Announcement • Jul 28
Dasher Neuroscience Holdings Inc. Completes Patient Enrollment In Phase 2 Global Clinical Trial Of YA-101 For Multiple System Atrophy Dasher Neuroscience Holdings Inc. has successfully completed patient enrollment in its global, multi-center Phase 2 clinical trial evaluating YA-101, its flagship candidate for the treatment of Multiple System Atrophy (MSA). Top-line clinical data from the trial are expected in the first quarter of 2027. Dasher Neuroscience is actively pursuing global out-licensing partnerships while concurrently planning a global multi-center Phase 3 trial to accelerate YA-101 toward clinical commercialization as a potential first-in-class therapy for MSA. The Phase 2 trial of YA-101 is a global, multi-center, double-blind, placebo-controlled, dose-escalation study. A total of 90 participants have been enrolled across clinical sites in the United States, Japan, and Taiwan. The trial aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of YA-101 in patients aged 30 and older diagnosed with MSA according to Movement Disorder Society (MDS) clinical criteria, encompassing both the Parkinsonian subtype (MSA-P) and cerebellar subtype (MSA-C). The primary endpoint of the trial is the incidence and severity of Adverse Events (AEs) to assess the safety and tolerability profile of YA-101. Secondary endpoints include pharmacokinetic (PK) parameters, as well as clinical efficacy evaluated via the Unified Multiple System Atrophy Rating Scale (UMSARS) and the 10-Meter Walk Test. YA-101 is a New Chemical Entity (NCE) and a D-amino acid oxidase inhibitor (DAOI) that can inhibit inflammatory cytokines, primarily by reducing neuroinflammation and enhancing neuroplasticity to improve disease outcomes. It is being developed with the potential to serve as a novel treatment option for MSA patients worldwide. YA-101 has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), alongside Orphan Drug Designation (ODD) from regulatory agencies in the U.S., Japan, and the European Union. MSA is a rare, rapidly progressive, and fatal neurodegenerative disease. Onset typically occurs in a patient's 50s, with up to 80% of patients becoming severely disabled within 5 years of diagnosis and a mean survival of just 6 to 10 years. Current clinical management is limited to symptomatic relief, with no approved disease-modifying therapies available—representing a critical unmet medical need worldwide. The global prevalence of MSA is approximately 5 cases per 100,000 individuals, affecting an estimated 15,000 to 50,000 individuals in the U.S., 18,000 to 70,000 in the EU, 12,000 in Japan, and 2,000 in Taiwan. Upon regulatory approval, YA-101 aims to fill this severe treatment gap and offer new therapeutic hope to patients worldwide. New Risk • Jun 25
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: NT$3.18b (US$99.8m) This is considered a minor 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 Less than 1 year of cash runway based on free cash flow trend (-NT$354m free cash flow). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (NT$3.18b market cap, or US$99.8m). New Risk • May 14
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: NT$3.14b (US$99.7m) This is considered a minor 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 Less than 1 year of cash runway based on free cash flow trend (-NT$354m free cash flow). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (NT$3.14b market cap, or US$99.7m). 
