Company: CRNX
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001658247-25-000019
Chunk: 78

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 8
Chunk 78
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 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 PALSONIFY on September 25, 2025, we have not yet generated product revenues from sales of PALSONIFY as of September 30, 2025 and we expect operating expenses to increase in future periods as product revenues increase. We also expect our expenses will increase substantially as we conduct our ongoing and planned clinical trials, continue our research and development activities and conduct preclinical studies, commercialize PALSONIFY and other potential approved product candidates, if any, and incur general and administrative costs to support our on-going growth. We expect our operating losses will increase in future periods until such time, if ever, we can generate substantial product revenues to support our cost structure.

As a new commercial-stage company, we are continuing to build our market presence We expect product revenues to increase as we continue to expand our commercial activities. However, we do not anticipate generating significant or sustained revenues from product sales until our product achieves broader market acceptance and, in some cases, until we obtain additional regulatory approvals for our product candidates in the pipeline. We expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Accordingly, until such time as we can generate significant revenue from PALSONIFY along with other product candidates in the pipeline, if ever, we expect to finance our cash needs through equity offerings, debt financings or other sources as may be required, including potentially, collaborations, licenses and other similar arrangements. However,