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 obligation of the registrant under any of the following provisions:
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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.
Item 2.02 Results of Operations and Financial Condition.
On May 12, 2022, Crinetics Pharmaceuticals, Inc. (the “Company” or “Crinetics”) issued a press release reporting its financial results for the period ended March 31, 2022. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
In accordance with General Instruction B.2 of Form 8-K, the information contained or incorporated herein, including the press release filed as Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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. |
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Date: |
May 12, 2022 |
By: |
/s/ R. Scott Struthers, Ph.D. |
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R. Scott Struthers, Ph.D. |
Exhibit 99.1
Crinetics Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Corporate Update
SAN DIEGO – May 12, 2022 – Crinetics Pharmaceuticals, Inc.(Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today reported financial results for the first quarter ended March 31, 2022.
“We continue to build the foundation needed to establish Crinetics as the world’s leading endocrine company, as recent progress has strengthened our clinical dataset, balance sheet and leadership team,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “This is highlighted by CRN04777’s recent Phase 1 top-line results, which further demonstrated the molecule’s dose-dependent effects on biomarkers that are critically important to the pathophysiology and medical management of hyperinsulinism. Later this quarter, we expect to report data from a healthy volunteer study designed to evaluate CRN04894’s potential to counteract the effects of excess ACTH with a novel mechanism of action. The pharmacologic proof-of-concept these Phase 1 studies aim to achieve highlights the unique efficiency of our endocrine drug development paradigm. Looking forward, we will continue to combine the advantages of this paradigm with the efforts of our deeply talented drug discovery team to thoughtfully expand our pipeline as we work to advance our current clinical-stage candidates towards registration.”
First Quarter 2022 and Recent Highlights
First Quarter 2022 Financial Results
About Crinetics Pharmaceuticals
Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company’s lead product candidate, paltusotine, is an investigational, oral, selective nonpeptide somatostatin receptor type 2 (SST2) biased agonist for the treatment of acromegaly, an orphan disease affecting more than 26,000 people in the United States. A Phase 3 clinical program in acromegaly with paltusotine is underway. Crinetics Pharmaceuticals is also developing paltusotine for the treatment of carcinoid syndrome associated with neuroendocrine tumors. The company is developing CRN04777, an investigational, oral, nonpeptide somatostatin receptor type 5 (SST5) agonist for congenital and other forms of hyperinsulinism, as well as CRN04894, an investigational, oral, nonpeptide adrenocorticotropic hormone (ACTH) antagonist for the treatment of congenital adrenal hyperplasia, Cushing’s disease and other diseases of excess ACTH. All of the company’s drug candidates are new chemical entities resulting from in-house drug discovery efforts.
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 potential for Crinetics to be a leader in the design and development of novel small molecule drugs for endocrine diseases; the plans and timelines for the clinical development of paltusotine, CRN04777 and CRN04894, including the therapeutic potential and clinical benefits thereof; the expected timing of data from the Phase 1 clinical trial of
CRN04984 and Phase 3 clinical trials of paltusotine; Crinetics’ plans to advance a Phase 2 clinical trial of CRN04777 and the timing thereof; Crinetics’ potential to receive future milestone and royalty payments from Sanwa; Crinetics’ anticipated cash runway and plans to advance other pipeline product candidates or discovery efforts. 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” 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, preliminary data that we report may change following a more comprehensive review of the data related to the clinical trials and such data may not accurately reflect the complete results of a clinical trial, and the FDA and other regulatory authorities may not agree with our interpretation of such results; advancement of CRN04894 and CRN04777 into later stage trials is dependent on and subject to the receipt of further feedback from the FDA and other regulatory agencies; 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; unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval and/or commercialization; the company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics’ clinical trials and nonclinical studies; regulatory developments in the United States and foreign countries; Crinetics’ ability to receive milestone or royalty payments from Sanwa will depend on Sanwa’s ability to advance the pipeline through clinical development, regulatory approval and ultimately commercial sales, all of which will take significant time, will be subject to inherent risks in drug development and may be impacted by changes in regulatory requirements, healthcare reform measures and competitive dynamics; clinical trials 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; Crinetics may use its capital resources sooner than expected; and the other risks and uncertainties described in the company’s periodic filings with the 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 reports, including its annual report on Form 10-K for the year ended December 31, 2021, 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.
Contacts:
Marc Wilson
Chief Financial Officer
IR@crinetics.com
(858) 450-6464
Investors / Media:
Corey Davis
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
(212) 915-2577
Aline Sherwood
Scienta Communications
asherwood@scientapr.com
(312) 238-8957
CRINETICS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA
(In thousands, except per share data)
(Unaudited)
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Three months ended March 31, |
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STATEMENTS OF OPERATIONS DATA: |
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2022 |
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2021 |
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License revenues |
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$ |
3,131 |
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$ |
— |
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Operating expenses: |
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Research and development |
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28,252 |
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17,584 |
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General and administrative |
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8,706 |
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5,334 |
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Total operating expenses |
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36,958 |
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22,918 |
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Loss from operations |
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(33,827 |
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(22,918 |
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Total other income (expense), net |
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210 |
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17 |
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Loss before equity method investment |
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(33,617 |
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(22,901 |
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Loss on equity method investment |
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(1,010 |
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— |
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Net loss |
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$ |
(34,627 |
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$ |
(22,901 |
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Net loss per share - basic and diluted |
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$ |
(0.73 |
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$ |
(0.69 |
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Weighted-average shares - basic and diluted |
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47,712 |
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33,012 |
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BALANCE SHEET DATA: |
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March 31, |
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December 31, |
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Cash, cash equivalents and investments |
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$ |
319,725 |
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$ |
333,707 |
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Working capital |
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$ |
307,992 |
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$ |
328,725 |
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Total assets |
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$ |
333,286 |
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$ |
351,015 |
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Total liabilities |
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$ |
30,242 |
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$ |
19,071 |
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Accumulated deficit |
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$ |
(309,882 |
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$ |
(275,255 |
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Total stockholders’ equity |
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$ |
303,044 |
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$ |
331,944 |
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