# EDGAR Filing Document

**Accession Number:** 0001658247
**File Stem:** 0000950170-25-091613
**Filing Date:** 2025-6
**Character Count:** 22523
**Document Hash:** c8a2d39a6bdc2f82f32faaa72e1f8f17
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-25-091613.hdr.sgml**: 20250630

**ACCESSION NUMBER**: 0000950170-25-091613

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 11

**CONFORMED PERIOD OF REPORT**: 20250630

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250630

**DATE AS OF CHANGE**: 20250630

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Crinetics Pharmaceuticals, Inc.
- **CENTRAL INDEX KEY:** 0001658247
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 263744114
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38583
- **FILM NUMBER:** 251092412

**BUSINESS ADDRESS:**
- **STREET 1:** 6055 LUSK BLVD.
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121
- **BUSINESS PHONE:** 858-450-6464

**MAIL ADDRESS:**
- **STREET 1:** 6055 LUSK BLVD.
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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## **FORM** 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** June 30, 2025<br>

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Crinetics Pharmaceuticals, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-38583 | 26-3744114 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 6055 Lusk Boulevard |  |  |
| San Diego**,** California |  | 92121 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** (858) 450-6464<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation 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:**

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock, par value $0.001 per share | CRNX | Nasdaq Global Select Market |

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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 7.01 Regulation FD Disclosure.** 
On June 30, 2025, Crinetics Pharmaceuticals, Inc. (the "Company" or "Crinetics") issued a press release announcing eight abstracts from its novel clinical development programs to be presented at the Endocrine Society's Annual Meeting, ENDO 2025, which is taking place from July 12-15, 2025 in San Francisco, California. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Item 7.01, including in Exhibit 99.1 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 (the "Exchange Act"), 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 (the "Securities Act"), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

**Forward-Looking Statements**

This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements other than statements of historical facts contained in this Current Report on Form 8-K are forward-looking statements, including statements regarding the plans and timelines for the clinical development of atumelnant and paltusotine, including the therapeutic potential and clinical benefits or safety profile thereof; the plans and timelines for the commercial launch of PALSONIFY if approved; the potential clinical benefits of Crinetics' TSHR antagonist, CRN12755, in patients across multiple indications, and the anticipated timing of clinical trials, registration applications or the therapeutic potential for Crinetics' development candidates. These forward-looking statements speak only as of the date of this Current Report on Form 8-K and are subject to a number of known and unknown risks, uncertainties and assumptions, including, without limitation, initial or topline data that Crinetics reports may change following completion or a more comprehensive review of the data related to the clinical studies and such data may not accurately reflect the complete results of a clinical study, and the FDA and other regulatory authorities may not agree with Crinetics' interpretation of such results; geopolitical events may disrupt Crinetics' business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; the success of Crinetics' clinical studies and nonclinical studies; regulatory developments in the United States and foreign countries; clinical studies and preclinical studies may not proceed at the time or in the manner expected, or at all; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics' drug candidates may not advance in development or be approved for marketing; and the other 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, 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.

## **Item 9.01 Financial Statements and Exhibits.** 
(d) Exhibits

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [<u>Press Release dated June 30, 2025.</u>](crnx-ex99_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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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 thereunto duly authorized.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | Crinetics Pharmaceuticals, Inc. |
| Date: | June 30, 2025 | By:  | /s/ R. Scott Struthers, Ph.D. |
|  |  |  | R. Scott Struthers, Ph.D.<br>President and Chief Executive Officer<br>(Principal Executive Officer) |

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## Exhibit 99.1

**Exhibit 99.1**

**Crinetics to Showcase the Next Generation of Endocrinology Innovation at ENDO 2025 with Eight Presentations From its Deep Pipeline** 

*Long-term efficacy and safety data on PALSONIFY*<sup>TM</sup>*(paltusotine) in acromegaly to be presented, including evidence of both biochemical and symptom control with a well-tolerated safety profile in patients switching treatments and those not previously pharmacologically treated* 

*Atumelnant Phase 2 trial results in congenital adrenal hyperplasia (CAH) to be featured in oral presentation*

 *Data from early-stage development program in Graves' hyperthyroidism and orbitopathy also to be featured* 

**SAN DIEGO – June 30, 2025** – Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced eight abstracts from its novel clinical development programs, including oral presentations featuring its lead investigational drug candidate, PALSONIFY™ (paltusotine)\* and investigational candidate atumelnant, will be presented at the Endocrine Society's Annual Meeting, ENDO 2025, July 12-15, 2025, in San Francisco, California.

"ENDO 2025 will be an incredibly meaningful moment for Crinetics in our mission to be the premier endocrine-focused global pharmaceutical company," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "For our lead investigational candidate PALSONIFY for acromegaly, we are excited to present long-term data that continue to support the durable, consistent response profile it has shown in earlier pivotal trials. Additionally, compelling Phase 2 trial results from atumelnant in CAH and new data from one of our early-stage development programs demonstrate that the Crinetics pipeline can address significant unmet needs."

Four abstracts will report results from the PALSONIFY development program, including an oral presentation featuring open-label extension data from the registrational Phase 3 PATHFNDR trials. This presentation will highlight long-term efficacy, safety, and symptom control in people with acromegaly who switched from injectable somatostatin receptor ligands (SRLs) to once-daily oral PALSONIFY. In addition, Crinetics will present three poster presentations, one evaluating symptom stability in acromegaly, one analyzing patient-reported outcomes from both PATHFNDR-1 and PATHFNDR-2 and another on PATHFNDR-2 open-label extension data. Together, these abstracts show PALSONIFY continues to be well tolerated, while providing consistent biochemical and symptomatic disease control.

Crinetics will also present three abstracts from its atumelnant clinical development program, including an oral presentation of Phase 2 trial results in congenital adrenal hyperplasia (CAH). Additional presentations focus on reduction of adrenal volume and rapid and sustained reductions in potent 11-oxygenated androgens, a novel biomarker, in Phase 2 trial participants.

Beyond its two lead programs, Crinetics will present new data from its early-stage pipeline, including data from CRN12755 for Graves' hyperthyroidism and orbitopathy.

Additional presentation details are shown below. All times are PT:

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*\*The U.S. Food and Drug Administration recently conditionally approved PALSONIFY as the trade name for paltusotine, our once-daily, oral investigational candidate for acromegaly.* 

**PALSONIFY™ (paltusotine) Presentations** 

**Title**: Paltusotine Results in Improved Symptom Stability in Biochemically Controlled Acromegaly

**Authors**: David Clemmons, MD et. al.

**Date/Time**: July 13, 12:00-1:30 PM

**Location**: Session P34 – Neuroendocrinology and Pituitary: Acromegaly, Prolactinoma, Other Functioning Pituitary Tumors (Except Cushing) II – ENDOExpo Poster Area: SUN-043

**Title**: Effects of Paltusotine Treatment on Patient-Reported Symptoms of Acromegaly in Phase 3 Randomized Placebo-Controlled Studies (PATHFNDR-2 and PATHFNDR-1)

**Authors**: Avery A. Rizio, PhD et. al.

**Date/Time**: July 13, 12:00-1:30 PM

**Location**: Session P34 – Neuroendocrinology and Pituitary: Acromegaly, Prolactinoma, Other Functioning Pituitary Tumors (Except Cushing) II – ENDOExpo Poster Area: SUN-052

**Title**: Disease Control in Patients With Acromegaly Switching From Injected Somatostatin Receptor Ligands to Once-Daily Oral Paltusotine: Interim Results of the PATHFNDR-1 Open-Label Extension

**Authors**: Beverly M. K. Biller, MD et. al.

**Date/Time**: July 13, 2:45-3:00 PM

**Location**: Session OR12-07 – Neuroendocrinology and Pituitary: Management of Pituitary Disorders – Room 201

**Title**: Once-Daily Oral Paltusotine in the Treatment of Patients With Biochemically Uncontrolled Acromegaly: Interim Results of the PATHFNDR-2 Open-Label Extension

**Authors**: Monica R. Gadelha, MD, PhD et. al.

**Date/Time**: July 14, 12:00–1:30 PM

**Location**: Session P77 - Neuroendocrinology and Pituitary: Acromegaly, Prolactinoma, Other Functioning Pituitary Tumors (except Cushing) III - ENDOExpo: Poster Area; MON-069

**Atumelnant Presentations**

**Title**: Reductions in Adrenal Volume in Patients With Congenital Adrenal Hyperplasia Receiving Once-Daily Oral Atumelnant (CRN04894): Interim Results From a 12-Week, Phase 2, Open-Label Study

**Authors**: Tania A.S.S. Bachega, MD, PhD et. al.

**Date/Time**: July 12, 12:15-1:45 PM

**Location**: Session P18 – Adrenal (Excluding Mineralocorticoids): Adrenal Insufficiency and CAH I – ENDOExpo Poster Area: SAT-452

**Title**: Once-Daily Oral Atumelnant (CRN04894) Induces Rapid, Substantial, and Sustained Reductions of Androstenedione and 17-Hydroxyprogesterone in Adults With Classical Congenital Adrenal Hyperplasia: Interim Results From a 12-Week, Phase 2, Open-Label Study

**Authors**: Umasuthan Srirangalingam, MD, PhD et. al.

**Date/Time**: July 12, 2:30-2:45 PM

**Location**: Session OR07-06 – Adrenal (Excluding Mineralocorticoids): All About Congenital Adrenal Hyperplasia and Adrenal Insufficiency – Room 204

**Title**: -Rapid and Sustained Reduction of 11-Oxygenated Androgens in Adults With Classic Congenital Adrenal Hyperplasia Following Once-Daily Oral Atumelnant (CRN04894): Results From a 12-Week, Phase 2, Open-Label Study

**Authors**: Nicole Reisch, MD et. al.

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**Date/Time**: July 13, 12:00-1:30 PM

**Location**: Session P55 - Adrenal (Excluding Mineralocorticoids): Adrenal Insufficiency and CAH II – ENDOExpo Poster Area: SUN-438

**Early-Stage Pipeline Presentations**

**Title**: Discovery and Characterization of an Orally Bioavailable Nonpeptide Thyroid Stimulating Hormone Receptor (TSHR) Antagonist for the Treatment of Graves' Disease and Thyroid Eye Disease

**Authors**: Eulalia A. Coutinho, PhD et. al.

**Date/Time**: July 14, 12:00-1:30 PM

**Location**: Session P92 – Thyroid Biology and Disease: Benign Thyroid Disorders (Auto-Immune) II – ENDOExpo Poster Area: MON-365

**Crinetics Sponsored Science & Innovation Theaters**

**Title**: Optimizing Long-Term Control in Acromegaly: Key to Improved Patient Outcomes

**Presenters**: Shlomo Melmed, MB ChB, FRCP, MACP; Christian J. Strasburger, MD

**Date/Time**: July 14, 9:30 AM-10:30 AM

**Location**: Theater 1

**Title**: Navigating the Complexities & Challenges of Acromegaly Management

**Presenters**: Lisa B. Nechtinall, MD; Laurence Katznelson, MD; Scott Struthers, PhD

**Date/Time**: July 14, 12:30 PM -1:30 PM

**Location**: Theater 1

**About PALSONIFY™** (**Paltusotine)** 

Crinetics' lead development candidate, PALSONIFY, is the first investigational once-daily, oral, selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide agonist that has completed Phase 3 clinical development for acromegaly and is in Phase 3 clinical development for carcinoid syndrome associated with neuroendocrine tumors. It was designed to be a once-daily oral option for the control of acromegaly and carcinoid syndrome. In Phase 3 studies, once-daily, oral PALSONIFY maintained IGF-1 levels and symptom control in patients with acromegaly who were switched from monthly injectable medications (PATHFNDR-1) and rapidly decreased IGF-1 levels and symptom burden in medically untreated acromegaly patients (PATHFNDR-2). IGF-1 is the primary biomarker endocrinologists use to manage acromegaly patients. Results from a Phase 2 study in carcinoid syndrome demonstrated rapid and sustained reductions in flushing episodes and bowel movement frequency, which are the most common symptoms of carcinoid syndrome, leading to the initiation of a Phase 3 trial for control of carcinoid syndrome in patients with neuroendocrine tumors.

**About Atumelnant**<br>Atumelnant, Crinetics' second investigational compound, is the first once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist that acts selectively at the melanocortin type 2 receptor (MC2R) on the adrenal gland. Diseases associated with excess ACTH can have significant impact on physical and mental health. Atumelnant has exhibited strong binding affinity for MC2R in preclinical models and has demonstrated suppression of adrenally derived glucocorticoids and androgens that are under the control of ACTH. Data from a 12-week Phase 2 study demonstrated compelling treatment benefits of atumelnant, evidenced by the rapid, substantial and sustained statistically significant reductions in key CAH disease related biomarkers, including androstenedione and 17-hydroxyprogesterone, in a diverse population. Atumelnant is in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome, with the Phase 3 CALM-CAH trial and a Phase 1/2b trial in ADCS currently enrolling patients.

**About Crinetics Pharmaceuticals** 

Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors. Crinetics'

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lead development candidate, PALSONIFY (paltusotine), is the first investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist that is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors. Atumelnant is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing's syndrome. All of the company's drug candidates are orally delivered, small molecule, new chemical entities resulting from in-house drug discovery efforts, including additional discovery programs addressing a variety of endocrine conditions such as hyperparathyroidism, polycystic kidney disease, Graves' disease (including thyroid eye disease), diabetes, obesity and GPCR-targeted oncology indications.

**Forward-Looking Statements** 

*This press release 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 press release are forward-looking statements, including statements regarding the plans and timelines for the clinical development of atumelnant and paltusotine, including the therapeutic potential and clinical benefits or safety profile thereof; the plans and timelines for the commercial launch PALSONIFY if approved; the potential clinical benefits of our TSHR antagonist, CRN12755, in patients across multiple indications, and the anticipated timing of clinical trials, registration applications or the therapeutic potential for our development candidates. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential," "upcoming" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, initial or topline data that we report may change following completion or a more comprehensive review of the data related to the clinical studies and such data may not accurately reflect the complete results of a clinical study, and the FDA and other regulatory authorities may not agree with our interpretation of such results; geopolitical events may disrupt Crinetics' business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; the success of Crinetics' clinical studies and nonclinical studies; regulatory developments in the United States and foreign countries; clinical studies and preclinical studies may not proceed at the time or in the manner expected, or at all; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics' drug candidates may not advance in development or be approved for marketing; and the other 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, 2024 and quarterly report on Form 10-Q for the quarter ended March 31, 2025. 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.*

**Contact:** 

**Media:** <br>Natalie Badillo <br>Head of Corporate Communications <br>

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nbadillo@crinetics.com <br>(858) 345-6075

**Investors:** <br>Gayathri Diwakar <br>Head of Investor Relations <br>gdiwakar@crinetics.com <br>(858) 345-6340

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