PharmaTher Provides Update on FDA New Drug Application for Ketamine

PharmaTher expects to submit the MINOR AMENDMENT to the CRL by end-February 2025 and expects a new approval date for a Q2-2025 FDA approval of ketamine

TORONTO, February 12, 2025 -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company seeking FDA approval for ketamine, today announced that the Company is on track to resubmit information to the FDA by end-February 2025. This resubmission, which addresses the deficiencies classified as MINOR in the complete response letter (“CRL”) provided by the FDA dated October 22, 2024, is a significant step towards obtaining FDA approval. The Company expects to receive a new approval date for a Q2-2025 FDA approval.

As noted by the FDA in the CRL, the resubmission to this CRL will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested.

PharmaTher is fully committed to the potential of ketamine and is dedicated to its development and approval.

With pending FDA approval for ketamine on the horizon, the Company remains focused on its mission to be a leading innovator and provider of ketamine to treat unmet medical needs. It is well-known that ketamine is an essential medicine used for anesthesia and analgesia (pain relief) and has been used as a sedative and painkiller in hospital settings. Outside of the FDA and Health Canada approved indications, ketamine is also being administered in hospitals and clinics to treat various mental health, neurological and pain disorders. The potential of ketamine to make a significant impact on patient lives is immense. PharmaTher, with its innovative approaches and commitment to patient care, is poised to play a pivotal role in making ketamine available to millions of people globally.

PharmaTher is committed to keeping stakeholders informed and will continue to provide updates as they occur.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of KETARX™ (Ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, neurological, and medical countermeasures indications. Learn more at PharmaTher.com.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

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