On November 5, 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, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Crinetics Pharmaceuticals, NOV 5, 2021, View Source [SID1234594591]).
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"Positive Phase 1 readouts from our CRN04894 and CRN04777 programs during the third quarter have us advancing a diverse pipeline that includes three wholly-owned new chemical entities (NCEs) with clinical proof-of-concept," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "The drug development blueprint followed by these NCEs, which aims for early de-risking through animal and healthy volunteer studies leveraging well-established endocrine biomarkers, is now being applied to our recently unveiled parathyroid hormone receptor antagonist program and other discovery efforts. We also continue to make strong progress in our efforts to develop paltusotine as an oral treatment for acromegaly and neuroendocrine tumors complicated by carcinoid syndrome. With a strong financial foundation that was recently bolstered by our successful common stock offering, we believe we are well positioned to advance our pipeline programs and achieve a regular cadence of milestones."
Dr. Struthers continued, "Beyond our internal pipeline, our drug discovery platform has also generated exciting radiopharmaceutical candidates with the potential to treat a broad range of cancers. This led us to co-found Radionetics Oncology, which has positioned Crinetics to participate in the value of these assets while maintaining focus on our core mission of delivering much-needed therapies to patients with endocrine diseases."
THIRD QUARTER AND SUBSEQUENT HIGHLIGHTS
Reported positive data from single-ascending dose (SAD) cohorts of first-in-human study of CRN04777. In September 2021, Crinetics announced preliminary data from the SAD cohorts of an ongoing Phase 1 study of CRN04777, its somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism. The data provided evidence of clinically meaningful suppression of insulin secretion by showing dose-dependent reductions in glucose-stimulated insulin secretion and a dose-dependent reversal of sulfonylurea-induced insulin secretion in a pharmacologic model of congenital hyperinsulinism. In addition, the data suggest CRN04777 was orally bioavailable and demonstrated dose-proportional pharmacokinetics. Single doses of CRN04777 were well tolerated, as all adverse events were considered mild/moderate. Data from multiple-ascending dose (MAD) cohorts of the Phase 1 study are expected in the first quarter of 2022.
Reported positive data from SAD cohorts of first-in-human study of CRN04894. In August 2021, Crinetics announced preliminary data from the SAD cohorts of an ongoing Phase 1 study of CRN04894, its adrenocorticotropic hormone (ACTH) antagonist being developed as a treatment for diseases of ACTH excess. The data provided evidence of clinically relevant cortisol suppression and showed dose-dependent reductions in basal cortisol levels as well as suppression of cortisol following ACTH challenge. In addition, the data suggest that CRN04894 was orally bioavailable and demonstrated dose-proportional pharmacokinetics. Single doses of CRN04894 were well-tolerated, as all adverse events were considered mild. Data from the MAD cohorts of the Phase 1 study are expected in the first quarter of 2022.
Unveiled its parathyroid hormone receptor antagonist program. In September 2021, Crinetics announced its intent to develop a nonpeptide oral parathyroid hormone (PTH) receptor antagonist for the treatment of hypercalcemia associated with hyperparathyroidism (HPT) and other diseases of PTH receptor type 1 (PTHR1) over-activation. Details on the preclinical efforts supporting the program were presented in a late-breaking poster at the annual meeting of the American Society for Bone and Mineral Research (ASBMR). More information on the program and a copy of the poster can be found here.
Co-founded Radionetics Oncology. In October 2021, Crinetics, together with 5AM Ventures and Frazier Healthcare Partners, founded Radionetics Oncology, an independently operated company that aims to develop a deep pipeline of novel, targeted, nonpeptide radiopharmaceuticals for the treatment of a broad range of oncology indications. In conjunction with formation of the company, Radionetics received an exclusive world-wide license to a radiotherapeutics technology platform and intellectual property from Crinetics in exchange for equity, milestones in excess of $1 billion and single-digit royalties on net sales. Radionetics launched with a $30 million private financing with 5AM Ventures and Frazier Healthcare Partners as the sole investors.
Strengthened balance sheet with successful common stock offerings. In July 2021, Crinetics entered into a securities purchase agreement with Frazier Healthcare Partners for the private placement of 851,306 shares at $17.62 per share, raising gross proceeds of $15.0 million. In October 2021, Crinetics completed an underwritten public offering of 8,712,400 shares of its common stock at a price to the public of $19.80 per share, raising gross proceeds of $172.5 million.
THIRD QUARTER 2021 FINANCIAL RESULTS
Research and development expenses were $21.6 million for the three months ended September 30, 2021, compared to $13.7 million for the same period in 2020. The increase was primarily attributable to increased spending on manufacturing and development activities of $4.3 million associated with our clinical and nonclinical activities for paltusotine and our other clinical and preclinical programs, and an increase in personnel costs of $3.2 million, of which stock-based compensation was $1.2 million.
General and administrative expenses were $6.2 million for the three months ended September 30, 2021, compared to $4.8 million for the same period in 2020. The increase was primarily due to additional personnel costs of $1.0 million, of which stock-based compensation was $0.6 million.
Net loss for the three months ended September 30, 2021, was $27.9 million, compared to a net loss of $18.3 million for the three months ended September 30, 2020.
Unrestricted cash, cash equivalents and investments totaled $193.3 million as of September 30, 2021, compared to $170.9 million as of December 31, 2020. The $193.3 million in unrestricted cash, cash equivalents and investments does not include the $172.5 million in gross proceeds from the Company’s October 2021 common stock offering.
As of October 31, 2021, the company had 47,499,886 common shares outstanding.