PHARMATHER HLDGS LTD - PHRRF STOCK NEWS

PharmaTher Holdings Ltd. (OTCQB: PHRRF) reported a total of nearly $12 million in cash and investments as of February 28, 2022, ensuring full funding for ongoing development programs focused on ketamine products targeting mental health and pain disorders. Key highlights include progress towards FDA approval for KETARX™, a ketamine injection product, and successful clinical studies evaluating its microneedle patch and other formulations. The Company aims to lead in advancing ketamine therapeutics and plans to submit regulatory applications by the end of 2022.

PharmaTher Holdings Ltd. announced its plan to file ANDA and 505(b)(2) submissions with the FDA for innovative ketamine formulations aimed at mental health and neurological disorders. The company secured an exclusive license agreement with Gesval S.A. for a patented continuous-flow technology to enhance ketamine production efficiency. The company aims to launch its Ketamine Injection product and address various medical needs, including future pivotal studies for Parkinson's and ALS. Notably, PharmaTher's strategy includes partnerships for secure cGMP ketamine supply and novel dosage forms.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced positive topline results from its ketamine study for treating levodopa-induced dyskinesia in Parkinson's disease. The study found that 100% of patients treated showed a reduction in dyskinesias, and ketamine was well tolerated with no serious adverse events reported. These results support the preparation for a Phase 3 clinical study aimed at FDA approval of KETARX™ under the 505(b)(2) pathway. The global market for Parkinson's disease is projected to grow significantly, indicating potential commercial opportunities.

PharmaTher Holdings Ltd. announced the grant of U.S. Patent No. 11,213,495 for its KETABET™ formulation, combining FDA-approved ketamine with betaine anhydrous. This patent enhances the antidepressant effects while potentially reducing ketamine's side effects. The patent strengthens PharmaTher's intellectual property and global portfolio, with similar patents in Japan and Taiwan. The company plans to advance KETABET™ in Phase 2 clinical studies based on ongoing research. The patent protection for KETABET™ is expected to last until 2036.

PharmaTher Holdings Ltd. announced that the FDA granted Orphan Drug Designation for its ketamine product to treat Status Epilepticus (SE), a severe neurological condition requiring emergency treatment. This marks the third orphan designation for ketamine, adding to its portfolio for treating amyotrophic lateral sclerosis and complex regional pain syndrome. SE affects approximately 120,000-180,000 individuals annually in the U.S., with a mortality rate of 17%. Orphan status grants benefits including seven years of marketing exclusivity and potential tax credits.

PharmaTher Holdings Ltd. announced that the FDA has accepted its IND application to initiate a Phase 2 clinical trial for ketamine in treating Amyotrophic Lateral Sclerosis (ALS). Conducted at the University of Missouri and led by Dr. Richard Barohn, this trial will include 36 participants and evaluate ketamine's safety and efficacy over 24 weeks. Following positive results, the company plans to meet with the FDA to discuss progression to Phase 3 trials. With ALS affecting around 50,000 individuals annually in the U.S. and Europe, ketamine may offer a new therapeutic avenue for this challenging condition.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced the publication of a study validating the efficacy of KETABET™, a combination of ketamine and betaine, in mitigating adverse psychiatric effects from ketamine in treating depression and chronic pain. The study, published in Biomedicine & Pharmacotherapy, suggests that betaine can protect against cognitive deficits associated with repeated ketamine use. With patent protection until 2036, PharmaTher aims to advance KETABET™ into Phase 2 clinical studies in H2-2022.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) focuses on specialty ketamine-based products. In 2022, it plans to initiate Phase 3 clinical studies for treating Parkinson's disease (KETLID), complete Phase 2 studies for ALS (KETALS), and develop a ketamine microneedle patch (KETAPATCH). Additionally, the company anticipates FDA approval for its Ketamine Hydrochloride Injection (KETARX). Key partnerships and exclusive licenses with universities strengthen its treatment pipeline, aiming to enhance therapeutic options for mental health and neurological disorders.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has entered a process development agreement with LTS LOHMANN Therapie-Systeme AG for the clinical trial scale-up of its proprietary Ketamine microneedle patch. The partnership aims to advance the development and non-commercial manufacturing of this innovative drug delivery system, targeting neuropsychiatric and pain disorders. The microneedle patch, developed with Queen’s University of Belfast, promises efficient delivery of ketamine and will support upcoming FDA and EMA submissions. PharmaTher plans to initiate Phase 1/2 clinical studies in 2022.