UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR § 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR § 240.12b-2).
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 8.01 Other Events.
On September 27, 2021, Crinetics Pharmaceuticals, Inc. (the “Company” or “Crinetics”) announced its intent to develop a nonpeptide oral parathyroid hormone (“PTH”) receptor antagonist for the treatment of hypercalcemia associated with primary hyperparathyroidism (“HPT”) and other diseases of PTH receptor type 1 (“PTHR1”) over-activation.
The Company’s family of novel PTHR1 antagonists are small molecules generated through the Company’s in-house discovery efforts. They are designed to specifically block PTHR1, which positions them to potentially address all conditions of excess PTH, including primary hyperparathyroidism due to parathyroid tumors or hyperplasia; secondary hyperparathyroidism due to chronic kidney disease (“CKD”); malignancy-associated hypercalcemia.
PTH regulates calcium and phosphate homeostasis in bone and kidney through activation of its receptor, PTHR1. Increased activation of PTHR1, either via PTH or PTH-related peptide (“PTHrP”) can lead to skeletal, renal, gastrointestinal, and neurological problems. Crinetics is not aware of any other PTH receptor antagonists for the treatment of PTH or PTHrP-driven diseases.
Crinetics is in the late stages of selecting a lead candidate from this family of compounds, which it anticipates will enable it to initiate IND-enabling studies in 2022.
Forward-Looking Statements
Crinetics cautions you that statements contained in this current report regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential benefits of PTH receptor antagonists for patients with primary hyperparathyroidism, secondary hyperparathyroidism due to CKD and other diseases of excess PTH receptor activation; and plans to identify and advance a lead candidate for development, including potential IND-enabling studies in 2022. The inclusion of forward-looking statements should not be regarded as a representation by Crinetics that any of its plans will be achieved. Actual results may differ from those set forth in this current report due to the risks and uncertainties inherent in Crinetics’ business, including, without limitation: the results of preclinical studies and early clinical trials are not necessarily predictive of future results; we may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; the COVID-19 pandemic may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics’ clinical trials, nonclinical studies and preclinical studies for paltusotine, CRN04894, CRN04777, its PTH receptor antagonist program and its other product candidates; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of the Company’s product candidates that may limit their development, regulatory approval and/or commercialization; Crinetics may use its capital resources sooner than it expects; and other risks described under the heading “Risk Factors” in documents the Company files from time to time with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Crinetics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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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.
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Date: September 27, 2021 |
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Crinetics Pharmaceuticals, Inc. |
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/s/ R. Scott Struthers, Ph.D. |
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R. Scott Struthers, Ph.D. |
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President and Chief Executive Officer (Principal Executive Officer) |
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Document and Entity Information |
Sep. 27, 2021 |
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| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Sep. 27, 2021 |
| Entity Registrant Name | Crinetics Pharmaceuticals, Inc. |
| Entity Central Index Key | 0001658247 |
| Entity Emerging Growth Company | true |
| Entity Ex Transition Period | true |
| Entity Incorporation, State or Country Code | DE |
| Entity File Number | 001-38583 |
| Entity Tax Identification Number | 26-3744114 |
| Entity Address, Address Line One | 10222 Barnes Canyon Road |
| Entity Address, Address Line Two | Bldg #2 |
| 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 | 450-6464 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Security 12b Title | Common Stock, par value $0.001 per share |
| Trading Symbol | CRNX |
| Security Exchange Name | NASDAQ |