BioNxt Reports Expanded Research, Development and Commercialization Capability with Centralized Munich Laboratory

Rhea-AI Summary

BioNxt Solutions (BNXTF) has announced the consolidation of its research, development, and commercialization activities at the Gen-Plus CRDO facility in Munich, Germany. The integration provides access to a 1,000-square-meter state-of-the-art laboratory space equipped for high-potency pharmaceutical development and GMP-compliant processes.

The company will leverage Gen-Plus's advanced infrastructure to enhance its drug delivery systems, focusing on their lead product BNT23001, a sublingual thin-film formulation of Cladribine for multiple sclerosis treatment. Immediate plans include preparation for human bioequivalence studies, including placebo trials, product transfer, manufacturing upscaling, and analytical validation.

Positive

• Access to 1,000 square meters of state-of-the-art laboratory space in a major European biotech hub
• Enhanced R&D capabilities through advanced technologies for solid and semi-solid dosage forms
• Progress towards commercialization of lead MS treatment product BNT23001

Negative

• None.

VANCOUVER, BC / ACCESS Newswire / May 13, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience company specializing in advanced drug delivery systems, is pleased to announce the integration of its research, development and commercialization activities to the Gen-Plus GmbH & Co. KG (Gen-Plus) Contract Research and Development Organization (CRDO) in Munich, Germany. The move provides BioNxt with enhanced R&D capabilities, collaboration opportunities, and accelerated innovation potential within a major European biotech hub.

The Company seeks to leverage the advanced and innovative infrastructure of the Gen-Plus Laboratory and harness the facility's 1,000 square meters of state-of-the-art space designed for high-potency active pharmaceutical ingredients and GMP-compliant processes. The lab's specialized equipment, including advanced technologies for solid and semi-solid dosage forms and capabilities in drug printing, will empower BioNxt to maximize the potential of its proprietary drug delivery systems, neurodegenerative disease therapeutics, and next-generation biomedical technologies.

In the coming weeks, BioNxt and Gen-Plus will be working together closely and focused on the development and commercialization of the Company's lead product, BNT23001, a sublingual thin-film formulation of Cladribine for the treatment of multiple sclerosis (MS). Preparation activities for the planned human bioequivalence study include placebo trials, product and technology transfer, upscaling of manufacturing, and analytical validation of the active pharmaceutical ingredient.

About Gen-Plus GmbH & Co. KG

Gen-Plus, headquartered in Munich, Germany, is a premier Contract Research and Development Organization (CRDO) with over 25 years of experience in pharmaceutical formulation and development. The company operates a 1,000-square-meter state-of-the-art laboratory equipped for handling high-potency active pharmaceutical ingredients and licensed for GMP-compliant production, including narcotics.

Gen-Plus specializes in developing solid and semi-solid dosage forms, transdermal patches, and oral thin films, offering end-to-end services from feasibility studies to clinical trial supply production. The company leverages advanced technologies such as hot-melt extrusion, drug printing, and amorphization of APIs to deliver comprehensive pharmaceutical solutions.

Committed to innovation, Gen-Plus collaborates with leading European research institutions and biotech companies to drive advancements in pharmaceutical solutions. The company's expertise and cutting-edge infrastructure make it a trusted partner in accelerating drug development and commercialization.

About BioNxt Solutions Inc.

BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company's proprietary platforms-Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated Tablets)-target key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity.

With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.

BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets: BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit www.bionxt.com.

Investor Relations & Media Contact

Hugh Rogers, Co-Founder, CEO and Director
Email: investor.relations@bionxt.com
Phone: +1 778.598.2698

Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt

Cautionary Statement Regarding "Forward-Looking" Information

This press release contains "forward-looking information" within the meaning of applicable securities laws. Forward-looking information is based on management's expectations, estimates, projections, and assumptions as of the date of this press release. It is subject to significant risks, uncertainties, and other factors that could cause actual results or events to differ materially from those expressed or implied. These risks and uncertainties include, but are not limited to, general economic conditions, market conditions, regulatory risks, technological advancements, and other factors described in the Company's public disclosure filings.

Readers are cautioned not to place undue reliance on forward-looking information, as actual outcomes may differ significantly from those expressed or implied, due to various factors beyond the Company's control. The Company undertakes no obligation to update or revise any forward-looking information, except as required by law.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

FAQ

What is BioNxt's (BNXTF) new laboratory facility in Munich?

BioNxt has integrated its operations into the Gen-Plus CRDO facility in Munich, Germany, which provides 1,000 square meters of state-of-the-art laboratory space designed for high-potency pharmaceutical development and GMP-compliant processes.

What is BioNxt's (BNXTF) lead product BNT23001?

BNT23001 is a sublingual thin-film formulation of Cladribine being developed for the treatment of multiple sclerosis (MS).

What are the immediate plans for BioNxt's (BNXTF) MS treatment development?

BioNxt plans to conduct placebo trials, product and technology transfer, manufacturing upscaling, and analytical validation in preparation for human bioequivalence studies of their MS treatment.

What capabilities does the new Munich facility provide to BioNxt (BNXTF)?

The facility provides advanced technologies for solid and semi-solid dosage forms, drug printing capabilities, and GMP-compliant processes for developing drug delivery systems and neurodegenerative disease therapeutics.