Moderna's Coronavirus Vaccine Development In The Spotlight When Biotech Reports Q1 Results

Moderna Inc MRNA is a coronavirus vaccine play that has seen its shares rally close to 160% year-to-date. The company is a frontrunner among the biotechs working on a vaccine to treat SARS-CoV-2, the virus that causes COVID-19.

The Moderna Expectations

Moderna, a pioneer in messenger RNA, or mRNA, therapeutics, is scheduled to release its first-quarter results Thursday before the market opens.

Analysts, on average, estimate a loss per share of 35 cents per share for the quarter compared to a loss of 40 cents per share in the year-ago quarter. Revenues are estimated at $17.09 million, up 6.6%. The company has yet to market a commercial product, and its revenues come primarily from collaborations and grants.

Moderna has a diverse pipeline of 24 developmental candidates, 12 of which are in clinical trials.

As of Dec. 31, 2019, the company had cash, cash equivalents and marketable securities of about $1.3 billion.

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Moderna's Coronavirus Vaccine Development

Moderna, which first unveiled plans to develop a vaccine against the novel coronavirus Jan. 23, quickly progressed with its development. With initial funding by the Coalition for Epidemic Preparedness Innovations, Moderna collaborated with the National Institute of Allergy and Infectious Diseases, or NIAID, on developing a mRNA vaccine against the virus.

The NIAID is conducting a Phase 1 study with the vaccine, codenamed mRNA-1273, supplied by Moderna.

Subsequently, the company announced an award of up to $483 million in BARDA funding to move the vaccine through the FDA licensing process. 

In late April, Moderna said it has submitted IND to the FDA for commencing a Phase 2 study and is hoping to begin the study in the second quarter, contingent on the FDA accepting the application and the Phase 1 NIAID-sponsored study turning in positive safety and efficacy results.

The company also gave a timeline of the "fall of 2020" for the start of a Phase 3 study.

Most recently, Moderna announced a partnership with Lonza to scale up manufacturing of the vaccine to supply 1 billion doses per year.

The company has given a 12-18-month timeline for a full approval, although it looks ahead to make available the vaccine under emergency use authorization by the year end.

Moderna investors are awaiting further updates from the company on the vaccine program both in the earnings release as well as the earnings call.

MRNA Stock

Moderna went public in late December 2018 by offering 26.3 million shares in an initial public offering at $23 each. It did not get off to a strong start, with the stock trading mostly below the offer price and hitting a low of $11.54 in early August 2019.

The stock began picking up momentum only after the company plunged headlong into the development of mRNA-1273.

Out of 11 analysts covering the stock, nine have assigned Buy ratings and 2 Hold ratings, according to Tipranks. The average analysts' price target for the stock is $46, with a high estimate of $83 and a low of $32.