Moderna Plans COVID-19 Vaccine Development, $1.34-Bn Stock OfferingBy
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, and which is developing a mRNA vaccine candidate against the novel coronavirus, announced a public offering of 17,600,000 shares of common stock at $76.00 per share, which would amount to gross proceeds of approximately $1.34 billion. The offering is expected to close on or about May 21, 2020, subject to the satisfaction of customary closing conditions.
The company also reported on May 18, 2020 positive interim clinical data of mRNA-1273, its vaccine candidate against the novel coronavirus (SARS-CoV-2), from a Phase I study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The company reports that immunogenicity data are currently available for the 25-µg and 100- µg dose level (ages 18-55) after two doses (day 43) and at the 250-µg level (ages 18-55) after one dose (day 29). The company reported that dose-dependent increases in immunogenicity were seen across the three dose levels and between prime and boost within the 25-µg and 100- µg dose levels.
The company reports that at this time (as of May 18, 2020), neutralizing antibody data are available only for the first four participants in each of the 25-µg and 100-µg dose-level cohorts. The company says that consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participantsas measured by plaque- reduction neutralization assays against live SARS-CoV-2.
Based on the interim Phase I data, the company reports that its Phase II study will be amended to study two dose levels, 50 µg and 100 µg, with the aim of selecting a dose for pivotal studies. The NIAID-led Phase I study is being amended to include a 50-µg dose level cohort across each of the three age groups. Moderna anticipates the dose for the Phase III study to be between 25 µg and 100 µg and expects Phase III trial initiation in July (July 2020), subject to finalization of the clinical trial protocol.
Funding from the Biomedical Advanced Research and Development Authority, a division of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services, supported the planning for the Phase II and Phase III studies of mRNA-1273 and will also support the execution of these studies as well as the scale-up of mRNA-1273 manufacturing both at the Company’s facilities and that of its strategic collaborator, Lonza.