Crinetics Pharmaceuticals, Inc.
Crinetics Pharmaceuticals, Inc. Q3 FY2024 earnings call
November 12, 2024 · fiscal period ended 2024-09
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2024-11-12
Management highlights
• Pipeline advancements: Submitted NDA for paltusotine for acromegaly, Japan Phase 3 trial ongoing for paltusotine, atumelnant in Phase 2 for CAH and Cushing's disease with data to be shared early next year, early stage pipeline with four new candidates in first-in-human enabling activities. • Introduced non-peptide drug conjugates (NDCs) with CRN09682, a novel platform for targeted anti-tumor agents. • Strong financial position: Ended Q3 2024 with ~$863 million in cash and investments, completed $575 million equity offering strengthening position to fund operations into 2029.
Segment performance
No product segments with reported revenue.
Guidance
• Proceeds from equity offering to fund operating plan into 2029, including commercialization of paltusotine and initiation of multiple later stage clinical trials. • Anticipate increase in R&D spend as initiating and advancing paltusotine and atumelnant into clinical trials. • Expect increases in SG&A expenses as preparing for paltusotine launch.
Risks
• Risks associated with forward-looking statements as actual results may differ. • Regulatory uncertainties in NDA reviews and clinical trial approvals. • Uncertainties in clinical trial outcomes and competitive landscape for pipeline candidates.
Q&A highlights
Q: Congrats on the NDC news, anything more on CRN09682 program?
A: Encourage attending NANETS meeting for preclinical data, NDC platform offers advantages like simpler synthesis, tuneable internalization vs antibodies.
Q: When to expect Phase 1 data from new programs?
A: Difficult to predict precisely, but expect new info from programs over next year.
Q: Thoughts on obesity indications for GLP-1/GIP candidates?
A: Looking for best-in-class small molecule with good tolerability and synthesis, not settling for less.
Q: Toxicities of MMAE in NDC?
A: Explored in preclinical, tuned molecules to have little circulating free MMAE, good margins.
Q: Criteria for TSH antagonist candidate?
A: High quality, careful testing for liability, physical properties, scalability for large indications.
Q: Carcinoid syndrome Phase 3 feedback from FDA?
A: Interaction went well, anticipated perspectives, finalizing protocol.
Q: Development path for TSH antagonist in Graves’ and TED?
A: Early to discuss strategy, but best approach for both, need to stage investments.
Q: CAH learnings from Neurocrine programs?
A: Crinecerfont potential as first CAH drug, learned about HPA axis hormones role.
Q: NETs development path?
A: Oncology style Phase 1, escalating doses in SST2 expressing tumor patients, exploring dose expansion and phases.
Key numbers
Reported versus consensus
Earnings calendar feed
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Transcript
November 12, 2024Full transcript unavailable for redistribution
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