On March 27, 2024 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the fourth quarter and full year ended December 31, 2023 and other recent business developments (Press release, Celcuity, MAR 27, 2024, View Source [SID1234641489]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2023, we made significant progress advancing development of gedatolisib while strengthening our balance sheet and adding to our leadership team," said Brian Sullivan, CEO and Co-Founder of Celcuity. "Our Phase 3 VIKTORIA-1 trial remains on track to report topline data from the PI3KCA wild type patient sub-group in the second half of this year. We were also excited to begin development of gedatolisib for patients with metastatic castration resistant prostate cancer this past year. Enrollment has begun in our Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide, and we look forward to sharing preliminary data from this trial in the first half of 2025."

Fourth Quarter 2023 Business Highlights and Other Recent Developments

● The VIKTORIA-1 Phase 3 trial remains on track to provide topline data for the PIK3CA wild type patient sub-group in the second half of 2024 and for the PIK3CA mutant patient sub-group in the first half of 2025.

○ VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant with and without palbociclib in adults with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor.
○ The Phase 3 VIKTORIA-1 clinical trial is enrolling patients at approximately 220 sites in 23 countries in North and South America, Europe, and Asia.

● The Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide for the treatment of metastatic castration resistant prostate cancer (mCRPC) was initiated in the fourth quarter of 2023. In February 2024, the first patient was dosed.

○ The trial is expected to enroll up to 54 patients with mCRPC whose disease progressed after treatment with an androgen receptor signaling inhibitor.

● In December 2023, Celcuity presented data from nonclinical studies evaluating gedatolisib and other PI3K/AKT/mTOR (PAM) inhibitors in breast cancer cell lines during a poster session at the 2023 San Antonio Breast Cancer Symposium (SABCS). In a panel of breast cancer cell lines, gedatolisib was found to be more cytotoxic and at least 300-fold more potent, on average, compared to the single node PAM inhibitors.

● In February 2024, Eldon Mayer was appointed Chief Commercial Officer. His 30 years of biopharmaceutical commercial experience includes senior leadership roles at several companies where he led the launch of their first drug.

Fourth Quarter and Full Year 2023 Financial Results

Unless otherwise stated, all comparisons are for the fourth quarter and full year ended December 31, 2023, compared to the fourth quarter and full year ended December 31, 2022.

Total operating expenses were $19.7 million for the fourth quarter of 2023, compared to $11.6 million for the fourth quarter of 2022. Operating expenses for the full year 2023 were $66.2 million, compared to $39.4 million for the full year 2022.

Research and development (R&D) expenses were $18.1 million for the fourth quarter of 2023, compared to $10.6 million for the prior-year period. Of the approximately $7.5 million increase in R&D expenses, $6.8 million primarily related to activities supporting the VIKTORIA-1 Phase 3 trial and the initiation of the CELC-G-201 Phase 1b/2 clinical trial, and $0.7 million was related to increased employee and consulting expenses.

R&D expenses for the full year 2023 were $60.6 million, compared to $35.3 million for the prior year. Of the approximately $25.3 million increase in R&D expenses, $22.9 million was related to activities supporting the VIKTORIA-1 Phase 3 trial and the initiation of the CELC-G-201 Phase 1b/2 clinical trial. The remaining $2.4 million increase in R&D expenses was related to increased employee and consulting expenses.

General and administrative (G&A) expenses were $1.6 million for the fourth quarter of 2023, compared to $1.0 million for the prior-year period. Employee-related expenses accounted for $0.5 million of the increase. The remaining increase resulted from professional fees and other expenses associated with compliance related activities that support financing and clinical operations.

G&A expenses for the full year 2023 were $5.6 million, compared to $4.1 million for the prior year. Of the approximately $1.5 million increase in G&A expenses, $1.1 million was related to increased employee-related expenses, and $0.4 million was related to professional fees and other expenses associated with compliance related activities that support financing and clinical operations.

Net loss for the fourth quarter of 2023 was $18.8 million, or $0.65 loss per share, compared to a net loss of $11.6 million, or $0.69 loss per share, for the fourth quarter of 2022. Net loss for the full year 2023 was $63.8 million, or $2.69 loss per share, compared to a net loss of $40.4 million, or $2.64 loss per share, in 2022. Non-GAAP adjusted net loss for the fourth quarter of 2023 was $17.6 million, or $0.61 loss per share, compared to non-GAAP adjusted net loss of $10.3 million, or $0.61 loss per share, for the fourth quarter of 2022. Non-GAAP adjusted net loss for the full year 2023 was $57.8 million, or $2.44 loss per share, compared to non-GAAP adjusted net loss of $35.0 million, or $2.27 loss per share, for 2022. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the fourth quarter of 2023 was $18.5 million, compared to $9.5 million for the fourth quarter of 2022. Net cash used in operating activities for the full year 2023 was $53.8 million, compared to $36.0 million for the full year 2022.

In October of 2023, Celcuity closed a private placement of equity that resulted in gross proceeds of approximately $50 million. In December 2023, Celcuity closed on an additional $15 million of gross proceeds through its at-the-market offering. The Company expects to use the net proceeds to advance the clinical development of gedatolisib and for general corporate purposes.

At December 31, 2023, Celcuity reported cash, cash equivalents and short-term investments of $180.6 million. We expect cash, cash equivalents, investments and available funds under our debt facility to provide adequate capital to fund current operational activities into the first half of 2026.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the fourth quarter and full year 2023 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-888-886-7786 or 1-416-764-8658. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=04c7a07803. A replay of the webcast will be available on the Celcuity website following the live event.