Efforts to further increase commercial readiness ongoing as Phase 3 PATHFNDR trials of paltusotine in acromegaly approach topline data readouts which are expected in 2H 2023 Phase 2 trial of paltusotine in carcinoid syndrome on track for topline data in 2H 2023 Clinical trials of CRN04894 in ACTH-dependent Cushing’s Syndrome and Congenital Adrenal Hyperplasia expected to begin in 1Q 2023 SAN DIEGO, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that Scott Struthers, Ph.D., founder and chief executive officer of Crinetics, will provide a company update at the 41st Annual J.P. Morgan Healthcare Conference, which is taking place in San Francisco, CA from January 9-12, 2023. Dr. Struthers’ presentation will take place on Wednesday, January 11th at 3:00 p.m. Pacific Time. A live webcast of the presentation may be accessed on the Events page of the company’s website. A replay of the webcast will be accessible at the same location. The presentation will feature an overview of Crinetics’ key priorities and anticipated milestones for 2023. These include: The continued advancement of the Phase 3 PATHFNDR-1 and PATHFNDR-2 trials of once-daily oral paltusotine in acromegaly. The trials remain on track for topline data readouts in the third and fourth quarters of 2023, respectively. If successful, Crinetics plans to submit data from the two studies to regulatory authorities in support of applications seeking approval for the use of paltusotine for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from other therapies. Efforts to further increase commercial readiness so that the company can rapidly provide acromegaly patients with access to once-daily oral paltusotine, if approved. The continued advancement of the Phase 2 trial of paltusotine in carcinoid syndrome, which remains on track for topline data in the second half of 2023. Following proof-of-concept Phase 1 results for CRN04894, an investigational adrenocorticotropic hormone (ACTH) antagonist, initiating clinical trials in ACTH-dependent Cushing’s syndrome and congenital adrenal hyperplasia. Both studies are expected to begin in the first quarter of 2023. Building off proof-of-concept Phase 1 results for CRN04777, an investigational, oral somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism. The continued preclinical evaluation of investigational, oral small molecule parathyroid hormone receptor antagonists to identify a candidate for advancement into clinical trials. Initial target indications for this program may include primary hyperparathyroidism and hypercalcemia of malignancy, with potential opportunities in chronic kidney disease also being evaluated.Leveraging the company’s leading G-protein-coupled receptor (GPCR) drug discovery platform to generate and develop additional small molecule drug candidates with the potential to address unmet needs in indications such as polycystic kidney disease, Graves’ Disease (including thyroid eye disease) and metabolic diseases (including diabetes and obesity). “Crinetics is entering 2023 with strong momentum and potentially transformative milestones expected over the next year,” said Dr. Struthers. “If successful, upcoming readouts from our Phase 3 PATHFNDR trials will support regulatory filings seeking paltusotine’s approval in acromegaly, while significantly de-risking its development in carcinoid syndrome. As in acromegaly, many patients with carcinoid syndrome are not well served by burdensome SST2 agonist injections and therefore may benefit from oral paltusotine. We are currently evaluating this hypothesis in a Phase 2 trial that we expect to provide proof-of-concept data later this year.” “Looking broadly, we believe successful readouts from our acromegaly and carcinoid syndrome trials could validate our endocrine driven strategy that is also being applied to CRN04894, CRN04777, and each of our other programs,” continued Dr. Struthers. “Paltusotine is only the first of what we hope will be many future products that will come from the remarkable discovery and development engine that we have built. We are now beginning to lay the foundations for a commercial capability serving the same global community of endocrinologists that are helping us evaluate our drug candidates in their clinics. This coming year will be a critical step towards our long-term goal of building the premier fully integrated endocrine company that can sustainably innovate pioneering therapies for our patients around the world.” 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. Paltusotine, an investigational, oral somatostatin receptor type 2 (SST2) agonist, is in Phase 3 clinical development for acromegaly and Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics has demonstrated pharmacologic proof-of-concept in Phase 1 clinical studies for CRN04777, an investigational, oral somatostatin receptor type 5 (SST5) agonist in development for congenital hyperinsulinism, and for CRN04894, an investigational, oral ACTH antagonist in development for the treatment of Cushing’s disease, congenital adrenal hyperplasia, and other diseases of excess ACTH. All of the company’s drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the plans and timelines for the clinical development of paltusotine, CRN04777 and CRN04894, including the therapeutic potential and clinical benefits thereof; the expected timing of topline data from the ongoing Phase 3 clinical trials of paltusotine in acromegaly and Phase 2 trial of paltusotine in carcinoid syndrome; plans to submit data from the ongoing Phase 3 clinical trials of paltusotine in acromegaly to regulators in support of applications seeking approval for the use of paltusotine in acromegaly patients; the expected timing of the initiation of studies of CRN04894 in ACTH-dependent Cushing’s syndrome and congenital adrenal hyperplasia; plans to continue evaluation of investigational, oral small molecule parathyroid hormone receptor antagonists to identify a candidate for advancement into clinical trials; and plans to generate and develop additional small molecule new chemical entities with the potential to address nonfunctional pituitary adenomas, polycystic kidney disease, metabolic diseases and Graves’ Disease. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, topline data that we report may change following a more comprehensive review of the data related to the clinical trials and such data may not accurately reflect the complete results of a clinical trial, and the FDA and other regulatory authorities may not agree with our interpretation of such results; we may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; 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; unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval and/or commercialization; 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; regulatory developments in the United States and foreign countries; clinical trials and preclinical studies may not proceed at the time or in the manner expected, or at all; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics’ drug candidates may not advance in development or be approved for marketing; Crinetics may use its capital resources sooner than expected; any future impacts to our business resulting from geopolitical developments outside our control; and the other risks and uncertainties described in the company’s periodic filings with the SEC. The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading “Risk Factors” in Crinetics’ periodic reports, including its annual report on Form 10-K for the year ended December 31, 2021. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: Investor Relations ir@crinetics.com (858) 450-6464 Investors / Media: Corey Davis LifeSci Advisors, LLC cdavis@lifesciadvisors.com (212) 915-2577 Aline Sherwood Scienta Communications asherwood@scientapr.com (312) 238-8957
