Daily Archives: May 12, 2020

Open Compute Project Foundation (OCP) Announces New Board Seat for Google and New Board Member

Google joins OCP as an Executive Member, Google Engineer joins OCP Board of Directors

Google Distinguished Engineer, Parthasarathy (Partha) Ranganathan, will serve as the Director of the OCP Board.

AUSTIN, Texas, May 12, 2020 (GLOBE NEWSWIRE) — The Open Compute Project Foundation (OCP), a collaborative community focused on redesigning hardware technology to efficiently support the growing demands on compute infrastructure, announces today that Google is now an Executive Member and will hold a seat on its Board of Directors. Parthasarathy (Partha) Ranganathan will serve as the Director.

“Google has been very active in the OCP Community in recent years, and we are excited that it is expanding its participation and the potential for great technology collaboration,” states Rocky Bullock, CEO for the Open Compute Project Foundation.

“Google’s new board participation further represents how fundamental open hardware continues to be within the industry, and the only way we’ll continue to drive innovation within the industry is together,” comments Mark Roenigk, Chair of the Board of Directors for the Open Compute Project Foundation.

Kushagra Vaid of MIcrosoft joins the Open Compute Project Foundation (OCP) Board of Directors

The Open Compute Project Foundation (OCP) also announces today the selection of Kushagra Vaid to serve on its Board of Directors representing Microsoft.

“Open standards for system and hardware design are essential to meet modern compute requirements,” adds Partha Ranganathan, Distinguished Engineer at Google. “We look forward to extending our involvement with the OCP Community to help drive greater choice and agility for the industry.”

About Dr. Partha Ranganathan
Partha Ranganathan is a distinguished engineer at Google, where he designs the company’s next-generation systems. Before this, he was a HP Fellow and Chief Technologist at Hewlett Packard Labs where he led their research on systems and data centers. He has worked on several interdisciplinary systems projects with broad impact on both academia and industry, including widely-used innovations in energy-aware user interfaces, heterogeneous multi-cores, power-efficient servers, accelerators, and disaggregated and data-centric data centers.

Dr. Ranganathan is a co-inventor on more than 100 patents, and has also published extensively, including several award-winning papers. He has been named a top-15 enterprise technology rock star by Business Insider and one of the world’s top young innovators by MIT Tech Review. He received his B. Tech degree from the Indian Institute of Technology, Madras (where he was named a distinguished alumnus last year) and his M.S. and Ph.D. from Rice University, Houston. He is also a Fellow of the IEEE and ACM.

The Open Compute Project Foundation (OCP) also announces today the selection of Kushagra Vaid to serve on the Board of Directors representing Microsoft. Mr. Vaid replaces Mike Neil, who has served over the past year. Mr. Vaid has been actively engaged with OCP since 2014 and previously served on the OCP Incubation Committee for several years.

“OCP would like to thank Mike Neil for his service as a member of the Board of Directors as we successfully worked through both key opportunities and key challenges over the past year,” states Rocky Bullock, CEO of the Open Compute Project Foundation. “Mike’s active participation was appreciated by all.”

About Kushagra Vaid
Kushagra Vaid is GM and Distinguished Engineer in Microsoft’s Azure Division, and is responsible for the architecture and design for cloud hardware infrastructure hosting Azure’s global scale services. Kushagra has been instrumental in driving Microsoft’s success as a leading hyperscale public cloud operator and is a recognized industry leader on infrastructure innovation and Open Source hardware. In this role, Kushagra also works closely with industry executives, VC firms and startups to shape the future of cloud infrastructure and is an influential change agent driving innovative disruption for new technologies and business models.

Kushagra is a strategic advisor to the Global Semiconductor Alliance (GSA) and also to several infrastructure startups. He is a sought after keynote speaker at top tier conferences and industry events.

Prior to joining Microsoft in 2007, Kushagra was a Principal Engineer at Intel where his responsibilities included technology strategy, architecture and design for Intel’s Enterprise and Cloud CPU/Platforms. He has published over 25+ research papers in international conferences, and is also the holder of 30+ patents in computer architecture and systems design.

Kushagra holds a M.S. in Computer Science (SUNY Binghamton) and B.E. in Computer Engineering (VJTI Mumbai).

This news comes during the 2020 OCP Virtual Summit taking place May 12-15. This year’s Summit will be an interactive virtual experience for collaboration focusing on solutions for the growing demands of compute infrastructure. The 4-day event includes, keynote sessions, executive tracks, a Virtual Expo Hall with Expo Hall talks, Engineering Workshops and the OCP Experience Center. Click here to register. Registration is free for all attendees and the full schedule can be found here.

About Open Compute Project Foundation (OCP)
The Open Compute Project Foundation (OCP) was initiated in 2011 with a mission to apply the benefits of open source and open collaboration to hardware and rapidly increase the pace of innovation in, near and around the data center’s networking equipment, general purpose and GPU servers, storage devices and appliances, and scalable rack designs. OCP’s collaboration model is being applied beyond the data center, helping to advance the telecom industry & EDGE infrastructure. www.opencompute.org

Find out more about how to participate in the OCP Community at: http://opencompute.org/participate

OCP Contact:
Dirk Van Slyke
Open Compute Project Foundation
(303) 999-7398
dirkv@opencompute.org

Media Contact:
Jaymie Scotto & Associates (JSA)
1-866-695-3629 ext. 11
jsa_ocp@jsa.net

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/415666fb-f021-411f-8877-5424f1695504

https://www.globenewswire.com/NewsRoom/AttachmentNg/5a91ffd5-1ed2-4dfa-97d7-fea62e332f80

Interesting Films and Disabled Hollywood Director Stephan Pacheco Unveil Brand New Movie About Heroic Nurses That Saved the Screenwriter’s Life in This True Story

“Nurses Do It Better” because they do

YUMA, Ariz., May 12, 2020 (GLOBE NEWSWIRE) — Film Director Stephan Pacheco unveils “Nurses Do It Better” at select film festivals throughout the world; hoping to find its audience at the Raindance Film Festival in London, The New Media Festival in Los Angeles, the Tribeca Film Festival, or the Sundance Film Festival. “Nurses Do It Better” is the first independent feature film with a true story from Interesting Films. A company that continues to expand the creation of intellectual property; starting as a digital publishing company in 1998.

The movie, produced in Los Angeles, brings together more than 40 actors with the most diverse cast ever assembled in Hollywood. This a direct reflection of the healthcare industry in the United States. With strong social relevance the film portrays America’s “two hospitals;” where some receive treatment while others are denied Humanity, even when comparable healthcare insurance covers the same services. Find details at: https://www.imdb.com/title/tt6241888/ and http://www.NursesDoItBetterFlix.com and please join us for the worldwide premiere of this indie film on May 20, 2020 at: https://vimeo.com/ondemand/239954 

An incredible true story about the reality of the US Healthcare system that mangles John, an average young man of 24. Who’s driven into hospital after hospital by a mysterious illness and the only thing he knows about it is that it can kill him within 30-minutes. Mr. Pacheco says, “NDIB could only be made as a first film. It’s far too important and real for a major Studio to make it.

Over 300 emergency attacks from inside John’s body force him to face prejudice from ER to ER as he’s treated like the junkie he might be by too many malicious doctors. He finds solace in the careful care of several beautiful nurses as time passes in between the seasons with the changing of his girlfriends.

“Greek Goddess” star of television and film, Despina Mirou is a featured Nurse and as a possible hallucination. Asian performer “Stresh” McNulty shows the audience how subtle medical malice can be. Transsexual method actor Tyler Vogel-Disalvo plays the real-life person that lived through it all. Learn more about the making of “Nurses Do It Better” here: https://medium.com/@spachec4/a-low- budget-film-director-thanks-his-cast-and-crew-with-the-most-heartwarming-letter-11809c093ee4

Creative Director Stephan Pacheco
Interesting Films
310-853-5953
DirectorSCP@InterestingFilms.pro
http://www.NursesDoItBetterFlix.com

https://www.globenewswire.com/NewsRoom/AttachmentNg/3067376d-ab25-4a77-84e6-021574e79167

Sumitomo Chemical Innovates with Anaqua’s AQX IP Management Platform

Diverse chemical company selects Anaqua software and services to unify and enhance global patent and trademark management processes

BOSTON, May 11, 2020 (GLOBE NEWSWIRE) — Anaqua, the leading provider of innovation and intellectual property management solutions, today announced that Japanese multinational company Sumitomo Chemical will enhance its IP management system by moving to Anaqua’s AQX platform.

Sumitomo Chemical, a manufacturer in petrochemicals, organic chemicals, IT-related chemicals, agrochemicals, and pharmaceuticals, opted for Anaqua when replacing its previous IP management system. The company will leverage Anaqua’s latest version of AQX software to streamline the entire IP management lifecycle from innovation creation and disclosure to patent annuity payment services. The platform’s fully integrated software and services will support Sumitomo Chemical in unifying patent and trademark management processes globally, and its real-time IP data analytics and forecasting capability will help the company enhance its IP strategy.

“We are thrilled to welcome another world-leading Japanese company to Anaqua’s client community and to provide integrated software and services that will enable them to manage their IP operations and strategy in a holistic fashion,” said Bob Romeo, CEO of Anaqua. “Sumitomo Chemical has established itself as one of the most innovative companies in its field, and AQX will help IP portfolio managers at Sumitomo Chemical ensure they maximize the value of the organization’s IP assets.”

About Anaqua
Anaqua is a premium provider of integrated, end-to-end innovation and intellectual property (IP) management solutions, serving more than 50% of the top 25 U.S. patent filers, more than 50% of the top 25 global brands, and a growing number of the most prestigious, forward-looking law firms. The company’s global operations are headquartered in Boston, with offices across Europe and Asia. Anaqua’s IP platform is used by nearly one million IP executives, attorneys, paralegals, administrators, and innovators globally. Its solution suite merges best practice workflows with big data analytics and tech-enabled services to create one intelligent environment designed to inform IP strategy, enable IP decision-making, and streamline IP operations. For additional information, please visit anaqua.com.

About Sumitomo Chemical
Sumitomo Chemical Company is a global chemical manufacturer established in 1914. The organization operates through the following segments: Basic Chemicals, Petrochemicals and Plastics, Information Technology (IT) related Chemicals, Health and Crop Sciences, Pharmaceuticals, and others. For more information visit sumitomo-chem.co.jp/english/

Company Contact:
Amanda Hollis
PR Manager, Anaqua
617-375-2626
ahollis@Anaqua.com

Novavax Reports First Quarter 2020 Financial Results

  • CEPI increases investment up to $388 million for NVX‑CoV2373 vaccine development & manufacturing
  • NVXCoV2373 Phase I trial initiating in May with preliminary results in July
  • NanoFlu recently achieved all primary endpoints in pivotal Phase 3 clinical trial
  • Company to host conference call today at 4:30 p.m. ET

GAITHERSBURG, Md., May 11, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the first quarter ended March 31, 2020.

“Our accomplishments to-date in 2020, including significant progress in our influenza and COVID‑19 vaccine programs, are the most impressive in the company’s history,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We shared successful pivotal Phase 3 results for NanoFlu that demonstrated both efficacy and safety in a pivotal trial, a significant milestone towards bringing this innovative product to an influenza market in need of new options. We also reacted quickly to the coronavirus pandemic by developing and quickly advancing NVX‑CoV2373, our COVID‑19 vaccine candidate, which shows strong potential to have a positive impact on this global health crisis. Looking ahead, with a strengthened balance sheet and CEPI’s substantial funding, we will focus on scaling up manufacturing and delivering clinical data for NVX‑CoV2373, while simultaneously completing the necessary actions needed to prepare our BLA filing for NanoFlu.”

First Quarter 2020 and Subsequent Operational Highlights

NanoFlu™ Program

  • Novavax announced in March that NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix‑M™ adjuvant, achieved all primary objectives in its pivotal Phase 3 clinical trial in older adults. As required by the FDA’s accelerated approval pathway, the trial’s primary objectives were to demonstrate non-inferior immunogenicity of NanoFlu compared to a licensed vaccine (Fluzone® Quadrivalent), using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR), as well as the overall safety of NanoFlu. These endpoints were met for all four strains included in NanoFlu. Immunogenicity was measured by hemagglutination inhibition (HAI) assays using egg-derived reagents. NanoFlu was well-tolerated, with a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events (AEs).
  • NanoFlu also achieved statistical significance for key secondary endpoints. These key endpoints assessed GMT and SCR, but with an HAI assay based on wild-type reagents. NanoFlu demonstrated significantly higher GMT and SCR than Fluzone Quadrivalent across all four strains included in the vaccine and, importantly, for four tested drifted H3N2 strains not included in the vaccine but circulating this year.
  • Results from this Phase 3 clinical trial will support a U.S. biologics license application (BLA) and licensure of NanoFlu using the U.S. Food and Drug Administration’s (FDA) accelerated approval pathway.

COVID-19 Program

  • As announced today, the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to an additional $384 million to advance clinical development of NVX‑CoV2373. Novavax will use the CEPI funds to advance NVX‑CoV2373 into clinical testing. With its earlier $4 million commitment in March, the extended collaboration brings CEPI’s total investment in NVX‑CoV2373 to $388 million.
  • In January, Novavax identified its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. Novavax’ proprietary Matrix‑M adjuvant is included in NVX‑CoV2373, to enhance immune responses and stimulate high levels of neutralizing antibodies.
  • NVX‑CoV2373 was highly immunogenic in animal models measuring spike protein-specific antibodies, with ACE‑2 human receptor binding domain blocking activity and SARS‑CoV‑2 wild-type virus neutralizing antibodies observed. Blocking of the binding of the spike protein to the receptor as well as wild-type virus neutralizing antibodies was also observed, with high levels of spike protein-specific antibodies after a single immunization. The already high microneutralization titers seen after one dose increased eight fold with a second dose. High titer microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans.
  • The NVX‑CoV2373 clinical development plan combines a Phase 1/Phase 2 approach to allow rapid advancement during the current coronavirus pandemic. The Phase 1 portion of this trial will be placebo-controlled and observer blinded in ~130 healthy adults and will include assessment of dosage and vaccination. Recruiting for the trial began this month with preliminary immunogenicity and safety results expected in July.
  • Novavax entered into an agreement with Emergent BioSolutions to provide contract development and manufacturing services, supplying Novavax with GMP vaccine product for use in its clinical trials. This agreement offers the potential to leverage Emergent’s rapid deployment capabilities and expertise that provide Novavax scalability and capacity to produce vaccine product.

ResVax™ Program

  • Novavax is currently discussing the opportunity to bring ResVax to market globally with multiple potential commercial partners. In addition, Novavax continues to define regulatory licensure requirements and pathways in the U.S., the European Union and other geographies.

Matrix-M Partnership

  • In March, Novavax announced a commercial license agreement related to its Matrix‑M vaccine adjuvant. Matrix‑M is a key component of Serum Institute of India’s malaria vaccine candidate, which it licensed from Jenner Institute at Oxford University. The vaccine candidate is currently in a Phase 2b clinical trial being conducted in Burkina Faso with top-line data expected in the second quarter of 2020.

Corporate

  • Through utilization of At-the-market (ATM) offerings during the first quarter of 2020, Novavax raised net proceeds of $186 million. Subsequent to quarter-end, through May 8, 2020, Novavax raised additional net proceeds of $74 million, for a total of $260 million since the beginning of the year.

Financial Results for the Three Months Ended March 31, 2020

Novavax 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 primarly due to the conclusion of the Prepare™ trial in 2019, partially offset by revenue from CEPI’s funding.

Research and development expenses decreased 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 same period in 2019.

Share and per share data have been restated to reflect the reverse stock split that was completed in May 2019.

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 (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 1274143. A replay of the conference call will be available starting at 7:30 p.m. ET on May 11, 2020 until 7:30 p.m. ET on May 18, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 1274143.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the “Investor Info”/“Events” tab on the Novavax website. A replay of the webcast will be available on the Novavax website until August 11, 2020.

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. Top-line data from Novavax’ ongoing Phase 3 clinical trial of NanoFlu is expected late in the first quarter of 2020.

About NVX-CoV2373

NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence 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 contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated efficient binding with receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX‑CoV2373 will initiate in May 2020 with preliminary immunogenicity and safety results expected in July 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million of funding to advance clinical development of NVX‑CoV2373.

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.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases and address urgent, global health needs. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

NOVAVAX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
(unaudited)

Three Months Ended
March 31
2020 2019
 
Revenue $     3,377 $ 3,982
 
Expenses:  
Research and development 16,895 35,473
General and administrative 9,379 8,732
Total expenses 26,274 44,205
Loss from operations (22,897 ) (40,223 )
Interest income (expense), net (2,967 ) (2,983 )
Other income (expense) (12 )
Net loss $     (25,864 ) $ (43,218 )
 
Basic and diluted net loss per share $     (0.58 ) $ (2.11 )
Basic and diluted weighted average number of common shares outstanding 44,421 20,442

SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)

March 31,
2020
December 31,
2019
(unaudited)
 
Cash and cash equivalents $   179,881 $ 78,823
Marketable securities 57,474
Total restricted cash 7,311 3,357
Total current assets 255,232 97,247
Working capital 236,250 71,452
Total assets 328,068 172,957
Notes payable 320,967 320,611
Total stockholders’ deficit (23,971 ) (186,017 )

Contacts:

Investors
Novavax, Inc.
Erika Trahan
ir@novavax.com
240-268-2022

Westwicke
John Woolford
john.woolford@westwicke.com
443-213-0506

Media
Brandzone/COGS Communication
Edna Kaplan
kaplan@kogspr.com
617-974-8659

Novavax to Receive up to $388 Million Funding from CEPI for COVID-19 Vaccine Development and Manufacturing

  • Funds clinical development of NVX-CoV2373 through Phase 2
  • Supports rapid scale-up of vaccine manufacturing
  • Allows for increased production of Matrix-M adjuvant
  • Reserves global large-scale manufacturing capacity

GAITHERSBURG, Md., May 11, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance clinical development of NVX-CoV2373, Novavax’ coronavirus vaccine candidate against SARS-CoV-2. The additional funding from CEPI will also support rapid scale-up of the NVX-CoV2373 vaccine antigen, as well as Novavax’ proprietary Matrix-M™ adjuvant, which is expected to enhance immune responses by stimulating high levels of neutralizing antibodies. In addition, the CEPI funding will allow Novavax to dramatically increase its large-scale manufacturing capacity for both antigen and adjuvant in multiple locations.

“CEPI plays a vital role in advancing innovative technologies against the COVID-19 pandemic. Their partnership and support allows Novavax to leverage its innovative vaccine platform and expertise in this global crisis,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “For the last few months, the entire Novavax team has been working nonstop in an ongoing effort to make our vaccine a reality, and we appreciate CEPI’s confidence in our technology platform and our progress.”

Novavax plans to use CEPI funding to advance NVX-CoV2373 with:

  • A Phase 1/2 clinical trial with the Phase I portion starting this month in Australia and the Phase 2 portion conducted in multiple countries following successful Phase 1 top-line results that are expected in July.
  • Process development for scaled-up production to potentially allow manufacturing of up to 100 million vaccine doses by end of 2020.
  • Access to large-scale manufacturing capacity in multiple countries with a goal of potentially producing over one billion doses during 2021.

Novavax and CEPI agree on the importance of global equitable access to the vaccines produced out of the partnership. It is anticipated that vaccines will be procured and allocated through global mechanisms now under discussion as part of the Access to COVID-19 Tools (ACT) Accelerator, an international initiative launched by the WHO and global leaders earlier this month.

“The expansion of our partnership with Novavax represents CEPI’s single biggest investment to date”, said Richard Hatchett, Chief Executive Officer of CEPI. “Our vaccine R&D programmes are starting to show progress, so it is vital that we invest now to boost manufacturing capacity, so that our partners have the ability to produce vaccines at a global scale. We still have a long way to go, but we’re making important steps forward to deliver a safe, effective, and globally accessible vaccine as quickly as possible.”

About Coronavirus

SARS-CoV-2 first appeared in late 2019 in China before beginning its rapid spread across the globe. The disease, named COVID-19, continues to cause severe pneumonia-like symptoms in many of those infected. Coronaviruses, so named for their “crown-like” appearance, are a large family of viruses that are believed to have spread from animals to humans and include the viruses causing SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). While much remains unknown about the latest coronavirus, it is known to spread via human-to-human transmission before symptoms appear.

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 and helping an immunized person make antibodies against the virus.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil society organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programs will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.

Before the emergence of COVID-19 CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

About Novavax

Novavax, Inc. (Nasdaq:NVAX), is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases and address urgent, global health needs. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors
Novavax, Inc.
Erika Trahan
ir@novavax.com
240-268-2022

Westwicke
John Woolford
john.woolford@westwicke.com
443-213-0506

Media
Brandzone/COGS Communication
Edna Kaplan
kaplan@kogspr.com
617-974-8659