Edge Therapeutics, Inc.

Edge Therapeutics®, Inc. is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms in the management of acute, life-threatening neurological and other conditions. Our product candidates utilize Edge’s proprietary, programmable, biodegradable polymer-based development platform
(the Precisa™ development platform), and a novel delivery mechanism that seeks to enable targeted and sustained drug exposure and avoid the dose-limiting side effects associated with the current standard of care systemic delivery. Our initial product candidates target rare, acute, life-threatening neurological conditions for which we believe the approved existing therapies, if any, are inadequate.

We believe EG-1962, our lead product candidate, can fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, or aSAH, which is bleeding around the brain due to a ruptured brain aneurysm. A single dose of EG-1962 delivers a high concentration of nimodipine, the current standard of care, directly to the brain with sustained drug exposure over 21 days. EG-1962 is currently being investigated in the pivotal Phase 3 NEWTON 2 clinical study comparing the efficacy and safety of EG-1962 to oral nimodipine in adults who suffer an aSAH resulting from a ruptured brain aneurysm.

1

In addition to EG-1962, we are using our Precisa development platform to develop additional product candidates targeting other acute, serious conditions where limited or no current therapies exist.

 

Management Team

Brian Leuthner

President and CEO

Brian A. Leuthner has been the Co-Founder, President and CEO of Edge Therapeutics, Inc. since its inception and also serves on the company’s board of directors. He has more than 25 years of experience in the hospital acute care marketplace, with a specific expertise in critical care and neurocritical care.

Prior to founding Edge, Mr. Leuthner was the CEO of Fontus Pharmaceuticals, the Senior Head of Marketing for The Medicines Company and the Director of Market Development for ESP Pharma. He also held marketing and sales positions of significant responsibility at Burroughs Wellcome, GlaxoWellcome and Ortho Biotech. In these leadership roles, he helped create and advance hospital business units, develop and launch new critical care products and strengthen customer relationships.

Mr. Leuthner received his B.S. and M.B.A. degrees from the University of North Carolina at Chapel Hill.

R. Loch Macdonald, M.D., Ph.D.

Chief Scientific Officer

Dr. R. Loch Macdonald has been the Co-Founder and Chief Scientific Officer of Edge Therapeutics, Inc. since its inception in 2008 and also serves on the company’s board of directors. Dr. Macdonald is a scientist, researcher and neurosurgeon and a recognized expert on brain hemorrhage, including delayed cerebral ischemia (DCI). For the past 20 years, his research interest has focused on improving patient outcome after brain hemorrhage, with a specific focus on developing a cure for cerebral vasospasm and DCI.

Since 2007, he has served as Keenan Endowed Chair, Head, Division of Neurosurgery at St. Michael’s Hospital and Professor of Neurosurgery at the University of Toronto. Dr. Macdonald has published numerous articles and authored multiple textbooks, including one of the definitive textbooks on cerebral vasospasm used in medical schools throughout the world and the American Heart / American Stroke Association Guidelines on the management of intracerebral hemorrhage. His publications have been cited thousands of times and he has spoken at many international conferences on the topic of cerebral vasospasm and DCI. Prior to St. Michael’s Hospital, he was Professor of Surgery and Radiation & Cellular Oncology at the University of Chicago Medical Center.

Dr. Macdonald completed medical school at the University of British Columbia, Vancouver, British Columbia, Canada and completed his Ph.D. in Experimental Surgery at the University of Alberta, Edmonton, Alberta, Canada. He completed his Neurosurgery residency at the University of Toronto, Toronto, Ontario, Canada.

Daniel Brennan

Chief Operating Officer

Dan Brennan is the Chief Operating Officer of Edge Therapeutics, Inc.   He has nearly 20 years of experience in the pharmaceutical industry in various roles of progressive leadership in sales and marketing, led business development functions, new product development teams, and was trained in Lean Six Sigma.  Prior to his pharmaceutical experience, he worked in human resources management in a manufacturing setting and social work with inner city abused and neglected children.

Prior to joining Edge Therapeutics, Mr. Brennan served as Chief Operating Officer for Insys Therapeutics from 2015-2016.   From 2009 through 2015, he was the Vice President/Group General Manager of Lundbeck’s U.S. Neurology Business Unit and Business Development group.  During the time of his leadership, the Lundbeck U.S. Neurology group launched four specialty orphan products and achieved growth in annual sales from $60 million to $820 million.   While at Abbott Laboratories, Mr. Brennan served as Divisional Vice President/General Manager, Acute Care Hospital Business Unit responsible for more than 80 commercial personnel and over $240 million in hospital-based pharmaceutical sales. Mr. Brennan also served in various sales, marketing and new product development roles of increasing responsibility for Eli Lilly and Company from 1997 to 2007.

Mr. Brennan received a B.A. degree in Psychology from the University of Notre Dame and an MBA degree, with distinction, from the Kellogg Graduate School of Business at Northwestern University in Evanston, Illinois.  

Herbert J. Faleck, D.O.

Chief Medical Officer

Dr. Herbert J. Faleck has been the Chief Medical Officer of Edge Therapeutics, Inc. since 2013. He is a pediatric neurologist trained at the Cleveland Clinic and has more than 25 years of extensive and successful experience in clinical research and development in the pharmaceutical and biotechnology industries.
Prior to joining Edge, Dr. Faleck was with Celgene Corporation for over 9 years. At Celgene, he served in several roles including the Chief Medical Officer position at Celgene Cellular Therapeutics, where he led the clinical, medical, regulatory and organizational development for a key division of the company. He was also Celgene’s first Vice President of Clinical Research and Development building the Clinical R&D group and leading programs that resulted in the approvals of several of the company’s key drugs. Previously, he held positions of increasing responsibility at Novartis Pharmaceuticals.

Dr. Faleck received his medical degree from The University of Health Sciences College of Osteopathic Medicine in Kansas City, Missouri.

Bert Marchio

Chief Accounting and Administrative Officer, Interim Chief Financial Officer

Bert Marchio is the Chief Accounting and Administrative Officer, and Interim Chief Financial Officer, of Edge Therapeutics, Inc. Previously, he served as the Chief Financial Officer of the company. He brings 25 years of experience in the pharmaceutical industry and in senior financial leadership positions in both the public and private sectors.

Prior to joining Edge, Mr. Marchio was a Managing Operating Partner with Three Fields Capital, a multi-strategy healthcare focused investment firm and provided consulting services to Life Science companies through Rockabye Valley Consulting. Previously, Mr. Marchio served two private equity sponsored companies as the Executive Vice President, Chief Financial Officer of Informed Medical Communications and as the Vice President, Treasurer of MedPointe Pharmaceuticals. He began his career in Life Sciences as the Vice President, Treasurer of NYSE listed Alpharma Inc.

Mr. Marchio holds a B.A. in Economics from Muhlenberg College, an M.B.A. in Professional Accounting from Rutgers Graduate School of Business and a Post-M.B.A. Certificate in Taxation from Bernard Baruch College of the City University of New York.

Brad Middlekauff

Senior Vice President and General Counsel

Brad Middlekauff is the Senior Vice President, General Counsel and Secretary of Edge Therapeutics, Inc. Most recently, Mr. Middlekauff served as Executive in Residence at Princeton University.  Previously, Mr. Middlekauff was Chief Legal Officer, General Counsel and Secretary at Kolltan Pharmaceuticals, Inc., where he also ran the business development function and Senior Vice President, General Counsel and Secretary of Medarex, Inc.  Mr. Middlekauff was an associate with the law firm of Cooley Godward, where he advised life science companies on a broad range of business and legal matters.

Mr. Middlekauff has served as Chairman of the Biotechnology Industry Organization (BIO) General Counsels' Committee and Vice President of the Yale Law School Executive Committee and has spoken at numerous conferences on legal and business issues relating to biotechnology.

Mr. Middlekauff received a bachelor’s degree from Brown University and a law degree from Yale Law School.

Alpaslan Yaman, Ph.D.

Vice President, Operations and Manufacturing

Dr. Alpaslan Yaman has been the Vice President of Operations and Manufacturing of Edge Therapeutics, Inc. since 2013. He has more than 28 years of biotech, pharmaceutical and medical device industry experience in sterile and non-sterile formulation development, process development and scale-up, validation, technology transfer and technical services, with specific experience in sterile microparticle process design and scale-up.

Prior to joining Edge, Dr. Yaman has been an independent consultant and has worked as Principal Consultant & Co-founder of Quality by Design Auditing, Inc. Previously Dr. Yaman worked for Johnson & Johnson in Product Support/Technical Services and for Schering Plough as Director, Pharmaceutical Technology Transfer and Global Technical Services. He has also performed similar roles at Purdue Pharma, Novartis and Hoffmann-LaRoche.

Dr. Yaman holds a B.S. in Pharmacy and a B.A. in Biology and Chemistry from Drake University. He earned his Ph.D. in Pharmaceutics at the University of Missouri-Kansas City.

Alyssa J. S. Wyant

Senior Vice President, Regulatory Affairs

Alyssa Wyant has been our Senior Vice President, Regulatory Affairs, since February 2017. Ms. Wyant has nearly 20 years of global regulatory experience with a focus on the development, registration and successful launches of several innovative, biologic and small molecule orphan disease products. Most recently, Ms. Wyant served as Vice President, Global Regulatory Affairs at PTC Therapeutics. While at PTC, she was responsible for the strategic planning and execution of global regulatory activities relating to several orphan disease indications and acted as regulatory agency liaison for a number of drug approval filings with the European Medicines Agency (EMA), FDA and Health Canada, among other significant regulatory responsibilities. Prior to her tenure at PTC, Ms. Wyant served as Senior Director, International Regulatory Affairs at NPS Pharmaceuticals. Earlier in her career, she held multiple leadership positions in global regulatory affairs at Shire Human Genetic Therapies in the U.S. and Switzerland. She also held regulatory affairs positions at Vertex Pharmaceuticals and Genetics Institute / Wyeth-Ayerst Pharmaceuticals. Ms. Wyant holds a B.S. in cell and molecular biology from the University of Washington.

Board of Directors

Brian Leuthner

President and CEO

Brian A. Leuthner has been the Co-Founder, President and CEO of Edge Therapeutics, Inc. since its inception and also serves on the company’s board of directors. He has more than 25 years of experience in the hospital acute care marketplace, with a specific expertise in critical care and neurocritical care.

Prior to founding Edge, Mr. Leuthner was the CEO of Fontus Pharmaceuticals, the Senior Head of Marketing for The Medicines Company and the Director of Market Development for ESP Pharma. He also held marketing and sales positions of significant responsibility at Burroughs Wellcome, GlaxoWellcome and Ortho Biotech. In these leadership roles, he helped create and advance hospital business units, develop and launch new critical care products and strengthen customer relationships.

Mr. Leuthner received his B.S. and M.B.A. degrees from the University of North Carolina at Chapel Hill.

R. Loch Macdonald, M.D., Ph.D.

Chief Scientific Officer

Dr. R. Loch Macdonald has been the Co-Founder and Chief Scientific Officer of Edge Therapeutics, Inc. since its inception in 2008 and also serves on the company’s board of directors. Dr. Macdonald is a scientist, researcher and neurosurgeon and a recognized expert on brain hemorrhage, including delayed cerebral ischemia (DCI). For the past 20 years, his research interest has focused on improving patient outcome after brain hemorrhage, with a specific focus on developing a cure for cerebral vasospasm and DCI.

Since 2007, he has served as Keenan Endowed Chair, Head, Division of Neurosurgery at St. Michael’s Hospital and Professor of Neurosurgery at the University of Toronto. Dr. Macdonald has published numerous articles and authored multiple textbooks, including one of the definitive textbooks on cerebral vasospasm used in medical schools throughout the world and the American Heart / American Stroke Association Guidelines on the management of intracerebral hemorrhage. His publications have been cited thousands of times and he has spoken at many international conferences on the topic of cerebral vasospasm and DCI. Prior to St. Michael’s Hospital, he was Professor of Surgery and Radiation & Cellular Oncology at the University of Chicago Medical Center.

Dr. Macdonald completed medical school at the University of British Columbia, Vancouver, British Columbia, Canada and completed his Ph.D. in Experimental Surgery at the University of Alberta, Edmonton, Alberta, Canada. He completed his Neurosurgery residency at the University of Toronto, Toronto, Ontario, Canada.

Sol Barer, Ph.D.

Board Chairman, Chair of Compensation Committee

Dr. Sol Barer has served on the Edge Therapeutics, Inc. Board of Directors since September of 2011 and is the current Board Chairman and Chair of Compensation Committee. He is the Managing Partner of SJ Barer Consulting and was the founder of the group at Celanese that spun out to form Celgene Corporation. Dr. Barer has spent 18 years leading the company as President, COO and CEO, culminating with his tenure as Celgene’s Executive Chairman and Chairman before retiring in June of 2011. Under his leadership, Celgene became the third-largest independent biotechnology company in the world and a member of the S&P 500.

Dr. Barer has more than 30 years of experience with publicly traded biotechnology companies including product development, scientific and business strategy, manufacturing, marketing and the building of an international company. He currently serves as on the Board of a number of other biotechnology companies including Amicus Therapeutics, Inc. and Aegerion Pharmaceuticals, Inc. Dr. Barer is Chairman of the Board of Centrexion Inc., Cerecor, Inc., ContraFect Corp., InspireMD, Inc., Medgenics, Inc. and RestorGenex.

Dr. Barer holds a B.S. from Brooklyn College. He earned his Ph.D. in Organic and Physical Chemistry from Rutgers University.

Isaac Blech

Board Vice Chairman

Isaac Blech has served as the Vice Chairman of Edge Therapeutics, Inc. since January of 2013. His current roles include Founder and Vice Chairman of Cerecor, Inc., a private company developing new treatments for central nervous system disorders and Director of ContraFect Corporation, a private company developing therapies for infectious diseases. Since 2011, he has served as Vice Chairman of Premier Alliance Group, a public company working in the areas of financial regulations, clean energy and cyber security, Vice Chairman of The SpendSmart Payments Company, a mobile marketing and payments company and Director of Medgenics, Inc. a public company on the American Stock Exchange which has a new proprietary technology for providing protein therapies to patients with a wide range of illnesses. He is also Vice Chairman of Centrexion Corporation, a private company developing new modalities of pain control and Vice Chairman of RestorGenex Corporation, a public company developing products in the areas of dermatology and restorative medicine.
Over the past 33 years, Mr. Blech has founded some of the leading biotechnology companies including Celgene Corporation, ICOS Corporation, Pathogenesis Corporation, Nova Pharmaceutical Corporation and Genetic Systems Corporation. These companies are responsible for major advances in oncology, infectious disease and cystic fibrosis.
Mr. Blech holds a B.A. from Baruch College.

Kurt Conti

Mr. Conti has been a member of the Edge Therapeutics, Inc. Board of Directors since June of 2010. He brings more than 25 years of business experience and leadership to the company. He has skillfully grown successful businesses and startup ventures in new markets, working closely with the investment community, completing every project started. As a result, he was recently named by Ernst & Young as the 2012 Entrepreneur of the Year for Real Estate and Construction.

An entrepreneurial leader in the construction industry, Mr. Conti has been the CEO and President of the Conti Group since 1995.  Conti is a nationally recognized general contractor delivering program management, construction services, and engineering across the United States and internationally. In addition, Mr. Conti is an active corporate citizen and serves on executive boards and advisory committees such as the New York Building Congress, the Salvation Army, the Pingry School, and the Moles.

Mr. Conti is an honors graduate of Villanova University in Civil Engineering, where he received the 2012 College of Engineering’s Alumni Award for Outstanding leadership and of the distinguished Harvard University Business School Owner/President Management Program in 2000.

James J. Loughlin

Chair of Audit Committee

Mr. Loughlin has served on the Board of Directors at Edge Therapeutics Inc. since November of 2011 and is the current Chair of the Audit Committee. Since 2007, he has served as an independent director for Celgene Corporation, where he has chaired the Audit Committee. Mr. Loughlin has also been a member of Celgene’s Compensation Committee since 2008. He is a member of the Board of InspireMD, served as a member of the Board and lead director of Datascope Corporation and on the Board of Alfacell Corporation.

Mr. Loughlin retired after 40 years at KPMG LLP, one of the world’s leading professional accounting and business consulting firms. As a partner at KPMG, he served for five years as a member of the Board of Directors as well as National Director of the Pharmaceuticals Practice and as Chairman of the Pension and Investment Committee of the KPMG Board from 1995 through 2001.

Robert Spiegel, M.D., FACP

Robert J. Spiegel has served on Edge Therapeutics, Inc. Board of Directors since August of 2013. He has been an Associate Professor at Weill Cornell Medical College since 2012, is an Advisor at Warburg Pincus and serves as Chief Medical Officer of PTC Therapeutics, Inc. Prior to joining Edge, Dr. Spiegel spent more than 25 years at Schering-Plough where he was deeply involved in clinical development, culminating with his position as Chief Medical Officer and Senior Vice President of the Schering-Plough Research Institute.

At Schering-Plough, Dr. Spiegel was involved in the filing of over 30 New Drug Applications and interacted with regulatory authorities in the U.S. and globally, serving on the executive committees overseeing all research projects and drug licensing activities. After joining Schering-Plough in 1983, he held titles of increasing responsibility including Director of Clinical Research, Vice President of Clinical Research, and Senior Vice President of Worldwide Clinical Research until he became Chief Medical Officer in 1998. Dr. Spiegel retired from Schering- Plough in 2009. He has also served on the Board of Directors of a number of companies, including Geron Corporation since May 2010, and Cancer Care, Inc.

Dr. Spiegel holds a B.A. from Yale University and an M.D. from the University of Pennsylvania. Following a residency in internal medicine, he completed a fellowship in medical oncology at the National Cancer Institute and held academic positions at the National Cancer Institute and New York University Cancer Center.

Liam Ratcliffe

Liam Ratcliffe joined the Edge Board of Directors in 2016.  Liam is a Managing Director at New Leaf Venture Partners, and concentrates on biopharmaceutical investing. Liam joined New Leaf in September 2008. Liam was previously Senior Vice President and Development Head for Pfizer Neuroscience, as well as Worldwide Head of Clinical Research and Development. Additional positions during his 12 years at Pfizer included Vice President of Exploratory Development for the Mid West region (based in Ann Arbor, MI), and Head of Experimental Medicine at Pfizer’s Sandwich, UK Laboratories.

Liam received his M.D. degree and Ph.D. degree in immunology from the University of Cape Town and his M.B.A. degree from the University of Michigan. He completed his internal medicine training and fellowship in Immunology at Groote Schuur Hospital and associated teaching hospitals in Cape Town, South Africa.

Liam serves on several academic and industry advisory boards, as well as a director on the boards of the following companies: Afferent Pharmaceuticals, Aptinyx, Inc., Arvinas, Inc., Calchan Ltd., Deciphera Pharmaceuticals, Karus Therapeutics and Unum Therapeutics.

Dr. James Healy

Dr. James Healy joined Edge’s Board of Directors in 2015 and has over 20 years of experience in biomedical research, development and finance. Dr. Healy joined Sofinnova in 2000 as a General Partner, and specializes in funding private and publicly traded biopharmaceutical companies. He serves on the board of directors of a number of public and private biopharmaceutical companies.

He has financed and served on the board of 10 companies, which received drug approvals from either the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). He was an early investor and board member of 10 companies which subsequently completed initial public offerings and 10 companies that have been acquired as private or public companies.

In 2011, Dr. Healy won the IBF Risk Master Innovator Award and was named as one of the industry's top life science investors in 2013 by Forbes Magazine. He is a Director on the Board of the National Venture Capital Association and has been appointed to the Emerging Companies Section Governing Board of the Biotechnology Industry Organization. Prior to Sofinnova, he worked at Bayer (Miles), Sanderling, and consulted at ISTA Pharmaceuticals.

Dr. Healy graduated with a B.A. in Molecular Biology and a B.A. in Scandinavian Studies from the University of California at Berkeley where he graduated with Honors and received a Departmental Citation. Dr. Healy received his M.D. and Ph.D. in Immunology from Stanford University School of Medicine through the NIH Medical Scientist Training Program.

Clinical and Scientific Advisory Committees

Robert S. Langer, Ph.D.
Chair, Scientific Advisory Committee

Dr. Robert S. Langer has served as chair of Scientific Advisory Committee for Edge Therapeutics, Inc. since August 2012. He is a world-renowned scientist and entrepreneur with vast experience in the healthcare, biotechnology and pharmaceutical industries.

Since 2009, Dr. Langer has been a David H. Koch Institute Professor at the Massachusetts Institute of Technology (MIT). Prior to this position, he was an institute professor at MIT from 2005 to 2009. He has authored more than 1,200 journal articles and has had his patents licensed or sub-licensed to over 250 companies worldwide.  Dr. Langer is also one of seven individuals to have received both the 2006 United States National Medal of Science and the 2011 United States National Medal of Technology and Innovation. As a recipient of the Charles Stark Draper Prize. Dr. Langer is regarded as one of the pioneers in drug-delivery-related inventions. He was also named by Time magazine and CNN as one of the 100 most important people in America.

Dr. Langer received his Bachelors of Science degree from Cornell University and his Doctor of Science degree from the Massachusetts Institute of Technology, both in Chemical Engineering. In addition, he holds honorary degrees from 22 universities worldwide.

Daniel Hänggi, MD

Dr. Daniel Hänggi is the principal investigator of the NEWTON-2 study of EG-1962 at Edge Therapeutics, Inc. Professor Dr. Hänggi is the Chairman of Neurosurgery at the University Medical Center Mannheim, Ruprecht-Karls-University Heidelberg, Germany. Previously, he was the Vice Chairman of the Department of Neurosurgery at Heinrich Heine University in Düsseldorf, German. Prior to joining Edge Dr. Hänggi was the senior physician and head of Vascular Neurosurgery at the Neurosurgical Clinic at the University Hospital Düsseldorf as well the University Hospital in Basel, Switzerland. In 2011, the Josef Klüh Foundation presented him with the Promotion of Innovation in Science and Research Award.

Dr. Hängii received his doctorate in Human Medicine from the University of Basel.