On February 28, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) reported financial results for the fourth quarter and year ended December 31, 2022 (Press release, Crinetics Pharmaceuticals, FEB 28, 2023, View Source [SID1234627838]).
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"We continue to make great progress in our vision to build a premier fully integrated endocrine company that can sustainably innovate pioneering therapies for our patients around the world," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "In 2022, we demonstrated pharmacologic proof-of-concept for CRN04894 and CRN04777, established global clinical study capabilities with our Phase 3 PATHFNDR program for paltusotine in acromegaly, and began laying groundwork for a potential commercial launch."
Dr. Struthers continued, "Looking forward, we believe our efforts in acromegaly position us for success not only in this program, but also in additional indications with our multiple oral small molecule drug candidates. Going into 2023, I am especially proud of our discovery team who continues to bring innovative opportunities forward in the areas of hyperparathyroidism, polycystic kidney disease, Graves’ disease, including thyroid eye disease, and metabolic diseases including diabetes and obesity."
Key Corporate Updates:
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Phase 3 PATHFNDR-1 study enrollment complete. PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 clinical studies of oral paltusotine in participants with acromegaly. The study enrolled participants with acromegaly who were biochemically controlled (IGF-1 ≤ 1.0x upper limit of normal) on octreotide or lanreotide depot monotherapy. Topline data from PATHFNDR-1 are expected in the third quarter of 2023.
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Phase 3 PATHFNDR-2 study enrollment ongoing. PATHFNDR-2 is the second placebo-controlled Phase 3 clinical study of oral paltusotine in participants with acromegaly. The study is enrolling participants with acromegaly with elevated IGF-1 levels who are either medication naïve or who are not being treated with pharmacotherapy. Enrollment is ongoing in the study and the company is aggressively navigating prolonged pandemic-related and geopolitical disruptions in certain key study regions. Momentum and interest in the study continue to build despite these disruptions, however, based on current enrollment projections, the company’s anticipated timeline for topline results from the study now extends into the first quarter of 2024.
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Paltusotine NDA Submission. Pending a successful outcome from the PATHFNDR studies, Crinetics plans to seek regulatory approval for paltusotine for the treatment of acromegaly in the United States with an anticipated submission of a new drug application (NDA) in 2024.
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Phase 2 open-label study of paltusotine in carcinoid syndrome ongoing. Paltusotine is also being studied in a Phase 2 open-label study in carcinoid syndrome associated with neuroendocrine tumors. Enrollment is ongoing and data from the study are expected in the second half of 2023.
EXHIBIT 99.1
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CRN04894 studies in Cushing’s disease and congenital adrenal hyperplasia. Based on successful Phase 1 studies demonstrating pharmacologic proof-of-concept, Crinetics is advancing CRN04894 into clinical studies in Cushing’s disease and congenital adrenal hyperplasia. Start-up activities for studies in each of these indications began in the first quarter of 2023.
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CRN04777 progress. In November 2022, the U.S. Food and Drug Administration (FDA) informed Crinetics that the company’s planned Phase 2 study of CRN04777 in a pediatric population was not yet permitted to proceed. Crinetics is in the process of collecting additional information and data to submit to the FDA, with the goal of gaining allowance to proceed with the Phase 2 study. The planned Phase 2 study is supported by pharmacologic proof-of-concept results from a successful Phase 1 study in healthy adult volunteers conducted under a Clinical Trial Application in Germany.
Full Year 2022 Highlights:
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Reported long-term safety and efficacy data from ACROBAT Advance open-label extension study of paltusotine in acromegaly. Once-daily oral paltusotine was shown to lower and maintain IGF-1 at levels comparable to prior injected somatostatin receptor ligand (SRL) therapy for up to 103 weeks. In addition, paltusotine was well tolerated and 89% of study participants surveyed selected paltusotine as their preferred treatment option over injected SRLs.
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Reported positive topline results from multiple-ascending dose (MAD) cohorts of the CRN04894 Phase 1 study in healthy adult volunteers. Pharmacodynamic data from the Phase 1 study’s MAD cohorts demonstrated pharmacologic proof-of-concept for CRN04894, an adrenocorticotropic hormone (ACTH) antagonist being developed as a treatment for conditions of ACTH-excess. Pharmacokinetic data demonstrated CRN04894’s oral bioavailability. No serious adverse events nor study drug discontinuations due to treatment-related adverse events were observed.
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Reported positive topline results from MAD cohorts of the CRN04777 Phase 1 study in healthy adult volunteers. Pharmacodynamic data from the Phase 1 study’s MAD cohorts demonstrated pharmacologic proof-of-concept for CRN04777, a somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism. Pharmacokinetic data indicated CRN04777 was orally bioavailable and support a once daily dosing schedule. No serious adverse events nor discontinuations due to adverse events were reported in the Phase 1 study, which was conducted under a Clinical Trial Application in Germany.
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Received UK Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Passport for CRN04777 for the treatment of congenital hyperinsulinism. The Innovation Passport enables sponsors to access the Innovative Licensing and Access Pathway (ILAP), which was launched in 2021 with the goal of reducing the time to market for designated medicines. The ILAP is designed to achieve this goal by enabling enhanced coordination between sponsors and the MHRA leading up to Marketing Authorization Application (MAA) submissions and by providing the opportunity for accelerated MAA reviews.
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Entered into strategic licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd. (Sanwa) for the development and commercialization of paltusotine in Japan. Per the agreement, Crinetics received $13 million upfront and is also eligible to receive development, regulatory and commercial milestones, as well as tiered royalties on net product sales should paltusotine receive marketing approval in Japan. In exchange, Sanwa was granted an exclusive right to develop and commercialize paltusotine in Japan. Sanwa will assume all costs associated with clinical studies and regulatory applications in Japan. Crinetics retains all rights to develop and commercialize paltusotine in territories other than Japan.
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Strengthened balance sheet with successful $125 million common stock offering. In April 2022, Crinetics successfully completed an underwritten follow-on offering of its common stock, raising gross proceeds of approximately $125 million.
EXHIBIT 99.1
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Made key additions to management team and Board of Directors. Crinetics strengthened the company’s leadership throughout 2022 by appointing James Hassard to the role of chief commercial officer, Chris Robillard to the role of chief business officer, Dana Pizzuti, M.D., to the role of chief development officer, and Rogério Vivaldi Coelho, M.D., M.B.A., and Caren Deardorf to the Board of Directors.
Fourth Quarter and Full Year 2022 Financial Results
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Research and development expenses were $37.0 million and $130.2 million for the three months and full year ended December 31, 2022, respectively, compared to $24.6 million and $84.3 million for the same periods in 2021. The increases were primarily attributable to an increase in supplies and spending on manufacturing and development activities of $5.6 million for the quarter ended December 31, 2022 and $25.3 million for the year ended December 31, 2022 associated with our clinical and nonclinical activities for paltusotine, CRN04777, CRN04894 and our preclinical programs and an increase in personnel costs of $5.0 million for the quarter ended December 31, 2022 and $16.2 million for the year ended December 31, 2022.
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General and administrative expenses were $11.3 million and $42.4 million for the three months and full year ended December 31, 2022, respectively, compared to $7.4 million and $24.5 million for the same periods in 2021. The increases were primarily attributable to an increase in personnel costs of $2.7 million for the quarter ended December 31, 2022 and $10.8 million for the year ended December 31, 2022.
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Net loss for the three months ended December 31, 2022, was $45.0 million, compared to a net loss of $30.8 million for the same period in 2021. For the year ended December 31, 2022, the company’s net loss was $163.9 million compared to a net loss of $107.6 million for the year ended December 31, 2021.
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Revenues were $0.7 million and $4.7 million for the three months and full year ended December 31, 2022, respectively, primarily consisting of license revenue recognized from the license agreement entered into with Sanwa in February 2022.
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Unrestricted cash, cash equivalents, and investments totaled $334.4 million as of December 31, 2022, compared to $368.4 million as of September 30, 2022, and $333.7 million as of December 31, 2021. Based on its current projections, the company expects that current cash, cash equivalents and short-term investments will fund its current operating plan through 2024.
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The company had 53,908,865 common shares outstanding as of February 24, 2023.