The PHRRF has published its financial results for the fiscal year ended May 31, 2022, which was the subject of an audit by PharmaTher Holdings Ltd.
The company, which focuses on delivering ketamine for treating mental health disorders, closed the annual period as follows:
Net loss for the year ending May 31, 2022 was $2.928. In recent months, PharmaTher has been busy with research, partnerships, pipeline development and commercialization.
In its legal search, it obtained FDA approval for its IND application for ketamine to treat amyotrophic lateral sclerosis ALS orphan drug designations for ketamine to treat complex regional pain syndrome and status epilepticus, and is currently seeking the agency s approval for its ketamine injection and infusion products for anesthesia and procedural sedation.
PharmaTher signed several development agreements. One was with CCBIO for its novel ketamine wearable delivery technology, another with LTS Lohmann for its ketamine microneedle patch and a latter with Alcami for the clinical and commercial manufacturing of ketamine.
The company has full funding for its ketamine development programs, including injection and infusion products, a microneedle patch and a wearable delivery device.
PharmaTher s CEO Fabio Chianelli believes that the company has achieved important clinical and business milestones this fiscal year, and that will lead to the company becoming a commercial-stage firm next year.
Chianelli said that in order to support the commercial objectives, the company hopes to file abbreviated new drug applications with the FDA for our ketamine injectable products for anesthesia and procedural sedation, and expect to get approvals by the second half of 2023.
The clinical development objectives for the next twelve months include obtaining FDA approval to conduct a Phase 3 trial of ketamine for Parkinson s, presenting clinical study results in depression and pain with proprietary ketamine microneedle patch and ketamine wearable pump device, as well as partnering with other pharma companies for PharmaTher's ketamine products, drug delivery systems and clinical programs.