UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 13, 2019
Crinetics Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-38583 |
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26-3744114 |
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(State or Other Jurisdiction of Incorporation or Organization) |
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(Commission File Number) |
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(I.R.S. Employer Identification Number) |
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10222 Barnes Canyon Road, Bldg #2
San Diego, California 92121
(858) 450-6464
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
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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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Common Stock, par value $0.001 per share |
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CRNX |
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Nasdaq Global Select Market |
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 2.02 Results of Operations and Financial Condition.
On August 13, 2019, Crinetics Pharmaceuticals, Inc. issued a press release reporting its financial results for the quarter ended June 30, 2019. 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
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Exhibit No |
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Description |
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99.1 |
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2
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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Crinetics Pharmaceuticals, Inc. |
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Date: August 13, 2019 |
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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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Exhibit 99.1
FOR IMMEDIATE RELEASE
Crinetics Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Corporate Update
SAN DIEGO – August 13, 2019 – 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 quarter ended June 30, 2019 and provided an update on its corporate activities and product pipeline.
“This July marks the end of a full year as a public company for Crinetics and we are excited by the progress we made this past quarter, and our evolution during the past year,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. “As the ACROBAT trials continue to enroll patients with acromegaly, we are progressing the rest of our pipeline, as highlighted by the initiation of our Phase 1 trial for CRN01941 aimed at neuroendocrine tumors and are making strides with our preclinical programs for Cushing’s Disease and congenital hyperinsulinemia.”
Second Quarter and Subsequent Highlights
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Initiated Phase 1 study of CRN01941 for the treatment of neuroendocrine tumors. In May 2019, Crinetics initiated a Phase 1, double blind, randomized, placebo-controlled, single- and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CRN01941 in healthy volunteers with topline data expected in late 2019 or early 2020. CRN01941 is an oral nonpeptide somatostatin receptor subtype 2 (sst2) biased agonist designed for the treatment of neuroendocrine tumors (NETs) that originate from neuroendocrine cells commonly found in the gut, lung, or pancreas. |
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Received final award of SBIR grant from NIH for congenital hyperinsulinism. In July 2019, Crinetics announced that it would receive up to approximately $0.9 million in continued funding under its Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney diseases (NIDDK) of the National Institutes of Health (NIH). The funds are being used to support the ongoing research and development of Crinetics’ nonpeptide somatostatin agonists for congenital hyperinsulinemias (CHI). |
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Expanded board of directors. In July 2019, Crinetics appointed Stephanie S. Okey, M.S. to its board of directors as an independent board member. Ms. Okey brings extensive leadership and management experience having spent her career in senior commercial roles including, most recently, Head of North America and U.S. General Manager of Rare Diseases at Genzyme. |
Second Quarter 2019 Financial Results
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Research and development expenses were $10.3 million for the three months ended June 30, 2019, compared to $5.2 million for the same period in 2018. The increases were primarily attributable to development and manufacturing activities for CRN00808 and CRN01941 as well as the company’s preclinical programs and higher personnel costs. |
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General and administrative expenses were $3.1 million for the three months ended June 30, 2019, compared to $1.1 million for the same period in 2018. The increases were primarily due to costs to operate as a public company, as well as personnel costs to support the company’s growth. |
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Net loss for the three months ended June 30, 2019 was $12.4 million, compared to a net loss of $5.6 million for the same period in 2018. |
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Unrestricted cash, cash equivalents and investments totaled $145.0 million as of June 30, 2019, compared to $157.2 million as of March 31, 2019 and $163.9 million as of December 31, 2018. |
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As of July 31, 2019, the company had 24,199,972 common shares outstanding. |
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, CRN00808, is an oral selective nonpeptide somatostatin receptor type 2 biased agonist undergoing two Phase 2 clinical trials for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the United States. Crinetics’ second oral product development candidate, CRN01941, has entered the clinic for the treatment of neuroendocrine tumors. The company is also developing oral nonpeptide somatostatin agonists for hyperinsulinism, as well as oral nonpeptide ACTH antagonists for the treatment of Cushing's disease. All of the company’s drug candidates are new chemical entities resulting from in-house drug discovery efforts. For more information, please visit www.crinetics.com.
Forward-Looking Statements
Crinetics cautions you that statements contained in this press release 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 anticipated timing of clinical trials for CRN00808 and CRN01941 and plans to advance other pipeline programs. 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 press release due to the risks and uncertainties inherent in Crinetics’ business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; 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 for CRN00808, CRN01941 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, or may result in recalls or product liability claims; Crinetics’ ability to obtain and maintain intellectual property protection for its product candidates; 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.
Contacts:
Marc Wilson
Chief Financial Officer
IR@crinetics.com
(858) 450-6464
Robert H. Uhl
Westwicke Partners
robert.uhl@westwicke.com
(858) 356-5932
CRINETICS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA
(UNAUDITED)
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Three months ended June 30, |
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Six months ended June 30, |
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STATEMENTS OF OPERATIONS DATA: |
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2019 |
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2018 |
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2019 |
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2018 |
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Grant revenues |
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$ |
- |
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$ |
657 |
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$ |
367 |
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$ |
1,099 |
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Operating expenses: |
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Research and development |
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10,285 |
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5,222 |
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17,540 |
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9,942 |
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General and administrative |
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3,060 |
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1,118 |
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6,216 |
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2,366 |
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Total operating expenses |
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13,345 |
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6,340 |
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23,756 |
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12,308 |
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Loss from operations |
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(13,345 |
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(5,683 |
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(23,389 |
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(11,209 |
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Total other income (expense), net |
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918 |
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115 |
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1,946 |
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177 |
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Net loss |
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$ |
(12,427 |
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$ |
(5,568 |
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$ |
(21,443 |
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$ |
(11,032 |
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Net loss per share - basic and diluted |
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$ |
(0.51 |
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$ |
(2.41 |
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$ |
(0.89 |
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$ |
(5.28 |
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Weighted-average shares - basic and diluted |
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24,161 |
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2,307 |
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24,128 |
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2,089 |
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BALANCE SHEET DATA: |
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June 30, 2019 |
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December 31, 2018 |
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Cash, cash equivalents and investments |
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$ |
144,974 |
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$ |
163,875 |
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Working capital |
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$ |
140,008 |
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$ |
158,758 |
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Total assets |
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$ |
155,149 |
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$ |
171,415 |
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Total liabilities |
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$ |
13,048 |
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$ |
11,190 |
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Accumulated deficit |
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$ |
(64,823 |
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$ |
(43,380 |
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Total stockholders’ equity |
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$ |
142,101 |
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$ |
160,225 |
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