Tharimmune's TH104 Demonstrates Opioid-Resistant Respiratory Depression in Phase I Trials

Tharimmune's TH104 has demonstrated protection from respiratory depression caused by opioids in clinical trials. The company's transmucosal buccal film is being developed for liver-related and inflammatory conditions. Tharimmune is also developing a pipeline of novel therapeutic candidates targeting high-value immune-oncology targets, including HER2, HER3, and PD-1.

Tharimmune, Inc., a clinical-stage biotechnology company focused on developing therapeutic candidates for immunology and inflammation conditions, has released its Form 10-Q report for the second quarter of 2025. The report highlights significant improvements in financial performance and key advancements in its business operations.

Financial Highlights
Tharimmune reported a net loss of $1.9 million for the second quarter of 2025, an improvement of $0.5 million compared to the same period in 2024. This improvement was primarily due to a decrease in research and development expenses. Total operating expenses decreased by $0.5 million, or 22%, compared to the same period in 2024, driven by reduced research and development costs. Research and development expenses decreased by 45%, primarily due to lower pre-clinical vendor expenses and license fees. General and administrative expenses decreased by 5%, mainly due to reduced personnel expenses. Interest income decreased by 96%, reflecting a decrease in cash balances, while interest expense increased by 18%, primarily related to insurance premium financing liability and legal fees settlement [1].

Business Highlights
Tharimmune is advancing its pipeline with a focus on TH104 and TH103, targeting chronic pruritus and prophylaxis of respiratory and nervous system depression in high-potency opioid exposure scenarios. The company is prioritizing the development of TH104 as a transmucosal buccal film product for temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders. The FDA has provided positive feedback on the regulatory pathway, allowing for a 505(b)(2) NDA submission without additional clinical trials. The company is also working on TH023, an oral anti-TNF-α monoclonal antibody infliximab, licensed from Intract Pharma. The company plans to initiate a first-in-human bioavailability clinical trial after optimizing its CMC program. Additionally, Tharimmune is expanding its early-stage pipeline with novel therapeutic candidates targeting high-value immuno-oncology targets, including HER2, HER3, and PD-1. The company is advancing HS1940, a bispecific biologic targeting PD-1 and VEGF, and has completed initial pre-clinical in-vitro testing for HS3215, a HER2/HER3 bispecific antibody. Tharimmune is also actively pursuing strategic collaboration opportunities to maximize the value of its pipeline and bring novel therapies to patients.

Future Outlook
Tharimmune intends to pursue a capital-efficient strategy to file an NDA for TH104's PrHPO indication and subsequently focus on the pruritus in PBC indication. The company is also committed to advancing its CMC plan to meet FDA requirements for NDA filing.

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[1] https://www.tradingview.com/news/tradingview:ac31c8ef9a0d8:0-tharimmune-inc-sec-10-q-report/