Berliner Boersenzeitung - BioNxt Advances Cladribine Clinical Program for MS with Completion of the Investigational Medicinal Product Dossier (IMPD) Ahead of Human Clinical Studies

The IMPD is currently undergoing final technical and regulatory review prior to its planned submission as part of the Company's Clinical Trial Application (CTA) package in Europe. As one of the principal regulatory documents required to support clinical trial authorization, the IMPD consolidates the pharmaceutical, manufacturing, analytical, non-clinical and clinical documentation necessary for regulatory review of an investigational medicinal product.

Completion of this comprehensive dossier reflects the successful integration of BioNxt's proprietary formulation development, GMP manufacturing, analytical method development, quality systems and preclinical research into a single regulatory package designed to support regulatory review and the planned initiation of human clinical studies.

A Major Regulatory Milestone for BioNxt's Lead Drug Candidate

The Investigational Medicinal Product Dossier (IMPD) is among the most comprehensive regulatory submissions prepared during pharmaceutical product development. It provides regulators with detailed information regarding product quality, manufacturing controls, analytical validation, stability, non-clinical evaluation and the proposed clinical study design, serving as a cornerstone of the Clinical Trial Application process in Europe.

The IMPD was prepared with the support of BioNxt's pharmaceutical development partners and is currently undergoing final technical review prior to regulatory submission.

"Completion of the IMPD marks a significant achievement for BioNxt and reflects the tremendous progress our team and partners have made in advancing BNT23001 toward human clinical evaluation," said Hugh Rogers, Chief Executive Officer of BioNxt Solutions Inc. "Over the past several years, we have systematically advanced every major component of the program-from formulation development and GMP manufacturing to preclinical evaluation and regulatory documentation. With the IMPD now complete and undergoing final review, we are preparing for the next stage of regulatory engagement as we work toward initiating our first human clinical study. This milestone further validates our proprietary oral dissolvable film platform and demonstrates our ability to transform established pharmaceutical compounds into differentiated, patient-centric therapies."

Building a Comprehensive Clinical Development Package

Completion of the IMPD builds upon a series of important scientific, manufacturing and regulatory achievements, including:

• Development of BioNxt's proprietary BNT23001 sublingual cladribine oral dissolvable film (ODF);

• Completion of GMP process development and manufacture of the clinical trial batch;

• Successful comparative pharmacokinetic studies evaluating systemic exposure of the cladribine ODF formulation in relevant preclinical models;

• Successful completion of local tolerability studies supporting sublingual administration;

• Finalization of the clinical protocol for the planned human bioequivalence study;

• Secured patent protection in Europe and the Eurasian region covering BioNxt's proprietary sublingual cladribine technology.

Collectively, these accomplishments demonstrate the maturity of BioNxt's lead development program and provide the scientific, manufacturing and regulatory foundation supporting its planned transition into clinical development.

Advancing Toward Human Clinical Studies

Following completion of the IMPD and subject to regulatory review and approval, BioNxt intends to submit a Clinical Trial Application (CTA) for a randomized, open-label, crossover bioequivalence study comparing BNT23001 with the reference product, Mavenclad®, in healthy volunteers.

The planned study is designed to evaluate pharmacokinetic bioequivalence while assessing the safety and tolerability of BioNxt's proprietary sublingual formulation.

Successful completion of the planned study would represent an important clinical and regulatory milestone supporting the continued development of BNT23001 under BioNxt's hybrid regulatory pathway in Europe.

Advancing Next-Generation Drug Delivery

BioNxt's proprietary oral dissolvable film platform is designed for rapid sublingual administration, providing a needle-free and patient-friendly dosage form that dissolves without water and is intended to facilitate systemic drug exposure through transmucosal absorption.

The platform is being developed to improve treatment convenience, particularly for patients experiencing swallowing difficulties, while leveraging an established active pharmaceutical ingredient through an innovative drug delivery system.

By combining proprietary formulation technologies with approved pharmaceutical compounds, BioNxt believes its development strategy may enable a more efficient regulatory pathway than the development of entirely new molecular entities, while creating opportunities for differentiated lifecycle management of established therapeutics.

BioNxt's proprietary sublingual ODF platform is particularly well suited for neurological indications such as multiple sclerosis, where swallowing difficulties (dysphagia) affect approximately 45% of patients. By eliminating the need to swallow conventional oral tablets with water, the platform is designed to improve convenience, support patient adherence and provide a patient-friendly, needle-free alternative for individuals living with MS.

Expanding the Clinical Opportunity

BNT23001 is BioNxt's lead neurological development program and is initially being developed for the treatment of relapsing forms of multiple sclerosis.

The Company also believes its proprietary cladribine ODF platform has the potential to support future development opportunities in additional autoimmune neurological disorders, including myasthenia gravis, where patient-friendly, needle-free drug delivery may provide meaningful therapeutic and commercial advantages.

Beyond BNT23001, BioNxt continues to evaluate opportunities to expand its oral dissolvable film platform across additional therapeutic indications where improved drug delivery may enhance patient experience and support future product development.

The Company believes completion of the IMPD further strengthens the clinical and regulatory foundation of its proprietary oral dissolvable film platform and represents another important step in executing its strategy to advance innovative drug delivery technologies through clinical development and potential strategic partnering opportunities.

About BNT23001: BioNxt's Proprietary Cladribine ODF Candidate

BNT23001 is BioNxt's proprietary sublingual oral dissolvable film formulation of cladribine, developed as a needle-free alternative to conventional oral tablets for the treatment of relapsing forms of multiple sclerosis. The product is designed to deliver cladribine through the oral mucosa using BioNxt's proprietary oral dissolvable film platform with the objective of achieving systemic drug exposure comparable to the reference product while improving patient convenience and ease of administration. BioNxt is pursuing a hybrid regulatory pathway in Europe based on demonstration of bioequivalence to the reference product, Mavenclad®.

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 more selectively to tumors with the goal of reducing systemic exposure.

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

Email: [email protected]

Wolfgang Probst
Co-Founder, CFO & Director
Phone: +49 151 25284192

Hugh Rogers
Co-Founder, CEO & Director
Phone: +1 604-250-6162

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 information" and "forward-looking statements" within the meaning of applicable Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements are based on management's current expectations, estimates, projections, beliefs and assumptions as of the date of this news release and are subject to known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements.

Forward-looking statements in this news release include, but are not limited to, statements regarding the completion, review and planned submission of the Investigational Medicinal Product Dossier (IMPD); the planned submission of a Clinical Trial Application (CTA); the timing, design, initiation and completion of planned human bioequivalence studies; the continued development and advancement of BNT23001 and the Company's proprietary oral dissolvable film (ODF) platform; anticipated regulatory review processes and approvals; the Company's hybrid regulatory pathway in Europe; the therapeutic, commercial and strategic potential of its product candidates and drug delivery technologies; future development activities; intellectual property protection; commercialization, licensing and strategic partnering opportunities; and the achievement of future development, regulatory and commercial milestones.

Forward-looking statements involve significant risks, uncertainties and assumptions, many of which are beyond the Company's control. These include, without limitation, risks associated with pharmaceutical research and development; formulation development; manufacturing and scale-up; analytical method development; preclinical and clinical testing; regulatory review, approvals and inspections; preparation and acceptance of regulatory submissions; intellectual property protection and enforcement; reliance on third-party manufacturers, suppliers, contract research organizations and development partners; product performance; financing requirements; market acceptance; competitive technologies; and general economic, financial and capital market conditions.

There can be no assurance that the Company's planned regulatory submissions, clinical studies or development activities will proceed as currently anticipated or at all, that regulatory authorities will accept the Company's submissions or grant required approvals, that intellectual property protection will be obtained or maintained as expected, or that any product candidate will successfully complete clinical development or achieve commercialization. Readers are cautioned not to place undue reliance on these forward-looking statements.

Except as required by applicable securities laws, BioNxt Solutions Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Mavenclad® is a registered trademark that is not owned by, affiliated with, sponsored by, or associated with BioNxt Solutions Inc.

SOURCE: BioNxt Solutions Inc.

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