Newleos secures US $93.5M to advance dropped Roche neuropsychiatric drugs

USA – Newleos Therapeutics, a newly launched biotech company, has raised US $93.5 million in Series A funding to develop four neuropsychiatric drugs that were previously discontinued by Roche.

These drugs had already progressed through at least Phase I clinical trials before Roche removed them from its pipeline in February 2024.

The Boston-based company officially launched with the funding announcement and is led by former Roche executives with extensive experience in CNS drug development.

Chief Medical Officer Federico Bolognani and co-founder William Martin bring years of expertise in neuropsychiatry, which Bolognani emphasized is a highly specialized field requiring experienced teams.

“Developing drugs in neuropsychiatry is a little different than in other spaces,” he told BioSpace. “You need people who have done it before, and we’ve got people who’ve been doing it for a long time.”

Aiming for safer anxiety treatments

The lead drug in Newleos’ pipeline, NTX-1955, is a GABAA-γ1 selective positive allosteric modulator being developed for anxiety. It works by targeting receptors in the amygdala, the brain region linked to fear and stress.

Unlike traditional benzodiazepines, which act on GABA receptors throughout the brain and body—leading to safety concerns and potential abuse—NTX-1955 focuses specifically on a subunit in the amygdala, potentially reducing side effects.

Bolognani highlighted Roche’s long-standing involvement in this area, stating, “Roche was the first to invent [benzodiazepines] in the 1950s.

They eventually exited that space, then came back 10 years ago looking for the next benzo.” However, Roche withdrew from the area again after some drug candidates failed to meet clinical trial endpoints.

Expanding the pipeline for neuropsychiatric disorders

Newleos’ pipeline includes three additional drugs with promising applications:

• Basmisanil – Another GABA modulator, initially tested by Roche for ischemic stroke and schizophrenia. Newleos plans to investigate its use in cognitive impairment for rare neurodevelopmental disorders such as dup15q11 syndrome.
• NTX-2001 – A TAAR1 agonist designed to block dopamine release, which could help treat substance use disorders by curbing cravings. “Dopamine is involved in all addictions, not just tobacco or alcohol, but even things like food addiction,” Bolognani explained.
• NTX-1472 – A V1a antagonist aimed at treating social anxiety. The company clarified that it is distinct from Roche’s balovaptan, another V1a antagonist that was discontinued last year.

Strong backing and future plans

The Series A funding round was led by Goldman Sachs Alternatives, with additional investments from Novo Holdings A/S, Longwood Fund, DCVC Bio, and Arkin Bio Capital.

The company was co-founded by Longwood Fund members, including Christoph Westphal, Miguel Sobral, and Rob Hadfield, alongside Newleos President David Donabedian, who was previously a partner at Longwood.

With the US $93.5 million funding, Newleos expects to generate Phase II clinical data for all four drugs by fall 2027.

Since Roche had already conducted extensive research on these molecules, Newleos hopes to speed up development and bring innovative treatments to patients sooner.

When asked about potential future investment rounds, Donabedian noted that the Series A was already oversubscribed but added, “We’re always looking and always talking to investors.”