On August 7, 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 second quarter ended June 30, 2020 and provided a corporate update (Press release, Crinetics Pharmaceuticals, AUG 7, 2020, View Source [SID1234563159]).

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"Crinetics has made significant progress in the second quarter of the year, which began with our positive interim data from the Phase 2 ACROBAT Edge trial, and Orphan Drug Designation for paltusotine for the treatment of acromegaly, both solidifying the confidence we have in our lead product to be an effective, orally available treatment for patients with this rare disease," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "Looking ahead to the rest of the year, we see additional clinical milestones for the company with topline data from our ongoing Phase 2 trials expected to be presented in the fourth quarter of 2020. Additionally, with the capital from our April financing, we are well positioned to execute on our planned Phase 3 trial in acromegaly, a Phase 2 trial of paltusotine in carcinoid syndrome associated with neuroendocrine tumors, as well as the planned Phase 1 trials for our ACTH antagonist and SST5 agonist programs."

Second Quarter and Subsequent Highlights

Received Orphan Drug Designation for paltusotine for the treatment of acromegaly. In July 2020, the U.S. Food and Drug Administration (FDA) granted paltusotine Orphan Drug Designation for the treatment of acromegaly. Orphan Drug Designation qualifies Crinetics for certain development incentives, that may include exemption from FDA prescription drug user fees, financial incentives for qualified clinical development, and seven years of market exclusivity in the U.S. if the treatment is approved.

Confirmed completion for half of the enrolled patients in the ongoing Phase 2 ACROBAT Edge clinical trial for paltusotine. In June 2020, Crinetics announced that over 50% (28/47) of the patients enrolled in the ACROBAT Edge Phase 2 clinical trial have completed the study, which is investigating the effects of once daily oral paltusotine on IGF-1

levels after switching patients from injectable depot therapy. Recruitment for the Edge and Evolve trials has been completed with 47 and 13 patients, respectively, and topline data is planned for the fourth quarter of 2020.

Reported positive interim results for the ACROBAT Edge Phase 2 trial of paltusotine in acromegaly patients. In April 2020, Crinetics reported interim results from its ongoing ACROBAT Edge Phase 2 trial. Results as of the February 23, 2020 data cutoff showed that acromegaly patients switching from injectable depot therapy to once daily oral paltusotine maintained IGF-1 levels previously achieved with commercially available depot injections of somatostatin receptor ligands.

Successful public offering strengthens cash position. In April 2020, Crinetics completed a public offering in which the company sold an aggregate of 8,222,500 shares of common stock at a price to the public of $14.00 per share. Net proceeds from the public offering after deducting underwriting discounts, commissions and offering expenses, were approximately $107.9 million.

Second Quarter 2020 Financial Results

Research and development expenses were $12.6 million for the three months ended June 30, 2020, compared to $10.3 million for the same period in 2019. The increase was primarily attributable to development and manufacturing activities for paltusotine as well as the advancement of the company’s preclinical programs and higher personnel costs.

General and administrative expenses were $4.3 million for the three months ended June 30, 2020, compared to $3.1 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 June 30, 2020 was $16.5 million, compared to a net loss of $12.4 million for the three months ended June 30, 2019.

Cash, cash equivalents and investments totaled $205.2 million as of June 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 July 31, 2020, the company had 32,883,582 common shares outstanding.