(MENAFN- Newsfile Corp) 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 KetAImineTM, 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. KetAImineTM 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 KetaVaultTM, the Company's proprietary ketamine data repository, and the KetAImineTM platform.

"Our Digital Health AI division will be a force-multiplier," said Fabio Chianelli, Founder and CEO of PharmaTher. "With KetAImineTM, we aim to unite real-world data, published evidence, our proprietary ketamine-based clinical findings, and data from KetaVaultTM-and leverage the validated CMC from our FDA-approved ketamine ANDA-to compress timelines, reduce risk, and generate protectable IP. Importantly, KetAImineTM 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."

KetAImineTM 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.

KetAImineTM 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 KetAImineTM 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 KetaVaultTM, 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. KetaVaultTM standardizes these assets for reuse, enabling KetAImineTM 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 .

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