Indaptus Therapeutics Inc Stock Price, News & Analysis

Indaptus Therapeutics (Nasdaq: INDP) has secured new patent approvals in China, Japan, and Israel for its Decoy platform, covering treatments for Hepatitis B virus (HBV) and HIV infections. The patents extend to combination therapies with approved and investigational treatments.

The company's Decoy platform uses attenuated and killed bacteria to stimulate the immune system. Preclinical studies have shown significant single-agent activity in HBV and HIV infection models. The Decoy20 candidate is currently in Phase 1 clinical trials for advanced cancers in the U.S.

The patent expansion is particularly significant in Asia, where China accounts for approximately 87 million people living with chronic HBV, representing one-third of global cases. Japan has approximately 1.1-1.2 million HBV-affected individuals. Globally, HBV caused an estimated 1.1 million deaths in 2022, primarily from cirrhosis and liver cancer.

Indaptus Therapeutics (Nasdaq: INDP) announced that Founder and Chief Scientific Officer Dr. Michael Newman will present at the 10th Annual Innate Killer Summit in San Diego on March 4, 2025.

Dr. Newman's presentation, titled "Employing Attenuated & Killed Gram-Negative Bacteria to Induce NK-Mediated Anti-Tumor Immunity," will cover:

• The science behind Indaptus' Decoy platform, a multi-immune receptor agonist designed to trigger broad immune activation against tumors
• The Company's "Pulse-Prime" approach for safe and effective anti-tumor activity in pre-clinical models
• Clinical data from the ongoing Phase 1 trial of Decoy20 in advanced solid tumors

CEO Jeffrey Meckler emphasized that their Decoy platform is designed to harness multiple arms of the immune system, including Natural Killer (NK) cells, to combat cancer. The summit, taking place March 3-5, 2025, brings together experts to advance NK-based therapeutic approaches in oncology.

Indaptus Therapeutics (NASDAQ: INDP) has received Clinical Trial Authorization from Health Canada to expand its ongoing U.S. clinical trial, INDP-D101, for its lead asset Decoy20. The expansion will allow patient enrollment in Canadian sites under the current protocol of weekly Decoy20 dosing.

The company plans to submit an amendment to Health Canada to incorporate its upcoming combination trial pairing Decoy20 with Beigene's PD-1 checkpoint inhibitor, tislelizumab. This expansion aims to create a more diverse and robust data set, following Health Canada's comprehensive review of safety data and trial design.

The addition of Canadian trial sites is expected to accelerate the collection of clinical data from a broader population, helping evaluate Decoy20's ability to activate both innate and adaptive immune systems in treating solid tumors.

Indaptus Therapeutics (Nasdaq: INDP), a clinical stage biotechnology company, announced a $2.25 million private placement priced at-the-market under Nasdaq rules. The placement involves the issuance and sale of 2,109,383 shares of common stock and accompanying warrants to purchase an equal number of shares. Each share and warrant combination is priced at $1.065. The closing is expected around January 15, 2025, subject to customary closing conditions. The warrants, exercisable immediately at $0.94 per share, have a five-year term. Paulson Investment Company, is the exclusive placement agent for this offering. The gross proceeds are anticipated to be around $2.25 million, before deducting placement agent fees and other expenses. Indaptus plans to use the net proceeds to fund research and development, working capital, and general corporate purposes. The securities are offered under Section 4(a)(2) of the Securities Act of 1933 and Rule 506(b) of Regulation D, not registered under the Securities Act or state securities laws, and cannot be resold in the U.S. without registration or an applicable exemption.

Indaptus Therapeutics (Nasdaq: INDP) has released its year-end review for 2024 and strategic goals for 2025, highlighting significant clinical progress and planned trials. The company's lead candidate, Decoy20, showed promising results in its Phase 1 trial. Key milestones include:

• March 2024: Second cohort results demonstrated broad immune response across multiple tumor types.
• May 2024: Initiation of weekly-dose cohort with no new significant adverse effects.
• September 2024: Higher-dose expansion following positive safety review.

Indaptus presented Decoy20’s potential at major conferences like AACR and ASCO and published research in peer-reviewed journals. A key achievement was a clinical supply agreement with BeiGene to evaluate Decoy20 in combination with tislelizumab, their PD-1 checkpoint inhibitor.

Financially, Indaptus raised $5.5 million in 2024 to support ongoing R&D. For 2025, the company plans to:

• Launch a combination cohort with Decoy20 and tislelizumab.
• Expand clinical sites beyond the current eight.
• Provide updates on higher-dose cohorts.
• Start dosing the first patients in the combination cohort.

CEO Jeffrey Meckler expressed optimism about the progress and potential of their platform to address challenging cancers.

Indaptus Therapeutics (Nasdaq: INDP) has announced a $2.135 million registered direct offering and concurrent private placement. The company will issue 1,817,017 common shares along with unregistered warrants to purchase an equal number of shares. The combined purchase price is $1.175 per share, with warrants exercisable at $1.05 per share for five years. The proceeds will fund research and development activities, working capital, and general corporate purposes. The offering, expected to close around November 25, 2024, includes participation from a company officer and is being facilitated by Paulson Investment Company as the exclusive placement agent.

Indaptus Therapeutics (Nasdaq: INDP) reported Q3 2024 financial results and corporate updates. The company announced a clinical supply agreement with BeiGene to evaluate cancer treatment combinations and progressed its Phase 1 trial of Decoy20. Research and development expenses decreased to $1.5 million from $2.2 million year-over-year. General and administrative expenses fell to $1.7 million from $2.0 million. Loss per share improved to $0.32 from $0.47. Cash position stood at $7.4 million as of September 30, 2024, expected to support operations into Q1 2025. The company completed a $3 million registered direct offering in August 2024, netting approximately $2.5 million.

Indaptus Therapeutics (NASDAQ: INDP) announced the publication of groundbreaking research in Frontiers in Immunology, detailing their novel Decoy platform and Decoy20 immunotherapy candidate. The research demonstrates how their technology activates multiple immune pathways using attenuated, killed bacteria to fight cancer.

Preclinical studies showed Decoy20's effectiveness against various cancers, including colorectal, pancreatic, hepatocellular cancers, and lymphomas, both as a single agent and in combination with other therapies. The platform's unique 'pulse-prime' approach enables broad immune system activation while reducing toxicity compared to traditional immunotherapies. The company is currently conducting Phase 1 clinical trials for Decoy20 in advanced solid tumors and plans to combine it with BeiGene's tislelizumab.

Indaptus Therapeutics has presented interim safety data from its Phase 1 clinical trial of Decoy20 at the SITC 2024 Annual Meeting. The data comes from two cohorts totaling 13 patients receiving single administration and one cohort of 6 patients receiving weekly administration. Results showed mainly mild to moderate and transient side effects with weekly intravenous administration. The pharmacokinetic analysis confirmed rapid clearance from bloodstream, supporting the company's 'pulse' approach. One patient with squamous cell carcinoma of the head and neck showed stable disease at first imaging. The trial is now enrolling patients with 6 tumor types for weekly dosing, and the company has partnered with BeiGene to test Decoy20 in combination with tislelizumab.