Celcuity (CELC) Q2 Earnings call transcript Aug 14, 2024

In a recent earnings call, Celcuity, a biopharmaceutical company focused on developing therapies for cancer, provided an update on its financial results and ongoing clinical trials. The call, led by CEO Brian Sullivan, highlighted key themes and trends that underscore the company's progress in advancing its clinical programs, particularly for its investigational drug, gedatolisib.

Clinical Progress and Financial Health

Celcuity's second quarter financial results showed a net loss of $23.7 million, or $0.62 per share, compared to $14.6 million, or $0.66 per share, in the same period last year. The company's financial position was strengthened by a successful $129 million equity and debt offering in the first half of 2024. This financing has enabled Celcuity to accelerate its clinical trials, including the Phase III study, VIKTORIA-2, which evaluates gedatolisib as a first-line treatment for patients with HR+/HER2- advanced breast cancer.

VIKTORIA-1 and VIKTORIA-2 Studies

The VIKTORIA-1 study, which investigates gedatolisib in combination with fulvestrant and palbociclib, is enrolling patients at a robust rate and remains on track. Celcuity has also announced plans for VIKTORIA-2, a Phase III study designed to evaluate gedatolisib as a first-line treatment for patients with HR+/HER2- advanced breast cancer. This study will investigate the combination of gedatolisib with a CDK4/6 inhibitor and fulvestrant. The potential market size for this indication is significant, with an estimated 15,000 to 20,000 patients diagnosed annually in the United States alone.

Market Opportunities and Competitive Landscape

Celcuity's focus on developing more efficacious therapeutic regimens for patients with advanced breast cancer resistant to endocrine therapy highlights the significant need for new treatments in this area. The company's clinical data demonstrates the potential of gedatolisib in combination with other therapies, such as palbociclib and darolutamide, in treating metastatic castration-resistant prostate cancer. Celcuity's ongoing research in multiple tumor types and pathways underscores its commitment to addressing unmet medical needs and exploring novel therapeutic approaches.

Investor Questions and Outlook

During the Q&A session, key investors and analysts posed questions about the company's enrollment progress, clinical trial design, and market potential. Celcuity's management team provided detailed responses, emphasizing the importance of carefully evaluating safety data and optimizing clinical trial designs to maximize potential efficacy. The company remains focused on delivering top-line results as soon as possible while ensuring the highest standards of safety and efficacy.

Conclusion

Celcuity's second quarter financial results and business update underscore the company's strategic focus on advancing its clinical programs and exploring new opportunities in cancer therapy. The successful financing, ongoing clinical trials, and positive investor interest provide a solid foundation for Celcuity's future growth and development. With a robust pipeline and a clear commitment to addressing unmet medical needs, Celcuity is well-positioned to make significant strides in the field of cancer therapeutics.