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Crinetics Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Corporate Update Reported positive topline results for the ACROBAT Edge and Evolve Phase 2 trials of oral paltusot

Key Takeaway: Crinetics Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Corporate Update Reported positive topline results for the ACROBAT Edge and Evolve Phase 2 trials of oral paltusotine for the treatment of acromegaly CRN04777 received Rare Pediatric Disease De

Full Press Release Details

Crinetics Pharmaceuticals Reports Third Quarter 2020 Financial Results
and Provides Corporate Update
Reported positive topline results for the ACROBAT Edge and Evolve Phase 2 trials of oral paltusotine for the treatment of acromegaly
CRN04777 received Rare Pediatric Disease Designation for the treatment of congenital hyperinsulinism
SAN DIEGO - November 6, 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 third quarter ended September 30, 2020 and provided a corporate update.
"Crinetics made significant progress in the third quarter, and we are excited by the recently reported positive topline ACROBAT Edge results showing that the study met its primary endpoint," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "With this data, we are well positioned for a productive end-of-Phase 2 meeting with regulatory authorities and we look forward to finalizing our Phase 3 program for paltusotine in the first half of next year. In addition, we are eager to initiate clinical studies for our ACTH antagonist and SST5 agonist programs in the coming months, as there is a high unmet need for the patients who can be served by these novel approaches. Like paltusotine, Phase 1 studies for these drug candidates are expected to produce key biomarker data that are intended to be predictive of efficacy and de-risk the clinical programs."
Third Quarter and Subsequent Highlights
Third Quarter 2020 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 for the treatment of acromegaly, an orphan disease affecting more than 25,000 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 (NETs) in 2021. The company is also developing CRN04777, an oral nonpeptide somatostatin receptor type 5 (SST5) agonist for hyperinsulinism, as well as an 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 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 potential benefits of paltusotine for acromegaly patients; the potential to initiate a Phase 3 program of paltusotine in acromegaly based on the Edge and Evolve topline results and the timing thereof; Crinetics' plans to meet with the FDA to finalize plans for a Phase 3 program for paltusotine; the planned expansion of the paltusotine development program to include the treatment of carcinoid syndrome in patients with NETs and the expected timing thereof, including initiation of a Phase 2 trial in these patients; Crinetics' eligibility to receive a priority review voucher following approval of CRN04777 for the treatment of congenital hyperinsulinism; the initiation of clinical trials for its other development programs; and expected cash runway and future capital needs. 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: topline data that Crinetics reports is based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trials and such topline data may not accurately reflect the complete results of a clinical trial, and the FDA and other regulatory authorities may not agree with Crinetics' interpretation of such results; advancement of paltusotine into a Phase 3 program for acromegaly or a Phase 2 trial for carcinoid syndrome and CRN04777 into a Phase 1 trial for congenital hyperinsulinism are dependent on and subject to the receipt of further feedback from the FDA; Crinetics may not meet the eligibility criteria for a PRV; 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 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
Life Science Advisors
Scienta Communications
CRINETICS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA
Three months ended September 30, Nine months ended September 30,
STATEMENTS OF OPERATIONS DATA: 2020 2019 2020 2019
Grant revenues $ - $ 505 $ 71 $ 872
Operating expenses:
Research and development 13,699 11,823 40,168 29,363
General and administrative 4,752 3,911 13,065 10,127
Total operating expenses 18,451 15,734 53,233 39,490
Loss from operations (18,451 ) (15,229 ) (53,162 ) (38,618 )
Total other income (expense), net 131 799 991 2,745
Net loss $ (18,320 ) $ (14,430 ) $ (52,171 ) $ (35,873 )
Net loss per share - basic and diluted $ (0.56 ) $ (0.60 ) $ (1.76 ) $ (1.49 )
Weighted-average shares - basic and diluted 32,890 24,208 29,608 24,155
BALANCE SHEET DATA: September 30, 2020 December 31, 2019
Cash, cash equivalents and investment securities $ 186,824 $ 118,392
Working capital $ 185,289 $ 114,999
Total assets $ 200,317 $ 130,377
Total liabilities $ 13,095 $ 13,238
Accumulated deficit $ (145,973 ) $ (93,802 )
Total stockholders' equity $ 187,222 $ 117,139
Last updated: Nov 6, 2020