Tharimmune Reports $12.2 Million Net Loss for Fiscal Year 2024, Faces Financial Challenges

Tharimmune, Inc., a clinical-stage biotechnology company focused on developing therapeutic candidates for inflammatory and immunologic conditions, reported a net loss of $12.2 million for the fiscal year ending December 31, 2024, compared to a net loss of $9.3 million in the previous year. The company's total operating expenses increased to $12.4 million from $9.5 million, primarily driven by a significant rise in research and development costs, which surged by 80% to $6.4 million. This increase was attributed to clinical trial expenses related to the completion of a Phase 1 trial and preparations for a Phase 2 trial for its lead product candidate, TH104.

In terms of strategic developments, Tharimmune entered into several key agreements during the reporting period. Notably, the company signed a patent license agreement with Avior Bio, granting it exclusive rights to develop and commercialize TH104 and TH103. Additionally, a patent license agreement with Intract Pharma was established to develop an oral formulation of infliximab, an anti-TNF-alpha monoclonal antibody. These agreements are expected to enhance Tharimmune's product pipeline and market position.

Operationally, Tharimmune is preparing to initiate a Phase 2 clinical trial for TH104, which is designed to treat moderate-to-severe chronic pruritus in patients with primary biliary cholangitis (PBC). The company anticipates obtaining topline data from this trial in the fourth quarter of 2025. As of March 1, 2025, Tharimmune employed three individuals, reflecting its current scale as it gears up for clinical trials and potential commercialization efforts.

Despite these advancements, the company faces significant financial challenges, with an accumulated deficit of approximately $36.9 million as of December 31, 2024. Management has expressed substantial doubt about the company's ability to continue as a going concern without additional funding. Tharimmune has primarily financed its operations through public and private offerings, raising approximately $3.6 million in net proceeds from recent PIPE offerings and an at-the-market agreement. The company plans to seek further capital to support its ongoing development activities and operational needs.

Looking ahead, Tharimmune's future hinges on the successful development and commercialization of its product candidates. The company is focused on advancing TH104 and its early-stage candidates, HS3215 and HS1940, through clinical trials. However, the unpredictability of clinical trial outcomes, regulatory approvals, and market acceptance poses substantial risks to its business model. The company remains committed to pursuing strategic collaborations and additional funding to navigate these challenges and achieve its long-term objectives.