Celcuity Inc.

What they do

Celcuity develops targeted therapies for solid tumor indications. Its lead asset is gedatolisib, a pan-class I PI3K and mTORC1/2 inhibitor that comprehensively blockades the PI3K/AKT/mTOR pathway. Gedatolisib is licensed globally from Pfizer and is administered intravenously on a four-week cycle of three weeks on, one week off. The company also runs the Phase 3 VIKTORIA-1 and VIKTORIA-2 trials and the Phase 1b/2 CELC-G-201 trial in mCRPC.

Revenue drivers

• REVTORPYK (gedatolisib) - PIK3CA wild-type 2nd line — The company's first FDA-approved product, approved July 14, 2026 for HR+/HER2- locally advanced or metastatic breast cancer without a detected PIK3CA mutation after at least one line of endocrine therapy in the metastatic setting; shipments are expected to begin late in the third quarter of 2026, so no product revenue has been reported.
• Potential PIK3CA mutant 2nd line expansion — The Phase 3 PIK3CA mutant cohort of VIKTORIA-1 achieved its primary endpoint by doubling the likelihood of survival without disease progression or death versus alpelisib plus fulvestrant; an sNDA is planned for submission in the third quarter of 2026.
• First-line HR+/HER2- advanced breast cancer (VIKTORIA-2) — VIKTORIA-2 was expanded to two independent studies: Study 1 in endocrine-resistant patients and Study 2 in endocrine-sensitive patients, both first-line in the advanced setting, which management says could position gedatolisib regimens for nearly all first- and second-line patients.
• Metastatic castration resistant prostate cancer (CELC-G-201) — A Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide in mCRPC is ongoing; initial preliminary Phase 1 data were reported in the fourth quarter of 2025.

Recent performance

Celcuity has no product revenue to date and has reported net losses each year: $-29.6M in 2021, $-40.4M in 2022, $-63.8M in 2023, $-111.8M in 2024 and $-177.0M in 2025. Operating cash use has widened in parallel, from $-20.3M in 2021 to $-153.3M in 2025. At June 30, 2026, total assets were $828.2M, total liabilities were $841.0M, shareholders' equity was $-12.8M, cash and equivalents were $182.0M, and long-term debt was $0.00. In the second quarter of 2026 the company completed a $575.0 million convertible note offering, generating net proceeds of $557.2 million. Diluted EPS was $-2.21 in 2021 and $-3.79 in 2025.

Strategy

The company is shifting from clinical-stage development toward commercializing REVTORPYK, with commercial launch activities beginning immediately after the July 14, 2026 FDA approval and shipments expected late in the third quarter of 2026. It says the build-out of the commercialization infrastructure needed to support launch is complete, and it opened an Expanded Access Program to distribute gedatolisib to physicians before commercial availability. Celcuity plans to submit an sNDA for the PIK3CA mutant cohort in the third quarter of 2026 and has expanded VIKTORIA-2 to test gedatolisib in first-line, endocrine-sensitive patients. It also continues the CELC-G-201 Phase 1b/2 trial in mCRPC. The company funds these activities largely through equity and convertible note financings, including the $575.0 million convertible offering completed in the second quarter of 2026.

Risks

• No product revenue yet; history of losses — Celcuity states it has had no revenue since inception and has incurred significant operating losses, with the 2025 net loss reaching $177.0M, and may never generate sufficient revenue to achieve profitability.
• Negative shareholders' equity — At June 30, 2026, total liabilities of $841.0M exceeded total assets of $828.2M, leaving shareholders' equity of negative $12.8M.
• Need for additional capital — The company's own risk factors state that an inability to raise additional capital on acceptable terms may limit its ability to develop and commercialize gedatolisib.
• Single-asset dependence and label scope — The business centers on gedatolisib, and the current approval covers only HR+/HER2- patients without a detected PIK3CA mutation after at least one prior endocrine therapy line in the metastatic setting, so broader use depends on the planned PIK3CA mutant sNDA and the ongoing VIKTORIA-2 trial.

Outlook

Management says REVTORPYK shipments are expected to begin late in the third quarter of 2026, with the commercial infrastructure for launch already built out. The company plans to submit an sNDA for the PIK3CA mutant cohort of VIKTORIA-1 in the third quarter of 2026. It has expanded VIKTORIA-2 to include first-line treatment of endocrine-sensitive patients, aiming to make gedatolisib regimens available to nearly all first- and second-line patients regardless of endocrine sensitivity or PIK3CA mutation status. The CELC-G-201 trial in mCRPC remains ongoing.