May 2021

An ambitious push to create a “Global Pandemic Center” in suburban Maryland got a $500,000 boost Tuesday from the Montgomery County Council, which said the project could help drive the county’s post-pandemic economic recovery and foster resilience against the next major health crisis.

Spearheaded by the regional nonprofit Connected DMV, the center would involve scientists and policymakers from across the globe but operate primarily from the D.C. region, with a likely headquarters in Montgomery.

It would “identify and launch strategic projects needed to advance pandemic avoidance and preparedness,” Connected DMV said in its pitch to the council, including a $2 billion flagship initiative, titled “AHEAD 100,” that would stockpile monoclonal antibodies — laboratory-made treatments — for 100 pathogens most likely to cause global pandemics.

“We were the first place [in Maryland] hit by this covid-19 initially, and we paid a heavy price,” Montgomery County Executive Marc Elrich (D) said in an interview Tuesday, citing the county’s high death toll during the first part of the pandemic. “Anything we can do to avoid being that off-guard is going to be worthwhile.”

The county dollars, which are coming out of its general reserves, will go toward Connected DMV’s $2.5 million “strategy phase” to secure federal support, private- sector partnerships and other resources needed to launch “AHEAD 100.”

Other early contributors include the state of Maryland and the Bill & Melinda Gates Foundation, said Connected DMV chief executive Stu Solomon. The organization hopes to nail down a strategic plan by the end of August.

Click here to read more via the Washington Post.

GAITHERSBURG, Md., May 3, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated a pediatric expansion of its Phase 3 clinical trial for NVX-CoV2373, the company’s recombinant protein vaccine candidate against COVID-19. The additional arm of the ongoing PREVENT-19 pivotal trial will evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 3,000 adolescents aged 12-17 across up to 75 sites in the United States.

Participants will randomly receive either the vaccine candidate or placebo in two doses, administered 21 days apart. Two-thirds of volunteers will receive intramuscular injections of the vaccine and one-third will receive placebo. A blinded crossover is planned to take place six months after the initial set of vaccinations to ensure that all trial participants receive active vaccine. Participants will be monitored for safety for up to two years following the final dose.

“Through the expansion of our PREVENT-19 clinical trial, we hope to build upon the encouraging safety and efficacy data generated to-date in adults for our vaccine candidate and to play a significant global role in offering vaccination to as many people as possible across age groups to end the suffering caused by the pandemic,” said Gregory M. Glenn, M.D., President, Research and Development, Novavax.

Dr. Glenn will share an update regarding this arm of the PREVENT-19 trial during the 21^st annual World Vaccine Congress taking place online, May 4-6. He will participate in two sessions during the congress, including a presentation and a panel discussion. Details are as follows:

Morning Plenary:

Date: Tuesday, May 4
Time: 9:10am – 10:40am EST
Title: Safety, efficacy, and uptake of COVID-19 vaccines
Moderator: Jakob Cramer, M.D., Head of Clinical Development, CEPI

Afternoon Session: COVID-19: Vaccine Response & Approaches

Date: Tuesday, May 4
Time: 3:30pm – 3:45pm EST
Title: Novavax COVID-19 Program Update

To register, please visit the World Vaccine Congress website here. Dr. Glenn’s presentation slides will be posted to the company’s website following the presentation here.

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 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 biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

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

Novavax 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, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on 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 Schultz | 240-268-2022
ir@novavax.com

Solebury Trout
Alexandra Roy | 617-221-9197
aroy@soleburytrout.com

Novavax Media
Laura Keenan | 202-709-7521
media@novavax.com

On April 26, 2021, AlgometRx Inc., a Children’s National spinout company developing a handheld device to objectively measure pain by pupillary response, will relocate to Johnson & Johnson Innovation – JLABS @ Washington, DC on the Children’s National Research & Innovation Campus. The AlgometRx move comes following the company being awarded the JLABS @ Washington, DC Children’s QuickFire Challenge, which includes a one-year residency at the newly opened JLABS @ Washington, DC – a 32,000-square-foot incubator located at the new Children’s National Research & Innovation Campus in northwest Washington, D.C. As an awardee, AlgometRx also receives access to research and development space, capital equipment, mentorship, resources and programming.

Located on a nearly 12-acre portion of the former Walter Reed Army Medical Center campus, the Children’s National Research & Innovation Campus is the nation’s first campus dedicated to pediatrics, which formally opens in September 2021. This campus aims to help address a significant problem: the development of medical and surgical devices for children has long lagged behind that for adults. Over the past decade, only one in four medical devices approved by the Food and Drug Administration (FDA) were indicated for use in children, and the majority were for those ages 12 and up.

By bringing together public and private partners, the campus is a one-of-a-kind innovation ecosystem that aims to accelerate breakthrough discoveries into new treatments and technologies.

AlgometRx was founded by pediatric anesthesiologist Julia C. Finkel, M.D., and originated at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National.

“Pain is the only vital sign that is not objectively measured,” Finkel said. “The current standard of measuring pain is the 0-10 scale, which is based on observations and subjective assessment. This technique increases the likelihood for inaccuracies, especially for infants and children who cannot clearly communicate their pain.”

Click here to read more via Innovation District.

AditxtScore™ Center is the first of a planned immune monitoring network and will initially monitor COVID-19 immunity status;
New facility expects to target more than 300 jobs over three years to the area

Mountain View, CA and Richmond, VA – May 3, 2021— Aditxt (Aditx Therapeutics, Inc.) (Nasdaq: ADTX), a biotech innovation company focused on improving the health of the immune system, today announced plans to build a high-capacity AditxtScore™ Center in Richmond, VA in the second half of 2021. Aditxt is targeting a capital investment of $31.5 million over three years to scale up its state-of-the-art immune monitoring center, including projected new jobs, laboratory equipment, and construction. The announcement was made at a joint press conference with Governor Ralph Northam, Richmond Mayor Levar Stoney and other local business executives and political officials.

The new immune monitoring center is being developed to increase processing capacity for the company’s flagship AditxtScore™, a pioneering new approach to immune health monitoring that provides a comprehensive profile of the immune system. By assessing an individual’s immune biomarkers, AditxtScore™ will be able to measure indications of immunity to specific disease. AditxtScore™ applications include the recently commercialized AditxtScore™ for COVID-19, developed for use in detecting antibodies and neutralizing antibodies against SARS-CoV-2 antigens. Other applications under development include, among others, predicting dynamic monitoring of the immune system in infectious and autoimmune diseases, organ transplantation, and allergy.

Amro Albanna, co-founder and CEO of Aditxt, commented, “Richmond is an ideal location for our first high-capacity AditxtScore Center given its skilled workforce, location, and infrastructure. As we begin rolling out the AditxtScore platform and applications for immune monitoring, the establishment of an AditxtScore Immune Monitoring Network is vital to realizing our full vision for AditxtScore, which is to transform how we monitor the immune system from reactive testing to proactive monitoring. We look forward to working with the community to complete this important step in the execution of Aditxt’s strategic plan, and we are grateful to the Commonwealth of Virginia, Governor Northam, his team, and all involved for their support and welcoming reception.”

Aditxt expects to create more than 300 new jobs over the next three years to increase AditxtScore™ processing capacity up to a projected 10 million reports annually in efforts to provide more access to individuals to monitor and understand their immune profiles. The company will occupy 25,000 square feet of BioTech 8 in the Virginia Bio+Tech Park, a campus of Activation Capital, with plans for future expansion.

“The Richmond region has emerged as a hub for cutting-edge biotech companies, and this thriving industry will be bolstered by the addition of Aditxt’s Immune Monitoring Center,” said Governor Northam. “The Virginia Bio+Tech Park is an ideal location for the company to continue its groundbreaking work to improve the health of our communities and help us better understand our own immune systems—something that has become extremely important over the past year. We are honored to welcome Aditxt to the Commonwealth, and we thank the company for creating more than 300 well-paid jobs for the people of Virginia.”
View the Governor’s Press Release

Support for Aditxt’s job creation will be provided through the Virginia Talent Accelerator Program, a workforce initiative created by VEDP in collaboration with the Virginia Community College System and other higher education partners, with funding support from the Northam Administration and the Virginia General Assembly. Launched in 2019, the program accelerates new facility start-ups through the direct delivery of recruitment and training services that are fully customized to a company’s unique products, processes, equipment, standards, and culture. All program services are provided at no cost to qualified new and expanding companies as an incentive for job creation.

About Aditx Therapeutics
Aditxt is developing technologies specifically focused on improving the health of the immune system through immune monitoring and reprogramming. The immune monitoring technology is designed to provide a personalized comprehensive profile of the immune system. The immune reprogramming technology is currently at the pre-clinical stage and is designed to retrain the immune system to induce tolerance with an objective of addressing rejection of transplanted organs, autoimmune diseases, and allergies. For more information, please visit: www.aditxt.com

Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product and business development; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as those risks more fully discussed in the section titled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s other filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Media and Investor Relations Contact:
Sunny Uberoi
Chief Communications Officer
Aditxt
917-747-2018
ir@aditxt.com