Shares of Novavax Inc. (NASDAQ: NVAX) jumped as much as 18% on Tuesday after the start of testing of its coronavirus vaccine candidate in people. The biotech expects to release data from the phase 1 portion of the trial this July.
In a press release dated May 25, 2020, Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX‑CoV2373 includes Novavax’ proprietary Matrix‑M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.
Stanley C. Erck, President and Chief Executive Officer of Novavax said, “Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID‑19 pandemic. We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial.”
The company stated that the Phase 1/2 clinical trial would be conducted in two parts. The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX‑CoV2373. The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix‑M and without.
The Phase 2 portion is expected to be conducted in multiple countries, including the United States, and would assess immunity, safety, and COVID‑19 disease reduction in a broader age range. This Phase 1/2 approach allows for the rapid advancement of NVX‑CoV2373 during the pandemic.
This early-stage trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI). The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million of funding to advance the clinical development of NVX‑CoV2373.
On May 11, 2020, Novavax had reported a net loss of $25.9 million, or $0.58 per share, for the first quarter of 2020, compared to a net loss of $43.2 million, or $2.11 per share, for the first quarter of 2019.
Novavax revenue in the first quarter of 2020 was $3.4 million, compared to $4.0 million in the same period in 2019. This 15% decrease was primarily due to the conclusion of the Prepare™ trial in 2019, partially offset by revenue from CEPI’s funding.
Research and development expenses decreased by 52% to $16.9 million in the first quarter of 2020, compared to $35.5 million in the same period in 2019. This decrease was primarily due to decreased development activities of ResVax, lower employee-related costs, and other cost savings due to the Catalent transaction in 2019.
General and administrative expenses increased to $9.4 million in the first quarter of 2020, compared to $8.7 million for the same period in 2019.
Interest income (expense), net for the first quarter of 2020 and 2019 was ($3.0) million.
As of March 31, 2020, Novavax had $244.7 million in cash, cash equivalents, marketable securities and restricted cash, compared to $82.2 million as of December 31, 2019. Net cash used in operating activities for the first quarter of 2020 was $23.1 million, compared to $50.6 million for the same period in 2019.
Novavax’s valuation has expanded to more than 1,000% to about $2.7 billion since the beginning of the year in spite of having no products on the market. Novavax has said it is targeting emergency-use authorization and production could be scaled up to 100 million doses by year-end.
“Our investment in Novavax allows us to focus on manufacturing in parallel with the clinical development of the vaccine so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay,” CEPI chief executive Richard Hatchett, said in a statement.
With its shares currently soaring, the stock could go as high as it did mid-may. Interested investors are recommended to buy the shares ahead of its July results.