Company: CRNX
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001658247-25-000019
Chunk: 7

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part II, Item 1A
Chunk 7
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ITEM 1A. RISK FACTORS

We do not believe that there have been any material changes to the risk factors set forth in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 except as relates to the Risks related to our limited operating history, financial position and capital requirements, with the following paragraph replaced in its entirety:  

We have a limited operating history, have incurred significant operating losses since our inception and expect to continue to incur losses. We may never generate enough revenue or become profitable or, if we achieve profitability, we may not be able to sustain it. 

Pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We are a global pharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We commenced operations in 2010 and we have focused primarily on organizing and staffing our company, business planning, raising capital, discovering potential product candidates, conducting preclinical studies and clinical trials; more recently, commercial launch activities for PALSONIFY. While we have obtained FDA regulatory approval, we have not yet demonstrated that we can commercialize PALSONIFY.  

We are not profitable and have incurred significant operating losses since our inception. Our prospects are highly dependent on the successful launch and commercialization of PALSONIFY and other late stage clinical drug candidates. The commercial success of PALSONIFY will depend on the degree of market acceptance by physicians, patients, third-party payors and others in the health care community. To the extent that we cannot generate enough revenue from commercial sales of PALSONIFY, our business, financial condition and results of operations may be materially adversely affected and the price of our securities may decline. Regarding our other late stage clinical drug candidates, if those product candidates are not successfully developed and approved, we may never  generate revenue from commercial sales or successfully commercialize those drug candidates.  We have incurred cumulative net losses since our inception and, as of September 30, 2025, we had an accumulated deficit of $1.3 billion. Our losses have primarily resulted from expenses incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations. More recently, we have begun to incur losses associated with pre-commercialization and commercial activities for PALSONIFY associated with its  U.S. approval,  EMA submission, and pre-commercialization activities in other jurisdictions.  In addition,  all of our product candidates will require substantial