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Genelux Corporation to Participate in a Fireside Chat at the Citizens Life Sciences Conference
GlobeNewswire· 2025-05-01 20:05
WESTLAKE VILLAGE, Calif., May 01, 2025 (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, and Matt Pulisic, CFO, will discuss clinical-stage programs and upcoming milestones in a fireside chat at the Citizens Life Sciences Conference taking place May 7-8, 2025, in New York. The conversation with Biotech Equity Research Managing Director, Silvan Tuerkcan, PhD, is scheduled to be ...
Genelux Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-03-28 20:10
– Alignment reached with U.S. Food and Drug Administration on key elements of the approval pathway for Olvi-Vec in Platinum Resistant/Refractory Ovarian Cancer – – Positive Preliminary Phase 1b/2 Data of Olvi-Vec in Advanced Small-Cell Lung Cancer – – Matt Pulisic joined the company as its new Chief Financial Officer – – Closing of $10.5 Million Underwritten Offering of Common Stock – – $30.9 million in cash, cash equivalents and short-term investments – WESTLAKE VILLAGE, Calif., March 28, 2025 (GLOBE NEWSW ...
Genelux (GNLX) - 2024 Q4 - Annual Report
2025-03-28 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-41599 GENELUX CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer incorporation ...
Down -29.7% in 4 Weeks, Here's Why Genelux Corporation (GNLX) Looks Ripe for a Turnaround
ZACKS· 2025-03-28 14:36
Genelux Corporation (GNLX) has been on a downward spiral lately with significant selling pressure. After declining 29.7% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether ...
Genelux (GNLX) - 2024 Q4 - Annual Results
2025-03-25 13:03
Financial Position - As of December 31, 2024, Genelux Corporation estimates its cash, cash equivalents, and short-term investments to be approximately $30.9 million[4]. - The Company has not yet completed its financial close process for the quarter and year ended December 31, 2024, and the preliminary cash estimate is subject to change[4]. - The corporate presentation made available on March 25, 2025, includes forward-looking statements regarding the Company's financial position and clinical trial outcomes[5]. Clinical Trials - In a Phase 1b clinical trial, 71% of evaluable participants (5 out of 7) achieved disease control with Olvi-Vec immunochemotherapy, showing tumor reductions ranging from 24% to 79%[11]. - The FDA indicated that a clinically meaningful progression-free survival advantage could support traditional approval for Olvi-Vec in treating platinum-resistant/refractory ovarian cancer[12]. - The Company anticipates reporting interim results from the Phase 2 VIRO-25 trial in the second half of 2025[14]. - Topline results from the Phase 3 OnPrime/GOG-3076 trial are expected to be reported in the first half of 2026[13]. - Treatment-related adverse events in the Olvi-Vec trial were mostly mild to moderate, with no maximum tolerated dose reached to date[8]. - The Company plans to provide an interim readout of updated data from the ongoing clinical trial in the second half of 2025[10]. - The FDA recommended a pre-BLA meeting to discuss next steps following the completion of the trial[12].
Genelux Corporation Announces Pricing of $10.5 Million Underwritten Offering of Common Stock
Newsfilter· 2025-03-25 12:31
Group 1 - Genelux Corporation announced the pricing of an underwritten offering of 3,000,000 shares of its common stock at $3.50 per share, expecting gross proceeds of $10.5 million before deductions [1][2] - The net proceeds from the offering will be utilized for working capital and general corporate purposes, including the continued clinical development of Olvi-Vec [2] - The offering is expected to close on or about March 26, 2025, subject to customary closing conditions [2] Group 2 - Genelux is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for aggressive and difficult-to-treat solid tumors [4] - Olvi-Vec is currently being evaluated in two U.S.-based clinical trials: a Phase 3 trial for platinum-resistant ovarian cancer and a Phase 2 trial for non-small-cell lung cancer [4] - The company utilizes its proprietary CHOICE™ platform to develop an extensive library of oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec [4]
Genelux and Newsoara Announce Positive Preliminary Phase 1b/2 Data of Olvi-Vec in Advanced Small-Cell Lung Cancer
Newsfilter· 2025-03-25 12:30
Core Insights - Olvi-Vec shows promise as a platinum resensitizing agent for various solid tumors, particularly in platinum-relapsed or platinum-refractory extensive small cell lung cancer [1][3][10] - The ongoing Phase 1b trial indicates a favorable safety profile and preliminary anti-tumor activity, with a 71% disease control rate observed [5][7][8] Company Overview - Genelux Corporation is a late clinical-stage immuno-oncology company focused on developing oncolytic immunotherapies, with Olvi-Vec as its leading candidate [15] - Newsoara BioPharma Co., Ltd. is a pre-commercial-stage biopharmaceutical company collaborating with Genelux on the Olvi-Vec clinical trials [16] Clinical Trial Details - The Olvi-Vec-SCLC-202 trial is a Phase 1b/2 study assessing the safety, tolerability, pharmacokinetics, and efficacy of Olvi-Vec in patients with extensive small cell lung cancer [10][12] - The trial is currently enrolling patients in China, with Shanghai Chest Hospital as the lead clinical site [10] Safety and Efficacy Findings - The systemic administration of Olvi-Vec demonstrated a manageable safety profile, with treatment-related adverse events primarily mild to moderate [5][6] - In the initial dose escalation cohorts, 71% of participants achieved disease control, with significant tumor reductions noted in several cases [7][8] Future Directions - Ongoing evaluation of Phase 1b results will inform the design of the Phase 2 portion of the clinical trial [9][13] - Genelux plans to provide updates on trial progress through future publications and conference presentations [4]
Genelux Announces Alignment with FDA on Key Elements of the Approval Pathway for Olvi-Vec in Platinum Resistant/Refractory Disease
GlobeNewswire· 2025-03-25 12:30
- U.S. Food and Drug Administration states that data from the ongoing OnPrime/GOG-3076 Phase 3 registrational trial could potentially support traditional approval - WESTLAKE VILLAGE, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that Genelux has concluded a productive Type D meeting with the U.S. Food and Drug Administration (FDA) for Olvi-Vec in the treatment of platinum resistant/refractory ovarian cancer (PRRO ...
Genelux Corporation Announces New Chief Financial Officer
GlobeNewswire· 2025-02-03 11:45
WESTLAKE VILLAGE, Calif., Feb. 03, 2025 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that Matthew Pulisic has joined the company as its new Chief Financial Officer, effective January 30, 2025. "I am very pleased to welcome Matt as our new Chief Financial Officer. Matt’s financial acumen, strategic mindset and proven leadership abilities are an ideal fit for Genelux,” said Thomas Zindrick, President, CEO and Chairman of the Board. “Hi ...
Genelux Corporation to Participate in a Fireside Chat with H.C. Wainwright
GlobeNewswire Inc.· 2024-12-13 12:01
Company Overview - Genelux Corporation is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for aggressive and difficult-to-treat solid tumors [3] - The company's lead candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a modified strain of the vaccinia virus [3] Clinical Programs - Olvi-Vec is currently being evaluated in a Phase 3 registrational trial (OnPrime/GOG-3076) for platinum-resistant/refractory ovarian cancer, comparing its efficacy and safety in combination with platinum-doublet + bevacizumab against physician's choice of chemotherapy and bevacizumab [3] - The company is also conducting a Phase 1b/2 trial in small-cell lung cancer (SCLC) and a Phase 2 trial in non-small cell lung cancer (NSCLC) [2] Upcoming Events - Thomas Zindrick, President, CEO, and Chairman of the Board, will participate in a virtual fireside chat with H.C. Wainwright & Co. on December 16, 2024 [1] - The session will be moderated by Emily Bodnar, a biotech equity research analyst, and will begin at 11:00 a.m. ET [2]