UNITED STATES
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FORM
CURRENT REPORT
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Item 8.01. Other Events.
On March 25, 2024, Indaptus Therapeutics, Inc. (the “Company”) announced that Dr. Michael Newman, Founder and Chief Scientific Officer of the Company, will present a poster containing new data regarding the Company’s research compound, Decoy10, at the 2024 Annual Meeting of the American Association for Cancer Research (“AACR”) in San Diego on April 10, 2024. An abstract of the data to be presented has been published online in the AACR Journal, Cancer Research. The data confirm and significantly extend the proposed mechanism of action of the Company’s proprietary platform technology of attenuated and killed, non-pathogenic bacteria containing multiple immune receptor agonists for pulsed anti-tumor immunotherapy. The data demonstrate that the Company’s single agent Decoy bacteria were able to induce or activate multiple human innate and adaptive immune cell types involved in anti-tumor responses, including M1 macrophages, natural killer cells, dendritic cells, Th1 CD4, and CD8 T cells.
Forward-Looking Statements
This Current Report on Form 8-K (the “Form 8-K”) 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, expectations regarding the impact of the data to be discussed at AACR; the anticipated effects of our product candidates; the plans and objectives of management for future operations; and our research and development activities. 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, 2024, 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 Form 8-K. All forward-looking statements speak only as of the date of this Form 8-K and are expressly qualified in their entirety by the cautionary statements included in this Form 8-K. 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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: March 25, 2024
| INDAPTUS THERAPEUTICS, INC. | ||
| By: | /s/ Nir Sassi | |
| Name: | Nir Sassi | |
| Title: | Chief Financial Officer | |