Ketamine Hydrochloride

TORONTO, Aug. 14, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, announced today that Fabio Chianelli, the Company’s Founder, Chairman and Chief Executive Officer, has issued the following letter to shareholders. Dear Fellow Shareholders, Earlier this year, I wrote to you about the challenges we faced with our FDA Priority Original Abbreviated New Drug Application for our ketamine product, which we have named KETARx™. I was thrilled to receive the FDA approval letter on Friday, August 8, 2025, for KETARx™, for its use in surgical pain management (anesthesia and sedation). We proudly announced this milestone on Monday, August 11, 2025. This approval is more than just an achievement—it is a turning point. Our journey has been long, filled with determination, resilience, and belief in ketamine’s transformative potential. Now, we have not just seen the light at the end of the tunnel—we’ve stepped into it. With this success, a new era begins for PharmaTher, and I believe the opportunities ahead could be game-changing for PharmaTher, our shareholders, and most importantly, the millions of patients in need. The Road Ahead – From Approval to Impact We are moving swiftly into pre-launch commercialization of KETARx™ in the U.S. while also preparing international regulatory filings. Bringing a drug to market requires handling of many moving parts—marketing, sales, manufacturing, and global cost-optimization strategies, just to name a few. While this complexity is expected, the immediate surge of interest from specialty pharmaceutical companies—ranging from large to mid-sized industry players to niche innovators—has been nothing short of exhilarating. Partnership discussions are already underway, but make no mistake—we are also advancing our commercial plan to launch KETARx™ this year. We have a clear and scalable sales channel targeting hospitals, specialty clinics, government institutions such as the U.S. Department of Defense and Veterans Health Administration, as well as clinical research programs and support for special or expanded access programs. And this is only Phase One. Millions of surgical patients stand to benefit today, but the long-term potential for KETARx™ across other indications is vast. Unlocking the Full Power of Ketamine Our FDA approval reinforces our mission: to unlock the full pharmaceutical potential of ketamine for mental health, neurological, and pain disorders. I am especially excited about our clinical-stage programs, which include: Parkinson’s disease (treatment for levodopa-induced dyskinesia)Amyotrophic Lateral Sclerosis (ALS)Complex Regional Pain Syndrome (CRPS)A ketamine patch and wearable pump for diverse mental health and pain conditions These programs fall under the FDA’s 505(b)(2) pathway, and with the current momentum in regulatory openness toward psychedelic-assisted therapies—plus potential fast-track opportunities—we believe the landscape for ketamine innovation is only improving. While our immediate focus remains on KETARx™ commercialization, our discussions with potential partners include these pipeline programs, which could significantly expand our market reach and value creation. From Vision to Reality When I founded PharmaTher in April 2020, our vision was clear: be all-in on ketamine. That conviction has carried us through the highs and lows to this moment—FDA approval of our first ketamine product. This milestone isn’t just a win for us; it’s a validation of ketamine’s place as a transformative treatment option and a springboard into an entirely new chapter for the Company, unlocking an unprecedented array of opportunities that were once beyond our reach. We are standing at the threshold of what I believe will be a new era in medicine—one where ketamine’s proven benefits can touch millions more lives worldwide. Our commitment is unwavering: to innovate, to grow, and to deliver on the promise of ketamine to transform global health outcomes. With your continued support, I believe we will build PharmaTher into a leader in next-generation ketamine therapeutics—creating meaningful impact for patients, expanding globally, and unlocking the full potential of ketamine. The opportunities ahead are vast, the timing is perfect, and our determination has never been stronger. PharmaTher is poised for an extraordinary next chapter. Sincerely, Fabio ChianelliFounder, Chairman and CEOPharmaTher Holdings Ltd. About PharmaTher Holdings Ltd.PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on unlocking the pharmaceutical potential of Ketamine (KETARx™) for mental health, neurological, and pain disorders. For more information, visit PharmaTher.com. For more information about PharmaTher, please contact: Fabio ChianelliChief Executive OfficerPharmaTher Holdings Ltd.Tel: 1-888-846-3171Email: info@pharmather.com Website: www.pharmather.com Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release. Cautionary Statement This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “closer”, "could", “confident”, "would", "intend", "expect", "believe", "will", "projected", "estimated", "potential",”promise”, “strong”, "aim", “may”, “plan”, “proposed”, “lead”, “toward”, “anticipate”, “provide”, “position”, “leverage”, “mitigate”, “before”, “prior”, and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the three and nine months ended February 28, 2025 dated April 24, 2025, which is available on the Company's profile at www.sedarplus.ca. This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.