Genelux Corporation Reports First Quarter 2024 Financial Results and Provides General Business Update

Genelux Corporation

WESTLAKE VILLAGE, Calif., May 9, 2024 (GLOBE NEWSWIRE) – Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced Q1 2024 financial results and provided general business updates.

“Our pivotal Phase 3 registration trial of Olvi-Vec in platinum-resistant/refractory ovarian cancer continues to enroll patients,” he said. Thomas Zindrick, Chairman, President and CEO of Genelux. “Looking ahead, we are excited about advancing Olvi-Vec into additional cancer indications through intravenous administration, a route of administration preferred by clinicians, and seeking to further validate our hypothesis that Olvi-Vec can reverse the platinum resistance in various tumor types.”

The Company expects to initiate our Phase 2 study in recurrent non-small cell lung cancer in the second quarter of this year and report interim data from our Phase 1b study in recurrent small cell lung cancer later this year. Both trials were designed to administer Olvi-Vec intravenously and to rechallenge patients who previously failed platinum-based chemotherapy. The projects build on an earlier clinical trial showing the benefit of Olvi-Vec administered intravenously in patients with lung disease (primary or metastatic) and our Phase 2 data in platinum-resistant/refractory ovarian cancer (PRROC). ).

Pipeline highlights

We are actively enrolling patients in the ongoing Phase 3 OnPrime/GOG-3076 registrational trial at PRROC in the United States. Currently, 22 sites have been activated to enroll patients with additional sites identified and in various stages of activation (NCT05281471). We are on track to achieve top-line results in the second half of 2025.

Patient recruitment has been increasing in the ongoing Phase 1b portion of the Phase 1b/2 study testing systemic administration of Olvi-Vec in patients with recurrent small cell lung cancer. The trial is co-sponsored with our partner Newsoara BioPharma Co., Ltd. and is being conducted at prominent locations in China. We anticipate the provisional reading in the second half of 2024.

The initiation of the Phase 2 trial in the United States, testing systemic administration of Olvi-Vec in recurrent non-small cell lung cancer trials, is expected to begin in the first half of 2024.

Business Updates

In the first quarter of 2024, we filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission. Pursuant to the shelf registration statement, we may offer and sell, from time to time, up to $300.0 million of common stock, preferred stock, debt securities and/or warrants in one or more offerings. Concurrently with the shelf registration statement, the Company entered into a sales agreement under which the Company may offer to sell shares of common stock up to $100.0 million through Guggenheim Securities, acting as our sales agent.

The story continues

First Quarter 2024 Financial Results

Cash, cash equivalents and short term investments was $19.6 million as of March 31, 2024. We expect our cash, cash equivalents and existing short-term investments to provide inflow in the second quarter of 2025.

Research and development (R&D) expenses were $4.0 million in Q1 2024 compared to $2.8 million in Q1 2023, respectively. The $1.2 million year-over-year increase in R&D expenses in 2024 was primarily due to a $0.4 million increase related to new employee hires after the first quarter of 2023, an increase of $0.3 million in stock compensation and a $0.4 million increase related to clinical manufacturing, regulatory expenses and other R&D expenses.

General and administrative expenses (G&A) were $4.1 million in the first quarter of 2024, compared to $3.8 million in the first quarter of 2023. The $0.3 million year-over-year increase in general and administrative expenses in 2024 was primarily the result of a $0.4 million increase in professional services expenses in 2024, primarily due to costs associated with our shelf registration on Form S-3 and a $0.5 million increase due to consulting expenses , employee-related costs and other general and administrative expenses, offset by a $0.6 million reduction in stock compensation expense in the first quarter of 2024 compared to the first quarter of 2023.

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

About Genelux Corporation

Genelux is an advanced clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. The company’s most advanced product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, engineered strain of the vaccinia virus. Olvi-Vec is currently being evaluated in OnPrime/GOG-3076, a multicenter, randomized, open-label Phase 3 registration trial evaluating the efficacy and safety of Olvi-Vec in combination with platinum doublet + bevacizumab compared to Physician choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer. The core of Genelux’s discovery and development efforts revolves around its proprietary CHOICE™ platform, from which the company has developed an extensive library of isolated and engineered immunotherapeutic product candidates for oncolytic vaccinia virus, including Olvi-Vec. For more information please visit www.genelux.com and follow us on Twitter @Genelux_Corp and so on LinkedIn.

Forward-looking statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made in accordance with the provisions of safe harbor of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results or strategies and are generally preceded by words such as “believe,” “anticipate,” “expect,” “may” , “plans” or “will”. Forward-looking statements in this release include, but are not limited to, statements relating to Genelux’s future plans and prospects, Genelux’s anticipated cash flow and sufficiency of its resources to support its planned operations, the planned timing of results of data from Genelux on its ongoing clinical trials and continued development of Olvi-Vec, the planned initiation of the Phase 2 trial in non-small cell lung cancer and its timing; and the potential capabilities and advantages of Olvi-Vec. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the heading “Risk Factors” in Genelux’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date they are made and are based on management’s assumptions and estimates as of that date. Genelux undertakes no obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

Contacts with investors and media

Ankit Bhargava, MD
Alelo Communications, LLC
genelux@allelecomms.com

Source: Genelux Corporation

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