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PharmaTher Holdings Ltd. (OTCQB: PHRRF) is a biopharmaceutical company focused on the development and commercialization of KETARX™ (Ketamine) to address global unmet medical needs for anesthesia, sedation, pain, mental health, and neurological indications. The company also owns 49% of Sairiyo Therapeutics Inc., which is advancing the clinical development of an improved enteric-coated orally bioavailable formulation of cepharanthine (PD-001) for treating responsive cancers and infectious diseases, including COVID-19.
PharmaTher Holdings Ltd. has initiated the KET-LID Phase 2 clinical trial to evaluate the safety and efficacy of ketamine for treating levodopa-induced dyskinesia in patients with Parkinson's disease. Patient screening begins in October 2021, with data expected by late-Q4 2021. The study is randomized, double-blind, and active placebo-controlled, focusing on several primary endpoints related to dyskinesia symptoms. If successful, PharmaTher plans to discuss moving to Phase 3 under the 505(b)2 regulatory pathway in 2022.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has appointed Dr. Thomas Laughren as a Regulatory Affairs Advisor to assist in regulatory matters concerning KETABET™, a novel formulation combining FDA-approved ketamine and betaine for treating neuropsychiatric disorders. Dr. Laughren, with 29 years of experience at the FDA, will help finalize the IND application for a Phase 2 study on KETABET™ targeting depression. The treatment aims to mitigate major depressive disorder symptoms in over 300 million people globally, potentially enhancing ketamine's efficacy while reducing its side effects.
PharmaTher Holdings Ltd. has successfully closed a private placement with institutional investors, raising CAD$10 million. The Company issued 15,625,000 common shares and warrants at CAD$0.64 per share, with each warrant allowing the purchase of one share at CAD$0.80 over five years. Proceeds will fund the development of its microneedle patch program and proprietary ketamine product. The placement agent, H.C. Wainwright & Co., received an 8% commission and warrants. Securities are restricted in the U.S. and not registered under U.S. laws.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) is now part of the North American Psychedelics Index, included in the Horizons Psychedelic Stock Index ETF (NEO: PSYK). This Index focuses on public companies in the psychedelics sector and aims to reflect the industry's evolution. CEO Fabio Chianelli stated that this inclusion enhances investor awareness and boosts confidence in PharmaTher's business model, which emphasizes research and development of ketamine treatments for mental health and neurological disorders. The Index is regularly rebalanced quarterly.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced significant advancements in its clinical pipeline, including a Phase 2 study using ketamine for Parkinson's disease, with 10 U.S. clinical sites selected. The IND for KETABET™, aimed at treating depression, is set for submission in October 2021. Additionally, the company completed its Phase 2 protocol for ALS treatment and is developing microneedle patches for psychedelics. With FDA approvals and a focus on commercialization in 2022, PharmaTher is positioned as a leader in psychedelic therapies.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. CEO Fabio Chianelli will present updates on the company’s FDA Phase 2 clinical studies involving ketamine for conditions like Parkinson’s disease and treatment-resistant depression. The firm is also developing microneedle patches for psychedelic delivery. This presentation will be available to registered attendees for on-demand viewing starting 7:00 AM EST on September 13.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) released its fiscal year results for 2021, highlighting innovative developments in psychedelic therapies. The company solidified four exclusive licensing agreements for ketamine treatments, particularly in Parkinson’s disease and ALS. A key achievement was the FDA approval for a Phase 2 clinical trial on ketamine's efficacy for levodopa-induced dyskinesia. Financially, the company reported net losses of $2.66 million with cash reserves of approximately $5.88 million.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has received FDA orphan drug designation for ketamine as a potential treatment for Amyotrophic Lateral Sclerosis (ALS). This significant milestone allows the company to advance to a Phase 2 clinical study in the U.S. CEO Fabio Chianelli emphasized that this validation expedites regulatory and product development plans. With approximately 50,000 ALS patients in the U.S. and a lack of effective treatments, ketamine’s neuroprotective properties could be pivotal. The designation also offers financial incentives and seven years of marketing exclusivity upon regulatory approval.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) has filed a provisional patent for a novel ketamine formulation aimed at intradermal administration, expanding its intellectual property portfolio to 19 patents across over 150 countries. The innovative delivery method bypasses skin barriers, potentially enhancing bioavailability and reducing irritation. CEO Fabio Chianelli highlighted the company's commitment to developing prescription-based ketamine products. PharmaTher's pipeline includes FDA-approved studies for treating Parkinson's disease and novel microneedle patches for psychedelic delivery.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) announced CEO Fabio Chianelli's participation in the Grizzle Psychedelics Con on June 28, 2021, at 12 PM ET. Chianelli expressed enthusiasm for this virtual conference aimed at investors interested in psychedelics, highlighting PharmaTher's promising product pipeline, including an FDA Phase 2 study of ketamine for Parkinson’s disease and a microneedle patch for delivering psychedelics for mental health and pain disorders. The event will also be available for later viewing.
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