Shares of Moderna (MRNA) are under pressure on Tuesday after a stock offering was announced on Monday night and following a report by STAT News saying that several vaccine experts asked by the publication concluded that "there's really no way to know how impressive - or not" that the company's COVID-19 vaccine may be. The stock had jumped on Monday after the company reported interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus, from a Phase 1 study led by the National Institute of Allergy and Infectious Diseases.
CAPITAL RAISE: Piper Sandler analyst Edward Tenthoff lowered his price target on Moderna to $100 from $102, while keeping an Overweight rating on the shares after the company issued 17.6M shares at $76, raising $1.34B. Tenthoff estimates Moderna now has pro forma cash of around $3B. The analyst, who believes potential COVID-19 vaccine mRNA-1273 could become available next year and be a "blockbuster," trimmed the target to reflect dilution from the capital raise.
TOO EARLY TO ASSESS VACCINE CANDIDATE: Moderna shares surged on Monday after the company "blitzed the media" regarding its COVID-19 vaccine candidate appearing to generate an immune response in Phase 1 trial subjects, but "several vaccine experts asked by STAT concluded that, based on the information made available by the Cambridge, Mass.-based company, there's really no way to know how impressive - or not - the vaccine may be," Helen Branswell reported in the pharma-focused publication. The author said that the company "revealed very little information - and most of what if did disclose were words, not data." Even the figures the company did release "don't mean much on their own, because critical information - effectively the key to interpreting them - was withheld," Branswell added.
COVID-19 VACCINE DATA: On Monday, Moderna announced interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus, from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, or NIH. Immunogenicity data are currently available for the 25 microgram and 100 microgram dose level after two doses and at the 250 microgram level after one dose. Dose dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 microgram and 100 microgram dose levels. All participants ages 18-55 across all three dose levels seroconverted by day 15 after a single dose. At day 43, two weeks following the second dose, at the 25 microgram dose level, levels of binding antibodies were at the levels seen in convalescent sera tested in the same assay. At day 43, at the 100 microgram dose level, levels of binding antibodies significantly exceeded the levels seen in convalescent sera. Samples are not yet available for remaining participants.
At this time, neutralizing antibody data are available only for the first four participants in each of the 25 microgram and 100 microgram dose level cohorts. Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization, or PRNT, assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera. mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies. The sole incidence of a grade 3 adverse event in the 25 microgram and 100 microgram dose cohorts was a single participant at 100 microgram who experienced grade 3 erythema around the injection site. To date, the most notable adverse events were seen at the 250 microgram dose level, comprising three participants with grade 3 systemic symptoms, only following the second dose. All adverse events have been transient and self-resolving. No grade 4 adverse events or serious adverse events have been reported
"These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 microgram," said Tal Zaks, Chief Medical Officer at Moderna. "When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials."
'ENCOURAGING' VACCINE DATA: Goldman Sachs analyst Salveen Richter raised his price target on Moderna to $105 from $63, while keeping a Buy rating on the shares after the company reported "encouraging" Phase 1 interim safety and immunogenicity data for its potential COVID-19 vaccine mRNA-1273. The analyst highlighted that the vaccine candidate was safe and well tolerated and all 45 participants across the three dose levels developed antibodies against SARS-CoV-2 by day 15 after a single dose. Importantly, said Richter, neutralizing antibodies in the initial participants across the 25 microgram and 100 microgram dose cohorts were at or above levels seen in convalescent sera. The analyst is positive on the results and optimistic on the forward outlook for the vaccine. Richter also raised the probability of success for the mRNA-1273 vaccine programs to 75% from 70% prior.
'POTENTIAL BLOCKBUSTER SALES': Also keeping an Overweight rating on the shares, Piper Sandler analyst Edward Tenthoff raised his price target on Moderna to $102 from $57. The analyst noted that safety was "exceedingly clean" at the go-forward 25 microgram and 100 microgram doses and all patients seroconverted by day 15 after a single dose. He believes mRNA-1273 could be available early next year with "potential blockbuster sales." Moderna partnered with Lonza to increase vaccine manufacturing capacity up to 1 billion doses per year, which could provide Moderna with annual mRNA-1273 revenues of $10B, Tenthoff estimated.
PRICE ACTION: In afternoon trading, shares of Moderna have dropped over 10% to $71.65. On Monday, prior to the company's stock offering announcement after the closing bell, the stock had gained almost 20%.
Moderna
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