UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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In this report, “Cidara Therapeutics,” “Cidara,” “Company,” “we,” “us” and “our” refer to Cidara Therapeutics, Inc.
Item 7.01 Regulation FD Disclosure.
On August 17, 2021, Cidara and Mundipharma Medical Company (“Mundipharma”) issued a press release announcing the completion of recruitment for the Phase 3 ReSTORE trial evaluating the efficacy and safety of rezafungin as a potential first-line treatment for candidemia and invasive candidiasis. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
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 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 except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.
Item 8.01 Other Events.
On August 17, 2021, Cidara and Mundipharma issued a press release announcing the completion of recruitment for the Phase 3 ReSTORE trial evaluating the efficacy and safety of rezafungin as a potential first-line treatment for candidemia and invasive candidiasis. The trial includes 184 patients diagnosed with candidemia and/or invasive candidiasis. Cidara expects to announce top-line data from the ReSTORE trial by the end of 2021 and anticipates filing a New Drug Application for rezafungin in the U.S. and similar regulatory filings outside the U.S. in the middle of 2022.
Forward Looking Statements
Statements contained in this Current Report on Form 8-K regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements about Cidara’s expectations with respect to the anticipated timing for the announcement of top-line data from the ReSTORE trial and filing of a New Drug Application in the U.S. and similar regulatory filings outside the U.S. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Cidara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with unanticipated delays in or negative results from Cidara’s clinical trials, impacts of the COVID-19 pandemic on patient enrollment or other obstacles to the development of rezafungin. Additional factors that could cause actual results to differ materially from those stated or implied by Cidara’s forward-looking statements are disclosed in its filings with the SEC, including in the section captioned “Risk Factors” in Cidara’s quarterly report on Form 10-Q for the quarterly period ended June 30, 2021. All forward-looking statements contained in this report speak only as of the date on which they were made. Cidara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release issued August 17, 2021. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
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.
| Cidara Therapeutics, Inc. | ||||||
| Date: August 17, 2021 | /s/ Jeffrey L. Stein | |||||
| Jeffrey L. Stein | ||||||
| President and Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) | ||||||