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Genelux Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

1. Genelux received FDA alignment for Olvi-Vec in ovarian cancer. 2. Positive Phase 1b/2 data for Olvi-Vec in small-cell lung cancer reported. 3. Matt Pulisic appointed as new CFO, enhancing management team. 4. Closed $10.5 million common stock offering for clinical development. 5. Genelux holds $30.9 million in cash and investments as of December 2024.

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FAQ

Why Bullish?

FDA support and positive trial data suggest strong potential for Olvi-Vec, historically boosting GNLX stock during positive developments.

How important is it?

Material FDA updates and clinical progress are critical for Genelux's future, indicating very high relevance.

Why Long Term?

Expected topline data from trials in 2026 may significantly influence investor sentiment and stock price.

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– 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, MDAllele Communications, LLCgenelux@allelecomms.com  Source: Genelux Corporation Genelux CorporationBalance 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 CorporationStatements 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)$(1.16)   WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING -    BASIC AND DILUTED 31,450,727  24,429,278       The accompanying notes are an integral part of these financial statements.    Genelux CorporationStatements of Comprehensive Loss(in thousands)    Years Ended December 31,  2024  2023    Net loss$(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 CorporationStatements of Shareholders' Equity (Deficit)(in thousands, except share amounts)        Accumulated          Other   Preferred StockCommon StockTreasury Stock AdditionalComprehensiveAccumulated  SharesAmountSharesAmountSharesAmountPaid-in CapitalIncome (Loss)DeficitTotal           Balance, December 31, 202222,094,889 $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)$26,274                       The accompanying notes are an integral part of these financial statements.            Genelux CorporationStatements of Cash Flows(In thousands) Years Ended December 31,  2024  2023 Cash Flows from Operating Activities  Net loss$(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.

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