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Crinetics Pharmaceuticals Announces 2021 Clinical Plans and Reports Fourth Quarter and Full Year 2020 Financial Results Advancing paltusotine into a Phase 3 program for acromegaly following an FDA m

Key Takeaway: Crinetics Pharmaceuticals Announces 2021 Clinical Plans and Reports Fourth Quarter and Full Year 2020 Financial Results Advancing paltusotine into a Phase 3 program for acromegaly following an FDA meeting Phase 1 clinical proof-of-concept data for CRN04894 and CRN04777 expected

Full Press Release Details

Crinetics Pharmaceuticals Announces 2021 Clinical Plans and Reports Fourth Quarter and Full Year 2020 Financial Results
Advancing paltusotine into a Phase 3 program for acromegaly following an FDA meeting
Phase 1 clinical proof-of-concept data for CRN04894 and CRN04777 expected in 1H 2021 and mid-2021, respectively
Management hosting webcast and conference call today at 4:30 p.m. ET
SAN DIEGO - March 30, 2021 - 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 its 2021 clinical plans and reported financial results for the fourth quarter and year ended December 31, 2020.
"We are entering 2021 poised to achieve several key milestones that we believe will consolidate our position as a leader in the design and development of novel small molecule drugs for endocrine diseases," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Our positive Phase 2 acromegaly data demonstrate the potential of orally administered paltusotine to replace injectable somatostatin receptor ligand (SRL) depots as the standard-of-care. With input from a recently completed FDA meeting, we have designed the paltusotine Phase 3 program to support its approval for all acromegaly patients who require pharmacotherapy, including both untreated patients and those switching from injected standard of care."
Dr. Struthers continued, "Paltusotine's success and progress serve as a blueprint for our new therapeutic candidates in endocrinology. We plan to follow a similar path with CRN04777 and CRN04894, both of which recently entered Phase 1 proof-of-concept trials in healthy volunteers. Much like paltusotine's Phase 1 program, we've designed these trials to evaluate safety, drug-like pharmacokinetics, and corresponding pharmacodynamic effects on well-validated hormonal biomarkers for their respective indications. We look forward to reporting results from the Phase 1 trials later this year, and to the continued progression of our clinical and preclinical pipelines."
Full Year 2020 and Recent Highlights
Fourth Quarter and Full Year 2020 Financial Results
Webcast and Conference Call Information
Crinetics will hold a live webcast and conference call today, March 30, 2021 at 4:30 p.m. Eastern Time to discuss its 2021 clinical plans and 2020 financial results. To access the webcast, please visit this link to the event. To participate by phone, please dial 877-407-0789 (domestic) or 201-689-8562 (international) and refer to conference ID 13717687. Following the live event, the archived webcast will be available for 90 days.
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 investigational, oral, selective nonpeptide somatostatin receptor type 2 biased agonist for the treatment of acromegaly, an orphan disease affecting more than 26,000 people in the United States. Crinetics plans to advance paltusotine into a Phase 3 program in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors. The company is also developing CRN04777, an investigational, oral, nonpeptide somatostatin receptor type 5 (SST5) agonist for congenital hyperinsulinism, as well as CRN04894, an investigational, oral, nonpeptide ACTH antagonist for the treatment of Cushing's disease, congenital adrenal hyperplasia, and other diseases of excess ACTH. All of the company's drug candidates are new chemical entities resulting from in-house drug discovery efforts and are wholly owned by the company. For more information, please visit 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 potential for the company to be a leader in the design and development of novel small molecule drugs for endocrine diseases; the initiation of a Phase 3 program of paltusotine in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors and the expected timing thereof; the potential for such Phase 3 program to support broad approval of paltusotine for all acromegaly patients who require pharmacotherapy; the potential to generate safety, pharmacodynamic, pharmacokinetic and pharmacologic activity data from the Phase 1 studies in healthy volunteers with CRN04894 and CRN04777 and the expected timing thereof; the potential that such data will provide important clinical proof-of-concept for Crinetics' CRN04894 and CRN04777 programs; and the potential for Crinetics to receive PRV following approval of CRN04777. 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: the FDA or other regulatory agencies may require one or more additional clinical trials of paltusotine or suggest changes to our planned Phase 3 clinical trials prior to and in support of the approval of a New Drug Application or applicable foreign regulatory approval; advancement of paltusotine into a Phase 2 trial for carcinoid syndrome is dependent on and subject to the receipt of further feedback from the FDA; 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 and nonclinical studies for paltusotine, CRN04894 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.
Chief Financial Officer
LifeSci Advisors, LLC
Scienta Communications
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: 2020 2019 2020 2019
Grant revenues $ - $ 321 $ 71 $ 1,193
Operating expenses:
Research and development 16,830 12,143 56,998 41,506
General and administrative 4,961 3,392 18,026 13,519
Total operating expenses 21,791 15,535 75,024 55,025
Loss from operations (21,791 ) (15,214 ) (74,953 ) (53,832 )
Total other income (expense), net 150 665 1,141 3,410
Net loss $ (21,641 ) $ (14,549 ) $ (73,812 ) $ (50,422 )
Net loss per share - basic and diluted $ (0.66 ) $ (0.60 ) $ (2.42 ) $ (2.09 )
Weighted-average shares - basic and diluted 32,952 24,235 30,448 24,175
BALANCE SHEET DATA: December 31, 2020 December 31, 2019
Cash, cash equivalents and investments $ 170,880 $ 118,392
Working capital $ 167,003 $ 114,999
Total assets $ 183,445 $ 130,377
Total liabilities $ 14,526 $ 13,238
Accumulated deficit $ (167,614 ) $ (93,802 )
Total stockholders' equity $ 168,919 $ 117,139
Last updated: Mar 30, 2021