Mr. Fabio Chianelli reports
PHARMATHER HIGHLIGHTS STRATEGIC KETAMINE OPPORTUNITY FOLLOWING NEW U.S. EXECUTIVE ORDER ON PSYCHEDELIC TREATMENTS FOR SERIOUS MENTAL ILLNESS
Pharmather Holdings Ltd. believes the recent U.S. executive order, "Accelerating Medical Treatments for Serious Mental Illness," signed on April 18, 2026, may help create a more supportive political and regulatory backdrop for innovative ketamine-based programs, particularly where severe unmet need, depression, suicidality and other difficult-to-treat mental health conditions are involved.
"We believe the recent U.S. executive order is another signal that policy-makers are placing greater urgency on advancing new treatment options for serious mental illness," said Fabio Chianelli, chief executive officer of Pharmather. "We believe this evolving regulatory environment strengthens the strategic value of our ketamine portfolio, including our microneedle patch program, KetaVault partnership portal, retained specialty ketamine programs and our ongoing economic exposure from the prior sale of our FDA-approved ketamine ANDA."
Supportive U.S. policy momentum for serious mental illness
The executive order is focused on psychedelic drugs for serious mental illness and emphasizes accelerated research, clinical trial participation, data sharing and real-world evidence generation, including collaboration among HHS, Food and Drug Administration, the Department of Veterans Affairs, and the private sector. Pharmather believes the broader direction of U.S. policy reflects growing support for accelerating the development of important therapies for patients with severe and treatment-resistant mental health conditions. These measures could contribute to a more supportive backdrop for advancing differentiated ketamine programs, particularly in areas involving severe unmet need, mental health and veteran-focused treatment opportunities.
Re-emphasizing the ketamine patch opportunity
Pharmather believes its ketamine microneedle patch program could represent an important differentiated opportunity within this evolving environment. The company has previously reported completion of an investigational-new-drug-enabling pharmacokinetic and tolerability study for its ketamine patch, and has described the program as part of its broader effort to develop patient-friendly ketamine delivery options across mental health, neurological and pain disorders. Pharmather believes a patch-based approach could offer strategic life cycle value through controlled and sustained delivery, reduced treatment burden, and broader commercial flexibility.
FDA-approved ketamine foundation provides continuing upside
In addition to its proprietary development programs, Pharmather believes its prior FDA approval for its generic ketamine (ANDA No. 217858) remains strategically important. The company previously sold its U.S. ketamine ANDA to a sterile-injectables pharmaceutical company and disclosed that the transaction could generate more than $25-million (U.S.) over time, subject to commercial performance, including milestone and profit-sharing payments. Pharmather believes that the transaction provides economic participation in the U.S. ketamine market while avoiding the capital requirements, inventory burden and commercial infrastructure needed to launch a generic injectable product independently.
Broader ketamine portfolio remains in place
Pharmather has stated that the ANDA sale did not include its broader ketamine portfolio and that the company continues to own its ketamine-based programs for Parkinson's disease, amyotrophic lateral sclerosis and complex regional pain syndrome, as well as its ketamine microneedle patch program. While these neurological and pain programs are separate from the executive order's specific focus on serious mental illness, Pharmather believes they remain important long-term assets within its broader ketamine strategy and could continue to benefit from increasing strategic and commercial interest in differentiated ketamine development.
KetaVault strengthens Pharmather's partnership and platform value
Pharmather believes KetaVault strengthens its ketamine platform by offering a proprietary portal to proprietary ketamine data (including INDs, CMC and clinical data) for pharmaceutical, biotech, academic and government entities. This portal could accelerate partnerships and commercial planning across mental health, neurology, pain and other ketamine opportunities. With increasing policy focus on serious mental illness, Pharmather believes its differentiated delivery technology, retained ketamine rights, regulatory experience and partnership-enabling platforms such as KetaVault position it well to advance its ketamine programs through internal development, strategic collaborations and regulatory engagement.
About Pharmather Holdings Ltd.
Pharmather is a specialty pharmaceutical company focused on developing, acquiring, and commercializing pharmaceutical products and enabling technologies.
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