Opexa Therapeutics Stock Tanks After Failed MS Trial, Cuts 40% Staff
November 2, 2016
By Mark Terry, BioSpace.com Breaking News Staff
In the wake of a failed Phase IIb clinical trial, Opexa Therapeutics , located in The Woodlands, Texas, announced it will be laying off about 40 percent of its workforce.
On October 28, Opexa announced that its Phase IIb Abili-T trial to evaluate the efficacy and safety of Tcelna (imilecleucel-T) in patients with secondary progressive multiple sclerosis (SPMS) failed to meet its primary and secondary endpoints. The primary endpoint was the reduction of brain volume change, i.e., atrophy. The secondary endpoint was a decrease in the rate of sustained disease progression. The drug had a favorable safety and tolerability profile.
The Abili-T trial involved 183 patients conducted at 35 trial sites in the U.S. and Canada. Patients in the Tcelna arm received two course of Tcelna through the year consisting of five subcutaneous injections.
As part of the cuts, the company indicates it will have $95,000 of incremental aggregate cash charges. Opexa also indicates that more restructuring will take place by the end of the year.
The company’s chief development officer, Donna Rill, has resigned, effective November 4. In addition, Scott Seaman, a member of the Opexa’s board of directors, has resigned.
“This reduction in force is a difficult but necessary step as a result of the disappointing results of our lead product candidate, Tcelna, announced last week,” said Neil Warma, Opexa’s president and chief executive officer, in a statement. “I would like to personally express my appreciation to each of the employees impacted by this decision for their commitment to Tcelna and Opexa. The Opexa team has endeavored to increase the understanding of secondary progressive multiple sclerosis, and we hope our work will contribute to the development of a safe and effective therapy for this devastating disease. I would also like to thank Scott Seaman for his long-time service as a Director of Opexa and note our special heartfelt appreciation of Donna Rill who has dedicated over 15 years to Opexa.”
Opexa took a huge hit. Shares traded on August 13 for $4.69, drifted to $3.96 on October 10, and were trading for $3.35 on October 26 before the news broke. Shares are currently trading for $0.71.
CNA Finance ran a lengthy article on Monday questioning whether the company can survive. At June 30, at the end of the second quarter, the company had about $7.8 million in cash and cash equivalent, but was spending about $2.7 million per quarter. That suggests it has about $4 million on hand at the moment.
“Given the weak tone and guidance by OPXA management on Friday,” CNA wrote, “the company appears to be rudderless as it evaluates options, and, with no emerging clinical candidate to market to interested investors, Opexa might be left to wind down operations and leave the scraps to a company like Merck , who might be able to salvage at least some of the safety and tolerability data for future studies. At best, though, the value to OPXA stock will be minimal.”