PharmaTher Holdings Ltd. PHRRF has published its operational and audited financial results for fiscal year ended May 31, 2022.
The company, which focuses on delivering ketamine for treating mental health disorders closed the annual period as follows:
Cash and cash equivalents totaled $6.684.912, compared to $2.028.554 as of May 31, 2022.
Investment reached $2.166.260, somewhat less than the gathered $2.263.620 as of May 31, 2021.
R&D annual expenses for a total of $1.902.274, an almost 250% increase of the $548.770 yearly invested in the prior period.
Net loss for the annual period ending May 31, 2022, was $2.928.566.
As for research, partnerships, pipeline development and commercialization, PharmaTher has stayed quite busy in recent months.
The company presented positive efficacy and safety data from its Phase 1/2 clinical trial of ketamine as treatment of levodopa-induced dyskinesia in Parkinson’s disease as well as for its IND-enabling study of proprietary LSD and psilocybin microneedle patches.
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.
Lastly, 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 also achieved 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 the company has achieved important clinical and business milestones this fiscal year, and that will pave the way towards becoming a commercial-stage firm next year.
Chianelli explained that in order to support the commercial objectives, the company aims “to file abbreviated new drug applications with the FDA for our ketamine injectable products for anesthesia and procedural sedation,” expecting to get the approvals by the second half of 2023.
PharmaTher’s clinical development objectives for the next twelve months include obtaining FDA green light to conduct a Phase 3 trial studying ketamine for Parkinson’s, presenting results from the Phase 2 trial of ketamine for Amyotrophic Lateral Sclerosis (ALS), 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.
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