Genelux Corporation Announces Q2 2024 Financial Results and Business Updates

Genelux Corporation, a clinical-stage immuno-oncology company, reported its financial results for the second quarter of 2024 and shared business updates. This period has been transformative for Genelux as they completed significant financing, which is expected to support the company through three pivotal trial readouts, including a Phase 3 trial for platinum-resistant/refractory ovarian cancer.

The company is also anticipating interim data for the systemic delivery of their lead product candidate Olvi-Vec in both small cell and non-small cell lung cancer within the next year. Specifically, interim results from the Phase 2 trial for recurrent non-small cell lung cancer are expected by mid-2025. Meanwhile, interim data from the Phase 1b trial in recurrent small cell lung cancer is projected for later this year. Both studies involve intravenous administration of Olvi-Vec in patients who have previously not responded to platinum-based chemotherapy. These trials build on prior clinical evidence showing the benefits of intravenously administered Olvi-Vec in lung disease patients and data from their Phase 2 trial in ovarian cancer.

Currently, Genelux's Phase 3 OnPrime/GOG-3076 registration trial in platinum-resistant/refractory ovarian cancer (PRROC) is ongoing, with more than 23 sites activated. Topline results from this trial are anticipated in the second half of 2025. Additionally, the U.S.-based Phase 2 trial in recurrent non-small cell lung cancer aims to report interim results by mid-2025, and interim results from the Phase 1b part of the Phase 1b/2 trial in recurrent small cell lung cancer in China are expected in the latter half of 2024. These trials highlight Olvi-Vec's potential to become the first Phase 3 systemic oncolytic vaccinia virus therapy.

In May 2024, Genelux completed a public offering of common stock and accompanying warrants, raising $27.7 million in net proceeds. These funds are expected to provide the company with working capital into the first quarter of 2026, supporting general corporate objectives and the ongoing clinical development of Olvi-Vec.

Financially, Genelux reported cash, cash equivalents, and short and long-term investments totaling $40.4 million as of June 30, 2024. The company believes these funds will sustain operations through the first quarter of 2026. Research and development expenses for the second quarter of 2024 were $4.4 million, up from $2.9 million in the second quarter of 2023. The increase was driven by higher clinical and regulatory expenses, outsourced manufacturing services, employee compensation, and stock-related compensation. General and administrative expenses remained stable year-over-year at $2.5 million. Increased stock compensation costs were balanced by decreased professional service expenses, primarily from reduced corporate legal costs.

Genelux reported a net loss of $6.6 million for the second quarter of 2024, compared to a net loss of $5.8 million for the same period in 2023. The loss per share was $0.22, a slight improvement from $0.23 in the previous year.

Genelux Corporation specializes in developing next-generation oncolytic immunotherapies targeted at aggressive and hard-to-treat solid tumors. Their most advanced product candidate, Olvi-Vec, is a modified strain of the vaccinia virus currently being evaluated in a multi-center, randomized, open-label Phase 3 registrational trial. The company’s research efforts are centered around their proprietary CHOICE™ platform, which has led to the development of a comprehensive library of oncolytic vaccinia virus product candidates, including Olvi-Vec.