Celcuity

Brian Sullivan serves as Chairman and CEO, leading the firm since its founding in 2012. He is responsible for capital allocation, corporate strategy, and the decision to in-license gedatolisib from Pfizer. The firm's publicly traded structure (Nasdaq: CELC) places ultimate strategic oversight with the board of directors and shareholders.

CELsignia measures the functional activity of cellular signaling pathways in live tumor cells, providing a real-time view of whether pathways such as PI3K or MAPK are hyperactive. This contrasts with genomic sequencing, which identifies mutations but cannot confirm whether the associated pathway is functionally driving tumor growth. The technology was in-licensed from the Moffitt Cancer Center and the University of South Florida.

Celcuity generates revenue through two channels. The diagnostics business provides pathway-activity testing services to pharmaceutical companies for use in oncology clinical trials, helping to identify and stratify patients likely to respond to investigational drugs. The therapeutic business is pre-revenue and centers on gedatolisib, a pan-PI3K/mTOR inhibitor currently in Phase 3 clinical development.

Celcuity acquired global rights to gedatolisib from Pfizer in 2021. The decision reflected a strategic rationale: Celcuity's CELsignia platform had generated data suggesting that PI3K pathway hyperactivity is present in a broader subset of breast cancer patients than previously understood. Owning a therapeutic candidate allowed the firm to directly test this hypothesis while retaining full economic interest in the drug program.

VIKTORIA-1 is a Phase 3 registrational trial evaluating gedatolisib in combination with fulvestrant, with or without palbociclib, in patients with HR+/HER2- advanced breast cancer. Celcuity announced the first patient dosed in February 2024. The trial is designed to support a regulatory submission for marketing approval if the endpoints are met.

Celcuity has disclosed collaborations with Novartis, Genentech (a Roche subsidiary), and Puma Biotechnology, among others. These partnerships typically involve using the CELsignia platform to identify patients with dysregulated cellular signaling pathways for enrollment in clinical trials of targeted oncology agents.

The foundational CELsignia technology was developed at the H. Lee Moffitt Cancer Center and the University of South Florida. Celcuity in-licensed the intellectual property and has built the commercial diagnostic platform and clinical trial infrastructure around it.