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Terry Lynch Joins BioNxt as Capital Markets Advisor

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BioNxt Solutions Inc. (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) has announced that Terry Lynch has joined as a capital markets advisor. Lynch brings extensive experience in start-up and emerging growth capital markets, particularly in resource and bioscience sectors. He is currently the CEO of Power Nickel Inc. and a cofounder of Cardiol Therapeutics.

BioNxt's lead program is developing a proprietary sublingual Cladribine dosage form for the MS market. The company recently reported positive results from animal toxicity and pharmacokinetics studies for this product. A human comparative bioequivalence study is planned for early Q1 2025.

The company also received a positive international examination report from the European Patent Office for its patent application on sublingual delivery of anticancer drugs for autoimmune neurodegenerative diseases. BioNxt is also developing a sublingual drug delivery system for Myasthenia Gravis as its second clinical indication.

BioNxt Solutions Inc. (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) ha annunciato che Terry Lynch è entrato a far parte del team come consulente per i mercati finanziari. Lynch porta con sé una vasta esperienza nei mercati del capitale per start-up e aziende in crescita, specialmente nei settori delle risorse e delle bioscienze. Attualmente è CEO di Power Nickel Inc. e cofondatore di Cardiol Therapeutics.

Il programma principale di BioNxt sta sviluppando una forma di dosaggio sublinguale di Cladribina per il mercato della sclerosi multipla (SM). Recentemente, l'azienda ha riportato risultati positivi da studi di tossicità animale e farmacocinetica per questo prodotto. È previsto uno studio di bioequivalenza comparativa sull'uomo per inizio Q1 2025.

L'azienda ha anche ricevuto un rapporto di esame internazionale positivo dall'Ufficio Europeo dei Brevetti per la sua domanda di brevetto relativo alla somministrazione sublinguale di farmaci anticancro per malattie neurodegenerative autoimmuni. BioNxt sta anche sviluppando un sistema di somministrazione di farmaci sublinguali per la miastenia gravis come seconda indicazione clinica.

BioNxt Solutions Inc. (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) ha anunciado que Terry Lynch se ha unido como asesor en mercados de capital. Lynch aporta una amplia experiencia en mercados de capital para startups y empresas en crecimiento, especialmente en los sectores de recursos y biociencias. Actualmente es CEO de Power Nickel Inc. y cofundador de Cardiol Therapeutics.

El programa principal de BioNxt está desarrollando una forma de dosificación sublingual de Cladribina para el mercado de EM. La empresa recientemente informó sobre resultados positivos de estudios de toxicidad en animales y farmacocinética para este producto. Se planea un estudio de bioequivalencia comparativa en humanos para principios del Q1 2025.

La empresa también recibió un informe de examen internacional positivo de la Oficina Europea de Patentes para su solicitud de patente sobre la entrega sublingual de medicamentos anticancerígenos para enfermedades neurodegenerativas autoinmunes. BioNxt también está desarrollando un sistema de entrega de medicamentos sublinguales para la miastenia gravis como su segunda indicación clínica.

BioNxt Solutions Inc. (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT)는 Terry Lynch가 자본 시장 고문으로 합류했다고 발표했습니다. Lynch는 스타트업 및 성장 중인 자본 시장에서 광범위한 경험을 제공하며, 특히 자원 및 바이오 과학 분야에서 활동하고 있습니다. 그는 현재 Power Nickel Inc.의 CEO이며 Cardiol Therapeutics의 공동 창립자입니다.

BioNxt의 주요 프로그램은 다발성 경화증(MS) 시장을 위한 독점적인 설하 클라드리빈 제형을 개발하고 있습니다. 회사는 이 제품에 대해 동물 독성 및 약동학 연구의 긍정적인 결과를 최근 발표했습니다. 인간 비교 생체 동등성 연구는 2025년 1분기 초로 계획되고 있습니다.

회사는 또한 자가면역 신경퇴행성 질환을 위한 항암제의 설하 전달에 대한 특허 신청에 대해 유럽 특허청으로부터 긍정적인 국제 심사 보고서를 받았습니다. BioNxt는 중증 근무력증을 두 번째 임상 적응증으로 하는 설하 약물 전달 시스템도 개발 중입니다.

BioNxt Solutions Inc. (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) a annoncé que Terry Lynch a rejoint l'équipe en tant que conseiller en marchés de capitaux. Lynch apporte une vaste expérience dans les marchés de capitaux pour les startups et les entreprises en croissance, en particulier dans les secteurs des ressources et des biosciences. Il est actuellement PDG de Power Nickel Inc. et cofondateur de Cardiol Therapeutics.

Le programme principal de BioNxt développe une forme de dosage sublinguale de Cladribine pour le marché de la sclérose en plaques (SEP). L'entreprise a récemment rapporté des résultats positifs d'études de toxicité animale et de pharmacocinétique pour ce produit. Une étude de bioéquivalence comparativa chez l'homme est prévue pour début Q1 2025.

L'entreprise a également reçu un rapport d'examen international positif de l'Office européen des brevets pour sa demande de brevet concernant l'administration sublinguale de médicaments anticancéreux pour les maladies neurodégénératives auto-immunes. BioNxt développe également un système d'administration de médicaments sublinguaux pour la myasthénie grave comme deuxième indication clinique.

BioNxt Solutions Inc. (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) hat bekannt gegeben, dass Terry Lynch als Berater für Kapitalmärkte hinzugekommen ist. Lynch bringt umfassende Erfahrung in den Bereichen Start-Up und aufstrebende Wachstums-Kapitalmärkte, insbesondere in den Ressourcensektoren und der Biowissenschaft mit. Derzeit ist er CEO von Power Nickel Inc. und Mitgründer von Cardiol Therapeutics.

Das Hauptprogramm von BioNxt entwickelt eine proprietäre sublinguale Cladribin-Dosierungsform für den MS-Markt. Das Unternehmen berichtete kürzlich über positive Ergebnisse aus Tierversuchen und pharmakokinetischen Studien für dieses Produkt. Eine vergleichende Bioäquivalenzstudie am Menschen ist für Anfang Q1 2025 geplant.

Das Unternehmen erhielt zudem einen positiven internationalen Prüfbericht vom Europäischen Patentamt für seine Patentanmeldung zur sublingualen Verabreichung von Antikrebsmedikamenten bei autoimmunen neurodegenerativen Erkrankungen. BioNxt entwickelt auch ein sublinguales Arzneimittelabgabe-System für Myasthenia Gravis als zweite klinische Indikation.

Positive
  • Terry Lynch, an experienced capital markets advisor, has joined BioNxt
  • Positive results from animal toxicity and pharmacokinetics studies for sublingual Cladribine
  • Human comparative bioequivalence study planned for Q1 2025
  • Positive patent examination report from European Patent Office
  • Development of sublingual drug delivery system for Myasthenia Gravis as second clinical indication
Negative
  • None.

VANCOUVER, BC / ACCESSWIRE / October 7, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) is pleased to announce that Terry Lynch has joined the BioNxt team as a capital markets advisor. Mr. Lynch brings decades of start-up and emerging growth capital markets experience in the resource and bioscience sectors, including finance and M&A, as well as an extensive and influential network of market professionals.

Mr. Lynch is currently the CEO of Power Nickel Inc., a publicly traded mining company with an advanced high grade polymetallic Nickel project based in Quebec, Canada, and is a cofounder of TSX and NASDAQ listed Cardiol Therapeutics, a market leader in pharmaceutical grade CBD production and the developer of groundbreaking therapies for the treatment of cardiovascular disease. He holds a joint honours degree in business administration and economics from St. Francis Xavier University.

Mr. Lynch is also the founder and managing director of Save Canadian Mining ("SCM"). Launched in November 2019, SCM is an industry lobby group created to support Canada's junior mining sector in requesting regulatory changes to Canada's capital markets. He was successful in unifying support from the TSX Venture Exchange, the Ontario Mining Association, the Ontario Prospectors Association, as well as mining industry leaders such as Eric Sprott (Sprott Mining), Sean Roosen (Osisko Mining), Keith Neumeyer (First Majestic Silver Corp), and Rod McEwan (McEwan Mining Inc.) and over 25 junior mining companies and over 5,000 individual members.

"It's quite an exciting time to be joining the BioNxt team," said Mr. Lynch. "Positive toxicology and PK results for their sublingual Cladribine product for MS give me confidence going into the upcoming human bioavailability study. And with the Company's recent patent news, I see a scalable opportunity for the accelerated development of multiple sublingual products for the treatment neurological disorders."

BioNxt's lead program is the development of a 100% owned and proprietary sublingual Cladribine dosage form, directed at the MS market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with 2023 annual sales in excess of one billion USD according to Merck KGaA. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is anticipated to top USD 41 billion by 2033 according to Market.us. BioNxt's sublingual Cladribine product is expected to yield a significant advantage over the tablet form for patients suffering from Dysphagia (difficulty swallowing), which is a common symptom among MS patients.

In the first half of 2024, the Company announced positive results for both its sublingual Cladribine animal toxicity study and animal pharmacokinetics ("PK") studies. The animal toxicity study results demonstrated zero adverse clinical abnormalities or indications of toxicity in any participants after consecutive days of dosing. The PK study results demonstrated highly comparable rapid absorption and bioequivalence between the Company's sublingual product and the name-brand reference drug for all administered samples. The next steps in the development and commercialization process include technology and process transfer, upscaling of manufacturing capability, analytical method development and validation, and clinical sample manufacturing preparation, manufacturing, and product release for use in the human comparative bioequivalence study planned for early Q1 2025. The bioequivalence study will be carried out with a European contract research organization in accordance with EU medical regulatory guidelines.

SOURCE: BioNxt Solutions Inc.

On September 9, 2024, BioNxt reported that the European Patent Office ("EPO") issued a positive international examination report for the Company's comprehensive patent application for sublingual delivery of anticancer drugs for the treatment of autoimmune neurodegenerative diseases, such as MS. The Company expects the EU patent to be granted within four weeks and to rapidly enter the national phase of the Patent Cooperation Treaty ("PCT") patent process with submissions planned for the US, Canada, China, Japan, Australia, and other jurisdictions.

BioNxt confirms that its second clinical indication using anticancer compounds in a sublingual drug delivery system will be Myasthenia Gravis ("MG"). MG is an autoimmune and neuromuscular disease characterised by muscle weakness and fatigue. MG patients also commonly experience Dysphagia whereby a sublingual product is expected to yield a significant advantage over conventional tablet forms. The global MG market is expected to reach USD 6.7 billion by 2032 according to Clinical Trials Arena.

About BioNxt Solutions Inc.

BioNxt Solutions Inc. is a bioscience accelerator focused on next-generation drug formulations and delivery systems, diagnostic screening tests, and new active pharmaceutical production and evaluation, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization and clinical evaluation of emerging active pharmaceutical ingredients for neurological applications. The Company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.

BioNxt Solutions Inc.

Wolfgang Probst, CEO and Director
Email: info@bionxt.com
Phone: +1 780-818-6422

Cautionary Statement Regarding "Forward-Looking" Information

Some of the statements contained in this news release are forward-looking statements and information within the meaning of applicable securities laws. Forward-looking statements and information can be identified by the use of words such as "expects", "intends", "is expected", "potential", "suggests" or variations of such words or phrases, or statements that certain actions, events or results "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements and information are not historical facts and are subject to a number of risks and uncertainties beyond the Company's control. Actual results and developments are likely to differ, and may differ materially, from those expressed or implied by the forward-looking statements contained in this news release. Accordingly, readers should not place undue reliance on forward-looking statements. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements, except as may be required by law.

SOURCE: BioNxt Solutions Inc.



View the original press release on accesswire.com

FAQ

What is BioNxt's stock symbol on the OTC market?

BioNxt's stock symbol on the OTC market is BNXTF.

What is BioNxt's lead program focusing on?

BioNxt's lead program is developing a proprietary sublingual Cladribine dosage form for the Multiple Sclerosis (MS) market.

When is BioNxt planning to conduct the human comparative bioequivalence study for sublingual Cladribine?

BioNxt is planning to conduct the human comparative bioequivalence study for sublingual Cladribine in early Q1 2025.

What recent positive development did BioNxt receive from the European Patent Office?

BioNxt received a positive international examination report from the European Patent Office for its patent application on sublingual delivery of anticancer drugs for autoimmune neurodegenerative diseases.

What is the second clinical indication BioNxt is developing using anticancer compounds in a sublingual drug delivery system?

BioNxt's second clinical indication using anticancer compounds in a sublingual drug delivery system is for Myasthenia Gravis (MG).

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