Olvimulogene nanivacirepvec

WESTLAKE VILLAGE, Calif., May 23, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (Genelux) (Nasdaq: GNLX), a late clinical-stage immuno-oncology company, today announced that it has commenced an underwritten public offering of its common stock and accompanying warrants. All shares of common stock and accompanying warrants are being offered by Genelux. In addition, Genelux expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering (including shares underlying the warrants). Guggenheim Securities is acting as sole book-running manager for the offering. Newbridge Securities Corporation is acting as co-manager for the offering. The offering is subject to market and other customary closing conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. The shares are being offered by Genelux pursuant to an effective shelf registration statement previously filed by Genelux with the U.S. Securities and Exchange Commission (SEC). This offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and may be obtained for free by visiting the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting: Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Genelux 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. Genelux’s most advanced product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus. Olvi-Vec currently is being evaluated in OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination with platinum-doublet + bevacizumab compared with physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer. The core of Genelux's discovery and development efforts revolves around its proprietary CHOICE™ platform from which Genelux has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec. Forward-Looking Statements This release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include, but are not limited to, statements regarding the completion, timing and size of the proposed public offering and the expectation to grant the underwriters a 30-day option to purchase additional shares and warrants. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the proposed public offering. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Genelux’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024 and in other filings that Genelux makes with the SEC from time to time. There can be no assurance that any of the forward-looking information provided herein will be proven accurate. These forward-looking statements speak only as of the date hereof and Genelux undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. Contacts Ankit Bhargava, MDAllele Communications, LLCgenelux@allelecomms.com Source: Genelux Corporation

WESTLAKE VILLAGE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the first quarter of 2024 and provided general business updates. “Our pivotal Phase 3 registration trial of Olvi-Vec in platinum resistant/refractory ovarian cancer continues to enroll patients,” said Thomas Zindrick, President, Chairman and CEO of Genelux. “Looking ahead, we are excited about advancing Olvi-Vec into additional cancer indications through intravenous administration, a physician-preferred route of delivery, and seeking to further validate our hypothesis that Olvi-Vec may reverse resistance to platinum in multiple tumor types.” The Company expects to initiate our Phase 2 trial in recurrent non-small cell lung cancer in the second quarter of this year and to report interim data of our Phase 1b trial in recurrent small cell lung cancer later this year. Both trials are designed to intravenously administer Olvi-Vec and to re-challenge patients who previously failed platinum-based chemotherapy. The designs build on a previous clinical trial showing the benefit of intravenously administered Olvi-Vec in patients with lung disease (primary or metastatic) and on our Phase 2 data in platinum resistant/refractory ovarian cancer (PRROC). Pipeline Highlights We are actively enrolling patients in ongoing Phase 3 OnPrime/GOG-3076 registrational trial in PRROC in the United States. Currently, 22 sites have been activated to enroll patients with additional sites identified and in various stages of activation (NCT05281471). We are on track for topline results in the second half of 2025. Patient enrollment has been increasing in the ongoing Phase 1b part of the Phase 1b/2 trial testing systemic administration of Olvi-Vec in patients with recurrent small cell lung cancer. The trial is co-sponsored with our partner Newsoara BioPharma Co., Ltd. and is being conducted at pre-eminent sites in China. We anticipate interim readout in the second half of 2024. Initiation of the Phase 2 trial in the United States testing systemic administration of Olvi-Vec in recurrent non-small cell lung cancer trial is anticipated to begin in the first half of 2024. Business Updates In the first quarter of 2024, we filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission. Under the shelf registration statement, we may offer and sell, from time to time, up to $300.0 million in common stock, preferred stock, debt securities and/or warrants in one or more offerings. Concurrent with the shelf registration statement, the Company entered into a sales agreement under which the Company may offer to sell shares of our common stock up to $100.0 million through Guggenheim Securities, acting as our sales agent. First Quarter 2024 Financial Results Cash, cash equivalents and short-term investments were $19.6 million as of March 31, 2024. We expect our existing cash, cash equivalents, and short-term investments will provide runway into the second quarter of 2025. Research and development (R&D) expenses were $4.0 million for the first quarter of 2024, as compared to $2.8 million for the first quarter 2023, respectively. The $1.2 million year-over-year increase in R&D expenses in 2024 was primarily due to a $0.4 million increase related to new employee hires after the first quarter of 2023, a $0.3 million increase in stock compensation and a $0.4 million increase related to clinical manufacturing, regulatory and other R&D expenses. General and administrative (G&A) expenses were $4.1 million in the first quarter of 2024, as compared to $3.8 million for the first quarter of 2023. The $0.3 million year-over-year increase in G&A expenses in 2024 was primarily the result of a $0.4 million increase in professional service expenses in 2024, primarily due to costs associated with our shelf registration on Form S-3 and a $0.5 million increase due to consulting expenses, employee related costs and other G&A expenses, offset by a $0.6 million decrease in stock compensation expense in the first quarter of 2024 compared to the first quarter of 2023. Net loss was $7.9 million for the first quarter of 2024 or a net loss per share of $0.29, as compared to net loss of $10.4 million for the first quarter of 2023, or a net loss per share of $0.53. 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. The Company's most advanced product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus. Olvi-Vec currently is being evaluated in OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination with platinum-doublet + bevacizumab compared to compared with physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian 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 planned timing of the Genelux’s data results in its ongoing clinical trials and continued development of Olvi-Vec, the planned initiation of the Phase 2 non-small cell lung cancer trial and the timing thereof; and the potential capabilities and advantages 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 CorporationCondensed Balance Sheets(in thousands, except for share amounts and par value data) March 31,December 31, 2024 2023 ASSETS(Unaudited) Current Assets Cash and cash equivalents$4,061 $9,418 Short-term investments 15,566 13,773 Prepaid expenses and other current assets 1,577 1,012 Total Current Assets 21,204 24,203 Property and equipment, net 1,116 1,170 Right of use assets 2,264 2,428 Other assets 92 92 Total Other Assets 3,472 3,690 TOTAL ASSETS$24,676 $27,893 LIABILITIES AND SHAREHOLDERS' EQUITY Current Liabilities Accounts payable and accrued expenses$5,313 $3,784 Accrued payroll and payroll taxes 1,908 2,117 Lease liabilities, current portion 584 653 Total Current Liabilities 7,805 6,554 Lease liabilities, long-term portion 1,787 1,866 Total Liabilities 9,592 8,420 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; 26,996,740 and 26,788,986 shares issued and outstanding, respectively 27 27 Treasury stock, 433,333 shares, at cost (433) (433)Additional paid-in capital 244,869 241,389 Accumulated other comprehensive income (loss) (5) 14 Accumulated deficit (229,374) (221,524)Total Shareholders' Equity 15,084 19,473 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $24,676 $27,893 The accompanying notes are an integral part of these condensed financial statements. Genelux CorporationCondensed Statements of Operations(in thousands, except for share amounts and per share data) Three Months Ended March 31, 2024 2023 (Unaudited) Revenues$8 $170 Operating expenses: Research and development 4,010 2,845 General and administrative 4,113 3,787 Total operating expenses 8,123 6,632 Loss from operations (8,115) (6,462) Other income (expenses): Interest income 265 - Interest expense - (143) Debt discount amortization - (649) Financing costs - (3,110)Total other income (expenses), net 265 (3,902) NET LOSS$(7,850)$(10,364) LOSS PER COMMON SHARE - BASIC AND DILUTED$(0.29)$(0.53) WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - BASIC AND DILUTED 26,849,737 19,575,631 The accompanying notes are an integral part of these condensed financial statements. Genelux CorporationCondensed Statements of Comprehensive Loss(in thousands) Three Months Ended March 31, 2024 2023 (Unaudited) Net loss$(7,850)$(10,364) Other comprehensive loss: Net unrealized loss on short-term investments (19) - Comprehensive loss$(7,869)$(10,364) The accompanying notes are an integral part of these condensed financial statements.