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VBI Vaccines Reports Third Quarter 2023 Financial Results

By November 14, 2023April 16th, 2024No Comments
  • PreHevbrio (Hepatitis B Vaccine [Recombinant]) global net revenue increased 52% quarter-over-quarter from Q2 to Q3 2023
  • Continued execution across earlier-stage pipeline, including:
    • Initiation of Phase 2b study of VBI-1901 in recurrent glioblastoma (GBM) patients
    • Interim Phase 1 data announced for pan-coronavirus candidate, VBI-2901
    • Novel mRNA-launched eVLP platform technology announced

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended September 30, 2023.

“In Q3, we were focused on pipeline execution with continued revenue growth for PreHevbrio, meaningful data readouts and clinical advancements of our lead development candidates, and the announcement of a next-generation proprietary technology that blends the benefits of our eVLP technology with those of mRNA platforms,” said Jeff Baxter, VBI’s President and CEO. “Additionally, in this period of challenging financial markets for biotechnology companies, we are intensely focused on managing our operating expenses and capital to fuel sustainable growth and value for key stakeholders.”

Recent Key Program Achievements and Projected Upcoming Milestones

Hepatitis B (HBV)

PreHevbrio [Hepatitis B Vaccine (Recombinant)]

  • Global net product sales increased 52% from Q2 2023 with $1.1 million earned in Q3 2023
    • Net product sales are net of the provision for discounts, chargebacks, rebates, and fees – in the aggregate, these discounts reduced sales by $0.6 million in Q3 2023, from $1.7 million gross sales to $1.1 million net sales
  • Quarter-over-quarter momentum continues to grow, with more than a 10% increase in total customer base in Q3 as compared to Q2 2023
  • Contracting network across multiple market segments also continues to see growth, including with retail partners, Integrated Delivery Networks (IDNs) and large hospital systems, multiple large military and federal facilities, prisons, and independent and public health clinics
  • July 2023: Exclusive licensing deal with Brii Biosciences (Brii Bio) announced for the development and commercialization of PreHevbri in the Asia Pacific region, excluding Japan
  • October 2023: Peer-reviewed publication of review of data from studies of PreHevbrio published in Expert Review of Vaccines
  • Q4 2023: New market launches expected in additional European Union countries through partnership with Valneva (under brand name PreHevbri®)

VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

  • July 2023: Announced exclusive global licensing agreement with Brii Bio for the development and commercialization of VBI-2601
    • This expanded partnership adds VBI-2601 to Brii Bio’s HBV portfolio, which, through a series of strategic investments and partnerships is among the most advanced in the chronic HBV field
    • VBI will continue to share in the success of VBI-2601, with the potential to receive regulatory and commercial milestone payments, in addition to potential double-digit royalties on global sales of VBI-2601
  • September 2023: Brii Bio announced topline interim results of Phase 2 study evaluating VBI-2601 in combination with pegylated interferon-alpha (PEG-IFNα) in chronic HBV patients
    • The combination treatment elicited improved hepatitis B S-antigen (HBsAg) loss and seroconversion vs. PEG-IFNα alone both at the end of treatment and after 12 weeks of follow up
  • November 2023: In two late-breaking poster presentations at AASLD The Liver Meeting® 2023, Brii Bio announced new data from Phase 2 studies of VBI-2601 (BRII-179) highlighting progress towards achieving HBV functional cure:
    • Direct evidence that BRII-179-induced functional antibody responses can contribute to increased and sustained HBsAg loss rate
    • New insight utilizing BRII-179 to enrich patients with intrinsic humoral immune responses for higher HBsAg loss or HBV functional cure rates

Glioblastoma (GBM)

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

  • September 2023: Announcement of first patients dosed in the randomized, controlled Phase 2b study of VBI-1901, an FDA Fast Track and Orphan Drug Designated cancer vaccine candidate, in recurrent GBM patients
  • Around Year-End 2023: Expected initiation of VBI-1901 study arm, as part of Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial, in combination with Agenus Inc.’s anti-PD-1, balstilimab, in primary GBM patients
  • H2 2024: Interim data analyses from Phase 2b study in recurrent GBM patients expected, subject to speed of patient enrollment

COVID-19 & Coronaviruses

VBI-2901: Multivalent Pan-Coronavirus Vaccine Candidate

  • September 2023: Initial data from Phase 1 study of VBI-2901 reported – the first clinical data from a pan-coronavirus vaccine candidate
    • VBI-2901 demonstrated vaccine benefit – reflected as boosting of and/or greater durability of antibody titer maintenance:
      • All participants saw boosting and/or high neutralizing antibody responses against a panel of COVID-19 variants and two animal coronaviruses
      • Participants with lower baseline antibody titers, reflecting a higher-risk population, saw the greatest boosting effect (5-14x strain-dependent boosting)
      • Durability benefit observed regardless of baseline antibody levels, with only about 25% reduction in geometric mean titer (GMT) against the Wuhan strain after 5 months vs. peak responses – compared to an approximate 77% decline in GMT against the Wuhan strain vs. peak responses to a licensed mRNA vaccine [Gilboa M, 2022]1
  • Q1 2024: Additional durability and breadth data from the Phase 1 study expected
  • Funds from existing partners, including the Canadian government and the Coalition for Epidemic Preparedness Innovations (CEPI) are available to fund the next phase of clinical development

Novel mRNA-Launched eVLP (MLE) Technology Platform

  • October 2023: Development of a novel mRNA-launched eVLP (MLE) technology platform announced, supported by preclinical data that have demonstrated significant immunologic and manufacturing benefits
    • MLE technology enables the manufacture of particulate vaccines, capable of driving polyfunctional B-cell and T-cell activation, on accelerated timelines, similar to other mRNA vaccine production timelines
    • New platform has the potential to be leveraged across infectious disease, cancer, and allergic and autoimmune disease indications

Third Quarter 2023 Financial Results

  • Cash Position: VBI ended the third quarter of 2023 with $35.5 million in cash as compared with $62.6 million in cash as of December 31, 2022.
  • Revenues, net: Revenues, net for the third quarter of 2023 were $6.6 million as compared to $0.3 million for the same period in 2022. The revenue increase was a result of an increase in product sales of PreHevbrio in the U.S. and of PreHevbri to our partner, Valneva, in Europe, in addition to the license revenue and R&D services revenue associated with the HBV license agreement, expanded in July 2023, with Brii Bio.
  • Cost of Revenues: Cost of revenues was $2.5 million in the third quarter of 2023 as compared to $2.7 million in the third quarter of 2022. The decrease in the cost of revenues was due to increased product sales, offset by lower direct labor costs as a result of the recent organization changes that reduced our internal workforce.
  • Research and Development (R&D): R&D expenses for the third quarter of 2023 were $1.5 million as compared to $5.0 million for the third quarter of 2022. R&D expenses were offset by $2.7 million in the third quarter of 2023 and $2.4 million in the third quarter of 2022 due to government grants and funding arrangements.
  • Sales, General, and Administrative (SG&A): SG&A expenses for the third quarter of 2023 were $9.0 million as compared to $14.2 million for the same period in 2022. The decrease in SG&A expenses was mainly a result of the recent organizational changes that reduced our internal workforce, as announced in April 2023, the redefined deployment strategy of our U.S. commercial field force, and a reduction in activity-based commercial expenses related to PreHevbrio.
  • Net Cash Used in Operating Activities: Net cash used in operating activities for the nine months ended September 30, 2023, was $48.8 million compared to $54.6 million for the same period in 2022. The decrease in cash outflows is largely a result of non-cash reconciling items, mainly impairment charges and unrealized foreign exchange loss, and the change in operating working capital, most notably in inventory, other current assets, accounts payable, deferred revenues, and other current liabilities. As announced on April 4, 2023, VBI implemented cost saving measures that are expected to reduce operating expenses from normal business in the second half of 2023 by 30-35% compared to the second half of 2022.
  • Net Loss and Net Loss Per Share: Net loss and net loss per share for the third quarter of 2023 were $20.4 million and $1.01, respectively, compared to a net loss and net loss per share of $25.2 million and $2.93 for the third quarter of 2022, respectively.
  • Net Loss, Excluding Impairment Charges and Foreign Exchange Loss, and Net Loss Per Share, Excluding Impairment Charges and Foreign Exchange Loss: Net loss, excluding impairment charges and foreign exchange loss, and net loss per share, excluding impairment charges and foreign exchange loss, for the third quarter of 2023 were $8.0 million and $0.38, respectively, compared to $22.5 million and $2.62 for the third quarter of 2022, respectively. See “Non-GAAP Financial Information” below for additional information regarding this non-GAAP financial measure, and “GAAP to Non-GAAP Reconciliation” for a reconciliation of this non-GAAP financial measure to net loss and net loss per share.
    • Impairment charges and foreign exchange loss for the third quarter of 2023 were $3.6 million and $8.8 million, respectively, as compared to none and $2.7 million for the third quarter of 2022. Certain intercompany loans between the Company and its subsidiaries are denominated in a currency other than the functional currency of each entity. The primary driver of the increase in foreign exchange loss was the impact of the relative strengthening of the U.S. and Canadian Dollars against the New Israeli Shekel upon translation of these intercompany loans.

Use of Non-GAAP Financial Measures

Net Loss, Excluding Impairment Charges and Foreign Exchange Loss, and Net Loss Per Share, Excluding Impairment Charges and Foreign Exchange Loss, are non-GAAP financial measures and are defined as Net Loss and Net Loss Per Share excluding the non-cash impairment charges and foreign exchange loss in both calculations. Net Loss, Excluding Impairment Charges and Foreign Exchange Loss, and Net Loss Per Share, Excluding Impairment Charges and Foreign Exchange Loss, are not intended to replace Net Loss or Net Loss Per Share or other measures of financial performance reported in accordance with generally accepted accounting principles (GAAP). VBI’s management believes that the presentation of Net Loss, Excluding Impairment Charges and Foreign Exchange Loss, and Net Loss Per Share, Excluding Impairment Charges and Foreign Exchange Loss, are useful to investors because management does not consider foreign exchange loss, which is primarily driven by changes in exchange rates related to certain intercompany loans, and non-cash impairment charges, both of which are non-recurring items, when evaluating VBI’s operating performance. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. The presentation of these non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company’s financial statements prepared in accordance with GAAP. Reconciliations of the Company’s non-GAAP measures are included below.

The following represents a reconciliation of Net Loss to Net Loss, Excluding Impairment Charges and Foreign Exchange Loss, and Net Loss Per Share to Net Loss Per Share, Excluding Impairment Charges and Foreign Exchange Loss. See “Non-GAAP Financial Information” below for additional information regarding this non-GAAP financial measure, and “GAAP to Non-GAAP Reconciliation” for a reconciliation of this non-GAAP financial measure to net loss and net loss per share.

About PreHevbrio [Hepatitis B Vaccine (Recombinant)]

PreHevbrio is the only 3-antigen hepatitis B vaccine, comprised of the three surface antigens of the hepatitis B virus – Pre-S1, Pre-S2, and S. It is approved for use in the U.S., European Union/European Economic Area, United Kingdom, Canada, and Israel. The brand names for this vaccine are: PreHevbrio® (US/Canada), PreHevbri® (EU/EEA/UK), and Sci-B-Vac® (Israel).

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

U.S. Indication

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

U.S. Important Safety Information (ISI)

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Please see Full Prescribing Information.

 

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology and a proprietary mRNA-launched eVLP (“MLE”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

References

1. Gilboa, Mayan, Regev-Yochay, Gili, Mandelboim, Michael et al. Durability of Immune Response After COVID-19 Booster Vaccination and Association With COVID-19 Omicron Infection. JAMA Network Open. September 2022

Cautionary Statement on Forward-looking Information

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such forward-looking statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, market, industry or political conditions in the United States or internationally; the impact of the COVID-19 endemic and the continuing effects of the COVID-19 endemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; our ability to regain and maintain compliance with the Nasdaq Capital Market’s listing standards; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 13, 2023, and filed with the Canadian security authorities at sedar.com on March 13, 2023, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

VBI Contact

Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: IR@vbivaccines.com

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© 2023 VBI Vaccines Inc. All rights reserved.

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Pierre Van Damme, M.D., Ph.D.

Pierre Van Damme is full professor at the University of Antwerp, Faculty of Medicine and Health Sciences. He chairs the Vaccine & Infectious Disease Institute (VAXINFECTIO, University of Antwerp); VAXINFECTIO is a consortium of three research units within the university. In 2000, he was appointed Professor at the Faculty of Medicine and Health Sciences, University of Antwerp – he teaches infectious diseases and vaccinology in the Faculty of Medicine and Health Sciences as well as in the Faculty of Pharmacy and Biomedical Sciences, and within master programs in vaccinology at the University of Florence and Siena.

Professor Van Damme has authored more than 350 peer-reviewed papers and is on the editorial board of several scientific journals that focus on the study of vaccines and vaccine-preventable infectious diseases. Professor Van Damme was awarded with the Research Award of the University of Antwerp, and in 2000 with the Belgian Social Medicine Award ‘Jean Van Beneden’ for his work on the introduction of universal hepatitis B immunization programs. In May 2014, he was awarded with the prestigious Bill Marshall award of the ESPID society.

John D. Grabenstein, Ph.D., R.Ph.

Dr. Grabenstein is a global vaccinologist, pharmacist, epidemiologist, and public-health leader specializing in adult vaccines, implementation, and vaccine history. Currently, Dr. Grabenstein is president of consulting service Vaccine Dynamics SP, and is also Associate Director of Scientific Communications for the Immunization Action Coalition (IAC), a non-profit organization working to increase immunization rates and prevent disease by creating and distributing educational materials for health professionals and the public. Previously, he spent over 13 years at Merck Vaccines, most recently serving as Global Executive Director of Medical Affairs until his retirement in late 2019. Before joining Merck, Dr. Grabenstein served for 27 years in the U.S. Army Medical Department, achieving the rank of Colonel. From 1999 to 2006, he directed the scientific elements of the U.S. Department of Defense (DoD) anthrax and smallpox vaccination programs. As Director, Military Vaccine Agency, he was responsible for science, communication, education, and safety surveillance of military immunizations for 2.6 million U.S. Army, Navy, Marine Corps, Air Force, and Coast Guard personnel deployed globally.

Damian Braga

Director, Chair of Commercial Advisory Board

Dr. Bresnitz is an accomplished public health physician bringing over four decades of experience in academia, government public health, and the pharmaceutical industry, with a focus on the development of vaccines and implementation of vaccine policy. Dr. Bresnitz is currently serving as Medical Advisor to the New Jersey State Department of Health’s COVID-19 Response and was formerly the New Jersey State Epidemiologist with successive positions as Assistant, Senior Assistant, and Deputy Commissioner of Health for Public Health Services from 1999-2008. In 2020, Dr. Bresnitz retired from a 12-year career at Merck & Co., Inc., where he served as Medical Director, Global Medical Affairs and Policy, as well as Executive Director, Adult Vaccines, Global Vaccine Medical Affairs. As Executive Director, Dr. Bresnitz was responsible for the development and execution of medical affairs strategies for the adult vaccine portfolio that included pneumococcal, herpes zoster, and the hepatitis A and B vaccines, Vaqta and Recombivax HB, respectively. Prior to his service in the New Jersey State Government, Dr. Bresnitz was Chairman of the Department of Community and Preventive Medicine at Drexel University’s School of Medicine.

Adam Finn, M.D., Ph.D.

Adam Finn is Professor of Paediatrics at the University of Bristol, UK. He studied Medical Sciences at Cambridge University and then moved to University of Oxford Medical School to complete his clinical degree in 1983. After qualifying he did training jobs in paediatrics in Sheffield, Bristol and Guy’s Hospital London before taking up a fellowship in Infectious Diseases at the Children’s Hospital of Philadelphia in 1987. He completed his academic training as Lecturer in Immunology at the Institute of Child Health, Great Ormond St, London where he wrote his Ph.D.

In 1992, he took up a senior lecturer position at the University of Sheffield, UK. Over the following 9 years he established both clinical and laboratory research groups there, focussing on mucosal immune responses to paediatric conjugate vaccines and the pathogenesis of upper and lower respiratory tract pneumococcal infection. In 2001, he moved to Bristol where he is now Theme Leader for Infection & Immunity, University of Bristol and Clinical Research Lead – Children, Genetics, Haematology, Reproductive Health and Childbirth for the NIHR Clinical Research Network: West of England. He is also a senior clinician in the paediatric immunology and infectious diseases clinical service at Bristol Royal Hospital for Children and the South West region and heads the Bristol Children’s Vaccine Centre. In addition, he became Chairman of the WHO European Technical Advisory Group of Experts (ETAGE) on Immunization in December 2011 and ex officio member of the WHO Strategic Advisory Group of Experts, Member of the UK Department of Health Joint Committee on Vaccination and Immunisation (JCVI) since October 2014. In 2015, he was elected President of the European Society for Paediatric Infectious Diseases (ESPID).

His research interests are elucidation of the nature of naturally acquired mucosal immunity to pneumococcus, meningococcus and other respiratory bacteria, the determinants of bacterial transmission and vaccine indirect effects and development of tools to assess human immune responses to candidate vaccine antigens. He also leads and supports numerous clinical trials of drugs and medicines in children.

Peter A. Patriarca, M.D.

Peter A. Patriarca, M.D., is the Principal of Immuno-Vax, LLC, and a senior affiliate consultant with the Biologics Consulting Group, Inc. (Alexandria, Virginia), and has provided technical and regulatory consulting services for all phases of vaccine and drug development for the past 13 years. Prior to consulting, Dr. Patriarca was Corporate Head and Vice President, Worldwide Regulatory Affairs and Pharmacovigilance at MedImmune, Inc. (2001-2005) and also served as Medical Officer in the U.S. Public Health Service at the Centers for Disease Control and Prevention (1980-1992) and the US Food and Drug Administration (1993-2001). At FDA, Dr. Patriarca served, among other positions, as Director of the Division of Viral Products in the Office of Vaccines Research and Review (OVRR), CBER. In that capacity, he oversaw research and review activities of more than 100 scientific staff in eight laboratories, and was intimately involved with regulatory decisions and policy affecting vaccine development and licensure. While at CDC, Dr. Patriarca was assigned to the National Immunization Program, where, among other positions, he served as the Chief Medical Epidemiologist in the Influenza Division and the first head of CDC’s program in support of the Global Poliomyelitis Eradication Initiative. He has authored more than 100 peer-review publications and has served on multiple scientific advisory bodies for CDC, WHO, the Bill and Melinda Gates Foundation, the American Academy of Pediatrics, the National Academy of Sciences, and numerous pharmaceutical companies.

Michel De Wilde, Ph.D.

Director, Chair of Scientific and Clinical Advisory Boards

Michel De Wilde, Ph.D., was Senior Vice President, Research & Development, at Sanofi Pasteur, the human vaccines division of Sanofi from 2001 until June 2013. In this position, he was responsible for managing approximately 1,500 employees and a broad portfolio of approximately 20 development projects.

Prior to joining Sanofi Pasteur in January 2000, Dr. De Wilde was at SmithKline Beecham Biologicals (now GSK Vaccines) in Rixensart, Belgium. Dr. De Wilde joined the group in 1978 as a research scientist upon formation of a unit focusing on the application of recombinant DNA technology to vaccine development. He subsequently held positions of increasing responsibility and, as Vice President, Research & Development at Sanofi Pasteur, headed a team of approximately 400 specialists, active in all aspects of preclinical vaccine development.

Dr. De Wilde a member of a number of Scientific Advisory Boards, including COVAX Independent Product Group and other COVID related advisory bodies.

Dr. De Wilde received his degree in Chemistry from the Free University of Brussels in 1971, followed by a Ph.D. in Biochemistry in 1976. He carried out postdoctoral work at the University of Wisconsin, Madison (U.S.) and the University of Ghent (Belgium). Dr. De Wilde authored over 50 publications during the early part of his career.

Dr. De Wilde is also a Senior Scientific Advisor on all three of VBI’s Scientific and Clinical Advisory Boards.

Daniel Shouval, M.D.

Dr. Daniel Shouval is a graduate of the Hadassah–Hebrew University Medical School in Jerusalem, Israel. After completing his residency in Internal Medicine at Hadassah, Dr. Shouval was trained in Cell Biology, Immunology, and Molecular Biology at the Liver Research Center at Albert Einstein College of Medicine in New York, and the Massachusetts General Hospital in Boston. His main research interests and publications include Biology of and immune response to hepatitis B and A virus infection and liver tumors . Dr Shouval has been involved in the development of several vaccines and anti-viral agents against viral hepatitis B ,C and A. In recent years his main efforts are focused on developing a third generation Pre-S/S hepatitis B vaccine; intervention in persistent hepatitis B infection, prevention of hepatitis B infection in liver transplant recipients, adoptive transfer of immunity against hepatitis B and pre/post-exposure prophylaxis against hepatitis A. Dr. Shouval is the author/co-author of >250 publications, Editorials in leading Hepatology journals and chapters in books.

Dr. Shouval is Professor Emeritus of Medicine at the Hebrew University and Hadassah Medical School in Jerusalem and former Dean of the Faculty of Medicine. He was a visiting Professor at the Albert Einstein College of Medicine in New York and had similar positions at the Harvard Medical School and Massachusetts General Hospital in Boston, USA (1987-88) and at the Liver Transplantation Center , Paul Brousse hospital, the University of Paris, France (1998-99). Prof. Shouval served as President of the European Association for the Study of the Liver in 1996/7; he is the recipient of EASL’s Recognition Award and nomination to EASL’s hall of fame and recently served as EASL honorary president(2016) . Between 1998-2002 he was Chairman of the Educational Committee of EASL. He served in a number of editorial boards in hepatology journals and was the founding editor of the FOCUS section in the Journal of Hepatology. Dr Shouval is a standing adviser to the European Viral Hepatitis Prevention Board and the World Health Organization.

Bruce Smith, Ph.D.

Dr. Bruce Smith is a Professor in the Department of Mathematics and Statistics at Dalhousie University, and a member of the Canadian Center for Vaccinology. Bruce received a Ph.D. in Biostatistics from the University of California, Berkeley, in 1988, and has been at Dalhousie since that time, where he has served as Director of the Division of Statistics and Chair of the Department of Mathematics and Statistics. His research interests are in applied statistics and time series analysis, with applications to vaccinology, the estimation of quantitative genetic traits, and environmetrics. He is President Elect of the Statistical Society of Canada.

Stefan Thoelen, M.D.

Dr. Thoelen has been a vaccinology consultant since 2008. Prior to consulting, Dr. Thoelen accrued over 20 years of experience as the Global Head of Clinical Development and Operations Vaccines for Sanofi Pasteur, and also as the Head of Clinical Development, Operations and Medical Affairs in Latin America for GlaxoSmithKline.

Nadia G. Tornieporth, M.D.

Dr. Tornieporth is a physician with extensive leadership experience and technical expertise in the clinical development of vaccines. She is Professor of Clinical Research and Pharmacovigilance at the University of Applied Sciences and Arts in Hannover, Germany. Previously, Dr. Tornieporth served as Vice President and Head of Global Clinical Research and Development at Sanofi Pasteur where she oversaw all aspects of clinical development from First-in-Man to successful registration. Prior to her time at Sanofi, she was Vice President of Clinical Development, Prophylactic Vaccines at GlaxoSmithKline Biologicals. Over the course of her career, Dr. Tornieporth contributed to the successful licensure of more than 20 vaccines. She has served as an advisor to the World Health Organization, USAID, the Wellcome Trust, and the European Forum for Good Clinical Practice, among others. She contributes to several vaccine development programs as member of Independent Data Monitoring Committees and Scientific Advisory Boards, and currently serves as acting Head, Clinical Development, for the Coalition of Epidemic Preparedness Innovations (CEPI). Earlier in her career, Dr. Tornieporth held international research and teaching positions at Weill Cornell Medical College and Ludwig-Maximilian University. Dr. Tornieporth received her M.D. from Ludwig-Maximilian University in Munich, Germany and her Diploma in Tropical Medicine and Hygiene from the London School of Hygiene and Tropical Medicine. She holds clinical patents for the RTS,S malaria and dengue vaccines and has co-authored more than 60 peer-reviewed publications in infectious diseases and vaccine development.

Michael D. Decker, M.D., M.P.H.

Current Adjunct Professor of Preventive Medicine at Vanderbilt University Medical Center, Dr. Decker is a well-published expert on vaccines, preventive medicine, and public health policy. In 2016, Dr. Decker retired from Sanofi Pasteur after more than 15 years, where he was Vice President and Global Medical Expert from 2013-2016 and Vice President, Scientific and Medical Affairs, and Chief Medical Officer, Sanofi Pasteur U.S., from 2000-2012. From 1984-2000, Dr. Decker was a Professor of Preventive Medicine and Medicine (Infectious Diseases) at Vanderbilt University School of Medicine. He has also previously served as a Medical Officer in the U.S. Public Health Service at the Centers for Disease Control and Prevention (CDC), as Editor-in-Chief of the journal Infection Control and Hospital Epidemiology from 1993 to 2001, and as Co-Editor of the International Journal of Health Governance from 2016 to 2020.

Denis R. Burger, Ph.D.

Current Vice Chairman and Chief Science Officer of CytoDyn Inc., and lead independent director of Aptose Bioscience Inc., Dr. Burger co-founded Trinity Biotech plc, and is currently its lead independent director. Previously, Dr. Burger was the Chairman and Chief Executive Officer of AVI Biopharma Inc. (now Sarepta Therapeutics), and co-founder of Epitope Inc. (now Orasure Technologies), as well as a professor in the Department of Microbiology and Immunology and Surgery (Surgical Oncology) at the Oregon Health and Sciences University in Portland.

Michael Lim, M.D.

Dr. Michael Lim is a Professor of Neurosurgery, Oncology, Otolaryngology, and Radiation Oncology at Johns Hopkins. Dr. Lim obtained his MD from the Johns Hopkins University School of Medicine. He then completed his residency in Neurosurgery at Stanford University Hospital. Dr. Lim’s surgical interest is in both benign and malignant brain tumors, with a particular interest in gliomas (including ependymoma), meningioma, pituitary tumors and skull base tumors. He has extensive experience in new and innovative neurosurgical techniques including image guided surgery, microsurgery, minimally invasive procedures and endoscopic surgery. Dr. Lim is also the Director of the Brain Tumor Immunotherapy Program at Johns Hopkins. His primary research interest is developing immune-based therapies against brain tumors. His research laboratory is focused on understanding the mechanisms of immune evasion by primary brain tumors. Findings from Dr. Lim’s laboratory are directed towards translation to novel therapies against brain tumors. In addition to running a laboratory, he also directs the immunotherapy clinical trials program at Johns Hopkins. Dr. Lim currently serves as the principal investigator of several large brain tumor immunotherapy clinical trials based on findings from his laboratory.

Allen Waziri, M.D.

Dr. Waziri is currently CEO and Co-Founder of iCE Neurosystems, a privately held medical device company. He was previously Director of the Brain Tumor Program at the Inova Neuroscience Institute. Prior to taking the position at Inova he was Assistant Professor of Neurological Surgery and faculty in the Cancer Biology program at the University of Colorado. His research has focused on the study of mechanisms involved with the suppression of cellular immunity by myeloid-lineage cells in human glioblastoma, identified through the analysis of fresh human tissues. Dr. Waziri has served as Principal Investigator for a range of early- to late-phase clinical trials in primary and secondary glioblastoma, including several investigator-initiated first-in-human pilot studies encompassing serial immunomonitoring in patients to explore restitution of cellular immune function by targeting myeloid-derived immunosuppression.

Patrick Yung Wen, M.D.

Dr. Wen is Professor of Neurology at Harvard Medical School, Director of the Center For Neuro-Oncology at Dana-Farber Cancer Institute, Co-PI of the Adult Brain Tumor Consortium, Steering Committee Member of the Response Assessment in Neuro-Oncology (RANO) Working Group, and President of the Society of Neuro-Oncology. He was previously the Editor-In-Chief of Neuro-Oncology. His research is focused on novel treatments of brain tumors and optimizing clinical trial design, endpoints, and response assessment.

Robert Pass, M.D.

Dr. Robert Pass is a Professor of Pediatrics at the University of Alabama at Birmingham where he led clinical and epidemiological studies of maternal and congenital cytomegalovirus CMV infection for a number of years. Early in his research career Dr. Pass became convinced that the most important goal of CMV research should be prevention of congenital infection. He focused his research on understanding how CMV is spread, risk factors for CMV infection during pregnancy, and sources of maternal infection. In the 1990s, Dr. Pass conducted a number of industry supported clinical trials of a CMV glycoprotein B vaccine, which led to an investigator initiated, National Institutes of Health sponsored clinical trial of a CMV glycoprotein B vaccine. This work provided the first evidence of vaccine efficacy for prevention of maternal and congenital CMV infection.

Stanley Plotkin, M.D.

Dr. Stanley A. Plotkin is Emeritus Professor of the University of Pennsylvania, and Adjunct Professor of the Johns Hopkins University. Until 1991, he was Professor of Pediatrics and Microbiology at the University of Pennsylvania, Professor of Virology at the Wistar Institute, and at the same time, Director of Infectious Diseases and Senior Physician at the Children’s Hospital of Philadelphia. In 1991, Dr. Plotkin left the University to join the vaccine manufacturer, Pasteur-Mérieux-Connaught, where for seven years he was Medical and Scientific Director, based at Marnes-la-Coquette, now known as Sanofi Pasteur.

Dr. Plotkin has developed several pediatric vaccines including the rubella vaccine now in standard use throughout the world and a recently licensed pentavalent rotavirus vaccine. He has also been involved in other vaccine development programs including anthrax, oral polio, rabies, varicella, and cytomegalovirus.

Dr. Plotkin’s bibliography includes nearly 700 articles and he has edited several books including the standard textbook on vaccines, now in its 5th edition. He is a consultant to vaccine manufacturers, biotechnology companies, and non-profit research organizations as principal of Vaxconsult, LLC.

Dr. Plotkin attended New York University, where he received a B.A. degree, and then the State University of New York Medical School in Brooklyn, where he received an M.D. degree in 1956.

Nadia G. Tornieporth, M.D.

Dr. Tornieporth is a physician with extensive leadership experience and technical expertise in the clinical development of vaccines. She is Professor of Clinical Research and Pharmacovigilance at the University of Applied Sciences and Arts in Hannover, Germany. Previously, Dr. Tornieporth served as Vice President and Head of Global Clinical Research and Development at Sanofi Pasteur where she oversaw all aspects of clinical development from First-in-Man to successful registration. Prior to her time at Sanofi, she was Vice President of Clinical Development, Prophylactic Vaccines at GlaxoSmithKline Biologicals. Over the course of her career, Dr. Tornieporth contributed to the successful licensure of more than 20 vaccines. She has served as an advisor to the World Health Organization, USAID, the Wellcome Trust, and the European Forum for Good Clinical Practice, among others. She contributes to several vaccine development programs as member of Independent Data Monitoring Committees and Scientific Advisory Boards, and currently serves as acting Head, Clinical Development, for the Coalition of Epidemic Preparedness Innovations (CEPI). Earlier in her career, Dr. Tornieporth held international research and teaching positions at Weill Cornell Medical College and Ludwig-Maximilian University. Dr. Tornieporth received her M.D. from Ludwig-Maximilian University in Munich, Germany and her Diploma in Tropical Medicine and Hygiene from the London School of Hygiene and Tropical Medicine. She holds clinical patents for the RTS,S malaria and dengue vaccines and has co-authored more than 60 peer-reviewed publications in infectious diseases and vaccine development.

Vaughn Himes, Ph.D.

Director

Dr. Himes brings over three decades of industry experience to VBI’s Board, including nearly 15 years at Seagen, where he is currently the Chief Technology Officer and leads the manufacturing, supply chain, process sciences, and quality functions. During his tenure at Seagen, Dr. Himes has helped lead the transition from a research and development-stage company through the successful commercial launch of its first four commercially marketed products, and has played key roles in Seagen’s M&A activity leading to the recent announcement of Pfizer’s intent to acquire the company. Prior to joining Seagen in 2009, Dr. Himes spent 20 years in leadership roles overseeing CMC, manufacturing, supply chain and logistics, quality control, process development, and product development operations at ZymoGenetics Corporation (acquired by Bristol Myers Squibb), Corixa Corporation (acquired by GlaxoSmithKline), Targeted Genetics Corporation, Genovo Inc., and Wyeth-Lederle Vaccines (later acquired by Pfizer). Dr. Himes holds a Ph.D. in Chemical Engineering from the University of Minnesota, and a B.A in Chemistry from Pomona College. He also serves as a director on the Board for Achieve Life Sciences, Inc.

Christopher McNulty

Chief Financial Officer and Head of Business Development

Mr. McNulty joined VBI in 2018 after two decades of financial and business development experience across the pharmaceutical, biotechnology, and medical device industries. Prior to joining VBI, he served as Chief Financial Officer and Senior Vice President, Business Development and Investor Relations, of Invivo Therapeutics. He also served as the Senior Director of Business Development for Repligen Corporation, where he spearheaded the acquisition of Novozymes Biopharma Sweden in 2011. Other prior management positions include Director, Corporate Development at Seventh Sense Biosystems, and Associate Director, Business Development at Genzyme Corporation. Mr. McNulty holds B.S. and M.Eng. degrees from the Massachusetts Institute of Technology, as well as an M.B.A. from Harvard Business School.

Steven Gillis, Ph.D.

Chairman of the Board

Steven Gillis, Ph.D., has been a Managing Director of ARCH Venture Partners since 2006 and joined the firm in 2005. Dr. Gillis is focused on the evaluation of new life science technologies and also on the development and growth of ARCH’s biotechnology portfolio companies. He is a director of Takeda Pharmaceutical Co. Ltd. (TAK), Homology Medicines, Inc. (FIXX), and also serves as Chairman of Codiak Biosciences (CDAK). Dr. Gillis represents ARCH as a managing director and serves as Chairman of a number of ARCH’s private, biotechnology portfolio companies.

Dr. Gillis was a founder and director of Corixa Corporation and served as CEO from its inception and as its Chairman from 1999 until its acquisition in 2005 by GlaxoSmithKline. Prior to Corixa, Dr. Gillis was a founder and director of Immunex Corp. From 1981 until his departure in 1994, Dr. Gillis served as Immunex’s Director of Research and Development, Chief Scientific Officer, and as CEO of Immunex’s R&D subsidiary. Dr. Gillis was interim CEO of Immunex Corp. following its majority purchase by American Cyanamid Company and remained a member of the board until 1997. Amgen, Inc. acquired Immunex in 2002.

Dr. Gillis is an immunologist by training with over 300 peer-reviewed publications in the areas of molecular and tumor immunology. He is credited as being a pioneer in the field of cytokines and cytokine receptors, directing the development of multiple marketed products including Leukine, (GM-CSF), Prokine (IL-2) and Enbrel (soluble TNF receptor-Fc fusion protein) as well as the regulatory approval of Bexxar (radiolabeled anti-CD20). Dr. Gillis received a B.A. from Williams College and a Ph.D. from Dartmouth College.

David E. Anderson, Ph.D.

Chief Scientific Officer

A dynamic and well-published immunologist with broad expertise in the areas of vaccine development, autoimmunity and tumor immunology, Dr. Anderson joined VBI full time in 2009 from Harvard Medical School, where he held a position as Assistant Professor. As a co-founder and Chief Scientific Officer of VBI, Dr. Anderson is an inventor of much of the Company’s intellectual property and actively manages its ongoing expansion. Dr. Anderson holds a Ph.D. from Harvard University and a B.S. from the University of California at Davis.

Nell Beattie

Chief Financial Officer and Head of Corporate Development

Ms. Beattie joined VBI in 2015 after completing her M.B.A at the Tuck School of Business at Dartmouth College. Prior to receiving her M.B.A., she was a consultant at Artisan Healthcare Consulting, where she worked with pharmaceutical and biotechnology companies to develop financial and strategic analyses, as well as provided guidance and support for corporate and business development efforts. Ms. Beattie also holds a B.A. from Dartmouth College.

Adam Buckley

Senior Vice President, Business Development

In 2001, Mr. Buckley helped establish VBI. His efforts included attracting seed capital to VBI, developing its first business plan, protecting intellectual property and structuring the company. He had an active role in the company’s Series A financing, raising $35.7 million (U.S.), and has led several key technology acquisitions for the company. Mr. Buckley obtained his M.B.A. and Bachelor of Science in Biology and Psychology at McMaster University in Canada. Prior to joining VBI, he built experience in project management and corporate development at Riverview Hospital in Coquitlam, British Columbia, and at the Children’s Hospital of Eastern Ontario in Ottawa, Ontario.

Francisco Diaz-Mitoma, M.D., Ph.D.

Chief Medical Officer

Dr. Diaz-Mitoma is a renowned medical scientist and professor who most recently served as a professor of the Northern Ontario School of Medicine (“NOSM”). While in this position, Dr. Diaz-Mitoma was Vice President of Research at Health Sciences North and founder of the Advanced Medical Research Institute of Canada (“AMRIC”) and served as its Chief Executive Officer and Chief Scientist. AMRIC is focused on translational medical and vaccine development research. Prior to joining the faculty at the NOSM, Dr. Diaz-Mitoma was a professor of Pediatrics, Pathology, Laboratory Medicine, and Microbiology at the University of Ottawa. While in this position, he founded the Vaccine and Infectious Disease Centre at the Children’s Hospital of Eastern Ontario (“CHEO”), a pediatric health and research center. Dr. Diaz-Mitoma received his medical degree from the University of Guadalajara, completed fellowship training in Infectious Diseases at the University of Manitoba, and earned a Ph.D. in Virology from the University of Alberta.

John Dillman

Chief Commercial Officer

Mr. Dillman joined VBI in 2022 after two years as VBI’s Commercial Lead at Syneos Health, VBI’s partner for the U.S. commercialization of PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], and nearly two decades of commercial sales and marketing leadership experience at Sanofi Pasteur, the human vaccines business of the Sanofi Group. His most recent role was Vice President of Sales, where he was responsible for the direction and oversight of the sales force, marketing and sales training, and telesales organization, with full P&L responsibility delivering over $3 billion of sales annually. While at Sanofi Pasteur, Mr. Dillman was also responsible for all segment, consumer, and digital marketing activities, and spent three years as the General Manager of VaxServe, a Sanofi Pasteur company and a leading specialty distributor of vaccines. Mr. Dillman holds a Bachelor of Business Administration degree from Bridgewater State University, and an M.B.A. with a focus in marketing from West Virginia University.

Athena Kartsaklis

Senior Vice President, Finance

Ms. Kartsaklis is a U.S. Certified Public Accountant and Canadian Chartered Professional Accountant who joined VBI in 2017 with over 25 years of financial management experience, including financial reporting, budgeting and forecasting, auditing, and the management of internal controls. Prior to joining VBI, Ms. Kartsaklis held financial leadership roles at SkyWave Mobile Communications Inc. and Alterna Savings. From 2000 to 2012, Ms. Kartsaklis was a Partner at Deloitte, Hadjipavlou, Sofianos & Cambanis S.A., Athens, Greece (Member of Deloitte & Touche International), having worked there since 1992. Ms. Kartsaklis received a Bachelor of Commerce degree from Dalhousie University in Halifax, Nova Scotia.

Avi Mazaltov

Global Head of Manufacturing and SciVac General Manager

Mr. Mazaltov is an operations executive with broad experience across industries in defining, managing, and optimizing manufacturing and supply chain activities. Mr. Mazaltov joined VBI in 2017 from Omrix Biopharmaceuticals (a Johnson & Johnson company). At Omrix, Mr. Mazaltov was responsible for Biosurgery operations in Israel and was a member of the Biosurgery leadership team. Prior to joining Omrix, Mr. Mazaltov led the Operations and Infrastructures division of Alvarion Technologies. Prior to Alvarion, Mr. Mazaltov held various high-ranking operational roles at Teva Pharmaceuticals, including Director, Global Manufacturing and Plant Manager, Kfar Saba, where he managed a production facility with 1,000+ employees. Mr. Mazaltov holds a B.Sc. in Production Management from Ben Gurion University of the Negev, Israel.

Jeff Baxter

President and CEO

Mr. Baxter joined VBI in September of 2009. Previously, he was a managing partner for the venture capital firm, The Column Group. Until July of 2006, Mr. Baxter was SVP, R&D Finance and Operations, of GlaxoSmithKline (GSK). In his 19 years of pharma experience, he has held line management roles in commercial, manufacturing and IT and the office of the CEO. His most recent position in R&D included responsibility for finance, pipeline resource planning and allocation, business development deal structuring and SROne (GSK’s in-house $125m venture capital fund). He also chaired GSK’s R&D Operating Board. Prior to GSK, he worked at Unilever. Mr. Baxter was educated at Thames Valley University and is a Fellow of the Chartered Institute of Management Accountants (FCMA).

Misha Nossov

Senior Vice President, Global Commercial Supply Strategy & Head of Europe

Mr. Nossov joined VBI in 2010 after completing the Master in Biotechnology (MBiotech) program at the University of Toronto. Prior to his current role as Senior Vice President, Global Commercial Supply Strategy & Head of Europe, Mr. Nossov held operational roles of increasing responsibility, including as Head of the VBI Research and Development site in Ottawa, Canada, ensuring execution of the company’s research strategy. Mr. Nossov holds a B.Sc. Honours in Biochemistry from McGill University.

Damian Braga

Director

Damian Braga was Senior Vice President, Global Commercial Operations & President, U.S. and the Americas at Sanofi Pasteur, the human vaccines division of Sanofi, until his retirement in 2015. In these roles, he was responsible for leading the development and execution of the commercial strategy for all existing and late-stage products for Sanofi Pasteur’s Global Vaccine Business.

Mr. Braga brings three decades of vaccine experience from his tenure at Sanofi Pasteur, serving as Senior Vice President, Global Commercial Operations, from 2010 to 2015, as President, U.S. and the Americas, from 2008 to 2015, and as President, U.S., from 2002-2007. During this time, Mr. Braga was responsible for growing U.S. vaccine revenues from $766 million in 2001 to over $3.1 billion in 2015. He was also responsible for successfully launching both a high-dose and quadrivalent flu vaccine, generating over $1.5 billion in global flu vaccine annual revenue. Prior to assuming responsibility as the most senior company executive in the Americas, Mr. Braga held a number of other roles within Sanofi Pasteur, including Chief Financial Officer for the U.S. Business Unit.

Since retirement from Sanofi Pasteur in 2015, Mr. Braga founded DAB Consulting Services, a pharmaceutical commercialization consulting firm, and since 2017, he has served as an advisor for VaxCare, a company that provides vaccination solutions for physicians, healthcare systems, employers, and school systems.

Mr. Braga is also the Chairperson of VBI’s Commercial Advisory Board.

Joanne Cordeiro

Director

Ms. Cordeiro most recently served as Chief Human Resources Officer and Executive Vice President of Human Resources at Shire PLC, where she served as the strategic partner and advisor to the CEO, Executive Team, and Board of Directors on matters of organizational vision, human capital strategies, total rewards, ethics, and cultural topics with a focus on shareholder value. Ms. Cordeiro was also a member of the Shire Steering Committee responsible for leading the strategic direction and integration for mergers, acquisitions, and divestitures. Prior to joining Shire in 2011, she was Head of Human Resources for Covansys Corporation (a CSC Company), Clam/Availant, and Elliason Group, and served in various human resources management roles at Teradyne Inc., Avid Technology, Inc., and Sybase Inc. (an SAP company).

Ms. Cordeiro received her Bachelor of Science in Business Administration from Northeastern University.

Michel De Wilde, Ph.D.

Director

Michel De Wilde, Ph.D., was Senior Vice President, Research & Development, at Sanofi Pasteur, the human vaccines division of Sanofi from 2001 until June 2013. In this position, he was responsible for managing approximately 1,500 employees and a broad portfolio of approximately 20 development projects.

Prior to joining Sanofi Pasteur in January 2000, Dr. De Wilde was at SmithKline Beecham Biologicals (now GSK Vaccines) in Rixensart, Belgium. Dr. De Wilde joined the group in 1978 as a research scientist upon formation of a unit focusing on the application of recombinant DNA technology to vaccine development. He subsequently held positions of increasing responsibility and, as Vice President, Research & Development at Sanofi Pasteur, headed a team of approximately 400 specialists, active in all aspects of preclinical vaccine development.

Dr. De Wilde a member of a number of Scientific Advisory Boards, including COVAX Independent Product Group and other COVID related advisory bodies.

Dr. De Wilde received his degree in Chemistry from the Free University of Brussels in 1971, followed by a Ph.D. in Biochemistry in 1976. He carried out postdoctoral work at the University of Wisconsin, Madison (U.S.) and the University of Ghent (Belgium). Dr. De Wilde authored over 50 publications during the early part of his career.

Dr. De Wilde is also a Senior Scientific Advisor on all three of VBI’s Scientific and Clinical Advisory Boards.

Blaine McKee, Ph.D.

Director

Blaine McKee, Ph.D., is the President and Chief Executive Officer at Walden Biosciences, a biotechnology company focused on transforming the treatment of kidney disease.

Prior to joining TrisaQ in January 2020, Dr. McKee was Executive Vice President and Chief Business Officer of ImmunoGen, Inc. Dr. McKee also previously served as Head of Corporate Development at Shire PLC, where he led corporate strategy, M&A, due diligence, commercial assessment, and alliance management efforts. During his four-year tenure at Shire, Dr. McKee was responsible for executing multiple M&A, licensing, and divestment transactions, most recently the sale of Shire’s commercial oncology franchise to Servier S.A.S. for ~$2.4 billion. Dr. McKee’s most significant and recent roles prior to joining Shire include Executive Vice President and Chief Business Officer of 480 Biomedical, as well as a 15-year tenure at Genzyme Corporation, which culminated in the role of Senior Vice President of Strategic Development for the Oncology, Transplant, and Multiple Sclerosis divisions.

Dr. McKee previously served as Director for the New York Pharma Forum. He received a Bachelor of Science in Chemistry from Colorado State University, a Ph.D. in Organic Chemistry from the Massachusetts Institute of Technology (MIT), and an MBA in Finance from the MIT Sloan School of Management.

Jeff Baxter, FCMA

President, CEO, and Director

Mr. Baxter joined VBI in September of 2009 as Chief Executive Officer. Previously, he was a managing partner for the venture capital firm, The Column Group. Until July of 2006, Mr. Baxter was SVP, R&D Finance and Operations, of GlaxoSmithKline (GSK). In his 19 years of pharma experience, he has held line management roles in commercial, manufacturing and IT and the office of the CEO. His most recent position in R&D included responsibility for finance, pipeline resource planning and allocation, business development deal structuring and SROne (GSK’s in-house $125M venture capital fund). He also chaired GSK’s R&D Operating Board. Prior to GSK, he worked at Unilever and British American Tobacco. Mr. Baxter was educated at Thames Valley University and is a Fellow of the Chartered Institute of Management Accountants (FCMA).

Nell Beattie

Chief Financial Officer, Head of Corporate Development, and Director

Ms. Beattie joined VBI in 2015 after completing her M.B.A at the Tuck School of Business at Dartmouth College. Prior to receiving her M.B.A., she was a consultant at Artisan Healthcare Consulting, where she worked with pharmaceutical and biotechnology companies to develop financial and strategic analyses, as well as provided guidance and support for corporate and business development efforts. Ms. Beattie also holds a B.A. from Dartmouth College.

Eddy A. Bresnitz, M.D., M.S.C.E.

Dr. Bresnitz is an accomplished public health physician bringing over four decades of experience in academia, government public health, and the pharmaceutical industry, with a focus on the development of vaccines and implementation of vaccine policy. Dr. Bresnitz is currently serving as Medical Advisor to the New Jersey State Department of Health’s COVID-19 Response and was formerly the New Jersey State Epidemiologist with successive positions as Assistant, Senior Assistant, and Deputy Commissioner of Health for Public Health Services from 1999-2008. In 2020, Dr. Bresnitz retired from a 12-year career at Merck & Co., Inc., where he served as Medical Director, Global Medical Affairs and Policy, as well as Executive Director, Adult Vaccines, Global Vaccine Medical Affairs. As Executive Director, Dr. Bresnitz was responsible for the development and execution of medical affairs strategies for the adult vaccine portfolio that included pneumococcal, herpes zoster, and the hepatitis A and B vaccines, Vaqta and Recombivax HB, respectively. Prior to his service in the New Jersey State Government, Dr. Bresnitz was Chairman of the Department of Community and Preventive Medicine at Drexel University’s School of Medicine.