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Newleos Launches with $94M Series A and Roche's CNS Portfolio to Target Mental Health Disorders

• Boston-based Newleos Therapeutics emerges with a $94 million Series A funding round led by Goldman Sachs, acquiring Roche's CNS drug portfolio with four clinical-stage candidates.

• The company's pipeline targets significant unmet needs in mental health, including generalized anxiety disorder, substance use disorder, and cognitive impairment, affecting over 60 million U.S. adults.

• Led by industry veterans from Longwood Fund, Newleos aims to advance multiple proof-of-concept clinical trials, with their most advanced candidate already completing Phase 1 studies for a rare neurodevelopmental disorder.

A new player in the neuroscience therapeutics space emerged today as Newleos Therapeutics announced its launch with a substantial $94 million Series A financing round. The Boston-based biotech company has acquired a portfolio of central nervous system (CNS) drug candidates from Roche, positioning itself to address critical unmet needs in mental health treatment.
The funding round, led by Goldman Sachs, attracted prominent investors including Novo Holdings, DCVC Bio, and Arkin Bio Capital. This significant investment reflects growing confidence in neuroscience drug development, a field that has seen venture capital investments exceed $1.5 billion in the past year.

Strategic Pipeline Targeting Mental Health

Newleos's pipeline includes four clinical-stage drug candidates licensed from Roche, targeting conditions with substantial unmet medical needs. The compounds are designed to modulate various molecular pathways involved in neuronal communication, with applications in:
  • Generalized anxiety disorder
  • Substance use disorder
  • Cognitive impairment
  • A rare genetic neurodevelopmental disorder
The company's most advanced candidate has successfully completed Phase 1 clinical trials and is being evaluated for a rare neurodevelopmental condition, though specific details about the disorder remain undisclosed.

Leadership and Expertise

The company brings together a seasoned leadership team with extensive experience in CNS drug development and company building. Key executives include:
  • David Donabedian, CEO and Longwood Fund Executive Partner
  • William Martin, Chief Development Officer
  • Michael Miguel Sobral, Head of Strategy and Operations
  • Federico Bolognani, MD, Ph.D., Chief Medical Officer, formerly of Roche, VectivBio, and Therachon

Addressing Critical Mental Health Needs

"Anxiety and substance use disorders represent some of the most prevalent neuropsychiatric indications with high unmet need, representing over 25% of mental illnesses in U.S. adults and impacting over 60 million individuals," stated CEO David Donabedian. The company plans to utilize its capital to conduct proof-of-concept clinical trials across multiple programs.

Market Context and Industry Momentum

The launch of Newleos comes amid renewed interest in neuroscience drug development. Despite historically being considered a challenging area for drug research, the sector has seen increased venture capital activity. This trend is evidenced by recent successful fundraising rounds, including Atalanta Therapeutics' $97 million raise and Engrail Therapeutics' $157 million Series B round.
Christoph Westphal, Longwood Fund's founding partner and Newleos's executive chairman, emphasized the critical need for innovation in mental health treatments, noting that current therapeutic options fall short of meeting patient needs. With its robust pipeline and experienced leadership team, Newleos aims to address these gaps in mental health treatment options.
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