On 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, reported financial results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Crinetics Pharmaceuticals, NOV 6, 2020, View Source [SID1234570158]).

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"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

Reported positive topline results for the ACROBAT Edge and Evolve Phase 2 trials of paltusotine in acromegaly patients. In October 2020, Crinetics reported topline results from its ACROBAT Edge and Evolve Phase 2 trial. The prespecified primary endpoint in Edge was achieved, showing that once-daily oral paltusotine maintained insulin-like growth factor-1 (IGF-1) levels at Week 13 in acromegaly patients who were switched from an injected somatostatin receptor ligand (SRL) depot of either octreotide or lanreotide monotherapy. This data showed that acromegaly patients switching to once-daily oral paltusotine from first-line injected depot monotherapies maintained IGF-1 levels previously achieved with octreotide or lanreotide.

Received Rare Pediatric Disease Designation for CRN04777 for the treatment of congenital hyperinsulinism. In September 2020, the U.S. Food and Drug Administration (FDA) granted CRN04777 Rare Pediatric Disease (RPD) Designation for the treatment of congenital hyperinsulinism. The FDA developed the Rare Pediatric Disease Priority Review Voucher (PRV) Program whereby companies are eligible to receive a priority review voucher following approval of a product with an RPD designation if the marketing application submitted for the product satisfies certain additional conditions. If issued, a sponsor may redeem a PRV for priority review of a subsequent marketing application for a different product candidate, or the PRV could be sold or transferred to another sponsor.
Third Quarter 2020 Financial Results

Research and development expenses were $13.7 million for the three months ended September 30, 2020, compared to $11.8 million for the same period in 2019. The increase was primarily attributable to higher personnel costs and clinical and nonclinical development and manufacturing activities for the company’s programs.
General and administrative expenses were $4.8 million for the three months ended September 30, 2020, compared to $3.9 million for the same period in 2019. The increase was primarily due to personnel costs to support the company’s growth.
Net loss for the three months ended September 30, 2020 was $18.3 million, compared to a net loss of $14.4 million for the three months ended September 30, 2019.

Cash, cash equivalents and investments totaled $186.8 million as of September 30, 2020, compared to $118.4 million as of December 31, 2019. The cash balance includes the $107.9 million of net proceeds from the public equity offering completed in April.
As of October 31, 2020, the company had 32,922,328 common shares outstanding.