Cladribine

VANCOUVER, BC / ACCESS Newswire / August 4, 2026 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to provide a comprehensive update on the progress of its proprietary sublingual thin-film drug delivery pipeline. The Company continues to advance multiple pharmaceutical development programs, including Cladribine for multiple sclerosis, autoimmune disease expansion, Everolimus and Semaglutide, while strengthening the intellectual property portfolio supporting its platform and preparing for the next phase of clinical and commercial development. "Our vision has always been to build a differentiated pharmaceutical platform capable of improving the delivery of established therapies across multiple high-value therapeutic areas," said Hugh Rogers, Chief Executive Officer of BioNxt Solutions. "During the past several months we have continued executing against that strategy through scientific development, manufacturing preparation, intellectual property expansion and pipeline diversification. We believe these achievements position BioNxt for an important next stage of growth as we advance toward clinical evaluation and future commercialization." Cladribine Program Advancing Toward Clinical Development BioNxt's lead program remains its proprietary sublingual Cladribine oral dissolvable film ("ODF") for the treatment of multiple sclerosis (MS). ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Over the past several months, the Company has continued advancing activities supporting the transition from pharmaceutical development into clinical execution. Current activities include regulatory documentation, analytical and manufacturing preparation, and planning for the Company's first human bioavailability study. BioNxt believes its proprietary sublingual formulation has the potential to improve patient convenience by providing a needle-free, orally dissolving dosage form while leveraging the established therapeutic pro Cladribine. The Company also continues evaluating strategic commercialization opportunities and discussions with potential development and licensing partners to maximize the long-term value of the program. Expanding Opportunities in Autoimmune Diseases Building upon the Cladribine platform, BioNxt continues evaluating additional autoimmune indications where its proprietary drug delivery technology may provide meaningful clinical and commercial advantages. The Company's intellectual property portfolio supports potential applications beyond multiple sclerosis, including Myasthenia Gravis and other autoimmune neurological disorders. BioNxt continues assessing future development priorities and regulatory pathways for these additional indications. Everolimus Program Progress BioNxt continues advancing formulation development for its proprietary sublingual Everolimus ODF program. Everolimus is an established pharmaceutical used in organ transplantation and oncology and has attracted increasing scientific interest for potential applications in longevity and healthy ageing research. The Company continues optimizing formulation characteristics while evaluating future preclinical and clinical development pathways. Semaglutide Program Initiated BioNxt has initiated development of its proprietary sublingual Semaglutide ODF program, expanding its platform into one of the world's fastest-growing pharmaceutical markets. The active pharmaceutical ingredient (API) has been ordered, and development activities are being prepared to commence upon receipt. Initial work will focus on formulation development and evaluating the suitability of BioNxt's proprietary thin-film platform for peptide-based therapeutics. The program represents an important strategic expansion of the Company's platform into metabolic disease and GLP-1 therapies. Strengthening Global Intellectual Property BioNxt continues strengthening the intellectual property foundation supporting its proprietary drug delivery platform. The Company has secured patent protection for its core Cladribine thin-film technology in both Europe and Eurasia, representing the culmination of several years of scientific research, formulation development and intellectual property strategy. These patent grants establish an important foundation for future clinical development, commercial partnerships and licensing opportunities. In the United States, the Company's corresponding patent application continues under the U.S. Patent and Trademark Office's Track One Prioritized Examination program, which is intended to accelerate examination and final disposition. Additional patent applications continue progressing through examination in other key international jurisdictions. BioNxt believes a robust international patent portfolio is fundamental to maximizing the commercial potential of both its lead Cladribine program and future pipeline assets developed using its proprietary sublingual drug delivery platform. Building a Diversified Pharmaceutical Pipeline BioNxt continues executing a disciplined development strategy focused on advancing multiple proprietary pharmaceutical programs through formulation, manufacturing, regulatory preparation and clinical development. By leveraging a common sublingual thin-film technology platform across multiple therapeutic areas-including neurology, autoimmune diseases, longevity and metabolic disorders-the Company aims to create multiple long-term value creation opportunities while reducing reliance on a single development asset. The Company expects to provide additional updates as key development, regulatory, intellectual property and commercial milestones are achieved. 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 . Investor Relations & Media Contact Email: investor.relations@bionxt.com Wolfgang Probst Co-Founder, CFO & Director Phone: +49 151 25284192 Hugh Rogers Co-Founder, CEO & Director Phone: +1 604-250-6162 Web: LinkedIn: Instagram: Cautionary Statement Regarding "Forward-Looking" Information This news release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable 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 development, advancement, regulatory pathway and potential commercialization of the Company's pharmaceutical pipeline, including its Cladribine, Everolimus, Semaglutide and other sublingual thin-film programs; the advancement of additional autoimmune disease programs; planned formulation, manufacturing, preclinical and clinical development activities; regulatory submissions and approvals; human bioavailability studies; commercialization, licensing and strategic partnering opportunities; the potential therapeutic and commercial advantages of the Company's proprietary drug delivery platform; the examination, prosecution and potential grant of pending patent applications, including the Company's U.S. Track One prioritized patent application; the scope and value of the Company's intellectual property portfolio; and the anticipated timing and achievement of future development milestones. SOURCE: BioNxt Solutions Inc. View the original press release on ACCESS Newswire

Under new CEO Kai Beckmann, Merck KGaA is emphasizing M&A to stock its early- to mid-stage pharma pipeline, the company said in reporting its first quarter results on Wednesday. Merck KGaA made its largest acquisition in a decade in April 2025, when it snapped up Connecticut rare disease specialist SpringWorks Therapeutics for $3.9 billion. A year later, as the German conglomerate presented its first-quarter earnings, it reiterated its focus on M&A, largely to fuel its pharma pipeline.“We will broaden our M&A scope,” new CEO Kai Beckmann said during a conference call.In laying out the company’s business update (PDF), Beckmann said M&A is a growth lever that is “critical” for innovation and that acquiring external innovation is needed to build a risk-balanced pharma pipeline.“By combining our core strengths in biology, chemistry and physics with data and AI, we will become a more agile company that delivers at greater speed and scale,” Beckmann said.While Merck KGaA has three unrelated phase 3 programs, the company’s Healthcare CEO, Danny Bar Zohar, called its early- to midstage pipeline “rather slim.”“We need to build that in order to sustain, or to ensure, that we grow beyond that low-to-mid single-digit mid-term guidance that we gave you beyond 2030, beyond 2031,” Bar Zohar said. “This is something that we need to start building now.” After the 2024 failure of BTK inhibitor evobrutinib, Merck KGaA is relying heavily on a trio of late-stage oncology assets, including pimicotinib, which is under review by the FDA, and antibody-drug conjugate precemtabart tocentecan. The company is also pointing to a second-half launch in the U.S. of the fertility drug Pergoveris, which is being assessed under the FDA’s new Commissioner’s National Priority Review Voucher (CNPV) program.Merck KGaA reported first-quarter sales of 5.1 billion euros, down from 5.3 billion euros in the same period last year. Healthcare sales fell 3%, driven largely by a 5% decline in oncology product sales and a 9% drop in neurology and immunology treatment sales. That segment includes multiple sclerosis drug Mavenclad, which posted a 7% sales decline. The company raised its revenue projection by 10 million euros at the midpoint of its guidance range, as competition for Mavenclad is expected to arrive two months later than previously anticipated. The company also attributed a 16% increase in Process Solutions revenue to stockpiling of lab supplies by clients anticipating supply chain disruptions tied to the war in Iran.With the upgraded guidance, Merck KGaA’s share price increased by 8%.