Indaptus Therapeutics, Inc., a clinical-stage biotechnology company, announced progress in its Phase 1 clinical trial for Decoy20 and a new clinical supply agreement with BeiGene Switzerland GmbH. These developments were highlighted in the company's Form 10-Q report for the quarter ended September 30, 2024.
Decoy20 Clinical Trial Advancement
The Phase 1 clinical trial for Decoy20, a novel anti-cancer and anti-viral immunotherapy, has shown positive momentum. Six patients have completed one month of treatment at the 3 x 10^7 Decoy20 dose. The Safety Review Committee has authorized the initiation of unrestricted enrollment at this dose, signaling confidence in the drug's safety profile at the tested dosage.
Collaboration with BeiGene
In October 2024, Indaptus entered into a clinical supply agreement with BeiGene Switzerland GmbH to evaluate Decoy20 in combination with BeiGene’s anti-PD-1 antibody, tislelizumab. This combination study is anticipated to begin in 2025, pending FDA approval. The collaboration aims to explore the synergistic potential of Decoy20 and tislelizumab in enhancing anti-tumor immune responses.
Financial Overview
For the quarter ended September 30, 2024, Indaptus Therapeutics reported a total operating expense of $3.1 million, a 26% decrease compared to the same period in 2023. This reduction is attributed to the completion of certain manufacturing processes for Decoy20. The net loss for the quarter was $3.1 million, or $0.32 per share, compared to a net loss of $0.47 per share in the same period in 2023.
Research and development expenses for the quarter were approximately $1.5 million. As of September 30, 2024, the company had approximately $7.4 million in cash and cash equivalents.
Strategic Outlook and Challenges
Indaptus Therapeutics is actively pursuing strategic initiatives to support its long-term growth, including advancing Decoy20 through clinical trials and seeking additional capital. The company anticipates needing additional funding to support its operations beyond the first quarter of 2025 and plans to secure this through various means, including equity or debt financings, collaborations, strategic alliances, or license agreements.
However, the company faces substantial financial challenges. The report indicates that there is substantial doubt about the company’s ability to continue as a going concern if it cannot secure sufficient financing. As of September 30, 2024, the company had approximately $7.4 million in cash and cash equivalents but used $8.9 million of cash in operations during the nine-month period ended September 30, 2024. Without securing additional financing, the company may need to delay, reduce, or eliminate its research and development programs or cease operations.
Indaptus also faces operational, regulatory, and market risks inherent to clinical-stage biotechnology companies. These include dependence on third parties, product liability exposure, and the ability to retain key personnel and protect intellectual property rights.
