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KETARx

Generic name: ketamine hydrochloride
Treatment for: Pain

PharmaTher Announces FDA Extends Review Period for Ketamine

TORONTO, May 16, 2025 -- PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) ("PharmaTher" or the "Company"), a specialty pharmaceutical company focused on ketamine for unmet medical needs, today announced the U.S. Food and Drug Administration (FDA) has extended the approval goal date for the review of its new drug application for ketamine. The new approval goal date is August 9, 2025, revised from the previous date of June 4, 2025. The extension allows the FDA additional time to review additional information requests, which the FDA has classified as a MINOR amendment. Importantly, this is not a Complete Response Letter. PharmaTher confirms it has previously addressed all issues raised in the FDA's Complete Response Letter dated October 22, 2024.
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"While we were prepared for a decision by June 4, 2025, we acknowledge the FDA's need for additional time to review our recent submission and additional information request for the ketamine new drug application," said Fabio Chianelli, CEO of PharmaTher. "We do not anticipate this extension to August 9, 2025, will materially impact our ongoing operational, business development, and commercialization initiatives for 2025."

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the research and commercialization of KETARX™ (Ketamine) to fill the unmet medical needs for surgery, pain, mental health, neurological, and medical countermeasures indications. Learn more at PharmaTher.com.


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", "aim", “may”, “plan”, “proposed”, “lead”, “toward”, “anticipate”, “provide”, 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.

Source: PharmaTher Holdings Ltd.

Posted: May 2025

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