Pharmather signs definitive deal to sell ketamine ANDA

Mr. Fabio Chianelli reports PHARMATHER ANNOUNCES SALE OF KETAMINE ANDA WITH POTENTIAL TO GENERATE OVER US$25 MILLION IN MILESTONE AND PROFIT-SHARING PAYMENTS Pharmather Holdings Ltd. has entered into a definitive asset purchase agreement for the sale of its abbreviated new drug application (ANDA No. 217858) for ketamine hydrochloride injection USP to a well-established global pharmaceutical company specializing in sterile injectables and complex generics. "This transaction validates the significant value embedded in our ketamine assets," said Fabio Chianelli, chief executive officer of Pharmather. "We are excited to announce this agreement with a leading global sterile injectables company, structured to allow Pharmather to share in the upside of future sales of the growing ketamine market. Importantly, it also enables us to leverage the foundation we built with our ketamine program to advance our proprietary next-generation therapies, which we believe represent multiple high-value opportunities for both patients and shareholders." Transaction terms Under the terms of the agreement, Pharmather will receive a confidential upfront cash payment at closing and is eligible for milestone payments based on cumulative sales thresholds, along with continuing profit sharing for a period of seven years following the first commercial sale. In total, the agreement contemplates potential consideration of more than $25-million (U.S.); however, there can be no assurance that any or all of these payments will be realized, as they are contingent on the product's commercial performance. The buyer has requested confidentiality at this time for strategic business reasons, including competitive positioning in the U.S. ketamine and sterile injectable generics market. Investors should note that the buyer is a credible, U.S. Food and Drug Administration-approved (FDA) sterile injectables manufacturer with an established record of securing multiple ANDA approvals. Through its rapidly growing U.S. subsidiary, the buyer is actively commercializing a portfolio of more than 40 approved ANDAs across the United States, in addition to global operations. Its demonstrated expertise in developing, manufacturing and commercializing of injectable medicines makes it a strong partner to unlock the commercial potential of ketamine in the U.S. The agreement enables Pharmather to participate in the potential long-term commercial success of the ANDA while maintaining meaningful exposure to the global ketamine market. It also allows the company to focus on advancing next-generation ketamine programs, including long-acting injectables and novel delivery methods for potential psychiatric, pain, neurological and orphan drug indications. The agreement is subject to customary closing conditions, including required regulatory notifications, with the effective date of closing expected to occur in the near term. About Pharmather Holdings Ltd. Pharmather Holdings is focused on unlocking the pharmaceutical potential of ketamine for mental health, pain and neurological disorders. We seek Safe Harbor.