Financial Performance - For the nine months ended September 30, 2024, the company reported a net loss of $14.6 million, compared to a net loss of $16.2 million for the same period in 2023, indicating a decrease in losses of approximately 9.9%[107] - The company recognized revenue of $0.01 million for the nine months ended September 30, 2024, compared to $0.2 million for the same period in 2023, reflecting a significant decrease in revenue[112] - Total operating expenses for the three months ended September 30, 2024, were $6.941 million, an increase of 30.8% from $5.307 million in the same period of 2023[121] - Research and development expenses for the three months ended September 30, 2024, were $4.051 million, up from $2.819 million in 2023, representing an increase of 43.6%[122] - General and administrative expenses increased to $2.9 million for the three months ended September 30, 2024, up from $2.5 million in 2023, primarily due to a $0.7 million rise in stock compensation expenses[124] - Research and development expenses rose to $12.5 million for the nine months ended September 30, 2024, from $8.6 million in 2023, reflecting a $3.9 million increase due to higher clinical trial costs and employee compensation[127] - General and administrative expenses for the nine months ended September 30, 2024, were $9.5 million, an increase from $8.7 million in 2023, mainly due to higher stock compensation and consulting expenses[128] - Net loss for the nine months ended September 30, 2024, was $20.9 million, a slight improvement from a net loss of $21.5 million in 2023[130] - Cash used in operating activities was $16.9 million for the nine months ended September 30, 2024, compared to $13.4 million in 2023[136] - The company incurred a net loss of $28.3 million for the year ended December 31, 2023, with an accumulated deficit of $221.5 million[131] Funding and Cash Flow - The company expects its cash and cash equivalents, totaling $35.1 million at September 30, 2024, to last until the first quarter of 2026[110] - The company raised $27.7 million in net proceeds from a secondary public offering completed in 2024[132] - Total cash and cash equivalents, along with short and long-term investments, amounted to $35.1 million as of September 30, 2024, expected to last into the first quarter of 2026[132] - The company will need substantial additional funding to support its operations and growth strategy, relying on public or private equity offerings and debt financings[109] - The company anticipates needing further funding to achieve business objectives beyond the next 12 months[147] - Financing needs may be met through public or private equity offerings, debt financings, or collaboration agreements, which could dilute existing stockholders' ownership[148] - The company may have to relinquish valuable rights to technologies or revenue streams if it raises funds through collaborations or licensing arrangements[150] - The company is evaluating potential remedies for $24.0 million in committed investment amounts that certain investors have not paid[145] Research and Development - The company announced the initiation of a Phase 2 clinical trial for Olvi-Vec in patients with recurrent non-small cell lung cancer (NSCLC) in October 2024[111] - The company has entered into a Clinical Trial Services Agreement with Hong Kong Tigermed Consulting Co., Ltd., with a total contract amount of up to $10.1 million for regulatory and development support services for the NSCLC trial[111] - The company expects expenses to increase significantly due to ongoing research and development, preclinical studies, clinical trials, and potential commercialization efforts[145] - The company believes existing cash and short-term investments will fund operating expenses for at least the next 12 months, but future capital requirements depend on various factors including clinical trial costs and regulatory reviews[146] Legal and Compliance - The company has not had any off-balance sheet arrangements during the nine months ended September 30, 2024 and 2023[162] - There have been no changes in internal control over financial reporting that materially affected the company during the third quarter of 2024[167] - The company is not currently subject to any material legal proceedings but may face future claims or investigations in the ordinary course of business[167]

Company Overview - Genelux Corporation is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for patients with aggressive and difficult-to-treat solid tumors [4] - The company's most advanced product candidate, Olvi-Vec, is a modified strain of the vaccinia virus currently being evaluated in a Phase 3 trial for platinum-resistant/refractory ovarian cancer [4] Upcoming Events - Thomas Zindrick, President, CEO, and Chairman of the Board, will discuss clinical-stage programs and upcoming milestones at the Guggenheim Inaugural Healthcare Innovation Conference from November 11-13, 2024 [1] - The conversation with Brittany Stopa, MD, is scheduled for November 11, 2024, at 1:30 p.m. ET, with a webcast link available for the event [2] - The company will also participate in one-on-one meetings during the conference for institutional investors [3]

Core Insights - Genelux Corporation (NASDAQ: GNLX) is preparing for a significant milestone in the upcoming year, with topline results expected from its phase 3 OnPrime/GOG-3076 registrational study for the oncolytic immunotherapy drug Olvi-Vec [2] Company Overview - Genelux Corporation is focused on developing innovative cancer therapies, particularly through its oncolytic immunotherapy approach [2] Investment Analysis - The Biotech Analysis Central service offers extensive resources for investors, including a library of over 600 biotech investing articles and a model portfolio featuring more than 10 small and mid-cap stocks [2]

Core Insights - Genelux Corporation has initiated the Phase 2 (VIRO-25) trial for Olvi-Vec in recurrent non-small cell lung cancer (NSCLC) patients who have failed previous treatments, marking a significant milestone for patients with limited options [1][2] - The trial aims to evaluate the efficacy and safety of Olvi-Vec combined with platinum-doublet chemotherapy and a physician's choice of immune checkpoint inhibitor (ICI) compared to docetaxel [2] - Interim results from the trial are expected to be available by mid-2025 [1][2] Company Overview - Genelux Corporation is a late-stage clinical biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for aggressive solid tumors [4] - The company's lead product candidate, Olvi-Vec, is a modified strain of the vaccinia virus, currently being evaluated in multiple clinical trials, including a Phase 3 trial for platinum-resistant ovarian cancer [4] - Olvi-Vec has been administered to over 150 patients across seven clinical trials, demonstrating a generally well-tolerated safety profile and evidence of clinical benefit [3] Product Details - Olvi-Vec is a proprietary oncolytic vaccinia virus with a large engineering capacity, designed to infect and kill various tumor cell types while eliciting an anti-tumor immune response [3] - The ongoing Phase 1b/2 trial for intravenous delivery of Olvi-Vec in recurrent small cell lung cancer is co-sponsored with Newsoara Biopharma Co. Ltd., highlighting the potential of Olvi-Vec as a systemically administered treatment option [2]

WESTLAKE VILLAGE, Calif., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that Thomas Zindrick, President, CEO and Chairman of the Board, will participate at the 2024 Maxim Healthcare Virtual Summit taking place October 15-17, 2024. Mr. Zindrick will discuss clinical-stage programs, recent announcements, and upcoming milestones in a fireside chat with Jason McCarthy, Ph.D., Senior Managing Director, Head of Biotechnology Re ...

WESTLAKE VILLAGE, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that Thomas Zindrick, President, Chairman and CEO, will discuss clinical-stage programs, recent announcements, and upcoming milestones in a fireside chat at the H.C. Wainwright Global Healthcare Conference, taking place September 9-11, 2024, in New York City, New York. The conversation with Emily Bodnar, Vice President, Equity Research and H.C. Wainw ...

WESTLAKE VILLAGE, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that Thomas Zindrick, President, CEO and Chairman, will discuss clinical-stage programs, recent announcements, and upcoming milestones in a fireside chat at BTIG's Virtual Biotechnology Conference 2024. The conversation with Kaveri Pohlman, PhD, Director and BTIG Biotechnology Analyst, is scheduled to begin at 12:00 p.m. ET on Tuesday, August 6, 2024. ...

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. WESTLAKE VILLAGE, Calif., May 24, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (Genelux) (Nasdaq: GNLX), a late clinical-stage immuno-oncology co ...

Company Overview - Genelux Corporation is a late clinical-stage immuno-oncology company focused on developing next-generation oncolytic immunotherapies for aggressive and difficult-to-treat solid tumors [5] - The company's leading product candidate, Olvi-Vec, is a modified strain of the vaccinia virus currently undergoing a Phase 3 trial for platinum-resistant/refractory ovarian cancer [5] Public Offering Details - Genelux has initiated an underwritten public offering of its common stock and accompanying warrants, with the expectation to grant underwriters a 30-day option to purchase an additional 15% of the shares sold [1][2] - Guggenheim Securities is the sole book-running manager, while Newbridge Securities Corporation acts as co-manager for the offering [2] Regulatory Compliance - The shares are being offered under an effective shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC), and the offering will be conducted via a written prospectus [3]

WESTLAKE VILLAGE, Calif., May 23, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (Genelux) (Nasdaq: GNLX), a late clinical-stage immuno-oncology company, today announced that it has commenced an underwritten public offering of its common stock and accompanying warrants. All shares of common stock and accompanying warrants are being offered by Genelux. In addition, Genelux expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in conne ...