Genelux Corp. Reports $29.9 Million Net Loss for 2024 Amid Decreased Revenue

Genelux Corp., a late-stage biopharmaceutical company focused on oncolytic viral immunotherapies, reported a net loss of $29.9 million for the year ended December 31, 2024, compared to a net loss of $28.3 million in 2023. Revenue for 2024 totaled $8,000, a significant decrease from $170,000 in 2023. The increase in net loss is primarily attributable to higher research and development expenses, which rose to $18.998 million from $12.767 million in 2023, and a slight increase in general and administrative expenses to $12.706 million from $11.568 million.

Significant changes in research and development expenses were driven by a $1.2 million increase in employee compensation, a $1.2 million increase in stock-based compensation, and a $4.5 million increase in clinical and regulatory expenses related to the Phase 3 OnPrime trial and a Phase 2 trial for non-small cell lung cancer. General and administrative expense increases stemmed from higher employee compensation, stock compensation, and consulting expenses, partially offset by a decrease in professional services. The company received $11 million in payments from Newsoara BioPharma Co. Ltd. in 2021 and 2022, related to a licensing agreement for Olvi-Vec in China. In 2024, Genelux received $10,000 in revenue from a license agreement with Elias Animal Health, LLC.

Key operational developments include the initiation of a Phase 3 OnPrime registration trial for Olvi-Vec in platinum-resistant/refractory ovarian cancer in the third quarter of 2022, with topline results anticipated in the first half of 2026. A Phase 2 VIRO-25 trial for recurrent non-small cell lung cancer began enrollment in the fourth quarter of 2024, with interim results expected in the second half of 2025. A co-sponsored Phase 1b/2 trial in recurrent small cell lung cancer in China is ongoing. The company also has a cGMP manufacturing facility in San Diego, California, and leased a second building for future laboratory and office space. As of December 31, 2024, Genelux employed 24 full-time and part-time employees.

The company's financial statements included a "going concern" explanatory paragraph, indicating substantial doubt about its ability to continue as a going concern. Genelux anticipates needing substantial additional financing to advance its development programs, which may not be available on acceptable terms or at all. The company plans to pursue additional development and commercial collaborations for Olvi-Vec and other product candidates, while retaining U.S. rights and developing commercial capabilities. The company also intends to leverage its CHOICE discovery platform to build a portfolio of oncology product candidates.

Genelux's outlook is contingent upon successful clinical trial outcomes, regulatory approvals, and securing sufficient funding. The company acknowledges numerous risks, including those related to its financial position, product development, regulatory approvals, manufacturing, reliance on third parties, commercialization, intellectual property, government regulation, and competition. The company's ability to achieve profitability and successfully commercialize its product candidates remains uncertain.