Indaptus Therapeutics Inc Stock Price, News & Analysis

Indaptus Therapeutics (INDP) has initiated a new expansion arm in its Phase 1b/2 clinical trial, combining Decoy20 with BeiGene's PD-1 checkpoint inhibitor, tislelizumab. The study will evaluate safety, dosing, and preliminary anti-tumor activity in advanced solid tumors.

The expansion marks a significant development in testing Decoy20's synergistic potential with checkpoint inhibitors in patients for the first time. The combination aims to address the limitations of current checkpoint inhibitor treatments, where many patients either don't respond or don't experience lasting effects.

Decoy20 is designed to activate the immune system in a way that could potentially enhance and expand the effectiveness of checkpoint inhibitors, representing a possible breakthrough in solid tumor treatment approaches.

Indaptus Therapeutics (NASDAQ: INDP) has reported significant progress in its Phase 1 trial of Decoy20, with over 20 patients enrolled in the weekly dosing cohort. The company has observed promising early results, including stable disease in some patients and favorable safety profiles.

Key developments include a clinical supply agreement with BeiGene for combination therapy with tislelizumab, new patents in China, Japan, and Israel for HBV and HIV treatments, and Clinical Trial authorization from Health Canada. The company presented positive results at ASCO and SITC annual meetings.

Financial results show R&D expenses of $2.5M for Q4 2024 (up from $2.0M in Q4 2023) and $7.2M for FY2024 (down from $7.6M in FY2023). Loss per share improved to $1.61 in 2024 from $1.83 in 2023. Cash position stands at $5.8M as of December 31, 2024, with additional $2.0M raised in January 2025 and a new $20M equity line established with Yorkville in February 2025. The current cash runway extends into Q2 2025.

Indaptus Therapeutics (NASDAQ: INDP) has announced an upcoming webinar presentation titled 'Keys To The Kingdom: Unlocking The Power Of Your Immune System' scheduled for March 17, 2025, at 9:00 AM Pacific/12:00 PM Eastern time.

The event will feature CEO Jeffrey Meckler and will be hosted by Tribe Public's Managing Member John F. Heerdink, Jr. Participants can register for free at INDP-KEYS.TribePublic.com and will have the opportunity to submit questions either in advance via email or during the event through the ZOOM chat feature.

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.