Item 7.01 Regulation FD Disclosure.
On June 3, 2024, Crinetics Pharmaceuticals, Inc. (the “Company,” “Crinetics,” “we,” “us,” or “our”) issued a press release and made available a corporate presentation announcing positive initial findings from the development program of its second clinical product candidate, atumelnant* (CRN04894), a novel, once-daily oral adrenocorticotropic hormone (“ACTH”) receptor antagonist. The results, presented at the Endocrine Society’s Annual Meeting (“ENDO 2024”), include initial data from the Phase 1b/2a, open-label study in ACTH-dependent Cushing’s syndrome conducted in collaboration with the National Institutes of Health, and the Phase 2 open-label TouCAHn study in congenital adrenal hyperplasia. Copies of the press release and corporate presentation are attached as Exhibits 99.1 and 99.3, respectively, to this Current Report on Form 8-K and are incorporated herein by reference. The press release and corporate presentation will also be available under the “Investors” section of the Company’s website. The Company intends to deliver the corporate presentation during a conference call and live webcast with the investment community on June 3, 2024, at 4:30 p.m. Eastern Time.
Also on June 3, 2024, the Company issued a press release announcing findings from its clinical development program evaluating oral, once-daily investigational paltusotine in acromegaly. The data was presented at ENDO 2024 and included results of the Phase 3 PATHFNDR-2 trial, a new analysis of patient reported outcome data from the Phase 3 PATHFNDR-1 trial, and interim long-term efficacy and safety results at 42 months from the open-label ACROBAT Advance extension study. A copy of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The press release will also be available under the “Investors” section of the Company’s website.
The information that is solely contained in this Item 7.01 of this Current Report on Form 8-K, including in Exhibit 99.3 hereto, is being “furnished” and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, is not subject to the liabilities of that section and is not deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.
* Proposed international non-proprietary name under review.
Item 8.01 Other Events.
The information regarding the press releases referred to in Item 7.01 of this Current Report on Form 8-K is incorporated herein by reference. Copies of the press releases are attached as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and are incorporated herein by reference.
Forward-Looking Statements
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this report are forward-looking statements. These forward-looking statements speak only as of the date of this report and are subject to a number of known and unknown risks, uncertainties and assumptions, including, without limitation, the risks and uncertainties described in the Company’s periodic filings with the Securities and Exchange Commission (“SEC”). The events and circumstances reflected in the Company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading “Risk Factors” in Crinetics’ periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2023 and quarterly report on Form 10-Q for the quarter ended March 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
