BioNxt Solutions（BNXT）株式概要バイオネクスト・ソリューションズ社は、神経疾患や自己免疫疾患のための薄膜（舌下）および皮膚パッチ（経皮）薬物送達の研究開発および製造に従事し、患者のコンプライアンスとバイオアベイラビリティを向上させる。 詳細BNXT ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長0/6過去の実績0/6財務の健全性0/6配当金0/6リスク分析キャッシュランウェイが1年未満である マイナスの株主資本 収益が 100 万ドル未満 ( CA$0 )意味のある時価総額がありません ( CA$55M )すべてのリスクチェックを見るBNXT Community Fair Values Create NarrativeSee what 17 others think this stock is worth. Follow their fair value or set your own to get alerts.Top Community NarrativesBioNxt SolutionsRURuhliCommunity ContributorNew era of chemotherapyBioNxt is developing two platform technologies: a sublingual thin-film technology (ODF) for smart drug delivery and a novel chemotherapy platform in which the active ingredient is activated directly in the tumor—targeting and killing cancer cells while sparing healthy cells. The ODF technology is protected by a European broad patent (intention-to-grant, May 2025), covering a wide range of sublingual active ingredients and is being nationalized in key markets.View narrativeCA$1.2FV65.0% 割安 内在価値ディスカウントSet Fair ValueView215users have viewed this narrative1users have liked this narrative0users have commented on this narrative16users have followed this narrative8 months ago author updated this narrativeTop Community NarrativesBioNxt SolutionsRURuhliCommunity ContributorNew era of chemotherapyBioNxt is developing two platform technologies: a sublingual thin-film technology (ODF) for smart drug delivery and a novel chemotherapy platform in which the active ingredient is activated directly in the tumor—targeting and killing cancer cells while sparing healthy cells. The ODF technology is protected by a European broad patent (intention-to-grant, May 2025), covering a wide range of sublingual active ingredients and is being nationalized in key markets.View narrativeCA$1.2FV65.0% 割安 内在価値ディスカウントSet Fair ValueView215users have viewed this narrative1users have liked this narrative0users have commented on this narrative16users have followed this narrative8 months ago author updated this narrativeView all narrativesBioNxt Solutions Inc. 競合他社Lobe SciencesSymbol: CNSX:LOBEMarket cap: CA$41.2mQuantum BioPharmaSymbol: CNSX:QNTMMarket cap: CA$55.2mPlanet 13 HoldingsSymbol: CNSX:PLTHMarket cap: CA$60.8mSweet Earth HoldingsSymbol: CNSX:SEMarket cap: CA$6.6m価格と性能株価の高値、安値、推移の概要BioNxt Solutions過去の株価現在の株価CA$0.4252週高値CA$1.1052週安値CA$0.34ベータ1.381ヶ月の変化-6.67%3ヶ月変化-37.31%1年変化-22.22%3年間の変化-32.26%5年間の変化-80.09%IPOからの変化-58.00%最新ニュースNew Risk • Mar 01New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 15% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$5.2m free cash flow). Negative equity (-CA$8.3m). Revenue is less than US$1m (CA$16k revenue, or US$12k). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Significant insider selling over the past 3 months (CA$171k sold). Market cap is less than US$100m (CA$81.5m market cap, or US$59.8m).Recent Insider Transactions • Jan 29Co-Founder recently sold CA$98k worth of stockOn the 22nd of January, Wolfgang Probst sold around 183k shares on-market at roughly CA$0.54 per share. This transaction amounted to 14% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Wolfgang has been a net seller over the last 12 months, reducing personal holdings by CA$167k.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.Reported Earnings • Nov 30Third quarter 2025 earnings released: CA$0.014 loss per share (vs CA$0.013 loss in 3Q 2024)Third quarter 2025 results: CA$0.014 loss per share (further deteriorated from CA$0.013 loss in 3Q 2024). Net loss: CA$1.60m (loss widened 9.4% from 3Q 2024). Over the last 3 years on average, earnings per share has increased by 47% per year but the company’s share price has only increased by 9% per year, which means it is significantly lagging earnings growth.Recent Insider Transactions • Nov 20Co-Founder recently sold CA$55k worth of stockOn the 13th of November, Hugh A. Rogers sold around 68k shares on-market at roughly CA$0.82 per share. This transaction amounted to 7.0% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Hugh A. has been a net seller over the last 12 months, reducing personal holdings by CA$76k.最新情報をもっと見るRecent updatesNew Risk • Mar 01New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 15% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$5.2m free cash flow). Negative equity (-CA$8.3m). Revenue is less than US$1m (CA$16k revenue, or US$12k). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Significant insider selling over the past 3 months (CA$171k sold). Market cap is less than US$100m (CA$81.5m market cap, or US$59.8m).Recent Insider Transactions • Jan 29Co-Founder recently sold CA$98k worth of stockOn the 22nd of January, Wolfgang Probst sold around 183k shares on-market at roughly CA$0.54 per share. This transaction amounted to 14% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Wolfgang has been a net seller over the last 12 months, reducing personal holdings by CA$167k.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.Reported Earnings • Nov 30Third quarter 2025 earnings released: CA$0.014 loss per share (vs CA$0.013 loss in 3Q 2024)Third quarter 2025 results: CA$0.014 loss per share (further deteriorated from CA$0.013 loss in 3Q 2024). Net loss: CA$1.60m (loss widened 9.4% from 3Q 2024). Over the last 3 years on average, earnings per share has increased by 47% per year but the company’s share price has only increased by 9% per year, which means it is significantly lagging earnings growth.Recent Insider Transactions • Nov 20Co-Founder recently sold CA$55k worth of stockOn the 13th of November, Hugh A. Rogers sold around 68k shares on-market at roughly CA$0.82 per share. This transaction amounted to 7.0% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Hugh A. has been a net seller over the last 12 months, reducing personal holdings by CA$76k.New Risk • Nov 20New minor risk - Insider sellingThere has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: CA$112k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$8.4m). Revenue is less than US$1m (CA$22k revenue, or US$15k). Minor Risks Significant insider selling over the past 3 months (CA$112k sold). Market cap is less than US$100m (CA$84.0m market cap, or US$59.8m).Recent Insider Transactions • Nov 19Co-Founder recently sold CA$55k worth of stockOn the 13th of November, Hugh A. Rogers sold around 68k shares on-market at roughly CA$0.82 per share. This transaction amounted to 7.0% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Hugh A. has been a net seller over the last 12 months, reducing personal holdings by CA$76k.New Risk • Sep 15New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$8.4m). Revenue is less than US$1m (CA$22k revenue, or US$16k). Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (CA$100.5m market cap, or US$73.0m).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 CanadaReported Earnings • Aug 31First half 2025 earnings released: CA$0.028 loss per share (vs CA$0.023 loss in 1H 2024)First half 2025 results: CA$0.028 loss per share (further deteriorated from CA$0.023 loss in 1H 2024). Net loss: CA$3.27m (loss widened 28% from 1H 2024). Over the last 3 years on average, earnings per share has increased by 48% per year but the company’s share price has only increased by 38% per year, which means it is significantly lagging earnings growth.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.New Risk • Jun 27New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -CA$3.4m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$3.4m free cash flow). Negative equity (-CA$7.6m). Revenue is less than US$1m (CA$23k revenue, or US$17k). Minor Risk Market cap is less than US$100m (CA$60.8m market cap, or US$44.5m).Reported Earnings • Jun 27First quarter 2025 earnings released: CA$0.017 loss per share (vs CA$0.014 loss in 1Q 2024)First quarter 2025 results: CA$0.017 loss per share (further deteriorated from CA$0.014 loss in 1Q 2024). Net loss: CA$1.97m (loss widened 26% from 1Q 2024). Over the last 3 years on average, earnings per share has increased by 50% per year but the company’s share price has fallen by 1% per year, which means it is significantly lagging earnings.New Risk • Jun 17New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended September 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$7.4m). Revenue is less than US$1m (CA$42k revenue, or US$31k). Minor Risks Latest financial reports are more than 6 months old (reported September 2024 fiscal period end). Market cap is less than US$100m (CA$64.1m market cap, or US$47.2m).New Risk • May 06New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: CA$7.33m (US$5.32m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$7.4m). Revenue is less than US$1m (CA$42k revenue, or US$30k). Market cap is less than US$10m (CA$7.33m market cap, or US$5.32m).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.Reported Earnings • Dec 01Third quarter 2024 earnings released: CA$0.013 loss per share (vs CA$0.014 loss in 3Q 2023)Third quarter 2024 results: CA$0.013 loss per share. Net loss: CA$1.47m (loss widened 4.4% from 3Q 2023).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 CanadaReported Earnings • Aug 29Second quarter 2024 earnings released: CA$0.009 loss per share (vs CA$0.024 loss in 2Q 2023)Second quarter 2024 results: CA$0.009 loss per share (improved from CA$0.024 loss in 2Q 2023). Net loss: CA$974.4k (loss narrowed 59% from 2Q 2023). Over the last 3 years on average, earnings per share has increased by 45% per year but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings.New Risk • Aug 20New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Canadian stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Negative equity (-CA$6.1m). Earnings have declined by 7.9% per year over the past 5 years. Revenue is less than US$1m (CA$207k revenue, or US$152k). Minor Risks Shareholders have been diluted in the past year (15% increase in shares outstanding). Market cap is less than US$100m (CA$29.4m market cap, or US$21.5m).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.Reported Earnings • Jun 04First quarter 2024 earnings released: CA$0.014 loss per share (vs CA$0.016 loss in 1Q 2023)First quarter 2024 results: CA$0.014 loss per share. Revenue: CA$4.1k (down 98% from 1Q 2023). Net loss: CA$1.57m (loss widened 5.2% from 1Q 2023).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.Reported Earnings • Apr 23Full year 2023 earnings released: CA$0.078 loss per share (vs CA$0.15 loss in FY 2022)Full year 2023 results: CA$0.078 loss per share (improved from CA$0.15 loss in FY 2022). Revenue: CA$372.2k (up 25% from FY 2022). Net loss: CA$7.72m (loss narrowed 38% from FY 2022). Over the last 3 years on average, earnings per share has increased by 37% per year but the company’s share price has fallen by 47% per year, which means it is significantly lagging earnings.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.Reported Earnings • Nov 24Third quarter 2023 earnings released: CA$0.014 loss per share (vs CA$0.023 loss in 3Q 2022)Third quarter 2023 results: CA$0.014 loss per share (improved from CA$0.023 loss in 3Q 2022). Revenue: CA$5.7k (down 86% from 3Q 2022). Net loss: CA$1.40m (loss narrowed 26% from 3Q 2022). Over the last 3 years on average, earnings per share has increased by 31% per year but the company’s share price has fallen by 38% per year, which means it is significantly lagging earnings.お知らせ • Nov 17BioNxt Solutions Inc Reports on New Cladrabine Odf Product Development and Commercialization ProgramBioNxt Solutions Inc. provide further development details on its recently announced 100% Cladribine IP acquisition and related development program. BioNxt has commenced the development and commercialization of a proprietary oral dissolvable film ("ODF") based Cladribine product for the treatment of neurodegenerative diseases, namely Multiple Sclerosis ("MS"). After ten years of use as a niche oncology therapeutic for the treatment of certain forms of leukemia, Cladribine was re-discovered as a powerful agent for the treatment of MS. Launched by a major drug company in 2017 in Europe and 2019 in the US as a proprietary tablet formulation for the treatment of MS, Cladribine tablets reached over one billion in global sales in 2022 with a three-year CAGR of 18%. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe. The global Multiple Sclerosis drug market is expected to top US$ 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.分析記事 • Oct 27Why We Think BioNxt Solutions Inc.'s (CSE:BNXT) CEO Compensation Is Not Excessive At AllKey Insights BioNxt Solutions to hold its Annual General Meeting on 2nd of November Salary of CA$231.0k is part of CEO...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.Reported Earnings • Aug 31Second quarter 2023 earnings released: CA$0.024 loss per share (vs CA$0.017 loss in 2Q 2022)Second quarter 2023 results: CA$0.024 loss per share (further deteriorated from CA$0.017 loss in 2Q 2022). Revenue: CA$177.3k (up 81% from 2Q 2022). Net loss: CA$2.36m (loss widened 74% from 2Q 2022). Over the last 3 years on average, earnings per share has increased by 26% per year but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings.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.New Risk • Jun 26New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$6.7m free cash flow). Negative equity (-CA$2.3m). Earnings have declined by 26% per year over the past 5 years. Revenue is less than US$1m (CA$346k revenue, or US$263k). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (CA$54.1m market cap, or US$41.2m).Reported Earnings • May 31First quarter 2023 earnings released: CA$0.016 loss per share (vs CA$0.023 loss in 1Q 2022)First quarter 2023 results: CA$0.016 loss per share (improved from CA$0.023 loss in 1Q 2022). Revenue: CA$169.6k (up 40% from 1Q 2022). Net loss: CA$1.50m (loss narrowed 15% from 1Q 2022). Over the last 3 years on average, earnings per share has increased by 19% per year but the company’s share price has fallen by 42% per year, which means it is significantly lagging earnings.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.Reported Earnings • Apr 13Full year 2022 earnings released: CA$0.15 loss per share (vs CA$0.29 loss in FY 2021)Full year 2022 results: CA$0.15 loss per share (improved from CA$0.29 loss in FY 2021). Revenue: CA$297.4k (up 3.8% from FY 2021). Net loss: CA$12.4m (loss narrowed 40% from FY 2021). Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 39% per year, which means it is significantly lagging earnings.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.お知らせ • Dec 08BioNxt Solutions Inc. announced that it has received CAD 2.808 million in fundingOn December 7, 2022, BioNxt Solutions Inc. closed the transaction.お知らせ • Nov 30BioNxt Solutions Inc. announced that it expects to receive CAD 2.6 million in fundingBioNxt Solutions Inc. announced a non brokered 2,600 debenture units at an issue price of CAD 2,600,000 on November 29, 2022.Each Unit is convertible into 1,923 common shares and one-half share purchase warrants. The Debentures will bear interest from their issue date at 8.0% 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. The principal amount of each Debenture will be convertible at the option of the holder into common shares in the capital of the company. Each Warrant will be exercisable to acquire one common share at an exercise price of CAD 0.80 per warrant for a period of two years from the closing date. 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.分析記事 • Nov 30BioNxt Solutions (CSE:BNXT) Is Making Moderate Use Of DebtSome say volatility, rather than debt, is the best way to think about risk as an investor, but Warren Buffett famously...Reported Earnings • Nov 29Third quarter 2022 earnings released: CA$0.023 loss per share (vs CA$0.036 loss in 3Q 2021)Third quarter 2022 results: CA$0.023 loss per share (improved from CA$0.036 loss in 3Q 2021). Net loss: CA$1.91m (loss narrowed 27% from 3Q 2021). Over the last 3 years on average, earnings per share has fallen by 2% per year but the company’s share price has fallen by 12% per year, which means it is performing significantly worse than earnings.Board Change • Nov 16Less than half of directors are independentFollowing the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Per Thoresen was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • Oct 18XPhyto Reports Excellent Rotigotine In-Vitro/Ex-Vivo Results for Parkinson's Disease TreatmentXPhyto Therapeutics Corp. reported the results of its Rotigotine transdermal ("TDS") patch human skin cadaver study and dissolution data. The Company's Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH ("Vektor"). Further to the Company's product update on October 11, 2022, XPhyto reported excellent results from its recent Rotigotine TDS human cadaver skin absorption study. The study compared drug absorption between XPhyto's optimized new formula and the name brand product in three separate samples over a 24-hour period in accordance with EMA's Guideline on quality of transdermal patches. 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. The therapeutic market for Parkinson's disease is over 10 million people worldwide and growing.お知らせ • Oct 12Xphyto Therapeutics Corp. Completes Rotigotine Transdermal Patch Optimization and Comparative Skin Absorption StudyXPhyto Therapeutics Corp. provided a product development report on its Rotigotine transdermal ("TDS") patch. The Company's Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH ("Vektor"). Over the past 90 days, the Company has been focused on the optimization of its Rotigotine TDS formulation for the treatment of Parkinson's disease, with multiple novel but related formulas under development. After several rounds of skin permeation studies using mouse and human cadaver skin samples to compare Rotigotine absorption between XPhyto's formulas and the name brand product, XPhyto announced that its Rotigotine TDS formula is complete. Upon the recent formula completion, the Company carried out what it anticipates to be the final comparative human skin cadaver study. This study is now complete and analytical results are expected to be finalized and announced within the coming days. 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. The therapeutic market for Parkinson's Disease is over 10 million people with PD worldwide and growing. The top selling name brand product launched by the originator in 2007 independently sold over $375 million of its Rotigotine TDS patches in 2021. According to Wissen Market Research, total global sales for Rotigotine patches were approximately US$518 million in 2021 with the market expected to surpass US$766 million by 2030. XPhyto'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. According to Research and Markets, the global transdermal skin patch market had a value of nearly US$6.5 billion in 2020 while Kuick Research, Pharmaceutical and Healthcare, estimate the market will reach approximately US$20 billion by 2028.お知らせ • Sep 20XPhyto Therapeutics Corp. Files Patent Application for Library of Novel Psychedelic CompoundsXPhyto Therapeutics Corp. report that it has filed a patent application for a significant library of novel psychedelic compounds. Each compound was designed to provide specific alterations in their respective biopharmaceutical properties. The library of compounds can be selected to target (personalize) the treatment of neuropsychiatric, and neurodegenerative, neuroinflammatory and pain disorders including depression, as well as tobacco, opiate, and cocaine addiction, alcoholism, post-traumatic stress disorder, and pain syndromes including cluster headaches and chemotherapy induced peripheral neuropathy. Novel methods of administration might be applied for dosing to further optimize therapeutic outcomes. This significant library of psychedelic derived molecules secures XPhyto a platform technology to which variations of the molecules can be applied to various indications as noted. The potential applications are subject to the requisite clinical and regulatory commercialization processes. The global psychedelic drugs market is expected to gain significant market growth in the forecast period from 2022 to 2029. Data Bridge Market Research reports that the market is growing with a CAGR of 13.3% in the forecast period from 2022 to 2029 and is expected to reach USD 6,401.95 million by 2029 from USD 2,386.72 million in 2021. Related development work has been carried out as part of an ongoing exclusive psychedelic R&D partnership with Applied Pharmaceutical Innovation. XPhyto is pursuing a multi-strategic approach to psychedelic medicine including drug synthesis, drug delivery and novel psychedelic analogue engineering. Applied is a not-for-profit institution at the University of Alberta created to support translational drug development for industry and innovators. The intellectual property is retained 100% by XPhyto. The Company will provide further updates in due course.お知らせ • Sep 03XPhyto Therapeutics Corp. announced that it has received CAD 3.6 million in fundingOn September 2, 2022, XPhyto Therapeutics Corp. closed the transaction. On the same date, the company has issued 2,190,000 units for gross proceeds of CAD 788,400 in its third and final tranche bringing the total funds raised in the transaction to CAD 3,600,000. The company paid CAD 63,072 and issued 175,200 share purchase warrants in finder’s fees with respect to the placement. Each finder’s warrant is exercisable into one common share at a price of CAD 0.50 per share for a period of two years from the date of issue.Reported Earnings • Aug 27Second quarter 2022 earnings released: CA$0.017 loss per share (vs CA$0.061 loss in 2Q 2021)Second quarter 2022 results: CA$0.017 loss per share (up from CA$0.061 loss in 2Q 2021). Net loss: CA$1.35m (loss narrowed 68% from 2Q 2021). Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has fallen by 32% per year, which means it is performing significantly worse than earnings.お知らせ • Aug 13XPhyto Therapeutics Corp., Annual General Meeting, Oct 12, 2022XPhyto Therapeutics Corp., Annual General Meeting, Oct 12, 2022.お知らせ • Jul 23XPhyto Therapeutics Corp. announced that it expects to receive CAD 3.6 million in fundingXPhyto Therapeutics Corp. announced a non brokered private placement for maximum of 10,000,000 units at an issue price of CAD 0.36 per unit gross proceeds of a maximum of CAD 3,600,000 on July 22, 2022. Each Unit will consist of one common share and one half of one common share purchase warrant. Each Warrant will entitle the holder to acquire one Common Share at an exercise price of CAD 0.50 per Warrant Share for a period of 24 months from the date of issuance. The Offering is anticipated to result in a maximum of 10,000,000 Units of the Company being issued, and the Offering may close in one or more tranches. In connection with the Offering, eligible parties may receive a cash finder’s fee payment equal to up to 8% of the gross proceeds of the Units that are sold to subscribers introduced by such parties, and warrants to purchase that number of Common Shares equal to up to 8% of the Units that are sold to subscribers introduced by such parties, with each Finder’s Warrant being exercisable for one Finder’s Warrant Share at a price of CAD 0.50 per Finder’s Warrant Share for a period of 24 months from the closing of the Offering.お知らせ • Jul 19Xphyto Pursues Potential Application of its Oral Dissolvable Biosensor Inflammation Test for Buprenorphine-Related Dental DiseaseXPhyto Therapeutics Corp. reported a significant potential market opportunity for its oral dissolvable biosensor screening tests for oral inflammation. Certain buprenorphine medicines prescribed to treat opioid use disorder and pain have been recently associated with numerous serious oral health problems requiring medical intervention. Buprenorphine is a medication approved by the U.S. Food and Drug Administration (the "FDA") to treat OUD as a medication-assisted treatment (MAT). The number of US adolescent and adult individuals with OUD in 2019 was estimated between 6.77.6 million. XPhyto is investigating the potential application of one or more of its ODF biosensor screening tests for oral inflammation to detect buprenorphine-related dental problems. This year, the FDA issued a Drug Safety Communication titled "FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain." The DSC notes that the dental problems include "tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues." Notwithstanding the seriousness of the side-effects, the FDA is recommending the continued use of these medications as the benefits outweigh the risks and oral care can assist. The global buprenorphine market is expected to surpass USD 10.9 billion by 2027 according to Coherent Market Insights (CMI). XPhyto's proprietary ODF biosensor development portfolio includes multiple oral health products, including for the detection of stomatitis, periodontitis, and periimplantitis. The Company's first ODF biosensor screening product is for general oral inflammation. Positive detection of the causative inflammatory agents results in an enzymatic release of a bitter compound in the user's mouth, with no medical training, analytical equipment or power supply required. The oral inflammation biosensor is designed to function as a simple, low-cost, and self-administered screening test to identify users for follow-up medical testing. The Company's oral dissolvable inflammation screening test was EU registered in late 2021 and is currently licensed for marketing and sale in Europe.お知らせ • Jun 10Xphyto Therapeutics Corp. Adds Dr. Flon A. Sahr to Its European Teateam as Head of Project ManagementXPhyto Therapeutics Corp. reported that Dr. Florian A. Sahr has joined its European operations as Head of Project Management. Dr. Sahr is a German-born and internationally trained leader in drug formulation, technology transfer and new-product manufacturing. Dr. Sahr has a strong track record of drug development, including transdermal ("TDS") and oral dissolvable ("ODF") delivery systems, as well as the physical and regulatory establishment of GMP and FDA compliant pharmaceutical manufacturing facilities. Several employment highlights include his work as Senior Scientist, Head of Manufacturing, Gen-Plus GmbH & Co. KG, Munich, Germany, where he developed TDS and ODF drug formulations and transferred these new formulations and technologies to manufacturing systems and facilities; and his work as Project Manager, Advanced Projects, tesa Labtec GmbH, Langenfeld, Germany, focusing on project management and technology transfer of generic TDS formulations to the company's manufacturing facilities. Dr. Sahr has held the regulated position of Head of Manufacturing according to AMG/AMWHV (German Medicines Act) for the production of clinical trial materials for a number of companies. Dr. Sahr is engaged full-time with Vektor Pharma TF GmbH ("Vektor"), XPhyto's wholly owned German subsidiary. Dr Sahr's management of Vektor's TDS and ODF product development programs, and his technology transfer skills are highly relevant as XPhyto reviews its ODF novel biosensor manufacturing options and opportunities.Reported Earnings • May 01Full year 2021 earnings released: CA$0.29 loss per share (vs CA$0.29 loss in FY 2020)Full year 2021 results: CA$0.29 loss per share. Net loss: CA$20.6m (loss widened 22% from FY 2020). Over the next year, revenue is forecast to grow 326%, compared to a 98% growth forecast for the pharmaceuticals industry in Canada.Board Change • Apr 27Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Independent Director Per Thoresen was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.Recent Insider Transactions • Mar 23President recently sold CA$184k worth of stockOn the 14th of March, Hugh A. Rogers sold around 178k shares on-market at roughly CA$1.04 per share. This was the largest sale by an insider in the last 3 months. This was Hugh A.'s only on-market trade for the last 12 months.Recent Insider Transactions Derivative • Mar 21President exercised options to buy CA$357k worth of stock.On the 16th of March, Hugh A. Rogers exercised options to buy 364k shares at a strike price of around CA$0.50, costing a total of CA$182k. This transaction amounted to 69% of their direct individual holding at the time of the trade. Since June 2021, Hugh A. has owned 525.00k shares directly. Company insiders have collectively bought CA$210k more than they sold, via options and on-market transactions, in the last 12 months.お知らせ • Dec 07XPhyto Therapeutics Corp. (CNSX:XPHY) completed the acquisition of 3a-diagnostics GmbH.XPhyto Therapeutics Corp. (CNSX:XPHY) s signed a definitive agreement to acquire 3A-Diagnostics GmbH for €3.9 million on July 20, 2021. As per the agreement, €0.4 million will be paid immediately and remaining €3.5 million will be paid closing, planned for on or around October 31, 2021. XPhyto Therapeutics launched a non-brokered private placement of up to 5 million common shares of XPhyto Therapeutics at a price of $1.00 per Share for total gross proceeds of up to $5 million and up to $2.5 million of unsecured convertible debentures and 2 million common share purchase warrants. XPhyto Therapeutics intends to use the net proceeds of the Offering and Debentures for research and development, inventory purchases, general working capital purposes, and to complete the acquisition of 3a. Further to the acquisition agreement between XPhyto and 3a, the parties have agreed to extend the closing terms which is expected to complete on or around December 1, 2021. XPhyto Therapeutics Corp. (CNSX:XPHY) completed the acquisition of 3a-diagnostics GmbH on December 6, 2021.Reported Earnings • Nov 28Third quarter 2021 earnings: EPS in line with analyst expectations despite revenue beatThird quarter 2021 results: CA$0.036 loss per share (up from CA$0.11 loss in 3Q 2020). Net loss: CA$2.60m (loss narrowed 62% from 3Q 2020). Revenue exceeded analyst estimates by 1,458%.お知らせ • Nov 27XPhyto Therapeutics Corp. announced that it has received CAD 7 million in fundingOn November 26, 2021, XPhyto Therapeutics Corp. closed the transaction. The company issued 4,500,000 common shares for gross proceeds of CAD 4,500,000 and debentures in the principal amount of CAD 2,500,000. The company also issued 2,000,000 share purchase warrants, exercisable into shares at an exercise price of CAD 1.50 for a period of 2 years. The Company issued 360,000 common share purchase warrants, exercisable at CAD 1.11 into common shares of the company for a period of 24 months from closing, and paid cash commissions aggregating CAD 360,000 to finders as finder fees. The eligible finder that introduced the subscriber to the company for purpose of completing the debenture offering received 160,000 common share purchase warrants, exercisable at CAD 1.25 into common shares of the Company for a period of 24 months from closing, and were paid CAD 200,000 in cash commission. The chief financial officer of the company participated in the equity offering by purchasing a total of 25,000 shares.Reported Earnings • Aug 28Second quarter 2021 earnings released: CA$0.061 loss per share (vs CA$0.064 loss in 2Q 2020)Second quarter 2021 results: Net loss: CA$4.16m (loss widened 16% from 2Q 2020).Director Overboarding • Aug 07Director Peter Damouni has joined 7th company boardDirector Peter Damouni has been appointed to the board of XPhyto Therapeutics Corp. (CNSX:XPHY). Damouni now sits on a total of 7 company boards. According to the Simply Wall St Risk Model, the director is at risk of having too many board obligations.Director Overboarding • Aug 07Director Peter Damouni has joined 7th company boardDirector Peter Damouni has been appointed to the board of XPhyto Therapeutics Corp. (CNSX:XPHY). Damouni now sits on a total of 7 company boards. According to the Simply Wall St Risk Model, the director is at risk of having too many board obligations.Director Overboarding • Aug 07Director Peter Damouni has joined 7th company boardDirector Peter Damouni has been appointed to the board of XPhyto Therapeutics Corp. (CNSX:XPHY). Damouni now sits on a total of 7 company boards. According to the Simply Wall St Risk Model, the director is at risk of having too many board obligations.Director Overboarding • Aug 07Director Peter Damouni has joined 7th company boardDirector Peter Damouni has been appointed to the board of XPhyto Therapeutics Corp. (CNSX:XPHY). Damouni now sits on a total of 7 company boards. According to the Simply Wall St Risk Model, the director is at risk of having too many board obligations.株主還元BNXTCA PharmaceuticalsCA 市場7D-3.4%-6.3%-0.2%1Y-22.2%44.6%32.6%株主還元を見る業界別リターン: BNXT過去 1 年間で44.6 % の収益を上げたCanadian Pharmaceuticals業界を下回りました。リターン対市場: BNXTは、過去 1 年間で32.6 % のリターンを上げたCanadian市場を下回りました。価格変動Is BNXT's price volatile compared to industry and market?BNXT volatilityBNXT Average Weekly Movement11.8%Pharmaceuticals Industry Average Movement11.2%Market Average Movement10.3%10% most volatile stocks in CA Market18.1%10% least volatile stocks in CA Market3.9%安定した株価: BNXT 、 Canadian市場と比較して、過去 3 か月間で大きな価格変動はありませんでした。時間の経過による変動: BNXTの 週次ボラティリティ ( 12% ) は過去 1 年間安定しています。会社概要設立従業員CEO（最高経営責任者ウェブサイト2017n/aHugh A. Rogerswww.bionxt.comBioNxt Solutions Inc.は、神経疾患や自己免疫疾患のための薄膜（舌下）および皮膚パッチ（経皮）薬物送達の研究開発および製造に従事し、患者のコンプライアンスとバイオアベイラビリティを向上させています。精密経皮・経口溶解性製剤、口腔衛生スクリーニング検査、神経学的応用のための新薬有効成分の標準化と臨床評価など、診断スクリーニング検査、新薬有効成分の製造と評価を行っている。同社は以前はXPhyto Therapeutics Corp.として知られていたが、2022年11月にBioNxt Solutions Inc.に社名変更した。同社は2017年に法人化され、カナダのバンクーバーに本社を置いている。もっと見るBioNxt Solutions Inc. 基礎のまとめBioNxt Solutions の収益と売上を時価総額と比較するとどうか。BNXT 基礎統計学時価総額CA$54.58m収益（TTM）-CA$7.03m売上高(TTM)n/a0.0xP/Sレシオ-7.8xPER（株価収益率BNXT は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計BNXT 損益計算書（TTM）収益CA$0売上原価CA$0売上総利益CA$0その他の費用CA$7.03m収益-CA$7.03m直近の収益報告Dec 31, 2025次回決算日該当なし一株当たり利益（EPS）-0.054グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率-63.5%BNXT の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation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2026/05/20 19:20終値2026/05/20 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
New Risk • Mar 01New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 15% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$5.2m free cash flow). Negative equity (-CA$8.3m). Revenue is less than US$1m (CA$16k revenue, or US$12k). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Significant insider selling over the past 3 months (CA$171k sold). Market cap is less than US$100m (CA$81.5m market cap, or US$59.8m).
Recent Insider Transactions • Jan 29Co-Founder recently sold CA$98k worth of stockOn the 22nd of January, Wolfgang Probst sold around 183k shares on-market at roughly CA$0.54 per share. This transaction amounted to 14% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Wolfgang has been a net seller over the last 12 months, reducing personal holdings by CA$167k.
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.
Reported Earnings • Nov 30Third quarter 2025 earnings released: CA$0.014 loss per share (vs CA$0.013 loss in 3Q 2024)Third quarter 2025 results: CA$0.014 loss per share (further deteriorated from CA$0.013 loss in 3Q 2024). Net loss: CA$1.60m (loss widened 9.4% from 3Q 2024). Over the last 3 years on average, earnings per share has increased by 47% per year but the company’s share price has only increased by 9% per year, which means it is significantly lagging earnings growth.
Recent Insider Transactions • Nov 20Co-Founder recently sold CA$55k worth of stockOn the 13th of November, Hugh A. Rogers sold around 68k shares on-market at roughly CA$0.82 per share. This transaction amounted to 7.0% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Hugh A. has been a net seller over the last 12 months, reducing personal holdings by CA$76k.
New Risk • Mar 01New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 15% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$5.2m free cash flow). Negative equity (-CA$8.3m). Revenue is less than US$1m (CA$16k revenue, or US$12k). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Significant insider selling over the past 3 months (CA$171k sold). Market cap is less than US$100m (CA$81.5m market cap, or US$59.8m).
Recent Insider Transactions • Jan 29Co-Founder recently sold CA$98k worth of stockOn the 22nd of January, Wolfgang Probst sold around 183k shares on-market at roughly CA$0.54 per share. This transaction amounted to 14% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Wolfgang has been a net seller over the last 12 months, reducing personal holdings by CA$167k.
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.
Reported Earnings • Nov 30Third quarter 2025 earnings released: CA$0.014 loss per share (vs CA$0.013 loss in 3Q 2024)Third quarter 2025 results: CA$0.014 loss per share (further deteriorated from CA$0.013 loss in 3Q 2024). Net loss: CA$1.60m (loss widened 9.4% from 3Q 2024). Over the last 3 years on average, earnings per share has increased by 47% per year but the company’s share price has only increased by 9% per year, which means it is significantly lagging earnings growth.
Recent Insider Transactions • Nov 20Co-Founder recently sold CA$55k worth of stockOn the 13th of November, Hugh A. Rogers sold around 68k shares on-market at roughly CA$0.82 per share. This transaction amounted to 7.0% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Hugh A. has been a net seller over the last 12 months, reducing personal holdings by CA$76k.
New Risk • Nov 20New minor risk - Insider sellingThere has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: CA$112k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$8.4m). Revenue is less than US$1m (CA$22k revenue, or US$15k). Minor Risks Significant insider selling over the past 3 months (CA$112k sold). Market cap is less than US$100m (CA$84.0m market cap, or US$59.8m).
Recent Insider Transactions • Nov 19Co-Founder recently sold CA$55k worth of stockOn the 13th of November, Hugh A. Rogers sold around 68k shares on-market at roughly CA$0.82 per share. This transaction amounted to 7.0% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Hugh A. has been a net seller over the last 12 months, reducing personal holdings by CA$76k.
New Risk • Sep 15New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$8.4m). Revenue is less than US$1m (CA$22k revenue, or US$16k). Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (CA$100.5m market cap, or US$73.0m).
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
Reported Earnings • Aug 31First half 2025 earnings released: CA$0.028 loss per share (vs CA$0.023 loss in 1H 2024)First half 2025 results: CA$0.028 loss per share (further deteriorated from CA$0.023 loss in 1H 2024). Net loss: CA$3.27m (loss widened 28% from 1H 2024). Over the last 3 years on average, earnings per share has increased by 48% per year but the company’s share price has only increased by 38% per year, which means it is significantly lagging earnings growth.
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.
New Risk • Jun 27New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -CA$3.4m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$3.4m free cash flow). Negative equity (-CA$7.6m). Revenue is less than US$1m (CA$23k revenue, or US$17k). Minor Risk Market cap is less than US$100m (CA$60.8m market cap, or US$44.5m).
Reported Earnings • Jun 27First quarter 2025 earnings released: CA$0.017 loss per share (vs CA$0.014 loss in 1Q 2024)First quarter 2025 results: CA$0.017 loss per share (further deteriorated from CA$0.014 loss in 1Q 2024). Net loss: CA$1.97m (loss widened 26% from 1Q 2024). Over the last 3 years on average, earnings per share has increased by 50% per year but the company’s share price has fallen by 1% per year, which means it is significantly lagging earnings.
New Risk • Jun 17New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended September 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$7.4m). Revenue is less than US$1m (CA$42k revenue, or US$31k). Minor Risks Latest financial reports are more than 6 months old (reported September 2024 fiscal period end). Market cap is less than US$100m (CA$64.1m market cap, or US$47.2m).
New Risk • May 06New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: CA$7.33m (US$5.32m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$7.4m). Revenue is less than US$1m (CA$42k revenue, or US$30k). Market cap is less than US$10m (CA$7.33m market cap, or US$5.32m).
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.
Reported Earnings • Dec 01Third quarter 2024 earnings released: CA$0.013 loss per share (vs CA$0.014 loss in 3Q 2023)Third quarter 2024 results: CA$0.013 loss per share. Net loss: CA$1.47m (loss widened 4.4% from 3Q 2023).
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
Reported Earnings • Aug 29Second quarter 2024 earnings released: CA$0.009 loss per share (vs CA$0.024 loss in 2Q 2023)Second quarter 2024 results: CA$0.009 loss per share (improved from CA$0.024 loss in 2Q 2023). Net loss: CA$974.4k (loss narrowed 59% from 2Q 2023). Over the last 3 years on average, earnings per share has increased by 45% per year but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings.
New Risk • Aug 20New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Canadian stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Negative equity (-CA$6.1m). Earnings have declined by 7.9% per year over the past 5 years. Revenue is less than US$1m (CA$207k revenue, or US$152k). Minor Risks Shareholders have been diluted in the past year (15% increase in shares outstanding). Market cap is less than US$100m (CA$29.4m market cap, or US$21.5m).
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.
Reported Earnings • Jun 04First quarter 2024 earnings released: CA$0.014 loss per share (vs CA$0.016 loss in 1Q 2023)First quarter 2024 results: CA$0.014 loss per share. Revenue: CA$4.1k (down 98% from 1Q 2023). Net loss: CA$1.57m (loss widened 5.2% from 1Q 2023).
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.
Reported Earnings • Apr 23Full year 2023 earnings released: CA$0.078 loss per share (vs CA$0.15 loss in FY 2022)Full year 2023 results: CA$0.078 loss per share (improved from CA$0.15 loss in FY 2022). Revenue: CA$372.2k (up 25% from FY 2022). Net loss: CA$7.72m (loss narrowed 38% from FY 2022). Over the last 3 years on average, earnings per share has increased by 37% per year but the company’s share price has fallen by 47% per year, which means it is significantly lagging earnings.
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.
Reported Earnings • Nov 24Third quarter 2023 earnings released: CA$0.014 loss per share (vs CA$0.023 loss in 3Q 2022)Third quarter 2023 results: CA$0.014 loss per share (improved from CA$0.023 loss in 3Q 2022). Revenue: CA$5.7k (down 86% from 3Q 2022). Net loss: CA$1.40m (loss narrowed 26% from 3Q 2022). Over the last 3 years on average, earnings per share has increased by 31% per year but the company’s share price has fallen by 38% per year, which means it is significantly lagging earnings.
お知らせ • Nov 17BioNxt Solutions Inc Reports on New Cladrabine Odf Product Development and Commercialization ProgramBioNxt Solutions Inc. provide further development details on its recently announced 100% Cladribine IP acquisition and related development program. BioNxt has commenced the development and commercialization of a proprietary oral dissolvable film ("ODF") based Cladribine product for the treatment of neurodegenerative diseases, namely Multiple Sclerosis ("MS"). After ten years of use as a niche oncology therapeutic for the treatment of certain forms of leukemia, Cladribine was re-discovered as a powerful agent for the treatment of MS. Launched by a major drug company in 2017 in Europe and 2019 in the US as a proprietary tablet formulation for the treatment of MS, Cladribine tablets reached over one billion in global sales in 2022 with a three-year CAGR of 18%. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe. The global Multiple Sclerosis drug market is expected to top US$ 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.
分析記事 • Oct 27Why We Think BioNxt Solutions Inc.'s (CSE:BNXT) CEO Compensation Is Not Excessive At AllKey Insights BioNxt Solutions to hold its Annual General Meeting on 2nd of November Salary of CA$231.0k is part of CEO...
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.
Reported Earnings • Aug 31Second quarter 2023 earnings released: CA$0.024 loss per share (vs CA$0.017 loss in 2Q 2022)Second quarter 2023 results: CA$0.024 loss per share (further deteriorated from CA$0.017 loss in 2Q 2022). Revenue: CA$177.3k (up 81% from 2Q 2022). Net loss: CA$2.36m (loss widened 74% from 2Q 2022). Over the last 3 years on average, earnings per share has increased by 26% per year but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings.
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.
New Risk • Jun 26New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$6.7m free cash flow). Negative equity (-CA$2.3m). Earnings have declined by 26% per year over the past 5 years. Revenue is less than US$1m (CA$346k revenue, or US$263k). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (CA$54.1m market cap, or US$41.2m).
Reported Earnings • May 31First quarter 2023 earnings released: CA$0.016 loss per share (vs CA$0.023 loss in 1Q 2022)First quarter 2023 results: CA$0.016 loss per share (improved from CA$0.023 loss in 1Q 2022). Revenue: CA$169.6k (up 40% from 1Q 2022). Net loss: CA$1.50m (loss narrowed 15% from 1Q 2022). Over the last 3 years on average, earnings per share has increased by 19% per year but the company’s share price has fallen by 42% per year, which means it is significantly lagging earnings.
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.
Reported Earnings • Apr 13Full year 2022 earnings released: CA$0.15 loss per share (vs CA$0.29 loss in FY 2021)Full year 2022 results: CA$0.15 loss per share (improved from CA$0.29 loss in FY 2021). Revenue: CA$297.4k (up 3.8% from FY 2021). Net loss: CA$12.4m (loss narrowed 40% from FY 2021). Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 39% per year, which means it is significantly lagging earnings.
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.
お知らせ • Dec 08BioNxt Solutions Inc. announced that it has received CAD 2.808 million in fundingOn December 7, 2022, BioNxt Solutions Inc. closed the transaction.
お知らせ • Nov 30BioNxt Solutions Inc. announced that it expects to receive CAD 2.6 million in fundingBioNxt Solutions Inc. announced a non brokered 2,600 debenture units at an issue price of CAD 2,600,000 on November 29, 2022.Each Unit is convertible into 1,923 common shares and one-half share purchase warrants. The Debentures will bear interest from their issue date at 8.0% 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. The principal amount of each Debenture will be convertible at the option of the holder into common shares in the capital of the company. Each Warrant will be exercisable to acquire one common share at an exercise price of CAD 0.80 per warrant for a period of two years from the closing date. 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.
分析記事 • Nov 30BioNxt Solutions (CSE:BNXT) Is Making Moderate Use Of DebtSome say volatility, rather than debt, is the best way to think about risk as an investor, but Warren Buffett famously...
Reported Earnings • Nov 29Third quarter 2022 earnings released: CA$0.023 loss per share (vs CA$0.036 loss in 3Q 2021)Third quarter 2022 results: CA$0.023 loss per share (improved from CA$0.036 loss in 3Q 2021). Net loss: CA$1.91m (loss narrowed 27% from 3Q 2021). Over the last 3 years on average, earnings per share has fallen by 2% per year but the company’s share price has fallen by 12% per year, which means it is performing significantly worse than earnings.
Board Change • Nov 16Less than half of directors are independentFollowing the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Per Thoresen was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • Oct 18XPhyto Reports Excellent Rotigotine In-Vitro/Ex-Vivo Results for Parkinson's Disease TreatmentXPhyto Therapeutics Corp. reported the results of its Rotigotine transdermal ("TDS") patch human skin cadaver study and dissolution data. The Company's Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH ("Vektor"). Further to the Company's product update on October 11, 2022, XPhyto reported excellent results from its recent Rotigotine TDS human cadaver skin absorption study. The study compared drug absorption between XPhyto's optimized new formula and the name brand product in three separate samples over a 24-hour period in accordance with EMA's Guideline on quality of transdermal patches. 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. The therapeutic market for Parkinson's disease is over 10 million people worldwide and growing.
お知らせ • Oct 12Xphyto Therapeutics Corp. Completes Rotigotine Transdermal Patch Optimization and Comparative Skin Absorption StudyXPhyto Therapeutics Corp. provided a product development report on its Rotigotine transdermal ("TDS") patch. The Company's Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH ("Vektor"). Over the past 90 days, the Company has been focused on the optimization of its Rotigotine TDS formulation for the treatment of Parkinson's disease, with multiple novel but related formulas under development. After several rounds of skin permeation studies using mouse and human cadaver skin samples to compare Rotigotine absorption between XPhyto's formulas and the name brand product, XPhyto announced that its Rotigotine TDS formula is complete. Upon the recent formula completion, the Company carried out what it anticipates to be the final comparative human skin cadaver study. This study is now complete and analytical results are expected to be finalized and announced within the coming days. 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. The therapeutic market for Parkinson's Disease is over 10 million people with PD worldwide and growing. The top selling name brand product launched by the originator in 2007 independently sold over $375 million of its Rotigotine TDS patches in 2021. According to Wissen Market Research, total global sales for Rotigotine patches were approximately US$518 million in 2021 with the market expected to surpass US$766 million by 2030. XPhyto'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. According to Research and Markets, the global transdermal skin patch market had a value of nearly US$6.5 billion in 2020 while Kuick Research, Pharmaceutical and Healthcare, estimate the market will reach approximately US$20 billion by 2028.
お知らせ • Sep 20XPhyto Therapeutics Corp. Files Patent Application for Library of Novel Psychedelic CompoundsXPhyto Therapeutics Corp. report that it has filed a patent application for a significant library of novel psychedelic compounds. Each compound was designed to provide specific alterations in their respective biopharmaceutical properties. The library of compounds can be selected to target (personalize) the treatment of neuropsychiatric, and neurodegenerative, neuroinflammatory and pain disorders including depression, as well as tobacco, opiate, and cocaine addiction, alcoholism, post-traumatic stress disorder, and pain syndromes including cluster headaches and chemotherapy induced peripheral neuropathy. Novel methods of administration might be applied for dosing to further optimize therapeutic outcomes. This significant library of psychedelic derived molecules secures XPhyto a platform technology to which variations of the molecules can be applied to various indications as noted. The potential applications are subject to the requisite clinical and regulatory commercialization processes. The global psychedelic drugs market is expected to gain significant market growth in the forecast period from 2022 to 2029. Data Bridge Market Research reports that the market is growing with a CAGR of 13.3% in the forecast period from 2022 to 2029 and is expected to reach USD 6,401.95 million by 2029 from USD 2,386.72 million in 2021. Related development work has been carried out as part of an ongoing exclusive psychedelic R&D partnership with Applied Pharmaceutical Innovation. XPhyto is pursuing a multi-strategic approach to psychedelic medicine including drug synthesis, drug delivery and novel psychedelic analogue engineering. Applied is a not-for-profit institution at the University of Alberta created to support translational drug development for industry and innovators. The intellectual property is retained 100% by XPhyto. The Company will provide further updates in due course.
お知らせ • Sep 03XPhyto Therapeutics Corp. announced that it has received CAD 3.6 million in fundingOn September 2, 2022, XPhyto Therapeutics Corp. closed the transaction. On the same date, the company has issued 2,190,000 units for gross proceeds of CAD 788,400 in its third and final tranche bringing the total funds raised in the transaction to CAD 3,600,000. The company paid CAD 63,072 and issued 175,200 share purchase warrants in finder’s fees with respect to the placement. Each finder’s warrant is exercisable into one common share at a price of CAD 0.50 per share for a period of two years from the date of issue.
Reported Earnings • Aug 27Second quarter 2022 earnings released: CA$0.017 loss per share (vs CA$0.061 loss in 2Q 2021)Second quarter 2022 results: CA$0.017 loss per share (up from CA$0.061 loss in 2Q 2021). Net loss: CA$1.35m (loss narrowed 68% from 2Q 2021). Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has fallen by 32% per year, which means it is performing significantly worse than earnings.
お知らせ • Aug 13XPhyto Therapeutics Corp., Annual General Meeting, Oct 12, 2022XPhyto Therapeutics Corp., Annual General Meeting, Oct 12, 2022.
お知らせ • Jul 23XPhyto Therapeutics Corp. announced that it expects to receive CAD 3.6 million in fundingXPhyto Therapeutics Corp. announced a non brokered private placement for maximum of 10,000,000 units at an issue price of CAD 0.36 per unit gross proceeds of a maximum of CAD 3,600,000 on July 22, 2022. Each Unit will consist of one common share and one half of one common share purchase warrant. Each Warrant will entitle the holder to acquire one Common Share at an exercise price of CAD 0.50 per Warrant Share for a period of 24 months from the date of issuance. The Offering is anticipated to result in a maximum of 10,000,000 Units of the Company being issued, and the Offering may close in one or more tranches. In connection with the Offering, eligible parties may receive a cash finder’s fee payment equal to up to 8% of the gross proceeds of the Units that are sold to subscribers introduced by such parties, and warrants to purchase that number of Common Shares equal to up to 8% of the Units that are sold to subscribers introduced by such parties, with each Finder’s Warrant being exercisable for one Finder’s Warrant Share at a price of CAD 0.50 per Finder’s Warrant Share for a period of 24 months from the closing of the Offering.
お知らせ • Jul 19Xphyto Pursues Potential Application of its Oral Dissolvable Biosensor Inflammation Test for Buprenorphine-Related Dental DiseaseXPhyto Therapeutics Corp. reported a significant potential market opportunity for its oral dissolvable biosensor screening tests for oral inflammation. Certain buprenorphine medicines prescribed to treat opioid use disorder and pain have been recently associated with numerous serious oral health problems requiring medical intervention. Buprenorphine is a medication approved by the U.S. Food and Drug Administration (the "FDA") to treat OUD as a medication-assisted treatment (MAT). The number of US adolescent and adult individuals with OUD in 2019 was estimated between 6.77.6 million. XPhyto is investigating the potential application of one or more of its ODF biosensor screening tests for oral inflammation to detect buprenorphine-related dental problems. This year, the FDA issued a Drug Safety Communication titled "FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain." The DSC notes that the dental problems include "tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues." Notwithstanding the seriousness of the side-effects, the FDA is recommending the continued use of these medications as the benefits outweigh the risks and oral care can assist. The global buprenorphine market is expected to surpass USD 10.9 billion by 2027 according to Coherent Market Insights (CMI). XPhyto's proprietary ODF biosensor development portfolio includes multiple oral health products, including for the detection of stomatitis, periodontitis, and periimplantitis. The Company's first ODF biosensor screening product is for general oral inflammation. Positive detection of the causative inflammatory agents results in an enzymatic release of a bitter compound in the user's mouth, with no medical training, analytical equipment or power supply required. The oral inflammation biosensor is designed to function as a simple, low-cost, and self-administered screening test to identify users for follow-up medical testing. The Company's oral dissolvable inflammation screening test was EU registered in late 2021 and is currently licensed for marketing and sale in Europe.
お知らせ • Jun 10Xphyto Therapeutics Corp. Adds Dr. Flon A. Sahr to Its European Teateam as Head of Project ManagementXPhyto Therapeutics Corp. reported that Dr. Florian A. Sahr has joined its European operations as Head of Project Management. Dr. Sahr is a German-born and internationally trained leader in drug formulation, technology transfer and new-product manufacturing. Dr. Sahr has a strong track record of drug development, including transdermal ("TDS") and oral dissolvable ("ODF") delivery systems, as well as the physical and regulatory establishment of GMP and FDA compliant pharmaceutical manufacturing facilities. Several employment highlights include his work as Senior Scientist, Head of Manufacturing, Gen-Plus GmbH & Co. KG, Munich, Germany, where he developed TDS and ODF drug formulations and transferred these new formulations and technologies to manufacturing systems and facilities; and his work as Project Manager, Advanced Projects, tesa Labtec GmbH, Langenfeld, Germany, focusing on project management and technology transfer of generic TDS formulations to the company's manufacturing facilities. Dr. Sahr has held the regulated position of Head of Manufacturing according to AMG/AMWHV (German Medicines Act) for the production of clinical trial materials for a number of companies. Dr. Sahr is engaged full-time with Vektor Pharma TF GmbH ("Vektor"), XPhyto's wholly owned German subsidiary. Dr Sahr's management of Vektor's TDS and ODF product development programs, and his technology transfer skills are highly relevant as XPhyto reviews its ODF novel biosensor manufacturing options and opportunities.
Reported Earnings • May 01Full year 2021 earnings released: CA$0.29 loss per share (vs CA$0.29 loss in FY 2020)Full year 2021 results: CA$0.29 loss per share. Net loss: CA$20.6m (loss widened 22% from FY 2020). Over the next year, revenue is forecast to grow 326%, compared to a 98% growth forecast for the pharmaceuticals industry in Canada.
Board Change • Apr 27Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Independent Director Per Thoresen was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
Recent Insider Transactions • Mar 23President recently sold CA$184k worth of stockOn the 14th of March, Hugh A. Rogers sold around 178k shares on-market at roughly CA$1.04 per share. This was the largest sale by an insider in the last 3 months. This was Hugh A.'s only on-market trade for the last 12 months.
Recent Insider Transactions Derivative • Mar 21President exercised options to buy CA$357k worth of stock.On the 16th of March, Hugh A. Rogers exercised options to buy 364k shares at a strike price of around CA$0.50, costing a total of CA$182k. This transaction amounted to 69% of their direct individual holding at the time of the trade. Since June 2021, Hugh A. has owned 525.00k shares directly. Company insiders have collectively bought CA$210k more than they sold, via options and on-market transactions, in the last 12 months.
お知らせ • Dec 07XPhyto Therapeutics Corp. (CNSX:XPHY) completed the acquisition of 3a-diagnostics GmbH.XPhyto Therapeutics Corp. (CNSX:XPHY) s signed a definitive agreement to acquire 3A-Diagnostics GmbH for €3.9 million on July 20, 2021. As per the agreement, €0.4 million will be paid immediately and remaining €3.5 million will be paid closing, planned for on or around October 31, 2021. XPhyto Therapeutics launched a non-brokered private placement of up to 5 million common shares of XPhyto Therapeutics at a price of $1.00 per Share for total gross proceeds of up to $5 million and up to $2.5 million of unsecured convertible debentures and 2 million common share purchase warrants. XPhyto Therapeutics intends to use the net proceeds of the Offering and Debentures for research and development, inventory purchases, general working capital purposes, and to complete the acquisition of 3a. Further to the acquisition agreement between XPhyto and 3a, the parties have agreed to extend the closing terms which is expected to complete on or around December 1, 2021. XPhyto Therapeutics Corp. (CNSX:XPHY) completed the acquisition of 3a-diagnostics GmbH on December 6, 2021.
Reported Earnings • Nov 28Third quarter 2021 earnings: EPS in line with analyst expectations despite revenue beatThird quarter 2021 results: CA$0.036 loss per share (up from CA$0.11 loss in 3Q 2020). Net loss: CA$2.60m (loss narrowed 62% from 3Q 2020). Revenue exceeded analyst estimates by 1,458%.
お知らせ • Nov 27XPhyto Therapeutics Corp. announced that it has received CAD 7 million in fundingOn November 26, 2021, XPhyto Therapeutics Corp. closed the transaction. The company issued 4,500,000 common shares for gross proceeds of CAD 4,500,000 and debentures in the principal amount of CAD 2,500,000. The company also issued 2,000,000 share purchase warrants, exercisable into shares at an exercise price of CAD 1.50 for a period of 2 years. The Company issued 360,000 common share purchase warrants, exercisable at CAD 1.11 into common shares of the company for a period of 24 months from closing, and paid cash commissions aggregating CAD 360,000 to finders as finder fees. The eligible finder that introduced the subscriber to the company for purpose of completing the debenture offering received 160,000 common share purchase warrants, exercisable at CAD 1.25 into common shares of the Company for a period of 24 months from closing, and were paid CAD 200,000 in cash commission. The chief financial officer of the company participated in the equity offering by purchasing a total of 25,000 shares.
Reported Earnings • Aug 28Second quarter 2021 earnings released: CA$0.061 loss per share (vs CA$0.064 loss in 2Q 2020)Second quarter 2021 results: Net loss: CA$4.16m (loss widened 16% from 2Q 2020).
Director Overboarding • Aug 07Director Peter Damouni has joined 7th company boardDirector Peter Damouni has been appointed to the board of XPhyto Therapeutics Corp. (CNSX:XPHY). Damouni now sits on a total of 7 company boards. According to the Simply Wall St Risk Model, the director is at risk of having too many board obligations.
Director Overboarding • Aug 07Director Peter Damouni has joined 7th company boardDirector Peter Damouni has been appointed to the board of XPhyto Therapeutics Corp. (CNSX:XPHY). Damouni now sits on a total of 7 company boards. According to the Simply Wall St Risk Model, the director is at risk of having too many board obligations.
Director Overboarding • Aug 07Director Peter Damouni has joined 7th company boardDirector Peter Damouni has been appointed to the board of XPhyto Therapeutics Corp. (CNSX:XPHY). Damouni now sits on a total of 7 company boards. According to the Simply Wall St Risk Model, the director is at risk of having too many board obligations.
Director Overboarding • Aug 07Director Peter Damouni has joined 7th company boardDirector Peter Damouni has been appointed to the board of XPhyto Therapeutics Corp. (CNSX:XPHY). Damouni now sits on a total of 7 company boards. According to the Simply Wall St Risk Model, the director is at risk of having too many board obligations.
