CELCUITY Business Summary

Celcuity Inc. is a clinical-stage biotechnology company transitioning into a commercial-stage entity focused on developing targeted oncology therapies guided by its proprietary CELsignia functional cellular analysis platform. The company’s primary revenue model is centered on the clinical development and anticipated commercialization of its lead therapeutic candidate, gedatolisib—a potent, reversible pan-PI3K and mTOR inhibitor licensed from Pfizer—following the FDA’s January 2026 acceptance of its New Drug Application (NDA) with a PDUFA goal date of July 17, 2026. Celcuity operates through a single business segment dedicated to oncology, leveraging its platform to identify patient subpopulations whose tumors are driven by signaling pathways that traditional genomic sequencing may overlook. In the competitive landscape, Celcuity contends with established pharmaceutical players like Novartis (Piqray) and AstraZeneca (Truqap) in the PI3K/AKT/mTOR inhibitor market, as well as precision diagnostic firms such as Guardant Health and Foundation Medicine. The company distinguishes itself by utilizing live-cell functional analysis to predict drug response, positioning it as a leader in functional precision medicine relative to static genomic-based competitors. The company was co-founded by Brian Sullivan and Dr. Lance Laing, both of whom possess extensive pedigrees in healthcare technology and drug development. Brian Sullivan serves as Chairman and CEO, having previously co-founded and led SterilMed until its acquisition by Johnson & Johnson. Dr. Lance Laing, the Chief Scientific Officer, provides the technical foundation for the CELsignia platform, drawing on his experience in drug discovery and diagnostic development at Pfizer and Monsanto. The executive team is further supported by CFO Vicky Hahne, who manages the firm’s approximately $450 million cash position and strategic capital allocation. In February 2026, Celcuity expanded its board with the appointment of Charles (Chip) R. Romp, the CEO of Secura Bio and former EVP at Seagen, to bolster its commercial launch readiness for gedatolisib. The company is backed by prominent institutional investors, including Perceptive Advisors and Venrock, reflecting strong market confidence in its transition to a vertically integrated biopharmaceutical company.