Indaptus Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Indaptus Therapeutics (Nasdaq: INDP) has reported its Q2 2025 financial results and provided significant corporate updates. The company has reached a major clinical milestone by dosing its first patient in the Phase 1b/2 combination study of Decoy20 with PD-1 checkpoint inhibitor tislelizumab.
Financial highlights include R&D expenses of $2.2 million for Q2 2025, up from $1.7 million in Q2 2024, and a net loss per share of $9.09. The company strengthened its balance sheet by raising $5.7 million through convertible notes and warrants, which were converted to equity in July 2025. Cash position stands at $6.2 million, expected to fund operations into Q4 2025.
Indaptus Therapeutics (Nasdaq: INDP) ha annunciato i risultati finanziari del Q2 2025 e fornito importanti aggiornamenti aziendali. L'azienda ha raggiunto una tappa clinica significativa somministrando il primo paziente nello studio combinato di Fase 1b/2 di Decoy20 in combinazione con l'inibitore del checkpoint PD-1 tislelizumab.
I punti finanziari evidenziano spese R&S di $2,2 milioni per il Q2 2025, in aumento rispetto a $1,7 milioni nel Q2 2024, e una perdita netta per azione di $9,09. La società ha rafforzato la propria struttura patrimoniale raccogliendo $5,7 milioni tramite note convertibili e warrant, poi convertiti in capitale a luglio 2025. La posizione di cassa è di $6,2 milioni, prevista per finanziare le operazioni fino al Q4 2025.
Indaptus Therapeutics (Nasdaq: INDP) ha presentado sus resultados financieros del 2T 2025 y ofrecido importantes actualizaciones corporativas. La compañía alcanzó un hito clínico al administrar la primera dosis al primer paciente en el estudio combinado de Fase 1b/2 de Decoy20 junto con el inhibidor del checkpoint PD-1 tislelizumab.
Los aspectos financieros incluyen gastos de I+D de $2.2 millones en el 2T 2025, frente a $1.7 millones en el 2T 2024, y una pérdida neta por acción de $9.09. La empresa reforzó su balance recaudando $5.7 millones mediante notas convertibles y warrants, que se convirtieron en capital en julio de 2025. La posición de caja es de $6.2 millones, que se espera financien las operaciones hasta el 4T 2025.
Indaptus Therapeutics (Nasdaq: INDP)는 2025년 2분기 재무실적을 발표하고 주요 회사 업데이트를 공개했습니다. 회사는 PD-1 체크포인트 억제제 티슬레리주맙(tislelizumab)과의 병용 임상인 Decoy20의 1b/2상 병용 연구에서 첫 환자 투약이라는 중요한 임상 성과를 달성했습니다.
재무 하이라이트로는 2025년 2분기 연구개발비(R&D) $2.2 백만으로, 2024년 2분기의 $1.7 백만에서 증가했으며 주당 순손실 $9.09를 기록했습니다. 회사는 $5.7 백만의 전환사채 및 워런트를 통해 재무구조를 강화했으며, 이는 2025년 7월에 주식으로 전환되었습니다. 현금 잔고는 $6.2 백만으로, 2025년 4분기까지 운영 자금으로 활용될 것으로 예상됩니다.
Indaptus Therapeutics (Nasdaq: INDP) a publié ses résultats du T2 2025 et fourni d'importantes mises à jour d'entreprise. La société a franchi une étape clinique majeure en adminstrant la première dose au premier patient dans l'étude de combinaison de phase 1b/2 de Decoy20 avec l'inhibiteur du checkpoint PD‑1 tislelizumab.
Parmi les points financiers : dépenses R&D de 2,2 M$ pour le T2 2025, en hausse par rapport à 1,7 M$ au T2 2024, et une perte nette par action de 9,09 $. La société a renforcé son bilan en levant 5,7 M$ via des billets convertibles et des warrants, convertis en actions en juillet 2025. La trésorerie s'élève à 6,2 M$, prévue pour financer les opérations jusqu'au T4 2025.
Indaptus Therapeutics (Nasdaq: INDP) hat die Finanzergebnisse für das 2. Quartal 2025 veröffentlicht und wichtige Unternehmensupdates bekanntgegeben. Das Unternehmen erreichte einen bedeutenden klinischen Meilenstein, indem es den ersten Patienten in der Phase‑1b/2‑Kombinationsstudie von Decoy20 zusammen mit dem PD‑1‑Checkpoint‑Inhibitor tislelizumab dosierte.
Zu den finanziellen Eckdaten gehören Forschungs‑ und Entwicklungsausgaben von $2,2 Millionen im 2. Quartal 2025, gegenüber $1,7 Millionen im 2. Quartal 2024, sowie ein Nettoverlust je Aktie von $9,09. Die Gesellschaft stärkte ihre Bilanz durch die Aufnahme von $5,7 Millionen über wandelbare Schuldverschreibungen und Warrants, die im Juli 2025 in Eigenkapital umgewandelt wurden. Die Kassenbestände belaufen sich auf $6,2 Millionen, die voraussichtlich bis ins 4. Quartal 2025 den Betrieb finanzieren werden.
- Initiated Phase 1b/2 combination trial of Decoy20 with tislelizumab
- Successfully raised $5.7 million in gross proceeds through convertible notes
- Cash position increased to $6.2 million from $5.8 million at end of 2024
- Reduced G&A expenses by $0.1 million compared to Q2 2024
- Decreased loss per share to $9.09 from $13.16 year-over-year
- R&D expenses increased by $0.5 million (29%) year-over-year
- Net cash burn increased by $2.5 million compared to prior year
- Current cash runway only extends into Q4 2025
- Operating expenses increased due to ongoing Phase 1 study
Insights
Indaptus shows clinical progress with first combination trial patient dosed, but faces tight cash runway extending only into Q4 2025.
Indaptus Therapeutics has reached a significant clinical milestone by dosing its first patient in the Phase 1b/2 combination study of Decoy20 with the PD-1 inhibitor tislelizumab. This represents a critical inflection point in their development timeline, progressing from IND-enabling studies to active combination trials in under four years - relatively quick execution for a small biotech.
The company's approach combining Decoy20 (which enhances both innate and adaptive immune responses) with checkpoint inhibition is scientifically rational. Preclinical data suggesting synergistic effects with PD-1 inhibitors provides some scientific foundation, though we must await clinical validation. Initial combination trial data expected later this year will be crucial for establishing preliminary proof-of-concept.
On the financial front, while Indaptus secured
R&D expenses increased to
The narrowing loss per share (
Company Initiates Combination Trial and Strengthens Balance Sheet to Support Continued Clinical Progress
NEW YORK, Aug. 13, 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 second quarter ended June 30, 2025, and provides a corporate update.
Jeffrey Meckler, Indaptus Therapeutics’ Chief Executive Officer, commented, “This quarter marks a major clinical inflection point for Indaptus. In under four years since our founding, we have progressed from IND-enabling studies to an active combination trial in patients. This pace of development is a testament to the dedication of the small, but focused Indaptus Team. A few weeks ago, we dosed the first patient in our Phase 1b/2 combination study evaluating Decoy20 with the PD-1 checkpoint inhibitor tislelizumab. Our preclinical studies showed that Decoy20 broadly enhances both innate and adaptive immune cell activation and works synergistically with a PD-1 inhibitor to induce solid tumor regression. This trial marks the first clinical evaluation of that combination, with the aim of delivering new options for patients who have not benefited from existing immunotherapies.”
“On the financial front, we raised approximately
Key Highlights:
- Dosed first patient in Phase 1b/2 study evaluating combination of Decoy20 and PD-1 checkpoint inhibitor tislelizumab (TEVIMBRA®)
- Raised
$5.7 million in gross proceeds via private placement of convertible notes and warrants (converted to equity in July) - Strengthened executive visibility: Dr. Michael Newman, Founder and Chief Scientific Officer, named chair and expert speaker at the Cytokine-Based Drug Development Summit
Financial Highlights for the Second Quarter Ended June 30, 2025
Research and development expenses for the three months ended June 30, 2025, were approximately
General and administrative expenses for the three months ended June 30, 2025, were approximately
Loss per share for the three months ended June 30, 2025, was approximately
As of June 30, 2025, 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 six months ended June 30, 2025, was approximately
Outlook
Indaptus remains focused on executing its clinical strategy with discipline, efficiency, and scientific rigor. The Company expects to share initial combination trial data from the first cohort of patients later this year.
Jeffrey Meckler added, “With our first patient dosed in combination and a financial foundation in place, we believe Indaptus is entering its most exciting phase yet. We remain focused on executing our clinical strategy and ultimately delivering on our mission to help more patients benefit from immunotherapy.”
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 Phase 1 clinical trial of Decoy20 and 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 | ||||||||
| June 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,157,701 | $ | 5,786,753 | ||||
| Prepaid expenses and other current assets | 255,357 | 831,577 | ||||||
| Total current assets | 6,413,058 | 6,618,330 | ||||||
| Non-current assets: | ||||||||
| Right-of-use asset | 33,577 | 82,175 | ||||||
| Other assets - deposits to third parties | 392,572 | 638,251 | ||||||
| Total non-current assets | 426,149 | 720,426 | ||||||
| Total assets | $ | 6,839,207 | $ | 7,338,756 | ||||
| Liabilities and stockholders’ equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and other current liabilities | $ | 1,975,687 | $ | 3,309,717 | ||||
| Operating lease liability, current portion | 34,373 | 84,164 | ||||||
| Fair value of convertible promissory notes | 6,502,503 | - | ||||||
| Total current liabilities | 8,512,563 | 3,393,881 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock: | 6,050 | 4,288 | ||||||
| Preferred stock: | - | - | ||||||
| Additional paid in capital* | 68,521,126 | 64,379,770 | ||||||
| Accumulated deficit | (70,200,532 | ) | (60,439,183 | ) | ||||
| Total stockholders’ equity (deficit) | (1,673,356 | ) | 3,944,875 | |||||
| Total liabilities and stockholders’ equity (deficit) | $ | 6,839,207 | $ | 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| 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 | ||||||||||||
| Loss from operations | (4,456,763 | ) | (4,108,885 | ) | (9,029,322 | ) | (8,052,124 | ) | ||||||||
| Other income, net | 15,547 | 93,618 | 55,676 | 230,180 | ||||||||||||
| Change in fair value of convertible promissory notes | (787,703 | ) | - | (787,703 | ) | - | ||||||||||
| Net loss | $ | (5,228,919 | ) | $ | (4,015,267 | ) | $ | (9,761,349 | ) | $ | (7,821,944 | ) | ||||
| Net loss available to common stockholders per share of common stock, basic and diluted* | $ | (9.09 | ) | $ | (13.16 | ) | $ | (18.09 | ) | $ | (25.79 | ) | ||||
| Weighted average number of shares used in calculating net loss per share, basic and diluted* | 574,923 | 305,140 | 539,538 | 303,336 | ||||||||||||
| * Retroactively restated for one-for-twenty-eight share consolidation on June 27, 2025. | ||||||||||||||||
| Unaudited Condensed Consolidated Statements of Cash Flows | ||||||||
| For the Six Months Ended | ||||||||
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (9,761,349 | ) | $ | (7,821,944 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | - | 735 | ||||||
| Stock-based compensation | 421,654 | 1,557,543 | ||||||
| Change in fair value of convertible promissory notes | 787,703 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | 821,899 | 696,430 | ||||||
| Accounts payable and other current liabilities | (1,334,030 | ) | (847,502 | ) | ||||
| Operating lease right-of-use asset and liability, net | (1,193 | ) | 325 | |||||
| Net cash used in operating activities | (9,065,316 | ) | (6,414,413 | ) | ||||
| 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 | 4,057,719 | 375,588 | ||||||
| Issuance costs | (336,255 | ) | (21,477 | ) | ||||
| 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 beginning of period | 5,786,753 | 13,362,053 | ||||||
| Cash and cash equivalents at end of period | $ | 6,157,701 | $ | 7,301,751 | ||||
| Noncash investing and financing activities | ||||||||
| Issuance of commitment shares* | $ | 109 | - | |||||
| * Retroactively restated for one-for-twenty-eight share consolidation on June 27, 2025. | ||||||||
FAQ
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