- Looking to shore up cash for the potential commercialization of its lead candidate, Trevena Inc. has decided to stop early-stage research efforts and layoff 30% of its workforce. The job cuts will affect 21 full time employees — including the Trevena's Chief Scientific Officer Michael Lark, who is slated to leave in mid-December.
- The "re-positioning" should save the Pennsylvania-based biotech $40 million in operating expenses over the next three years, according to a Wednesday announcement. The company intends to file its pain medication Olinvo for approval later this month, and plans on using that freed up cash for the drug's regulatory and marketing costs.
- Trevena has two other clinical-stage pain therapies in its pipeline: TRV734 and TRV250. The company will review options for TRV250 after it caps off a Phase 1 study testing the drug as a treatment for acute migraine.
Investors haven't been too keen on Trevena in recent years. Its stock opened at $2 per share on Thursday, down nearly 16% from the prior day's close. Shares traded at roughly the same price on Friday morning, and have fallen about 34% year-to-date.
At least part of that decline stems from the progress of Olinvo (oliceridine injection), a treatment for moderate-to-severe pain in patients who received surgery for bunion removal or abdominoplasty.
While Trevena has touted Phase 3 data showing drug's efficacy across multiple doses, safety remains a big concern. For example, there were two serious adverse events in the experimental arm of the APOLLO-2 study, which enrolled healthier patients.
Trevena is currently recruiting patients for the late-stage ATHENA-1 study who have moderate to severe pain caused by medical conditions or surgery and who need intravenous opioids, patient-controlled analgesia or both.
"In APOLLO, these patients are essentially healthy volunteers who are having surgery, and so the more fragile patients — patients with higher [body mass indices] with multiple risk factors and so forth — will really come from the ATHENA data set," David Soergel, Trevena's recently departerd chief medical officer, said back in February.
Surely amplifying safety concerns is the opioid epidemic sweeping across the U.S. As more and more lives are lost to prescription pain killer overdoses, state and federal officials have pursued greater restrictions on development and manufacturing of opioid-based products.
Even against that backdrop, Trevena remains faithful to its lead candidate.
"After a thorough review of our portfolio, we have decided to reduce our capital needs and focus our resources on the future approval and commercialization of Olinvo, which we believe will be an important new option for physicians and patients. As part of this plan we made the very difficult, yet necessary, decision to reduce our work force," Trevena CEO Maxine Gowen said in an Oct. 11 statement.
Regarding the job cuts, Trevena anticipates spending $1.7 million in cash for severance costs and related expenses and $2 million overall. The company had $76.7 million in cash, cash equivalents and marketable securities as of Sept. 30, which it believes should finance its operations into the fourth quarter of 2018, according to the statement.