Full Press Release Details
Crinetics Pharmaceuticals Reports Fourth Quarter and Full Year 2019
Financial Results and Provides Corporate Update
SAN DIEGO - March 9, 2020 - 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 announced financial results for the fourth quarter and year ended December 31, 2019 and provided a corporate update.
"Crinetics made significant progress in 2019 advancing our development programs, as highlighted by the initiation of the ACROBAT Phase 2 clinical trials for acromegaly with our lead product candidate paltusotine," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Paltusotine is a first-in-class nonpeptide small molecule, which demonstrates our ability to develop novel drugs for diseases and patients that have not seen truly innovative therapies in a long time. We anticipate that 2020 will be a year of additional important milestones as our pipeline continues to advance. Importantly, we plan to provide guidance on timing of our acromegaly and neuroendocrine tumor programs early in the second quarter. In addition, we are advancing our ACTH antagonist development candidate for Cushing's disease and congenital adrenal hyperplasia as well as our sst5 agonist development candidate for congenital hyperinsulinemia towards the clinic as IND enabling activities for both programs are underway."
Full Year 2019 Highlights
Fourth Quarter and Full Year 2019 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 (formerly 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 potential treatment of neuroendocrine tumors. The company is also developing oral nonpeptide somatostatin agonists for hyperinsulinemia, as well as oral nonpeptide ACTH antagonists for the treatment of Cushing's disease and other diseases of excess ACTH excess, including congenital adrenal hyperplasia. 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 paltusotine and CRN01941 and the reporting of results from such clinical trials; plans to advance other development programs into the clinic; and anticipated cash runway. 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 paltusotine, CRN01941 and its other development 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 may use its available capital resources sooner than it expects; 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.
Chief Financial Officer
CRINETICS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA
(In thousands, except per share data)
| Three months ended December 31, | Twelve months ended December 31, | |||||||||||||||
| STATEMENTS OF OPERATIONS DATA: | 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Grant revenues | $ | 321 | $ | 781 | $ | 1,193 | $ | 2,428 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 12,143 | 7,651 | 41,506 | 24,479 | ||||||||||||
| General and administrative | 3,392 | 2,561 | 13,519 | 6,659 | ||||||||||||
| Total operating expenses | 15,535 | 10,212 | 55,025 | 31,138 | ||||||||||||
| Loss from operations | (15,214 | ) | (9,431 | ) | (53,832 | ) | (28,710 | ) | ||||||||
| Total other income (expense), net | 665 | 936 | 3,410 | 1,595 | ||||||||||||
| Net loss | $ | (14,549 | ) | $ | (8,495 | ) | $ | (50,422 | ) | $ | (27,115 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.60 | ) | $ | (0.35 | ) | $ | (2.09 | ) | $ | (2.23 | ) | ||||
| Weighted-average shares - basic and diluted | 24,235 | 24,046 | 24,175 | 12,142 |
| BALANCE SHEET DATA: | December 31, 2019 | December 31, 2018 | ||||||||||
| Cash, cash equivalents and investments | $ | 118,392 | $ | 163,875 | ||||||||
| Working capital | $ | 114,999 | $ | 158,758 | ||||||||
| Total assets | $ | 130,377 | $ | 171,415 | ||||||||
| Total liabilities | $ | 13,238 | $ | 11,190 | ||||||||
| Accumulated deficit | $ | (93,802 | ) | $ | (43,380 | ) | ||||||
| Total stockholders' equity | $ | 117,139 | $ | 160,225 |