aibioCelcuity files for up to $125,000,000 of at-the-market stock sales
Tickers CELC
The supplement covers up to $125,000,000 of common stock sold through Jefferies LLC under a February 4, 2022 sales agreement. Shares with an aggregate offering price of up to $22,182,550 remained unsold under the 2022 supplement, and the filing gives a $12.71 last sale price on December 4, 2024.
Key facts
- Company
- Celcuity Inc. (NASDAQ: CELC)
- News type
- Financings
- Primary source
- Celcuity Inc. 424B5 (2024-12-06)
Celcuity Inc. (Nasdaq: CELC) filed a prospectus supplement dated December 6, 2024 covering up to $125,000,000 of common stock. The supplement is filed under shelf registration statement No. 333-281887, and it refers to the prospectus dated December 2, 2024. Sales run through an Open Market Sale Agreement with Jefferies LLC, which the filing names as sales agent, dated February 4, 2022.
What happens to the 2022 program
Celcuity filed a separate supplement under the same agreement on February 4, 2022, for up to $50,000,000 of stock. Immediately before the new filing, shares with an aggregate offering price of up to $22,182,550 remained unsold under that earlier supplement. The filing says those shares will no longer be sold under the earlier prospectus and will instead be sold under the new supplement.
Jefferies is not required to sell any specific amount, and it will use commercially reasonable efforts. Sales may be made at the market, meaning at prevailing prices on Nasdaq. The commission is up to 3.0% of the gross proceeds of shares sold under the agreement. The filing says the company cannot assure that it will sell any shares under this supplement, or fully use the Jefferies agreement as a source of financing.
Faegre Drinker Biddle & Reath LLP will pass on the validity of the shares for Celcuity. Cooley LLP of New York represents Jefferies LLC in the offering. The company says it intends to use the net proceeds for general corporate purposes, which may include working capital, capital expenditures and research and development.
The filing gives a last reported sale price of $12.71 per share on December 4, 2024. At that price the full amount would mean 9,834,775 new shares, taking the count outstanding to up to 46,951,042 from 37,116,267 on September 30, 2024. The supplement says buyers would see immediate dilution of $7.56 per share. It also says Celcuity has issued 11,499,341 shares in equity financings since December 2023. The supplement gives no cash balance or loss figure.
The lead drug and its trials
The company describes gedatolisib, a pan-PI3K/mTOR inhibitor, as its lead therapeutic candidate. It obtained exclusive global development and commercialization rights to the drug under a license agreement with Pfizer, Inc. in April 2021. The filing describes VIKTORIA-1, a Phase 3 study, as one that began enrolling patients in 2022. It tests gedatolisib and fulvestrant, with and without palbociclib, as second-line treatment for HR-positive, HER2-negative advanced breast cancer. The company announced plans for VIKTORIA-2, a second Phase 3 trial, in May 2024. That study would test gedatolisib with fulvestrant and a CDK 4/6 inhibitor as first-line treatment.
A separate Phase 1b/2 study, CELC-G-201, began enrolling in early 2024. It combines gedatolisib with darolutamide in metastatic castration-resistant prostate cancer. The supplement reports no Phase 3 outcome for either VIKTORIA trial, so the efficacy case rests on studies that have not yet read out in the filing.
The safety base is built mostly on combinations. As of September 30, 2024, 492 patients with solid tumors had received gedatolisib in eight completed clinical trials. Of those patients, 129 were treated with gedatolisib alone in three trials, and 363 received it in combination with other anti-cancer agents in five trials. The supplement reports no safety results from the Phase 3 trials.
What the filing leaves open
The company says it intends to use the net proceeds for general corporate purposes and names no specific program for them. It expects topline data from VIKTORIA-1 for the PIK3CA wild-type group in late Q1 2025 or during Q2 2025, and for the mutant group in the second half of 2025. The first patient in VIKTORIA-2 is expected in the second quarter of 2025, and preliminary CELC-G-201 data in Q2 2025. These are the company's forecasts, and none of the Phase 3 results are in hand. The filing also says there can be no assurance that the company will sell any shares under the Jefferies agreement, so the $125,000,000 is a ceiling, not a commitment.