BioSig Technologies(BSGM)2020-04-07 23:58Summary of BioSig Technologies, Inc. and ViralClear Pharmaceuticals Conference Call Company and Industry Overview - Company: BioSig Technologies, Inc. (OTCQB: BSGM) and its subsidiary ViralClear Pharmaceuticals - Industry: Pharmaceutical industry focusing on antiviral drug development, particularly in response to COVID-19 Key Points and Arguments 1. Introduction of ViralClear: BioSig is focusing on its new subsidiary, ViralClear, which is developing the drug candidate Vicromax for treating COVID-19. Vicromax was previously developed for chronic hepatitis C and has shown promise against COVID-19 in preclinical tests [9][10][11]. 2. Funding and Spin-off Plans: BioSig has secured over $12 million in cash and plans to fund ViralClear through direct investments rather than selling BioSig stock. The intention is to spin off ViralClear into a public entity on NASDAQ, allowing BioSig shareholders to retain ownership in the new company [12][11]. 3. Drug Development Timeline: ViralClear aims to file an Investigational New Drug (IND) application soon, with human trials expected to start in May 2020. If successful, pivotal phase development could occur over the summer [21][20]. 4. Mechanism of Action: Vicromax (MMPD) targets RNA-dependent RNA polymerase and has shown activity against various RNA viruses, including SARS-CoV-2. The drug's mechanism involves inhibiting an enzyme crucial for viral replication, potentially preventing the emergence of resistant viral strains [27][60][31]. 5. Collaboration with Mayo Clinic: Dr. Andrew Badley from the Mayo Clinic is involved in overseeing the clinical trials for MMPD. The Mayo Clinic is considering a financial investment in ViralClear, indicating a strong partnership [24][26]. 6. Market Positioning: The company does not view other antiviral candidates as direct competition but rather as potential collaborators for combination therapies. This approach aims to reduce the risk of viral resistance [42][50]. 7. Regulatory Environment: The FDA has established a task force to expedite the review of drugs for COVID-19, which may facilitate a faster path to market for ViralClear's products [67][66]. 8. Commercial Strategy: ViralClear plans to utilize a virtual drug development model, contracting manufacturing resources in the U.S. and Europe to ensure supply for clinical and commercial needs [34][33]. Additional Important Information - Intellectual Property: ViralClear possesses a robust intellectual property portfolio, which is crucial for its competitive positioning in the market [21]. - Clinical Trial Design: The trials will focus on various endpoints, including viral load and clinical symptoms, to assess the drug's efficacy [75][74]. - Future Outlook: The company sees potential for MMPD to be stockpiled for future pandemics, emphasizing its long-term business viability beyond the current crisis [88][89]. This summary encapsulates the critical aspects of the conference call, highlighting the strategic direction of BioSig Technologies and its subsidiary ViralClear in the context of antiviral drug development amidst the COVID-19 pandemic.