Celcuity Inc. Announces Q1 Financial Results and Corporate Update

Celcuity Inc., a clinical-stage biotechnology firm listed on Nasdaq under the ticker CELC, recently released its financial results for the first quarter of 2024, ending March 31, 2024. Alongside the financial report, the company highlighted significant milestones in its ongoing clinical trials.

Brian Sullivan, the CEO and co-founder of Celcuity, expressed satisfaction with the company's progression, stating that the VIKTORIA-1 study remains on schedule. Additionally, the first patient was administered a dose in the company's Phase 1b/2 trial for metastatic castration-resistant prostate cancer. The company also welcomed Eldon Mayer as Chief Commercial Officer to bolster efforts for the potential commercial launch of their lead therapeutic candidate, gedatolisib.

In the VIKTORIA-1 Phase 3 trial, Celcuity is evaluating gedatolisib combined with fulvestrant, with or without palbociclib, in adults with HR+, HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor. This trial is being conducted at approximately 220 sites across 23 countries, spanning North and South America, Europe, and Asia. The trial aims to deliver topline data for the PIK3CA wild type patient subgroup in the latter half of 2024 and for the PIK3CA mutant patient subgroup in the first half of 2025.

In another critical development, Celcuity initiated a Phase 1b/2 clinical trial in the fourth quarter of 2023, assessing gedatolisib in combination with darolutamide for treating metastatic castration-resistant prostate cancer (mCRPC). The first patient was dosed in February 2024, and the trial is set to enroll up to 54 patients whose disease has progressed following treatment with an androgen receptor signaling inhibitor. Preliminary data from this trial is expected in the first half of 2025.

Financially, Celcuity reported total operating expenses of $22.5 million for the first quarter of 2024, a significant increase from $12.6 million in the first quarter of 2023. Research and development expenses alone were $20.7 million in the first quarter of 2024, up from $11.3 million in the same period the previous year. This $9.4 million increase in R&D expenses was primarily due to activities supporting the VIKTORIA-1 trial and the initiation of the CELC-G-201 Phase 1b/2 trial.

General and administrative expenses also saw a rise, reaching $1.8 million in the first quarter of 2024 compared to $1.3 million in the same period last year. The increase in G&A expenses was attributed to higher employee-related costs and professional fees.

The net loss for the first quarter of 2024 was reported at $21.6 million, equating to a loss of $0.64 per share. This is a greater loss compared to $11.9 million, or $0.55 per share, in the first quarter of 2023. The non-GAAP adjusted net loss for the first quarter of 2024 was $19.9 million, or $0.59 per share, compared to $11.9 million, or $0.55 per share, for the same period last year. The non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income.

Celcuity's net cash used in operating activities for the first quarter of 2024 was $17.1 million, compared to $12.9 million in the same quarter of 2023. As of March 31, 2024, the company reported cash, cash equivalents, and short-term investments totaling $177.7 million. This cash reserve is expected to fund the company's operational activities into the first half of 2026.

Celcuity's focus remains on developing targeted therapies for various solid tumor indications, with gedatolisib as its leading therapeutic candidate. The company's innovative CELsignia companion diagnostic platform is uniquely capable of analyzing live patient tumor cells to identify new groups of cancer patients who may benefit from existing targeted therapies.