Mr. Fabio Chianelli reports

PHARMATHER ENTERS INTO COLLABORATION AGREEMENT FOR KETAMIST(R) TO ADVANCE NEEDLE-FREE KETAMINE TREATMENT TOWARD FDA APPROVAL

Pharmather Holdings Ltd. has struck a collaboration with Curtis W. Cassidy, MD, the inventor and developer of KetaMist, a needle-free ketamine treatment platform, to pursue U.S. Food and Drug Administration (FDA) approval for treatment-resistant depression (TRD) and other neuropsychiatric and medical conditions where ketamine has demonstrated therapeutic benefit.

KetaMist is a proprietary, patient-controlled and needle-free ketamine treatment platform developed by Dr. Cassidy for patients with treatment-resistant depression and other conditions. According to Dr. Cassidy, KetaMist has been used in more than 9,000 patient treatments, creating a meaningful body of real-world clinical experience that Pharmather believes may support an efficient and potentially expedited FDA development strategy.

Targeting the large and growing TRD market while building a ketamine franchise

Treatment-resistant depression represents a significant unmet medical need, affecting millions of patients in the United States who do not respond adequately to standard antidepressant therapies. The current FDA-approved ketamine-based therapy for TRD, Spravato (esketamine nasal spray), has demonstrated strong commercial traction, generating approximately $1.7-billion in worldwide sales in 2025, with trailing 12-month sales through June 30, 2026, of approximately $2.0-billion. Analysts have reportedly projected that Spravato could generate approximately $3-billion in annual sales by 2027 and up to $5-billion in peak annual sales, highlighting the significant commercial opportunity for differentiated ketamine-based treatments.

Pharmather believes KetaMist has the potential to compete in this large and growing market by offering a differentiated treatment approach that may address certain limitations associated with existing therapies.

KetaMist is designed as a patient-controlled and needle-free delivery system, which may offer several potential advantages, subject to FDA approval:

• Personalized dosing and administration, allowing physicians to tailor treatment to individual patient response;

• Simplified delivery method, potentially improving patient comfort and accessibility;

• Potential for broader clinical adoption, depending on regulatory requirements and labelling;

• Use of racemic ketamine, which may provide a differentiated pharmacological profile compared with esketamine.

Beyond TRD, Pharmather views KetaMist as a franchise platform with the potential to be developed across multiple indications where ketamine has already demonstrated clinical utility, including but not limited to depression, anxiety disorders, posttraumatic stress disorder (PTSD), chronic pain, and other neuropsychiatric and neurological conditions. While many of these uses are currently off-label, the company believes KetaMist's flexible and personalized delivery approach may support expansion into additional therapeutic areas over time, subject to regulatory approval.

A potentially expedited path toward FDA approval

Pharmather and Dr. Cassidy plan to work with the FDA to find an efficient path to approval for KetaMist.

Because ketamine is already an FDA-approved drug, the company may be able to build on existing knowledge. KetaMist has already been used in more than 9,000 patient treatments, providing real-world experience on how the therapy is administered, how patients respond, and overall safety. Pharmather will prepare regulatory documents to help guide discussions with the FDA toward a potentially expedited approval pathway.

Leveraging Pharmather's FDA-approved ketamine foundation

Pharmather previously obtained FDA approval for ketamine hydrochloride injection USP under ANDA No. 217858, demonstrating the company's ability to complete the regulatory, manufacturing, analytical and quality requirements necessary to secure an FDA ketamine approval.

Although Pharmather completed its sale of its ANDA in December, 2025, the company retained its rights to pursue non-generic ketamine opportunities, including new formulations, delivery technologies and therapeutic indications. Pharmather also retained significant regulatory and product-development experience generated through the successful ANDA program.

As part of the KetaMist collaboration, Pharmather intends to apply its ketamine regulatory, analytical and chemistry, manufacturing, and controls experience to the KetaMist development program and seek FDA feedback on the most efficient pathway toward approval.

Positioned at the intersection of Ketamine, personalized medicine and regulatory momentum

The collaboration follows Pharmather's recently announced strategy to advance personalized medicines for peptides and psychedelics through differentiated products, enabling technologies and regulatory pathways.

The program arrives during a period of increased U.S. regulatory attention toward ketamine and innovative mental-health treatments.

"KetaMist fits our strategy perfectly -- a doctor-developed ketamine treatment with over 9,000 patient uses and a path to FDA approval. While we are initially focused on treatment-resistant depression, we believe KetaMist represents a broader franchise opportunity across multiple indications where ketamine has already shown clinical benefit. By combining this real-world experience with our prior FDA-approved ketamine work, we believe we can move faster and more efficiently than traditional drug development and unlock meaningful value across several large markets," said Fabio Chianelli, chief executive officer of Pharmather.

Near-term development priorities

The collaboration activities will include preparing an FDA meeting package to obtain guidance for a potentially accelerated path toward FDA approval.

Near-term milestones are expected to include regulatory engagement with the FDA, definition of the clinical and data requirements for a potential NDA submission, and evaluation of how existing real-world data may support the development program.

The collaboration agreement provides Pharmather with a one-year evaluation period to assess KetaMist for potential development and commercial testing. During this period, the parties may negotiate and enter into one or more additional agreements relating to the further development and commercialization of KetaMist, subject to mutually acceptable terms.

KetaMist is not currently approved by the FDA, and its existing clinical use is considered off-label.

About Pharmather Holdings Ltd.

Pharmather Holdings is a specialty pharmaceutical company focused on developing, acquiring, and commercializing personalized medicines and enabling technologies, with an emphasis on peptides and psychedelics.

We seek Safe Harbor.