Form 8-K - Current report

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 23, 2024

 

Cidara Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware

001-36912

46-1537286

(State or Other Jurisdiction of Incorporation or Organization)

(Commission File Number)

(I.R.S. Employer Identification Number)

 

6310 Nancy Ridge Drive, Suite 101

San Diego, California 92121

[phone]

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, Par Value $0.0001 Per Share

CDTX

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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Item 8.01 Other Events.

On September 23, 2024, Cidara Therapeutics, Inc. (the “Company”) announced the dosing of the first subject in the Company’s Phase 2b NAVIGATE trial to evaluate the efficacy and safety of CD388 for the pre-exposure prophylaxis of influenza during the current flu season.

The Phase 2b clinical trial is expected to be a randomized, double blind, controlled trial targeting 5,000 healthy unvaccinated adult subjects who are not at risk of complications from influenza. Three CD388 dose groups or placebo will be administered to subjects as a single dose at the beginning of the influenza season. Subjects will then be followed for the remainder of the influenza season to monitor for breakthrough cases. Rates of laboratory and clinically-confirmed influenza will be compared between subjects receiving the various single doses of CD388 or placebo. The study is expected to include sites in the United States and United Kingdom.

Forward-Looking Statements

This Current Report on Form 8-K contains “forward-looking statements” which include, but are not limited to, all statements that do not relate solely to historical or current facts, such as statements regarding the Company’s expectations, intentions or strategies regarding the study design, timing and locations for the Phase 2b NAVIGATE clinical trial for CD388 and the potential impact and benefits of CD388 on influenza. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. The Company’s expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances, including but not limited to risks and uncertainties related to unanticipated delays in or negative results from Cidara’s clinical trials and other risks related to clinical development and other risks and uncertainties from time to time described in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024 filed with Securities and Exchange Commission (“SEC”) on August 13, 2024, and in the Company’s other filings with the SEC. The Company cautions that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements which speak only as of the date made. Except as required by law, the Company does not undertake any obligation to update publicly any forward-looking statements for any reason after the date of this Current Report on Form 8-K to conform these statements to actual results or to changes in its expectations.

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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: September 23, 2024									/s/ Jeffrey Stein, Ph.D.
									Jeffrey Stein, Ph.D.
									President and Chief Executive Officer (Principal Executive Officer)

Cover Page	Sep. 23, 2024
Cover [Abstract]
Document Type	8-K
Document Period End Date	Sep. 23, 2024
Entity Registrant Name	Cidara Therapeutics, Inc.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-36912
Entity Tax Identification Number	46-1537286
Entity Address, Address Line One	6310 Nancy Ridge Drive,
Entity Address, Address Line Two	Suite 101
Entity Address, City or Town	San Diego,
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92121
City Area Code	858
Local Phone Number	752-6170
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, Par Value $0.0001 Per Share
Trading Symbol	CDTX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Entity Central Index Key	0001610618
Amendment Flag	false

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