WESTLAKE VILLAGE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Genelux Corporation (“Genelux”) (Nasdaq: GNLX), a late clinical-stage immuno-oncology company, today announced the pricing of an underwritten public offering of 6,666,667 shares of its common stock at a price to the public of $3.00 per share. All of the shares in the offering are to be sold by Genelux. The gross proceeds to Genelux from the offering are expected to be approximately $20.0 million, before deducting underwriting discounts and commissi ...

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]

Several biotechnology and pharmaceutical names posted notable gains in after-hours trading on Monday, driven by clinical trial updates, regulatory progress, and investor anticipation ahead of key data releases.Alumis Inc. (ALMS) surged 17.33% to $9.75, adding $1.44 after announcing that topline data from its Phase 3 ONWARD clinical program evaluating envudeucitinib in patients with moderate-to-severe plaque psoriasis will be reported on January 6, 2026. The company also confirmed it will host a conference ...

Core Insights - Genelux Corporation announced interim results from ongoing trials evaluating Olvi-Vec in patients with progressive lung cancers, showing promising anti-tumor activity and tolerability [1][3][5] Group 1: Trial Results - In the Phase 1b/2 SCLC trial, 33% of patients (3 out of 9) achieved partial responses (PRs), with significant tumor shrinkage observed in the highest dose cohort [1][5] - The overall response rate (ORR) in the highest dose cohort (Cohort 4) was 67% (2 out of 3 patients), indicating a potential dose-response trend [5] - The disease control rate (DCR) was 67% (6 out of 9 patients), with tumor shrinkage ranging from 24% to 85% among DCR patients [5][12] Group 2: Future Expectations - Additional data from the SCLC and NSCLC trials are expected throughout 2026, with topline data from the Phase 3 ovarian cancer trial anticipated in the second half of 2026 [1][13] - The company aims to optimize the efficacy, safety, and tolerability of Olvi-Vec through ongoing dose escalation cohorts [8] Group 3: Mechanism and Development - Olvi-Vec is designed to resensitize tumors to platinum-based chemotherapy and is being evaluated across multiple solid tumor types [2][9] - The company has administered Olvi-Vec to over 150 patients across seven completed clinical trials, demonstrating general tolerability and clinically meaningful benefits [9]

WESTLAKE VILLAGE, Calif., Jan. 02, 2026 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced the appointment of Jason Litten, M.D., as Chief Medical Officer, effective January 2, 2026. Dr. Litten will oversee all clinical development and medical strategy as the company advances Olvi-Vec through multiple upcoming pivotal milestones. “We are excited to welcome Jason, who is widely recognized for his strategic approach to clinical development a ...

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 - Genelux Corporation is advancing its Olvi-Vec program in multiple solid tumor indications, with significant clinical milestones expected in the coming year, particularly in ovarian and lung cancer, which represent a multi-billion-dollar market opportunity [2][3][5] Clinical Program Highlights - Olvi-Vec is being developed for platinum-resistant/refractory ovarian cancer, with intraperitoneal administration aimed at delivering high doses to patients needing effective anti-tumor options [3][5] - Two ongoing trials for lung cancer are assessing the systemic delivery of Olvi-Vec, with the goal of demonstrating its efficacy across various solid tumors and its potential to resensitize tumors to platinum-based chemotherapy [3][6] - The Phase 3 OnPrime trial for ovarian cancer is expected to provide topline data in the second half of 2026, with the Independent Data Monitoring Committee recommending the continuation of the trial without modifications [5][6] Financial Results - As of September 30, 2025, the company reported cash, cash equivalents, short-term investments, and restricted cash totaling $21.0 million, which is expected to fund operations into the third quarter of 2026 [4][7] - Research and development expenses increased to $4.7 million in Q3 2025 from $4.1 million in Q3 2024, primarily due to stock compensation and increased clinical trial costs [8] - General and administrative expenses rose to $3.5 million in Q3 2025 from $2.9 million in Q3 2024, driven by stock compensation and salary increases [9] - The net loss for Q3 2025 was $8.0 million, or $0.21 per share, compared to a net loss of $6.5 million, or $0.19 per share, in Q3 2024 [9][15]

Financial Performance - Revenue for the nine months ended September 30, 2025, was $0, compared to $8,000 for the same period in 2024, indicating a significant drop in revenue[18] - Net loss for the three months ended September 30, 2025, was $7,950,000, compared to a net loss of $6,467,000 for the same period in 2024, reflecting a 23% increase in losses[18] - The net loss for the nine months ended September 30, 2025, was $22.9 million, compared to a net loss of $20.9 million for the same period in 2024[24] - The company reported a loss per share of $0.21 for the three months ended September 30, 2025, compared to a loss per share of $0.19 for the same period in 2024[18] - The company has experienced recurring losses since inception, raising substantial doubt about its ability to continue as a going concern[28] Assets and Liabilities - Total assets decreased from $34,716,000 in December 2024 to $24,987,000 in September 2025, a decline of approximately 28%[15] - Total liabilities decreased from $8,442,000 in December 2024 to $6,396,000 in September 2025, a decline of approximately 24%[15] - Total stockholders' equity decreased from $26,274,000 in December 2024 to $18,591,000 in September 2025, a decline of approximately 29%[15] - Cash and cash equivalents decreased from $8,565,000 in December 2024 to $4,692,000 in September 2025, a reduction of approximately 45%[15] - The accumulated deficit increased from $251,393,000 in December 2024 to $274,291,000 in September 2025, indicating a worsening financial position[15] Operating Expenses - Total operating expenses increased from $21,956,000 for the nine months ended September 30, 2024, to $23,802,000 for the same period in 2025, representing an increase of about 8.4%[18] - Research and development expenses rose from $12,478,000 for the nine months ended September 30, 2024, to $14,197,000 for the same period in 2025, an increase of about 13.8%[18] - General and administrative expenses rose by $0.6 million to $3.453 million for the three months ended September 30, 2025, from $2.890 million in 2024, driven by higher stock compensation and employee compensation[113] - General and administrative expenses for the nine months ended September 30, 2025, were $9.605 million, a slight increase of $0.127 million from $9.478 million in 2024, primarily due to higher employee compensation[117] Cash Flow and Financing - Cash used in operating activities for the nine months ended September 30, 2025, was $19.1 million, an increase from $16.9 million in 2024[24] - The company reported a net cash provided by financing activities of $9.6 million for the nine months ended September 30, 2025[24] - The company plans to fund its development activities through public or private equity offerings and debt financing, with existing resources expected to last into the third quarter of 2026[29] - The company anticipates needing further funding to achieve business objectives beyond the third quarter of 2026[127] Clinical Trials and Development - The company is engaged in a Phase 2 clinical trial for its product candidate Olvi-Vec for patients with recurrent non-small cell lung cancer, funded by its partner Newsoara BioPharma[98] - The Company is required to conduct a multi-center Phase 2 clinical trial for Olvi-Vec in NSCLC, with Newsoara funding the costs of the trial in the US and China[42] - The ongoing VIRO-25 trial for Olvi-Vec in recurrent NSCLC has the first patient dosed in October 2024, funded by Newsoara, which may defer reimbursement payments until December 31, 2026[165] - The Phase 3 registration trial of Olvi-Vec in PRROC initiated enrollment in Q3 2022, with topline results anticipated in the second half of 2026[149] Collaborations and Agreements - The company entered into a License Agreement with Newsoara BioPharma Co. Ltd. for exclusive rights to develop and commercialize oncolytic viruses in specific territories[40] - The Company has received a total of $11.0 million from Newsoara, including $5.0 million as an upfront payment and $6.0 million as a milestone payment[41] - Newsoara is obligated to pay additional milestone payments up to $160.5 million and royalties on net sales of licensed products in the mid-single-digit to mid-teens percentage range[41] - The company expects to finance operations through potential collaboration agreements, strategic alliances, and licensing arrangements[29] Stock and Equity - As of September 30, 2025, the company had 38,046,778 shares of common stock issued and outstanding, an increase from 34,728,140 shares as of December 31, 2024, representing a growth of approximately 9.4%[61] - In March 2025, the company completed an offering of 3,000,000 shares of common stock at $3.50 per share, resulting in net proceeds of $9.6 million after expenses[62] - The company granted 821,213 Restricted Stock Units (RSUs) to employees in August 2025, with an aggregate fair value of $2.9 million[69] - The total number of stock options outstanding as of September 30, 2025, was 6,810,380, with a weighted average exercise price of $6.23[68] Risks and Challenges - The company has not generated any revenue to date and may never develop a marketable product[149] - The success of product candidates depends on various factors, including successful completion of clinical trials and obtaining regulatory approvals[155] - Serious adverse events or undesirable side effects may emerge during development, potentially halting clinical programs or leading to regulatory refusals[160] - Collaborations with biopharmaceutical companies pose risks, including potential delays in clinical trials and insufficient funding, which could adversely affect product development and commercialization[166] Regulatory and Compliance - Disruptions to FDA operations due to government shutdowns could delay the review and approval of regulatory submissions, adversely impacting the company's business[173] - The uncertainty surrounding regulatory changes and government policies could present new challenges in navigating product development and approval processes[174] - The company may face increased costs and operational risks due to potential civil or criminal enforcement actions related to compliance with trade regulations[178]

Core Viewpoint - Biotech stocks are experiencing renewed momentum, with small-cap companies like Nautilus Biotechnology, PepGen, Lixte, RenovoRx, Genelux, and VolitionRx attracting investor interest through various catalysts such as insider buying, strategic partnerships, and clinical trial progress Group 1: Nautilus Biotechnology (NAUT) - Nautilus Biotechnology's stock surged 5.52% during regular trading, closing at $0.7070, and rose an additional 7.5% in after-hours trading to $0.76, with trading volume nearly double its average at 647,399 shares [2] - Recent insider buying by CEO Sujal M. Patel, who purchased 83,500 shares on September 8 and 116,500 shares on September 5, totaling over $135,000, indicates strong leadership confidence [3] - The company reported a narrower loss of $0.12 per share in Q2 2025, with an 18% drop in operating expenses, and has $179.5 million in cash, providing a financial runway through 2027 [4] Group 2: PepGen Inc. (PEPG) - PepGen's stock rebounded 7.14% in after-hours trading to $1.50 after a regular session close of $1.40, with trading volume more than double its average at 638,576 shares [4] - The company completed dosing for its 15 mg/kg arm of the FREEDOM trial, with topline data expected in early Q4 2025, following a strategic narrowing of its pipeline [5] Group 3: Lixte Biotechnology Holdings Inc. (LIXT) - Lixte's stock rose 5.85% in after-hours trading to $5.25 after closing at $4.96, with a trading volume of 503,604 shares, notable given recent volatility [5] - The company announced a $2.6 million purchase of Bitcoin and Ethereum to diversify its treasury holdings, reflecting a strategic shift in financial strategy [6] Group 4: RenovoRx Inc. (RNXT) - RenovoRx shares increased 4.22% in after-hours trading to $1.2194 after a regular session close of $1.17, with trading volume significantly above its average at 886,119 shares [6] - The company received a positive recommendation to continue its Phase III TIGeR-PaC trial for pancreatic cancer, reinforcing confidence in its lead therapy platform [7] Group 5: Genelux Corp. (GNLX) - Genelux's stock rose 4.11% in after-hours trading to $3.80 after closing at $3.65, with trading volume relatively light at 60,339 shares [8] - The recent activity follows Genelux's participation in the H.C. Wainwright Global Investment Conference [9] Group 6: VolitionRx Ltd. (VNRX) - VolitionRx's stock increased 4.27% in after-hours trading to $0.6474 after closing at $0.6209, with trading volume slightly below its average at 183,777 shares [10] - The company announced a Research License and Exclusive Commercial Option Rights Agreement with Werfen's Immunoassay Technology Center, focusing on advancing its Nu.Q NETs assay for Antiphospholipid Syndrome [10]

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]