Celcuity Inc. develops targeted oncology therapies as a clinical-stage biotechnology company, with news centered on gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor for solid tumors. Company updates frequently cover Phase 3 VIKTORIA-1 data in HR+/HER2- advanced breast cancer, including PIK3CA wild-type and mutant cohorts and combination regimens with fulvestrant and palbociclib.
Recurring announcements also address FDA regulatory submissions and review status for gedatolisib, publications and medical-meeting presentations, quarterly financial results, corporate updates, investor conference participation, and board governance changes.
Celcuity (NASDAQ: CELC), a clinical-stage biotechnology company, announced the pricing of an underwritten offering of 3,871,000 shares of common stock at $15.50 per share, aiming to raise $60 million. Notable investors include BVF Partners L.P., Vivo Capital, and Eventide Asset Management. The offering is expected to close by May 31, 2024, pending customary conditions.
Proceeds are earmarked for working capital, corporate purposes, and a Phase 3 trial for advanced breast cancer treatment. Combined with existing cash and investments, these funds should cover expenses through late 2026. Leerink Partners, TD Cowen, and Stifel are joint bookrunning managers. The offering is registered under a previous SEC filing.
Celcuity announced plans to initiate a Phase 3 trial for gedatolisib as first-line treatment for HR+/HER2- advanced breast cancer. The trial will assess gedatolisib combined with a CDK4/6 inhibitor and fulvestrant, targeting patients resistant to endocrine therapy. Initial trial results show promising efficacy, with a median progression-free survival of 48.6 months and an overall response rate of 79% in Phase 1b. Additionally, Celcuity secured $62 million in debt financing to support this initiative, amending its agreement with Innovatus Capital Partners and adding Oxford Finance as a new lender, increasing the total debt facility to $180 million. The Phase 3 trial, named VIKTORIA-2, will involve approximately 638 subjects across 200 global sites, with enrollment beginning in Q2 2025.
Celcuity Inc. (Nasdaq: CELC) reported its first-quarter financial results and provided a corporate update. The Phase 3 VIKTORIA-1 trial remains on track, with topline data expected in the second half of 2024. The company also initiated a Phase 1b/2 trial for gedatolisib in prostate cancer, and dosed its first patient in February 2024. Financial highlights include a net loss of $21.6 million ($0.64 per share) for Q1 2024, compared to $11.9 million ($0.55 per share) in Q1 2023. Operating expenses rose to $22.5 million from $12.6 million year-over-year. Cash reserves stand at $177.7 million, expected to fund operations into early 2026.
Celcuity Inc. (Nasdaq: CELC) will release its first quarter 2024 financial results on May 15, 2024, with a webcast/conference call hosted by management to discuss the results and provide a corporate update. The company is a clinical-stage biotechnology firm developing targeted oncology therapies.
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