Berliner Tageszeitung - BioNxt Applies Advanced Drug Delivery Strategy and Psychedelic Compound Library to Emerging Therapeutics Market Amid Accelerating Global Momentum

Recent developments in the United States, including policy initiatives aimed at expanding and accelerating research pathways for investigational therapies addressing serious mental health conditions such as post-traumatic stress disorder, depression, and addiction, signal a growing institutional shift toward the structured evaluation of psychedelic compounds within established regulatory frameworks.

In parallel, Europe continues to advance clinical research in this field, with Germany emerging as a key hub for large scale psychedelic studies, including multi-center clinical trials evaluating psilocybin assisted therapies. These developments collectively underscore a global inflection point in the evolution of next generation mental health treatments.

BioNxt has previously established foundational capabilities in psychedelic pharmaceutical research, including the development of pharmaceutical grade active ingredients, novel compound engineering, and controlled substance research collaborations. The Company has also disclosed the development of a proprietary library of psychedelic inspired compounds designed to optimize pharmacokinetic and therapeutic profiles. BioNxt filed a patent application covering a portfolio of such novel compounds, with the associated intellectual property retained by the Company.

Advanced Drug Delivery as the Missing Link in Next Generation Psychedelic Therapies

While early-stage psychedelic research has primarily focused on naturally occurring compounds, a critical barrier to broader clinical and commercial adoption remains the lack of standardized, scalable, and patient friendly delivery systems.

Current approaches often rely on oral administration or supervised clinical settings, which can limit dosing precision, onset control, and overall treatment scalability.

BioNxt's core expertise lies in advanced drug delivery technologies, including sublingual oral thin film systems and transdermal platforms. These technologies are designed to enable precise and reproducible dosing, rapid and controllable onset of action, improved bioavailability, and non-invasive administration.

These attributes are particularly important for central nervous system active compounds, where therapeutic outcomes are closely linked to pharmacokinetic control and patient experience.

The Company's thin film drug delivery platform has already been applied in neurological and autoimmune indications, including its lead cladribine program. This platform is supported by an expanding international intellectual property portfolio, including Eurasian patent No. 051510 and European patent No. 4539857 covering sublingual drug delivery compositions for neurodegenerative and autoimmune diseases.

By combining delivery precision with compound innovation, BioNxt believes it can help enable a new class of clinically viable psychedelic therapeutics better suited for scalable and regulated healthcare environments.

Unlocking Strategic Value Through Platform Leverage

BioNxt believes that its integrated approach, combining formulation science, proprietary delivery technologies, and prior compound development capabilities, positions the Company to evaluate opportunities in what may represent the next phase of psychedelic therapeutics, where delivery, dosing precision, and patient experience become key differentiators.

Importantly, this strategy enables a capital efficient approach by leveraging existing technologies, intellectual property, and prior research rather than building a new platform from inception.

"The global momentum behind psychedelic medicine is increasingly supported by both policy developments and advancing clinical research," said Prof. Dr. Raimar Löbenberg, Co-Founder and Director of BioNxt. "Within BioNxt, we have established meaningful capabilities in this field, particularly in compound development, including an already isolated and established library of psychedelic molecules, as well as advanced drug delivery platforms. We believe these technologies may play an important role in enabling next-generation central nervous system therapies, and we are actively evaluating how they can be applied in this emerging space."

Expanding Market Opportunity in Psychedelic and Mental Health Therapeutics

Mental health disorders represent one of the largest global healthcare challenges, affecting approximately 970 million people worldwide, or about one in eight individuals, according to the World Health Organization. Conditions such as depression, post-traumatic stress disorder, and substance use disorders continue to present significant unmet medical needs, with a substantial proportion of patients not responding adequately to existing therapies.

Within this landscape, psychedelic based therapies are increasingly being explored as potential treatment options for these difficult to treat conditions. The global annual psychedelic therapeutics market is currently estimated by Data Bridge Global Market Research to in the low single digit billion dollar range, with forecasts indicating double digit growth over the coming decade.

As the sector evolves, BioNxt's focus is not limited to individual compounds but rather on enabling technologies that may improve dosing precision, patient experience, and scalability, supporting the development of clinically viable therapies across multiple central nervous system indications.

Strategic Outlook and Next Steps

BioNxt will continue to evaluate strategic opportunities related to its psychedelic medicine platform, including potential research collaborations, licensing arrangements, and development pathways, aligned with its expertise in advanced drug delivery technologies.

Any future activities will be subject to regulatory considerations, availability of resources, and applicable controlled substance licensing requirements.

BioNxt does not make any claims regarding the safety or efficacy of psychedelic compounds. All such substances remain investigational and subject to regulatory approval.

About BioNxt Solutions Inc.

BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery platforms, diagnostic screening systems, and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets, and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumors while reducing side effects.

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: [email protected]
Phone: +1 780-818-6422

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 news release contains forward looking statements within the meaning of applicable securities laws. Forward looking statements are based on management's current expectations, estimates, projections, beliefs, and assumptions as of the date of this release.

Forward looking statements in this release include, but are not limited to, statements regarding the development and advancement of the Company's cladribine oral thin film program, the potential performance and applicability of its drug delivery platform across central nervous system and autoimmune indications, including multiple sclerosis and myasthenia gravis, the scope and strength of the Company's intellectual property portfolio, including its patent estate and ability to secure and maintain protection in key jurisdictions, the anticipated timing and outcomes of research and development activities, potential regulatory pathways, and potential commercialization, licensing, or partnering opportunities.

Forward looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, risks associated with research and development, scientific and technical challenges, the possibility that preclinical or early stage results may not be predictive of future outcomes, uncertainties related to regulatory review and approval, risks related to intellectual property protection and enforcement, manufacturing and scale up risks, reliance on third party partners and service providers, competitive developments in the pharmaceutical and drug delivery sectors, and general economic and capital market conditions.

Readers are cautioned not to place undue reliance on forward looking statements. Except as required by applicable securities laws, BioNxt undertakes no obligation to update or revise any forward looking statements to reflect new information, future events, or otherwise.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

A. Lefebvre--BTZ