View Financial HealthBioNxt Solutions 配当と自社株買い配当金 基準チェック /06BioNxt Solutions配当金を支払った記録がありません。主要情報n/a配当利回り-4.6%バイバック利回り総株主利回り-4.6%将来の配当利回りn/a配当成長n/a次回配当支払日n/a配当落ち日n/a一株当たり配当金n/a配当性向n/a最近の配当と自社株買いの更新更新なしすべての更新を表示Recent updatesお知らせ • Jan 22BioNxt Solutions Inc. Reports Final Preclinical Results Demonstrating Approximately 40% Higher Cladribine DeliveryBioNxt 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.お知らせ • Jan 21+ 1 more updateBionxt Reports Successful Final In-Vivo Dosing Study Results Supporting Superior Bioavailability of Cladribine Sublingual OdfBioNxt Solutions Inc. announced that it has completed and received preliminary results from its comparative pharmacokinetics ("PK") large-mass animal study in pigs. The study measured how efficiently cladribine is absorbed into the bloodstream over time and compared BioNxt's proprietary orally dissolving film ("ODF") with the reference tablet formulation, evaluating the Company's swallow-free, sublingual ODF formulation for Multiple Sclerosis (MS). BioNxt reports that the study outcome was successful and supports superior bioavailability for the Company's cladribine ODF formulation under the study conditions. The Company has initiated a full internal screening and assessment of the final dataset, including calculations and interpretation of key pharmacokinetic parameters. Further information will be provided once BioNxt has completed its comprehensive internal analysis. To evaluate how effectively BioNxt's swallow-free cladribine ODF delivers cladribine into the bloodstream, the Company conducted a comparative crossover pharmacokinetics study in adult pigs, weighing approximately 40-50 kg. This specific breed of pig is widely used in pharmaceutical research as a non-rodent large-mass preclinical model due to their high physiological, anatomical, and metabolic similarities to humans, particularly in drug absorption and systemic exposure. The objective was to compare BioNxt's cladribine 10 mg orally dissolving film (ODF) with the reference name-brand 10 mg tablet, a commercially established Multiple Sclerosis therapy with annual global sales exceeding USD 1 billion and continued double-digit annual growth, with both formulations administered at a single dose equivalent to 5 mg of cladribine per animal. The reference tablet was administered by oral dosing via gavage, while the ODF was placed directly into the oral cavity to support sublingual absorption. To track cladribine levels over time, blood samples were collected before dosing and at several time points over 24 hours following administration. This allowed BioNxt to measure key performance indicators such as peak concentration, overall exposure, and how long cladribine remained in the body, supporting a clear assessment of bioavailability. The study was initiated in November 2025 and completed in December 2025, with the final dataset now received by the Company for internal analysis. The Company's study results confirm that enhanced bioavailability achieved through sublingual ODF delivery materially improves delivery efficiency compared with conventional oral administration. By enabling more efficient absorption of cladribine into the bloodstream, the ODF approach supports the achievement of therapeutic exposure with lower overall systemic drug exposure, which is a critical factor in managing tolerability for immunomodulatory therapies such as cladribine. This improved delivery efficiency directly supports BioNxt's strategy to reduce unnecessary systemic burden, creating the foundation for a meaningful reduction in dose-related side effects while maintaining pharmacokinetic performance. In addition, the swallow-free, sublingual ODF format offers a more patient-friendly treatment experience, particularly for patients with swallowing difficulties or sensitivity to conventional oral dosage forms. BioNxt views these findings as a key validation of its ODF drug-delivery platform and a strategically important step in building a differentiated Multiple Sclerosis therapy profile with strong commercial and partnering potential. Multiple Sclerosis represents a large global market, with approximately 2.3 million people living with MS worldwide and forecasts indicating the global MS drug market is expected to exceed USD 41 billion by 2033. Within this market, Mavenclad® (cladribine tablets) is a well-established high-efficacy therapy with annual global sales exceeding USD 1 billion and sustained double-digit growth, although systemic oral therapy can require monitoring and may be associated with adverse effects that influence real-world adoption. Cladribine also holds promise for the treatment of additional neurodegenerative diseases, such as Myasthenia Gravis (MG). BioNxt further confirms that patent protection for its cladribine ODF program has already been confirmed, with additional final (national level) patent grants expected shortly, strengthening the Company's intellectual property position and supporting potential future licensing and partnering opportunities. BioNxt has initiated internal screening and full evaluation of the study dataset and expects to provide additional disclosure once final calculations, interpretation, and internal validation are complete. The Company intends to share further updates regarding next development milestones in due course.お知らせ • Sep 08BioNxt Solutions Inc., Annual General Meeting, Nov 07, 2025BioNxt Solutions Inc., Annual General Meeting, Nov 07, 2025. Location: british columbia, vancouver Canadaお知らせ • Jul 13BioNxt Solutions Inc. announced that it expects to receive CAD 1.2 million in fundingBioNxt 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.お知らせ • Mar 15BioNxt Solutions Inc. announced that it has received CAD 2.5 million in fundingOn 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.お知らせ • Feb 25BioNxt Solutions Inc. announced that it expects to receive CAD 2.5 million in fundingBionxt 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.お知らせ • Jan 15BioNxt Solutions Inc. announced that it has received CAD 3 million in fundingOn January 14, 2025. BioNxt Solutions Inc. closed the transaction. it has issued notes with the principal amount of CAD 890,000. In connection with the offering, the company paid a cash fee of CAD 71,200 and issued 284,800 finder warrants to Canaccord Genuity Corp. Each finder's warrant entitles the holder thereof to purchase one common share at an exercise price of CAD 0.25 for a period of 24 months from the date of issuance.お知らせ • Dec 09BioNxt Solutions Inc. Reports Progress on BNT23001 Development for Multiple Sclerosis TreatmentBioNxt Solutions Inc. has achieved key milestones in the development of BNT23001, its proprietary sublingual thin-film (OFD) formulation of Cladribine for the treatment of Multiple Sclerosis (MS). These achievements in 2024 lay the groundwork for clinical trials and regulatory submissions in 2025, reinforcing BioNxt's commitment to advancing patient-centric therapeutic solutions. Preclinical Success: BNT23001 demonstrated high absorption rates of Cladribine through sublingual delivery in pharmacokinetic (PK) studies conducted in animal models. These studies confirmed the product's bioequivalence to the originator therapy, Mavenclad®, and validated the thin-film's rapid absorption and safety profile. Toxicity studies further demonstrated no adverse local effects, highlighting the viability of the sublingual delivery approach. Advancements in Manufacturing: BioNxt successfully transferred the BNT23001 production process to its GMP-certified manufacturing partner, Gen-Plus GmbH & Co KG in Munich (Germany), ensuring readiness for clinical batch production. This milestone supports the Company's plan to initiate clinical trials in 2025 with reliable, high-quality product supply. Strengthened Intellectual Property Position: A favorable International Preliminary Report on Patentability (IPRP) confirmed BNT23001's novelty, inventive step, and industrial applicability, underscoring its unique value in MS treatment. The Company has initiated patent nationalization in major jurisdictions, including Europe, the United States, and Canada, with patent grants anticipated in several regions by mid-2025. 2025 Roadmap: Advancing BNT23001 into Clinical Trials. Manufacturing Clinical Batches: BioNxt will complete GMP manufacturing and Qualified Person (QP) release of clinical trial batches in the second quarter of 2025. This step is critical for the successful initiation of human studies. Regulatory Filings and Approvals: The Company plans to submit the Investigational Medicinal Product Dossier (IMPD) to European regulatory authorities by mid-2025, paving the way for clinical trial approval. These regulatory submissions will include data from preclinical studies and stability assessments conducted at the manufacturing site. Clinical Study to Validate Performance: BioNxt aims to launch a pilot clinical study in the latter half of 2025. This trial will compare the efficacy, bioavailability, and safety of BNT23001 to Mavenclad®, the originator tablet product, positioning the thin-film formulation as a patient-friendly alternative. Ongoing Patent Protection: In addition to continuing the patent nationalization process, BioNxt expects granted patents in key regions to strengthen its intellectual property portfolio and provide competitive advantages as the product moves toward commercialization. BNT23001: Advancing Toward Clinical Validation for MS Treatment: BNT23001 offers a novel approach to MS management by addressing limitations in traditional oral therapies. Its sublingual thin-film format provides: Convenience: Easy-to-use and portable, ideal for patients with difficulty swallowing or active lifestyles. Rapid Absorption: Direct delivery through the sublingual mucosa for faster therapeutic action. Improved Compliance: A patient-friendly alternative designed to enhance adherence to prescribed regimens. By delivering these advantages, BNT23001 aligns with BioNxt's mission to improve outcomes for patients living with chronic diseases like MS.お知らせ • Nov 26BioNxt Solutions Inc. Announces Enhanced Sublingual Product Development Pipeline with Innovative Solutions for Autoimmune Diseases and LongevityBioNxt Solutions Inc. announced the expansion of its next-generation product pipeline. This includes proprietary Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated Tablet) drug delivery systems targeting autoimmune diseases such as Multiple sclerosis ("MS"), Myasthenia gravis ("MG"), Lupus nephritis ("LN"), and Rheumatoid arthritis ("RA"), as well as an exciting initiative in the fast-growing longevity market. These advancements highlight BioNxt's commitment to developing innovative, patient-centric solutions to improve compliance, enhance drug bioavailability, and address critical unmet medical needs. Pipeline Highlights: BioNxt Lead Product BNT23001: Multiple sclerosis (MS); BioNxt's lead pipeline product for MS is a proprietary sublingual (thin-film) formulation of Cladribine, offering an innovative alternative to traditional oral tablets. This next-generation delivery system is designed to overcome the challenges of swallowing difficulty, a common issue among MS patients, while enhancing drug absorption and compliance. Cladribine tablets are currently approved in over 75 countries and achieved sales exceeding USD 1 billion in 2023 (Merck KGaA). With the global MS drug market projected to exceed USD 41 billion by 2033 (Market.us), BioNxt's sublingual (thin- film) product offers a unique, patient-friendly approach. BioNxt BNT23001: Myasthenia gravis (MG). Building on its MS expertise, BioNxt is repurposing its sublingual (thin- Film) Cladribine technology for Myasthenia gravis, a chronic neuromuscular condition that causes muscle weakness and fatigue. Patients with MG often face difficulty swallowing, making BioNxt's sublingal delivery system an ideal solution. The global MG market is anticipated to reach USD 6.7 billion by 2032 (Clinical Trials Arena). BioNxt BNT24002: Lupus nephritis (LN). BioNxt is developing a proprietary sublingual (thin-film) product for Lupus nephritis, a serious autoimmune condition that can lead to kidney failure. This innovative drug delivery system focuses on maximizing bioavailability while minimizing side effects, addressing a critical gap in the LN treatment market, which is expected to grow to USD 3.2 billion by 2032. BioNxt BNT24003: Rheumatoid arthritis (RA) Rheumatoid arthritis is a prevalent autoimmune condition affecting millions globally, causing joint pain, switching, and reduced mobility. BioNxt is leveraging its expertise in sublingual (thin-fil) and oral (enteric-coated tablet) technologies to develop proprietary solutions that improve compliance and therapeutic outcomes. The global RA drug market is projected to surpass USD 27 billion by 2033 (Precedence Research). BioNxt BNT 24004: Formulation for L longevity and Anti-Aging: BioNxt is also entering the booming longevity and anti-aging sector, projected to reach USD 93 billion by 2027 (Statista). The Company is advancing proprietary sublingual (thin the LN) and oral (enterIC-coated tablet) drug products with active pharmaceutical ingredients that show early-stage evidence of benefits such as slowing ovarian aging, extending fertility, and promoting healthy aging.お知らせ • Oct 29BioNxt Solutions Inc. announced that it expects to receive CAD 3 million in fundingBioNxt Solutions Inc. announced a non-brokered private placement that it will issue convertible debentures for the gross proceeds of up to CAD 3,000,000 on October 28, 2024. The Debentures will bear interest from their issue date at 8% per annum and will mature two years following the closing date. The Debentures are unsecured and will rank pari passu in right of payment of principal and interest with all the existing and future unsecured indebtedness of the Company. Pursuant to a price reservation filed with the Canadian Securities Exchange on October 25, 2024, the principal amount of each Debenture will be convertible at the option of the holder into common shares in the capital of the Company at any time prior to the maturity date at a conversion price of CAD 0.25 per Common Share. Conversion of the Debentures may be forced at the option of the Company if the 15-day volume weighted average price of the Common Shares on the Canadian Securities Exchange exceeds 250% per share of the conversion price. All securities issued in connection with the Offering will be subject to a statutory hold period of four months and one day following the closing date of the Offering in accordance with applicable securities legislation. Completion of the Offering is subject to a number of conditions, including, but not limited to, the receipt of all regulatory approvals. The Company may pay a finder's fee in connection with the Offering to eligible arm's length finders in accordance with the policies of the Canadian Securities Exchange.お知らせ • Sep 26Bionxt Solutions Inc. Provides Update on Cladribine Program for Multiple Sclerosis, Sublingual Neurodegenerative Disease PatentBioNxt Solutions Inc. provided an update on its sublingual Cladribine drug formulation program for the treatment of Multiple Sclerosis ("MS"), broad sublingual patent application for the use of anticancer drugs for the treatment of autoimmune neurodegenerative diseases, and investor relations activities. BioNxt's lead program is the development of a 100% owned and proprietary sublingual ClADribine dosage form, directed at the MS market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with 2023 annual sales in excess of one billion USD according to Merck KGaA. Cladribine tablets is approved for several indications, namely highly active forms of relapsing-remitting MS. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is anticipated to top USD 41 billion by 2033 according to Market.us. BioNxt's sublingual Cladribines product is expected to yield a significant advantage over the tablet form for patients suffering from Dysphagia (diff difficulty allowing), which is a common symptom among MS patients. In the first half of 2024, the Company announced positive results for both its sublingual Cladivine animal toxicity study and animal pharmacokinetics ("PK") studies. The animal toxicity study results demonstrated zero adverse clinical abnormalities or indications of toxicity in any participants after consecutive days of dosing. The PK study results demonstrated highly comparable rapid absorption and bioequivalence between the Company's sublingual product and the name-brand reference drug for all administered samples. The next steps in the development and commercialization process include technology and process transfer, upscaling of manufacturing capability, analytical method development and validation, and clinical sample manufacturing preparation, manufacturing, and product release for use in the human comparative bioequivalence study planned for early First Quarter 2025. The bioequivalence study will be carried out with a European contract research organization in accordance with EU medical regulatory guidelines. On September 9, 2024, BioNxt reported that the European Patent Office ("EPO") issued a positive international examination report for the Company's comprehensive patent application for sublingual delivery of anticancer drugs for thetreatment of autoimmune neurodegenerative disease, such as MS. The Company expects the EU patent to be granted within four weeks and to rapidly enter the national phase of the Patent Cooperation Treaty ("PCT") patent process with submissions planned for the US, Canada, China, Japan, Australia, and other jurisdictions. BioNxt plans to continue development of and extend its patent portfolio regarding sublingual drug products containing highly potent anticancer compounds for neurodegenerative diseases. MG patients also commonly experience Dysphagia whereby a sublingual product is expected to yield asignificant advantage over conventional tablet forms. The global MG market is expected to reach USD 6.7 billion by 2032 according to Clinical Trials Arena. In general, the expectation of continued increasing prevalence of Central Nervous System ("CNS") pathologies will drive investment into new drugs and new drug delivery systems capable of targeting these diseases. The market size for drugs to treat CNS diseases is growing and expected to reach USD 238.8 billion by 2032 according to GMI Market Insights. The Options are exercisable for two years and will vest in stages over a 12-month period with 25% vesting every three months from the date of issuance.お知らせ • Sep 11BioNxt Solutions Inc. Receives Positive International Examination Report from the European Patent Office for Broad Patent Application for Sublingual Delivery of Anticancer Drugs for the Treatment of Autoimmune Neurodegenerative DiseasesBioNxt Solutions Inc. reported that the European Patent Office ("EPO") has issued a positive international examination report for the Company's comprehensive patent application for sublingual delivery of anticancer drug for the treatment of autoimmune neurodegenerative diseases. The Company expects the EU patent to be granted within eight weeks and to rapidly enter the national phase of the Patent Cooperation Treaty ("PCT") patent process with submissions planned for the US, Canada, China, Japan, Australia, and other jurisdictions. BioNxt plans to continue development of and extend its patent portfolio regarding orally dispersible films ("ODFs") containing highly potent anticancer compounds for neurodegenerative diseases. The Company intends to file several related provisional patent applications in the EU with three to four patents expected to be on file in multiple major international jurisdictions by late 2025 to early 2026 with potential patent protection extending to 2045. BioNxt's lead program is the development of a 100% owned and proprietary ODF Cladribine dosage form, directed at the multiple sclerosis ("MS") market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with 2023 annual sales in excess of one billion USD according to Merck KGaA. Cladribine tablets are approved for several indications, namely highly active forms of relapsingremitting MS. Further to the Company's MS program, BioNxt announced that its second clinical indication using anticancer compounds in an ODF delivery system will be Myasthenia Gravis ("MG"). MG is an autoimmune and neuromuscular disease characterised by muscle weakness and fatigue. Similar to MS patients, MG patients commonly experience Dysphagia (difficulty swallowing), which is expected to yield a significant advantage to ODF drug products over conventional tablet forms.お知らせ • Sep 03BioNxt Solutions Inc., Annual General Meeting, Nov 01, 2024BioNxt Solutions Inc., Annual General Meeting, Nov 01, 2024. Location: british columbia, vancouver Canadaお知らせ • Jun 28BioNxt Solutions Inc. announced that it has received CAD 0.945 million in fundingOn June 27, 2024, BioNxt Solutions Inc. closed the transaction. The company has issued 1,500,000 common shares at a price of CAD 0.27 per share for gross proceeds of up to CAD 405,000 in its third and final tranche closing. The total placement size, cumulative of all tranches, is 3,500,000 common shares for aggregate gross proceeds of CAD 945,000. The company did not pay any cash finder’s fees or issue any finder’s warrants in connection with closing of the final tranche. All securities issued in connection with closing of the final tranche are subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable securities legislation.お知らせ • Apr 27+ 1 more updateBioNxt Solutions Inc. Announces ODF Cladribine UpdateBioNxt Solutions Inc. announced that its Cladribine program is advancing to human comparative bioavailability studies in Europe. The Company is reviewing proposals from several contract research organizations to carry out the studies in accordance with EU medical regulatory guidelines. The recent success of both the Company's ODF Cladribine toxicity and comparative pharmacokinetic ("PK") studies and industry interest have set high expectations for the upcoming comparative bioavailability study. Further details on the study will be released in due course. BioNxt is developing a 100% owned and proprietary ODF Cladribine dosage form, directed at the multiple sclerosis ("MS") market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with annual sales in excess of one billion USD. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us. The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.お知らせ • Mar 20BioNxt Solutions Inc. Reports Commercialization of Odf Cladribine Product for MS Next StepsBioNxt Solutions Inc. reported that based on the recent success of its toxicity and comparative pharmacokinetic ("PK") studies the Company is advancing towards human comparative bioavailability studies on an expedited basis. The next steps in the development and commercialization process include technology and process transfer, upscaling of manufacturing capability, analytical method development and validation, and clinical sample manufacturing preparation, manufacturing, and product release for use in the upcoming planned human comparative bioequivalence study. Sample manufacturing is planned for Second Quarter 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission also planned for Second Quarter 2024. On February 7, 2024, the BioNxt announced positive animal toxicity study results with no adverse clinical abnormalities or indications of toxicity observed in any participants after consecutive days of dosing. On March 13, 2024, the Company announced positive animal PK study results that demonstrated highly comparable rapid absorption and bioequivalence between the Company's ODF product and the name-brand reference drug for all administered samples. The upcoming planned human comparative bioequivalence study will be carried out by a European contract research organization in accordance with EU medical regulatory guidelines. BioNxt is developing a 100% owned and proprietary hybrid-generic ODF Cladribine dosage form, directed at the multiple sclerosis ("MS") market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with annual sales in excess of one billion USD. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us. The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.お知らせ • Mar 13BioNxt Solutions Inc. Reports Successful Results from ODF Cladribine PK StudyBioNxt Solutions Inc. reported that the comparative pharmacokinetic ("PK") study for its oral dissolvable film ("ODF") based proprietary Cladribine product for the treatment of Multiple Sclerosis ("MS") has been completed and results received by the Company. The animal PK study results are highly promising and demonstrated comparable rapid absorption and systemic exposure between the Company's ODF product and the name-brand reference drug in all samples. BioNxt is developing a 100% owned and proprietary hybrid-generic ODF Cladribine dosage form, directed at the MS market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with annual sales in excess of one billion USD. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us. The comparative PK study was carried out by a European contract research organization in accordance with EU medical regulatory guidelines using animal models and a single administration of either sublingual (ODF) or oral (tablet) Cladribine. Blood testing and analysis was carried out pre-dose and at up to six time points after administration using blood aliquots. The animal PK study results closely follows the unanimously successful results of the ODF Cladribine animal toxicity study, announced February 7, 2024: positive results were observed in all study participants with no adverse clinical abnormalities or indications of toxicity observed in the study after consecutive days of dosing. BioNxt has accelerated its Cladribine ODF program in a priority manner with GMP product development and batch production planned for first quarter and second quarter of 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for second quarter of 2024. The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.お知らせ • Feb 07BioNxt Solutions Inc. Reports Successful Results from Odf Cladribine Toxicity StudyBioNxt Solutions Inc. reported that the toxicity study for its oral dissolvable film ("ODF") based proprietary Cladribine product for the treatment of Multiple Sclerosis ("MS") has been completed and results received by the Company. The study was unanimously successful with positive results in all study participants with no adverse clinical abnormalities or indications of toxicity observed in the study after consecutive days of dosing. BioNxt is developing a proprietary hybrid-generic ODF Cladribine dosage form, primarily directed at the MS market. Cladribine tablets are approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us. The oral toxicity study was carried out by a European contract research organization in accordance with EU medical regulatory guidelines using animal models for five consecutive days of sublingual ODF dosing. In addition, careful examination of the application site was done four times/day. The Company's Cladribine ODF did not cause any sign of treatment-related toxicity either at the site of application or within the oral cavity of the animals. There were no health or clinical abnormalities observed at any time during the study. Comparative pharmacokinetic studies in animal models have commenced in Europe with results expected in First Quarter 2024. GMP product development and batch production is planned for First Quarter and Second Quarter 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for Second Quarter 2024. The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044. BioNxt's wholly owned subsidiary is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Wurttemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of innovative, non-invasive drug delivery systems, particularly transdermal patches and sublingual strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions. According to Precedence Research, the global pharmaceutical drug delivery market size was valued at USD 1,525 billion in 2022 and expected to surpass approximately USD 2,047 billion by 2030.お知らせ • Jan 30BioNxt Solutions Inc. announced that it has received CAD 1.168 million in fundingOn January 29, 2024, BioNxt Solutions Inc closed the transaction. The company issued 720,000 units at an issue price of CAD 0.40 per unit for gross proceeds of CAD 288,000 under final tranche. Each Unit consists of one common share and one-half of one Share purchase warrant. Each Warrant entitles the holder thereof to acquire an additional Share at a price of CAD 0.70 per Warrant Share for a period of 24 months from the date of distribution of the Unit. The company paid cash finder's fees of CAD 23,040 and issued to the same finder 57,600 non-transferable Share purchase warrants (the "Finder's Warrants"), with each Finder's Warrant exercisable into a Share for a period of 24 months from the date of issuance at a price of CAD 0.67 per Share.お知らせ • Dec 23BioNxt Solutions Inc. announced that it expects to receive CAD 2.4 million in fundingBioNxt Solutions Inc announce a non-brokered private placement of 6,000,000 units at an issue price of CAD 0.40 per unit for gross proceeds of CAD 2,400,000 on December 21, 2023. Each Unit consists of one common share of the company and one-half of one Share purchase warrant. Each Warrant will entitle the holder thereof to acquire one additional Share at a price of CAD 0.70 per Warrant Share for a period of 24 months from the date of closing. All securities issued in connection with the Offering will be subject to a statutory hold period of four months and one day following the Closing Date in accordance with applicable Canadian securities laws.お知らせ • Dec 22BioNxt Solutions Announces Completion of Cladribine ODF Toxicity Study and FinancingBioNxt Solutions Inc. announced that the toxicity study for its proprietary oral dissolvable film ("ODF") based Cladribine product for the treatment of Multiple Sclerosis ("MS"), first announced November 20, 2023, is now complete. The study was carried out by a European contract research organization in accordance with EU medical regulatory guidelines. Results for the toxicology study are expected in January 2024. The Company is on schedule for GMP product development and batch production planned for first quarter and second quarter 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for second quarter 2024. Cladribine is approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), for several indications, namely highly active forms of relapsing-remitting Multiple Sclerosis ("MS") and certain forms of leukemia. MS represents the market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 Billion by 2033 according to Market.us.お知らせ • Nov 17BioNxt Solutions Inc Reports on New Cladrabine Odf Product Development and Commercialization ProgramBioNxt Solutions Inc. provide further development details on its recently announced 100% Cladribine IP acquisition and related development program. BioNxt has commenced the development and commercialization of a proprietary oral dissolvable film ("ODF") based Cladribine product for the treatment of neurodegenerative diseases, namely Multiple Sclerosis ("MS"). After ten years of use as a niche oncology therapeutic for the treatment of certain forms of leukemia, Cladribine was re-discovered as a powerful agent for the treatment of MS. Launched by a major drug company in 2017 in Europe and 2019 in the US as a proprietary tablet formulation for the treatment of MS, Cladribine tablets reached over one billion in global sales in 2022 with a three-year CAGR of 18%. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe. The global Multiple Sclerosis drug market is expected to top US$ 41 Billion by 2033 according to Market.us. BioNxt's new proprietary Cladribine ODF formulation is designed to provide several advantages over conventional tablet formulations. The primary expected advantage is instant dissolution in the oral cavity and absorption into the bloodstream thereby bypassing the stomach and upper intestine where absorption may be limited. As a result there is potential for greater dosing precision and efficiency which may permit a reduced daily and course dose for patients. The Company also recognizes the potential for greater application of ODF versus tablet formulations, particularly with dysphagic patients who cannot swallow or have difficulty swallowing, which represents over 40% of MS patients. BioNxt is planning human bioequivalence studies for 2024 with preclinical work already underway. The Company will provide greater details on its clinical strategy in due course. The Company has filed Cladribine ODF-related preliminary patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.お知らせ • Oct 05BioNxt Solutions Inc. Announces Change of DirectorsBioNxt Solutions Inc. announced that Per Thoresen and Peter Damouni have resigned as directors of the Company. The Company also announced that Joseph Meagher, the Chief Financial Officer of the Company, has been appointed as a director of the Company to fill one of the vacancies.お知らせ • Aug 07BioNxt Solutions Inc. announced that it expects to receive CAD 3.975 million in fundingBioNxt Solutions Inc. announced a non-brokered private placement to issue 15,000,000 shares at an issue price of CAD 0.265 per share for the gross proceeds of CAD 3,975,000 on August 5, 2023. The offering may close on one or more dates as the company may determine. The company may pay a finder's fee in connection with the offering to eligible arm's-length finders in accordance with the policies of the Canadian Securities Exchange. All securities issued in connection with the offering will be subject to a statutory hold period of four months and one day following the date of issuance in accordance with applicable Canadian securities laws.お知らせ • May 15Bionxt Solutions Inc. Receives Approval for European Clinical Study of Transdermal Rotigotine Patch for Parkinson's DiseaseBioNxt Solutions Inc. reported that it has received government approval for to proceed with its comparative drug absorption study for the Company's transdermal ("TDS") Rotigotine patch for the treatment of Parkinson's disease. The study is expected to commence in four to six weeks. Further to BioNxt's press releases dated February 13 and March 1, 2023, the Company has received governmental approval for planned human bioavailability study to be carried out by a qualified European contract research organization. The comparative study is designed as a randomized, crossover, two-period, single dose pilot study to assess the relative bioavailability, skin adhesion and skin tolerance of BioNxt's new formulation compared to the name brand product. Results from the study are expected four to six weeks after completion. The human study will be carried out in Europe in accordance with Good Clinical Practice (GCP) and the European Medical Agency (EMA) Guideline on quality of transdermal patches. The Company has completed the manufacture of all transdermal clinical samples to be used in the study based on the TDS platform technology developed by BioNxt's wholly owned German subsidiary. Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson's Disease and restless legs syndrome (RLS) in Europe and the United States. The active pharmaceutical ingredient is not well absorbed via oral delivery and is formulated as a once-daily TDS patch to increase bioavailability and provide a controlled and steady supply of the drug over the course of 24 hours. The therapeutic market for Parkinson's disease is over 10 million people worldwide and growing. The top selling name brand product launched by the originator in 2007 independently sold over USD375 million of its Rotigotine TDS patches in 2021. According to Wissen Market Research, total global sales for Rotigotine patches were approximately USD 5 million in 2021 with the market expected to surpass USD 766 million by 2030.お知らせ • Feb 13BioNxt Solutions Inc. Reports Update on Commercialization of Rotigotine Patch for Treatment of Parkinson's DiseaseBioNxt Solutions Inc. reported an update on its commercialization plan for its transdermal Rotigotine patch for the treatment of Parkinson's disease. The Company's Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH. On October 18, 2022, BioNxt announced excellent in-vitro/ex-vivo results for its PD treatment based on comparative drug absorption analysis between the Company's new optimized transdermal formulation and the global name brand Rotigotine product. With these results in hand, the Company is preparing for a human clinical pilot study in second quarter 2023. The comparative study is designed as a randomized, crossover, two-period, single dose pilot study to assess the relative bioavailability, skin adhesion and skin tolerance of BioNxt's new formulation compared to the name brand product. The study will be carried out in Europe in accordance with Good Clinical Practice (GCP) and the European Medical Agency (EMA) Guideline on quality of transdermal patches. In parallel to its clinical study, BioNxt is planning the development of commercial manufacturing capabilities at its German drug development facility. This will include EU GMP-approved manufacturing and packaging equipment as well as a modified manufacturing line capable of producing pivotal trial materials compliant with commercial regulatory approval applications and final commercial products (transdermal and oral dissolvable). The Company expects to make further announcements regarding its commercialization capabilities over the coming months. Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson's disease and restless legs syndrome (RLS) in Europe and the United States. The active pharmaceutical ingredient is not well absorbed via oral delivery and is formulated as a once-daily TDS patch to increase bioavailability and provide a slow and steady supply of the drug over the course of 24 hours. BioNxt's Rotigotine transdermal product is a single product based on its 100% owned platform technology which represents a scalable opportunity for additional TDS drug development and manufacturing programs.決済の安定と成長配当データの取得安定した配当: BNXT.Fの 1 株当たり配当が過去に安定していたかどうかを判断するにはデータが不十分です。増加する配当: BNXT.Fの配当金が増加しているかどうかを判断するにはデータが不十分です。配当利回り対市場BioNxt Solutions 配当利回り対市場BNXT.F 配当利回りは市場と比べてどうか？セグメント配当利回り会社 (BNXT.F)n/a市場下位25% (US)1.4%市場トップ25% (US)4.2%業界平均 (Pharmaceuticals)2.2%アナリスト予想 (BNXT.F) (最長3年)n/a注目すべき配当: BNXT.Fは最近配当金を報告していないため、配当金支払者の下位 25% に対して同社の配当利回りを評価することはできません。高配当: BNXT.Fは最近配当金を報告していないため、配当金支払者の上位 25% に対して同社の配当利回りを評価することはできません。株主への利益配当収益カバレッジ: BNXT.Fの 配当性向 を計算して配当金の支払いが利益で賄われているかどうかを判断するにはデータが不十分です。株主配当金キャッシュフローカバレッジ: BNXT.Fが配当金を報告していないため、配当金の持続可能性を計算できません。高配当企業の発掘7D1Y7D1Y7D1YUS 市場の強力な配当支払い企業。View Management企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/07 14:30終値2026/05/07 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋BioNxt Solutions Inc. 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。0
お知らせ • Jan 22BioNxt Solutions Inc. Reports Final Preclinical Results Demonstrating Approximately 40% Higher Cladribine DeliveryBioNxt 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.
お知らせ • Jan 21+ 1 more updateBionxt Reports Successful Final In-Vivo Dosing Study Results Supporting Superior Bioavailability of Cladribine Sublingual OdfBioNxt Solutions Inc. announced that it has completed and received preliminary results from its comparative pharmacokinetics ("PK") large-mass animal study in pigs. The study measured how efficiently cladribine is absorbed into the bloodstream over time and compared BioNxt's proprietary orally dissolving film ("ODF") with the reference tablet formulation, evaluating the Company's swallow-free, sublingual ODF formulation for Multiple Sclerosis (MS). BioNxt reports that the study outcome was successful and supports superior bioavailability for the Company's cladribine ODF formulation under the study conditions. The Company has initiated a full internal screening and assessment of the final dataset, including calculations and interpretation of key pharmacokinetic parameters. Further information will be provided once BioNxt has completed its comprehensive internal analysis. To evaluate how effectively BioNxt's swallow-free cladribine ODF delivers cladribine into the bloodstream, the Company conducted a comparative crossover pharmacokinetics study in adult pigs, weighing approximately 40-50 kg. This specific breed of pig is widely used in pharmaceutical research as a non-rodent large-mass preclinical model due to their high physiological, anatomical, and metabolic similarities to humans, particularly in drug absorption and systemic exposure. The objective was to compare BioNxt's cladribine 10 mg orally dissolving film (ODF) with the reference name-brand 10 mg tablet, a commercially established Multiple Sclerosis therapy with annual global sales exceeding USD 1 billion and continued double-digit annual growth, with both formulations administered at a single dose equivalent to 5 mg of cladribine per animal. The reference tablet was administered by oral dosing via gavage, while the ODF was placed directly into the oral cavity to support sublingual absorption. To track cladribine levels over time, blood samples were collected before dosing and at several time points over 24 hours following administration. This allowed BioNxt to measure key performance indicators such as peak concentration, overall exposure, and how long cladribine remained in the body, supporting a clear assessment of bioavailability. The study was initiated in November 2025 and completed in December 2025, with the final dataset now received by the Company for internal analysis. The Company's study results confirm that enhanced bioavailability achieved through sublingual ODF delivery materially improves delivery efficiency compared with conventional oral administration. By enabling more efficient absorption of cladribine into the bloodstream, the ODF approach supports the achievement of therapeutic exposure with lower overall systemic drug exposure, which is a critical factor in managing tolerability for immunomodulatory therapies such as cladribine. This improved delivery efficiency directly supports BioNxt's strategy to reduce unnecessary systemic burden, creating the foundation for a meaningful reduction in dose-related side effects while maintaining pharmacokinetic performance. In addition, the swallow-free, sublingual ODF format offers a more patient-friendly treatment experience, particularly for patients with swallowing difficulties or sensitivity to conventional oral dosage forms. BioNxt views these findings as a key validation of its ODF drug-delivery platform and a strategically important step in building a differentiated Multiple Sclerosis therapy profile with strong commercial and partnering potential. Multiple Sclerosis represents a large global market, with approximately 2.3 million people living with MS worldwide and forecasts indicating the global MS drug market is expected to exceed USD 41 billion by 2033. Within this market, Mavenclad® (cladribine tablets) is a well-established high-efficacy therapy with annual global sales exceeding USD 1 billion and sustained double-digit growth, although systemic oral therapy can require monitoring and may be associated with adverse effects that influence real-world adoption. Cladribine also holds promise for the treatment of additional neurodegenerative diseases, such as Myasthenia Gravis (MG). BioNxt further confirms that patent protection for its cladribine ODF program has already been confirmed, with additional final (national level) patent grants expected shortly, strengthening the Company's intellectual property position and supporting potential future licensing and partnering opportunities. BioNxt has initiated internal screening and full evaluation of the study dataset and expects to provide additional disclosure once final calculations, interpretation, and internal validation are complete. The Company intends to share further updates regarding next development milestones in due course.
お知らせ • Sep 08BioNxt Solutions Inc., Annual General Meeting, Nov 07, 2025BioNxt Solutions Inc., Annual General Meeting, Nov 07, 2025. Location: british columbia, vancouver Canada
お知らせ • Jul 13BioNxt Solutions Inc. announced that it expects to receive CAD 1.2 million in fundingBioNxt 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.
お知らせ • Mar 15BioNxt Solutions Inc. announced that it has received CAD 2.5 million in fundingOn 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.
お知らせ • Feb 25BioNxt Solutions Inc. announced that it expects to receive CAD 2.5 million in fundingBionxt 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.
お知らせ • Jan 15BioNxt Solutions Inc. announced that it has received CAD 3 million in fundingOn January 14, 2025. BioNxt Solutions Inc. closed the transaction. it has issued notes with the principal amount of CAD 890,000. In connection with the offering, the company paid a cash fee of CAD 71,200 and issued 284,800 finder warrants to Canaccord Genuity Corp. Each finder's warrant entitles the holder thereof to purchase one common share at an exercise price of CAD 0.25 for a period of 24 months from the date of issuance.
お知らせ • Dec 09BioNxt Solutions Inc. Reports Progress on BNT23001 Development for Multiple Sclerosis TreatmentBioNxt Solutions Inc. has achieved key milestones in the development of BNT23001, its proprietary sublingual thin-film (OFD) formulation of Cladribine for the treatment of Multiple Sclerosis (MS). These achievements in 2024 lay the groundwork for clinical trials and regulatory submissions in 2025, reinforcing BioNxt's commitment to advancing patient-centric therapeutic solutions. Preclinical Success: BNT23001 demonstrated high absorption rates of Cladribine through sublingual delivery in pharmacokinetic (PK) studies conducted in animal models. These studies confirmed the product's bioequivalence to the originator therapy, Mavenclad®, and validated the thin-film's rapid absorption and safety profile. Toxicity studies further demonstrated no adverse local effects, highlighting the viability of the sublingual delivery approach. Advancements in Manufacturing: BioNxt successfully transferred the BNT23001 production process to its GMP-certified manufacturing partner, Gen-Plus GmbH & Co KG in Munich (Germany), ensuring readiness for clinical batch production. This milestone supports the Company's plan to initiate clinical trials in 2025 with reliable, high-quality product supply. Strengthened Intellectual Property Position: A favorable International Preliminary Report on Patentability (IPRP) confirmed BNT23001's novelty, inventive step, and industrial applicability, underscoring its unique value in MS treatment. The Company has initiated patent nationalization in major jurisdictions, including Europe, the United States, and Canada, with patent grants anticipated in several regions by mid-2025. 2025 Roadmap: Advancing BNT23001 into Clinical Trials. Manufacturing Clinical Batches: BioNxt will complete GMP manufacturing and Qualified Person (QP) release of clinical trial batches in the second quarter of 2025. This step is critical for the successful initiation of human studies. Regulatory Filings and Approvals: The Company plans to submit the Investigational Medicinal Product Dossier (IMPD) to European regulatory authorities by mid-2025, paving the way for clinical trial approval. These regulatory submissions will include data from preclinical studies and stability assessments conducted at the manufacturing site. Clinical Study to Validate Performance: BioNxt aims to launch a pilot clinical study in the latter half of 2025. This trial will compare the efficacy, bioavailability, and safety of BNT23001 to Mavenclad®, the originator tablet product, positioning the thin-film formulation as a patient-friendly alternative. Ongoing Patent Protection: In addition to continuing the patent nationalization process, BioNxt expects granted patents in key regions to strengthen its intellectual property portfolio and provide competitive advantages as the product moves toward commercialization. BNT23001: Advancing Toward Clinical Validation for MS Treatment: BNT23001 offers a novel approach to MS management by addressing limitations in traditional oral therapies. Its sublingual thin-film format provides: Convenience: Easy-to-use and portable, ideal for patients with difficulty swallowing or active lifestyles. Rapid Absorption: Direct delivery through the sublingual mucosa for faster therapeutic action. Improved Compliance: A patient-friendly alternative designed to enhance adherence to prescribed regimens. By delivering these advantages, BNT23001 aligns with BioNxt's mission to improve outcomes for patients living with chronic diseases like MS.
お知らせ • Nov 26BioNxt Solutions Inc. Announces Enhanced Sublingual Product Development Pipeline with Innovative Solutions for Autoimmune Diseases and LongevityBioNxt Solutions Inc. announced the expansion of its next-generation product pipeline. This includes proprietary Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated Tablet) drug delivery systems targeting autoimmune diseases such as Multiple sclerosis ("MS"), Myasthenia gravis ("MG"), Lupus nephritis ("LN"), and Rheumatoid arthritis ("RA"), as well as an exciting initiative in the fast-growing longevity market. These advancements highlight BioNxt's commitment to developing innovative, patient-centric solutions to improve compliance, enhance drug bioavailability, and address critical unmet medical needs. Pipeline Highlights: BioNxt Lead Product BNT23001: Multiple sclerosis (MS); BioNxt's lead pipeline product for MS is a proprietary sublingual (thin-film) formulation of Cladribine, offering an innovative alternative to traditional oral tablets. This next-generation delivery system is designed to overcome the challenges of swallowing difficulty, a common issue among MS patients, while enhancing drug absorption and compliance. Cladribine tablets are currently approved in over 75 countries and achieved sales exceeding USD 1 billion in 2023 (Merck KGaA). With the global MS drug market projected to exceed USD 41 billion by 2033 (Market.us), BioNxt's sublingual (thin- film) product offers a unique, patient-friendly approach. BioNxt BNT23001: Myasthenia gravis (MG). Building on its MS expertise, BioNxt is repurposing its sublingual (thin- Film) Cladribine technology for Myasthenia gravis, a chronic neuromuscular condition that causes muscle weakness and fatigue. Patients with MG often face difficulty swallowing, making BioNxt's sublingal delivery system an ideal solution. The global MG market is anticipated to reach USD 6.7 billion by 2032 (Clinical Trials Arena). BioNxt BNT24002: Lupus nephritis (LN). BioNxt is developing a proprietary sublingual (thin-film) product for Lupus nephritis, a serious autoimmune condition that can lead to kidney failure. This innovative drug delivery system focuses on maximizing bioavailability while minimizing side effects, addressing a critical gap in the LN treatment market, which is expected to grow to USD 3.2 billion by 2032. BioNxt BNT24003: Rheumatoid arthritis (RA) Rheumatoid arthritis is a prevalent autoimmune condition affecting millions globally, causing joint pain, switching, and reduced mobility. BioNxt is leveraging its expertise in sublingual (thin-fil) and oral (enteric-coated tablet) technologies to develop proprietary solutions that improve compliance and therapeutic outcomes. The global RA drug market is projected to surpass USD 27 billion by 2033 (Precedence Research). BioNxt BNT 24004: Formulation for L longevity and Anti-Aging: BioNxt is also entering the booming longevity and anti-aging sector, projected to reach USD 93 billion by 2027 (Statista). The Company is advancing proprietary sublingual (thin the LN) and oral (enterIC-coated tablet) drug products with active pharmaceutical ingredients that show early-stage evidence of benefits such as slowing ovarian aging, extending fertility, and promoting healthy aging.
お知らせ • Oct 29BioNxt Solutions Inc. announced that it expects to receive CAD 3 million in fundingBioNxt Solutions Inc. announced a non-brokered private placement that it will issue convertible debentures for the gross proceeds of up to CAD 3,000,000 on October 28, 2024. The Debentures will bear interest from their issue date at 8% per annum and will mature two years following the closing date. The Debentures are unsecured and will rank pari passu in right of payment of principal and interest with all the existing and future unsecured indebtedness of the Company. Pursuant to a price reservation filed with the Canadian Securities Exchange on October 25, 2024, the principal amount of each Debenture will be convertible at the option of the holder into common shares in the capital of the Company at any time prior to the maturity date at a conversion price of CAD 0.25 per Common Share. Conversion of the Debentures may be forced at the option of the Company if the 15-day volume weighted average price of the Common Shares on the Canadian Securities Exchange exceeds 250% per share of the conversion price. All securities issued in connection with the Offering will be subject to a statutory hold period of four months and one day following the closing date of the Offering in accordance with applicable securities legislation. Completion of the Offering is subject to a number of conditions, including, but not limited to, the receipt of all regulatory approvals. The Company may pay a finder's fee in connection with the Offering to eligible arm's length finders in accordance with the policies of the Canadian Securities Exchange.
お知らせ • Sep 26Bionxt Solutions Inc. Provides Update on Cladribine Program for Multiple Sclerosis, Sublingual Neurodegenerative Disease PatentBioNxt Solutions Inc. provided an update on its sublingual Cladribine drug formulation program for the treatment of Multiple Sclerosis ("MS"), broad sublingual patent application for the use of anticancer drugs for the treatment of autoimmune neurodegenerative diseases, and investor relations activities. BioNxt's lead program is the development of a 100% owned and proprietary sublingual ClADribine dosage form, directed at the MS market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with 2023 annual sales in excess of one billion USD according to Merck KGaA. Cladribine tablets is approved for several indications, namely highly active forms of relapsing-remitting MS. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is anticipated to top USD 41 billion by 2033 according to Market.us. BioNxt's sublingual Cladribines product is expected to yield a significant advantage over the tablet form for patients suffering from Dysphagia (diff difficulty allowing), which is a common symptom among MS patients. In the first half of 2024, the Company announced positive results for both its sublingual Cladivine animal toxicity study and animal pharmacokinetics ("PK") studies. The animal toxicity study results demonstrated zero adverse clinical abnormalities or indications of toxicity in any participants after consecutive days of dosing. The PK study results demonstrated highly comparable rapid absorption and bioequivalence between the Company's sublingual product and the name-brand reference drug for all administered samples. The next steps in the development and commercialization process include technology and process transfer, upscaling of manufacturing capability, analytical method development and validation, and clinical sample manufacturing preparation, manufacturing, and product release for use in the human comparative bioequivalence study planned for early First Quarter 2025. The bioequivalence study will be carried out with a European contract research organization in accordance with EU medical regulatory guidelines. On September 9, 2024, BioNxt reported that the European Patent Office ("EPO") issued a positive international examination report for the Company's comprehensive patent application for sublingual delivery of anticancer drugs for thetreatment of autoimmune neurodegenerative disease, such as MS. The Company expects the EU patent to be granted within four weeks and to rapidly enter the national phase of the Patent Cooperation Treaty ("PCT") patent process with submissions planned for the US, Canada, China, Japan, Australia, and other jurisdictions. BioNxt plans to continue development of and extend its patent portfolio regarding sublingual drug products containing highly potent anticancer compounds for neurodegenerative diseases. MG patients also commonly experience Dysphagia whereby a sublingual product is expected to yield asignificant advantage over conventional tablet forms. The global MG market is expected to reach USD 6.7 billion by 2032 according to Clinical Trials Arena. In general, the expectation of continued increasing prevalence of Central Nervous System ("CNS") pathologies will drive investment into new drugs and new drug delivery systems capable of targeting these diseases. The market size for drugs to treat CNS diseases is growing and expected to reach USD 238.8 billion by 2032 according to GMI Market Insights. The Options are exercisable for two years and will vest in stages over a 12-month period with 25% vesting every three months from the date of issuance.
お知らせ • Sep 11BioNxt Solutions Inc. Receives Positive International Examination Report from the European Patent Office for Broad Patent Application for Sublingual Delivery of Anticancer Drugs for the Treatment of Autoimmune Neurodegenerative DiseasesBioNxt Solutions Inc. reported that the European Patent Office ("EPO") has issued a positive international examination report for the Company's comprehensive patent application for sublingual delivery of anticancer drug for the treatment of autoimmune neurodegenerative diseases. The Company expects the EU patent to be granted within eight weeks and to rapidly enter the national phase of the Patent Cooperation Treaty ("PCT") patent process with submissions planned for the US, Canada, China, Japan, Australia, and other jurisdictions. BioNxt plans to continue development of and extend its patent portfolio regarding orally dispersible films ("ODFs") containing highly potent anticancer compounds for neurodegenerative diseases. The Company intends to file several related provisional patent applications in the EU with three to four patents expected to be on file in multiple major international jurisdictions by late 2025 to early 2026 with potential patent protection extending to 2045. BioNxt's lead program is the development of a 100% owned and proprietary ODF Cladribine dosage form, directed at the multiple sclerosis ("MS") market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with 2023 annual sales in excess of one billion USD according to Merck KGaA. Cladribine tablets are approved for several indications, namely highly active forms of relapsingremitting MS. Further to the Company's MS program, BioNxt announced that its second clinical indication using anticancer compounds in an ODF delivery system will be Myasthenia Gravis ("MG"). MG is an autoimmune and neuromuscular disease characterised by muscle weakness and fatigue. Similar to MS patients, MG patients commonly experience Dysphagia (difficulty swallowing), which is expected to yield a significant advantage to ODF drug products over conventional tablet forms.
お知らせ • Sep 03BioNxt Solutions Inc., Annual General Meeting, Nov 01, 2024BioNxt Solutions Inc., Annual General Meeting, Nov 01, 2024. Location: british columbia, vancouver Canada
お知らせ • Jun 28BioNxt Solutions Inc. announced that it has received CAD 0.945 million in fundingOn June 27, 2024, BioNxt Solutions Inc. closed the transaction. The company has issued 1,500,000 common shares at a price of CAD 0.27 per share for gross proceeds of up to CAD 405,000 in its third and final tranche closing. The total placement size, cumulative of all tranches, is 3,500,000 common shares for aggregate gross proceeds of CAD 945,000. The company did not pay any cash finder’s fees or issue any finder’s warrants in connection with closing of the final tranche. All securities issued in connection with closing of the final tranche are subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable securities legislation.
お知らせ • Apr 27+ 1 more updateBioNxt Solutions Inc. Announces ODF Cladribine UpdateBioNxt Solutions Inc. announced that its Cladribine program is advancing to human comparative bioavailability studies in Europe. The Company is reviewing proposals from several contract research organizations to carry out the studies in accordance with EU medical regulatory guidelines. The recent success of both the Company's ODF Cladribine toxicity and comparative pharmacokinetic ("PK") studies and industry interest have set high expectations for the upcoming comparative bioavailability study. Further details on the study will be released in due course. BioNxt is developing a 100% owned and proprietary ODF Cladribine dosage form, directed at the multiple sclerosis ("MS") market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with annual sales in excess of one billion USD. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us. The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.
お知らせ • Mar 20BioNxt Solutions Inc. Reports Commercialization of Odf Cladribine Product for MS Next StepsBioNxt Solutions Inc. reported that based on the recent success of its toxicity and comparative pharmacokinetic ("PK") studies the Company is advancing towards human comparative bioavailability studies on an expedited basis. The next steps in the development and commercialization process include technology and process transfer, upscaling of manufacturing capability, analytical method development and validation, and clinical sample manufacturing preparation, manufacturing, and product release for use in the upcoming planned human comparative bioequivalence study. Sample manufacturing is planned for Second Quarter 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission also planned for Second Quarter 2024. On February 7, 2024, the BioNxt announced positive animal toxicity study results with no adverse clinical abnormalities or indications of toxicity observed in any participants after consecutive days of dosing. On March 13, 2024, the Company announced positive animal PK study results that demonstrated highly comparable rapid absorption and bioequivalence between the Company's ODF product and the name-brand reference drug for all administered samples. The upcoming planned human comparative bioequivalence study will be carried out by a European contract research organization in accordance with EU medical regulatory guidelines. BioNxt is developing a 100% owned and proprietary hybrid-generic ODF Cladribine dosage form, directed at the multiple sclerosis ("MS") market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with annual sales in excess of one billion USD. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us. The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.
お知らせ • Mar 13BioNxt Solutions Inc. Reports Successful Results from ODF Cladribine PK StudyBioNxt Solutions Inc. reported that the comparative pharmacokinetic ("PK") study for its oral dissolvable film ("ODF") based proprietary Cladribine product for the treatment of Multiple Sclerosis ("MS") has been completed and results received by the Company. The animal PK study results are highly promising and demonstrated comparable rapid absorption and systemic exposure between the Company's ODF product and the name-brand reference drug in all samples. BioNxt is developing a 100% owned and proprietary hybrid-generic ODF Cladribine dosage form, directed at the MS market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with annual sales in excess of one billion USD. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us. The comparative PK study was carried out by a European contract research organization in accordance with EU medical regulatory guidelines using animal models and a single administration of either sublingual (ODF) or oral (tablet) Cladribine. Blood testing and analysis was carried out pre-dose and at up to six time points after administration using blood aliquots. The animal PK study results closely follows the unanimously successful results of the ODF Cladribine animal toxicity study, announced February 7, 2024: positive results were observed in all study participants with no adverse clinical abnormalities or indications of toxicity observed in the study after consecutive days of dosing. BioNxt has accelerated its Cladribine ODF program in a priority manner with GMP product development and batch production planned for first quarter and second quarter of 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for second quarter of 2024. The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.
お知らせ • Feb 07BioNxt Solutions Inc. Reports Successful Results from Odf Cladribine Toxicity StudyBioNxt Solutions Inc. reported that the toxicity study for its oral dissolvable film ("ODF") based proprietary Cladribine product for the treatment of Multiple Sclerosis ("MS") has been completed and results received by the Company. The study was unanimously successful with positive results in all study participants with no adverse clinical abnormalities or indications of toxicity observed in the study after consecutive days of dosing. BioNxt is developing a proprietary hybrid-generic ODF Cladribine dosage form, primarily directed at the MS market. Cladribine tablets are approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us. The oral toxicity study was carried out by a European contract research organization in accordance with EU medical regulatory guidelines using animal models for five consecutive days of sublingual ODF dosing. In addition, careful examination of the application site was done four times/day. The Company's Cladribine ODF did not cause any sign of treatment-related toxicity either at the site of application or within the oral cavity of the animals. There were no health or clinical abnormalities observed at any time during the study. Comparative pharmacokinetic studies in animal models have commenced in Europe with results expected in First Quarter 2024. GMP product development and batch production is planned for First Quarter and Second Quarter 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for Second Quarter 2024. The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044. BioNxt's wholly owned subsidiary is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Wurttemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of innovative, non-invasive drug delivery systems, particularly transdermal patches and sublingual strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions. According to Precedence Research, the global pharmaceutical drug delivery market size was valued at USD 1,525 billion in 2022 and expected to surpass approximately USD 2,047 billion by 2030.
お知らせ • Jan 30BioNxt Solutions Inc. announced that it has received CAD 1.168 million in fundingOn January 29, 2024, BioNxt Solutions Inc closed the transaction. The company issued 720,000 units at an issue price of CAD 0.40 per unit for gross proceeds of CAD 288,000 under final tranche. Each Unit consists of one common share and one-half of one Share purchase warrant. Each Warrant entitles the holder thereof to acquire an additional Share at a price of CAD 0.70 per Warrant Share for a period of 24 months from the date of distribution of the Unit. The company paid cash finder's fees of CAD 23,040 and issued to the same finder 57,600 non-transferable Share purchase warrants (the "Finder's Warrants"), with each Finder's Warrant exercisable into a Share for a period of 24 months from the date of issuance at a price of CAD 0.67 per Share.
お知らせ • Dec 23BioNxt Solutions Inc. announced that it expects to receive CAD 2.4 million in fundingBioNxt Solutions Inc announce a non-brokered private placement of 6,000,000 units at an issue price of CAD 0.40 per unit for gross proceeds of CAD 2,400,000 on December 21, 2023. Each Unit consists of one common share of the company and one-half of one Share purchase warrant. Each Warrant will entitle the holder thereof to acquire one additional Share at a price of CAD 0.70 per Warrant Share for a period of 24 months from the date of closing. All securities issued in connection with the Offering will be subject to a statutory hold period of four months and one day following the Closing Date in accordance with applicable Canadian securities laws.
お知らせ • Dec 22BioNxt Solutions Announces Completion of Cladribine ODF Toxicity Study and FinancingBioNxt Solutions Inc. announced that the toxicity study for its proprietary oral dissolvable film ("ODF") based Cladribine product for the treatment of Multiple Sclerosis ("MS"), first announced November 20, 2023, is now complete. The study was carried out by a European contract research organization in accordance with EU medical regulatory guidelines. Results for the toxicology study are expected in January 2024. The Company is on schedule for GMP product development and batch production planned for first quarter and second quarter 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for second quarter 2024. Cladribine is approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), for several indications, namely highly active forms of relapsing-remitting Multiple Sclerosis ("MS") and certain forms of leukemia. MS represents the market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 Billion by 2033 according to Market.us.
お知らせ • Nov 17BioNxt Solutions Inc Reports on New Cladrabine Odf Product Development and Commercialization ProgramBioNxt Solutions Inc. provide further development details on its recently announced 100% Cladribine IP acquisition and related development program. BioNxt has commenced the development and commercialization of a proprietary oral dissolvable film ("ODF") based Cladribine product for the treatment of neurodegenerative diseases, namely Multiple Sclerosis ("MS"). After ten years of use as a niche oncology therapeutic for the treatment of certain forms of leukemia, Cladribine was re-discovered as a powerful agent for the treatment of MS. Launched by a major drug company in 2017 in Europe and 2019 in the US as a proprietary tablet formulation for the treatment of MS, Cladribine tablets reached over one billion in global sales in 2022 with a three-year CAGR of 18%. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe. The global Multiple Sclerosis drug market is expected to top US$ 41 Billion by 2033 according to Market.us. BioNxt's new proprietary Cladribine ODF formulation is designed to provide several advantages over conventional tablet formulations. The primary expected advantage is instant dissolution in the oral cavity and absorption into the bloodstream thereby bypassing the stomach and upper intestine where absorption may be limited. As a result there is potential for greater dosing precision and efficiency which may permit a reduced daily and course dose for patients. The Company also recognizes the potential for greater application of ODF versus tablet formulations, particularly with dysphagic patients who cannot swallow or have difficulty swallowing, which represents over 40% of MS patients. BioNxt is planning human bioequivalence studies for 2024 with preclinical work already underway. The Company will provide greater details on its clinical strategy in due course. The Company has filed Cladribine ODF-related preliminary patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.
お知らせ • Oct 05BioNxt Solutions Inc. Announces Change of DirectorsBioNxt Solutions Inc. announced that Per Thoresen and Peter Damouni have resigned as directors of the Company. The Company also announced that Joseph Meagher, the Chief Financial Officer of the Company, has been appointed as a director of the Company to fill one of the vacancies.
お知らせ • Aug 07BioNxt Solutions Inc. announced that it expects to receive CAD 3.975 million in fundingBioNxt Solutions Inc. announced a non-brokered private placement to issue 15,000,000 shares at an issue price of CAD 0.265 per share for the gross proceeds of CAD 3,975,000 on August 5, 2023. The offering may close on one or more dates as the company may determine. The company may pay a finder's fee in connection with the offering to eligible arm's-length finders in accordance with the policies of the Canadian Securities Exchange. All securities issued in connection with the offering will be subject to a statutory hold period of four months and one day following the date of issuance in accordance with applicable Canadian securities laws.
お知らせ • May 15Bionxt Solutions Inc. Receives Approval for European Clinical Study of Transdermal Rotigotine Patch for Parkinson's DiseaseBioNxt Solutions Inc. reported that it has received government approval for to proceed with its comparative drug absorption study for the Company's transdermal ("TDS") Rotigotine patch for the treatment of Parkinson's disease. The study is expected to commence in four to six weeks. Further to BioNxt's press releases dated February 13 and March 1, 2023, the Company has received governmental approval for planned human bioavailability study to be carried out by a qualified European contract research organization. The comparative study is designed as a randomized, crossover, two-period, single dose pilot study to assess the relative bioavailability, skin adhesion and skin tolerance of BioNxt's new formulation compared to the name brand product. Results from the study are expected four to six weeks after completion. The human study will be carried out in Europe in accordance with Good Clinical Practice (GCP) and the European Medical Agency (EMA) Guideline on quality of transdermal patches. The Company has completed the manufacture of all transdermal clinical samples to be used in the study based on the TDS platform technology developed by BioNxt's wholly owned German subsidiary. Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson's Disease and restless legs syndrome (RLS) in Europe and the United States. The active pharmaceutical ingredient is not well absorbed via oral delivery and is formulated as a once-daily TDS patch to increase bioavailability and provide a controlled and steady supply of the drug over the course of 24 hours. The therapeutic market for Parkinson's disease is over 10 million people worldwide and growing. The top selling name brand product launched by the originator in 2007 independently sold over USD375 million of its Rotigotine TDS patches in 2021. According to Wissen Market Research, total global sales for Rotigotine patches were approximately USD 5 million in 2021 with the market expected to surpass USD 766 million by 2030.
お知らせ • Feb 13BioNxt Solutions Inc. Reports Update on Commercialization of Rotigotine Patch for Treatment of Parkinson's DiseaseBioNxt Solutions Inc. reported an update on its commercialization plan for its transdermal Rotigotine patch for the treatment of Parkinson's disease. The Company's Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH. On October 18, 2022, BioNxt announced excellent in-vitro/ex-vivo results for its PD treatment based on comparative drug absorption analysis between the Company's new optimized transdermal formulation and the global name brand Rotigotine product. With these results in hand, the Company is preparing for a human clinical pilot study in second quarter 2023. The comparative study is designed as a randomized, crossover, two-period, single dose pilot study to assess the relative bioavailability, skin adhesion and skin tolerance of BioNxt's new formulation compared to the name brand product. The study will be carried out in Europe in accordance with Good Clinical Practice (GCP) and the European Medical Agency (EMA) Guideline on quality of transdermal patches. In parallel to its clinical study, BioNxt is planning the development of commercial manufacturing capabilities at its German drug development facility. This will include EU GMP-approved manufacturing and packaging equipment as well as a modified manufacturing line capable of producing pivotal trial materials compliant with commercial regulatory approval applications and final commercial products (transdermal and oral dissolvable). The Company expects to make further announcements regarding its commercialization capabilities over the coming months. Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson's disease and restless legs syndrome (RLS) in Europe and the United States. The active pharmaceutical ingredient is not well absorbed via oral delivery and is formulated as a once-daily TDS patch to increase bioavailability and provide a slow and steady supply of the drug over the course of 24 hours. BioNxt's Rotigotine transdermal product is a single product based on its 100% owned platform technology which represents a scalable opportunity for additional TDS drug development and manufacturing programs.