Genelux Corporation Reports First Quarter 2025 Financial Results and Provides General Business Updates
- FDA indicated potential traditional approval pathway for Olvi-Vec in ovarian cancer treatment
- Strong 71% disease control rate in Phase 1b lung cancer trial, with tumor reductions up to 79%
- Successful $10.5M equity raise extending cash runway into Q3 2026
- Reduced net loss to $7.5M ($0.21/share) from $7.9M ($0.29/share) year-over-year
- Decreased G&A expenses by $1.0M compared to Q1 2024
- R&D expenses increased by $0.7M compared to Q1 2024
- Share offering at $3.50 potentially dilutes existing shareholders
- Phase 3 trial results not expected until 1H 2026
Insights
Genelux's Olvi-Vec shows promising early data in multiple cancers with FDA providing clear regulatory pathway for ovarian cancer program.
The FDA's feedback on Genelux's OnPrime Phase 3 trial provides crucial regulatory clarity for Olvi-Vec in platinum-resistant/refractory ovarian cancer. The agency's statement that clinically meaningful progression-free survival without overall survival detriment could support traditional approval significantly derisks their lead program with readout expected in 1H 2026.
The preliminary data from the Phase 1b portion of their small cell lung cancer study deserves attention but careful interpretation. The 71% disease control rate (5/7 evaluable patients) including two partial responses and tumor reductions up to 79% is encouraging for this difficult-to-treat population. However, the extremely small sample size limits definitive conclusions at this stage. The favorable safety profile without reaching maximum tolerated dose suggests potential for further dose optimization.
Their ongoing Phase 2 trial in non-small cell lung cancer represents a second potential application, with interim data expected in 2H 2025. This parallel development strategy effectively balances pursuit of their lead indication with expansion into additional high-need cancer populations, potentially broadening Olvi-Vec's therapeutic utility.
These updates demonstrate progression across multiple indications, but the most significant value inflection point remains the Phase 3 ovarian cancer readout in 2026, which will definitively demonstrate whether Olvi-Vec can meet the FDA's efficacy threshold for approval.
Genelux extends cash runway through pivotal readout while modestly improving financials, reinforcing execution but not altering fundamental timeline.
Genelux's Q1 2025 financial position shows calculated capital allocation alongside advancing clinical programs. Their
The quarterly performance shows focused resource deployment with R&D expenses increasing by
The March offering of 3 million shares at
The appointment of Matthew Pulisic as CFO brings valuable industry experience from Arrowhead Pharmaceuticals and Amgen, including expertise in commercial manufacturing establishment—potentially valuable as Genelux approaches possible commercialization pending clinical success.
This update demonstrates solid execution on both clinical and financial fronts, but represents steady progression rather than a transformative event in the company's development timeline.
WESTLAKE VILLAGE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the first quarter of 2025 and provided general business updates.
“The first quarter of 2025 has been highly productive and sets a strong foundation for the year ahead. We are well positioned to advance Olvi-Vec across multiple high-need cancer indications, with encouraging regulatory feedback from the FDA on our OnPrime Phase 3 registrational trial in resistant/refractory ovarian cancer, promising early lung cancer clinical data from our ongoing Phase 1b/2 study, and increasing patient enrollment in our U.S. Phase 2 lung cancer trial” said Thomas Zindrick, President, CEO and Chairman of Genelux. “We are energized by our momentum and look forward to advancing our strategic initiatives through key upcoming value inflection points this year and into 2026.”
Pipeline Highlights
Earlier this quarter, the completion of a productive Type D meeting with the U.S. Food and Drug Administration (FDA) regarding Olvi-Vec for the treatment of platinum-resistant/refractory ovarian cancer was announced. The FDA stated that data from the ongoing OnPrime/GOG-3076 Phase 3 registrational trial (NCT05281471) could potentially support traditional approval if a clinically meaningful progression-free survival advantage is demonstrated without a decrement in overall survival. The FDA also recommended that Genelux request a pre-BLA meeting with topline safety and efficacy data following study completion to discuss next steps. The trial is expected to readout in 1H 2026 for topline data.
The company also announced preliminary safety and anti-tumor activity data from the Phase 1b dose escalation portion of their ongoing Phase 1b/2 trial (OLVI-VEC-SCLC-202) of Olvi-Vec immunochemotherapy in patients with platinum-relapsed or platinum-refractory extensive small cell lung cancer. Systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved a
Patient enrollment has been increasing in the ongoing US based Phase 2 trial for the systemic administration of Olvi-Vec in recurrent non-small cell lung cancer, with an interim readout anticipated in the second half of 2025.
Business Updates
In February, the company announced that Matthew Pulisic joined as its new Chief Financial Officer, effective January 30, 2025. Mr. Pulisic brings over 19 years of finance and commercial experience in the biopharmaceutical industry, with a background spanning the United States, Europe, and Asia. Prior to joining Genelux, he served as Vice President of Finance at Arrowhead Pharmaceuticals, where he played a key role in shaping the company’s financial direction, establishing a commercial manufacturing facility, and driving operational improvements. He began his career at Amgen as a Research Associate before transitioning into finance, eventually holding senior roles including Finance Director of Amgen Worldwide and Head of Capital Finance.
In March, the company completed an underwritten offering of 3,000,000 shares of its common stock at an offering price of
First Quarter 2025 Financial Results
Cash, cash equivalents and short-term investments were
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Net loss was
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. For more information, please visit www.genelux.com and follow us on Twitter @Genelux_Corp and on LinkedIn.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “believes,” “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to Genelux’s future plans and prospects, Genelux’s anticipated cash runway and the sufficiency of its resources to support its planned operations; the timing, likelihood or success of Genelux’s business strategy, as well as plans and objectives of management for future operations; the planned timing of Genelux’s data results in its ongoing clinical trials and continued development of Olvi-Vec, the potential capabilities advantages, safety and efficacy of Olvi-Vec and the potential regulatory approval pathway of Olvi-Vec. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Genelux’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Genelux does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
Investor and Media Contacts
Ankit Bhargava, MD
Allele Communications, LLC
genelux@allelecomms.com
Source: Genelux Corporation
| Genelux Corporation | ||||||
| Condensed Balance Sheets | ||||||
| (In thousands, except for share amounts and par value data) | ||||||
| March 31, | December 31, | |||||
| 2025 | 2024 | |||||
| (Unaudited) | ||||||
| ASSETS | ||||||
| Current Assets | ||||||
| Cash and cash equivalents | $ | 16,206 | $ | 8,565 | ||
| Short-term investments | 18,896 | 22,330 | ||||
| Prepaid expenses and other current assets | 843 | 653 | ||||
| Total Current Assets | 35,945 | 31,548 | ||||
| Property and equipment, net | 1,287 | 1,316 | ||||
| Right of use assets | 1,680 | 1,760 | ||||
| Other assets | 73 | 92 | ||||
| Total Other Assets | 3,040 | 3,168 | ||||
| TOTAL ASSETS | $ | 38,985 | $ | 34,716 | ||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
| Current Liabilities | ||||||
| Accounts payable and accrued expenses | $ | 6,688 | $ | 5,570 | ||
| Accrued payroll and payroll taxes | 664 | 1,004 | ||||
| Lease liabilities, current portion | 337 | 329 | ||||
| Total Current Liabilities | 7,689 | 6,903 | ||||
| Lease liabilities, long-term portion | 1,450 | 1,539 | ||||
| Total Liabilities | 9,139 | 8,442 | ||||
| Commitments and Contingencies | ||||||
| Shareholders' Equity | ||||||
| Preferred stock, par value | ||||||
| no shares issued and outstanding, respectively; | - | - | ||||
| Common stock, par value | ||||||
| 37,733,140 and 34,728,140 shares issued and outstanding | 38 | 35 | ||||
| Treasury stock, 433,333 shares, at cost | (433 | ) | (433 | ) | ||
| Additional paid-in capital | 289,097 | 278,001 | ||||
| Accumulated other comprehensive income | 29 | 64 | ||||
| Accumulated deficit | (258,885 | ) | (251,393 | ) | ||
| Total Shareholders' Equity | 29,846 | 26,274 | ||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 38,985 | $ | 34,716 | ||
| The accompanying notes are an integral part of these condensed financial statements. | ||||||
| Genelux Corporation | ||||||
| Condensed Statements of Operations | ||||||
| (in thousands, except for share amounts and per share data) | ||||||
| Three Months Ended | ||||||
| March 31, | ||||||
| 2025 | 2024 | |||||
| (Unaudited) | ||||||
| Revenues | $ | - | $ | 8 | ||
| Operating expenses: | ||||||
| Research and development | 4,698 | 4,010 | ||||
| General and administrative | 3,118 | 4,113 | ||||
| Total operating expenses | 7,816 | 8,123 | ||||
| Loss from operations | (7,816 | ) | (8,115 | ) | ||
| Other income (expenses): | ||||||
| Interest income | 184 | 114 | ||||
| Bond Accretion Income | 140 | 151 | ||||
| Total other income (expenses), net | 324 | 265 | ||||
| NET LOSS | $ | (7,492 | ) | $ | (7,850 | ) |
| LOSS PER COMMON SHARE - BASIC AND DILUTED | $ | (0.21 | ) | $ | (0.29 | ) |
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - | ||||||
| BASIC AND DILUTED | 34,926,075 | 26,849,737 | ||||
| The accompanying notes are an integral part of these condensed financial statements. | ||||||
FAQ
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