Crinetics Pharmaceuticals (CRNX) Q3 2024 earnings summary

Executive summary

• Submitted NDA for paltusotine for acromegaly in September 2024; FDA notification expected December 2024 and potential launch in 2025, with European MAA submission planned for 2025.

• Building commercial capabilities in the US and Europe, including new operations in Switzerland and hiring for European market access.

• Positive phase 2 results for paltusotine in carcinoid syndrome; phase 3 trial protocol finalized with FDA feedback and study expected in 2025.

• Atumelnant in phase 2 for CAH and Cushing's disease, with full 12-week data to be shared early next year and phase 3 initiation planned for 2025.

• Four new drug candidates in IND-enabling studies, including the first from the nonpeptide drug conjugate (NDC) platform; lead candidate CRN09682 targeting SST2-expressing tumors, with IND filing and clinical data presentation expected in early 2025.

Financial highlights

• Ended Q3 2024 with $862.7 million in cash and investments; post-offering pro forma cash totals $1.4 billion.

• Completed $575 million public equity offering after quarter-end, plus $542.9 million public offering and $335.5 million private placement earlier in 2024.

• No revenues for Q3 2024, compared to $0.3 million in Q3 2023; prior revenue from Japanese paltusotine partnership.

• R&D expenses rose to $61.9 million (from $43.8 million YoY); G&A expenses increased to $25.9 million (from $15.5 million YoY).

• Net loss for Q3 2024 was $76.8 million, up from $57.5 million YoY; net cash used in operations was $62.8 million.

Outlook and guidance

• Cash runway projected to fund operations into 2029, including commercialization and multiple late-stage trials.

• Anticipates increased R&D and SG&A expenses as clinical programs and commercial preparations accelerate in 2025.

• Plans to initiate Phase 3 trials for paltusotine in carcinoid syndrome and atumelnant in CAH in 2025, with additional IND filings for pipeline programs.

• Updated financial guidance to be provided in Q1 2025.

• Preclinical data for NDC platform candidate to be presented in November 2024.