PharmaTher Provides Corporate Update on Ketamine Development and Commercial Strategy

Executive Summary

• PharmaTher sold its Abbreviated New Drug Application (ANDA #217858) for Ketamine Hydrochloride Injection USP to a global pharmaceutical partner, generating non‑dilutive capital tied only to U.S. commercial sales.
• The transaction does not include PharmaTher’s broader ketamine pipeline (Parkinson’s, ALS, CRPS, microneedle patch, wearable pump), which remains fully owned and under development.
• Over the next six months the company will pursue international partnerships, engage with the FDA on expedited pathways for CRPS and Parkinson’s programs, and position these assets for future partnership or licensing opportunities.

Key Details

• Transaction Scope: Sale of a single generic ketamine injectable ANDA; broader ketamine portfolio retained.
• Strategic Rationale: Avoids the high capital, inventory, sales‑force, and manufacturing commitments required to launch the generic product independently; leverages partner’s scale, regulatory track record, and U.S. commercial infrastructure.
• Capital Impact: Provides “potential non‑dilutive capital” linked solely to U.S. sales of the ANDA (specific amount and terms remain confidential).
• CMC Benefit: Validated Chemistry, Manufacturing & Controls package from the ANDA development can be reused for future 505(b)(2) NDAs, reducing time and cost for subsequent ketamine programs.
• Future Development: Company will continue R&D on:
• Ketamine‑based therapies for Parkinson’s disease, ALS, CRPS, mental health, neurological, and pain disorders.
• Proprietary delivery platforms (microneedle patch, wearable pump).
• Next Six‑Month Initiatives:
• Seek new global partnerships to secure additional non‑dilutive funding.
• Conduct FDA meetings to define expedited clinical/regulatory pathways for CRPS and negotiate Phase 3 design for Parkinson’s disease.
• Position CRPS and Parkinson’s programs as attractive partnership/licensing candidates, alongside the microneedle patch and pump platforms.
• Confidentiality: Specific terms of the ANDA sale (price, consideration, etc.) are being kept confidential for competitive and regulatory reasons.

Notable Quotes

“Our investment in developing the Ketamine ANDA was a strategic move, designed not only for near‑term monetization but also to establish a long‑term foundation for our proprietary ketamine pipeline.” – Fabio Chianelli, CEO

Materiality Assessment: Material – Positive** (the transaction materially alters PharmaTher’s capital structure and strategic focus while providing funding to advance its pipeline).