Genelux Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
– Alignment reached with
– Positive Preliminary Phase 1b/2 Data of Olvi-Vec in Advanced Small-Cell
– Matt Pulisic joined the company as its new Chief Financial Officer –
– Closing of
– $30.9 million in cash, cash equivalents and short-term investments –
"Our progress in the fourth quarter of 2024 and into 2025 marks a pivotal period for patients, our company, and our investors,” said
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
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
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:
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,
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
Underwritten Offering of Common Stock
On
Fourth Quarter and 2024 Financial Results
Cash, cash equivalents and short-term investments were
Research and development expenses were
General and administrative expenses were
Net loss was
About
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
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, 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:
| Balance Sheets | ||||||
| (In thousands, except for share amounts and par value data) | ||||||
, | ||||||
| 2024 | 2023 | |||||
| ASSETS | ||||||
| Current Assets | ||||||
| Cash and cash equivalents | $ | 8,565 | $ | 9,418 | ||
| Short-term investments | 22,330 | 13,773 | ||||
| Prepaid expenses and other current assets | 653 | 1,012 | ||||
| Total Current Assets | 31,548 | 24,203 | ||||
| Property and equipment, net | 1,316 | 1,170 | ||||
| Right of use assets | 1,760 | 2,428 | ||||
| Other assets | 92 | 92 | ||||
| Total Other Assets | 3,168 | 3,690 | ||||
| TOTAL ASSETS | $ | 34,716 | $ | 27,893 | ||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
| Current Liabilities | ||||||
| Accounts payable and accrued expenses | $ | 5,570 | $ | 3,784 | ||
| Accrued payroll and payroll taxes | 1,004 | 2,117 | ||||
| Lease liabilities, current portion | 329 | 653 | ||||
| Total Current Liabilities | 6,903 | 6,554 | ||||
| Lease liabilities, long-term portion | 1,539 | 1,866 | ||||
| Total Liabilities | 8,442 | 8,420 | ||||
| Commitments and Contingencies | ||||||
| Shareholders' Equity | ||||||
| Preferred stock, par value | ||||||
| no shares issued and outstanding, respectively; | - | - | ||||
| Common stock, par value | ||||||
| 34,728,140 and 26,788,986 shares issued and outstanding | 35 | 27 | ||||
stock, 433,333 shares, at cost | (433 | ) | (433 | ) | ||
| Additional paid-in capital | 278,001 | 241,389 | ||||
| Accumulated other comprehensive income | 64 | 14 | ||||
| Accumulated deficit | (251,393 | ) | (221,524 | ) | ||
| Total Shareholders' Equity | 26,274 | 19,473 | ||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 34,716 | $ | 27,893 | ||
| The accompanying notes are an integral part of these financial statements. | ||||||
| Statements of Operations | ||||||
| (in thousands, except for share amounts and per share data) | ||||||
| Years Ended | ||||||
, | ||||||
| 2024 | 2023 | |||||
| Revenues | $ | 8 | $ | 170 | ||
| Operating expenses: | ||||||
| Research and development | 18,998 | 12,767 | ||||
| General and administrative | 12,706 | 11,568 | ||||
| Total operating expenses | 31,704 | 24,335 | ||||
| Loss from operations | (31,696 | ) | (24,165 | ) | ||
| Other income (expenses): | ||||||
| Interest income | 1,457 | 244 | ||||
| Gain on extinguishment of accounts payable | 370 | - | ||||
| Interest expense | - | (173 | ) | |||
| Debt discount amortization | - | (649 | ) | |||
| Financing costs | - | (3,152 | ) | |||
| Debt extinguishment costs | (402 | ) | ||||
| Total other income (expenses), net | 1,827 | (4,132 | ) | |||
| NET LOSS | $ | (29,869 | ) | $ | (28,297 | ) |
| LOSS PER COMMON SHARE - BASIC AND DILUTED | $ | (0.95 | ) | $ | (1.16 | ) |
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - | ||||||
| BASIC AND DILUTED | 31,450,727 | 24,429,278 | ||||
| The accompanying notes are an integral part of these financial statements. | ||||||
| Statements of Comprehensive Loss | ||||||
| (in thousands) | ||||||
| Years Ended | ||||||
, | ||||||
| 2024 | 2023 | |||||
| Net loss | $ | (29,869 | ) | $ | (28,297 | ) |
| Other comprehensive loss: | ||||||
| Net unrealized gain on short and long-term investments | 50 | 12 | ||||
| Comprehensive loss | $ | (29,819 | ) | $ | (28,285 | ) |
| The accompanying notes are an integral part of these financial statements. | ||||||
Source: Genelux Corporation