JanOne (US:JAN)2020-08-26 01:38Summary of JanOne Inc. Telebriefing and Corporate Update Call Company Overview - Company: JanOne Inc. (NASDAQ: JAN) - Transition: JanOne transitioned from a recycling business to a biopharma business, acquiring exclusive licenses for over 30 patents related to peripheral artery disease (PAD) and pain management using sodium nitrite, now known as JAN101 [5][6] Core Product and Development - Lead Product: JAN101, a sustained release formulation of sodium nitrite, aims to treat PAD and associated pain, targeting approximately 8.5 million Americans suffering from PAD [8][12] - Clinical Trials: Three human clinical trials have shown significant pain reduction and improvement in nerve conduction velocity in diabetic neuropathic pain patients [9][10] - Opioid Alternative: JAN101 is positioned as a non-addictive, non-sedating alternative to opioids for pain management, addressing the opioid crisis [10][11] COVID-19 Applications - Potential Use: JanOne is exploring the use of JAN101 for treating COVID-19 patients, as COVID-19 has been identified as a vascular disease affecting endothelial function [7][13] - IND Application: The company plans to submit an Investigational New Drug (IND) application for COVID-19 treatment in the coming weeks [7][16] Clinical Trial Plans - Phase 2b Study for PAD: Scheduled for early 2021, focusing on diabetic patients with PAD, evaluating two doses (40 mg and 80 mg) in a placebo-controlled study with 300 participants [20][23] - Endpoints: Primary endpoint is the ability to walk without pain; secondary endpoints include pain reduction, improved sensory nerve function, and quality of life [20] Safety and Efficacy - Safety Profile: Previous trials indicated that sodium nitrite is safe, with only mild side effects (headaches and dizziness) reported [27][30] - Methemoglobinemia Risk: No significant risk of methemoglobinemia was observed in trials, with levels remaining below 2% [30] Market Opportunity - Market Size: The PAD market is estimated to be between $16 billion and $24 billion, with a significant number of patients lacking effective treatment options [48] - Reimbursement Potential: The company anticipates reasonable reimbursement rates due to the lack of existing treatments and the high costs associated with surgical interventions [49] Competitive Landscape - Current Competitors: Limited competition in the oral formulation of sodium nitrite for PAD; existing products focus on other indications or are injectable [46][47] Conclusion - Strategic Focus: JanOne is advancing its biotechnology asset, targeting PAD and COVID-19 as key treatment areas, with a strong emphasis on the vascular implications of COVID-19 [21][22] - Investor Recognition: The company believes its intellectual property and clinical advancements will attract continued interest from investors and the medical community [23]