- 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. 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, 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 | ||||||
| Balance Sheets | ||||||
| (In thousands, except for share amounts and par value data) | ||||||
| December 31, | ||||||
| 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 $0.001, 10,000,000 shares authorized; | ||||||
| no shares issued and outstanding, respectively; | - | - | ||||
| Common stock, par value $0.001, 200,000,000 shares authorized; | ||||||
| 34,728,140 and 26,788,986 shares issued and outstanding | 35 | 27 | ||||
| Treasury 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. | ||||||
| Genelux Corporation | ||||||
| Statements of Operations | ||||||
| (in thousands, except for share amounts and per share data) | ||||||
| Years Ended | ||||||
| December 31, | ||||||
| 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. | ||||||
| Genelux Corporation | ||||||
| Statements of Comprehensive Loss | ||||||
| (in thousands) | ||||||
| Years Ended | ||||||
| December 31, | ||||||
| 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. | ||||||
| Genelux Corporation | |||||||||||||||||||||||
| Statements of Shareholders' Equity (Deficit) | |||||||||||||||||||||||
| (in thousands, except share amounts) | |||||||||||||||||||||||
| Accumulated | |||||||||||||||||||||||
| Other | |||||||||||||||||||||||
| Preferred Stock | Common Stock | Treasury Stock | Additional | Comprehensive | Accumulated | ||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Paid-in Capital | Income (Loss) | Deficit | Total | ||||||||||||||
| Balance, December 31, 2022 | 22,094,889 | $ | 22 | 9,126,726 | $ | 9 | (433,333 | ) | $ | (433 | ) | $ | 154,401 | $ | 2 | $ | (189,784 | ) | $ | (35,783 | ) | ||
| Stock compensation | - | - | - | - | - | - | 2,515 | - | - | 2,515 | |||||||||||||
| Unrealized gain on short-term investments | - | - | - | - | - | - | - | 12 | - | 12 | |||||||||||||
| Issuance of common shares upon the closing of the initial public | |||||||||||||||||||||||
| offering, net of offering costs | - | - | 2,653,000 | 3 | - | - | 12,629 | - | - | 12,632 | |||||||||||||
| Issuance of common shares upon the closing of private | |||||||||||||||||||||||
| financings, net of offering costs | - | - | 1,292,079 | 2 | - | - | 25,140 | - | - | 25,142 | |||||||||||||
| Issuance of common shares upon conversion of preferred stock | (22,094,889 | ) | (22 | ) | 8,359,143 | 8 | - | - | 14 | - | - | - | |||||||||||
| Issuance of common shares upon conversion of convertible | |||||||||||||||||||||||
| notes payable, accrued interest and loan fees | - | - | 4,137,760 | 4 | - | - | 29,970 | - | - | 29,974 | |||||||||||||
| Issuance of common shares upon conversion of preferred | |||||||||||||||||||||||
| stock dividends payable | - | - | 272,101 | - | - | - | 3,443 | - | (3,443 | ) | - | ||||||||||||
| Fair value of vested restricted stock units | - | - | 113,500 | - | - | - | 940 | - | - | 940 | |||||||||||||
| Cost of stock option repricing | - | - | - | - | - | - | 2,689 | - | - | 2,689 | |||||||||||||
| Reclassification of warrant liabilities upon the closing of | |||||||||||||||||||||||
| the initial public offering | - | - | - | - | - | - | 169 | - | - | 169 | |||||||||||||
| Fair value of warrants issued in connection with the | |||||||||||||||||||||||
| the conversion of convertible notes payable | - | - | - | - | - | - | 3,152 | - | - | 3,152 | |||||||||||||
| Conversion of notes payable-shareholders and accrued interest | - | - | 73,134 | - | - | - | 1,865 | - | - | 1,865 | |||||||||||||
| Issuance of common shares upon exercise of stock options | - | - | 232,787 | - | - | - | 1,474 | - | - | 1,474 | |||||||||||||
| Issuance of common shares upon exercise of stock warrants | - | - | 528,756 | 1 | - | - | 2,988 | - | - | 2,989 | |||||||||||||
| Net loss during the year ended December 31, 2023 | - | - | - | - | - | - | - | - | (28,297 | ) | (28,297 | ) | |||||||||||
| Balance, December 31, 2023 | - | - | 26,788,986 | 27 | (433,333 | ) | (433 | ) | 241,389 | 14 | (221,524 | ) | 19,473 | ||||||||||
| Stock compensation | - | - | - | - | - | - | 5,738 | - | - | 5,738 | |||||||||||||
| Unrealized gain on short and long-term investments | - | - | - | - | - | - | - | 50 | - | 50 | |||||||||||||
| Fair value of vested restricted stock units | - | - | 303,389 | - | - | - | 2,044 | - | - | 2,044 | |||||||||||||
| Cost of stock option modifications and repricing | - | - | - | - | - | - | 332 | - | - | 332 | |||||||||||||
| Issuance of common shares for cash and warrants, net of costs | - | - | 7,505,460 | 8 | - | - | 27,685 | - | - | 27,693 | |||||||||||||
| Issuance of common shares in connection with the Company's | |||||||||||||||||||||||
| equity award programs | - | - | 53,818 | - | - | - | 125 | - | - | 125 | |||||||||||||
| Issuance of common shares upon exercise of stock warrants | - | - | 76,487 | - | - | - | 688 | - | - | 688 | |||||||||||||
| Net loss during the year ended December 31, 2024 | - | - | - | - | - | - | - | - | (29,869 | ) | (29,869 | ) | |||||||||||
| Balance, December 31, 2024 | - | $ | - | 34,728,140 | $ | 35 | (433,333 | ) | $ | (433 | ) | $ | 278,001 | $ | 64 | $ | (251,393 | ) | $ | 26,274 | |||
| The accompanying notes are an integral part of these financial statements. | |||||||||||||||||||||||
| Genelux Corporation | ||||||
| Statements of Cash Flows | ||||||
| (In thousands) | ||||||
| Years Ended | ||||||
| December 31, | ||||||
| 2024 | 2023 | |||||
| Cash Flows from Operating Activities | ||||||
| Net loss | $ | (29,869 | ) | $ | (28,297 | ) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||
| Depreciation expense | 235 | 499 | ||||
| Net amortization of premiums and discounts on short-term investments | (757 | ) | (62 | ) | ||
| Right-of-use asset | 668 | 519 | ||||
| Amortization of debt discount | - | 649 | ||||
| Stock compensation | 5,738 | 2,515 | ||||
| Fair value of restricted stock units | 2,044 | 940 | ||||
| Cost of stock option modifications and repricing | 332 | 2,689 | ||||
| Gain on extinguishment of accounts payable | (370 | ) | - | |||
| Debt extinguishment costs | - | 402 | ||||
| Fair value of warrants issued in connection with the conversion of convertible notes payable | - | 3,152 | ||||
| Changes in Assets and Liabilities | ||||||
| (Increase) Decrease in: | ||||||
| Prepaid expenses and other assets | 359 | 483 | ||||
| (Decrease) Increase in: | ||||||
| Accounts payable and accrued expenses | 2,156 | (2,358 | ) | |||
| Accrued payroll and payroll taxes | (1,113 | ) | (735 | ) | ||
| Accrued interest payable | - | 22 | ||||
| Deferred revenue | - | (170 | ) | |||
| Lease liability | (651 | ) | (523 | ) | ||
| Net cash used in operating activities | (21,228 | ) | (20,275 | ) | ||
| Cash Flows from Investing Activities | ||||||
| Purchases of property and equipment | (381 | ) | (1,025 | ) | ||
| Purchase of short and long-term investments | (29,000 | ) | (13,699 | ) | ||
| Proceeds from sales and maturities of short and long-term investments | 21,250 | - | ||||
| Net cash used in investing activities | (8,131 | ) | (14,724 | ) | ||
| Cash Flows from Financing Activities | ||||||
| Proceeds from notes payable - shareholders | - | 900 | ||||
| Repayment of notes payable - shareholders | - | (685 | ) | |||
| Payment of deferred offering costs | - | (303 | ) | |||
| Proceeds from common stock issued in connection with the Company's equity award programs | 125 | - | ||||
| Proceeds from the exercise of stock options | - | 1,474 | ||||
| Proceeds from the exercise of stock warrants | 688 | 2,989 | ||||
| Proceeds from common stock issued for cash in connection with the closing of the IPO | - | 14,503 | ||||
| Proceeds from common stock issued for cash in connection with the closing of private financings | - | 25,142 | ||||
| Proceeds from common stock issued for cash in connection with the closing of a second public offering | 27,693 | - | ||||
| Net cash provided by financing activities | 28,506 | 44,020 | ||||
| Net increase (decrease) in cash and cash equivalents | (853 | ) | 9,021 | |||
| Cash and cash equivalents at the beginning of year | 9,418 | 397 | ||||
| Cash and cash equivalents at the end of year | $ | 8,565 | $ | 9,418 | ||
| Supplemental cash flows disclosures: | ||||||
| Interest paid | $ | - | $ | 72 | ||
| Taxes paid | $ | - | $ | - | ||
| Supplemental non-cash financing disclosures: | ||||||
| Effect of the extension of right-of-use asset and operating lease | $ | - | $ | 1,612 | ||
| Reclassification of deferred offering costs to shareholders' equity | $ | - | $ | 1,871 | ||
| Reclassification of warrant liabilities to shareholders' equity | $ | - | $ | 169 | ||
| Conversion of convertible notes payable, accrued interest and loan fees to shareholders' equity | $ | - | $ | 29,974 | ||
| Conversion of preferred stock to common stock | $ | - | $ | 22 | ||
| Conversion of dividends payable to shareholders' equity | $ | - | $ | 3,443 | ||
| Conversion of notes payable-shareholders and accrued interest to shareholders' equity | $ | - | $ | 1,463 | ||
| Unrealized gain on investments | $ | 50 | $ | 12 | ||
| The accompanying notes are an integral part of these financial statements. | ||||||
