Novavax, Inc. (NASDAQ:NVAX) is among the companies developing a coronavirus vaccine, and unlike the frontrunners that have advanced their respective vaccine candidates into Phase 3 trials, Novavax is still in Phase 2.
Despite trailing the frontrunners, Novavax has been assiduously stitching up manufacturing partnerships and supply agreements that should help to scale up production and also secure customers for its vaccine candidate, contingent upon emergency use authorization or full FDA approval.
Novavax's Vaccine Supply Deals
- Novavax announced an agreement June 4 to supply 10 million doses of NVX CoV2373, its coronavirus vaccine candidate, for the U.S. Department of Defense that could be used in Phase 2/3 clinical trials or under an EUA.
- A 100-million-dose supply agreement with the U.S. government on July 7.
- Announced a partnership agreement with the Serum Institute of India Aug. 6 to jointly manufacture and supply 1 billion doses of NVX CoV2373 to India and low- and middle-income countries.
- Struck a deal with Takeda Pharmaceutical Co Ltd (NYSE:TAK) Aug. 7 for the development, manufacturing and commercialization of NVX CoV2373 in Japan, with Takeda receiving funding from the Japanese government to manufacture over 250 million doses per year.
- Announced signing of a letter of intent with the South Korean government Aug. 13 to facilitate broad and equitable access to NVX-CoV2373 for the global market as well as to South Korea.
- Singed a term sheet agreement with the U.K. government Aug. 14 to supply 60 million doses of NVX-CoV2373.
- Announced Aug. 31 it has agreed in principle to supply the Canadian government with up to 76 million doses of NVX-CoV2373.
Novavax's Manufacturing Partnerships
- Acquired Praha Vaccines for about $167 million in cash May 27; The acquisition is expected to provide an annual capacity of over 1 billion doses of antigen starting in 2021 for NVX CoV2373.
- Struck a deal with FUJIFILM Diosynth Biotechnologies, a CDMO, on July 23 to manufacture bulk drug substance for NVX-CoV2373.
- Announced an agreement with South Korea's SK bioscience Aug. 13 for the latter to manufacture the vaccine antigen component for use in the final drug product globally.
Novavax's Funding Deals
- A Coalition for Epidemic Preparedness Innovations award of $4 million March 24 to expedite vaccine development to prepare for a Phase 1 study.
- An incremental $384 million CEPI award May 11 to support rapid scale-up of the NVX-CoV2373 vaccine antigen, as well as its proprietary Matrix-M adjuvant.
- Announced $60 million in U.S. DoD funding June 4 to support production of several components of the vaccine that will be manufactured in the U.S.
- Privately placed $200 million in debt in mid-June to support its coronavirus and NanoFlu vaccine programs.
- Announced July 7 $1.6 billion in federal funding under the Operation Warp Speed program to complete Phase 3 trials, scale up manufacturing and supply 100 million vaccine doses.
- Announced Aug. 17 a $15-million grant from the Bill & Melinda Gates Foundation for initiating a Phase 2b trial in South Africa.
NVAX Price Action
Despite the progress on the coronavirus vaccine front, the stock has remained under pressure in recent weeks.
Novavax shares ended Tuesday's session down 4.77% at $105.08, off their all-time highs of $189.40.