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Crinetics Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update
Late-Breaking Presentations of Initial Results From Phase 2 Studies of Atumelnant (CRN04894) in Congenital Adrenal Hyperplasia and ACTH-Dependent Cushing’s Syndrome Will be Presented at ENDO
Following Second Positive Phase 3 Study (PATHFNDR-2), Paltusotine NDA Submission in Acromegaly Expected in 2H 2024
Following Positive Phase 2 Data, Plan to Initiate Paltusotine Phase 3 Study in Carcinoid Syndrome by End of 2024
Management Hosting Conference Call at
“Building on the positive momentum from the first PATHFNDR readout in 2023, Crinetics began 2024 with continued strong performance. Our lead investigational compound, paltusotine, delivered positive data from two consecutive late-stage clinical trials in acromegaly and carcinoid syndrome. With our pivotal PATHFNDR Phase 3 program in acromegaly now complete, we are working diligently to submit an NDA in the second half of 2024. We also intend to discuss the positive results from our Phase 2 study in carcinoid syndrome with the FDA in preparation for the Phase 3 program, which is expected to be initiated by the end of this year,” said
“The clinical trials for the second compound in our pipeline, atumelnant, which is being developed for the treatment of CAH and Cushing's disease, continue to enroll patients. We plan to report initial results from a subset of patients from these trials in the second quarter,” continued
First Quarter 2024 and Recent Highlights:
- Phase 3 PATHFNDR-2 study achieved primary and all secondary endpoints. In March, Crinetics reported positive topline results from its placebo-controlled Phase 3 study of paltusotine in non-pharmacologically treated participants with acromegaly. PATHFNDR-2 was designed to support a treatment indication in those with uncontrolled acromegaly.
- Phase 2 study of paltusotine in carcinoid syndrome reported positive results. In March, Crinetics reported positive topline results from its open-label Phase 2 study of paltusotine in participants with carcinoid syndrome. Paltusotine was shown to result in rapid and sustained reductions in frequency and severity of flushing episodes and bowel movements.
- Strengthened balance sheet with
$350 million private placement financing. In February, Crinetics announced a private placement equity financing for gross proceeds of approximately$350 million .
Key Upcoming Milestones:
- Initial results from the ongoing Phase 2 studies of atumelnant* in congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing’s syndrome will be presented at the Endocrine Society’s annual meeting, ENDO 2024, being held
June 1-4, 2024 inBoston . The Phase 2 studies are evaluating the safety, efficacy and pharmacokinetics of different doses of atumelnant in participants with CAH and Cushing’s disease. - Submission of a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) seeking regulatory approval of paltusotine for the treatment of acromegaly is anticipated in the second half of 2024. - Initiation of a Phase 3 program of paltusotine for carcinoid syndrome by the end of 2024, pending discussions with the FDA.
First Quarter 2024 Financial Results:
- Research and development expenses were
$53.3 million for the three months endedMarch 31, 2024 , compared to$38.5 million for the same period in 2023. The increases were primarily attributable to an increase in personnel costs of$9.4 million , increased outside services and facilities costs of$3.8 million , and increased spending on manufacturing and development activities of$1.4 million . - General and administrative expenses were
$20.8 million for the three monthsMarch 31, 2024 , compared to$12.2 million for the same period in 2023. The increases were primarily attributable to an increase in personnel costs of$5.6 million . - Net loss for the three months ended
March 31, 2024 , was$66.9 million , compared to a net loss of$46.0 million for the same period in 2023. - Revenues were
$0.6 million for the three months endedMarch 31, 2024 , compared to$2.7 million for the same period in 2023. Revenues were derived from licensing arrangements for our paltusotine product candidate in 2024 and for paltusotine and CRN01941 product candidates in 2023. - Unrestricted cash, cash equivalents, and investments totaled
$901.0 million as ofMarch 31, 2024 , compared to$558.6 million as ofDecember 31, 2023 . OnFebruary 28, 2024 , the company announced a private placement equity financing for gross proceeds of approximately$350 million . Based on its current projections, the company now expects that its cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2028.
*Proposed international nonproprietary name under review.
Conference Call and Webcast Details
Management will hold a live conference call and webcast today,
ABOUT
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 atumelnant and paltusotine, including the therapeutic potential and clinical benefits or safety profile thereof; the expected timing of an NDA submission for paltusotine for the treatment or maintenance of treatment of acromegaly in
CONDENSED CONSOLIDATED FINANCIAL STATEMENT DATA (In thousands, except per share data) (Unaudited) |
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Three months ended |
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STATEMENTS OF OPERATIONS DATA: | 2024 | 2023 | |||||
Revenues | $ | 640 | $ | 2,679 | |||
Operating expenses: | |||||||
Research and development | 53,341 | 38,468 | |||||
General and administrative | 20,828 | 12,189 | |||||
Total operating expenses | 74,169 | 50,657 | |||||
Loss from operations | (73,529) | (47,978) | |||||
Total other income, net | 7,069 | 1,983 | |||||
Loss before equity method investment | (66,460) | (45,995) | |||||
Loss on equity method investment | (470) | — | |||||
Net loss | $ | (66,930) | $ | (45,995) | |||
Net loss per share - basic and diluted | $ | (0.93) | $ | (0.85) | |||
Weighted-average shares - basic and diluted | 72,289 | 53,908 | |||||
BALANCE SHEET DATA: | 2024 |
2023 |
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Cash, cash equivalents and investments | $ | 900,961 | $ | 558,555 | |||
Working capital | $ | 865,461 | $ | 530,211 | |||
Total assets | $ | 978,153 | $ | 635,353 | |||
Total liabilities | $ | 103,220 | $ | 96,247 | |||
Accumulated deficit | $ | (720,632) | $ | (653,702) | |||
Total stockholders’ equity | $ | 874,933 | $ | 539,106 | |||
Investors:
cdavis@lifesciadvisors.com
(212) 915-2577
Media:
Head of Corporate Communications
nbadillo@crinetics.com
(858) 345-6075
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Source: Crinetics Pharmaceuticals, Inc.