PharmaTher Holdings Ltd.( OTCQB: PHRRF | CSE: PHRM), a specialty pharmaceutical company focused on developing and commercializing novel uses and delivery forms of ketamine to treat mental health, neurological and pain disorders, today released business highlights and audited financial results for its fiscal year ended May 31, 2022. All amounts in this press release are in Canadian dollars.
“We had achieved important clinical and business milestones that will pave the way for PharmaTher to potentially become a commercial-stage company in 2023. With a little over $12 million in cash and investment on our balance sheet, we are in a strong position to advance our ketamine-based clinical development and commercial programs to treat mental health, neurological and pain disorders. To support our commercial objectives, we aim to file abbreviated new drug applications with the FDA for our ketamine injectable products for anesthesia and procedural sedation. We expect to obtain FDA approvals by 2H-2023. Our clinical development objectives for the next twelve months include obtaining FDA agreement to conduct a potential Phase 3 clinical trial evaluating ketamine for Parkinson’s disease, present results from the Phase 2 clinical trial evaluating ketamine for Amyotrophic Lateral Sclerosis, present clinical study results in depression and pain with our ketamine microneedle patch and ketamine wearable pump device, and partner with pharmaceutical companies for our ketamine products, drug delivery systems and clinical programs. Finally, I like to thank the PharmaTher team, our Board of Directors and our shareholders for supporting our objective in unlocking the therapeutic potential of ketamine for unmet medical needs.”Fabio Chianelli, Chief Executive Officer of PharmaTher
Cash and cash equivalents ($9,154,906) and Investment ($2,966,667) for a total of $12,121,573 as of May 31, 2022.
- Presented Late-Breaking Abstract Presentation of Positive Efficacy and Safety Data from Phase 1/2 Clinical Study of Ketamine in the Treatment of Levodopa-Induced Dyskinesia in Parkinson’s Disease at the MDS International Congress.
- Granted FDA Orphan Drug Designations For Ketamine To Treat Complex Regional Pain Syndrome and Status Epilepticus.
- Completed IND-Enabling Pharmacokinetic and Tolerability Study with Ketamine Microneedle Patch.
- Engaged CCBIO to Develop and Commercialize Novel Ketamine Wearable Delivery Device.
- Received FDA Approval of Investigational New Drug Application for Ketamine to Treat ALS.
- Entered into Process Development Agreement with LTS Lohmann for Ketamine Microneedle Patch.
- Presented Positive Research Results for LSD Microneedle Patch and Psilocybin Microneedle Patch.
- Engaged Alcami for Clinical and Commercial Manufacturing for Ketamine.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. is a specialty pharmaceutical company focused on developing and commercializing novel uses and delivery forms of ketamine to treat mental health, neurological and pain disorders. PharmaTher’s product portfolio consists of KETARX™ (ketamine) delivered by intravenous injection, intradermal microneedle patch, and subcutaneous pump administration.