PharmaTher Announces Path to Ketamine Commercialization with No Planned Financing, Confirms FDA Approval Goal Date of August 9th, 2025 for Ketamine

By: PharmaTher Holdings Ltd. via GlobeNewswire

July 02, 2025 at 08:00 AM EDT

TORONTO, July 02, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on the development and commercialization of ketamine-based pharmaceuticals, is pleased to provide a corporate update to its shareholders, outlining a clear strategy to become the global leader in unlocking the pharmaceutical potential of ketamine. The Company has reached a pivotal stage in its growth, marked by a defined regulatory timeline and a strategic plan for commercial and international expansion for its ketamine-based products.

Key Highlights:

FDA Approval Goal Date Set: The U.S. Food and Drug Administration (FDA) has set its approval goal date of August 9, 2025, for the potential approval of PharmaTher’s ketamine product on or before this date.
Fully-Funded for Commercial Launch: PharmaTher is fully-funded through its FDA approval goal date of August 9, 2025, and for its initial U.S. commercial launch.
Commitment to Shareholder Value: The Company has no plans for new equity or debt financing before the FDA approval goal date, underscoring its confidence in its current cash position and commitment to mitigating shareholder dilution through its existing capital structure.
Secure, US-Based Manufacturing: The manufacturing for the Company’s ketamine product is based in the United States, ensuring supply chain security, quality control, and readiness for commercial scale-up.
Strategic Global Expansion: PharmaTher is preparing for international regulatory submissions in Europe, the United Kingdom, Canada, Japan, and the APAC regions, expected to commence in the second half of 2025.
Advancing New Indications Inspired by HHS Initiatives on Psychedelics: The Company is actively exploring the expansion of ketamine's therapeutic applications, inspired by growing bipartisan support for psychedelic-assisted therapies, including recent federal initiatives on Kennedy-backed Make America Healthy Again movement. The Company has already submitted pre-INDs and INDs for ketamine in indications such as Parkinson's disease, ALS, CRPS, and for novel delivery systems, including an on-body wearable pump and microneedle patch.

A Clear Pathway to U.S. Market Approval

The establishment of an FDA approval goal date of August 9, 2025, represents the single most significant milestone in the Company’s history. This date provides investors with a clear and material catalyst, marking the culmination of years of dedicated research and development. An FDA approval would unlock a multi-billion-dollar market opportunity and establish PharmaTher as a frontrunner in the regulated psychedelics space, specifically by unlocking the pharmaceutical potential of ketamine. The current global market for ketamine is valued at $750 million and is projected to expand at a CAGR of 16.4% to reach a value of US$3.42 billion by the end of 2034 (Source: FactMR).

Fabio Chianelli, CEO of PharmaTher, stated, “Receiving an approval goal date from the FDA provides a clear line of sight to potential approval and commercialization for our ketamine product. Our primary focus between now and August 9, 2025, is executing on our pre-commercial strategy. We have the team, the capital, and the plan in place to deliver on our commitment. We believe this milestone significantly de-risks our path forward and presents a powerful value proposition for our shareholders.”

Financial Strength and Commitment to Shareholders

In a market environment where capital preservation is paramount, PharmaTher stands in a sound position. The Company is funded for all planned operations, including regulatory affairs, marketing preparations, and the initial U.S. commercial launch of ketamine.

“We have been diligent in our financial management to ensure we can achieve our objectives without diluting our shareholders’ stake in our collective success,” continued Mr. Chianelli. “Our current plan is not to seek any new equity or debt financing before our FDA approval goal date on August 9, 2025.”

Commercial Readiness and Future Growth

With a secure, U.S.-based manufacturing partner, PharmaTher has mitigated potential supply chain disruptions and is well-prepared to meet anticipated market demand upon approval for ketamine. Looking beyond the initial U.S. launch of ketamine, PharmaTher is positioning itself for global leadership. The Company is preparing regulatory dossiers for submission to key international bodies, including the European Medicines Agency (EMA) and Health Canada, beginning in H2 2025. This global expansion strategy signifies our commitment to growth and leadership in ketamine-based pharmaceuticals.

Furthermore, PharmaTher is at the forefront of the next wave of psychedelic medicine. Inspired by growing legislative momentum and support from influential figures like Robert F. Kennedy Jr. for expanded access and research into psychedelic therapies, the Company is strategizing to broaden its clinical pipeline. PharmaTher aims to leverage its expertise in ketamine to explore new indications and combination therapies, solidifying its role as an innovator in psychiatric, pain and neurological disorders.

“We are building a global ketamine pharmaceutical franchise,” concluded Mr. Chianelli. “The upcoming FDA approval goal date is our beachhead. From there, we will expand globally and into new indications, driven by science and a commitment to patients. We believe the coming 12-18 months will be transformative for PharmaTher, and we are thrilled to have our shareholders on this exciting journey.”

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.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: 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", "aim", “may”, “plan”, “proposed”, “lead”, “toward”, “anticipate”, “provide”, “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.

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PharmaTher Announces Path to Ketamine Commercialization with No Planned Financing, Confirms FDA Approval Goal Date of August 9th, 2025 for Ketamine

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