Cidara Therapeutics Enters Material Definitive Agreement

TL;DR

CDTX signed a big deal, details TBD.

AI Summary

On September 30, 2025, Cidara Therapeutics, Inc. reported an entry into a material definitive agreement. The filing does not disclose specific details of the agreement, the counterparty, or any associated financial terms.

Why It Matters

This filing indicates a significant new contract or partnership for Cidara Therapeutics, which could impact its future operations and financial performance.

Risk Assessment

Risk Level: medium — The lack of specific details in the filing creates uncertainty about the nature and impact of the material definitive agreement.

Key Players & Entities

• Cidara Therapeutics, Inc. (company) — Registrant
• September 30, 2025 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of incorporation
• 001-36912 (identifier) — SEC File Number
• 46-1537286 (identifier) — I.R.S. Employer Identification Number
• 6310 Nancy Ridge Drive, Suite 101 San Diego, California 92121 (address) — Principal Executive Offices
• 858-752-6170 (phone_number) — Registrant's Principal Executive Offices Telephone Number

FAQ

Key Financial Figures

• $0.0001 — ich registered Common Stock, Par Value $0.0001 Per Share CDTX The Nasdaq Stock Market
• $339.2 million — ial total investments by BARDA of up to $339.2 million. BARDA will invest approximately $58.1
• $58.1 million — illion. BARDA will invest approximately $58.1 million initially over a base period, commencin
• $281.1 million — stration ("FDA"), and consists of up to $281.1 million for up to such nine options. In additio
• $192.2 million — he Company may be responsible for up to $192.2 million for the Company's portion of cost shari

Filing Documents

• cdtx-20250930.htm (8-K) — 30KB
• 0001610618-25-000089.txt ( ) — 147KB
• cdtx-20250930.xsd (EX-101.SCH) — 2KB
• cdtx-20250930_lab.xml (EX-101.LAB) — 22KB
• cdtx-20250930_pre.xml (EX-101.PRE) — 13KB
• cdtx-20250930_htm.xml (XML) — 3KB

01 Entry into a Material Definitive Agreement

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 pe

Forward-Looking Statements

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 obligatio

SIGNATURES

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)

View Full Filing

View this 8-K filing on SEC EDGAR