Golden Cross
1年前
$GNLX Genelux Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
– 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 NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported fourth quarter and full year 2024 financial results and business updates.
“Our progress in the fourth quarter of 2024 and into 2025 marks a pivotal period for patients, our company, and our investors,” said Thomas Zindrick, President, CEO and Chairman of Genelux. “We are pleased with the continued progress and promise of our clinical development program. The strengthening of our management team, with the addition of Matt, and of our balance sheet, with our recent financing, further positions the Company to execute on our mission to transform the lives of patients who need it most.”
Pipeline Highlights
OnPrime/GOG-3076 Phase 3 Registrational Trial Update
The Company continues to enroll patients in the ongoing pivotal Phase 3 OnPrime/GOG-3076 registration trial (Phase 3 trial) in platinum resistant/refractory ovarian cancer (PRROC), with the primary endpoint of progression free survival (PFS) (Clinicaltrials. gov identifier NCT05281471), and continues to have productive discussions with the U.S. Food and Drug Administration (FDA).
The Company recently concluded a productive Type D meeting with the FDA for Olvi-Vec in the treatment of PRROC. In response to a question seeking the FDA’s guidance on their expectations regarding a confirmatory trial using the ongoing Phase 3 trial results, the FDA responded that “As stated previously, an interim analysis of overall survival (OS) should be planned at the time of the primary PFS analysis. If a clinically meaningful PFS advantage is demonstrated in the absence of a decrement in OS, this could potentially support traditional approval.” The FDA further recommended Genelux request a pre-BLA meeting with FDA with topline safety and efficacy data following completion of the study to discuss next steps. This could potentially avoid the need for conducting a separate confirmatory study.
The trial will enroll a sufficient number of patients to achieve 127 events, with the primary endpoint of PFS and with secondary endpoints including OS. The Company anticipates reporting topline data in the first half of 2026.
Recurrent Lung Cancer Trials: Systemic Administration of Olvi-Vec Update
Phase 1b/2 Olvi-Vec-SCLC-202 has generated preliminary safety and anti-tumor activity data from the dose escalation Phase 1b portion of the ongoing Phase 1b/2 clinical trial of Olvi-Vec immunochemotherapy in patients with platinum-relapsed or platinum-refractory extensive small cell lung cancer. The trial is co-sponsored by the Company and its licensing partner, Newsoara BioPharma Co., Ltd. (Newsoara).
Systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved a 71% disease control rate (5/7), with two partial responders. All participants with disease control experienced a reduction in all target lesions, with one participant achieving a tumor reduction of approximately 79%.
Additionally, three participants, including one individual with three prior lines of treatment, achieved stable disease at lower dose cohorts, with tumor size reductions ranging between 24% to 29.2%.
Olvi-Vec was generally well-tolerated with a favorable safety profile. Participant enrollment into dose escalation cohorts continues to investigate safety and the recommended intravenous dose of Olvi-Vec for Phase 2 portion of the trial, with updated interim results anticipated in the second half of 2025.
Phase 2 VIRO-25 is actively enrolling recurrent non-small cell lung cancer (NSCLC) patients (NCT06463665), with interim data anticipated in second half of 2025.
Business Updates
Chief Financial Officer
Matt Pulisic has joined the Company as its new Chief Financial Officer, effective January 30, 2025. Mr. Pulisic is an accomplished, senior executive with over 19 years of finance and commercial experience in the biopharmaceutical industry, having worked across the United States, Europe, and Asia. He is recognized for his expertise in financial leadership, corporate strategy and operational execution.
Underwritten Offering of Common Stock
On March 26, 2025, the Company closed an underwritten offering of 3,000,000 shares of its common stock at an offering price of $3.50 per share. The gross proceeds from the offering are expected to be $10.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The net proceeds from the offering are to be used for working capital and for general corporate purposes, including the continued clinical development of Olvi-Vec.
Fourth Quarter and 2024 Financial Results
Cash, cash equivalents and short-term investments were $30.9 million as of December 31, 2024. The Company expects its cash, cash equivalents and short-term investments as of December 31, 2024 will provide runway into the first quarter of 2026.
Research and development expenses were $19.0 million and $12.8 million for the years ended December 31, 2024 and 2023, respectively, an increase of approximately $6.2 million. Significant variations between periods are primarily a result of a $4.5 million increase in clinical and regulatory expenses relating to increased clinical trial costs associated with the Company’s Phase 3 On Prime Registration trial in 2024 and Phase 2 clinical trial for NSCLC, which the Company’s partner, Newsoara, is obligated to fully reimburse per the terms of their agreement; and a $1.2 million increase in employee compensation in 2024, primarily related to new employee hires in 2024.
General and administrative expenses were $12.7 million and $11.6 million for the years ended December 31, 2024 and 2023, respectively, an increase of approximately $1.1 million. Significant variations between periods are primarily a result of a $0.2 million increase in employee compensation in 2024, a $0.8 million increase in stock compensation expense in 2024, due to the increase in the cost of stock options and restricted stock units in 2024, and a $0.4 million increase in consulting and contract labor expenses in 2024, primarily resulting from increased accounting and finance costs in 2024, partially offset by a $0.5 million decrease in professional services, primarily resulting from the decrease in legal expenses in 2024.
Net loss was $29.9 million or $0.95 per share for the year ending December 31, 2024, as compared to $28.3 million or $1.16 for the year ending December 31, 2023.
About Genelux Corporation
Genelux is a late 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. Olvi-Vec currently is being evaluated in two U.S.-based clinical trials: OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician’s choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer; and, VIRO-25, a multi-center, randomized, open-label Phase 2 trial evaluating the efficacy and safety of Olvi-Vec & Platinum-doublet + physician’s choice of immune checkpoint inhibitor compared to docetaxel in non-small-cell lung cancer. Additionally, Olvi-Vec currently is being evaluated for dose selection in Olvi-Vec-SCLC-202, a China-based, multi-center, open label Ph1b evaluating the efficacy and safety of Olvi-Vec & Platinum-doublet in recurrent small-cell lung 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 oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec.
ihubstockmover
1年前
$GNLX Could Genelux's Olvi-Vec Emerge As A Powerful Tool In The Fight Against Difficult-to-treat Cancers?
Shares of Genelux Corp. (GNLX) have lost over 70% from their 52-week high of $12.12, recorded last January, and trade around $3.15.
This late clinical-stage biopharmaceutical company is developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumors. Its lead drug candidate is Olvi-Vec, a modified form of the oncolytic vaccinia virus.
Oncolytic immunotherapy refers to the treatment of cancer with viruses that selectively replicate in tumors and kill the cancer cells while leaving the normal cells untouched.
Olvi-Vec via intraperitoneal infusion is being evaluated in a phase III trial in heavily pretreated patients with platinum-resistant or platinum-refractory ovarian cancer, dubbed OnPrime. In this trial, the efficacy and safety of Olvi-Vec, platinum-doublet chemotherapy, and bevacizumab (Avastin) are compared with platinum-doublet chemotherapy plus bevacizumab.
Ovarian cancer is the second most common gynecologic cancer in the United States. Platinum-based chemotherapy treatments have proven effective for some individuals with cancer. However, if the cancer recurs following platinum treatment, it is classified as platinum-resistant. For patients with platinum-resistant ovarian cancer (PROC), treatment options are severely limited, and the prognosis for survival is generally poor.
Initiated in 2022, the OnPrime study is designed to enroll 186 women with platinum-resistant/refractory ovarian cancer and is being conducted as a collaboration between Genelux and The Gynecological Oncological Group (GOG).
The primary endpoint of the study is progression-free survival (PFS) based on *RECIST 1.1, as assessed by a blinded independent central review. Key secondary endpoints include overall response rate (ORR), overall survival (OS), and safety. (*RECIST 1.1, the most current version of the Response Evaluation Criteria in Solid Tumors, is a standardized set of criteria used to objectively measure tumor burden and assess the response to treatment in oncology clinical trials).
The OnPrime study continues to enroll patients, and topline results are expected in the second half of 2025.
Read more https://www.rttnews.com/3505338/could-genelux-s-olvi-vec-emerge-as-a-powerful-tool-in-the-fight-against-difficult-to-treat-cancers.aspx
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