INDP
Indaptus TherapeuticsFDocument history
Earnings documents stored for INDP.
Investor releaseQuarter not tagged2026-08-13Indaptus Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update
GlobeNewswire
Indaptus Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update
NEW YORK, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the "Company"), a biotechnology company dedicated to immunotherapy research, today announced financial results for the second quarter and six months ended June 30, 2026, and provided a corporate update. Junyi Dai, Indaptus Therapeutics' Chief Executive Officer and Chairman of the Board, commented, "During the second quarter, we strengthened the Company's balance sheet through a $12.0 million private placement and continued our review of the Decoy platform, our research activities and broader strategic alternatives. We are evaluating how our existing therapeutic assets, complementary research capabilities and potential strategic investments or business combinations may support the Company's long-term objectives." "We also began a research collaboration in neurological disorders and sleep as an extension of our immunotherapy research. As we allocate capital and evaluate potential opportunities, we intend to proceed in a disciplined manner based on scientific validation, strategic fit, regulatory considerations and available resources," Mr. Dai continued. Key Highlights June 2026 private placement completed. On June 17, 2026, the Company issued and sold 20,000,000 shares of common stock at $0.60 per share for aggregate gross proceeds of approximately $12.0 million before offering expenses. The transaction closed on the same day. Strategic review and Decoy20 status. The Company has discontinued further enrollment in its combination study, has no participants remaining in any ongoing Decoy20 clinical study and currently has no active clinical development programs. The Company has reduced activities related to further development of Decoy20 while it evaluates strategic alternatives for its Decoy20 program and broader operations, including research collaborations, investments in or acquisitions of operating businesses and other potential growth opportunities. During the second quarter, the Company began a research collaboration in neurological disorders and sleep as an extension of its immunotherapy research. Liquidity position. As of June 30, 2026, the Company had approximately $7.6 million in cash and cash equivalents and $4.0 million in short-term investments. Based on current operating plans and available financial resources, management believes that the Compan…Read full documentShow less
NEW YORK, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) ("Indaptus" or the "Company"), a biotechnology company dedicated to immunotherapy research, today announced financial results for the second quarter and six months ended June 30, 2026, and provided a corporate update. Junyi Dai, Indaptus Therapeutics' Chief Executive Officer and Chairman of the Board, commented, "During the second quarter, we strengthened the Company's balance sheet through a $12.0 million private placement and continued our review of the Decoy platform, our research activities and broader strategic alternatives. We are evaluating how our existing therapeutic assets, complementary research capabilities and potential strategic investments or business combinations may support the Company's long-term objectives." "We also began a research collaboration in neurological disorders and sleep as an extension of our immunotherapy research. As we allocate capital and evaluate potential opportunities, we intend to proceed in a disciplined manner based on scientific validation, strategic fit, regulatory considerations and available resources," Mr. Dai continued. Key Highlights June 2026 private placement completed. On June 17, 2026, the Company issued and sold 20,000,000 shares of common stock at $0.60 per share for aggregate gross proceeds of approximately $12.0 million before offering expenses. The transaction closed on the same day. Strategic review and Decoy20 status. The Company has discontinued further enrollment in its combination study, has no participants remaining in any ongoing Decoy20 clinical study and currently has no active clinical development programs. The Company has reduced activities related to further development of Decoy20 while it evaluates strategic alternatives for its Decoy20 program and broader operations, including research collaborations, investments in or acquisitions of operating businesses and other potential growth opportunities. During the second quarter, the Company began a research collaboration in neurological disorders and sleep as an extension of its immunotherapy research. Liquidity position. As of June 30, 2026, the Company had approximately $7.6 million in cash and cash equivalents and $4.0 million in short-term investments. Based on current operating plans and available financial resources, management believes that the Company’s liquidity position has been strengthened compared to the first quarter end. Financial Highlights for the Second Quarter and Six Months Ended June 30, 2026 Research and development expenses decreased 83% to approximately $0.4 million for the second quarter of 2026, compared with $2.2 million for the same period in 2025. For the first six months of 2026, expenses also decreased 83% to approximately $0.9 million, compared with $5.0 million in 2025. The decreases were primarily due to lower clinical costs for the Decoy20 Phase 1 study and lower payroll and related expenses following reductions in headcount and base salaries. General and administrative expenses decreased 37% to approximately $1.4 million for the second quarter of 2026, compared with $2.3 million for the same period in 2025. For the first six months of 2026, expenses decreased 23% to approximately $3.1 million, compared with $4.1 million in 2025. The decreases were primarily due to lower payroll and related costs following reductions in headcount and base salaries, as well as changes in certain public-company costs during the management transition. Net loss decreased to approximately $1.8 million for the second quarter of 2026, compared with $5.2 million for the same period in 2025. For the first six months of 2026, net loss decreased to approximately $4.3 million, compared with $9.8 million in 2025. Basic and diluted net loss per share was approximately $0.02 and $0.07 for the respective periods, compared with $9.09 and $18.09 in 2025. As of June 30, 2026, the Company had approximately $11.6 million in cash, cash equivalents and short-term investments, consisting of $7.6 million in cash and cash equivalents and $4.0 million in short-term investments. The Company’s liquidity position improved primarily due to the $12.0 million financing completed in June 2026. The Company may seek additional public or private equity or debt financing to support its operations and strategic objectives. About Indaptus Therapeutics Indaptus Therapeutics is a biotechnology company dedicated to immunotherapy research. The Company's patented Decoy technology uses attenuated and killed, non-pathogenic Gram-negative bacteria designed to activate multiple components of innate and adaptive immunity while reducing systemic toxicity. The Company is evaluating the Decoy platform and existing therapeutic assets while also assessing complementary research capabilities, strategic investments and potential business combinations. The Company seeks to better understand the relationship among sleep, physical recovery, neurological function and immune status, which could potentially support future immunotherapy evaluation, patient recovery monitoring and biomarker research. The scope and timing of any such activities will depend on scientific validation, strategic fit, market opportunities, available resources, regulatory considerations and other business factors. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements regarding management's expectations, beliefs and intentions concerning, among other things, the sufficiency of the Company's cash, cash equivalents and short-term investments to fund its activities; the Company's cash runway and ability to raise additional capital; the use of proceeds from the June 2026 private placement; the Company's review of the Decoy platform and Decoy20; the discontinuation and wind-down of clinical development activities; the Company's evaluation of complementary research areas; the Company's strategic review and potential Post-Investment Transaction, including a potential investment in or acquisition of an operating business; and the anticipated effects and development potential of the Company's technologies and any future product candidates. Forward-looking statements can be identified by words such as 'believe,' 'expect,' 'intend,' 'plan,' 'may,' 'should,' 'could,' 'might,' 'seek,' 'target,' 'will,' 'project,' 'forecast,' 'continue' or 'anticipate,' or their negatives or variations, or by the fact that the statements do not relate strictly to historical matters. Forward-looking statements are inherently subject to risks and uncertainties that could cause actual results to differ materially, including: the Company's limited operating history and history of losses; conditions and events that raise substantial doubt about its ability to continue as a going concern; the need for, and ability to raise, additional capital; dilution from future financings; the Company's ability to identify, negotiate and complete a Post-Investment Transaction and realize anticipated benefits; risks associated with investments, acquisitions and expansion into new research or business areas; the absence of active clinical development programs and the discontinuation and wind-down of Decoy20 clinical activities; uncertain outcomes and costs of clinical and preclinical development; reliance on third parties; competition; protection of proprietary or licensed technology; compliance with healthcare, securities and other laws; information technology failures, cyberattacks and cybersecurity deficiencies; Nasdaq continued-listing risks; stock-price volatility; and unfavorable global economic conditions. These and other important factors discussed under 'Risk Factors' in the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and in the Company's other filings with the Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements. 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 herein. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statement to reflect subsequent events or circumstances. Contact: [email protected] * Share and per-share amounts have been retroactively adjusted for the one-for-28 reverse stock split effected in June 2025. * Share and per-share amounts have been retroactively adjusted for the one-for-28 reverse stock split effected in June 2025.
Investor releaseQuarter not tagged2026-05-15Indaptus Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update
GlobeNewswire
Indaptus Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update
NEW YORK, May 15, 2026 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical-stage biotechnology company, today announced financial results for the first quarter ended March 31, 2026, and provided a strategic corporate update. Junyi Dai, Indaptus Therapeutics’ Chief Executive Officer and Chairman of the Board, commented, “Following recent changes in executive management, the Company has conducted a review of its development programs, operating resources and ongoing corporate initiatives. While this transition period involves certain operational and organizational adjustments, the Company remains focused on supporting and advancing its therapeutic and research activities.” “Currently we are evaluating our Decoy platform, including its preclinical data and underlying scientific rationale, as we assess its potential relevance to the Company’s ongoing therapeutic, immunological and translational research activities. As part of this process, we believe it is prudent to reassess the Company’s development priorities, operating initiatives and resource allocation considerations,” Mr. Dai commented. Key Highlights ● Executive management transition. Recent changes in executive management have resulted in a transition period during which certain operational and organizational adjustments are underway. The Company continues to evaluate operational priorities, ongoing corporate initiatives and resource allocation matters. ● Corporate and development evaluation activities. The Company continues to evaluate corporate initiatives, research activities and potential development opportunities intended to support the Company’s long-term operational and therapeutic objectives. Any such activities will be assessed based on scientific validation, clinical and regulatory considerations, resource availability and overall development planning. ● Preferred stock conversion completed. During the first quarter of 2026, all outstanding shares of the Company’s Series AA Preferred Stock and Series AAA Preferred Stock were converted into shares of common stock. Financial Highlights for the First Quarter Ended March 31, 2026 Research and development expenses for the three months ended March 31, 2026 were approximately $0.5 million, a decrease of approximately $2.3 million from approximately $2.8 million in the three months ended March 31, 20…Read full documentShow less
NEW YORK, May 15, 2026 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical-stage biotechnology company, today announced financial results for the first quarter ended March 31, 2026, and provided a strategic corporate update. Junyi Dai, Indaptus Therapeutics’ Chief Executive Officer and Chairman of the Board, commented, “Following recent changes in executive management, the Company has conducted a review of its development programs, operating resources and ongoing corporate initiatives. While this transition period involves certain operational and organizational adjustments, the Company remains focused on supporting and advancing its therapeutic and research activities.” “Currently we are evaluating our Decoy platform, including its preclinical data and underlying scientific rationale, as we assess its potential relevance to the Company’s ongoing therapeutic, immunological and translational research activities. As part of this process, we believe it is prudent to reassess the Company’s development priorities, operating initiatives and resource allocation considerations,” Mr. Dai commented. Key Highlights ● Executive management transition. Recent changes in executive management have resulted in a transition period during which certain operational and organizational adjustments are underway. The Company continues to evaluate operational priorities, ongoing corporate initiatives and resource allocation matters. ● Corporate and development evaluation activities. The Company continues to evaluate corporate initiatives, research activities and potential development opportunities intended to support the Company’s long-term operational and therapeutic objectives. Any such activities will be assessed based on scientific validation, clinical and regulatory considerations, resource availability and overall development planning. ● Preferred stock conversion completed. During the first quarter of 2026, all outstanding shares of the Company’s Series AA Preferred Stock and Series AAA Preferred Stock were converted into shares of common stock. Financial Highlights for the First Quarter Ended March 31, 2026 Research and development expenses for the three months ended March 31, 2026 were approximately $0.5 million, a decrease of approximately $2.3 million from approximately $2.8 million in the three months ended March 31, 2025. The change was primarily due to a decrease of approximately $1.9 million in clinical costs related to the Company’s Phase 1 study, as well as a decrease of approximately $0.4 million in payroll and related expenses due to reductions in headcount and base salaries. General and administrative expenses for the three months ended March 31, 2026 were approximately $1.7 million, a decrease of approximately $0.1 million, or 5%, from approximately $1.8 million for the three months ended March 31, 2025. The decrease was primarily attributable to a decrease in certain expenses related to operating as a public company and the transition of management. Net loss for the three months ended March 31, 2026 was approximately $2.5 million, compared with a net loss of approximately $4.5 million for the three months ended March 31, 2025. Loss per share for the three months ended March 31, 2026 was approximately $0.23, compared with approximately $9.11 for the three months ended March 31, 2025. The change in our other income (expense)was approximately $0.4 million and consists primarily of the warrant repricing as well as income earned on the Company’s cash and cash equivalent accounts. All share and per-share amounts have been retroactively adjusted to reflect the Company’s one-for-twenty-eight reverse stock split effected on June 27, 2025. As of March 31, 2026, the Company had cash and cash equivalents of approximately $1.5 million, compared with approximately $8.5 million as of December 31, 2025. The Company will need to raise additional capital to support its business objectives, and there can be no assurance that such financing will be available on acceptable terms, or at all. The Company continues to assess financing alternatives and strategic options that would support its corporate strategy. Net cash used in operating activities was approximately $7.0 million for the three months ended March 31, 2026, compared with net cash used in operating activities of approximately $5.0 million for the three months ended March 31, 2025. The increase in net cash used in operating activities was primarily attributable to a decrease in accounts payable and other current liabilities, partially offset by a decrease in net loss. There was no net cash provided by financing activities during the three months ended March 31, 2026, compared with net cash provided by financing activities of approximately $3.2 million for the three months ended March 31, 2025, which was primarily provided by the issuance and sale of common stock and warrants in the January 2025 financing and the issuance and sale of common stock under the Company’s standby equity purchase agreement. About Indaptus Therapeutics Indaptus Therapeutics is a clinical biotechnology company developing a novel and patented systemically-administered anti-cancer and anti-viral immunotherapy. The Company’s approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and associated anti-tumor and anti-viral immune responses requires a multi-targeted package of immune system-activating signals that can be administered safely intravenously. The Company’s patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cellular components of innate and adaptive immunity. The Company is currently reassessing its development priorities, operating initiatives and resource allocation considerations as part of its ongoing review of corporate and research activities. The Company expects that any future development or collaborative opportunities under evaluation will be assessed based on scientific validation, clinical and regulatory considerations, resource availability and overall development planning. 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 the Company’s cash and cash equivalents to fund its ongoing activities; the Company’s ability to raise additional capital; the Company’s plans regarding Decoy20, the Combination Study and any future clinical development activities; the Company’s strategic review and potential strategic transactions, including a potential investment in or acquisition of an operating business; the Company’s appointment of a scientific consultant and potential immunotherapy-related business area; and the anticipated effects and development potential of the Company’s 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 the Company’s 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 Company’s limited operating history; conditions and events that raise substantial doubt regarding the Company’s ability to continue as a going concern; the need for, and the Company’s ability to raise, additional capital given its lack of current cash flow; the Company’s clinical and preclinical development activities, which involve lengthy and expensive processes with uncertain outcomes; the Company’s decision to discontinue further enrollment in the Combination Study and not currently plan a new clinical trial; the Company’s ability to identify, evaluate and complete any strategic transaction; risks related to management transition and associated operational and governance uncertainties; the Company’s ability to successfully develop or commercialize Decoy20 or any future product candidates; reliance on third parties to conduct preclinical studies, clinical trials and manufacturing activities; competition from other product candidates and technologies; the Company’s ability to adequately protect its proprietary or licensed technology; compliance with healthcare, securities and other applicable laws and regulations; information technology system failures, cyberattacks or deficiencies in cybersecurity; and unfavorable global economic conditions. These and other important factors discussed under the caption “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, and in the Company’s other SEC filings, 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 herein. The Company undertakes 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: [email protected]
Investor releaseQuarter not tagged2025-11-12Indaptus Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Indaptus Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
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 $2.3 million through our at-the-market facility and further strengthening our balance sheet. We remain focused on disciplined execution and look forward to sharing more data from our combination trial by the end of the year.” 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 $1.52 million, an increase of approximately $50,000 from $1.47 million in the three months ended September 30, 2024. The change was primarily due to an increase of $0.35 million in the ongoing Phase 1 study and was offset by a decrease of approximately $0.3 million in payroll and related expenses and stock-based compensation. Research and development expenses for the nine months ende…Read full documentShow less
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 $2.3 million through our at-the-market facility and further strengthening our balance sheet. We remain focused on disciplined execution and look forward to sharing more data from our combination trial by the end of the year.” 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 $1.52 million, an increase of approximately $50,000 from $1.47 million in the three months ended September 30, 2024. The change was primarily due to an increase of $0.35 million in the ongoing Phase 1 study and was offset by a decrease of approximately $0.3 million in payroll and related expenses and stock-based compensation. Research and development expenses for the nine months ended September 30, 2025, were approximately $6.5 million, an increase of approximately $1.7 million from $4.8 million in the nine months ended September 30, 2024. The change was primarily due to an increase of $2.6 million in the ongoing Phase 1 study and was partially offset by a decrease of approximately $0.9 in payroll and related expense and stock-based compensation. General and administrative expenses for the three months ended September 30, 2025, were approximately $1.1 million, a decrease of approximately $0.6 million from $1.7 million in the three months ended September 30, 2024. The change was primarily due to a decrease of $0.7 million in stock-based compensation, payroll and related expenses, board of directors fees, investor relations costs and directors and officers insurance policy and was partially offset by an increase of approximately $0.1 million in professional fees. General and administrative expenses for the nine months ended September 30, 2025, were approximately $5.2 million, a decrease of approximately $1.2 million from $6.4 million in the nine months ended September 30, 2024. The change was primarily due to a decrease of $2.1 million in stock-based compensation, payroll and related expenses, board of directors fees, investor relations costs and directors and officers insurance policy and was partially offset by an increase of approximately $0.9 million in transaction-related expenses associated with the private placement of convertible notes and warrants completed in June 2025 and professional fees. Loss per share for the three months ended September 30, 2025, was approximately $2.98, compared with approximately $9.04 for the three months ended September 30, 2024. Loss per share for the nine months ended September 30, 2025, was approximately $18.48, compared with approximately $34.53 per share for the nine months ended September 30, 2024. As of September 30, 2025 and December 31, 2024, the Company had cash and cash equivalents of approximately $5.8 million. The Company expects that its current cash and cash equivalents will support ongoing operating activities into the first quarter of 2026. This cash runway guidance is based on current operational plans and excludes any additional funding and any business development activities that may be undertaken. The Company continues to assess all financing options that would support its corporate strategy. Net cash used in operating activities was approximately $11.6 million for the nine months ended September 30, 2025, compared with net cash used in operating activities of approximately $8.9 million for the nine months ended September 30, 2024. The increase of approximately $2.7 million in net cash used was primarily attributable to an increase in research and development activities which were mostly related to our Phase 1 clinical trial and an increase in transaction-related expenses associated with the private placement of convertible notes and warrants completed in June 2025. Net cash provided by financing activities for the nine months ended September 30, 2025, was approximately $11.7 million, which was provided by issuance and sale of common stock and warrants in the January 2025 financing, the issuance and sale of our common stock under an equity line purchase agreement, the June 2025 private placement of convertible notes and warrants and issuance and sale of our common stock under the at-the-market facility. Net cash provided by financing activities for the nine months ended September 30, 2024 was approximately $2.9 million, which was provided by issuance and sale of common stock under the at-the-market facility and issuance and sale of our common stock and warrants in a registered direct offering and concurrent private placement that we completed in August 2024. 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: [email protected] Investor Relations Contact: CORE IR Louie Toma [email protected]
Investor releaseQuarter not tagged2025-08-13Indaptus Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Indaptus Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
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 $5.7 million in gross proceeds through the sale of convertible promissory notes and accompanying warrants. In July 2025, the notes were converted into common stock and pre-funded warrants. This financing strengthens our balance sheet and supports the continued progress of our clinical development. We remain focused on disciplined execution and look forward to sharing initial combination trial data later this year.” 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 $…Read full documentShow less
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 $5.7 million in gross proceeds through the sale of convertible promissory notes and accompanying warrants. In July 2025, the notes were converted into common stock and pre-funded warrants. This financing strengthens our balance sheet and supports the continued progress of our clinical development. We remain focused on disciplined execution and look forward to sharing initial combination trial data later this year.” 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 $2.2 million, an increase of approximately $0.5 million from $1.7 million in the three months ended June 30, 2024. The change was primarily due to an increase of $0.8 million in the ongoing Phase 1 study and was offset by a decrease of approximately $0.3 million in stock-based compensation and payroll and related expenses. Research and development expenses for the six months ended June 30, 2025, were approximately $5.0 million, an increase of approximately $1.7 million from $3.3 million in the six months ended June 30, 2024. The change was primarily due to an increase of $2.3 million in the ongoing Phase 1 study and was offset by a decrease of approximately $0.6 in stock-based compensation and payroll and related expense. General and administrative expenses for the three months ended June 30, 2025, were approximately $2.3 million, a decrease of approximately $0.1 million from $2.4 million in the three months ended June 30, 2024. The change was primarily due to a decrease of $0.9 million in stock-based compensation, payroll and related expenses, legal fees, and investor relations costs and was offset by an increase of approximately $0.8 million in transaction-related expenses associated with the private placement of convertible notes completed in June 2025. General and administrative expenses for the six months ended June 30, 2025, were approximately $4.0 million, a decrease of approximately $0.7 million from $4.7 million in the six months ended June 30, 2024. The change was primarily due to a decrease of $1.5 million in stock-based compensation, payroll and related expenses, legal fees, and investor relations costs and was offset by an increase of approximately $0.8 million in transaction-related expenses associated with the private placement of convertible notes. Loss per share for the three months ended June 30, 2025, was approximately $9.09, compared with approximately $13.16 for the three months ended June 30, 2024. Loss per share for the six months ended June 30, 2025, was approximately $18.09, compared with approximately $25.79 per share for the six months ended June 30, 2024. As of June 30, 2025, the Company had cash and cash equivalents of approximately $6.2 million. As of December 31, 2024, the Company had cash and cash equivalents of $5.8 million. The Company expects that its current cash and cash equivalents will support ongoing operating activities into the fourth quarter of 2025. This cash runway guidance is based on current operational plans and excludes any additional funding and any business development activities that may be undertaken. The Company continues to assess all financing options that would support its corporate strategy. Net cash used in operating activities was approximately $9.1 million for the six months ended June 30, 2025, compared with net cash used in operating activities of approximately $6.4 million for the six months ended June 30, 2024. The increase of approximately $2.5 million in net cash used was primarily attributable to an increase in research and development activities, which were mostly related to the Phase 1 clinical trial and an increase in transaction-related expenses associated with the private placement of convertible notes. Net cash provided by financing activities for the six months ended June 30, 2025, was approximately $9.4 million, which was provided by issuance and sale of common stock and warrants in the January 2025 financing, the issuance and sale of our common stock under the SEPA and the June 2025 private placement of convertible notes and warrants. Net cash provided by financing activities for the six months ended June 30, 2024 was approximately $0.4 million, which was provided by issuance and sale of common stock under the at-the-market facility. 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: [email protected] Investor Relations Contact: CORE IR Louie Toma [email protected]
Investor releaseQuarter not tagged2025-05-14Indaptus Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Indaptus Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
NEW YORK, May 14, 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 announced financial results for the first quarter ended March 31, 2025, and provided a corporate update. Jeffrey Meckler, Indaptus Therapeutics’ Chief Executive Officer, commented, “We made meaningful progress in the first quarter across multiple fronts of our clinical and research programs. In March, we announced the initiation of the expansion arm of our Phase 1b/2 clinical trial of Decoy20. This arm will evaluate Decoy20 in combination with BeOne’s (formerly known as Beigene) PD-1 checkpoint inhibitor, Tislelizumab, with a focus on safety, dose optimization, and early signals of anti-tumor activity. In addition, we strengthened our intellectual property portfolio with new patents granted in China, Japan, and Israel for our Decoy platform—expanding our intellectual property portfolio. Finally, to date, we have enrolled 32 patients in the weekly dosing among the two Decoy20 dose levels and decided to conclude enrollment for this arm and shift our focus to the combination treatment of Decoy20 with Tislelizumab. Early data from the weekly dosing suggests that Decoy20 is generally well-tolerated, with a favorable safety profile and encouraging signs of clinical benefit, including instances of stable disease. Additionally, we have implemented a cost-reduction plan to focus on the combination study.” Key recent highlights: Financial Highlights for the First Quarter Ended March 31, 2025 Research and development expenses for the three months ended March 31, 2025, were $2.8 million, which compares with $1.6 million in the three months ended March 31, 2024. The change was primarily due to an increase of $1.5 million in expenses for our Phase 1 clinical trial and was offset by a decrease of $0.3 million in payroll and related expenses. General and administrative expenses for the three months ended March 31, 2025, were $1.8 million, which compares with $2.4 million in the three months ended March 31, 2024. The change was primarily due to a decrease in payroll and related expenses and in legal fees. Loss per share for the three-month period ended March 31, 2025 was $0.32, compared with $0.45 for the three-month period ended March 31, 202…Read full documentShow less
NEW YORK, May 14, 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 announced financial results for the first quarter ended March 31, 2025, and provided a corporate update. Jeffrey Meckler, Indaptus Therapeutics’ Chief Executive Officer, commented, “We made meaningful progress in the first quarter across multiple fronts of our clinical and research programs. In March, we announced the initiation of the expansion arm of our Phase 1b/2 clinical trial of Decoy20. This arm will evaluate Decoy20 in combination with BeOne’s (formerly known as Beigene) PD-1 checkpoint inhibitor, Tislelizumab, with a focus on safety, dose optimization, and early signals of anti-tumor activity. In addition, we strengthened our intellectual property portfolio with new patents granted in China, Japan, and Israel for our Decoy platform—expanding our intellectual property portfolio. Finally, to date, we have enrolled 32 patients in the weekly dosing among the two Decoy20 dose levels and decided to conclude enrollment for this arm and shift our focus to the combination treatment of Decoy20 with Tislelizumab. Early data from the weekly dosing suggests that Decoy20 is generally well-tolerated, with a favorable safety profile and encouraging signs of clinical benefit, including instances of stable disease. Additionally, we have implemented a cost-reduction plan to focus on the combination study.” Key recent highlights: Financial Highlights for the First Quarter Ended March 31, 2025 Research and development expenses for the three months ended March 31, 2025, were $2.8 million, which compares with $1.6 million in the three months ended March 31, 2024. The change was primarily due to an increase of $1.5 million in expenses for our Phase 1 clinical trial and was offset by a decrease of $0.3 million in payroll and related expenses. General and administrative expenses for the three months ended March 31, 2025, were $1.8 million, which compares with $2.4 million in the three months ended March 31, 2024. The change was primarily due to a decrease in payroll and related expenses and in legal fees. Loss per share for the three-month period ended March 31, 2025 was $0.32, compared with $0.45 for the three-month period ended March 31, 2024. As of March 31, 2025, the Company had cash and cash equivalents of $3.9 million. As of December 31, 2024, the Company had cash and cash equivalents of $5.8 million. The Company will need to obtain additional capital to fund its ongoing activities beyond the second quarter of 2025. Net cash used in operating activities was $5.0 million for the three-month period ended March 31, 2025, compared with net cash used in operating activities of $3.9 million for the three-month period ended March 31, 2024. The increase in net cash used was primarily attributable to an increase in our research and development activities which was mostly related to our Phase 1 clinical trial. There was no net cash provided by or used in investing activities in the three-month period ended March 31, 2025 and March 31, 2024. Net cash provided by financing activities was $3.2 million for the three months ended March 31, 2025 compared with net cash provided by financing activities of $0.3 million for the three-month period ended March 31, 2024. The $2.8 million increase in net cash provided was primarily attributable to the issuance and sale of our common stock and warrants in the January 2025 financing and by issuance and sale of our common stock under our equity line. 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 anticipated 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 to be filed with the SEC, 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: [email protected] Investor Relations Contact: CORE IR Louie Toma [email protected] INDAPTUS THERAPEUTICS, INC.
Investor releaseQuarter not tagged2025-03-13Indaptus Therapeutics Reports Fourth Quarter and Year-End 2024 Financial Results and Provides Corporate Update
GlobeNewswire
Indaptus Therapeutics Reports Fourth Quarter and Year-End 2024 Financial Results and Provides Corporate Update
Company Achieves Key Clinical Milestone with more than 20 Patients Enrolled in Weekly Dosing Cohort of Phase 1 Trial of Decoy20 Pharmacodynamic immune activation biomarker and pharmacokinetics profiles in initial data sets appear to meet or exceed initial expectations Early signs of potential benefit emerge with some patients demonstrating Stable Disease NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”) today announces financial results for the fourth quarter and fiscal year ended December 31, 2024 and provides a corporate update. Jeffrey Meckler, Chief Executive Officer of Indaptus, commented, “We continue to make significant progress in our Phase 1 trial of Decoy20, and enrolling more than 20 patients in the weekly dosing cohort marks an important milestone. We are particularly encouraged by the emerging clinical data, with some patients in this cohort demonstrating stable disease - an early sign that Decoy20’s immune-modulating approach may be having a meaningful impact. With a favorable safety profile observed so far, we are focused on efficiently advancing our trial and exploring Decoy20’s potential, both as a monotherapy and in combination therapy in difficult-to-treat cancers. We look forward to generating additional data in the months ahead as we prepare to initiate our planned combination trial with BeiGene’s PD-1 inhibitor, tislelizumab.” Key recent highlights: Successfully advanced Phase 1 study of Decoy20 in advanced solid tumors, with weekly dosing now underway following a positive Safety Review Committee assessment. Achieved key milestone with more than 20 patients enrolled in the weekly dosing cohort among the two Decoy20 dose levels, further supporting the clinical evaluation of Decoy20’s safety and activity. Additionally, early signs of potential benefit emerge with some patients with Stable Disease. Entered clinical supply agreement with BeiGene to advance Decoy20 for its evaluation in combination with BeiGene’s PD-1 inhibitor, tislelizumab, for use in multiple cancer types, with trial initiation expected in 2025. Secured new patents in China, Japan and Israel, covering Decoy bacteria compositions for the prevention or treatment of Hepatitis B virus (HBV) and human immunodeficiency virus (HIV), further expanding and reinforcing the company’s intellectual property position.…Read full documentShow less
Company Achieves Key Clinical Milestone with more than 20 Patients Enrolled in Weekly Dosing Cohort of Phase 1 Trial of Decoy20 Pharmacodynamic immune activation biomarker and pharmacokinetics profiles in initial data sets appear to meet or exceed initial expectations Early signs of potential benefit emerge with some patients demonstrating Stable Disease NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”) today announces financial results for the fourth quarter and fiscal year ended December 31, 2024 and provides a corporate update. Jeffrey Meckler, Chief Executive Officer of Indaptus, commented, “We continue to make significant progress in our Phase 1 trial of Decoy20, and enrolling more than 20 patients in the weekly dosing cohort marks an important milestone. We are particularly encouraged by the emerging clinical data, with some patients in this cohort demonstrating stable disease - an early sign that Decoy20’s immune-modulating approach may be having a meaningful impact. With a favorable safety profile observed so far, we are focused on efficiently advancing our trial and exploring Decoy20’s potential, both as a monotherapy and in combination therapy in difficult-to-treat cancers. We look forward to generating additional data in the months ahead as we prepare to initiate our planned combination trial with BeiGene’s PD-1 inhibitor, tislelizumab.” Key recent highlights: Successfully advanced Phase 1 study of Decoy20 in advanced solid tumors, with weekly dosing now underway following a positive Safety Review Committee assessment. Achieved key milestone with more than 20 patients enrolled in the weekly dosing cohort among the two Decoy20 dose levels, further supporting the clinical evaluation of Decoy20’s safety and activity. Additionally, early signs of potential benefit emerge with some patients with Stable Disease. Entered clinical supply agreement with BeiGene to advance Decoy20 for its evaluation in combination with BeiGene’s PD-1 inhibitor, tislelizumab, for use in multiple cancer types, with trial initiation expected in 2025. Secured new patents in China, Japan and Israel, covering Decoy bacteria compositions for the prevention or treatment of Hepatitis B virus (HBV) and human immunodeficiency virus (HIV), further expanding and reinforcing the company’s intellectual property position. Received Clinical Trial authorization from Health Canada, clearing the Company for expansion of clinical trial sites and broader patient recruitment. Presented promising PK, pharmacodynamic, and safety results for Decoy20 at the American Society for Clinical Oncology (ASCO) and the Society for Immunotherapy of Cancer (SITC) annual meetings. Published data in Frontiers in Immunology demonstrating the pre-clinical pharmacodynamic, mechanism of action, and safety results for the Decoy platform. Successfully completed multiple financings throughout the past year, including registered direct offerings and an equity line, bolstering financial flexibility. Financial Highlights for Fourth Quarter and Fiscal Year Ended December 31, 2024 Research and development expenses for the three months ended December 31, 2024, were $2.5 million, which compares with $2.0 million in the three months ended December 31, 2023. The change was primarily due to an increase of $0.7 million expenses in our Phase 1 clinical trial and was offset by a decrease of $0.2 million in payroll and related expenses. Research and development expenses for the twelve-month period ended December 31, 2024, were $7.2 million, which compares with $7.6 million in the twelve-month period ended December 31, 2023. The decrease for the twelve-month period was primarily due to a decrease of approximately $1.3 million in the development of our manufacturing processes of Decoy20 that were conducted in 2023. This was offset by an increase of $0.9 million in costs associated with our Phase 1 clinical trial. General and administrative expenses for the three months ended December 31, 2024, were $1.7 million, which compares with $2.2 million in the three months ended December 31, 2023. The change was primarily due to stock-based compensation, legal fees, and franchise tax expenses. General and administrative expenses for the twelve-month period ended December 31, 2024, were $8.1 million, which compares with $8.8 million in the twelve-month period ended December 31, 2023. The improvement for the twelve-month period was primarily due to a decrease of $1.3 million in legal fees, recruitment costs, payroll and related expenses, franchise tax, and directors’ and officers’ insurance expenses. This was offset by an increase of $0.6 million in investor relations and business development expenses. Loss per share for the twelve-month period ended December 31, 2024 was $1.61, compared with $1.83 for the twelve-month period ended December 31, 2023. As of December 31, 2024, the Company had cash and cash equivalents of $5.8 million. During January 2025, the Company conducted a private placement resulting in net proceeds of $2.0 million. During February 2025, the Company established a $20 million equity line of credit with Yorkville. As of December 31, 2023, the Company had cash and cash equivalents of $13.4 million. The Company expects that its current cash and cash equivalents will support its ongoing operating activities into the second quarter of 2025. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken. Indaptus continues to assess all financing options that would support its corporate strategy. Net cash used in operating activities was $12.3 million for the twelve-month period ended December 31, 2024, compared with net cash used in operating activities of $13.4 million for the twelve-month period ended December 31, 2023. The variance resulted primarily from net changes in operating asset and liability items. There was no net cash provided by or used in investing activities in the twelve-month period ended December 31, 2024. Net cash provided by investing activities was $17.1 million for the twelve-month period ended December 31, 2023, which was related to the maturity of $24.0 million in marketable securities, offset by net investment of $6.9 million in marketable securities. Net cash provided by financing activities for the twelve-month period ended December 31, 2024, was $4.7 million, which was provided by the issuance and sale of the Company’s common stock under its ATM program and the issuance and sale of our common stock and warrants in financings conducted in August and November 2024. There was no net cash provided by or used in financing activities in the twelve-month period ended December 31, 2023. 2025 Outlook The Company plans to dose the first patients in its combination study to evaluate potential synergy with BeiGene’s Tislelizumab. The Company is working to increase the number of trial sites to accelerate patient enrollment and data collection. The Company expects to provide further clinical updates throughout 2025, including data from weekly-dosing cohorts. The Company plans to provide new data on expansion of the Decoy platform and nominate a new candidate for IND enabling studies. 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, with associated “cold” to “hot” tumor inflammation signature transition. 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. Indaptus’ Decoy product candidates have also produced significant 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: our expectations and plans regarding our Phase 1 clinical trial of Decoy20 and our anticipated combination study, including the timing and design thereof; the anticipated effects of our product candidates, including Decoy20; the plans and objectives of management for future operations; our research and development activities and costs; the sufficiency of our cash and cash equivalents to fund our ongoing activities and our cash management strategy; and our assessment of financing options to support our corporate strategy. 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: [email protected] Investor Relations Contact: CORE IR Louie Toma [email protected] Media Contact: CORE IR Jules Abraham [email protected] 917-885-7378

