HCW Biologics Reports Third Quarter 2025 Business Highlights and Financial Results

Core Viewpoint - HCW Biologics Inc. reported its financial results for Q3 2025, highlighting advancements in its clinical programs, particularly the upcoming Phase 1 study for HCW9302 targeting autoimmune diseases, and the need for additional funding to ensure continued operations [1][12]. Business Highlights - The company plans to dose the first patient in a Phase 1 clinical study for HCW9302 in Q4 2025, which is aimed at treating autoimmune diseases and inflammatory conditions [2]. - HCW9302 is a novel IL-2 fusion molecule designed to enhance Treg cell activity, which is crucial for controlling inflammation in autoimmune diseases [2]. - The company is actively seeking a commercial partner for its T-cell engager (TCE) compounds, which aim to improve cancer treatment by targeting tumor antigens while reducing immunosuppression in the tumor microenvironment [3]. Financial Results - Revenues for Q3 2025 were $15,606, a significant decrease from $426,423 in Q3 2024. For the nine months ended September 30, 2025, revenues totaled $27,222 compared to $2.2 million in the same period of 2024 [7]. - R&D expenses increased by 18% in Q3 2025 to $1.4 million, while for the nine months, they decreased by 23% to $4.1 million due to prior year manufacturing costs [8]. - G&A expenses rose by 15% in Q3 2025 to $1.9 million, and for the nine months, they increased by 29% to $6.2 million, primarily due to higher salaries and professional fees [9]. - The net loss for Q3 2025 was $4.6 million, compared to $3.9 million in Q3 2024. For the nine months, the net loss was $8.7 million, significantly lower than $26.7 million in the same period of 2024 [11]. Financial Guidance - The company expressed substantial doubt regarding its ability to continue as a going concern for at least 12 months without additional funding [12]. - As of September 30, 2025, the company is not in compliance with Nasdaq's Equity Rule, which requires a minimum stockholders' equity of $2.5 million [13]. - A Nasdaq Hearings Panel granted the company continued listing on the exchange, contingent upon compliance with the Equity Rule by December 31, 2025 [14].