[8-K] Cidara Therapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

Cidara Therapeutics entered a BARDA agreement that can total $339.2M, with an initial investment of approximately $58.1M to begin in September 2025 and run through September 2027. The initial funds will support the onshoring of CD388 manufacturing to U.S. contractors, a clinical trial to show comparability of a higher‑concentration formulation and different presentations, additional non‑clinical characterization against pandemic influenza strains, and development of protocols for expanded populations. BARDA may exercise up to nine options covering further clinical and non‑clinical work totaling up to $281.1M; Cidara may owe up to $192.2M in cost share for up to three of those options. The agreement starts on September 30, 2025, initially runs to September 29, 2027, and may extend but not beyond July 3, 2030. Either party may terminate with 60 days' notice; BARDA may terminate for cause. Some termination costs may be reimbursable by BARDA. The instrument is funded under federal contract 75A50125C00017 and supports Cidara's potential BLA path for CD388. Forward‑looking statements are included and subject to stated risks and uncertainties.

Positive

• Up to $339.2M potential BARDA investment reduces capex burden for CD388 development
• $58.1M initial funding immediately supports U.S. onshoring of CD388 manufacturing
• Funds explicitly allocated for a comparability clinical trial and non‑clinical pandemic influenza work
• Agreement aligns with a potential BLA pathway and federal biodefense priorities

Negative

• $281.1M of funding is contingent on BARDA exercising up to nine options and is not guaranteed
• Company cost share up to $192.2M for up to three options may create material future cash obligations
• Agreement is terminable with 60 days' notice and subject to reimbursement limitations if ended
• Forward‑looking plans (BLA, purchase by U.S. government) are uncertain and explicitly conditional

Insights

Biotech Partnerships Analyst

TL;DR: BARDA funding materially de‑risks near‑term development and manufacturing scaling for CD388.

The agreement provides up to $339.2M in potential federal support with an immediate $58.1M base investment, which directly finances onshoring CD388 manufacturing and a comparability clinical study. That reduces near‑term capital pressure and supports supply‑chain redundancy for a biodefense asset.

However, the larger $281.1M in options is conditional on BARDA exercise, and the company may carry up to $192.2M in cost share for select options; those obligations could affect cash needs if exercised.

Regulatory & Clinical Strategy Expert

TL;DR: Funding targets both manufacturing comparability and expanded clinical characterization relevant to a potential BLA.

Initial work funds a clinical comparability trial of a higher‑concentration formulation and additional non‑clinical influenza characterization, which are concrete steps toward a potential BLA submission noted in the filing. This aligns clinical and regulatory activities with federal preparedness priorities.

The agreement's term structure through July 3, 2030 and the 60‑day termination clause mean program continuity depends on option exercises and performance milestones; regulatory progress remains subject to trial outcomes and FDA interactions disclosed as forward‑looking.

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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 30, 2025

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

(858) 752-6170

(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. ☐

Item 1.01 Entry into a Material Definitive Agreement.

On September 30, 2025, Cidara Therapeutics, Inc. (the “Company”) entered into an Award/Contract (the “BARDA Agreement”) with the Biomedical Advanced Research and Development Authority (“BARDA”), part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, to support expanded manufacturing and clinical development of CD388, the Company’s non-vaccine influenza preventative therapeutic.

The BARDA Agreement provides for potential total investments by BARDA of up to $339.2 million. BARDA will invest approximately $58.1 million initially over a base period, commencing in September 2025, and extending through September 2027, to support the onshoring of CD388 manufacturing to the United States as an addition to the initial commercial supply chain and conduct a clinical trial to demonstrate the comparability of a higher-concentration formulation and different presentations of CD388, further characterize its activity against pandemic influenza strains in non-clinical models and initiate the development of clinical trial protocols for expanded populations. The balance of the award is subject to BARDA exercising up to nine options and would support additional clinical and non-clinical studies of CD388 in specific populations, as a complement to the Company’s plans for a potential Biologics License Application (“BLA”) submission to the U.S. Food and Drug Administration (“FDA”), and consists of up to $281.1 million for up to such nine options. In addition, the Company may be responsible for up to $192.2 million for the Company’s portion of cost sharing applicable to up to a certain three of such options.

The BARDA Agreement has an initial term that commences on September 30, 2025, and extends through September 29, 2027, which may be extended by mutual agreement of the Company and BARDA, or, if any of the options are exercised by BARDA (as described above), to cover the period of such exercised option set forth in the BARDA Agreement; provided that the total duration of the BARDA Agreement shall not exceed beyond July 3, 2030.

The BARDA Agreement is terminable by BARDA or the Company at any time for any reason with 60 days’ prior written notice, following consultation between the parties, or by BARDA for cause, if the Company materially fails to comply with the provisions of the BARDA Agreement (subject to a standard cure period). In the case of termination other than for cause, certain termination costs incurred by the Company may be reimbursable by BARDA.

This project is being supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50125C00017. The BARDA Agreement and federal funding are not an endorsement of the study results, product or company.

The foregoing description of the material terms of the BARDA Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the BARDA Agreement, a copy of which the Company plans to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025.

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 potential benefits of and future plans for CD388, including future clinical trials and the potential submission of a BLA to the FDA, potential investment amounts by BARDA, whether the Company will be able to transfer manufacturing to U.S. contract manufacturers, whether an influenza pandemic will occur and if it does whether CD388 will be purchased by the U.S. government. 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 the Company’s clinical trials and other risks related to clinical development, uncertainty as to whether the anticipated benefits of the BARDA collaboration can be achieved, delays in action by regulatory authorities, other obstacles associated with the enrollment of patients or other aspects of CD388 development and other risks and uncertainties associated with the Company’s business in general described in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 filed with Securities and Exchange Commission (“SEC”) on August 7, 2025, 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.

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: October 3, 2025									/s/ Jeffrey Stein, Ph.D.
									Jeffrey Stein, Ph.D.
									President and Chief Executive Officer (Principal Executive Officer)

FAQ

What does the BARDA agreement mean for Cidara (CDTX)?

The agreement provides potential federal funding of up to $339.2M, with an initial $58.1M to support CD388 manufacturing onshoring and clinical comparability studies beginning in September 2025.

How much of the BARDA award is guaranteed to Cidara?

The filing specifies an initial base investment of approximately $58.1M; the remaining $281.1M is contingent on BARDA exercising up to nine options.

Does Cidara have any cost‑sharing responsibilities under the BARDA deal?

Yes. The company may be responsible for up to $192.2M for its portion of cost sharing applicable to up to three of the options described.

What activities will BARDA funding support?

The funds will support onshoring CD388 manufacturing to U.S. contractors, a clinical trial for a higher‑concentration formulation and different presentations, non‑clinical influenza studies, and development of clinical protocols for expanded populations.

What is the term and termination structure of the BARDA agreement?

The initial term runs from September 30, 2025 through September 29, 2027, potentially extending up to July 3, 2030 if options are exercised. Either party may terminate with 60 days' prior written notice; BARDA may terminate for cause.