Genelux Corporation Announces Q1 2024 Financial Results and Business Updates

Genelux Corporation, a late clinical-stage immuno-oncology company, has published its financial results for the first quarter of 2024 and shared its ongoing business developments. The company, listed under NASDAQ as GNLX, is actively progressing its pivotal Phase 3 registration trial of Olvi-Vec for treating platinum-resistant/refractory ovarian cancer.

The company’s President, Chairman, and CEO, Thomas Zindrick, highlighted the advancement of their Olvi-Vec trials. He emphasized the company’s enthusiasm in exploring the intravenous administration of Olvi-Vec as a method to potentially reverse resistance to platinum in various tumor types.

Looking forward, Genelux anticipates beginning a Phase 2 clinical trial in recurrent non-small cell lung cancer in the second quarter of the year. Additionally, interim data from the Phase 1b trial in recurrent small cell lung cancer is expected later this year. Both trials focus on patients previously treated with platinum-based chemotherapy, specifically through intravenous administration of Olvi-Vec. These trial designs stem from earlier clinical research demonstrating benefits in patients with primary or metastatic lung disease, as well as those with platinum-resistant/refractory ovarian cancer.

Several pipeline highlights were shared. Genelux continues to enroll patients in the Phase 3 OnPrime/GOG-3076 trial in the United States, which currently has 22 active sites and anticipates topline results by the second half of 2025. The company is also enrolling patients in the Phase 1b trial for recurrent small cell lung cancer in China, co-sponsored with Newsoara BioPharma Co., Ltd., with interim results expected in the latter half of 2024. Furthermore, the initiation of the Phase 2 trial in the United States for recurrent non-small cell lung cancer is projected for the first half of 2024.

On the business front, Genelux filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission in the first quarter of 2024. This allows the company to offer and sell up to $300 million in various securities over time. Concurrently, Genelux entered a sales agreement to potentially sell up to $100 million in common stock through Guggenheim Securities.

Financially, Genelux reported $19.6 million in cash, cash equivalents, and short-term investments as of March 31, 2024, projecting this will support operations into the second quarter of 2025. Research and development (R&D) expenses increased to $4.0 million in Q1 2024 from $2.8 million in Q1 2023, primarily due to new hires, stock compensation, and clinical manufacturing costs. General and administrative (G&A) expenses rose slightly from $3.8 million in Q1 2023 to $4.1 million in Q1 2024, driven by professional services and consulting costs related to the shelf registration, offset by lower stock compensation expenses.

The net loss for the first quarter of 2024 was $7.9 million, or $0.29 per share, compared to a net loss of $10.4 million, or $0.53 per share, in the same period in 2023.

Genelux Corporation is dedicated to developing oncolytic immunotherapies for treating aggressive and difficult-to-treat solid tumors. Their most advanced product, Olvi-Vec, a modified strain of the vaccinia virus, is currently under evaluation in a comprehensive Phase 3 trial. The company's innovative CHOICE™ platform underpins its extensive oncolytic vaccinia virus product pipeline, aiming to offer novel treatment options for cancer patients.