Paltusotine’s Phase 3 PATHFNDR-1 trial in acromegaly fully enrolled and on track for topline data in Q3 2023
Paltusotine lowered and maintained IGF-1 at levels comparable to prior injected SRL therapy for up to 103 weeks in participants living with acromegaly participating in the ACROBAT Advance Long-term Extension Study
SAN DIEGO, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the third quarter ended September 30, 2022.
“This has been yet another successful quarter of executing our strategy to build a leading endocrinology company by advancing our clinical pipeline of internally discovered drug candidates and preparing to add to that pipeline with our highly productive drug discovery efforts. Progress includes completion of enrollment in the Phase 3 PATHFNDR-1 trial and reporting Phase 2 open-label extension data demonstrating maintenance of IGF-1 as well as a strong preference among acromegaly patients for oral paltusotine over the injected standard-of-care,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “We remain on track for two Phase 3 readouts in acromegaly next year. Beyond acromegaly, we maintained strong momentum with our efforts to demonstrate paltusotine’s utility in carcinoid syndrome with a Phase 2 readout expected next year. We also continue to advance CRN04777 and CRN04894 toward patient trials based on the positive proof-of-pharmacology data we reported earlier this year.”
Third Quarter 2022 and Recent Highlights
Third Quarter 2022 Financial Results
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 CNR04894, 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 ability to gain access to an expedited review pathway in the United Kingdom for CRN04777; Crinetics’ plans to advance CRN04777 and CRN04894 toward patient trials; and Crinetics’ anticipated cash runway and plans to advance other pipeline product candidates or discovery efforts. 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 the conflict between Russia and Ukraine or other 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.
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: | 2022 | 2021 | 2022 | 2021 | ||||||||||||
| License revenues | $ | 458 | $ | — | $ | 4,028 | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 31,987 | 21,580 | 93,234 | 59,651 | ||||||||||||
| General and administrative | 11,925 | 6,227 | 31,120 | 17,163 | ||||||||||||
| Total operating expenses | 43,912 | 27,807 | 124,354 | 76,814 | ||||||||||||
| Loss from operations | (43,454 | ) | (27,807 | ) | (120,326 | ) | (76,814 | ) | ||||||||
| Total other income (expense), net | 1,529 | (44 | ) | 2,409 | (33 | ) | ||||||||||
| Loss before equity method investment | (117,917 | ) | (76,847 | ) | ||||||||||||
| Loss on equity method investment | — | — | (1,010 | ) | — | |||||||||||
| Net loss | $ | (41,925 | ) | $ | (27,851 | ) | $ | (118,927 | ) | $ | (76,847 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.78 | ) | $ | (0.73 | ) | $ | (2.32 | ) | $ | (2.13 | ) | ||||
| Weighted-average shares - basic and diluted | 53,768 | 38,309 | 51,356 | 36,147 | ||||||||||||
| BALANCE SHEET DATA: | September 30, 2022 | December 31, 2021 | ||||||||||
| Cash, cash equivalents and investments | $ | 368,362 | $ | 333,707 | ||||||||
| Working capital | $ | 353,767 | $ | 328,725 | ||||||||
| Total assets | $ | 384,880 | $ | 351,015 | ||||||||
| Total liabilities | $ | 33,508 | $ | 19,071 | ||||||||
| Accumulated deficit | $ | (394,182 | ) | $ | (275,255 | ) | ||||||
| Total stockholders’ equity | $ | 351,372 | $ | 331,944 | ||||||||
Contacts:
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