PharmaTher Announces KetAImine(TM) - AI Discovery Platform to Expand the Ketamine Portfolio, Enable Earlier Partnering, and Fast-Track 505(b)(2) NDA Filings

Rhea-AI Summary

PharmaTher (OTCQB: PHRRF) launched KetAImine™, an AI-driven ketamine repurposing and discovery platform within its new Digital Health AI division to accelerate indication discovery, partnering, and 505(b)(2) NDA pathways. The platform combines KetaVault™ proprietary datasets, published evidence, real-world signals, and the company's FDA-approved ketamine ANDA CMC to generate regulator-aligned study concepts, dosing algorithms, and protectable methods of use.

Near-term milestones: a shortlist of 6–8 priority programs in Q4 2025; two lead programs selected in Q1 2026 with planned FDA interactions; at least three collaborations targeted in H1 2026; and IP filings through 2026.

Positive

• FDA-approved ketamine ANDA CMC serves as validated regulatory backbone
• Near-term pipeline: 6–8 priority programs targeted by Q4 2025
• Selection milestone: 2 lead programs planned for Q1 2026 with FDA interactions
• Partnerships targeted: ≥3 data-access/co-development collaborations in H1 2026
• IP filings planned across dosing, delivery, and combination methods during 2026

Negative

• None.

Expanding ketamine indications, fortifying IP, enabling earlier partnerships, and accelerating FDA pathways - underpinned by PharmaTher's Digital Health AI division, leveraging the Company's FDA-approved ketamine ANDA CMC and KetaVault(TM) data advantage.

Toronto, Ontario--(Newsfile Corp. - October 15, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty life sciences company focused on unlocking the pharmaceutical potential of ketamine, today announced KetAImine™, a proprietary ketamine repurposing and discovery platform designed to create, prioritize, and de-risk new ketamine indications and combination therapies across therapeutic areas—forming a scalable pipeline for partnering opportunities and NDA submissions via the 505(b)(2) pathway. KetAImine™ complements PharmaTher's Clinical Development division by supplying a continuous flow of regulatory-aligned programs ready for focused, capital-efficient studies. The platform is part of the newly formed PharmaTher Digital Health AI division, which now comprises KetaVault™, the Company's proprietary ketamine data repository, and the KetAImine™ platform.

"Our Digital Health AI division will be a force-multiplier," said Fabio Chianelli, Founder and CEO of PharmaTher. "With KetAImine™, we aim to unite real-world data, published evidence, our proprietary ketamine-based clinical findings, and data from KetaVault™—and leverage the validated CMC from our FDA-approved ketamine ANDA—to compress timelines, reduce risk, and generate protectable IP. Importantly, KetAImine™ is built to discover novel uses and drug combinations with ketamine that enhance efficacy and safety, unlocking new unmet medical indications and multiple partnering opportunities across pharma and biotech."

KetAImine™ will advance opportunities spanning psychiatry, central nervous system disorders, peri-operative care, inflammatory conditions, addiction, supportive oncology, rare disorders, and other categories where ketamine's mechanisms may translate into meaningful clinical benefit. Beyond monotherapy discovery, the platform aims to identify synergistic co-therapies with ketamine—whether efficacy-enhancing or safety-modulating—to open new indications and intellectual-property positions, generate regulator-aligned study concepts that can enable shorter bridging studies and faster 505(b)(2) decisions, and expand the Company's partnering initiatives by enabling earlier co-development and licensing with pharmaceutical and biotechnology companies.

KetAImine™ will integrate domain-tuned natural language processing and foundation models that structure clinical text and literature into a ketamine-specific ontology; estimate real-world effects and identify responder subpopulations and synergy candidates; analytics that yield regulator-friendly priors for endpoints and sample size; and knowledge depictions that connect ketamine's mechanisms to diseases, biomarkers, and co-medications to surface non-obvious indication and combination matches. An 'AI-to-clinical IP' flywheel ensures that proprietary internal findings continuously refine KetAImine™ and are translated into protectable methods of use, dosing algorithms, delivery pairings, and combination regimens—while also acting as a pharma/biotech partnering engine to unlock earlier-stage partnerships and potential non-dilutive funding pathways.

The platform's data fabric is anchored by KetaVault™, PharmaTher's proprietary repository that consolidates (i) disease-area datasets in Parkinson's disease (including LID-PD), ALS, and CRPS; (ii) program files and readouts from formulation and delivery initiatives, including the microneedle patch and subcutaneous wearable pump; (iii) the Company's recently FDA-approved ketamine ANDA CMC backbone; and (iv) additional non-clinical and clinical datasets across neurological and pain indications. KetaVault™ standardizes these assets for reuse, enabling KetAImine™ to generate indication shortlists, dose/regimen proposals, and combination hypotheses that are directly translatable into regulatory-aligned development plans.

Near-term milestones (6-12 months)

In Q4 2025, PharmaTher expects to complete a short list of six to eight priority programs with probability-of-technical- and regulatory-success assessments and draft study concepts, including synergy rationales where applicable. In Q1 2026, the Company plans to down-select two lead indication or combination programs for protocol finalization oriented to 505(b)(2) bridging or Phase 2/3 studies and to initiate FDA interactions. During the first half of 2026, PharmaTher intends to announce at least three data-access and/or co-development collaborations, and throughout 2026 the Company expects to file new intellectual property covering clinically informed dosing paradigms, delivery and formulation strategies, and combination methods of use.

Strategic significance

By leveraging the Company's recent FDA-approved ketamine ANDA CMC as a clean, validated backbone, PharmaTher believes it can underpin multiple future NDAs via the 505(b)(2) pathway and systematically generate multiple "shots on goal" across monotherapy and combination programs. The result is a development model designed for capital efficiency—using data-driven decisions, focused trials, and non-dilutive options—while unlocking multiple partnering opportunities with global pharma and biotech stakeholders.

About PharmaTher

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on unlocking the pharmaceutical potential of ketamine. For more information, visit 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 and Forward-Looking Statements

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. There can be no assurance that the Company will proceed with the clinical development and that the FDA will support any potential request for an expedited path to approval. These risks include, among others, the commercial performance of the ANDA product, FDA acceptance of the regulatory plan, clinical development, CMC package, regulatory approvals, market acceptance and opportunities, competition, market size, the Company programs being partnered. Readers are cautioned not to place undue reliance on forward-looking statements. PharmaTher disclaims any obligation to update or revise forward-looking statements except as required by law. In addition, this press release contains cautionary and forward looking statements and information within the meaning of applicable Canadian securities legislation. These relate to future events or future performance. The use of any of the words "aim", "anticipate", "before", "believe", "closer", "confident", "could", "eligible", "enable", "ensure", "estimated", "expect", "intend", "lead", "leverage", "makes", "may", "mitigate", "plan", "position", "potential", "prior", "promise", "projected", "proposed", "provide", "purpose", "ready", "significant", "strong", "toward", "will", "would", 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 the Company's management's discussion and analysis for the year ended May 31, 2025, dated September 26, 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/270485

FAQ

What is KetAImine™ and how does it relate to PharmaTher (PHRRF)?

KetAImine™ is PharmaTher's AI-driven ketamine discovery platform that uses KetaVault™ data and the company's FDA-approved ketamine ANDA CMC to generate regulator-aligned programs for 505(b)(2) NDAs.

What are PharmaTher's (PHRRF) near-term milestones and timelines for KetAImine™?

PharmaTher expects a shortlist of 6–8 priority programs in Q4 2025, to down-select 2 lead programs in Q1 2026, initiate FDA interactions then, and target ≥3 collaborations in H1 2026.

How does PharmaTher plan to use the FDA-approved ketamine ANDA for future NDAs (PHRRF)?

The company intends to leverage the approved ANDA's CMC as a validated backbone to support 505(b)(2) filings and accelerate bridging studies for new indications.

Which therapeutic areas will KetAImine™ target for PharmaTher (PHRRF)?

KetAImine™ will screen opportunities across psychiatry, CNS disorders, peri-operative care, inflammatory conditions, addiction, supportive oncology, rare disorders, and related indications.

Will PharmaTher (PHRRF) seek partnerships or collaborations using KetAImine™ discoveries?

Yes; the platform is designed as a pharma/biotech partnering engine with plans to announce at least three data-access or co-development collaborations in H1 2026.