Moderna Announces FDA Nod For Phase 2 Coronavirus Vaccine Study, Hints At Approval In 2021

Moderna Inc MRNA reported Thursday ahead of the market open with a first-quarter loss that came in line with expectations and also issued an update on its coronavirus vaccine program.

The Cambridge, Massachusetts-based company reported a net loss of $124.23 million or 35 cents per share compared to the year-ago loss of $132.58 million or 40 cents per share. The loss was in line with the Street estimate. 

Revenue declined from $16.03 million to $8.39 million, trailing the consensus estimate of $17.09 million. The company attributed the decline to cumulative catch-up adjustments in revenue and the timing of amortization of deferred revenue.

Moderna said it has up to $2.4 billion to invest, including cash and investments of $1.7 billion and up to $700 million in potential grants and awards.

The company reaffirmed its 2020 guidance for net cash used in operating activities and for the purchase of property and equipment at $500 million.

In an update on its mRNA-1273 vaccine program, the company said the FDA completed its review of the IND application for the vaccine candidate and has approved the kickoff of a Phase 2 study. The company expects to commence the study shortly. The Phase 1 study of the vaccine candidate spearheaded by the NIAID is underway.

Moderna also said it is finalizing the protocol for a proposed Phase 3 study, which is expected to begin in early summer of 2020.

The company said it is now preparing to potentially have its first BLA approved as soon as 2021.

"We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective,” Moderna CEO Stéphane Bancel said in a statement.

Moderna shares were rising 16.73% to $57.14 in Thursday's premarket session.

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