New Risk • Mar 23
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 14% 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 Less than 1 year of cash runway based on free cash flow trend (-CA$5.2m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Negative equity (-CA$8.3m). Revenue is less than US$1m (CA$16k revenue, or US$12k). Minor Risks Significant insider selling over the past 3 months (€80k sold). Market cap is less than US$100m (€44.9m market cap, or US$51.9m). Recent Insider Transactions • Jan 29
Co-Founder recently sold €61k worth of stock On the 22nd of January, Wolfgang Probst sold around 183k shares on-market at roughly €0.33 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 €103k. New Risk • Jan 26
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 13% 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 Less than 1 year of cash runway based on free cash flow trend (-CA$5.2m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Negative equity (-CA$8.3m). Revenue is less than US$1m (CA$16k revenue, or US$12k). Minor Risks Significant insider selling over the past 3 months (€76k sold). Market cap is less than US$100m (€41.4m market cap, or US$49.2m). 공시 • Jan 22
BioNxt Solutions Inc. Reports Final Preclinical Results Demonstrating Approximately 40% Higher Cladribine Delivery BioNxt Solutions Inc. reported final results from a preclinical pig study demonstrating that its proprietary needle-free, swallow-free sublingual oral dissolvable film (ODF) cladribine formulation for the treatment of Multiple Sclerosis (MS) achieved significantly higher systemic drug delivery than a conventional oral tablet formulation of cladribine, such as those used in commercially successful therapies such as Mavenclad®?, which has reported annual global sales exceeding USD 1.2 billion and sustained double-digit growth. The results represent an important development milestone for BioNxt, demonstrating in a robust large-mass non-rodent model that reformulating cladribine as a sublingual oral dissolable film can materially improve systemic drug delivery compared with conventional oral tablet dosing. By directly comparing two fundamentally different routes of administration under controlled conditions, the study helps de-risk the clinical development and commercialization pathway and supports the rationale for advancing the sublingual ODF formulation into human pharmacokinetic studies. Final Study Results Validate the Efficiency of BioNxt's Sublingual Delivery Approach. The completed preclinical pig study showed that BioNxt's cladribine sublingual oral dissololvable film achieved meaningfully higher systemic drug availability than the conventional oral tablet formulation. Systemic exposure was assessed over a 48-hour period using AUC (0-48 h), a widely accepted calculated measure based on repeated blood concentration measurements that reflects how much drug reaches the bloodstream and how long it remains there. In this study, the approximately 40% higher AUC observed for BioNxt's sublingual ODF indicates that a greater amount of cladribine reached systemic circulation and was maintained for a longer period compared with conventional oral tablet administration. This finding supports the conclusion that the sublingual delivery approach provides more efficient and consistent overall drug availability under the study conditions. Importantly, improved delivery efficiency may also support dose optimization in future studies, with the potential to reduce systemic drug burden at equivalent therapeutic exposure and, in turn, improve tolerability and reduce side effects, an outcome BioNxt intends to evaluate in planned clinical development. Robust Preclinical Pig Model with High Translational Relevance. De-Risking the Transition Toward Human PK Studies. While Multiple Sclerosis remains the initial development focus, BioNxt views its sublingual oral dissol solvable film (ODF) technology as a scalable delivery platform with potential applications across a broader range of neuro-immunological and neurological diseases. As a first step beyond MS, the Company believes its cladribine ODF approach may also be applicable to indications such as Myasthenia Gravis (MG), where swallowing difficulties are common and needle-free, swallow- free sublingual therapies may offer meaningful clinical advantages. Beyond individual indications, BioNxt's platform strategy is designed to enable the reformulation of multiple established and late-stage drug candidates, particularly in chronic diseases where adherence, tolerability, and ease of administration are critical. Because the ODF platform focuses on optimizing the delivery of active ingredients that are already approved and widely used in clinical practice, development efforts can concentrate on pharmacokinetics, bioequivalence, and patient usability rather than on new molecular discovery. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets, and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumors while reducing side effects. BioNxt is committed to improving healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide. Forward-looking information includes, but is not limited to, statements regarding the interpretation and significance of the Company's preclinical study results; the potential advantages of BioNxt's sublingal oral dissolvable film ("ODF) technology; the planned progression into human pharmacokinetic and bioequivalence studies; the potential applicability of the Company's drug-delivery platforms to additional therapeutic indications; and statements regarding future development, regulatory, commercialization, licensing, or partnering activities. New Risk • Dec 05
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: €69k 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 Less than 1 year of cash runway based on free cash flow trend (-CA$5.2m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Negative equity (-CA$8.3m). Revenue is less than US$1m (CA$16k revenue, or US$11k). Minor Risks Significant insider selling over the past 3 months (€69k sold). Market cap is less than US$100m (€48.3m market cap, or US$56.2m). 