Company: CRNX
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001658247-25-000019
Chunk: 98

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 2
Chunk 98
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). CRN12755 was observed to decrease TSAb-stimulated thyroid hormone (T4) in a rat model, and was observed to decrease hyaluronic acid and IL-6 production in Graves Orbital Fibroblasts, or GOFs from TED patients. We also provided an overview of the clinical development strategy for CRN12755, including key biomarkers and other data to be captured in the Phase 1 trial. 

•CRN10329: We identified CRN10329 as a preclinical leading development candidate for a selective somatostatin receptor type 3 (SST3) nonpeptide agonist for the treatment of autosomal dominant polycystic kidney disease, or ADPKD. CRN10329 was observed to decrease cystic index, cellular proliferation, kidney weight and aberrant expression of renal tubular injury markers in a mouse model of ADPKD. We also shared data highlighting that SST3 is highly and consistently expressed in cyst-lining cells in ADPKD.

•Based on emerging data from IND enabling studies, focus of the TSHR antagonist program has shifted to bringing forward an alternative candidate with a superior profile. There is also follow-up preclinical work needed on the IND-enabling studies for the SST3 program that will postpone its IND submission. 

International Expansion:

•We continued international expansion activities in parallel with the ongoing review of our MAA for PALSONIFY  by the European Medicines Agency.

Financial operations overview

To date, we have devoted substantially all of our resources to drug discovery, conducting preclinical studies and clinical trials, obtaining and maintaining patents related to our product candidates, licensing activities, and the provision of selling, general and administrative support for these operations and commercial preparedness. We have recognized revenues from various research and development grants and license and collaboration agreements. We received FDA approval on PALSONIFY on September 25, 2025, but have not yet generated any product revenue during the quarter ended September 30, 2025. We have funded our operations primarily through license revenues and offerings of our preferred and common stock.

We have incurred cumulative net losses since our inception. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on our ability to successfully commercialize PALSONIFY and the associated costs, the timing of our revenues, our clinical trials and preclinical studies, our expenditures on other research and development activities, and other expenditures to support our on-going activities, including international expansion. While the FDA approved PAL