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A Biotech with Blockbuster Potential – TipRanks Financial Blog

A Biotech with Blockbuster Potential – TipRanks Financial Blog

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Breast cancer is the most frequently diagnosed cancer worldwide. Currently, about 4 million American women are living with breast cancer, with over 150,000 battling metastatic disease. The 5-year survival rate for localized breast cancer is significantly high, at 99%. However, for metastatic disease, it comes down to 29%. Celcuity (NASDAQ:CELC) aims to improve those numbers with its lead treatment candidate, currently entering Phase 3 trials. If successful, it could be a game-changing blockbuster drug. 

Celcuity Movado’s stock is up 6% over the past year. Given the upside potential, the stock warrants consideration from biotech investors.

Potential Blockbuster Drug

Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies to enhance the clinical outcomes of cancer patients. The company’s lead treatment candidate, Gedatolisib, is making notable progress.

The company is currently exploring the use of Gedatolisib for the treatment of patients with hormone receptor-positive, HER2-negative, advanced, or metastatic breast cancer. The drug has entered a Phase 3 registration-enabling clinical trial to assess Gedatolisib in patients with HR+/HER2- advanced breast cancer. The company anticipates sharing preliminary data from this trial in early 2025.

Current estimates for the target population are roughly 100,000 breast cancer patients globally per year, and the need for HR+/Her2 treatments is expected to witness significant growth.  The current market value of approximately $9 billion is expected to expand with a CAGR of 9.3% by 2032.

Financial Outlook

Like most clinical-stage biotech companies that have yet to bring a treatment to market, Celcuity operates at a net loss as it allocates capital towards research and development (R&D) efforts. The company recently posted Q4 and FY2023 financial results, reporting a net loss of $18.8 million, or -$0.65 per share. This was an increase from the net loss of $11.6 million, or -$0.69 loss per share, for the same period in the previous year. For 2023, the net loss totaled $63.8 million, or -$2.69 loss per share, up from the net loss of $40.4 million, or -$2.64 loss per share, in 2022.

The rate at which a biotech startup spends cash, or its “burn rate,” is a critical metric for investors to monitor. The net cash used in operating activities in Q4 2023 was $18.5 million, up from $9.5 million in Q4 2022. For the full year 2023, $53.8 million…

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