SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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Item 7.01 Regulation FD Disclosure.
On July 18, 2023, Genelux Corporation (the “Company”) made available the slide presentation attached hereto as Exhibit 99.1 (the “Corporate Presentation”). Information from the Corporate Presentation may also be used by the management of the Company in future meetings regarding the Company. For important information about forward-looking statements in the Corporate Presentation, see the slide titled “Forward-Looking Statements” in Exhibit 99.1 attached hereto.
The information contained or incorporated in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.
Item 8.01 Other Events.
As noted in Item 7.01, on July 18, 2023, the Company made available the Corporate Presentation.
In the Corporate Presentation, the Company announced that:
|●||The Company’s lead product candidate, Olvi-Vec, represents an estimated billion dollar plus annual market opportunity in the United States; and|
|●||Initial interim data for one or more systemic administration trials of Olvi-Vec in recurrent non-small-cell lung cancer in the United States is expected as early as mid-2024.|
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, which are subject to the “safe harbor” created by those sections. These forward-looking statements consist of statements regarding: (i) the Company’s estimation of the annual market opportunity for Olvi-Vec in the United States and (ii) the Company’s expectations regarding the timing of one or more systemic administration trials of Olvi-Vec in recurrent non-small-cell lung cancer in the United States. Actual future results may differ materially from those projected as a result of certain risks and uncertainties. These risks and uncertainties include, without limitation: the accuracy of the Company’s assumptions and expectations underlying its estimated annual market opportunity for Olvi-Vec in the United States; uncertainty regarding geopolitical and macroeconomic events and any resulting delays in clinical trials; risks associated with the discovery, development and regulation of Olvi-Vec; the risk that the Company or its partners may cease or delay preclinical or clinical development activities for any existing or future product candidates for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials); the possibility that existing collaborations could be terminated early; subsequent study or trial results and findings may contradict earlier study or trial results and findings; and the risks set forth under “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 and in the Company’s other filings with the Securities and Exchange Commission. The forward-looking statements are applicable only as of the date on which they are made, and the Company does not assume any obligation to update any forward-looking statements, except as may be required by law.
Item 9.01 Financial Statements and Exhibits.
|99.1||Slide presentation, dated July 18, 2023|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document).|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: July 18, 2023||By:||/s/ Thomas Zindrick, J.D.|
|Thomas Zindrick, J.D.|
|President and Chief Executive Officer|