What Newleos Therapeutics does

Newleos Therapeutics is a clinical-stage biotechnology company developing oral small molecule therapeutics for neuropsychiatric disorders. Founded in 2024-2025 by Longwood Fund alongside seasoned CNS drug development leaders, the company licensed its entire pipeline of four drug candidates from Roche's neuroscience research team. Newleos targets underserved neuropsychiatric indications including generalized anxiety disorder (GAD), social anxiety disorder (SAD), alcohol use disorder (AUD), and rare neurodevelopmental disorders such as Dup15q syndrome. The pipeline is positioned as first-in-class or best-in-class, with candidates designed to engage validated but previously inaccessible CNS mechanisms (GABAA-γ1, V1a, TAAR1, GABAA-α5) with improved selectivity to reduce side effects relative to current standard of care.

The lead clinical programs include NTX-1472, a highly selective brain-penetrant vasopressin 1a (V1a) receptor antagonist currently in Phase 2 development for SAD; NTX-1955, a GABAA-γ1 positive allosteric modulator designed to avoid the sedation, cognitive impairment, and dependence risks of benzodiazepines in GAD; NTX-2001, a TAAR1 selective partial agonist modulating dopaminergic circuits for AUD; and NTX-1511, a GABAA-α5 negative allosteric modulator for Dup15q syndrome. By early 2026 the company had dosed first participants in the SOAR Phase 2 study of NTX-1472, a U.K. Phase 1b of NTX-1955, and a Phase 1b of NTX-2001, and had secured FDA IND clearance for NTX-1472. NTX-2001 had previously been studied in eight Roche-sponsored trials involving approximately 645 participants, providing a meaningful translational data inheritance.

Newleos is pre-revenue and operates as a venture-backed private biotech headquartered in Boston. The company closed an oversubscribed $93.5 million Series A in February 2025 led by Goldman Sachs Alternatives, with participation from Novo Holdings, Arkin Bio Ventures, DCVC Bio, and Longwood Fund. Patients access the company's investigational products solely through clinical trial participation across the U.S., EU, and U.K.; the company does not offer expanded access. Future revenue is anticipated from commercialization of FDA-approved neuropsychiatric medicines through traditional pharmaceutical distribution channels, though no commercial product is currently approved and no pricing model has been disclosed.

Name

Newleos Therapeutics

Legal name

Newleos Therapeutics, Inc.

Website

https://newleos.com

Company type

Private

Founded year

2025

Operating status

Operating

Headcount range

11–50 employees

Short description

Newleos Therapeutics is a clinical-stage biotechnology company developing oral small molecule therapeutics for neuropsychiatric disorders including GAD, SAD, AUD, and rare neurodevelopmental conditions. Its four-asset pipeline, licensed from Roche, targets GABAA-γ1, V1a, TAAR1, and GABAA-α5 mechanisms with first-in-class or best-in-class potential.

Ownership category

akta.pro rank

Product category

Neuropsychiatric Pharmaceuticals

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industries

Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF), Rare Pediatric & Congenital Disorder Therapies (HLAIAIAN), Rare Neurology & Neurodegenerative Disorder Therapies (HLAIAIAD)

Keywords

• Clinical-stage biotechnology
• Neuropsychiatric drug development
• Small molecule therapeutics
• Anxiety disorder treatments
• CNS drug pipeline

Headquarters

HQ city

Boston

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain

Revenue model

1. Pharmaceutical Product Sales: Pre-revenue clinical-stage company. Future revenue anticipated from commercialization of FDA-approved neuropsychiatric medications. The company is conducting proof-of-concept clinical trials with plans to pursue regulatory approval and commercial launch.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Newleos Therapeutics is a clinical-stage biotechnology company developing a pipeline of four oral small molecule drug candidates for neuropsychiatric disorders, all licensed from Roche. The candidates target innovative mechanisms (GABAA-γ1 PAM, V1a antagonist, TAAR1 partial agonist, GABAA-α5 NAM) intended to provide first- or best-in-class treatments for generalized anxiety disorder, social anxiety disorder, alcohol use disorder, and rare neurodevelopmental conditions such as Dup15q syndrome.

Product overview

Newleos Therapeutics is a clinical-stage biotechnology company developing a pipeline of four oral small molecule drug candidates targeting innovative neuropsychiatric mechanisms of action. The company's clinical-stage pipeline includes: NTX-1955 (GABAA-γ1 PAM for generalized anxiety disorder), NTX-1472 (V1a receptor antagonist for social anxiety disorder), NTX-2001 (TAAR1 partial agonist for alcohol use disorder), and NTX-1511 (GABAA-α5 NAM for Dup15q syndrome). All programs were in-licensed from Roche and offer first- or best-in-class potential with reduced side effects compared to current standard of care.

Differentiator

Problem solved

Functional benefit

Products and services

• NTX-1955 A potential first-in-class GABAA-γ1 positive allosteric modulator (PAM) in clinical development for generalized anxiety disorder (GAD). Designed to selectively engage GABAergic transmission in the amygdala to avoid sedation, cognitive impairment, and dependence risks associated with benzodiazepines.
• NTX-1472 A potential best-in-class, highly selective, brain-penetrant vasopressin 1a (V1a) receptor antagonist in Phase 2 development for social anxiety disorder (SAD). Targets brain regions essential for social and threat processing.
• NTX-2001 A selective partial agonist of trace amine-associated receptor 1 (TAAR1) in Phase 1b development for alcohol use disorder (AUD). Modulates dopaminergic neurotransmission in addiction circuits to reduce alcohol cravings and consumption.
• NTX-1511 A selective negative allosteric modulator (NAM) of the GABAA-α5 subunit in clinical development for Dup15q syndrome, a rare neurodevelopmental disorder. Designed to reduce functional consequences of GABAA receptor gene duplication.

Quantifiable outcome

• NTX-1955 demonstrated dose-dependent anxiolytic activity matching benzodiazepine efficacy without the side effect profile in preclinical gold-standard anxiety models
• +3 more outcomes

Segments4 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• RochecoreTechnology or IntegrationLicensed the entire clinical-stage pipeline from Roche, including programs targeting GABAA-γ1 (NTX-1955), V1a (NTX-1472), TAAR1 (NTX-2001), and GABAA-α5 (NTX-1511). These were originally discovered by Roche's neuroscience research team.
• European Union Health AuthoritiescoreOthersFiled clinical trial applications with EU health authorities for two Phase 1b studies of NTX-1955 in generalized anxiety disorder. Dosing commenced for one study with EU health authority approval.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Cerevel Therapeutics: CNS-focused biotech developing therapies for schizophrenia, epilepsy, and Parkinson's disease, acquired by AbbVie for $8.7B. Highly comparable clinical-stage neuroscience pipeline with similar BD exit precedent.
• Axsome Therapeutics: Commercial-stage CNS biopharma with Auvelity (dextromethorphan-bupropion) for major depressive disorder and other neuropsychiatric programs. Direct peer in CNS specialty pharma targeting psychiatric indications.
• Sage Therapeutics: CNS-focused biopharma developing Zurzuvae (zuranolone) for postpartum depression and other neuropsychiatric indications. Comparable as a clinical-stage neurology specialty pharma with overlapping leadership talent (Tammy Phinney, Tiffany Lago came from Sage) and similar regulatory and clinical playbook.
• Karuna Therapeutics: Developed KarXT (xanomeline-trospium / Cobenfy) for schizophrenia and was acquired by Bristol Myers Squibb for $14B. Closest direct peer: clinical-stage CNS biotech with novel-mechanism psychiatry assets that achieved a major BD exit.
• Praxis Precision Medicines: Clinical-stage biotech developing precision medicines for CNS disorders including epilepsy and essential tremor. Closely comparable as a Boston-area, CNS-focused, clinical-stage biotech with similar headcount and funding profile.
• Alto Neuroscience: Clinical-stage neuropsychiatry biotech using AI-enabled biomarkers to develop precision depression and anxiety treatments. Comparable stage, mechanism-novelty, and indication overlap with Newleos's anxiety programs.
• Neumora Therapeutics: Clinical-stage neuropsychiatric biotech developing novel therapies for depression, schizophrenia, and other brain disorders with a multi-program platform approach. Comparable clinical-stage CNS portfolio model and BD exit potential.
• MapLight Therapeutics: Clinical-stage neuroscience company developing therapies for schizophrenia and other CNS disorders using novel mechanisms. Comparable as a clinical-stage CNS biotech with novel-mechanism candidates and similar funding trajectory.

Emerging players

• Rapport Therapeutics: Clinical-stage neuroscience company developing precision medicines for epilepsy and focal onset seizures. Comparable stage and CNS focus, with overlapping clinical operations and translational neuroscience expertise.
• Cybin: Clinical-stage neuropsychiatry company developing psychedelic-based therapies for depression and AUD. Adjacent peer sharing neuropsychiatric focus and clinical-stage AUD program (NTX-2001 comparable to Cybin's lead candidates); also shares Marcelo Gutiérrez as former VP Clinical Pharmacology.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/newleos-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds1 record

Investors5 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Newleos Therapeutics