Gamida Cell, a maker of cell and immune therapy technologies, is seeking to raise some $69 million in a Nasdaq share offering to help finance a final-stage trial for a drug it hopes will help increase the success of bone marrow transplants in blood cancer patients.
In a draft prospectus filed with the US Securities and Exchange Commission (SEC) and the Nasdaq exchange, the company said it is seeking to raise $69 million in an initial public offering of ordinary shares on the Nasdaq. Terms of the pricing of shares were not disclosed.
The biotechnology company has started enrolling patients for a last-stage clinical trial for its most advanced drug, NiCord, which it believes will help increase the success of bone marrow transplants in blood cancer patients who do not have a rapidly available, fully matched, bone marrow donor, and help them better withstand the ordeal of the lifesaving procedure. In addition to hematologic malignancies, the company is also seeking to develop NiCord for the treatment of bone marrow failure disorders.
Gamida, which has not yet generated any revenue from sales and has incurred losses since its founding, said it intends to use the proceeds of the offering for the clinical development of NiCord, for a manufacturing plant and for expenses.
Should the results of the trial, as hoped, be positive, that would lead to the launch of a commercially available product in 2020, Gamida Cell’s now former CEO Yael Margolin said in an interview with The Times of Israel last year.
Preliminary clinical data has revealed that the risk of NiCord not meeting its targets in the Phase 3 trial “is low,” Margolin said in the interview.
The drug has already received a breakthrough therapy designation by the US Food and Drug Administration. The designation is given to a drug that is meant to treat a serious or life-threatening condition, and where preliminary clinical evidence indicates that it may demonstrate a substantial improvement on at least one clinically significant target (endpoint) over other available therapies. The designation also entitles the company to get more and closer FDA guidance to help bring the treatment faster to patients.
Last year the firm raised $40 million from investors including Novartis, which was already a major shareholder in the firm. The funds were raised to support the Phase 3 trial for NiCord, whose first market will be the US. Other investors include Clal Biotechnology Industries Ltd., which holds an 18% stake in the firm, and Elbit Imaging Ltd. which also holds an 18% stake in Gamida via a unit, according to filings with the Tel Aviv Stock Exchange.
NiCord would be the first drug developed by Gamida to hit the market. As of end June the company employed 52 workers and is led by CEO Julian Adams, the Nasdaq filing said.