Aastrom Biosciences, Inc.

Company Profile
Publication Date: 28 Sep 2010

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Aastrom Biosciences, Inc.

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Aastrom Biosciences, Inc.

TABLE OF CONTENTS

TABLE OF CONTENTS
Company Overview..............................................................................................4 Key Facts...............................................................................................................4 Business Description...........................................................................................5 History...................................................................................................................6 Key Employees.....................................................................................................8 Key Employee Biographies..................................................................................9 Major Products and Services............................................................................14 Top Competitors.................................................................................................15 Locations and Subsidiaries...............................................................................16

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Aastrom Biosciences, Inc.

Company Overview

COMPANY OVERVIEW
Aastrom Biosciences (Aastrom) is engaged in the development of autologous cell therapies for use in the treatment of chronic cardiovascular diseases. It is involved in the development of cell therapies to repair or regenerate damaged or diseased tissues. Aastrom has its cell therapies into late-stage clinical development, including a planned Phase 3 clinical program for the treatment of patients with critical limb ischemia and two ongoing Phase 2 clinical trials in patients with dilated cardiomyopathy. The company primarily operates in the US, where it is headquartered in Ann Arbor, Michigan, and employs around 45 people. The company recorded revenues of $89 thousand in the fiscal year ended June 2010, a decrease of 51.1% compared to 2009. The company's operating loss was $17,804 thousand in fiscal 2010, as compared to an operating loss of $16,169 thousand in 2009. Its net loss was $17,729 thousand in fiscal 2010, as compared to the net loss of $15,946 thousand in 2009.

KEY FACTS
Head Office Aastrom Biosciences, Inc. Domino's Farms Lobby K 24 Frank Lloyd Wright Drive Ann Arbor Michigan 48105 USA 1 734 930 5555 1 734 665 0485 http://www.aastrom.com

Phone Fax Web Address

Revenue / turnover 89.0 (USD '000) Financial Year End Employees NASDAQ Ticker June 45 ASTM

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Aastrom Biosciences, Inc.

Business Description

BUSINESS DESCRIPTION
Aastrom Biosciences (Aastrom) is engaged in developing expanded autologous cellular therapies for the treatment of cardiovascular diseases. The company's proprietary cell-processing technology enables the production of cellular therapies expanded from a patient's own bone marrow and delivered directly to damaged tissues. Aastrom has its cell therapies into late-stage clinical development, including a planned Phase 3 clinical program for the treatment of patients with critical limb ischemia (CLI) and two ongoing Phase 2 clinical trials in patients with dilated cardiomyopathy (DCM). Currently, Aastrom has two clinical programs, which include cardiac regeneration and vascular regeneration. In cardiac regeneration program, the company develops catheter-based Cardiac Repair Cell (CRC) treatment for patients with heart failure due to dilated cardiomyopathy (DCM). CRC is based on Tissue Repair Cell (TRC) technology, which is used to repair and regenerate damaged heart tissue in patients with DCM. The company is focused on cardiovascular regeneration through a Phase II clinical trial with DCM patients (the IMPACT-DCM trial) and a Phase IIb clinical trial with critical limb ischemia (CLI) patients (the RESTORE-CLI trial). In vascular regeneration program, Aastrom develops Vascular Repair Cells (VRCs) based on TRC technology used to repair and regenerate the ischemic tissues of the patients by improving the blood flow in the affected areas. The company is conducting trials to evaluate the safety and efficacy of VRCs based on TRC technology to treat patients with peripheral artery disease-induced critical limb ischemia, and reduce the incidence of major amputations in the treated limbs. Aastrom operates a wholly owned subsidiary, Aastrom Biosciences GmbH, in Germany, to provide access to additional funding and collaboration opportunities in new product areas, and also to support Aastrom's European product commercialization efforts. Aastrom also has two other wholly-owned subsidiaries Aastrom Biosciences in Ireland and Aastrom Biosciences SL in Spain.

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Aastrom Biosciences, Inc.

History

HISTORY
Aastrom Biosciences (Aastrom) was founded in 1991 and floated on the stock exchange in 1997. In 1999, Aastrom formed Zellera as a wholly owned subsidiary based in Berlin, Germany. The company received a boost from the Michigan Economic Development Corporation in 2001, through the award of a $2.2 million Michigan Life Sciences Corridor grant to fund development of new cell-based therapies. In addition, the company formed an agreement of development with Neoprobe, in 2001. The partnership was aimed to develop a new immune system cell therapy product to treat cancer by integrating Neoprobe's proprietary lymph node lymphocyte (LNL) cell technology with the AastromReplicell system and lymphocyte production technologies. In 2002, the company received a patent for producing therapeutic cells. Later in 2002, Aastrom's SC-I autologous bone marrow stem cells, produced using the AastromReplicell system, was granted orphan product status by the US Food and Drug Administration. The company gained FDA approval for its Investigational New Drug (IND) application for a multi-center phase I/II clinical trial for the company's bone generation tissue repair cell (TRC) product, in 2003. In 2004, Aastrom received a Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) National Cancer Institute to develop an immunotherapeutic treatment of malignant melanoma utilizing its AastromReplicell System cell production technology. Clinical trials utilizing Aastrom's proprietary TRCs to treat limb ischemia in diabetic patients were initiated in 2005 in Germany. Following this, Aastrom initiated a human clinical trial for the evaluation of the company's TRC product to form new bone tissue in the spine. In 2006, Aastrom signed an agreement with Orthovita to develop products for the orthopedics market using Orthovita's synthetic ceramic matrices and ceramic-collagen matrices (VITOSS) and Aastrom's proprietary TRCs. Also in the same year, the company's proprietary TRCs received an Orphan Drug Designation from the US Food and Drug Administration (FDA) for use in the treatment of osteonecrosis. The company received the US Food & Drug Administration (FDA) approval for the company's Investigational New Drug (IND) application to initiate a 120 patient Phase III clinical trial for the treatment of osteonecrosis (also known as avascular necrosis) of the femoral head in 2007.

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Aastrom Biosciences, Inc.

History

In 2008, Aastrom received encouraging results from the first two compassionate use patients treated with the company's autologous stem cell therapy for dilated cardiomyopathy (DCM), a type of severe chronic heart failure. The company treated the first patient in its randomized, controlled, prospective, open-label IMPACT-DCM clinical trial in 2008. In March 2009, Aastrom commended the expansion of federal support designed to advance stem cell research. Aastrom appointed Harold C Urschel to the Board of Directors in October 2009. In the following month, the company initiated second phase II clinical trial for treatment of severe chronic heart failure. The company appointed Sharon Watling as the Vice President of Clinical and Regulatory Affairs in May 2010. In the following month, the company appointed Scott C Durbin as the Chief Financial Officer.

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Aastrom Biosciences, Inc.

Key Employees

KEY EMPLOYEES
Name
Timothy M Mayleben Nelson M Sims Harold C Urschel Alan L Rubino Robert L Zerbe Scott C Durbin Sharon Watling Ronnda L Bartel Sheldon A Schaffer

Job Title
President and Chief Executive Officer Lead Director Director Director Director Chief Financial Officer, Company Secretary and Treasurer Vice President, Clinical and Regulatory Affairs Chief Scientific Officer Vice President, Corporate Development and Intellectual Property Controller

Board
Executive Board Non Executive Board Non Executive Board Non Executive Board Non Executive Board Senior Management Senior Management Senior Management Senior Management

Compensation
1231744 USD

277521 USD

Julie A Caudill

Senior Management

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Key Employee Biographies

KEY EMPLOYEE BIOGRAPHIES

Timothy M Mayleben
Board: Executive Board Job Title: President and Chief Executive Officer Since: 2009 Age: 50 Mr. Mayleben has been the President and Chief Executive Officer at Aastrom Biosciences (Aastrom) since December 2009. He has been a Director at the company since 2005. Mr. Mayleben joined the company in 2005. He was formerly an Advisor to life science and healthcare companies through his advisory and investment firm, ElMa Advisors. Prior to this, Mr. Mayleben served as the President and Chief Operating Officer and a Director at NightHawk Radiology Holdings. He was also formerly the Chief Operating Officer at Esperion Therapeutics, which later became a division of Pfizer Global Research and Development. Mr. Mayleben joined Esperion in 1998 as the Chief Financial Officer. Prior to joining Esperion, he held various senior and executive management positions at Transom Technologies, now part of Electronic Data Systems and Applied Intelligent Systems, which was acquired by Electro-Scientific Industries in 1997. Mr. Mayleben serves on the Advisory Board for the Wolverine Venture Fund and serves as a Director for several private life science companies. He holds a Masters of Business Administration from the J.L. Kellogg Graduate School of Management at Northwestern University, and a Bachelor of Business Administration degree from the University of Michigan Ross School of Business.

Nelson M Sims
Board: Non Executive Board Job Title: Lead Director Since: 2009 Age: 63 Mr. Sims has been the Lead Director at Aastrom since December 2009. He has been a Director at the company since 2006. Mr. Sims served as the Chairman at the company from 2007 to 2009. Recently, he served as the President and Chief Executive Officer at Novavax, an international health and life science company from 2003 to 2005. From 1973 to 2001, Mr. Sims served in various executive positions in sales, marketing, business development, and general management at Eli Lilly and Company, a pharmaceutical company. He also served as an Executive Director at Alliance Management, Vice President of Sales and Marketing at Hybritech (which was acquired by Eli Lilly) and President at Eli Lilly Canada. In addition to serving as a Board Member of companies where Mr. Sims also led the executive management team, he has other significant board experience serving both public and private companies, including MDS, ATS Automation Tooling Systems and Novavax. Mr. Sims received a Bachelor of Science degree in Pharmacy from Southwestern Oklahoma State

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Key Employee Biographies

University, and completed the Tuck Executive Program at the Amos Tuck School of Business at Dartmouth College.

Harold C Urschel
Board: Non Executive Board Job Title: Director Since: 2009 Age: 80 Mr. Urschel has been a Director at Aastrom since October 2009. He served as the Chair of Cardiovascular and Thoracic Surgical Research, Education and Clinical Excellence at Baylor University Medical Center since 2002. Mr. Urschel served as a Professor of Cardiovascular and Thoracic Surgery at the University of Texas Southwestern Medical School since 1985. He has been a Visiting Professor at a number of medical centers in the US and abroad. Mr. Urschel is an Honorary Member of the Thoracic Surgery faculty at the University of Toronto and the Harvard Medical School. He has been President of five major medical and surgical societies: the Society of Thoracic Surgeons, American College of Chest Physicians, International Academy of Chest Physicians, Southern Thoracic Surgical Association and Texas Surgical Society. Mr. Urschel has served as the Chief of Experimental Surgery for the US Navy, Consultant to the Atomic Energy Commission, NASA, and the Surgeon General of the US Air Force. He served on the Board of Directors at Electronic Data Systems till 1986, when it was acquired by General Motors. Mr. Urschel was a Founding Member of the U.S. Heart Surgeons. He received a Doctor of Law from Pikeville College and a Doctor of Science from Ohio State University. Mr. Urschel holds a Bachelor of Arts degree from Princeton University and an MD from Harvard Medical School. He trained in Cardiac Surgery at Massachusetts General Hospital.

Alan L Rubino
Board: Non Executive Board Job Title: Director Since: 2005 Age: 56 Mr. Rubino has been a Director at Aastrom since 2005. He has served as the Chief Executive Officer and President at Akrimax Pharmaceuticals, an integrated specialty pharmaceutical company, since 2008. Prior to this, Mr. Rubino served as the President and Chief Operating Officer at Pharmos Corporation, a biopharmaceutical company, from 2005 to 2007. He has continued to expand upon a highly successful and distinguished career that included Hoffmann-LaRoche, a research-focused healthcare company. During his Roche tenure, Mr. Rubino held a series of key executive positions in marketing, sales, business operations, supply chain and human resource management. He also held senior executive positions at PDI, a sales and marketing support company, and Cardinal Health, a company focused on improving the cost-effectiveness of health care, from 2001 to 2005. Additionally, Mr. Rubino serves on the Board of Rutgers University School of Business and the Lerner Center for Pharmaceutical Studies. He received Bachelor of Arts degree in Economics from Rutgers University

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Aastrom Biosciences, Inc.

Key Employee Biographies

with a minor in Biology and Chemistry and also completed Post graduate educational programs at the University of Lausanne and Harvard Business School.

Robert L Zerbe
Board: Non Executive Board Job Title: Director Since: 2006 Age: 59 Mr. Zerbe has been a Director at Aastrom since 2006. He serves as the Chief Executive Officer at QUATRx Pharmaceuticals Company, a venture-backed drug development company which Mr. Zerbe co-founded in 2000. Prior to his role at QUATRx, he held several senior executive management positions with major pharmaceutical companies including Eli Lilly from 1982 to 1993 and Pfizer (formerly Parke-Davis) from 1993 to 2000. Mr. Zerbes clinical research and development positions included Managing Director at Lilly Research Center UK, and Vice President of Clinical Investigation and Regulatory Affairs. He joined Parke Davis in 1993 and became Senior Vice President of Worldwide Clinical Research and Development. In this capacity Mr. Zerbe led the clinical development programs for a number of key products, including Lipitor and Neurontin. Currently, he has been serving on the Boards of Directors at two public companies, A.P. Pharma, a specialty pharmaceutical company, since 2002 and Optimer Pharmaceuticals, a biopharmaceutical company since 2009. Mr. Zerbe also serves on the board of directors of, Metabolex, a privately held company that discovers and develops novel therapeutics to treat diabetes. He received MD from the Indiana University School of Medicine, and has completed Post-doctoral work in Internal Medicine, Endocrinology and Neuroendocrinology at Indiana University and the National Institutes of Health.

Scott C Durbin
Board: Senior Management Job Title: Chief Financial Officer, Company Secretary and Treasurer Since: 2010 Age: 42 Mr. Durbin has been the Chief Financial Officer, Company Secretary and Treasurer at Aastrom since June 2010. He joined the company in June 2010 and has more than 15 years of healthcare-related banking, financial and corporate development experience. Formerly, he was the Chief Operating Officer and Chief Financial Officer at Prescient Medical, which develops diagnostic and therapeutic catheter-based medical devices for the treatment of severe coronary artery disease. Previously, Mr. Durbin served as a Finance and Corporate Development Consultant for Scios (a Johnson & Johnson subsidiary) and Alteon. Prior to that, he served as an Investment Banker with Lehman Brothers and M&A transactions for life science companies. Mr. Durbin earned an MPH in Health Management from the Yale University School of Medicine & School of Management and a BS from the University of Michigan.

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Key Employee Biographies

Sharon Watling
Board: Senior Management Job Title: Vice President, Clinical and Regulatory Affairs Since: 2010 Ms. Watling has been the Vice President of Clinical and Regulatory at Aastrom since May 2010. She joined the company in February 2010. Ms. Watling has over 12 years of experience in clinical development, with an emphasis on translational and early stage development, as well as development of clinical strategies. Her industry career started in late stage development within Warner-Lambert/Parke Davis and evolved while at Pfizer to include an early clinical leadership role in cardiovascular-metabolic diseases. Following Pfizer, she was Site Leader and Senior Director of Clinical Development at Metabasis. Most recently, Ms. Watling served as the Research and Development Strategy Leader at Cognigen Corporation. Prior to industry, she served as an Intensive Care Unit Clinical Specialist at various academic institutions. Ms. Watling received a Doctor of Pharmacy Degree from the University of Michigan College of Pharmacy.

Ronnda L Bartel
Board: Senior Management Job Title: Chief Scientific Officer Since: 2010 Ms. Bartel has been the Chief Scientific Officer at Aastrom since May 2010. She joined the company in 2006. Ms. Bartel has more than 20 years of research and product development experience. Recently, He served as an Executive Director of Biological Research at MicroIslet and Vice president of Scientific Development at StemCells. Earlier in her career, she was Senior Principal Scientist of Cell Biology at Advanced Tissue Sciences and was involved in the development and approval of two of the first three cell based products approved by the FDA. She has also worked as a Senior Director of Science and Technology at SRS Capital, evaluating life science investments. She has also held positions in clinical development, drug delivery, business development and manufacturing. Ms. Bartel holds a PhD in Biochemistry from the University of Kansas, completed Postdoctoral work at the University of Michigan and received a BA in Chemistry and Biology from Tabor College.

Sheldon A Schaffer
Board: Senior Management Job Title: Vice President, Corporate Development and Intellectual Property Since: 2006 Mr. Schaffer has been the Vice President of Corporate Development and Intellectual Property at Aastrom since 2006. He has more than 30 years of experience in pharmaceutical and medical diagnostics industries at both large corporations and entrepreneurial start-up companies. Most recently, Mr. Schaffer has provided business development consulting services to the pharmaceutical

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Key Employee Biographies

industry. Prior to this, he served as President and Chief Executive Officer at Inveresk Research. Mr. Schaffer served as Vice President, Pharmaceutical Development at DepoTech Corporation, and as the Vice President of Pharmaceutical Development and as the Vice President of Business Development at Cholestech Corporation. Previously, he served as a Director of Inflammation and Atherosclerosis Research at Ciba-Geigy Corporation, a pharmaceutical company, and held senior scientific positions at the Medical Research Division of American Cyanamid. Mr. Schaffer holds BS in Chemistry from the University of California, Berkeley and a PhD in Chemistry from the University of Illinois, and served as a Postdoctoral and Teaching Fellow at Harvard Medical School.

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Aastrom Biosciences, Inc.

Major Products and Services

MAJOR PRODUCTS AND SERVICES

Aastrom Biosciences (Aastrom) focuses on developing automated cell therapy systems. The company's key products and activities include the following: Products: Development of autologous cell products for use in regenerative medicine Activities: Clinical development programs: Cardiac regeneration Vascular regeneration

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Aastrom Biosciences, Inc.

Top Competitors

TOP COMPETITORS

The following companies are the major competitors of Aastrom Biosciences, Inc.

Baxter International Inc. Cytori Therapeutics Inc Johnson & Johnson

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Aastrom Biosciences, Inc.

Locations and Subsidiaries

LOCATIONS AND SUBSIDIARIES

Head Office
Aastrom Biosciences, Inc. Domino's Farms Lobby K 24 Frank Lloyd Wright Drive Ann Arbor Michigan 48105 USA P:1 734 930 5555 F:1 734 665 0485 http://www.aastrom.com

Other Locations and Subsidiaries

Aastrom Biosciences, GmbH. DEU Aastrom Biosciences, Ltd. IRL

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