PharmaTher Announces KetAImine(TM) - AI Discovery Platform to Expand the Ketamine Portfolio, Enable Earlier Partnering, and Fast-Track 505(b)(2) NDA Filings
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.
PharmaTher (OTCQB: PHRRF) ha lanciato KetAImine™, una piattaforma AI-driven per il riposizionamento e la scoperta della ketamina all'interno della sua nuova divisione Digital Health AI, per accelerare la scoperta di indicazioni, le collaborazioni e i percorsi NDA 505(b)(2). La piattaforma combina i dataset proprietari KetaVault™, evidenze pubblicate, segnali del mondo reale e l'ANDA CMC della ketamina approvato dalla FDA dell'azienda per generare concetti di studio allineati ai regolatori, algoritmi di dosaggio e metodi d'uso protetti.
Obiettivi a breve termine: una shortlist di 6–8 programmi prioritari nel Q4 2025; due programmi leader selezionati nel Q1 2026 con interazioni pianificate con la FDA; almeno tre collaborazioni previste nel primo semestre 2026; e depositi IP fino al 2026.
PharmaTher (OTCQB: PHRRF) ha lanzado KetAImine™, una plataforma de reaprovechamiento y descubrimiento de ketamina impulsada por IA dentro de su nueva división Digital Health AI para acelerar el descubrimiento de indicaciones, asociaciones y rutas NDA 505(b)(2). La plataforma combina conjuntos de datos propietarios KetaVault™, evidencia publicada, señales del mundo real y el ANDA CMC de ketamina aprobado por la FDA de la empresa para generar conceptos de estudio alineados con los reguladores, algoritmos de dosificación y métodos de uso protegibles.
Hitos a corto plazo: una lista corta de 6–8 programas prioritarios en el Q4 de 2025; dos programas líderes seleccionados en el Q1 de 2026 con interacciones planificadas con la FDA; al menos tres colaboraciones objetivo en la primera mitad de 2026; y presentaciones de IP hasta 2026.
PharmaTher (OTCQB: PHRRF)는 AI 기반의 Ketamine 재목적화 및 발견 플랫폼인 KetAImine™를 새로운 Digital Health AI 부문에서 출시하여 적응성 발견, 파트너십 및 505(b)(2) NDA 경로를 가속화합니다. 이 플랫폼은 KetaVault™ 독점 데이터 세트, 발표된 증거, 실제 세계 신호 및 회사의 FDA 승인 Ketamine NDA-CMC를 결합하여 규제 당국에 맞춘 연구 개념, 투약 알고리즘 및 보호 가능한 사용 방법을 생성합니다.
단기 마일스톤: 2025년 4분기에 6–8개의 우선 프로그램의 간추림; 2026년 1분기에 두 개의 선도 프로그램 선정 및 FDA 상호작용 계획; 2026년 상반기에 최소 세 개의 협력 목표; 2026년까지 IP 출원.
PharmaTher (OTCQB: PHRRF) a lancé KetAImine™, une plateforme IA pour le remploi et la découverte de la kétamine, au sein de sa nouvelle division Digital Health AI afin d'accélérer la découverte d'indications, les partenariats et les voies NDA 505(b)(2). La plateforme combine des ensembles de données propriétaires KetaVault™, des preuves publiées, des signaux du monde réel et le CMC Ketamine ANDA approuvé par la FDA de l'entreprise pour générer des concepts d'études conformes aux régulateurs, des algorithmes de dosage et des méthodes d'utilisation protégeables.
Jalons à court terme : une liste restreinte de 6–8 programmes prioritaires au T4 2025 ; deux programmes phares sélectionnés au T1 2026 avec des interactions prévues avec la FDA ; au moins trois collaborations ciblées au premier semestre 2026 ; et des dépôts de propriété intellectuelle jusqu'en 2026.
PharmaTher (OTCQB: PHRRF) hat KetAImine™ eingeführt, eine KI-gesteuerte Plattform zur Umnutzung und Entdeckung von Ketamin innerhalb der neuen Digital Health AI-Division, um die Indikatorentdeckung, Partnerschaften und 505(b)(2) NDA-Wege zu beschleunigen. Die Plattform kombiniert die firmeneigenen KetaVault™-Datensätze, veröffentlichte Belege, Real-World-Signale und das FDA-genehmigte Ketamin-ANDA-CMC des Unternehmens, um regulatorisch konforme Studienkonzepte, Dosierungsalgorithmen und schützbare Verwendungsweisen zu generieren.
Kurzfristige Meilensteine: eine Shortlist von 6–8 Prioritätsprogrammen im 4. Quartal 2025; zwei Leitprogramme im 1. Quartal 2026 ausgewählt mit geplanten Interaktionen mit der FDA; mindestens drei Kooperationen im ersten Halbjahr 2026; und IP-Einreichungen bis 2026.
PharmaTher (OTCQB: PHRRF) أطلقت KetAImine™، منصة اكتشاف وإعادة استخدام Ketamine مدفوعة بالذكاء الاصطناعي ضمن قسمها الجديد للرعاية الصحية الرقمية دمج AI لتسريع اكتشاف المؤشرات والشراكات وطرق NDA 505(b)(2). تجمع المنصة مجموعات بيانات KetaVault™ الملكية، الأدلة المنشورة، الإشارات من العالم الواقعي وCMC Ketamine NDA المعتمدة من FDA للشركة لإنتاج مفاهيم دراسات متوافقة مع الجهات التنظيمية، وخوارزميات الجرعات، وطرق استخدام قابلة للحماية.
المعالم قصيرة الأجل: قائمة مختصرة من 6–8 برامج ذات أولوية في الربع الرابع من 2025؛ اختيار برنامجين رائدين في الربع الأول من 2026 مع تفاعلات مخطط لها مع FDA؛ وعلى الأقل ثلاث تعاونات مستهدفة في النصف الأول من 2026؛ وتقديمات IP حتى 2026.
PharmaTher (OTCQB: PHRRF) 推出 KetAImine™，在其新设立的数字健康 AI 部门内，利用 AI 驱动的 ketamine 重新定位与发现平台，以加速适应症发现、合作与 505(b)(2) NDA 路径。该平台结合 KetaVault™ 专有数据集、已发表的证据、真实世界信号，以及公司的 FDA 批准的 ketamine ANDA CMC，以生成符合监管要求的研究概念、给药算法以及可保护的使用方法。
近期里程碑：在 2025 年第 4 季完成 6–8 个优先计划的初选；在 2026 年第 1 季选出两个领先计划并计划与 FDA 互动；在 2026 年上半年目标至少完成三次合作；并在 2026 年前完成知识产权申请。
- 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
- 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.
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FAQ
What is KetAImine™ and how does it relate to PharmaTher (PHRRF)?
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