Neumora has 'inbound interest' as new CEO, depression data and phase 3 plans chart busy course

Less than two years since formally launching, Neumora is riding new phase 2 data and hundreds of millions in cash reserves toward a trio of phase 3 trials, a possibly tantalizing bundle for a pharmaceutical company looking to blast into the neuroscience space.

When asked whether the company has received interest in acquiring phase 3-ready major depression med navacaprant, or even the company as a whole, outgoing CEO and soon-to-be Executive Chairman Paul Berns originally had no comment. But that wasn’t his final answer.

“I think when a company has made as much progress as we have, and you have the diversity of the pipeline we have, of course, we have had an inbound interest,” Berns said in an interview with Fierce Biotech. But he couched that prospect by saying the biotech is able and willing to press ahead on its own given the financial and clinical momentum at its back.

The source of that newfound momentum is phase 2 data released Tuesday demonstrating that navacaprant improved symptoms in patients with moderate to severe major depression. Symptoms were measured by the 17-item Hamilton Rating Scale for Depression, showing a three-point reduction compared to placebo at four weeks after treatment and a 2.8-point reduction at Week 8. The drug had more mixed results as a treatment for anhedonia, a condition that reduces the ability to experience pleasure, with a reduction on a related scale that was not statistically significant at Week 4 but was statistically significant at Week 8. 

Bill Aurora, Neumora’s chief development officer, said at least a two-point placebo-adjusted change typically corresponds to clinical benefit. 

“So from the data that we've generated, we believe there's the opportunity to demonstrate, not just clinical benefit in treating major depressive disorder symptoms—core features—but anhedonia,” he said. Aurora also highlighted the drug’s safety profile, with fewer treatment-emergent side effects in the treatment arm versus placebo and no serious treatment-emergent side effects reported among patients who received navacaprant. 

Following what the biotech described as a “successful” end-of-phase-2 meeting with the FDA last month, Neumora is preparing to kick off a trio of replicant phase 3 trials, with one slated to start each quarter for the next three quarters. These studies will assess the impact of navacaprant using the Montgomery–Åsberg Depression Rating Scale, the same measure used (PDF) by Axsome Therapeutics in the major depression trial for now-approved Auvelity. Neumora's top brass is confident that switching up the scale used to measure symptoms won’t veer the drug off an approval pathway.

Leading the company through this period of hyperactivity will be incoming CEO Henry Gosebruch, former chief strategy officer at AbbVie. His experience shaping the Big Pharma's 10,000-foot view is likely to come in handy as Neumora, armed with $400 million as of the end of last year, heads into more trials and considers external interest.

What remains to be seen is how Neumora raises more money. Well-capitalized biotechs with a late-stage asset have been the crème de la crème of potential Wall Street arrivals, with the public market’s frosty conditions finally thawing this year. Gosebruch knows that well, as he was named to Acelyrin's board of directors about a month before the company went public. 

So will Neumora also head for an IPO? Chief Financial Officer Joshua Pinto, Ph.D., wouldn’t commit either way.

“You’ll kind of see us continue to look at financing alternatives in an opportunistic manner,” said Pinto. But the CFO emphasized that, for now, the company has plenty of cash to see its phase 3 ambitions to completion.