Celcuity’s breast cancer drug sends share price soaring

Celcuity, the Plymouth-based clinical-stage biotechnology company, has been the best-performing Minnesota stock of the summer and has outperformed all the S&P 500 stocks, including the tech giants comprising the “Magnificent Seven.”

On July 28, the company announced favorable Phase III clinical trial results for its drug to treat advanced breast cancer, and the stock soared 167%.

In the third quarter alone, Celcuity shares have more than quadrupled in value to a $55.07 close on Monday.

The trial results allowed Celcuity to raise $300 million from new debt and equity offerings during August, and a new term loan facility could give it $500 million in total.

Celcuity was founded in 2012 by Brian Sullivan and Lance Laing to find better ways to treat tumor growths. As a development-stage company, it has yet to produce any revenue.

In 2021, the company turned its attention to gedatolisib, a drug shown to block key pathways to breast tumor development.

The Phase III trial showed “statistically significant and clinically meaningful improvement,” according to Celcuity.

According to the U.S. Centers for Disease Control and Prevention, 279,731 new breast cancers were reported in females in the United States in 2022 and in 2023 42,213 women in the U.S. died from breast cancer.

It can take a decade or more for a new cancer drug to proceed through development, testing, multiple clinical trials and FDA registration before it can make it to the market.

Gedatolisib could proceed faster because Celcuity has already gained breakthrough therapy and fast-track designations by the FDA.

New drug development usually passes through Phase I, Phase II and Phase III clinical trials before moving on to the Food and Drug Administration approval process.

Additional trials and approvals would be needed to treat distinct patient populations or indications.

The subset of breast cancer patients that Celcuity would initially target is potentially worth $4 billion to $5 billion, according to Sullivan, and approvals for additional indications would increase that market potential further.

Sullivan hopes to get FDA approval for the first use of the drug in patients by the middle of 2026.

Doctors and analysts who’ve followed the clinical trial process are enthused. “We believe geda[tolisib] to be a blockbuster,” wrote Chase Knickerbocker, an analyst with Craig-Hallum Capital Markets, in a recent note to investors.