Financial Data and Key Metrics Changes - As of the end of 2021, the company held $17.4 million in cash, which is expected to be sufficient to reach the first in-human studies for the COVID-19 NanoAbs [12][37] - The company has agreed on terms for restructuring its outstanding debt to the European Investment Bank, extending the maturity date to December 31, 2027, which will provide a runway for development [10][11] Business Line Data and Key Metrics Changes - The company is progressing with the COVID-19 NanoAb development, focusing on technology transfer and scale-up of the manufacturing process [5][6] - A recent collaboration with the Max Planck Institute and University Medical Center Göttingen will expand the NanoAb platform to include nine additional NanoAbs targeting diseases with unmet medical needs [8][9] Market Data and Key Metrics Changes - The market for COVID-19 treatments is expected to grow, with estimates indicating it has already surpassed $2 billion [33] - The company is targeting therapeutic areas such as asthma, psoriasis, psoriatic arthritis, and macular degeneration, which have a compound annual growth rate (CAGR) of 8% to 12% [31][33] Company Strategy and Development Direction - The company aims to develop a self-administered inhaled COVID-19 NanoAb that is expected to have a lower adverse events profile and be more affordable than current therapies [30][31] - The strategy includes a focus on well-validated targets for existing monoclonal antibody treatments to reduce risk [43] Management's Comments on Operating Environment and Future Outlook - Management believes that COVID-19 will continue to circulate, necessitating a range of therapeutic options alongside vaccines [28][29] - The company anticipates initiating clinical trials for the COVID-19 NanoAb in 2023, with potential market entry depending on the pandemic situation [35][51] Other Important Information - The company has strengthened its R&D capabilities by hiring top talent and enhancing its Board with experienced individuals from the pharmaceutical industry [13][15] - The manufacturing site is designed to meet FDA and EMA standards, allowing for rapid drug development and lower risk of delays [36] Q&A Session Summary Question: What are the advantages of NanoAbs over similar therapies in general? - NanoAbs can be developed to be more potent and stable, allowing for lower concentrations and potentially fewer side effects [39][40] Question: What are the risks of using NanoAbs? - Risks include the potential for immune responses and on-target risks, but NanoAbs may be less immunogenic due to their compact structure [41][42] Question: What do you estimate will be the retail cost per unit of the COVID treatment relative to other COVID therapies? - The company expects to price its treatment substantially lower than existing therapies, which can cost around $2,000 per dose [44][45] Question: What are the upcoming catalysts? - Key catalysts include finalizing the agreement with the EIB and conducting proof-of-concept studies for the inhalation route of administration [46][47] Question: When do you expect the first COVID-19 drug to be in the market? - The company anticipates a worst-case scenario of filing for marketing approval by 2026, depending on the pandemic situation [51][52] Question: Are there any other companies developing NanoAbs? - Other companies exist, such as Ablynx, but the company believes its capabilities and partnerships provide a competitive edge [53][54] Question: How does the company plan to address COVID mutations? - The company plans to develop NanoAbs that can neutralize all variants of concern, adapting its approach similar to influenza vaccine strategies [56][57]
Scinai Immunotherapeutics .(SCNI) - 2021 Q4 - Earnings Call Transcript