공지 • Jan 22
BioNxt Solutions Inc. Reports Final Preclinical Results Demonstrating Approximately 40% Higher Cladribine Delivery BioNxt Solutions Inc. reported final results from a preclinical pig study demonstrating that its proprietary needle-free, swallow-free sublingual oral dissolvable film (ODF) cladribine formulation for the treatment of Multiple Sclerosis (MS) achieved significantly higher systemic drug delivery than a conventional oral tablet formulation of cladribine, such as those used in commercially successful therapies such as Mavenclad®?, which has reported annual global sales exceeding USD 1.2 billion and sustained double-digit growth. The results represent an important development milestone for BioNxt, demonstrating in a robust large-mass non-rodent model that reformulating cladribine as a sublingual oral dissolable film can materially improve systemic drug delivery compared with conventional oral tablet dosing. By directly comparing two fundamentally different routes of administration under controlled conditions, the study helps de-risk the clinical development and commercialization pathway and supports the rationale for advancing the sublingual ODF formulation into human pharmacokinetic studies. Final Study Results Validate the Efficiency of BioNxt's Sublingual Delivery Approach. The completed preclinical pig study showed that BioNxt's cladribine sublingual oral dissololvable film achieved meaningfully higher systemic drug availability than the conventional oral tablet formulation. Systemic exposure was assessed over a 48-hour period using AUC (0-48 h), a widely accepted calculated measure based on repeated blood concentration measurements that reflects how much drug reaches the bloodstream and how long it remains there. In this study, the approximately 40% higher AUC observed for BioNxt's sublingual ODF indicates that a greater amount of cladribine reached systemic circulation and was maintained for a longer period compared with conventional oral tablet administration. This finding supports the conclusion that the sublingual delivery approach provides more efficient and consistent overall drug availability under the study conditions. Importantly, improved delivery efficiency may also support dose optimization in future studies, with the potential to reduce systemic drug burden at equivalent therapeutic exposure and, in turn, improve tolerability and reduce side effects, an outcome BioNxt intends to evaluate in planned clinical development. Robust Preclinical Pig Model with High Translational Relevance. De-Risking the Transition Toward Human PK Studies. While Multiple Sclerosis remains the initial development focus, BioNxt views its sublingual oral dissol solvable film (ODF) technology as a scalable delivery platform with potential applications across a broader range of neuro-immunological and neurological diseases. As a first step beyond MS, the Company believes its cladribine ODF approach may also be applicable to indications such as Myasthenia Gravis (MG), where swallowing difficulties are common and needle-free, swallow- free sublingual therapies may offer meaningful clinical advantages. Beyond individual indications, BioNxt's platform strategy is designed to enable the reformulation of multiple established and late-stage drug candidates, particularly in chronic diseases where adherence, tolerability, and ease of administration are critical. Because the ODF platform focuses on optimizing the delivery of active ingredients that are already approved and widely used in clinical practice, development efforts can concentrate on pharmacokinetics, bioequivalence, and patient usability rather than on new molecular discovery. 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. BioNxt is committed to improving healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide. Forward-looking information includes, but is not limited to, statements regarding the interpretation and significance of the Company's preclinical study results; the potential advantages of BioNxt's sublingal oral dissolvable film ("ODF) technology; the planned progression into human pharmacokinetic and bioequivalence studies; the potential applicability of the Company's drug-delivery platforms to additional therapeutic indications; and statements regarding future development, regulatory, commercialization, licensing, or partnering activities. 공지 • Sep 08
BioNxt Solutions Inc., Annual General Meeting, Nov 07, 2025 BioNxt Solutions Inc., Annual General Meeting, Nov 07, 2025. Location: british columbia, vancouver Canada 공지 • Jul 13
BioNxt Solutions Inc. announced that it expects to receive CAD 1.2 million in funding BioNxt Solutions Inc. announces a non-brokered private placement to issue 2,000,000 Convertible debenture Units at a price of CAD 0.60 per unit for gross proceeds of CAD 1,200,000 on June 11, 2025. Each Debenture Unit consists of CAD 0.60 principal amount of 8.0% unsecured convertible debentures and one common share purchase warrant. Each Warrant entitles the holder to acquire one common share in the capital of the Company at a price of CAD 0.75 per Common Share for a period of two years following the date of issuance. The Debentures bear interest from their issue date at 8.0% per annum on an accrual basis, calculated and payable on an annual basis, up to and including the date which is two years following the date of issuance. 공지 • Mar 15
BioNxt Solutions Inc. announced that it has received CAD 2.5 million in funding On March 14, 225, BioNxt Solutions Inc., closed the transaction. The company issued 1,800,000 Debenture Units for CAD 900,000 in its second and final tranche closing. As a part of the transaction, the company paid CAD 72,000 as finder fee and 144,000 Finder’s Warrants. 공지 • Feb 25
BioNxt Solutions Inc. announced that it expects to receive CAD 2.5 million in funding Bionxt Solutions Inc. announced a non-brokered private placement of debenture units with each unit consisting of CAD 0.50 in principal amount of debenture bearing interest at a rate of 8% per annum for a period of two years following the closing date, convertible into a common share in the capital of the company and one common share purchase warrant exercisable at CAD 0.60 for a period of two years, for gross aggregate proceeds of up to CAD 2,500,000 on February 24, 2025. The company anticipates issuing up to 400,000 compensation warrants, each exercisable into one common share in the capital of the company at CAD 0.50 per finder's warrant, to eligible finders who introduce subscribers for the offering to the company, in addition to paying finders' fees in cash of up to 8% of the subscriptions so introduced. All securities issued in connection with the offering, including the finders' warrants, will be subject to a hold period of four months and one day from the date of issuance. Completion of the offering is subject to a number of conditions, including, but not limited to, receipt of any regulatory approvals as necessary. 
