On May 10, 2021 Novavax, Inc. (NASDAQ: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the first quarter ended March 31, 2021 (Press release, Novavax, MAY 10, 2021, View Source [SID1234579621]).
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"Novavax made great strides over the first quarter to pave the path for our COVID-19 vaccine candidate, NVX-CoV2373, notably achieving statistically significant efficacy across our Phase 3 UK and Phase 2b South Africa trials," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "In parallel, we have secured additional manufacturing and supply agreements, expanding our global supply chain to over 10 countries. In the coming months, we look forward to delivering on critical milestones, including announcing final data from our PREVENT-19 Phase 3 trial, completing our regulatory submissions, evaluating NVX-CoV2373 in younger populations and continuing to develop our booster strategy to address the evolving COVID-19 pandemic. As we continue our dialogue with regulatory authorities for authorization, we remain committed to promptly delivering our vaccine globally, ensuring equitable access and expansive distribution."
First Quarter 2021 and Recent Highlights
COVID-19 Clinical Development
Reported final efficacy analysis from UK Phase 3 trial and complete analysis from South Africa Phase 2b trial, expanding upon previously reported interim results
Demonstrated 100% protection against severe disease
Confirmed 96.4% efficacy against original strain of COVID-19 and 86.3% efficacy against B.1.1.7 variant strain in UK Phase 3 trial
Demonstrated efficacy of 88.9% in adults over the age of 65 and efficacy of 90.9% in adults with high-risk medical comorbidities in UK Phase 3 trial
Demonstrated efficacy of 55.4% among HIV-negative participants in South Africa Phase 2b trial, with the vast majority of cases due to the B.1.351 escape variant
South Africa Phase 2b results published in the New England Journal of Medicine
UK Phase 3 results submitted for publication to peer-reviewed journal and posted to medRxiv.org
Completed successful enrollment of 30,000 participants for PREVENT-19; final analysis to be reported in the second quarter of 2021
Initiated pediatric expansion of PREVENT-19 to evaluate efficacy, safety and immunogenicity of NVX-CoV2373 in adolescents
Enrolling up to 3,000 adolescent participants aged 12-17 across up to 75 sites in the U.S.
Blinded crossover expected to begin six months after initial set of vaccinations
Initiated crossovers and progressed booster studies of NVX-CoV2373
Initiated crossovers in PREVENT-19, UK Phase 3 and South Africa Phase 2b trials to ensure all trial participants have access to active vaccine
Completed 6-month booster doses in the U.S. and Australia Phase 2 study with immunology results expected in the third quarter of 2021
Com-COV2 Phase 2 clinical trial conducted by University of Oxford and UK Vaccines Taskforce
NVX-CoV2373 is one of four COVID-19 vaccines administered during trial to evaluate combined vaccine regimens in 1,050 participants
Top-line data expected in the third quarter of 2021
Advanced development of variant strain vaccines into preclinical studies
Preclinical data from study of B.1.351 variant strain vaccine candidate showed strong antibody response and functional immune response in non-human primates when boosted one year after receiving NVX-CoV2373
Expect to initiate clinical evaluation of one or more candidates
Successful collaboration on partner-initiated trials to advance clinical developmentof NVX-CoV2373
Takeda completed enrollment of 200 participants in Phase 1/2 clinical trial in Japan
Serum Institute of India (Serum Institute) completed enrollment of initial cohort in Phase 2/3 clinical trial in India, with total study including 1,600 participants
COVID-19 Manufacturing and Supply
Secured additional manufacturing capacity for NVX-CoV2373 globally, with continued progress toward achieving full manufacturing capacity
Anticipated capacity revised to 100 million doses per month by the end of the third quarter of 2021, with remainder of capacity expected to come online in the fourth quarter to support 150 million doses per month
Reached agreement in principle with GSK to support ‘fill and finish’ manufacturing of up to 60 million doses of NVX-CoV2373 for use in the UK
Established manufacturing presence in Canada through Memorandum of Understanding with Canadian government to produce NVX-CoV2373 at National Research Council’s Biologics Manufacturing Centre
Advanced purchase agreements globally, ensuring equitable access to low, middle and high income countries
Finalized advance purchase agreement with Government of Canada to supply 52 million doses with an option for up to an additional 24 million doses
Finalized advance purchase agreement with Gavi, the Vaccine Alliance, to provide 1.1 billion doses to the COVAX Facility
Novavax to manufacture and distribute 350 million doses to participants of the COVAX Facility
Serum Institute to manufacture and distribute remaining balance of the 1.1 billion doses to low- and middle-income countries
Furthered existing partnerships to expand global access of NVX-CoV2373
Finalized exclusive license agreement with Takeda for the development, manufacturing and commercialization of NVX-CoV2373
Takeda to manufacture over 250 million doses of NVX-CoV2373 annually
Takeda in discussions with Government of Japan to potentially purchase 150 million doses of NVX-CoV2373
Expanded existing partnership with SK bioscience to include license agreement for the manufacturing and commercialization of NVX-CoV2373
SK bioscience to supply 40 million doses to the Republic of Korea
COVID-19 Regulatory Pathway
Progressed regulatory processes for authorization of NVX-CoV2373 with multiple regulatory agencies globally
Intend to file for authorization with the U.S. Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) in Europe in the third quarter of 2021
Rolling reviews initiated with regulatory authorities, including Health Canada, Australian Therapeutic Goods Administration, New Zealand Medsafe, MHRA and EMA
SK bioscience initiated regulatory submission process in collaboration with Novavax to the Republic of Korea’s Ministry of Food and Drug Safety
Combination Vaccine
NanoFlu/NVX-CoV2373 combination vaccine candidate induced protective responses in preclinical studies
Preclinical data manuscript submitted for publication to a peer-reviewed journal and posted on bioRxiv.org
Expect to initiate clinical evaluation later this year
Malaria R21 Vaccine / Matrix-M Adjuvant Collaboration
Phase 2b clinical trial results for the University of Oxford’s malaria vaccine candidate (R21), including Matrix-M adjuvant, published in Preprints with The Lancet
Trial included 450 participants aged 5-17 months in Burkina Faso
Demonstrated high efficacy of 77% when using 5 micrograms of antigen and 50 micrograms of Matrix-M adjuvant
Novavax to manufacture and supply Matrix-M adjuvant to Serum Institute for use in R21
Serum Institute has rights to use the vaccine, comprised of R21 with Matrix-M adjuvant, in endemic regions, while Novavax will have rights to sell and distribute the vaccine in travelers’ and military vaccine markets
Phase 3 licensure trial underway in 4,800 participants, aged 5-36 months, across four countries in Africa to evaluate the safety and efficacy of R21
Corporate Highlights
Strengthened corporate leadership with executive management promotions and hiring
Gale E. Smith, Ph.D. promoted to Senior Vice President, Discovery and Preclinical Research and Chief Scientist
Madelyn ‘Lyn’ Caltabiano, Ph.D. as Senior Vice President, Global Program Management
Troy Morgan, J.D. as Senior Vice President, Chief Compliance Officer
Henrietta Ukwu, M.D. as Senior Vice President, Chief Regulatory and Quality Officer
Financial Results for the Three Months Ended March 31, 2021
Novavax reported a net loss of $223 million, or $3.05 per share, for the first quarter of 2021, compared to a net loss of $26 million, or $0.58 per share, for the first quarter of 2020.
Novavax revenue in the first quarter of 2021 was $447 million, compared to $3 million in the same period in 2020. This significant increase was due to increased development activities relating to NVX-CoV2373 for services performed under the U.S. government and Coalition for Epidemic Preparedness Innovations agreements.
Research and development expenses increased to $593 million in the first quarter of 2021, compared to $17 million in the same period in 2020. The significant increase was primarily due to the development of NVX-CoV2373.
General and administrative expenses increased to $63 million in the first quarter of 2021, compared to $9 million for the same period in 2020. The increase was primarily due to increased employee-related costs, stock-based compensation expenses, and supporting our NVX-CoV2373 program.
As of March 31, 2021, Novavax had $2 billion in cash, cash equivalents, marketable securities and restricted cash, compared to $806 million as of December 31, 2020. Net cash provided by operating activities for the first three months of 2021 was $663 million, compared to net cash used in operating activities of $23 million for same period in 2020. The increase in cash provided was primarily due to $772 million in payments under advance purchase agreements recorded as deferred revenue and the timing of payments to third parties.
Through utilization of At-the-market (ATM) offerings during the first quarter of 2021, Novavax raised net proceeds of $565 million.
Conference Call
Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (866) 652-5200 (Domestic) or (412) 317-6060 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET on May 10, 2021 until 11:59 p.m. ET on May 17, 2021. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 10155684.
A webcast of the conference call can also be accessed on the Novavax website at View Source A replay of the webcast will be available on the Novavax website until August 10, 2021.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated 100% protection against severe disease, efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 100% protection against severe disease and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.
NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.
About NanoFlu
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant.
About Matrix-M
Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.