Celcuity Inc. Announces Q2 Financial Results and Corporate Update

Celcuity Inc., a clinical-stage biotechnology firm specializing in targeted therapies for oncology, revealed its financial results for Q2 2024 and recent business developments. The company highlighted significant progress in the clinical development of its lead candidate, gedatolisib, aimed at treating advanced breast cancer.

CEO and co-founder Brian Sullivan reported robust enrollment in the VIKTORIA-1 Phase 3 trial, although a recent shift has resulted in a lower proportion of PIK3CA wild-type tumors than initially projected. Consequently, the enrollment target for this cohort is now expected to be met in Q4 2024, with topline data anticipated between late Q4 2024 and Q1 2025.

The VIKTORIA-1 trial is assessing the efficacy of gedatolisib combined with fulvestrant, with and without palbociclib, in HR+, HER2- advanced breast cancer patients previously treated with a CDK4/6 inhibitor. The study is set to provide topline data for the PIK3CA wild-type cohort by late 2024 or early 2025 and for the mutant cohort in the first half of 2025. Over 80% of the wild-type cohort has been enrolled, representing around 60% of the total patients in VIKTORIA-1.

Additionally, the company announced plans to initiate the VIKTORIA-2 Phase 3 trial, which will evaluate gedatolisib in combination with fulvestrant and a CDK4/6 inhibitor (either ribociclib or palbociclib) for first-line treatment of HR+/HER2- advanced breast cancer. This trial is expected to enroll approximately 638 patients across multiple regions and aims to start enrolling patients by Q2 2025.

Celcuity also secured $129 million from equity and debt financings, extending its financial runway through 2026. This funding will support ongoing clinical programs, including a Phase 1b/2 trial evaluating gedatolisib with darolutamide for metastatic castration-resistant prostate cancer (mCRPC). Preliminary data from this trial is anticipated in the first half of 2025.

Three significant manuscripts reporting gedatolisib's clinical and nonclinical results were recently published. In April, The Lancet Oncology shared findings from a Phase 1b study of gedatolisib with palbociclib and endocrine therapy in HR+/HER2- advanced breast cancer. In June, npj Breast Cancer published nonclinical studies indicating gedatolisib's superior potency and efficacy compared to single-node PI3K/AKT/mTOR inhibitors in breast cancer models. Finally, in August, Molecular Oncology published similar findings for prostate cancer models.

Financially, the company reported total operating expenses of $24.3 million in Q2 2024, up from $15.1 million in the same period the previous year. This increase was primarily driven by R&D expenses, which rose to $22.5 million 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 increased to $1.8 million.

Celcuity's net loss for Q2 2024 was $23.7 million, or $0.62 per share, compared to a net loss of $14.6 million, or $0.66 per share, in Q2 2023. The non-GAAP adjusted net loss was $22.2 million, or $0.58 per share, compared to $11.1 million, or $0.51 per share, for the same period the previous year. The company reported cash and short-term investments of $283.1 million as of June 30, 2024.

Celcuity continues to focus on developing gedatolisib, a potent inhibitor targeting PI3K and mTOR, aimed at treating multiple solid tumors. The company is headquartered in Minneapolis and remains dedicated to advancing its clinical programs to address unmet needs in oncology.

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