Atumelnant

FDA Assigns a Prescription Drug User Fee Act Target Action Date of September 25, 2025SAN DIEGO, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for investigational candidate paltusotine for the treatment and long-term maintenance therapy of acromegaly in adults. If approved, paltusotine will be the first and only once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist available for adults living with acromegaly. “With our patient-centered clinical development of paltusotine, we were guided by an unwavering ambition to deliver a new generation of treatment that provides a once-daily, oral alternative to the currently marketed peptide analog drugs,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. “We look forward to working with the FDA throughout the review of our new drug application, as we also prepare for a potential commercial launch by building out our infrastructure and engaging with payers and the endocrinology community.” The NDA submission for once-daily, oral paltusotine included data from the PATHFNDR-1 (NCT04837040) and PATHFNDR-2 (NCT05192382) Phase 3 clinical trials, which evaluated paltusotine’s safety and efficacy in previously treated and medically untreated adults, respectively. The FDA has set a Prescription Drug User Fee target action date of September 25, 2025, for completing review of the NDA. The FDA also confirmed that an advisory committee meeting is not anticipated as part of the application’s review. Paltusotine was granted Orphan Drug Designation for the treatment of acromegaly by the FDA in July 2020. This designation is provided to drugs defined as being intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. ABOUT PALTUSOTINECrinetics’ lead development candidate, paltusotine, is the first investigational once-daily, oral, selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide agonist that has completed Phase 3 clinical development for acromegaly and is initiating Phase 3 clinical development for carcinoid syndrome associated with neuroendocrine tumors. It was designed to be a once daily oral option for the control of acromegaly and the symptoms related to carcinoid syndrome. In Phase 3 studies, once-daily, oral paltusotine maintained IGF-1 levels and symptom control in patients with acromegaly who were switched from monthly injectable medications (PATHFNDR-1) and rapidly decreased IGF-1 levels and symptom burden in medically untreated acromegaly patients (PATHFNDR-2). IGF-1 is the primary biomarker endocrinologists use to manage acromegaly patients. Results from a Phase 2 study in carcinoid syndrome demonstrated rapid and sustained reductions in flushing episodes and bowel movement frequency, which are the most common symptoms of carcinoid syndrome. Crinetics is preparing to initiate a Phase 3 trial for control of symptoms associated with carcinoid syndrome in patients with neuroendocrine tumors. ABOUT ACROMEGALYAcromegaly is a serious rare disease generally caused by a benign pituitary adenoma (tumor) that secretes excess growth hormone (GH). Excess GH secretion causes excess secretion of insulin-like growth factor-1 (IGF-1) from the liver. Prolonged exposure to increased levels of IGF-1 and GH leads to progressive and serious systemic complications, often resulting in bone, joint, cardiovascular, metabolic, cerebrovascular, or respiratory disease. Acromegaly symptoms include headache, joint aches, fatigue, sleep apnea, severe sweating, hyperhidrosis/oily skin, bone and cartilage overgrowth, abnormal growth of hands and feet, enlargement of heart, liver and other organs and alteration of facial features. Uncontrolled acromegaly results in increased mortality and has a debilitating impact on daily functioning and quality of life. Monthly depot injections of peptide somatostatin receptor ligands are the most common pharmacologic treatment for people suffering with acromegaly. However, these depots typically require many months to achieve the correct dose level. People suffering with acromegaly often experience a return of symptoms towards the end of the monthly injection cycle and many must adjust their injection frequency to more often than monthly1. Further, these depots are difficult to administer and employ large gauge needles that are commonly associated with pain, injection site reactions and an increased burden on the lives of patients.ABOUT CRINETICS PHARMACEUTICALS Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors. Crinetics’ lead development candidate, paltusotine, is the first investigational once-daily, oral, selective somatostatin receptor type 2 (SST2) nonpeptide agonist that is in clinical development for acromegaly and carcinoid syndrome associated with neuroendocrine tumors. Crinetics is also developing atumelnant an investigational, first-in-class, oral ACTH antagonist that is currently completing Phase 2 clinical studies for the treatment of congenital adrenal hyperplasia and Cushing’s disease. All of the company’s drug candidates are orally delivered, small molecule, new chemical entities resulting from in-house drug discovery efforts, including additional discovery programs addressing a variety of endocrine conditions such as hyperparathyroidism, polycystic kidney disease, Graves’ disease (including thyroid eye disease), diabetes, obesity and GPCR-targeted oncology indications. FORWARD-LOOKING STATEMENTSThis 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 NDA review process and the expected timing of the completion of the FDA’s review of the NDA for paltusotine for the treatment or maintenance of treatment of acromegaly in the United States, the therapeutic potential and clinical benefits or safety profile of paltusotine for patients with acromegaly and carcinoid syndrome, the plans and timelines for the commercial launch paltusotine for acromegaly, if approved, the expected timing of initiation of a Phase 3 program of paltusotine for carcinoid syndrome or the pathway for regulatory approval, the clinical development of atumelnant, including the therapeutic potential and clinical benefits or safety profile thereof, and the potential of our other research, discovery, and clinical trial programs. 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,” “upcoming” 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, the expected timing of additional data and topline results from studies of atumelnant in CAH and Cushing’s syndrome; the possibility of unfavorable new clinical data and further analyses of existing clinical data; potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom; 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; geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies 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 studies and nonclinical studies; regulatory developments in the United States and foreign countries; 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; and the other risks and uncertainties described in the Company’s periodic filings with the Securities and Exchange Commission (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 filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2023 and its Quarterly reports on Form 10-Q for the quarters ended March 31, 2024, June 30, 2024 and September 30, 2024. 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. Investors:Gayathri DiwakarHead of Investor Relationsgdiwakar@crinetics.com(858) 345-6340 Media:Natalie BadilloHead of Corporate Communicationsnbadillo@crinetics.com(858) 345-6075 1 Data on file.

Submission of New Drug Application for Paltusotine for the Treatment of Acromegaly Completed Upsized Public Offering of $575M of Common Stock Debut of First Drug Candidate from a Novel Nonpeptide Drug Conjugate Platform at North American Neuroendocrine Tumor Society (NANETS) Total of Four New Drug Candidates in IND-Enabling Preclinical Studies Management Hosting Conference Call at 4:30 p.m. ET Today SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, today reported financial results for the third quarter ended September 30, 2024. “As we approach the end of 2024, it has been yet another remarkable year for Crinetics as we continued to consistently achieve key milestones to advance and expand our pipeline and strengthen the company’s position,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. “The submission of our first NDA was a significant milestone in the company’s history, and we remain on track for the expected launch of our investigational drug paltusotine for acromegaly in 2025, which will be a pivotal event for the company. The company’s core commitment to internal innovation continues to bear fruit with four new internally discovered drug candidates now in IND enabling activities, including the first candidate from our novel nonpeptide drug conjugate (NDC) targeted therapeutics platform emerging from our laboratories. We are excited to share preclinical data for this candidate intended for the treatment of SST2-expressing tumors at the North American Neuroendocrine Tumor Society (NANETS) in Chicago on November 21-23. Further, subsequent to quarter end, we strengthened our already robust balance sheet by issuing additional equity, allowing us to invest in these promising early-stage programs, while continuing to fully support the anticipated launch of paltusotine and later-stage clinical development efforts.” Third Quarter 2024 and Recent Highlights: Submitted New Drug Application (NDA) for paltusotine for the treatment of acromegaly. In September, Crinetics submitted an NDA to the U.S. Food and Drug Administration (FDA) for its investigational drug, paltusotine, the first once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist, for the proposed treatment of and long-term maintenance therapy for acromegaly. Crinetics anticipates receiving notification from the FDA on the status of the NDA submission in December 2024.Strengthened balance sheet with $575 million public offering. In October, Crinetics completed an upsized public offering of common stock for gross proceeds of $575 million.Selected development candidate in TSH antagonist program. Crinetics has identified an oral thyroid stimulating hormone (TSH) receptor antagonist for the potential treatment of Graves’ disease and thyroid eye disease. First-in-human-enabling studies have commenced and an Investigational New Drug (IND) filing is expected in 2025.Data from CRN09682, the first drug candidate from novel Nonpeptide Drug Conjugate (NDC) platform, to be presented at the North American Neuroendocrine Tumor Society (NANETS) Annual Meeting in November 2024. First-in-human-enabling activities are nearing completion and IND filing is expected in early 2025.Total of four development candidates currently in IND-enabling studies to support transition to clinical development in 2025. Key Upcoming Milestones: Additional data from the Phase 2 study of its investigational drug atumelnant* in CAH is anticipated by early 2025. Crinetics expects to finalize a Phase 3 protocol and initiate site startup activities for its investigational drug paltusotine in carcinoid syndrome by the end of 2024. Third Quarter 2024 Financial Results: Research and development expenses were $61.9 million for the three months ended September 30, 2024, compared to $43.8 million for the same period in 2023. The increase was primarily attributable to higher personnel costs, outside services costs, and manufacturing activities costs, all of which were driven by the advancement of our clinical programs and the expansion of our preclinical portfolio.General and administrative expenses were $25.9 million for the three months September 30, 2024, compared to $15.5 million for the same period in 2023. The increase was primarily driven by higher personnel costs and outside services costs.Net loss for the three months ended September 30, 2024, was $76.8 million, compared to a net loss of $57.5 million for the same period in 2023.There were no revenues during the three months ended September 30, 2024, compared to revenues of $0.3 million for the same period in 2023. Third quarter 2023 revenues were derived from the paltusotine licensing arrangement with our Japanese partner, Sanwa Kagaku Kenkyusho (SKK).Cash, cash equivalents, and investment securities totaled $862.7 million as of September 30, 2024, compared to $558.6 million as of December 31, 2023. On October 10, 2024, the Company completed an upsized underwritten public offering of common stock for gross proceeds of $575 million, strengthening its financial position with approximately $1.4 billion in cash, cash equivalents and investment securities. Based on current projections, Crinetics expects that its cash, cash equivalents and investment securities will be sufficient to fund its current operating plan into 2029. Conference Call and Webcast DetailsManagement will hold a live conference call and webcast today, Tuesday, November 12 at 4:30 p.m. ET. To participate, please dial 1-800-579-2543 (domestic) or 1-785-424-1789 (international) and refer to Conference ID CRNXQ3. To access the webcast, click here. Following the live event, a replay of the call will be available on the Investors section of the company’s website. *Proposed international nonproprietary name under review. About Crinetics PharmaceuticalsCrinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors. Crinetics’ lead development candidate, paltusotine, is the first investigational once-daily, oral, selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide agonist that has completed Phase 3 clinical development for acromegaly and is in Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics is also developing atumelnant (CRN04894), an investigational, first-in-class, oral ACTH antagonist, that is currently completing Phase 2 clinical studies for the treatment of congenital adrenal hyperplasia and Cushing’s disease. All of the company’s drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts, including additional discovery programs addressing a variety of endocrine conditions such as hyperparathyroidism, polycystic kidney disease, Graves’ disease (including thyroid eye disease), diabetes, obesity and GPCR-targeted oncology indications. Forward-Looking StatementsThis 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 atumelnant and paltusotine, including the therapeutic potential and clinical benefits or safety profile thereof; the plans and timelines for FDA response and the commercial launch of paltusotine if the NDA submission is approved; the expected timing of initiation of a Phase 3 program of paltusotine for carcinoid syndrome and FDA consultation; the expected timing of additional data and topline results from studies of atumelnant in CAH and Cushing’s syndrome; the expected timing of announcing preclinical data for a candidate on the NDC platform; the potential and expected timing for IND-enabling studies in four different development candidates to transition to clinical development; the expected timing of additional research pipeline updates; and the expected timing through which our cash, cash equivalents, and investment securities will fund our operating plans. 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,” “upcoming” 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 known and unknown risks, uncertainties and assumptions, including, without limitation, initial or topline data that we report may change following completion or a more comprehensive review of the data related to the clinical studies and such data may not accurately reflect the complete results of a clinical study, 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; geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies 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 studies and nonclinical studies; regulatory developments in the United States and foreign countries; clinical studies 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 Securities and Exchange Commission (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 filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2023 and its Quarterly reports on Form 10-Q for the quarters ended March 31, 2024 June 30, 2024 and September 30, 2024. 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. CRINETICS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA(In thousands, except per share data)(Unaudited) Three months ended September 30, Nine months ended September 30, STATEMENTS OF OPERATIONS DATA: 2024 2023 2024 2023 Revenues $— $346 $1,039 $4,013 Operating expenses: Research and development 61,905 43,839 173,590 122,947 General and administrative 25,892 15,484 71,558 41,016 Total operating expenses 87,797 59,323 245,148 163,963 Loss from operations (87,797) (58,977) (244,109) (159,950)Total other income, net 10,969 2,516 26,766 6,515 Loss before equity method investment (76,828) (56,461) (217,343) (153,435)Loss on equity method investment — (997) (470) (997)Net loss $(76,828) $(57,458) $(217,813) $(154,432)Net loss per share - basic and diluted $(0.96) $(1.01) $(2.82) $(2.81)Weighted-average shares - basic and diluted 80,091 56,808 77,173 55,003 BALANCE SHEET DATA: September 30,2024 December 31,2023 Cash, cash equivalents and investments $862,668 $558,555 Working capital $824,025 $530,211 Total assets $937,374 $635,353 Total liabilities $104,394 $96,247 Accumulated deficit $(871,515) $(653,702)Total stockholders’ equity $832,980 $539,106 Investors:Gayathri DiwakarHead of Investor Relationsgdiwakar@crinetics.com (858) 345-6340 Media: Natalie BadilloHead of Corporate Communications nbadillo@crinetics.com (858) 345-6075