Welcome to our dedicated page for Genelux news (Ticker: GNLX), a resource for investors and traders seeking the latest updates and insights on Genelux stock.
Genelux Corp (GNLX) is a clinical-stage biopharmaceutical company pioneering oncolytic viral immunotherapies for aggressive solid tumors. This page serves as the definitive source for official news, press releases, and scientific developments related to GNLX’s innovative pipeline and proprietary CHOICE™ platform.
Investors and researchers will find timely updates on clinical trial progress, regulatory milestones, and strategic partnerships. Content spans product development breakthroughs, peer-reviewed study outcomes, and operational announcements – all curated to support informed decision-making in the immuno-oncology sector.
Key updates include advancements in lead candidate Olvi-Vec’s clinical evaluation, platform technology enhancements, and analyses of treatment mechanisms for resistant cancers. All materials maintain compliance with financial disclosure standards while emphasizing therapeutic potential and scientific rigor.
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Genelux (NASDAQ: GNLX) reported its Q4 and full year 2024 financial results, highlighting key developments in its oncology pipeline. The company reached alignment with FDA on the approval pathway for Olvi-Vec in Platinum Resistant/Refractory Ovarian Cancer, with topline data expected in H1 2026.
In clinical developments, preliminary Phase 1b/2 data for Olvi-Vec in Advanced Small-Cell Lung Cancer showed a 71% disease control rate, with two partial responders and favorable safety profile. The company strengthened its financial position with a $10.5 million underwritten offering at $3.50 per share.
Financial highlights include:
- Cash position of $30.9 million as of December 31, 2024
- R&D expenses increased to $19.0 million from $12.8 million in 2023
- G&A expenses rose to $12.7 million from $11.6 million in 2023
- Net loss of $29.9 million ($0.95 per share) compared to $28.3 million ($1.16 per share) in 2023
Genelux (Nasdaq: GNLX) has announced the pricing of an underwritten offering of 3,000,000 shares of common stock at $3.50 per share, expected to raise gross proceeds of $10.5 million. The late clinical-stage immuno-oncology company plans to use the net proceeds for working capital and general corporate purposes, including the continued clinical development of Olvi-Vec.
The offering is expected to close on March 26, 2025, subject to customary closing conditions. Titan Partners Group, a division of American Capital Partners, is serving as the sole bookrunner for the offering. The securities are being offered through an effective shelf registration statement previously filed with the SEC.
Genelux and Newsoara BioPharma have announced promising preliminary data from their Phase 1b/2 trial of Olvi-Vec immunochemotherapy in platinum-relapsed/refractory small cell lung cancer patients. The trial showed a 71% disease control rate (5/7 patients), with two achieving partial responses.
Key highlights include:
- One participant achieved ~79% tumor reduction
- Three participants reached stable disease with tumor reductions of 24-29.2%
- All patients with disease control experienced reductions in all target lesions
- Treatment demonstrated favorable safety profile with mostly mild to moderate side effects
The data suggests Olvi-Vec's potential as a platinum resensitizing agent beyond ovarian cancer. The trial continues enrollment for dose escalation to determine the recommended intravenous dose for Phase 2.
Genelux (NASDAQ: GNLX) has announced a successful Type D meeting with the FDA regarding Olvi-Vec's approval pathway for treating platinum resistant/refractory ovarian cancer (PRROC). The FDA indicated that data from the ongoing OnPrime/GOG-3076 Phase 3 registrational trial could potentially support traditional approval without requiring a separate confirmatory study.
The FDA specified that if the trial demonstrates a clinically meaningful progression-free survival (PFS) advantage without decreasing overall survival (OS), it could be sufficient for traditional approval. The company plans to report topline safety and efficacy data in the first half of 2026.
Genelux (NASDAQ: GNLX) has appointed Matthew Pulisic as its new Chief Financial Officer, effective January 30, 2025. Pulisic brings over 19 years of finance and commercial experience in the biopharmaceutical industry, having worked across the United States, Europe, and Asia.
Prior to joining Genelux, Pulisic served as Vice President of Finance at Arrowhead Pharmaceuticals, where he led planning and analysis and established a commercial manufacturing facility. He previously worked at Amgen in various finance roles, including Finance Director of Amgen Worldwide and Head of Capital Finance.
As part of his appointment, Pulisic received an inducement award of stock options to purchase 275,000 shares at $3.95 per share, vesting over four years with 25% vesting after one year and the remainder monthly over 36 months.
Genelux (NASDAQ: GNLX) has announced its participation in a virtual fireside chat with H.C. Wainwright & Co. on December 16, 2024. The company's President, CEO and Chairman Thomas Zindrick will engage in discussions moderated by Biotech Equity Research Analyst Emily Bodnar, starting at 11:00 a.m. ET.
The session will focus on the clinical program of Olvi-Vec, including its ongoing:
- Phase 3 registration trial in platinum resistant/refractory ovarian cancer (PRROC)
- Phase 1b/2 trial in small-cell lung cancer (SCLC)
- Phase 2 trial in non-small cell lung cancer (NSCLC)
The event will be accessible through registration, with a replay available for approximately 90 days on the company's IR page.
Frazier Life Sciences (FLS) has appointed John Smither and Jim Williams as Senior Advisors. Smither brings over 25 years of biopharmaceutical financial experience, having served as CFO at companies including Arcutis Biotherapeutics, where he led their IPO and follow-on financings. He currently serves on the boards of NewAmsterdam Pharma (NAMS) and Genlux Williams contributes 35 years of investment strategy expertise, previously serving as Chief Investment Officer for the J. Paul Getty Trust and President of Harbor Capital Advisors. Both advisors will support FLS's private and public investment strategies in innovative therapeutics.
Genelux (NASDAQ: GNLX) reported Q3 2024 financial results and business updates. The company initiated a US-based Phase 2 trial (VIRO-25) for non-small cell lung cancer and continues a Phase 1b/2 trial for small cell lung cancer in China. Cash position stood at $35.1 million as of September 30, 2024, providing runway into Q1 2026. Q3 2024 showed increased expenses with R&D at $4.1 million (up $1.2M YoY) and G&A at $2.9 million (up $0.4M YoY). Net loss was $6.5 million ($0.19 per share) compared to $5.3 million ($0.20 per share) in Q3 2023.
Genelux (NASDAQ: GNLX) announced its participation in the Guggenheim Inaugural Healthcare Innovation Conference in Boston, Massachusetts, from November 11-13, 2024. CEO Thomas Zindrick will engage in a fireside chat on November 11 at 1:30 p.m. ET with Brittany Stopa, Biotech Equity Research Analyst at Guggenheim, discussing clinical-stage programs, recent announcements, and upcoming milestones.
The event will be accessible via webcast, with a replay available for 90 days on the company's IR page. Genelux management will also be available for one-on-one meetings during the conference, with institutional investors invited to register or contact the company directly.
Genelux (NASDAQ: GNLX) has announced the dosing of the first patient in its U.S.-based Phase 2 (VIRO-25) trial. This trial aims to evaluate the efficacy and safety of systemically delivered Olvi-Vec in patients with recurrent non-small cell lung cancer (NSCLC) who have failed frontline platinum and immune checkpoint inhibitor (ICI) therapies.
The VIRO-25 trial (NCT06463665) is an open-label, randomized study comparing Olvi-Vec followed by platinum-doublet chemotherapy + Physician's Choice of ICI to docetaxel. This marks the second indication for Olvi-Vec via systemic administration in the clinic. Genelux expects an interim data readout in mid-2025.
The company's CEO, Thomas Zindrick, emphasized the significance of this milestone for NSCLC patients with therapeutic options. This trial, along with an ongoing Phase 1b/2 trial in recurrent small cell lung cancer, positions Olvi-Vec as a potential systemically administered oncolytic virus treatment option.
