Novavax Inc. (NASDAQ: NVAX) topped market estimates on revenue for the first quarter of 2019 while earnings matched expectations. Analysts had forecasted a loss of $0.11 per share on revenue of $3.94 million. Shares gained 2.4% in aftermarket hours on Thursday.
Total revenue of $4 million was down 59% year-over-year, driven by the completion of enrollment of the Prepare trial in the second quarter of 2018.
The company reported a net loss of $43.2 million, or $0.11 per share, compared to $46.4 million, or $0.14 per share, in the year-ago quarter.
R&D expenses decreased 20% to $35.5 million, mainly due to decreased development activities, including lower clinical trial costs, of ResVax.
Novavax plans to meet with the FDA, European regulatory agencies, and potentially other national regulatory agencies during the second and third quarters of the year to assess opportunities for the submission of marketing applications for ResVax.
The company is also looking to reach an agreement with the FDA during the third quarter of 2019 on a proposed Phase 3 clinical trial design for NanoFlu utilizing accelerated approval criteria for licensure.
As of March 31, 2019, Novavax had $108.7 million in cash, cash equivalents, marketable securities and restricted cash.
On April 11, 2019, Novavax received a warning notice from Nasdaq saying that the stock could be delisted as the company’s stock fell below $1 for 30 consecutive days. The stock has to close at $1.00 or higher for a minimum of ten consecutive business days during the 180-day compliance period to avoid delisting and if this doesn’t happen by October 8, 2019, Nasdaq will be sending a delisting notice to Novavax.
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