Berliner Tageblatt - Over 40% of Adults Struggle to Swallow Pills - BioNxt Targets a Global Adherence Problem with Rapid-Dissolving Thin-Film “Melt-in-Your-Mouth” Therapies

In response, BioNxt has developed a proprietary rapid-dissolving, "melt-in-your-mouth" thin-film drug delivery platform and recently secured its first national-level patent, marking a major step toward commercialization in several high-value autoimmune markets.

Solving a Real Patient Problem: When Pills Are Hard to Swallow

Dysphagia is not a minor complaint - it is a structural barrier in chronic disease management. A recent systematic review found that the pooled prevalence of dysphagia in MS patients is about 45% (Source: medrxiv.org / Journal of Clinical Neuroscience). MG patients also frequently report swallowing difficulty as one of their most burdensome symptoms, with multiple studies highlighting dysphagia as a key clinical feature of the disease.

These challenges occur in disease areas representing multi-billion-dollar global markets. For example, the global MS drugs market is forecast to reach around USD 40-45 billion by 2033 (Source: ihealthcareanalyst.com; valuemarketresearch.com). Recent market analyses project the global MG treatment market to grow to between USD ~2.7-4.7 billion by 2032 (Source: fortunebusinessinsights.com; grandviewresearch.com).

For these patients, large tablets present a daily physical challenge, while injectable therapies introduce additional anxiety and treatment burden. BioNxt's thin-film technology - designed to dissolve under the tongue within seconds - offers a swallow-free, needle-free alternative that aligns with the real-world needs of autoimmune patients. The water-free format allows dosing anytime and anywhere, while being designed to reduce the risk of choking associated with conventional tablets.

The thin film melts rapidly and is absorbed through the sublingual mucosa, allowing a portion of the drug to bypass gastrointestinal transit and first-pass liver metabolism, which may support more rapid absorption and improved bioavailability through sublingual uptake. This approach is particularly relevant in chronic autoimmune conditions such as Lupus Nephritis (LN) and Rheumatoid Arthritis (RA).

"When up to 40% of adults report difficulty swallowing pills, and dysphagia affects roughly 45% of patients with multiple sclerosis, the dosage form becomes a key driver of adherence - not a secondary consideration," said Hugh Rogers, CEO of BioNxt Solutions Inc. "Our rapid-dissolving thin films melt under the tongue within seconds, are taken without water, and are designed to support reliable, comfortable dosing in everyday life."

First Patent Granted: Foundation for Commercialization and Global IP Protection

BioNxt recently received its first patent protecting BNT23001, a proprietary sublingual cladribine film intended for MS and MG. The reference drug, cladribine tablets (Mavenclad®), achieved annual sales exceeding USD 1.0 billion, reaching blockbuster status (Source: merckgroup.com). This underscores strong commercial demand for cladribine within the MS treatment landscape.

The newly granted Eurasian patent, valid through 2043, covers more than 200 million people across eight member states. It represents the first issued member of BioNxt's expanding global IP estate, with additional applications progressing in Europe, North America, and Asia-Pacific - regions that together account for the largest share of global autoimmune drug spending.

BioNxt has completed GMP clinical batch manufacturing for BNT23001 and is preparing for a comparative human bioequivalence study scheduled for the first quarter of 2026. Because cladribine is already approved as an oral tablet, the Company expects an accelerated, bioequivalence-driven regulatory pathway, reducing development timelines, clinical risk, and capital requirements compared with de novo drug development (Source: company development plans and regulatory framework for generic/bioequivalent products).

A Scalable Platform Strategy Supported by a Growing Patent Family

While BNT23001 leads development, BioNxt's thin-film technology is inherently platform-based and is protected as part of a broader patent family. This IP architecture supports the reformulation of multiple approved drugs across autoimmune and chronic disease categories - markets which, when combined, are projected to exceed USD 75-80 billion annually over the next decade (Source: grandviewresearch.com).

Each thin-film formulation benefits from shared manufacturing infrastructure, a streamlined bioequivalence-focused clinical pathway, and robust layered patent protection across key jurisdictions. This combination of platform scalability and IP strength provides BioNxt with pipeline diversification, reduced development risk, and strong partnering leverage in regional and global pharmaceutical markets.

The Company's technology sits within the broader oral transmucosal drug-delivery market, which is expected to grow from approximately USD 45.8 billion in 2025 to nearly USD 96.8 billion by 2033 (Source: sharewise.com citing market research on oral transmucosal systems). This reflects a clear industry shift toward patient-friendly, non-invasive drug delivery formats such as sublingual and buccal films.

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: [email protected]
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 news release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Forward-looking information in this news release includes the anticipated filing date of the Annual Filings. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.

SOURCE: BioNxt Solutions Inc.

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C.Meier--BTB