Investors & Partners

Strategic partnership opportunities in clinical-stage CNS therapeutics

Investment Highlights

FDA IND Cleared

Phase 1-ready CNS asset

~$7M USD

Discovery to IND clearance

Schedule IV

Regulatory pathway potential

~2042

Patent protection expected, including potential PTE

Asset Profile and Regulatory Position

PRX-P4-003 is a new chemical entity (NCE) available for strategic partnership. It delivers the active isomer of fencamfamine — a DEA-listed Schedule IV substance with a lower abuse profile than Schedule II stimulants such as methylphenidate and amphetamine, made further abuse-resistant through our gut-specific prodrug activation technology. Fencamfamine has several decades of prior clinical use experience but has never previously been approved for ADHD or apathy indications.

Authoritative records (DrugBank, PubChem, WHO ECDD) confirm fencamfamine's historical commercial exit reflected a manufacturer portfolio decision, not safety, dependence, or abuse concerns.

Capital-Efficient Development

Praxis Bioresearch advanced PRX-P4-003 from discovery to FDA IND clearance at under $7M USD — a fraction of the industry-standard cost (~$30M average) — through in-house innovation, focused execution, and non-dilutive funding support. This model is designed to maximize program value while reducing early development cost and timeline risk.

For qualified partnership discussions, Praxis can provide diligence materials, including access to the PRX-P4-003 Virtual Data Room (VDR) and IND package summary. Please contact us to request materials or schedule a technical discussion with Dr. Sandeep Patil.

Market Opportunity at a Glance

ADHD

  • Adults now drive the U.S. ADHD population: ~15.5M adults vs ~7M children diagnosed (CDC MMWR, Oct 2024) — roughly a 2:1 adult-to-pediatric ratio
  • Adult diagnoses rose ~15% from 2020–2023; pediatric incidence remained stable
  • Only ~33% of U.S. adults with ADHD filled a stimulant in the past 12 months (CDC MMWR, Oct 2024)
  • Among adults on stimulants, 71.5% reported difficulty filling prescriptions due to unavailability (CDC MMWR, Oct 2024)
  • US adult societal cost: ~$123B/year (~$156B combined across all ages)

PRX-P4-003 advances a Schedule IV-pathway alternative designed to reduce these access constraints in an adult-driven market.

See ADHD market detail →

Apathy in Alzheimer's Disease

  • Affects up to ~70% of AD patients (range 26–82%)
  • ~17–24 million globally living with apathy in AD
  • No FDA-approved therapy currently exists
  • Apathy adds ~$4.5B annually in additional US dementia-care costs (conservative estimate)

PRX-P4-003 is being developed as a first-in-class apathy treatment.

See AD apathy market detail →

Additional indications under exploration: apathy in Frontotemporal Dementia and post-TBI cognitive deficits.

For Qualified Partners

Praxis Bioresearch offers qualified partners structured access to:

  • PRX-P4-003 Virtual Data Room (VDR)
  • IND package summary
  • Executive briefing with Dr. Sandeep Patil
Request Partnership Access