Core Insights - Genelux Corporation is a late clinical-stage immuno-oncology company focused on developing next-generation oncolytic immunotherapies for patients with aggressive and difficult-to-treat solid tumors [3] Company Overview - Genelux is currently evaluating its lead product, Olvi-Vec, in two U.S.-based clinical trials: OnPrime/GOG-3076, a Phase 3 trial for platinum-resistant/refractory ovarian cancer, and VIRO-25, a Phase 2 trial for non-small-cell lung cancer [3] - Additionally, Olvi-Vec is being assessed in a China-based Phase 1b/2 trial for recurrent small-cell lung cancer [3] - The company utilizes its proprietary CHOICE™ platform to develop a library of engineered oncolytic vaccinia virus immunotherapeutic candidates, including Olvi-Vec [3] Upcoming Events - Key executives, including Thomas Zindrick (President, CEO, and Chairman), Matt Pulisic (CFO), and Dr. Jason Litten (CMO), will participate in a virtual fireside chat on January 19, 2026 [1] - The event will be hosted by Boris Peaker, PhD, Managing Director and Senior Equity Research Analyst at Titan Partners [1]

Core Viewpoint - Genelux Corporation has announced a public offering of 6,666,667 shares of its common stock at a price of $3.00 per share, aiming to raise approximately $20.0 million in gross proceeds [1][2]. Group 1: Offering Details - The offering consists of 6,666,667 shares priced at $3.00 each, with all shares being sold by Genelux [1]. - The gross proceeds from the offering are expected to be around $20.0 million before deducting underwriting discounts and commissions [2]. - An additional 30-day option has been granted to the underwriter to purchase up to 1,000,000 shares at the same price [2]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for general corporate purposes, which may include research and development expenses, clinical trial expenses, capital expenditures, and working capital [3]. Group 3: Company Overview - Genelux is a late clinical-stage biopharmaceutical company focused on developing oncolytic immunotherapies for aggressive and difficult-to-treat solid tumors [6]. - The company’s lead product, Olvi-Vec, is currently being evaluated in multiple clinical trials for various cancer types, including ovarian cancer and non-small-cell lung cancer [6].

Company Overview - Genelux Corporation is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for patients with aggressive and/or difficult-to-treat solid tumors [5] - The company's lead product, Olvi-Vec, is currently being evaluated in multiple clinical trials for various cancer types, including ovarian cancer and non-small-cell lung cancer [5] Proposed Offering - Genelux has announced a proposed underwritten public offering of its common stock, with an expectation to grant the underwriter a 30-day option to purchase up to an additional 15% of the shares sold [1] - The offering is subject to market conditions and customary closing conditions, with no assurance on the completion or terms of the offering [1] Management and Regulatory Details - Lucid Capital Markets is acting as the sole book-running manager for the proposed offering [2] - The offering is being made under an effective shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC) [3]

Core Insights - Genelux Corporation has appointed Dr. Jason Litten as Chief Medical Officer, effective January 2, 2026, to oversee clinical development and medical strategy for Olvi-Vec [2][3] Company Overview - Genelux is a late clinical-stage biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for aggressive and difficult-to-treat solid tumors [8] - The company is advancing Olvi-Vec through multiple pivotal clinical trials, including a Phase 3 trial for platinum-resistant ovarian cancer and a Phase 2 trial for non-small-cell lung cancer [8] Leadership Experience - Dr. Litten has over 20 years of experience in oncology drug development, having held senior roles at various biopharmaceutical companies, including Chimeric Therapeutics and Artiva Biotherapeutics [4][5] - His expertise includes leading clinical trials across liquid and solid tumors, with a focus on innovative therapies [3][4] Clinical Development Strategy - Dr. Litten's appointment is expected to enhance Genelux's clinical execution and support the development of Olvi-Vec as a leading immunotherapy option [3][6] - The company aims to unlock the full clinical and commercial potential of Olvi-Vec, which is seen as a compelling therapeutic platform for multiple tumor types [6] Stock Option Award - In connection with his appointment, Dr. Litten received a stock option award to purchase 275,000 shares of common stock, which will vest over four years [7]

Core Insights - 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 [3] Company Participation - Thomas Zindrick, President, CEO, and Chairman of the Board, along with Matt Pulisic, Chief Financial Officer, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025, at 12:00 p.m. ET in New York, NY [1] Clinical Trials - Olvi-Vec, the company's lead product, is currently being evaluated in two U.S.-based clinical trials: - OnPrime/GOG-3076, a Phase 3 trial for platinum-resistant/refractory ovarian cancer [3] - VIRO-25, a Phase 2 trial for non-small-cell lung cancer [3] - Additionally, Olvi-Vec is being evaluated in a China-based Phase 1b trial for recurrent small-cell lung cancer [3] Proprietary Technology - The core of Genelux's discovery and development efforts is its proprietary CHOICE™ platform, which has led to the development of an extensive library of oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec [3]

Core Viewpoint - The FDA has accepted the resubmission of the Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma treatment, with a target action date set for April 10, 2026 [1][2] Company Overview - Replimune Group, Inc. is a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies, founded in 2015 and headquartered in Woburn, MA [4] - The company's proprietary RPx platform utilizes a potent HSV-1 backbone to enhance immunogenic cell death and systemic anti-tumor immune response [4] Product Information - RP1 (vusolimogene oderparepvec) is Replimune's lead product candidate, engineered from a proprietary strain of herpes simplex virus, designed to maximize tumor killing potency and activate systemic anti-tumor immune responses [3] Regulatory Progress - The resubmission of the BLA for RP1 is considered a complete response to the FDA's complete response letter received in July 2025, with additional data and analyses included to address agency feedback [2]

Core Viewpoint - Replimune Group, Inc. is facing a class action lawsuit due to alleged misleading statements regarding the prospects of its IGNYTE trial, which led to a significant stock price drop after the FDA's response [4][5]. Group 1: Company Overview - Replimune is a clinical-stage biotechnology company focused on developing and commercializing oncolytic immunotherapies for cancer treatment [3]. Group 2: Legal Allegations - The class action lawsuit claims that Replimune's management made false and misleading statements about the IGNYTE trial, which they knew or should have known were overstated [4]. - The lawsuit highlights that the FDA deemed the IGNYTE trial inadequate and not well-controlled, impacting the company's credibility [4]. Group 3: Financial Impact - Following the FDA's issuance of a Complete Response Letter regarding the Biologics License Application for RP1, Replimune's stock price plummeted by over 77% [5].

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 [3] - The company's lead product, Olvi-Vec, is currently being evaluated in multiple clinical trials for various cancer types, including ovarian cancer and non-small-cell lung cancer [3] Upcoming Events - Thomas Zindrick, President, CEO, and Chairman, along with CFO Matt Pulisic, will participate in a fireside chat at H.C. Wainwright & Co's Annual Global Investment Conference on September 9, 2025 [1] - The session will be moderated by Biotech Equity Research Analyst Emily Bodnar and is scheduled to begin at 2:30 p.m. ET [2] Clinical Trials - Olvi-Vec is being evaluated in two U.S.-based clinical trials: - OnPrime/GOG-3076, a Phase 3 trial for platinum-resistant/refractory ovarian cancer [3] - VIRO-25, a Phase 2 trial for non-small-cell lung cancer [3] - Additionally, a China-based Phase 1b trial is assessing Olvi-Vec for recurrent small-cell lung cancer [3] Contact Information - For investor and media inquiries, contact Ankit Bhargava at Allele Communications, LLC [4]

Core Viewpoint - Replimune Group, Inc. is engaging with the FDA to discuss the complete response letter for its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment, emphasizing the urgent need for access to this therapy in the melanoma community [1][3]. Company Overview - Replimune Group, Inc. is a clinical-stage biotechnology company founded in 2015, focused on developing novel oncolytic immunotherapies to transform cancer treatment [5]. - The company's lead product candidate, RP1, is based on a proprietary strain of herpes simplex virus engineered to enhance tumor killing potency and activate systemic anti-tumor immune responses [4][5]. FDA Interaction - A Type A meeting with the FDA has been scheduled to address the complete response letter concerning the BLA for RP1, with the company submitting a briefing book that responds to the FDA's concerns [1][2]. - The briefing book includes prior agreements on patient population, PD-1 resistance criteria, and additional data analysis from the BLA [2]. Community Support - The melanoma community, including physicians and patient advocacy groups, has highlighted the urgent need for RP1 due to limited effective treatment options available [3].

Core Viewpoint - Replimune Group, Inc. is under investigation for potential violations of federal securities laws following a significant decline in stock price after the FDA's response regarding its lead product candidate RP1 [1][4]. Company Overview - Replimune is a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for cancer treatment, with RP1 as its lead product candidate aimed at melanoma [2]. Clinical Trial Results - On June 6, 2024, Replimune announced positive top-line results from the IGNYTE Phase 1/2 clinical trial for RP1 in combination with nivolumab [2]. - The company repeatedly promoted the results of the IGNYTE trial, but the trial design was criticized for not being adequate to produce reliable results [3]. Regulatory Response - On July 22, 2025, Replimune received a Complete Response Letter from the FDA, indicating that the IGNYTE trial was not considered adequate and well-controlled, leading to a significant stock price drop of over 75% [4]. - The FDA specifically noted that the trial's results could not be adequately interpreted due to the heterogeneity of the patient population [4].