INDP Indaptus Therapeutics Inc

Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical-stage biotechnology company pioneering innovative cancer and viral infection treatments, today highlights its accomplishments in 2024 and outlines the Company’s strategic goals for the year ahead.

Advancing Decoy20 in Clinical Trials2024 was a year of meaningful progress for Indaptus’ lead clinical candidate, Decoy20, a novel immunotherapy designed to harness both innate and adaptive immune responses. Highlights from the Company’s Phase 1 clinical trial include:

• Second Cohort Results (March 2024): Building on the Company’s November 2023 findings, Decoy20 demonstrated a broad immune response across multiple tumor types in patients, underscoring the platform’s potential as a monotherapy.
• Weekly-Dose Cohort Initiation (May 2024): After receiving Safety Review Committee approval, the Company dosed its first patient in the weekly-dose portion of the trial. Notably, no new, clinically significant treatment-related adverse effects were observed.
• Higher Dose Expansion (September 2024): Following a positive safety review, Indaptus initiated a higher-dose weekly regimen, further expanding the scope of the trial to evaluate Decoy20’s safety and efficacy.

Key Scientific Presentations, Publications and AdvancementsIndaptus showcased Decoy20’s potential through a variety of presentations at major industry conferences and peer reviewed journals:

• AACR Annual Meeting (April 2024): Demonstrated that Decoy activates multiple innate and adaptive immune cell types, highlighting its promise as an anti-tumor therapeutic.
• ASCO Annual Meeting (June 2024): Shared promising preliminary results, including immune marker activation in patients with advanced solid tumors following a single dose of Decoy20.
• STING & TLR Targeted Therapies Summit (June 2024): Dr. Michael Newman was named meeting Chairperson for the second year in a row, and presented pre-clinical and clinical Decoy data.
• Frontiers in Immunology (November 2024): Dr. Michael Newman’s groundbreaking research on the Decoy platform was published in Frontiers in Immunology, further validating the Company’s scientific foundation and enhancing visibility within the scientific community.
• Society for Immunotherapy of Cancer (SITC) (November 2024): Presented encouraging data highlighting consistent safety outcomes with weekly Decoy20 dosing, while demonstrating its sustained ability to activate the immune system over time.
• Decoy platform: The Company made significant progress expanding its Decoy platform, successfully producing engineered Decoy bacteria designed to activate targeted immune pathways, enhancing its potential for broader therapeutic applications.

Clinical Supply Agreement with BeiGene

In October 2024, Indaptus achieved a key milestone when it announced a clinical supply agreement with BeiGene to advance the evaluation of Decoy20 in combination with their PD-1 checkpoint inhibitor, tislelizumab. This agreement underscores the potential versatility of the Decoy platform as a standalone therapy and in synergy with an approved immunotherapy treatment modality. This clinical combination is important because, in pre-clinical animal models, Decoy20 demonstrated significant anti-tumor synergy in combination with a PD-1 checkpoint inhibitor.

Financial StrengthIndaptus raised a total of $5.5 million in 2024 through a series of strategic financing initiatives, ensuring funding to support ongoing research and development efforts into 2025.

2025 Outlook

Jeffrey Meckler, CEO of Indaptus Therapeutics, commented, “As we enter 2025, we remain committed to advancing Decoy20 through clinical trials and exploring its combination potential with BeiGene’s tislelizumab. We are excited about the progress we made in 2024 and optimistic about the transformative potential of our platform to address some of the most challenging cancers.”

Indaptus intends to maintain its commitment to robust data generation, with plans to share new findings at leading scientific forums as they become available, while actively pursuing opportunities to expand the applications of its Decoy platform.

The Company currently anticipates that it will achieve the following milestones in the first half of 2025:

• Launch of Combination Cohort: The Company plans to open an amendment to its clinical trial to include a combination cohort evaluating Decoy20 in conjunction with the PD-1 checkpoint inhibitor, tislelizumab.
• Expansion of Clinical Sites: Building on its progress in 2024, the Company intends to increase the number of participating clinical sites beyond the eight active locations at the end of last year, enabling broader patient enrollment.
• Higher Dose Cohort Update: The Company plans to provide an update on the patients treated in the higher dose expansion cohort, providing insights into safety and immune activation at this dose level.
• First Patient Dosed in Combination Cohort: The Company aims to start dosing the first patients in the combination cohort, marking an important step in evaluating Decoy20’s synergistic potential with checkpoint inhibitors.

The company believes these milestones, if achieved, will represent significant advancements in the clinical development of Decoy20 and the broader Decoy platform.

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. 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: our expectations and plans regarding our clinical supply agreement with BeiGene; our plans to advance clinical evaluation of the combination of BeiGene's anti-PD-1 antibody, tislelizumab, with Decoy20; our plans to seek FDA approval and to initiate a combination trial; the plans and objectives of management for future operations; our research and development activities; and the sufficiency of our cash and cash equivalents to fund our ongoing 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the SEC on November 12, 2024, 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 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 IRLouie Tomalouie@coreir.com