Genelux Corporation Reports First Quarter 2025 Financial Results and Provides 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
Pipeline Highlights
Earlier this quarter, the completion of a productive Type D meeting with the
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 71% disease control rate (5/7 evaluable participants), with (i) two of the five exhibiting partial responses and (ii) all five showing consistent reductions across all target lesions, including a tumor reduction of approximately 79% in one participant. Three participants, including one heavily pretreated individual, achieved stable disease with tumor size reductions of 24% to 29.2%. Olvi-Vec was generally well tolerated with a favorable safety profile, and no maximum tolerated dose had been reached at the time of data cutoff on
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
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
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
Investor and Media Contacts
genelux@allelecomms.com
Source:
| Condensed Balance Sheets | ||||||
| (In thousands, except for share amounts and par value data) | ||||||
| 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 | ||||
| (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. | ||||||
| Condensed Statements of Operations | ||||||
| (in thousands, except for share amounts and per share data) | ||||||
| Three Months Ended | ||||||
| 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. | ||||||
Source: Genelux Corporation