Overview

Genelux is a late clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic viral immunotherapies for patients with aggressive and/or difficult-to-treat solid tumor types. The company’s clinical and preclinical product candidates are intended to selectively kill tumor cells and induce a robust immune response against a patient’s tumor neoantigens. Genelux’s oncolytic immunotherapy product candidates are “off-the-shelf” personalized immunotherapies, where the same virus product is administered to different patients, but the cellular immune response generated is expected to be specific to the unique neoantigens in that patient.

Since inception, Genelux has incurred significant operating losses and does not have any approved products or revenue from product sales. The company expects to continue incurring significant expenses as it advances its current and future product candidates through preclinical and clinical development, manufacturing, and regulatory approval processes. Genelux will need substantial additional funding to support its operations and pursue its growth strategy, as it does not expect to generate revenue from commercially approved product sales until it successfully completes clinical development and obtains regulatory approval for its product candidates.

Recent Developments

In March 2025, Genelux completed an underwritten public offering of 3 million shares of common stock, raising $9.6 million in net proceeds. In October 2024, the company announced the first patient had been dosed in a Phase 2 clinical trial evaluating the efficacy and safety of Olvi-Vec, its lead oncolytic viral immunotherapy, for patients with recurrent non-small cell lung cancer (NSCLC) in the United States. Additionally, in January 2025, Genelux appointed Matthew Pulisic as the new Chief Financial Officer, replacing Lourie Zak.

Components of Results of Operations

Net Sales Genelux did not generate any revenue from product sales during the three months ended March 31, 2025. In the prior year period, the company recognized $0.008 million in revenue related to a license agreement.

Operating Expenses Genelux’s operating expenses consist of research and development (R&D) expenses and general and administrative (G&A) expenses.

Research and Development Expenses R&D expenses primarily include costs for employee compensation, stock-based compensation, manufacturing and laboratory materials, outsourced services, clinical and regulatory activities, facility-related expenses, and consulting. R&D costs are expensed as incurred, and the company expects these expenses to increase significantly as it advances its clinical programs.

General and Administrative Expenses G&A expenses consist of personnel-related costs, including salaries, benefits, and stock-based compensation, as well as professional services, facility-related expenses, insurance, and other administrative costs. Genelux anticipates G&A expenses will increase to support the growth of its research and development activities and as it operates as a public company.

Results of Operations

Comparison of the Three Months Ended March 31, 2025 and 2024

Research and development expenses increased by $0.7 million, primarily due to a $1.4 million increase in clinical and regulatory expenses related to the Phase 3 On Prime Registration trial, partially offset by a $0.6 million decrease in stock-based compensation.

General and administrative expenses decreased by $1.0 million, mainly due to a $0.7 million reduction in stock-based compensation.

Other income, consisting of interest and bond accretion, was $0.3 million in both periods.

Liquidity and Capital Resources

As of March 31, 2025, Genelux had $35.1 million in cash, cash equivalents, and short-term investments. The company used $5.4 million in cash for operating activities during the first quarter of 2025, compared to $4.4 million in the prior year period.

Genelux believes its existing cash balance will enable it to fund operations for at least the next 12 months. However, the company will need to obtain additional funding to achieve its long-term business objectives, as it does not expect to generate significant revenue from product sales until it successfully completes clinical development and obtains regulatory approval for its product candidates.

The company raised $9.6 million in net proceeds from a public offering of common stock in March 2025. Genelux may seek to raise additional capital through public or private equity offerings, debt financing, or other sources, such as potential collaborations, strategic alliances, and licensing arrangements.

Critical Accounting Policies and Significant Judgments and Estimates

Genelux’s critical accounting policies include the estimation of prepaid research and development expenses, the measurement of stock-based compensation, and the accounting for commitments and contingencies. The company makes significant judgments and estimates in these areas, which can materially impact its financial statements.