August 24, 2017 Source: drugdeliverybusiness 527
Cel-Sci said today that for a Phase III trial of its investigational immunotherapy, it inked an agreement with institutional investors for a $3.5 million registered direct offering.
The company said it plans to offer 1.75 million shares of common stock at $2.00 apiece. In a private placement, Cel-Sci will issue warrants to buy up to 1.75 million shares of common stock. For each share of stock purchased in the registered direct offering, investors in the private placement will receive an unregistered warrant to buy one share of common stock, which have an exercise price of $2.30 apiece.
The company is slated to use the offering’s net proceeds for a Phase III trial of its investigational immunotherapy, Multikine.
Earlier this month, the FDA lifted a partial hold on Cel-Sci’s late-stage Multikine trial. The hold was put in place in September last year, with the regulatory watchdog citing issues like an unreasonable and significant risk of illness or injury to participants and the lack of prompt reports by Cel-Sci to the FDA on particular issues.
The FDA also claimed that the Vienna, Va.-based company’s investigator brochure was misleading and materially incomplete, according to the Washington Business Journal.
Cel-Sci’s Multikine leukocyte interleukin injection is being evaluated as a potential therapy for patients with squamos cell carinoma of the head and neck.
The Phase III trial’s primary endpoint is an improvement in overall survival of the participants treated with the Multikine therapy plus the current standard of care compared to people treated with just the current standard of care.
CVM shares tumbled down to $1.95 apiece in morning activity today, a -15% drop.
By Ddu
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