With CEO search, PhIII study underway, Fulcrum Therapeutics raises $125M from stock offering

Whoever becomes the next CEO of Fulcrum Therapeutics will have $125 million more to work with.

Bryan Stuart

The company is selling off 9.6 million shares of its common stock at a price of $13 per share in a public offering, completely with a 30-day option for the underwriters to purchase up to 1.4 million shares with a closing date of Jan. 23, the company announced Tuesday.

The announcement of the public offering comes after a busy year for the company, including fast track designation from the FDA and the completion of several clinical trials and enrollment periods for more.

Two weeks ago, former CEO Bryan Stuart stepped down and Robert Gould, Fulcrum’s former chief, stepped up as interim CEO while the company searches for a new leader. Gould was the founding CEO of Fulcrum and served in that role from 2016 to 2021, and has remained on the board.

The FDA gave a fast track designation to FTX-6058, the company’s candidate for the genetic blood disorder sickle cell disease, in December. The drug moved into a Phase Ib trial and reported improved biomarkers of hemolysis on 6 mg doses. The company is now enrolling patients in a study using a 12 mg dose, with a new release of data planned for the fourth quarter of 2023.

Fulcrum’s most advanced candidate losmapimod, a protein kinase inhibitor for facioscapulohumeral muscular dystrophy, failed in 2020 but made a comeback after the company pressed on with trials. It received orphan drug designation from both the FDA and the EMA and also got fast track designation in April 2021.

Patients are now being enrolled in the US, Canada and Europe for a Phase III losmapimod trial after the Phase II trial found that the drug maintained effect through 96 weeks. Patients who started taking the drug after being on placebo showed a slowing in disease progression. Fulcrum plans to complete enrollment in the second half of this year.

Fulcrum touts FulcrumSeek, a “product engine” designed to discover cellular drug targets that have the potential to “modulate gene expression to treat the known root cause of genetically defined diseases.”

FulcrumSeek technology is how researchers identified losmapimod and FTX-6058, as well as other candidates in the company’s discovery pipeline. Fulcrum plans to submit its next IND application in 2023.

According to SEC filings, as of Sept. 30, 2022, Fulcrum had an accumulated deficit of $386.2 million. The company expects expenses and operating losses to increase “substantially” over the next several years.

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