Celcuity Inc.

Celcuity Inc. announced that the U.S. Food and Drug Administration (FDA) approved REVTORPYK (gedatolisib) for the treatment of patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), locally advanced or metastatic breast cancer without a PIK3CA mutation. REVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms and mTOR complexes mTORC1 and mTORC2. The approval is based on positive results from the Phase 3 VIKTORIA-1 trial, where the REVTORPYK triplet reduced the risk of disease progression or death by 76% compared to fulvestrant. Celcuity anticipates commercial launch in late Q3 2026 and plans to submit a supplemental New Drug Application (sNDA) for PIK3CA mutated breast cancer in Q3 2026.

Celcuity Inc. announced the completion of a $575 million offering of 0.250% Convertible Senior Notes due 2032. The net proceeds, approximately $557.0 million after expenses, will be used to fully repay outstanding obligations under a loan agreement, with the remainder allocated to working capital and general corporate purposes. These purposes may include clinical trial expenditures, commercialization efforts, and research and development. The notes mature in August 2032 and are convertible into Celcuity's common stock under specific conditions. The company also granted and the underwriters exercised an over-allotment option for an additional $75 million in notes.

Celcuity Inc. announced the pricing of its upsized underwritten public offering of $500 million aggregate principal amount of 0.250% convertible senior notes due 2032. The offering size was increased from the previously announced $400 million, and underwriters have an option to purchase an additional $75 million. The company estimates net proceeds of approximately $484.3 million, which will be used to repay existing loan obligations and for general corporate purposes, including potential acquisitions.

Celcuity Inc. announced a proposed underwritten public offering of $400,000,000 aggregate principal amount of convertible senior notes due 2032. The company intends to grant underwriters an option to purchase an additional $60,000,000 in notes. Proceeds from the offering will be used to repay outstanding obligations under its loan agreement with Oxford Finance, LLC, with the remainder allocated for working capital, general corporate purposes, and potential acquisitions. The closing of the offering is subject to market and other conditions.

Celcuity Inc. announced detailed positive efficacy and safety results from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 clinical trial for gedatolisib in HR+/HER2- PIK3CA mutated advanced breast cancer. The gedatolisib-triplet regimen significantly reduced the risk of disease progression or death by 50% (HR=0.50) and nearly doubled median progression-free survival to 11.1 months compared to alpelisib plus fulvestrant (5.6 months). Both gedatolisib regimens demonstrated robust responses and favorable safety profiles, with lower discontinuation rates due to adverse events. The company plans to submit these data to the FDA as a supplemental New Drug Application (sNDA) and anticipates potential FDA approval in Q3 2026.

Celcuity Inc. announced detailed efficacy and safety results from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 clinical trial for gedatolisib. The gedatolisib-triplet regimen demonstrated a statistically significant improvement in progression-free survival (PFS), doubling the likelihood of survival without disease progression or death compared to alpelisib plus fulvestrant. The company plans to submit these data to the FDA for a supplemental New Drug Application and anticipates potential FDA approval in Q3 2026.

Celcuity Inc. announced it will host a conference call and live webcast on Tuesday, June 2, 2026, to review results from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 clinical trial. The company is a clinical-stage biotechnology firm developing targeted therapies for solid tumors, with gedatolisib as its lead candidate. The VIKTORIA-1 trial has previously reported detailed results for Study 1 (PIK3CA wild-type) and topline results for Study 2 (PIK3CA mutant-type).

Celcuity Inc. announced that its Chief Executive Officer, Brian Sullivan, will present at two upcoming investor conferences. He is scheduled to participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 4, 2026, and at the Goldman Sachs 47th Annual Global Healthcare Conference on Wednesday, June 10, 2026. Live webcasts of both presentations will be available, with replays accessible shortly after the events on the company's investor relations website.

Celcuity Inc.'s Board of Directors expanded its size from seven to eight members and appointed Charles (Chip) R. Romp as a new independent director, effective February 11, 2026. Mr. Romp was also appointed to the Compensation Committee and the Nominating and Corporate Governance Committee. He will receive compensation in line with the company's non-employee director program, including an annual cash retainer of $70,000 and an annual equity award of $135,000, along with an initial pro-rated grant of 215 restricted shares.

Celcuity Inc. reported a net loss of $(52.8) million for the first quarter of 2026, an increase from $(37.0) million in the same period last year, driven by higher R&D and SG&A expenses. Despite the increased loss and cash burn, the company highlighted the FDA's acceptance of its New Drug Application (NDA) for gedatolisib in HR+/HER2- PIK3CA WT Advanced Breast Cancer, with a PDUFA goal date of July 17, 2026. Celcuity maintains $387.1 million in cash, cash equivalents, and investments, which it believes is sufficient to fund operations for at least one year.