Celcuity Inc (NASDAQ: CELC) is a clinical-stage biotechnology company that commenced activities in January 2012 and is developing gedatolisib, a PI3K/mTOR inhibitor, for treatment of breast cancer under a license agreement with Pfizer. The company has generated no revenue since inception and has financed operations through private placements, registered equity offerings, unsecured convertible notes, and borrowings under loan agreements. Celcuity's entire commercial path depends on completing clinical trials, obtaining FDA regulatory approval, and commercializing gedatolisib. As of the 10-K filed March 26, 2026, the company continued to incur significant operating losses with no approved products on the market. Competitors include major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, and academic research institutions, many of which have substantially greater financial and technical resources than Celcuity.

Revenue model

No revenue as of the 10-K filed 2026-03-26. The company has financed operations entirely through equity offerings, convertible notes, and debt facilities since inception in January 2012. Future revenue, if any, would depend on commercialization of gedatolisib following regulatory approval.

Products and services

Gedatolisib, a PI3K/mTOR inhibitor licensed from Pfizer, is the sole product candidate. Clinical trial arms tested gedatolisib in first-line CDK4/6 inhibitor-naive patients and second/third-line CDK4/6 inhibitor-pretreated patients with breast cancer, as disclosed in the 10-K filed 2026-03-26.

Customers and end markets

No commercial customers as of the 10-K filed 2026-03-26. Target end market is oncology, specifically breast cancer patients, with anticipated customers being patients, oncologists, and healthcare institutions upon potential future commercialization.

Value-chain role

Clinical-stage drug developer operating upstream of commercialization. The company conducts clinical trials and relies on a license agreement with Pfizer for gedatolisib. It has not yet built commercial infrastructure, a sales force, or distribution capabilities, as disclosed in the 10-K filed 2026-03-26.

Geographic exposure

Headquartered in the United States. Subject to EU/EEA data protection regulations (EU GDPR) indicating some clinical or operational activity in those jurisdictions, per the 10-K filed 2026-03-26. No commercial geographic revenue mix is applicable.

Competitors

Major multinational pharmaceutical companies, Established biotechnology companies, Specialty pharmaceutical companies, Universities and research institutions

Source: SEC 10-K, filed 2026-03-26

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