Helmed by Roche alums, Newleos Therapeutics is taking over four drugs dropped from the Swiss pharma’s pipeline in early 2024.
Newly launched Newleos Therapeutics has secured $93.5 million in series A funds with a plan to develop four cast-off drugs from Roche’s neuropsychiatric division.
All four drugs, now out-licensed to Boston-based Newleos, were put through at least Phase I clinical trials by Roche before being axed almost exactly one year ago in February 2024. The company launched Thursday with the fundraising announcement.
“After COVID, there were high rates of depression around the globe, and we have been thinking about how to make an impact in the neuro space,” David Donabedian, president and board member at the new company told BioSpace.
The Roche connection and licensing deal were facilitated by personal connections with the company—both Donabedian and Chief Medical Officer Federico Bolognani are Roche alums, and Bolognani and another co-founder, William Martin, bring prior CNS drug development experience.
“Developing drugs in neuropsychiatry is a little different than in other spaces,” Bolognani told BioSpace. “You need people who have done it before, and we’ve got people who’ve been doing it for a long time.”
Newleos’ lead molecule is NTX-1955, a GABAA-γ1 selective positive allosteric modulator for the treatment of anxiety, targeting receptors in the amygdala. It’s structurally related to benzodiazepines, which also target GABA receptors in the brain.
The issue with benzodiazepines is that they also target unrelated GABA receptors in other parts of the brain and the whole body, which creates a suite of safety and abuse issues. NTX-1955, according to Newleos, can potentially avoid those problems by targeting an amygdala-specific subunit of GABA receptors without affecting the rest of the brain or body.
“Roche was the first to invent [benzodiazepines] in the 1950s,” Bolognani said. “They eventually exited that space, then came back 10 years ago looking for the next benzo,” before exiting the whole treatment area when drugs started missing endpoints in clinical trials.
Because Roche had already put years of work into these molecules, the Newleos team is betting that they can generate data quickly. The $93.5 million gives them a two-and-a-half-year runway, with Phase II data from all four drugs expected by fall 2027.
“These are not the typical assets you might see in a biotechnology startup,” Bolognani said, in comparison to startups launching with molecules still in preclinical trials.
Another drug in Newleos’ pipeline is basmisanil, another GABA modulator that Roche dropped after trialing it for ischemic stroke and schizophrenia. Newleos hopes to try again with basmisanil in schizophrenia, along with Down syndrome.
Newleos is also testing NTX-2001, a TAAR1 agonist meant to block dopamine release and used to treat substance abuse disorders to curb cravings.
“Dopamine is involved in all addictions, not just tobacco or alcohol, but even things like food addiction,” Bolognani said.
The company’s final drug is NTX-1472, a V1a antagonist for social anxiety, which Newleos stressed is different from a Roche molecule, balovaptan, dropped last year.
Thursday’s series A raise was led by Goldman Sachs Alternatives with additional funds from Novo Holdings A/S, Longwood Fund, DCVC Bio and Arkin Bio Capital. The company was founded by Longwood—where Donabedian was a partner—along with Newleos co-founders Christoph Westphal, Miguel Sobral and Rob Hadfield.
When asked if Newleos had any plans for further investment rounds before the end of their runway around fall 2027, Donabedian said, “The series A is already oversubscribed, but we’re always looking and always talking to investors.”
