Crinetics Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update
Paltusotineās 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, November 14, 2022 — 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 paltusotineās 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
- Completed enrollment in Phase 3 PATHFNDR-1 study. PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 clinical trials evaluating the safety and efficacy of paltusotine in acromegaly patients. Topline data from PATHFNDR-1 are expected in the third quarter of 2023 and topline data from paltusotineās second Phase 3 trial, PATHFNDR-2, are expected in the fourth quarter of 2023. If successful, Crinetics plans to submit data from the PATHFNDR trials to regulatory authorities in support of applications seeking approval for the broad use of paltusotine for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from other therapies.
- Reported new long-term safety and efficacy data from ACROBAT Advance open-label extension trial of paltusotine in acromegaly. Results showed that once-daily oral paltusotine lowered and maintained IGF-1 at levels comparable to prior injected somatostatin receptor ligand (SRL) therapy for up to 103 weeks. In addition, paltusotine was well tolerated in the study and 89% of study participants surveyed selected paltusotine as their preferred treatment option over injected SRLs.
- Received a UK Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Passport for CRN04777 for the treatment of congenital hyperinsulinism. The Innovation Passport enables Crinetics to access the Innovative Licensing and Access Pathway (ILAP). The ILAP aims to reduce the time to market for designated medicines by enabling enhanced coordination between sponsors and MHRA leading up to Marketing Authorization Application (MAA) submissions and by providing the opportunity for accelerated MAA reviews.
- Reviewed analyses from preclinical and Phase 1 clinical studies of CRN04894 in an oral presentation at the 10th International Congress of Neuroendocrinology. CRN04894 is an adrenocorticotropic hormone (ACTH) antagonist being developed as a treatment for Cushingās disease, congenital adrenal hyperplasia (CAH) and other conditions of ACTH excess. The presentation was delivered by the Crineticsā vice president of clinical endocrinology, Dr. Peter J. Trainer, and featured the results of a Phase 1 healthy volunteer study demonstrating pharmacologic proof-of-concept for CRN04894. These results showed dose-dependent increases in CRN04894 plasma concentrations as well as reductions of both basal cortisol and elevated cortisol following an ACTH challenge.
- Strengthened leadership team with appointment of Dana Pizzuti, M.D. as chief development officer. Dr. Pizzuti is a board-certified physician with more than 30 years of pharmaceutical industry experience in clinical development, pharmacovigilance, medical and regulatory affairs.
Third Quarter 2022 Financial Results
- Research and development expenses were $32.0 million for the three months ended September 30, 2022, compared to $21.6 million for the same period in 2021. The increase was primarily attributable to an increase in spending on manufacturing and development activities of $5.2 million associated with our clinical and nonclinical activities for paltusotine, CRN04777, CRN04894 and our other clinical and preclinical programs and an increase in personnel costs of $4.2 million.
- General and administrative expenses were $11.9 million for the three months ended September 30, 2022, compared to $6.2 million for the same period in 2021. The increase was primarily attributable to an increase in personnel costs of $3.0 million.
- Net loss for the three months ended September 30, 2022, was $41.9 million, compared to a net loss of $27.9 million for the same period in 2021.
- Revenues were $0.5 million for the three months ended September 30, 2022, consisting of license revenue recognized from the license agreement entered into with Sanwa Kagaku Kenkyusho Co., Ltd. in February 2022.
- Unrestricted cash, cash equivalents and investments totaled $368.4 million as of September 30, 2022, compared to $333.7 million as of December 31, 2021.
- The company had 53,810,476 common shares outstanding as of November 9, 2022.
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 Cushingās disease, congenital adrenal hyperplasia, and other diseases of excess ACTH. All of the companyās 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; Crineticsā plans to advance CRN04777 and CRN04894 toward patient trials; and Crineticsā 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 āmay,ā āwill,ā āshould,ā āexpect,ā āplan,ā āanticipate,ā ācould,ā āintend,ā ātarget,ā āproject,ā ācontemplates,ā ābelieves,ā āestimates,ā āpredicts,ā āpotentialā or ācontinueā 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 Crineticsā 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 companyās product candidates that may limit their development, regulatory approval and/or commercialization; the companyās dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crineticsā 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 Crineticsā 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 companyās periodic filings with the SEC. The events and circumstances reflected in the companyās 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 āRisk Factorsā in Crineticsā 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) |
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Three months ended September 30, |
Nine months ended September 30, |
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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 |
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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 stockholdersā equity | $ | 351,372 | $ | 331,944 |
Contact:
Investor Relations
[email protected]
(858) 450-6464
Investors / Media:
Corey Davis
LifeSci Advisors
[email protected]
(212) 915-2577
Aline Sherwood
Scienta Communications
[email protected]
(312) 238-8957
Source: Crinetics Pharmaceuticals, Inc.