PharmaTher CEO Issues Letter to Shareholders
PharmaTher Holdings (OTCQB: PHRRF) provided a shareholder update outlining its 2025 strategic priorities. The company faced two Complete Response Letters from the FDA for its ketamine drug application in 2024 but plans to submit responses in February, anticipating FDA approval in Q2-2025.
Key focus areas include: Operations - maintaining cost control through third-party consultants and manufacturers, with sufficient cash for 2025 operations; Commercialization - plans to distribute ketamine to wholesalers, distributors, and work with Defense Health Agency and Veterans Health Administration; Clinical Development - pursuing strategic trial collaborations for ketamine research, leveraging FDA orphan designations for ALS, Rett Syndrome, and CRPS; Ketamine 2.0 - developing next-generation products including ketamine patch and wearable pump programs under 505(b)(2) pathway, with plans to select a lead compound in H2 2025.
PharmaTher Holdings (OTCQB: PHRRF) ha fornito un aggiornamento agli azionisti delineando le sue priorità strategiche per il 2025. L'azienda ha ricevuto due Lettere di Risposta Completa dalla FDA per la sua domanda di farmaco a base di ketamina nel 2024, ma prevede di inviare le risposte a febbraio, anticipando l'approvazione della FDA nel secondo trimestre del 2025.
Le aree chiave di focus includono: Operazioni - mantenere il controllo dei costi tramite consulenti e produttori esterni, con liquidità sufficiente per le operazioni del 2025; Commercializzazione - piani per distribuire la ketamina a grossisti e distributori, e collaborare con l'Agenzia per la Salute della Difesa e l'Amministrazione per la Salute dei Veterani; Sviluppo Clinico - perseguire collaborazioni strategiche per trial di ricerca sulla ketamina, sfruttando le designazioni orfane della FDA per SLA, Sindrome di Rett e CRPS; Ketamina 2.0 - sviluppo di prodotti di nuova generazione inclusi cerotti di ketamina e programmi di pompe indossabili secondo il percorso 505(b)(2), con piani per selezionare un composto leader nel secondo semestre del 2025.
PharmaTher Holdings (OTCQB: PHRRF) proporcionó una actualización a los accionistas que describe sus prioridades estratégicas para 2025. La compañía enfrentó dos Cartas de Respuesta Completa de la FDA para su solicitud de medicamento de ketamina en 2024, pero planea enviar respuestas en febrero, anticipando la aprobación de la FDA en el segundo trimestre de 2025.
Las áreas clave de enfoque incluyen: Operaciones - mantener el control de costos a través de consultores y fabricantes externos, con suficiente efectivo para las operaciones de 2025; Comercialización - planes para distribuir ketamina a mayoristas y distribuidores, y colaborar con la Agencia de Salud de Defensa y la Administración de Salud de Veteranos; Desarrollo Clínico - perseguir colaboraciones estratégicas para ensayos de investigación de ketamina, aprovechando las designaciones huérfanas de la FDA para ELA, Síndrome de Rett y CRPS; Ketamina 2.0 - desarrollo de productos de nueva generación, incluidos parches de ketamina y programas de bombas portátiles bajo la vía 505(b)(2), con planes para seleccionar un compuesto principal en la segunda mitad de 2025.
PharmaTher Holdings (OTCQB: PHRRF)는 2025년 전략 우선순위를 설명하는 주주 업데이트를 제공했습니다. 이 회사는 2024년 FDA의 케타민 약물 신청과 관련해 두 개의 완전 응답 서신을 받았으나, 2월에 응답을 제출할 계획이며, 2025년 2분기에 FDA 승인을 기대하고 있습니다.
주요 초점 분야는 다음과 같습니다: 운영 - 제3자 컨설턴트와 제조업체를 통해 비용 통제를 유지하며, 2025년 운영을 위한 충분한 현금을 확보; 상업화 - 케타민을 도매상 및 유통업체에 배급하고 방위 건강국 및 재향군인 건강 관리국과 협력할 계획; 임상 개발 - 케타민 연구를 위한 전략적 시험 협력을 추구하고, ALS, 레트 증후군 및 CRPS에 대한 FDA 고아 지정 혜택을 활용; Ketamine 2.0 - 505(b)(2) 경로에 따른 케타민 패치 및 착용 가능한 펌프 프로그램을 포함한 차세대 제품 개발, 2025년 하반기에 주요 화합물을 선정할 계획입니다.
PharmaTher Holdings (OTCQB: PHRRF) a fourni une mise à jour aux actionnaires décrivant ses priorités stratégiques pour 2025. L'entreprise a reçu deux lettres de réponse complète de la FDA pour sa demande de médicament à base de kétamine en 2024, mais prévoit d'envoyer ses réponses en février, anticipant une approbation de la FDA au deuxième trimestre 2025.
Les domaines clés d'intervention incluent : Opérations - maintenir le contrôle des coûts à travers des consultants et fabricants externes, avec des liquidités suffisantes pour les opérations de 2025 ; Commercialisation - plans pour distribuer la kétamine à des grossistes et distributeurs, et collaborer avec l'Agence de santé de la Défense et l'Administration de la santé des vétérans ; Développement clinique - rechercher des collaborations stratégiques pour des essais de recherche sur la kétamine, en tirant parti des désignations orphelines de la FDA pour la SLA, le syndrome de Rett et le CRPS ; Kétamine 2.0 - développement de produits de nouvelle génération, y compris des patchs de kétamine et des programmes de pompes portables selon le parcours 505(b)(2), avec des plans pour sélectionner un composé principal dans la seconde moitié de 2025.
PharmaTher Holdings (OTCQB: PHRRF) hat ein Update für die Aktionäre bereitgestellt, das die strategischen Prioritäten für 2025 umreißt. Das Unternehmen hatte 2024 zwei Complete Response Letters von der FDA für seinen Ketamin-Antrag erhalten, plant jedoch, im Februar Antworten einzureichen, wobei eine Genehmigung der FDA im 2. Quartal 2025 erwartet wird.
Die Schwerpunkte sind: Betrieb - Kostenkontrolle durch externe Berater und Hersteller aufrechterhalten, mit ausreichenden Mitteln für die Betriebe im Jahr 2025; Kommerzialisierung - Pläne zur Verteilung von Ketamin an Großhändler und Vertriebspartner sowie Zusammenarbeit mit der Defense Health Agency und der Veterans Health Administration; Klinische Entwicklung - strategische Testkooperationen zur Ketaminforschung anstreben, Nutzung der FDA-Orphan-Designationen für ALS, Rett-Syndrom und CRPS; Ketamin 2.0 - Entwicklung von Next-Generation-Produkten, einschließlich Ketamin-Pflaster und tragbaren Pumpenprogrammen im Rahmen des 505(b)(2)-Weges, mit Plänen zur Auswahl einer Hauptverbindung im zweiten Halbjahr 2025.
- FDA approval for ketamine drug expected in Q2-2025
- Sufficient cash reserves to cover 2025 operational needs
- FDA orphan drug designations secured for three conditions (ALS, Rett Syndrome, CRPS)
- VHA approval and payment coverage for ketamine infusions
- Development of next-generation ketamine delivery systems in progress
- Received two Complete Response Letters from FDA in 2024, delaying approval
- Commercialization timeline dependent on pending FDA approval
TORONTO, Jan. 06, 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, announced today that Fabio Chianelli, the Company’s Chairman and Chief Executive Officer, has issued the following letter to shareholders.
Dear Fellow Shareholders:
With the start of a new year, I sincerely thank our loyal shareholders for your continued patience, confidence and support. In 2024, we faced the challenge of two Complete Response Letters (CRL) for our Priority Original Abbreviated New Drug Application for our drug, Ketamine, by the U.S. Food and Drug Administration (FDA). Despite these hurdles, we immediately began to address these issues and are on track to submit our responses to the FDA in February. We expect to receive a new approval date for a Q2-2025 FDA approval. Our journey has been long, but I am very encouraged by our progress and can see the light at the end of the tunnel.
We are ‘All-in’ on Ketamine!
With pending FDA approval for our ketamine drug on the horizon, we remain focused on our mission to be a leading innovator and provider of ketamine to treat unmet medical needs. It is well-known that ketamine is an essential medicine used for anesthesia and analgesia (pain relief) and has been used as a sedative and painkiller in hospital settings. Outside of the FDA and Health Canada approved indications, ketamine is also being administered in hospitals and clinics to treat various mental health, neurological and pain disorders. The potential of ketamine to make a significant impact on patient lives is immense, and we are enthusiastic to be at the forefront of bringing our ketamine drug to millions of people globally.
As such, I want to share our priorities and expectations for 2025.
Operations. We are committed to controlling costs and ensuring efficient operations. To this end, we utilize third-party consultants and contract manufacturers. Our cash on hand is expected to satisfy our operational needs for 2025. We are focused on obtaining FDA approval for our ketamine drug and initiating commercialization activities, such as commercial manufacturing, global regulatory filings, new business development, and pharmaceutical partnerships.
Commercialization. With the FDA approval nearing, we plan to make our ketamine drug available to pharmaceutical wholesalers, distributors, prescribers, and researchers. We also intend to work with the Defense Health Agency and the Veterans Health Administration. Recently, the VHA approved and will pay for ketamine infusions to treat treatment-resistant depression, PTSD, and chronic pain.
Clinical Development. Our strategy is to pursue strategic clinical trial collaborations with pharmaceutical and biotech companies, research institutions, non-profit research associations and government agencies that conduct clinical research with ketamine for current and new indications. We have been granted FDA orphan designation for Amyotrophic Lateral Sclerosis (ALS), Rett Syndrome and Complex Regional Pain Syndrome (CRPS). We are in a position to support and supply ketamine for clinical studies for rare and near-rare neurological disorders such as Parkinson’s Disease, ALS, Rett Syndrome and CRPS.
Ketamine 2.0. As we enter the commercial stage of our business, we are also laying the foundation for the long term to develop next-generation ketamine and ketamine-like drugs. We have invested in product development programs, such as a ketamine patch and wearable pump, to treat new indications for which ketamine is not approved. Our ketamine patch and wearable pump programs aim to proceed under the 505(b)(2) regulatory pathway for FDA approval. These programs are expected to advance after we receive FDA approval for our ketamine drug. In addition, we are evaluating opportunities with new chemical entities, such as norketamines and the hydroxynorketamines, metaplastogens, and derivatives. We expect to commit to a lead compound in the second half 2025.
We are excited about the prospects for our ketamine drug. We believe it will lead the way for new treatments for people around the world suffering from mental health, neurological and pain disorders. Our enthusiasm for this future is unwavering, and we are committed to realizing this potential.
We believe our future is promising, and we are excited about the journey ahead in 2025. We look forward to continuing this journey with all of you, our valued shareholders.
Sincerely,
Fabio Chianelli
Chairman and CEO
PharmaTher Holdings Ltd.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of KETARX™ (Ketamine) to fill the global unmet medical needs for anesthesia, sedation, 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
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Cautionary Statement
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FAQ
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