May 2021

Gaithersburg, MD. (May, 25 2021) miRecule, Inc. (“miRecule”), an emerging biotech company focused on the development of cutting-edge RNA therapeutics, announced today it has closed over $5.7M in seed funding. The funding round was led by Alexandria Venture Investments, along with Boutique Venture Partners, Pathway Bioventures, Alumni Ventures Group, and national angel investors, with additional funding coming from the Maryland Momentum Fund and the FSHD Society. This funding includes a non-dilutive $2M Phase II SBIR grant from the National Cancer Institute.

miRecule will utilize the funding to drive its lead microRNA therapy (MC-30) towards clinical development for head & neck cancer, the 6th most common form of cancer worldwide. “We are hopeful MC-30 could be a real game-changer. By correcting the underlying mutation that creates resistance to treatment, we think we can triple response rates and give years of quality life back to many patients,” commented CEO Anthony Saleh.

miRecule’s DREAmiR^TM discovery platform was developed through over a decade of research in collaboration with the National Institutes of Health in Bethesda Maryland. DREAmiR integrates genomic and clinical outcomes data from thousands of patients to identify underlying genetic drivers of disease, and then designs matching RNA therapeutics that directly correct those abnormalities. miRecule is applying its platform to a range of diseases, including cancer, muscular dystrophy, and even viruses such as HIV and COVID-19.

miRecule has also utilized DREAmiR to develop MC-DX4, an antisense oligonucleotide treatment for Facioscapulohumeral Muscular Dystrophy (FSHD). FSHD is one of the most common muscular dystrophies, with over 40,000 patients in the US (many of whom are children). Currently, there are no FDA approved treatments for FSHD. “The FSHD Society is excited to be a funding partner in this endeavor, which aligns strongly with our mission to reduce obstacles inherent in the clinical & regulatory process for FSHD,” said Mark Stone, CEO of the FSHD society.

miRecule was founded in 2017 in Montgomery County, Maryland in BioHealth Innovation’s (BHI) incubator by CEO Anthony D. Saleh, PhD and Chief Operating Officer Ashwin Kulkarni, MS. miRecule has been able to raise much of its seed funding from investors in the BioHealth Capital Region. “BHI is proud to have been a co-founder with miRecule, and assist in their fundraising and growth here in Maryland. Anthony is a role model having transitioned from an academic scientist to a successful entrepreneur, and we are glad to have supported him through this process” said Rich Bendis CEO of BHI. miRecule was able to utilize two programs to leverage their investment and grant funding. The Maryland Biotechnology Investment Tax Credit program, which provided a 50% match to their investors, and the Montgomery County SBIR matching funds grant which provided $25,000 on top of their NCI grant.

“We think miRecule’s therapeutics will vastly improve the lives of patients by changing the course of their serious diseases” said Dr. Rami El Assal, Managing Partner & Co-founder of Boutique Venture Partners. “miRecule’s innovative, data-driven discovery engine shows true platform potential for the next generation of RNA therapeutics. We were really glad to have miRecule participate in Alexandria’s Seed Capital Platform, and ultimately participate in the company’s seed round,” said Conley Jones from Alexandria Venture Investments.

D.C. Mayor Muriel Bowser addresses cross-sector regional organization’s final COVID-19 Strategic Renewal Task Force meeting

The joint statement affirming the Task Force and its work from Mayor Bowser and Governors Hogan and Northam read:

“Whereas the greater Washington metropolitan area is a diverse and complex region with abundant assets and resources; and Whereas the opportunities for economic growth and social equity are fully achievable only by working together across our jurisdictions and sectors to improve our physical, digital, economic and social infrastructures so that all who live, work and play in the DMV region can thrive, especially those in our most vulnerable and underserved communities; Now, therefore, we hereby affirm the benefits of co-equal, cross-sector regional collaboration, as demonstrated by the work of the Connected DMV COVID-19 Strategic Renewal Task Force, and the enduring leadership of the resulting DMV Regional Congress.”

“Greater Washington is one of the most dynamic, diverse and fastest growing regions in the country and we want to ensure that everyone who calls the DMV home has the opportunity to thrive,” said Richard Bynum, Chief Corporate Responsibility Officer, PNC Financial Services Group and COVID-19 Task Force Member. “With a keen understanding that a going it alone approach was not an option, Connected DMV has been able to successfully bring the unique perspectives and strengths of all those invested in our region to the table for a common purpose of improving our region economically and equitably for the long-term. While there is much work left to do, the Task Force should be proud of what they have accomplished to date. I am excited for what’s to come as we advance our current initiatives and create new ones.

Connected DMV works with regional organizations across Washington D.C., Maryland and Virginia — the DMV — to deliver initiatives that provide a stronger and more equitable future for all who live, learn, work, and prosper in Greater Washington. Last year, Connected DMV and its regional partners created the organization’s COVID-19 Strategic Renewal Task Force that brought the region together with a mission of improving the long-term social, physical, and digital infrastructures for inclusive economic growth and renewal across the entire DMV region.

The 51-member Task Force, representing the CEOs of 17 regional organizations along with leaders from private industry, government, academia, philanthropy and community convened monthly to approve 13 region-wide key initiatives that address economic renewal and social equity in response to the pandemic in 10 key areas that are critical to making an impact on some of our region’s most vulnerable communities: technology and connectivity, finance, workforce development, education, public safety, transportation, food and water, energy, healthcare and housing.

These programs represent billions of dollars in net-new opportunities and jobs for Greater Washington and a major step forward in the work to close the stark East-West socioeconomic divide in the region. Key initiatives include creating a Global Pandemic Prevention & Biodefense Center, establishing a state-of-the art Hydrogen Center, positioning the region as a leader in next generation quantum technology through the launch of the Potomac Quantum Innovation Center (PQIC), and helping to close the digital divide in the region through its Connectivity for All initiative.

What the last year of collaboration by the Task Force and through the strategic initiatives has revealed is that this kind of cross-sector, co-equal collaboration works. As such, the Task Force has agreed to make this model sustainable and transition to a new body called the DMV Regional Congress. Its role will be to serve as an enduring body in the region, representing private industry, academia, philanthropy, and the community and ensure that all representatives have a co-equal seat at the table to continue the work already underway to bring further economic renewal and social equity to the region, as well as considering and approving new initiatives to solve some of the region’s greatest challenges.

“I want to thank all the members of the COVID-19 Strategic Renewal Task Force who came together, especially in a moment of crisis in our region, and worked hard and collaboratively on key innovative initiatives that help point the DMV towards sound economic footing while removing barriers to achieving a more equitable society,” said Stu Solomon, President & CEO, Connected DMV. “Their commitment to a single, results driven mission for our region was as unprecedented as it was remarkable. I’m thankful and encouraged by the Task Force commitments to be part of the DMV Regional Congress to further advance the important work that is already underway.”

One of the Task Force’s founding members was Major General Omar Jones, whose command of Joint Force Headquarters-National Capital Region will end in June. He also addressed the meeting and thanked Task Force Members on all that they have accomplished over the past two short years. “It has been a privilege and an honor to serve as a liaison to the Connected DMV’s COVID-19 Strategic Renewal Task Force, a group comprised of highly accomplished individuals in their respective fields,” said Major General Jones. “While we are a diverse group, we are united in a singular mission to ensure that we create thoughtful, responsible and achievable results driven initiatives to help our region grow economically, equitably and safely now and in the years to come. In terms of getting these initiatives off the ground, I am proud to say our mission is accomplished.”

In June, Connected DMV’s Regional Economic Development Strategy (REDS) Steering Committee – made up of 23 cross-sector organizations from around the region – will publish the Regional Economic Development Strategy Report, a blueprint for enduring cross-sector collaboration for regional economic development and equity. The REDS initiative was approved by the Task Force last year. The report is the culmination of a year of collaboration and will be the first time in our region’s history that a group of leaders from private industry, economic development and planning organizations, academia, philanthropy, and community organizations has come together to improve Greater Washington’s competitive advantages and focus directly on delivering equitable regional economic outcomes to improve the lives of all who live and work in Greater Washington.

The REDS report will also include a vision for the DMV Atlas: Accelerating Equitable Regional Growth, a collaborative platform and program that will aggregate, map, and analyze data from key regional stakeholders to inform better and more efficient cross-sector planning, partnerships, investment, programming, and tracking. It will help to drive improved leadership decision-making across sectors and jurisdictional boundaries, grounded in a nuanced regional context that advances equitable economic growth. Moving forward, the REDS effort will help generate, prioritize, and advance prospective strategic initiatives of regional economic development significance for consideration by the DMV Regional Congress.

The first meeting of the newly assembled DMV Regional Congress is slated for September of this year.

About Connected DMV

Connected DMV is an initiatives-based, charitable 501(c)(3) organization that works with regional organizations across Washington D.C., Maryland, and Virginia – the DMV – to help drive ongoing improvements to social, digital, and physical infrastructure. Connected DMV focuses on initiatives that span local jurisdictions and require public-private-academia-community collaboration to best achieve the dual objectives of enduring economic health and social equity. https://www.connecteddmv.org/

Contact

Toni DeLancey

tonidelancey@connecteddmv.org (703) 980-5935

New methods were created in collaboration with public health organizations, pharmacopeias, regulators, and manufacturers to help ensure quality and improve public trust

Rockville, MD, May 17, 2021 – The U.S. Pharmacopeia (USP) announced the release of a range of tools and resources to help reduce risks from substandard and falsified COVID-19 treatments, and to assist manufacturers, regulators, and quality control laboratories in helping to ensure quality COVID-19 treatments are being procured, produced, and distributed.

“While COVID-19 vaccines are essential to end the pandemic, treatments are a critical component to help patients, particularly those who are hospitalized with COVID-19,” said Jaap Venema, Ph.D., USP’s Chief Science Officer. “It is vital that regulators and manufacturers ensure approved therapeutics, like remdesivir, meet quality expectations. We have already seen the demand versus supply imbalance result in substandard and falsified remdesivir, particularly in low- and middle-income countries. USP is committed to helping to ensure quality throughout the medicines supply chain.”

The antiviral drug VEKLURY® (remdesivir), invented, developed and manufactured by Gilead Sciences, Inc., was the first U.S. Food and Drug Administration (FDA) approved treatment for pediatric and adult patients at least 12 years of age and weighing at least 40 kg who are hospitalized with COVID-19.  It was granted emergency use authorization by the FDA in May 2020 and was approved by the FDA under the tradename of VEKLURY on Oct. 22, 2020.^[i] As a standard of care, healthcare providers around the world are using remdesivir not only to treat patients, but also in clinical trials to understand its efficacy and safety in different patient populations and in combination with other investigational treatments.^[ii]

The USP Methods to Detect Falsified Remdesivir publication includes procedures developed by USP for determining the identity and strength of the remdesivir active pharmaceutical ingredient (API) and drug product – essential tools for detecting substandard and falsified medicines. The publication includes procedures using infrared spectroscopy (IR), ultra-high performance liquid chromatography (UHPLC), and nuclear magnetic resonance spectroscopy (NMR) technologies along with supporting validation results. It also features USP’s first quantitative NMR (qNMR)-based digital spectra for determining the identity of remdesivir API using either high field or benchtop qNMR instruments.

In addition to the USP Methods to Detect Falsified Remdesivir publication, USP announced other resources to help combat substandard and falsified COVID-19 treatments including:

Minilab’s Screening Tools for Dexamethasone:

In collaboration with USP, the Global Pharma Health Fund developed two new test methods on dexamethasone for the Minilab testing platform. These screening tools complement USP’s compendial standards available in the USP-NF for dexamethasone, a corticosteroid being widely used to treat COVID-19 patients.

IMWP draft monographs for Favipiravir

Pharmacopoeias around the world continue to work together to support the COVID-19 response. As part of the World Health Organization’s (WHO) International Meeting of World Pharmacopoeias (IMWP),  pharmacopeias have developed and made available two IMWP draft monographs for Favipiravir and Favipiravir Tablets to be used on a voluntary basis. Favipiravir is an antiviral approved for COVID-19 treatment in Japan, Russia and India.

Substandard and falsified medicines pose a threat to global health security and hinder the ability of strong and resilient public health systems to prevent, detect, and respond to infectious disease threats.

“Major public health events can increase the vulnerability of medicines to the threat of substandard and falsified products,” said Jeff Moore, Ph.D., Senior Director, Scientific Affairs & Strategy at U.S. Pharmacopeia. “These resources to help combat substandard and falsified COVID-19 treatments were created in collaboration with public health organizations, pharmacopeias, manufacturers, and regulators from around the world and are an important example of the value and importance of collaboration in times of need.”

For over 200 years, USP has supported the development, manufacturing, and distribution of quality medicines through development of standards and other tools that help ensure the quality of medicines. USP is working with government organizations, other pharmacopeias, manufacturers of drugs and other health products, and healthcare professionals in the US and around the world to help build the public’s trust in vaccines and treatments for COVID-19.

These resources are for informational purposes only and intended to provide tools to address substandard and falsified treatments during the COVID-19 pandemic. They are intended to complement standards developed by USP and other organizations by providing validated methods with supporting results to verify the ingredients and quality of these treatments. These tools are not part of the U.S. Pharmacopeia-National Formulary and does not reflect USP’s opinions on future revisions to official text of the USP–NF. Parties relying on these resources bear independent responsibility for awareness of, and compliance with, any applicable federal, state, or local laws and requirements.

About USP
U.S. Pharmacopeia (USP) is an independent, nonprofit, scientific organization that sets quality standards for medicines, dietary supplements and food ingredients worldwide. USP’s quality standards are legally recognized in the United States and elsewhere and are used in more than 140 countries. These standards, which are continuously developed and revised by more than 800 volunteer experts in science, industry, healthcare and academia. Learn more at www.usp.org.

For additional information about how USP is working to improve the supply of safe, trusted COVID-19 vaccines, treatments, and preventatives, visit www.usp.org/covid-19

• U.S. authorization gives healthcare professionals access to portable rapid testing device that can monitor immune status in relation to COVID-19
• Test based on QIAGEN partner Ellume’s proprietary eHub technology and helps ease testing shortfalls by using automation and providing easy-to-read results
• eHub digital device can handle eight tests at once, all working independently of each other, can process up to 32 samples per hour, can eventually be used simultaneously with the antigen test

GERMANTOWN, Md. & HILDEN, Germany–(BUSINESS WIRE)– QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the fast and easy-to-use QIAreach^® Anti-SARS-CoV-2 Total Test.

The authorization means QIAGEN can start making its portable antibody testing device available to health-care professionals in the U.S. Each antibody test takes only about 10 minutes to identify whether a person carries antibodies to the SARS-CoV-2 virus as a result of prior infection. Individual test results are read on a digital eHub device that can process up to 32 tests per hour – and will eventually also run the antigen test.

The QIAreach Anti-SARS-CoV-2 Total Test is a serological test that has been shown to have a sensitivity of 93.85% (CI 84.99–98.30%) and a specificity of 97.83 %–%% (CI 95.00–99.29%). QIAGEN’s technology detects total antibodies (Total immunoglobulin) specific to SARS-CoV-2 immune response – while most other tests currently identify only selected antibodies.

The QIAreach Anti-SARS-CoV-2 Total Test was developed in partnership with Ellume, an Australian digital diagnostics company. It is the first of two QIAGEN COVID-19 tests to make use of Ellume’s digital eHub and eStick system: QIAGEN in early September 2020 presented the QIAreach SARS-CoV-2 Antigen Test to detect active SARS-CoV-2 infection, which has been submitted to the FDA for an EUA.

Research into the SARS-CoV-2 pandemic also requires the monitoring of the immune status of individuals. QIAGEN is the only company that has developed both an antibody and a T-cell test to track immune responses. In November, it also launched the QuantiFERON SARS-CoV-2 test (for research use only) that can detect T-cell responses in people who have had natural infection or vaccination.

“Serological testing for antibodies is central to identifying people who have been recently infected by the virus or have been infected in the recent past, especially those who did not show any symptoms and therefore might not know of an infection,” said Davide Manissero, Chief Medical Officer of QIAGEN. “As societies are now returning to normal daily routines, understanding the COVID-19 immunity in a population can help guide public health measures.”

Traditional rapid lateral-flow antibody tests are hard to automate and results can be hard to read. The QIAreach Anti-SARS-CoV-2 Total Test generates easy-to-read results on the digital eHub platform. Each QIAreach eHub can handle up to eight samples on eight eSticks simultaneously, with each eStick test running independently. QIAGEN is using the same platform to develop QIAreach^® QuantiFERON^®-TB, a new testing solution for identifying latent tuberculosis (TB) infections in low-resource regions.

Further information on QIAGEN’s response to the coronavirus outbreak can be found here.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of March 31, 2020, QIAGEN employed approximately 5,700 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission.

ROCKVILLE, Md., May 12, 2021 /PRNewswire/ — Emmes (the “Company”), a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation and a portfolio company of Behrman Capital, today announced that it has acquired Orphan Reach, a CRO specialized in clinical research related to rare diseases. Financial terms of the transaction were not disclosed.

This marks Emmes’ second acquisition since Behrman’s investment in 2019 and builds on its recent acquisition of Neox S.R.O. (“Neox”) in December 2020. Founded nearly 20 years ago, Orphan Reach has its headquarters in the United Kingdom and offices in Ireland, Germany, India, Canada, and the United States. The acquisition expands Emmes’ geographic presence and complements Neox’s operations in central and eastern Europe. The transaction also bolsters the Company’s efforts with commercial biopharmaceutical clients and further augments its market-leading capabilities in rare diseases.

Grant Behrman, Managing Partner of Behrman Capital, said, “We are thrilled with the addition of Orphan Reach to the Emmes platform, which we believe greatly augments the Company’s BioPharma effort and builds on the recent and successful Neox transaction. Orphan Reach enhances Emmes’ momentum and steepens the Company’s growth trajectory through expansion of its geographic footprint and customer base, and we look forward to continuing to support the Company as it pursues organic initiatives and additional acquisitions.”

Dr. Christine Dingivan, Emmes’ Chief Executive Officer, said, “Our acquisition of Orphan Reach will accelerate our growth, bolstering our industry leadership in clinical research for orphan and rare diseases. Orphan Reach has an outstanding reputation, with longstanding experience in a multitude of rare disease clinical trials with over 50 biopharma customers throughout the world.”

She continued, “We believe that Orphan Reach and Emmes will be highly synergistic; we will combine Emmes’ deep strategic drug development and advanced statistical capabilities with the exceptional patient-centered global operations experience of the Orphan Reach team. With more than 7,000 rare diseases identified and only 400 treatments available, this represents a large research opportunity and demonstrates our commitment to advancing public health and addressing unmet medical needs for all populations.”

Orphan Reach Founder and CEO Thomas Ogorka said, “Orphan Reach and Emmes share a passion for the research we do, a dedication to the patients in our trials, and successful, long-term collaborations with our clients. I look forward to this new chapter in our history and to further extending our leadership in rare and orphan disease research that leads to new treatment options for these patients.”

Mr. Ogorka and the existing management of Orphan Reach will continue in their current roles.

“I am looking forward to working with Thomas and the Orphan Reach team, particularly as we broaden their research opportunities in the United States,” added Dr. Dingivan. “I am also very optimistic about collaboration between Orphan Reach and Neox and the potential for leveraging our growing global footprint and client relationships.”

In April, the Company announced that Rhonda Henry, a 30-year industry veteran, had been hired to become president of Emmes BioPharma, further reinforcing Emmes’ commitment to expansion in this market.

About Orphan Reach
Headquartered in the United Kingdom, Orphan Reach is a global and full-service CRO that has built a reputation for outstanding clinical research addressing rare diseases. Founded in 2002, the company has management teams in Europe, Asia and the U.S., and supports patients with rare diseases in more than 70 countries. The team’s goal is to accelerate access to new treatments in a wide range of orphan therapeutic areas.

About Emmes
Founded in 1977, Emmes is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The Company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical and medical device companies throughout the world. To learn more about how our research is making a positive impact on human health, go to the Emmes website at www.emmes.com.

About Behrman Capital
Based in New York City and San Francisco, Behrman Capital was founded in 1991 by Grant G. and Darryl G. Behrman. The firm invests in management buyouts, leveraged buildups and recapitalizations of established growth businesses. The company’s investments are focused in three industries: defense and aerospace, healthcare services, and specialty manufacturing and distribution. The firm has raised $3.5 billion since inception and is currently investing out of its sixth fund. For more information, please visit www.behrmancap.com.

Contact:
Ross Lovern / Daniel Hoadley
Kekst CNC
ross.lovern@kekstcnc.com / daniel.hoadley@kekstcnc.com

SOURCE Behrman Capital

GAITHERSBURG, MD., May 11, 2021 – Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that the company has closed a $40.75 million Series B investment round led by Deerfield Management Company. Also joining the Series B round are existing investor Mayo Clinic and an additional undisclosed institutional investor. Proceeds of this financing will be used to accelerate clinical development of PhageBank™ phage therapies as well as for general corporate purposes.

APT’s PhageBank™ technology is a growing collection of hundreds of bacteriophage, collectively providing broad spectrum coverage against six of the highest priority multi-drug resistant bacterial pathogens.  APT plans to use the proceeds from this Series B financing to fund the company’s clinical-stage therapeutic programs in prosthetic joint infection (PJI) and diabetic foot osteomyelitis (DFO), as well as for general corporate purposes including further development of a proprietary PhageBank™ Susceptibility Test (PST) to rapidly identify phage therapies required to eradicate specific bacterial infections.

“We are thrilled to announce this financial support from Deerfield, a prominent healthcare-focused investment firm, and Mayo Clinic, one of the world’s most distinguished nonprofit healthcare organizations,” said Greg Merril, APT’s CEO and Co-Founder. “This Series B funding round positions APT to continue aggressively expanding PhageBank’s coverage spectrum and advancing our clinical development pipeline of new therapeutic options to patients suffering from bacterial infections, many of which are notably difficult-to-treat multi-drug resistant and/or biofilm-mediated infections.”

“Adaptive Phage Therapeutics is taking a unique and differentiated approach to the therapeutic treatment of bacterial infections,” said Jonathan Leff, Partner at Deerfield. “We are excited to be working with the APT team on their unique PhageBank^TM platform, which has shown significant promise in patients treated for a variety of multi-drug resistant bacterial infections under compassionate use allowance from the FDA. Together, we believe we can bring PhageBank™ therapy into the mainstream, and work to solve one of the key challenges facing modern medicine, the growing problem of antibiotic-resistant bacteria.”

Adaptive Phage Therapeutics, Inc.

Adaptive Phage Therapeutics is a clinical-stage company advancing therapies to treat multi-drug resistant infections. Prior antimicrobial therapeutic approaches have been “fixed,” while pathogens continue to evolve resistance to each of those therapeutics, causing those drug products to become rapidly less effective in commercial use as antimicrobial resistance (AMR) increases over time.

APT’s PhageBank™ approach leverages an ever-expanding library of bacteriophage (phage) that collectively provide evergreen broad spectrum and polymicrobial coverage. PhageBank™ phages are matched through a proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale.

APT’s technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBank™ therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed.

For more information, visit http://www.aphage.com.

About Deerfield

Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy.

For more information, please visit www.deerfield.com

Adaptive Phage Therapeutics

Investor Relations:

Gilmartin Group, LLC.:

Laurence Watts

laurence@gilmartinir.com

619-916-7620

Deerfield Contact:

Deerfield Management Company

Karen Heidelberger

karenh@deerfield.com

212-583-7298

BALTIMORE, MARYLAND (May 10, 2021) – Governor Larry Hogan today announced that Ellume, an Australia-based digital diagnostics company, will establish its first U.S. manufacturing operation in Frederick County and create more than 1,500 new jobs by the end of 2022. Ellume, based in East Brisbane in Queensland, will lease about 200,000 square feet in two new buildings to accommodate demand for its diagnostic products targeting infectious diseases. The company signed a $231.8 million agreement in February 2021 with the U.S. Department of Defense, in coordination with the U.S. Department of Health and Human Services, to accelerate domestic production of its COVID-19 home tests and support ongoing U.S. pandemic preparation and response.

The project is a result of strengthening ties between Australia and Maryland, which were reinforced by Governor Hogan’s infrastructure and trade mission to Australia in September 2019. While there, he toured Sydney, Adelaide, and Melbourne, visited various infrastructure projects, and met with Australian officials and businesses.

“We look forward to building the foundation for Ellume’s long-term vision in the U.S. and recruiting the highly skilled talent in Maryland’s Biotech Corridor needed to fuel our flagship U.S. facility,” said Jeff Boyle, PhD, Ellume U.S. president. “Frederick is the ideal location for Ellume as we continue to work closely with the U.S. government in delivering COVID-19 tests to communities across the country. The facility will serve as a foundation for Ellume to support the domestic response to the COVID-19 pandemic and better prepare the U.S. for future public health crises.”

“It is outstanding news that Ellume has chosen Maryland for this significant expansion and will create more than 1,500 new life sciences jobs in our state at a time when they are needed the most,” said Governor Hogan. “We had a highly successful mission to Australia, and I am pleased that the partnerships and connections we created during that mission have resulted in bringing this world-class company to Maryland.”

Ellume’s focus is on the detection of common infectious diseases which affect the global population across all diagnostic settings: at home, point-of-care, and in-laboratory. Ellume has a global consumer health partnership with GlaxoSmithKline; a global COVID-19 and latent tuberculosis partnership with QIAGEN; and a range of professional products under its ellume·lab brand.

The Ellume COVID-19 Home Test was the first rapid self-test for COVID-19 detection authorized by the U.S. Food and Drug Administration for asymptomatic and symptomatic use without a prescription. With the Centers for Disease Control reporting that at least 50% of COVID-19 cases are transmitted asymptomatically, Ellume’s test will play a crucial role as one of the only diagnostic tools authorized for non-prescription use as a screening tool in the United States. Further information can be found at ellumehealth.com.

“This is great news for Frederick County. Ellume is on the cutting edge, making products that will help the world to overcome this health pandemic,” said Frederick County Executive Jan Gardner. “We are excited to welcome Ellume to our thriving life science and biopharma family. Frederick County has delivered on our fast-track permitting process to accelerate this project so production can begin in the second half of 2021. Frederick County is a great place to do business.”

“We are thrilled to have attracted a global leader like Ellume, which is at the forefront of diagnostic testing for a host of infectious diseases, including coronavirus,” said Maryland Commerce Secretary Kelly M. Schulz. “Being in Maryland will not only bring the company closer to their existing key federal partners, but will also provide access to our highly-educated workforce, research labs, and critical mass of resources that make our state an ideal place for a life sciences company to succeed.”

To assist with costs related to the development project, the Maryland Department of Commerce is working with the company on a conditional loan through Advantage Maryland, formerly the Maryland Economic Development Assistance Authority and Fund (MEDAAF), contingent on job creation and capital investment. Frederick County approved the project for Turbo Fast Track Permitting to meet the company’s timeline and the project is eligible for county tax credits over the next six years. The company is also eligible for local workforce services.

About Maryland Commerce

The Maryland Department of Commerce stimulates private investment and creates jobs by attracting new businesses, encouraging the expansion and retention of existing companies, and providing financial assistance to Maryland companies. The Department promotes the State’s many economic advantages and markets local products and services at home and abroad to spur economic development and international investment, trade and tourism. Because they are major economic generators, the Department also supports the Arts, film production, sports and other special events. For more information, visit commerce.maryland.gov.

GAITHERSBURG, Md., May 10, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced data from a preclinical study of the company’s combination quadrivalent seasonal flu vaccine (NanoFlu™) and COVID-19 vaccine candidate (NVX-CoV2373). The NanoFlu/NVX-CoV2373 combination vaccine demonstrated positive immune responses to both influenza and SARS-CoV-2. A pre-print of the manuscript is available at bioRxiv.org.

The manuscript, titled ‘Combination Respiratory Vaccine Containing Recombinant SARS-CoV-2 Spike and Quadrivalent Seasonal Influenza Hemagglutinin Nanoparticles with Matrix-M™ Adjuvant,’ studied a combination vaccine comprising a quadrivalent nanoparticle influenza vaccine formulated together with a recombinant SARS-CoV-2 spike protein vaccine and Matrix-M™ adjuvant. The combination vaccine elicited robust responses to both influenza A and B and protected against the SARS-CoV-2 virus. Clinical studies of the combination vaccine are expected to begin by the end of the year.

“Despite low rates during the COVID-19 pandemic, influenza remains a significant risk to global public health and the need for versatile, more effective vaccines is as important as ever, including against the flu. This study’s results build on our success to-date with NVX-CoV2373, and with NanoFlu, which successfully achieved all of its objectives in a pivotal Phase 3 trial announced last year,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “We believe that this novel combination vaccine candidate, which leverages Novavax’ technology platform and Matrix-M™ adjuvant, could be an important future tool in the long-term fight against both of these harmful respiratory viruses.”

Immunogenicity Results

The preclinical study found that the combination NanoFlu/NVX-CoV2373 (qNIV/CoV2373) vaccine induced functional influenza and COVID antibodies in ferrets. Hemagglutination inhibition (HAI) and ACE2 receptor-inhibiting titers were comparable between immunization with the combination vaccine and with its respective component vaccines. Antibody titers were elevated two weeks after a single dose and increased even further two weeks following a second immunization.

Hamsters that received the combination NanoFlu/NVX-CoV2373 vaccine had elevated levels of SARS-CoV-2 anti-S IgG two weeks after the first immunization, which increased significantly after a second dose, with levels comparable to animals that received the NVX-CoV2373 vaccine alone. Human ACE2 receptor inhibiting antibody levels responded similarly. The immune responses to influenza A and B strains elicited by NanoFlu/NVX-CoV2373 were comparable to immunization with NanoFlu alone. Further, the combination vaccine induced antibodies against SARS-CoV-2 neutralizing epitopes, including at hidden or cryptic sites, that are common between USA-WA1 and the B.1.351 variant.

Protection after SARS-CoV-2 challenge

When hamsters were challenged with SARS-CoV-2, animals immunized with NanoFlu/NVX-CoV2373 retained their body weight comparably to non-infected animals and those immunized with NVX-CoV2373 alone. An examination of viral load in the upper and lower respiratory tract showed that little or no virus was detected four days after COVID-19 infection in animals immunized with NanoFlu/NVX-CoV2373 or with just NVX-CoV2373. Microscopic and macroscopic observations of the lungs showed no remarkable findings in animals immunized with either the combination vaccine or with NVX-CoV2373 alone.

“Seasonal influenza and COVID-19 combination vaccines will likely be critical to combating emerging COVID-19 variants,” said Russell ‘Rip’ Wilson, Executive Vice President and NanoFlu General Manager, Novavax. “Millions of people are affected by influenza each year in the U.S., and despite our vaccination efforts, currently available flu vaccines are only partially effective. Our NanoFlu vaccine Phase 3 clinical trial achieved all of its primary endpoints, and we expect this combination vaccine will help control both COVID-19 and influenza illness.”

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 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 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
Amy Speak | 617-420-2461
Laura Keenan | 202-709-7521
media@novavax.com