Indaptus Therapeutics, Inc. has evolved from over a century of immunotherapy advances, dedicated to developing novel treatments for cancer and viral infections. The company's innovative 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.
Company Background
Indaptus was founded in 2021 following the domestication merger of Intec Pharma Ltd., an Israeli company, and the reverse merger with Decoy Biosystems, Inc. This strategic combination united the innovative approaches of both companies to develop cutting-edge cancer and viral infection treatments. As a clinical-stage biotechnology company with a limited operating history, Indaptus faced significant challenges in its early years. The company incurred net losses and utilized cash in operations since inception, which raised substantial doubt about its ability to continue as a going concern. To address these financial challenges, Indaptus worked diligently to secure additional capital through public and private offerings of its equity securities, ensuring the continued funding of its operations and research and development activities.
Technology and Product Pipeline
The company's patented Decoy technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria that are designed to prime or activate many of the cells and pathways of innate and adaptive immunity. This antigen-agnostic platform has demonstrated single-agent activity against various cancer types, including metastatic pancreatic and colorectal carcinomas, as well as combination-mediated eradication of established hepatocellular carcinomas, pancreatic, and non-Hodgkin's lymphomas in preclinical models.
In preclinical studies, Indaptus' Decoy product candidates have shown the ability to induce a broad yet controlled activation of the immune system, while reducing the toxicity often associated with other cancer immunotherapies. The company's unique "pulse-prime" approach is designed to trigger a strong and broad boost to the immune system that clears rapidly, minimizing toxicity and enabling safe systemic administration - a longstanding challenge with novel cancer immunotherapies.
Clinical Development
Indaptus initiated a Phase 1 clinical trial of its lead product candidate, Decoy20, in December 2022. The open-label, multi-center, dose escalation and expansion study is evaluating Decoy20 as a monotherapy in patients with advanced solid tumors. In August 2023, the company reported encouraging safety, pharmacokinetic, and biomarker data from the first four patients in the initial single-dose cohort. All patients experienced generally anticipated transient adverse events, and Decoy20 was cleared from the blood within 30-120 minutes, consistent with the company's "pulse-prime" hypothesis.
In September 2023, Indaptus began the second cohort of the Phase 1 trial, reducing the Decoy20 dose based on the significant pharmacodynamic effect seen in the initial cohort. In March 2024, the company completed the second cohort and advanced into the weekly dosing part of the trial. As of the latest update, Indaptus has dosed the first three patients at the lower 3 x 10^7 Decoy20 dose for one month of weekly administration, with the safety profile remaining consistent with expectations.
The objectives of the Phase 1 study are to assess the safety and tolerability of Decoy20, determine the maximum tolerated dose and recommended Phase 2 dose, as well as to assess Decoy20's pharmacokinetics, pharmacodynamics and clinical activity. The company plans to initiate weekly dosing at the 7 x 10^7 Decoy20 level later this year.
Intellectual Property and Recognition
Indaptus has also made progress in expanding its intellectual property portfolio, announcing the granting of a key patent in January 2024 that further protects the Decoy platform. Additionally, the company has been recognized for its scientific contributions, with its founder and Chief Scientific Officer, Dr. Michael Newman, being named chair of the 5th Annual STING & TLR-Targeted Therapies Summit in June 2024.
Financials and Liquidity
The company's financial position as of June 30, 2024, showed cash and cash equivalents of $7.3 million. In August 2024, Indaptus completed a $3 million registered direct offering and concurrent private placement, raising net proceeds of approximately $2.5 million. The company expects its current cash resources to support ongoing operations into the first quarter of 2025, excluding any additional funding or business development activities.
Indaptus' research and development expenses for the six months ended June 30, 2024, were $3.3 million, a decrease of $0.1 million compared to the same period in 2023. The decrease was primarily due to a reduction in manufacturing costs for Decoy20, offset by an increase in expenses related to the Phase 1 trial and payroll. General and administrative expenses for the first half of 2024 were $4.7 million, up $0.1 million year-over-year, driven by higher payroll and stock-based compensation costs.
The company's net loss for the six months ended June 30, 2024, was $7.8 million, or $0.92 per share, compared to a net loss of $7.5 million, or $0.89 per share, in the same period of 2023. Indaptus used $6.4 million in cash for operating activities during the first half of 2024, an improvement from the $7.1 million used in the prior-year period.
For the most recent fiscal year ended December 31, 2023, Indaptus reported a net loss of $15,423,471, with operating cash flow (OCF) and free cash flow (FCF) both at -$13,405,315. The company does not generate revenue at this stage.
In the most recent quarter ended June 30, 2024, Indaptus reported no revenue, a net loss of $4,015,267, and OCF and FCF of -$2,477,951. The decrease in net income, OCF, and FCF for the most recent quarter compared to the prior year quarter was primarily due to increased research and development and general and administrative expenses.
Regarding liquidity, as of June 30, 2024, Indaptus had a debt-to-equity ratio of 0.017, a current ratio of 3.88, and a quick ratio of 3.88. The company does not have any disclosed available credit lines.
Future Outlook
Looking ahead, Indaptus is focused on advancing its Phase 1 clinical trial of Decoy20, with plans to initiate a combination study with a PD-1 inhibitor in 2025. The company believes its unique approach to broadly stimulating the immune system, while minimizing toxicity, has the potential to meaningfully impact cancer treatment. Indaptus also continues to explore opportunities to expand its pipeline and leverage its Decoy platform for additional therapeutic applications, including viral infections.
Risks and Considerations
Despite the company's promising progress, Indaptus faces several risks that investors should be aware of. As a clinical-stage biotechnology company, Indaptus is subject to the inherent uncertainties and challenges of drug development, including the potential for delays or failures in clinical trials, regulatory approvals, and commercialization. The company's limited operating history, ongoing need for capital, and reliance on third-party manufacturers and service providers also introduce risks to its business model.
Business Overview
Indaptus Therapeutics is a clinical-stage biotechnology company focused on developing a novel, multi-targeted product that activates both innate and adaptive anti-tumor and anti-viral immune responses. 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.
In May 2022, the FDA allowed Indaptus to proceed under its IND for a Phase 1 clinical trial in patients with advanced solid tumors. The company initiated this open-label, multi-center, dose escalation and expansion, single arm monotherapy Phase 1 study of Decoy20 in December 2022. The primary endpoints of the study are to assess the safety and tolerability of Decoy20, determine the maximum tolerated dose and recommended Phase 2 dose, as well as assess Decoy20 pharmacokinetics and pharmacodynamics and clinical activity.
As of the latest update, Indaptus does not have any approved products or defined product segments beyond the Decoy20 program. The company's operations are focused solely on the development of Decoy20 as its lead and only clinical-stage product candidate. Additionally, Indaptus does not break out performance by geographic markets and appears to operate primarily in the United States.
Conclusion
In conclusion, Indaptus Therapeutics is pioneering a novel approach to cancer and viral infection treatments, leveraging its unique Decoy platform to stimulate both innate and adaptive immune responses. With encouraging early clinical data, a strengthened intellectual property position, and a focused strategy, the company is well-positioned to continue advancing its pipeline and exploring the full potential of its technology. However, investors should carefully consider the risks and uncertainties inherent to the biotechnology industry when evaluating Indaptus as a potential investment opportunity.