,677 | $ | 4,771,152 | ||||||||
| General and administrative | 1,130,764 | 1,676,020 | 5,182,132 | 6,423,029 | ||||||||||||
| Total operating expenses | 2,648,487 | 3,142,057 | 11,677,809 | 11,194,181 | ||||||||||||
| Loss from operations | (2,648,487 | ) | (3,142,057 | ) | (11,677,809 | ) | (11,194,181 | ) | ||||||||
| Other income, net | 39,088 | 73,021 | 94,764 | 303,201 | ||||||||||||
| Change in fair value of convertible promissory notes | (365,718 | ) | - | (1,153,421 | ) | - | ||||||||||
| Net loss | $ | (2,975,117 | ) | $ | (3,069,036 | ) | $ | (12,736,466 | ) | $ | (10,890,980 | ) | ||||
| Net loss available to common stockholders per share of common stock, basic and diluted* | $ | (2.98 | ) | $ | (9.04 | ) | $ | (18.48 | ) | $ | (34.53 | ) | ||||
| Weighted average number of shares used in calculating net loss per share, basic and diluted* | 997,038 | 339,659 | 689,174 | 315,451 | ||||||||||||
| * Retroactively restated for one-for-twenty-eight share consolidation on June 27, 2025. | ||||||||||||||||
| Unaudited Condensed Consolidated Statements of Cash Flows | ||||||||
| For the Nine Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (12,736,466 | ) | $ | (10,890,980 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | - | 735 | ||||||
| Stock-based compensation | 572,268 | 2,001,727 | ||||||
| Change in fair value of convertible promissory notes | 1,153,421 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other current and non- current assets | 463,902 | 634,419 | ||||||
| Accounts payable and other current liabilities | (1,084,078 | ) | (673,829 | ) | ||||
| Operating lease right-of-use asset and liability, net | (1,790 | ) | 487 | |||||
| Net cash used in operating activities | (11,632,743 | ) | (8,927,441 | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from issuance of convertible promissory notes | 5,714,800 | - | ||||||
| Proceeds from issuance of shares of common stock and warrants | 6,396,888 | 3,375,590 | ||||||
| Proceeds from exercise of pre-funded warrants | 154 | - | ||||||
| Issuance costs | (440,213 | ) | (429,516 | ) | ||||
| Net cash provided by financing activities | 11,671,629 | 2,946,074 | ||||||
| Net increase (decrease) in cash and cash equivalents | 38,886 | (5,981,367 | ) | |||||
| Cash and cash equivalents at beginning of period | 5,786,753 | 13,362,053 | ||||||
| Cash and cash equivalents at end of period | $ | 5,825,639 | $ | 7,380,686 | ||||
| Noncash investing and financing activities | ||||||||
| Transaction costs in accounts payable and other current liabilities | $ | - | $ | 129,993 | ||||
| Settlement of convertible promissory notes | $ | 6,868,221 | $ | - | ||||
| Issuance of commitment shares* | $ | 109 | $ | - | ||||
| * Retroactively restated for one-for-twenty-eight share consolidation on June 27, 2025. | ||||||||
FAQ
What did Indaptus (INDP) report about its Decoy20 and tislelizumab Safety Lead-In on Nov 12, 2025?
How much cash did Indaptus (INDP) have as of September 30, 2025 and how long is the runway?
How much financing did Indaptus (INDP) raise in 2025 from equity and ATM activity?
Why did Indaptus (INDP) pause enrollment in its combination trial?
What were key expense trends reported by Indaptus (INDP) for Q3 2025?
What is Indaptus (INDP) doing about financing given its projected runway?
