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Atossa Therapeutics Issues Letter to Shareholders

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Atossa Therapeutics Issues Letter to Shareholders

SEATTLE, Jan. 25, 2023 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet need in cancer, today announces the issuance of the following Letter to Shareholders from Steven C. Quay, M.D., Ph.D., the Company’s CEO and Chairman:

TO OUR VALUED STOCKHOLDERS:

2022 was a year of significant progress for Atossa. We focused our development efforts on advancing our breast cancer program with our patented (Z)-endoxifen, the highest potency Selective Estrogen Receptor Modifier (SERM). We currently have Phase 2 studies ongoing in the prevention and treatment settings, both focused on areas of unmet medical need. Our goal is to both help reduce the incidence of breast cancer and change the treatment paradigm for patients who are not benefiting from currently approved drugs.

In October 2022, the U.S. Food and Drug Administration (FDA) authorized the initiation of our EVANGELINE study, a Phase 2 trial of (Z)-endoxifen and Exemestane + Goserelin as neoadjuvant treatment in premenopausal women with ER+/HER2- breast cancer. While there are several FDA-approved neoadjuvant therapies for ER- breast cancers, few exist for the ER+ patients, which account for approximately 78% of breast cancers. We expect to enroll approximately 175 patients at up to 25 sites across the United States.

The EVANGELINE study marks the first time our proprietary (Z)-endoxifen is being investigated in the United States and builds on the Phase 2 “window of opportunity” study we conducted in Australia. In that study we showed treatment with (Z)-endoxifen reduced Ki-67, a commonly used measure of cellular proliferation and growth in breast cancer tissue, from an average of 25.6% at screening to 6% on the day of surgery, a 65.1% reduction. This is clinically meaningful because numerous studies by other groups have shown a reduction in Ki-67 below 25% improves long term survival for ER+ breast cancer patients.

The EVANGELINE study will help us better understand what happens to tumors when patients are treated with (Z)-endoxifen. For example, is there a pathological response or tumor shrinkage? Even a partial response in the neoadjuvant setting could change the primary treatment approach and potentially save patients from undergoing a radical mastectomy or systemic therapies including chemotherapy, hormonal therapy, and/or targeted therapy.

We are also testing the hypothesis that treatment with (Z)-endoxifen could provide clinical benefit without the need for ovarian suppression. Current treatment approaches for premenopausal women diagnosed with ER+ breast cancer include using drug therapy or surgery to prevent the ovaries from making estrogen. ER+ tumors need estrogen to grow, so lowering hormone levels can restrict growth. However, patients also experience menopausal symptoms, and in some cases, treatment induces natural menopause, which can dramatically impact a patient’s quality of life. There is a critical need for new treatment approaches that provide clinical benefit without ovarian suppression.

We also continue to enroll patients in our Phase 2 study investigating (Z)-endoxifen in premenopausal women with elevated mammographic breast density (MBD). We announced last fall that the study was approximately 40% enrolled which, assuming enrollment continues at the current pace, means we should enroll all 240 study participants by the end of this year.

MBD is an emerging public health issue affecting more than 10 million women in the United States and many millions more worldwide. It’s well understood that increased MBD reduces the ability of mammograms to detect cancer, but studies have also shown that women with MBD have an increased risk of developing breast cancer and that the higher the MBD, the higher the incidence of breast cancer. Importantly, we also know that reducing MBD can lead to a reduction in the incidence of breast cancer.

Our MBD study, known as the Karisma-Endoxifen study, is a randomized, double-blind, placebo-controlled trial of healthy, pre-menopausal women with increased breast density. The treatment cohort receives daily doses of (Z)-endoxifen for six months, over the course of which mammograms will be conducted to measure reduction in MBD. Patients will also be given a mammogram at 24 months to assess the durability of the MBD changes. We believe (Z)-endoxifen may provide an option for women to proactively reduce the density of their breasts, which could improve mammography accuracy and patient care by unmasking cancerous tumors that are otherwise hidden by breast density.

Given the importance of (Z)-endoxifen to the future of Atossa, and the significant impact it could have on the prevention and treatment of breast cancer, it’s critical that we protect the intellectual property covering our proprietary formulation of the drug. Our position was further strengthened in March of last year when the U.S. Patent and Trademark office issued U.S. Patent No. 11,261,151 (the ‘151 Patent). Titled “Methods for Making and Using Endoxifen,” the ‘151 Patent is directed to compositions of storage-stable (Z)-endoxifen and methods of treating hormone-dependent breast disorders using the storage-stable (Z)-endoxifen. The ‘151 Patent is estimated to expire in 2038.

Another important development in 2022 was our investment in Dynamic Cell Therapies, Inc. (DCT), a privately held, venture capital backed developer of CAR-T therapies. DCT is in the pre-clinical phase of developing controllable CAR-T cells to address difficult-to-treat cancers. Its platform technology of dynamic control of engineered T-cells is designed to improve the safety, efficacy, and durability of CAR-T cell therapies. While their initial focus is hematologic malignancies, their innovative approach could also have broad applicability in solid tumors and autoimmune diseases. Our investment, which totaled $4.7 million and resulted in Atossa owning approximately 19% of the outstanding capital stock of DCT, closed in December 2022.

Last year we also made the decision to discontinue our COVID-19 programs due to the rapidly shifting treatment landscape and the introduction of effective vaccines, which greatly reduced hospitalizations. Aligned with our sharpened focus on oncology, we expect to revisit the development of AT-H201 as an inhalation therapy for cancer patients with compromised lung-function resulting from radiation treatment in the future. This indication may fill a compelling unmet medical need because radiation-induced lung injury, which can limit the overall success of lung cancer treatment, is often irreversible and poorly treated with current therapies.

As we look forward to 2023, we are well positioned to continue accelerating the development of (Z)-endoxifen. Both of our Phase 2 trials are ongoing, and we will provide enrollment and other updates as developments warrant throughout the year. We also have a strong balance sheet with no debt and cash, cash equivalents and restricted cash of approximately $117 million as of September 30, 2022.

On behalf of the board of directors, management, and employees of Atossa Therapeutics, we thank you for your investment and continued support of our Company.

Sincerely,

Steven C. Quay, M.D., Ph.D.
Chairman of the Board of Directors and Chief Executive Officer

About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology with a current focus on breast cancer and lung injury caused by cancer treatments.
For more information, please visit www.atossatherapeutics.com

Contact:
Atossa Therapeutics, Inc.
Kyle Guse, General Counsel and Chief Financial Officer
kyle.guse@atossainc.com


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Jan 25, 2023

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Tessa Cigler, M.D., M.P.H

Director

Dr. Cigler joined the Company as a director in March 2024. Dr. Cigler is a medical oncologist and clinical investigator at the Weill Cornell Breast Center in New York City. As a member of the Weill Cornell Breast Center research team, she heads several clinical trials designed to provide her patients with access to the newest and most promising options for therapy. 

Her collaborative research focuses on ways to gain a better understanding of breast cancer pathogenesis and side effects of therapy, with the overall goal of improving breast cancer treatment and prevention.

Dr. Cigler received her undergraduate degree from Harvard College, and her medical degree from Duke University School of Medicine. She also holds a master’s degree in public health from the Harvard School of Public Health. She completed her residency in Internal Medicine at New York Presbyterian Hospital Weill Cornell Medical Center, followed by a fellowship in Medical Oncology and Hematology at the Dana-Farber Harvard Cancer Center.

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Shu-Chih Chen, PHD

Director

Dr. Chen has served as founder and director since April 2009. She served as Chief Scientific Officer of the Company since it was incorporated in April 2009 through August 2014. She was an Associate Professor at National Yang Ming University, Taipei, Taiwan, and served as the principal investigator of an NIH RO1 grant studying tumor suppression by gap junction protein connexin 43 at the Department of Molecular Medicine at Northwest Hospital, Seattle, WA.

She has two issued U.S. patents and 20 pending U.S. patent applications related to cancer therapeutics. Dr. Chen received her Ph.D. degree in microbiology and public health from Michigan State University in 1992 and has published extensively on molecular oncology. She received her B.S. degree in medical technology from National Yang Ming University, Taipei, Taiwan in 1984. Dr. Chen was selected to serve on the Company’s Board of Directors because of her role as a founder of the Company and her qualifications in medical technology and as a professor and researcher in the field of cancer therapeutics.

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Dr. Makarand (Mak) Jawadekar

PHD

Dr. Mak Jawadekar is currently an independent Pharma Professional. He worked at Pfizer, Inc. based in Groton-New London Connecticut for 28 consecutive years. In 2010, he was a Director, Portfolio Management at Pfizer Inc. During his career at Pfizer, he was responsible for Drug Delivery Technology Assessment function involving external ‘Drug Delivery’ technologies. He has extensive experience in creating and cultivating external partnerships and alliances for Drug Delivery Technologies. He began his professional career at Pfizer Central Research in early 1982, after having completed his Ph.D. in Pharmaceutics, under Prof. Ed Rippie at the University of Minnesota.

His 28+ years of experience with Pfizer Global R&D specifically includes Solids R&D, Drug Product formulation/ Dosage Form/ Drug Delivery development, Clinical Trials Supply Manufacturing, Scale-up and Technology Transfer & Research Pharmacy functions. He helped create various Pharma R&D Partnerships, JVs, and Collaborations. He managed several functions/groups within R&D for many years. As a bench Scientist, he worked on many challenging commercial formulations which became multibillion-dollar products for many years for Pfizer Inc. These R & D formulations & Product
development programs included ZOLOFT, ZITHROMAX, VIAGRA faster onset, DIFLUCAN ODT and EXUBERA pulmonary delivery system. He also worked on many “Life Cycle Management “projects for Pfizer’s existing products.

Post Pfizer career, he worked with KKR, a Private Equity group in New York, for acquisition of Capsugel division from Pfizer which Pfizer divested later in 2011. Mak has presented at many professional meetings and has participated in various Panel Discussions/Round Tables around the globe. During February 2018, he worked with Mr. Tonino Lamborghini, Chairman, Tonino Lamborghini S.p.A. from Italy in creating Strategic Collaborations in India, working through India’s Prime Minister Narendra Modi and the Chief Minister, D. Phadanavis.

Currently, he serves on various company Strategic & Scientific Advisory Boards around the globe. Some of the list includes:

  • Actinium Pharma, New York city
  • Applied DNA Technologies, Stony Brook, NY
  • Applied Materials Inc., Santa Clara, California
  • Tonino Lamborghini SpA, Italy.
  • NMBT, Albert Einstein College of Medicine, New York
  • Sonnet Bio Therapeutics Inc., Cranbury, NJ
  • Saama Technologies Inc., Campbell, California

Serving on the Board of Directors: (Public Companies)

  • Preveceutical Medical Inc., Vancouver, Canada
  • Cardax Pharma, Honolulu, Hawaii
  • Nanoviricides Inc. Shelton, Connecticut

Member of the Board of Directors at a NY based, Non-Profit organization,

  • Abilities Inc.
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Dr. Per Hall

MD, PHD

Dr. Hall is widely regarded as a leading researcher in the field of breast cancer and prevention. He is the Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. Dr. Hall is leading the unique KARMA (Karolinska Mammography Project for Risk Prediction of Breast Cancer) Cohort, including over 70,000 women, which is regarded as the best characterized breast cancer cohort in the world and serves as a resource for studies about breast cancer risk assessment and prevention, and the Karisma Intervention Study, which is studying the change in MBD in women taking various doses of oral tamoxifen.

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Dr. Carl Novina

MD, PHD

Dr. Novina is one of the leading researchers in the field of RNAi therapeutics. He is an Associate Professor of Medicine at the Dana-Farber Cancer Institute and Harvard Medical School and an Associate Member of the Broad Institute of Harvard and MIT. He is currently the Principal Investigator of the Novina Lab at the Dana-Farber Cancer Institute. His laboratory has made several important discoveries into the biology of noncoding RNAs, their dysregulation in cancers, and their development as biomedical tools.

Dr. Novina received his M.D. from Columbia University, College of Physicians and Surgeons in 2000 and his Ph.D. from Tufts University, Sackler School of Graduate Biomedical Sciences in 1998. His graduate work has resulted in 10 publications examining transcriptional regulation of TATA-less promoters. In 2014 he received the coveted National Institutes of Health Pioneer Award, which funds bold and innovative research proposals to attack challenging biomedical problems. Dr. Novina has established many collaborations between industry partners and physicians to facilitate his goal of bringing biomedical innovations from bench to bedside.

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Richard I. Steinhart

Director

Mr. Steinhart has served as a director of the Company since March 2014. Mr. Steinhart is currently the Vice President and Chief Financial Officer of BioXcel Therapeutics, Inc. From October 2015 to June 2017 he was Vice President and Chief Financial Officer of Remedy Pharmaceuticals, Inc. a privately held pharmaceuticals company. From January 2014 until he joined Remedy Pharmaceuticals, Mr. Steinhart acted as an independent financial consultant to the Biotechnology and Medical Device Industries.

From April 2006 to December 2013, Mr. Steinhart was an executive at MELA Sciences, Inc., most recently serving as its Senior Vice President, Chief Financial Officer, Treasurer and Secretary. From 1992 to 2006, Mr. Steinhart was Managing Director at Forest St. Capital/SAE Ventures. Earlier, he served as Vice President and Chief Financial Officer at Emisphere Technologies from 1991 to 1992 and as General Partner and Chief Financial Officer of CW Group Inc. Mr. Steinhart is a Member of the Board of Directors of Actinium Pharmaceuticals where he is Chairman of the Audit Committee and a member of the Compensation Committee. From 2004 to 2012, Mr. Steinhart was a Member of the Board of Directors of Manhattan Pharmaceuticals and was Chairman of the Audit Committee. Mr. Steinhart received his B.B.A. and M.B.A. degrees from Pace University. Mr. Steinhart has been selected to serve on the Company’s Board of Directors because of his qualifications as a business executive and audit committee financial expert, and his prior experience as a Chief Financial Officer, director and committee member of public companies.

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Gregory L. Weaver

Chief Financial Officer

Mr. Weaver has served as a director of Atossa Therapeutics since October 2013 and the Company’s Chief Financial Officer since 2023. Prior to joining Atossa as CFO, Mr. Weaver spent over 30 years in the life sciences industry in a variety of financial and operations leadership roles, having led corporate finance for several innovative biotech’s through IPO and accelerated growth stages. Most recently, he served as CFO of privately held BioIntelliSense, a commercial stage med-tech company focused on remote patient monitoring.. Mr. Weaver has also served as a board director for six life science companies since 2005 in the US and Europe. He began his career as a Certified Public Accountant with Arthur Andersen.

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H. Lawrence Remmel, ESQ.

Director

Mr. Remmel has served as a director of the Company since February 2012. He is currently a partner of the law firm Pryor Cashman LLP, located in New York City, where he chairs the Banking and Finance practice group. Mr. Remmel joined Pryor Cashman in 1988. His practice includes corporate and banking financings, issues relating to the Investment Company Act of 1940, and intellectual property and licensing issues, in particular in the biotechnology and biocosmeceutical areas.

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Stephen J. Galli, MD

Director

Dr. Galli has served as a director of the Company since July 2011. Dr. Galli has been a Professor of Pathology and of Microbiology & Immunology and the Mary Hewitt Loveless, M.D., Professor, Stanford University School of Medicine, Stanford, California since February 1999. He served as Chair of the Department of Pathology at Stanford University School of Medicine from 1999 to 2016. Before joining Stanford, he was on the faculty of Harvard Medical School. He holds 14 U.S. patents and has over 400 publications.

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Steven C. Quay, MD, PHD

Chairman of the Board and Chief Executive Officer

Dr. Quay has served as Chief Executive Officer, President and Chairman of the Board of Directors of the Company since the Company was incorporated in April 2009. Dr. Quay is certified in Anatomic Pathology with the American Board of Pathology, completed both an internship and residency in anatomic pathology at Massachusetts General Hospital, a Harvard Medical School teaching hospital, and is a former faculty member of the Department of Pathology, Stanford University School of Medicine.

Dr. Quay is a named inventor on 87 U.S. patents, 130 pending U.S. patent applications, and is named inventor on patents covering five pharmaceutical products that have been approved by the U.S. Food and Drug Administration. Dr. Quay received an M.D. in 1977 and a Ph.D. in 1975 from the University of Michigan. He received his B.A. degree in biology, chemistry and mathematics from Western Michigan University in 1971. He was selected to serve on the Company’s Board of Directors because of his role as a founder of the Company, as well as his qualifications as a physician and the principal researcher overseeing the clinical and regulatory development of the Company’s pharmaceutical programs.

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Arezoo Mirad, MD

Senior Medical Director, Clinical Development

Dr. Mirad brings extensive experience in oncology, clinical trials, and medical research to the company, after recently serving as Medical Director at Corcept Therapeutics. She has previously held industry roles focused on the development of clinical stage assets at Alkermes and Silicon DynamiX. She has experience in leading global site selection activities and the development of clinical trial designs for gynecologic and aerodigestive tract tumors, as well as the development of a peptide-based mRNA
vaccine for COVID-19.

Dr. Mirad’s previous experience also includes serving as Chief Research Analyst at University of Colorado where she developed clinical oncology tools in addition to conducting work in Medical Affairs. Dr. Mirad received her M.D. from The University of Colorado Anschutz Medical Campus and a M.S. in Mathematics from The University of North Carolina at Charlotte.

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Kyle Guse, ESQ, CPA

Chief Financial Officer, General Counsel and Secretary

Mr. Guse has served as Chief Financial Officer, General Counsel and Secretary since January 2013. His experience includes more than 20 years of counseling life sciences and other rapid growth companies through all aspects of finance, corporate governance, securities laws and commercialization.

Mr. Guse has practiced law at several of the largest international law firms, including from January 2012 through January 2013 as a partner at Baker Botts LLP and, prior to that, from October 2007 to January 2012, as a partner at McDermott Will & Emery LLP. Before working at McDermott Will & Emery, Mr. Guse previously served as a partner at Heller Ehrman LLP. Mr. Guse began his career as an accountant at Deloitte & Touche and he is a licensed Certified Public Accountant in the state of California. Mr. Guse earned a B.S. in Business Administration and an M.B.A. from California State University, Sacramento, and a J.D. from Santa Clara University School of Law.

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B. Heather Fraser, PHD

VP Clinical, Regulatory & CMC

Dr. Fraser brings over 20 years of extensive industry experience in the biotech industry to the Company, recently serving in a leadership role as VP Clinical Operations & Program Management at Cerecor, Inc. She held positions with increasing levels of responsibility at Anthera Pharmaceuticals and CV Therapeutics (acquired by Gilead Sciences) where the roles included preclinical and clinical sciences and regulatory affairs.

Dr. Fraser has experience in drug development across diverse therapeutic areas including psychiatry, central nervous system disorders, cardiovascular disorders, and rare diseases; and she has been involved in all stages of drug development from pre-clinical through Phase 4. Dr. Fraser received her BS in Zoology from the University of British Columbia, her MS in Pharmaceutical Sciences from the University of Montana and her PhD in Pharmacology from the University of Alberta. She also completed a post-doctoral fellowship at Johns Hopkins University School of Medicine.

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Delly Behen, PHR, SHRM-CP

SVP, Administration & HR

Delly Behen, PHR, SHRM-CP has served as Atossa’s SVP, Administration & Human Resources since July 2014. Delly brings over 20 years of human resources, administrative, and operational experience to the company. Her experience includes leading people, culture and administration at various biotech companies throughout the Puget Sound. Most recently, she served as Impel NeuroPharma’s HR Consultant, where she helped grow the company and implement HR policies and procedures. She also held positions with increasing responsibilities at CTI Biopharma. Delly received her B.A. degree from the University of Washington and her HR certification from Seattle Pacific University.

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Heather Rees

SVP, Finance & Principal Accounting Officer

Ms. Rees brings more than 25 years of experience in finance and accounting leadership roles within publicly traded, IPO startups and global organizations. Prior to her current role, Ms. Rees served as Atossa’s VP, Finance & Accounting from early 2021. She joined Atossa in 2017 as the Corporate Controller. She previously spent ten years working as an independent financial consultant serving public and private companies including, Avalara, Getty Images, Fisher Communications, and Flow International. Heather began her career with Deloitte & Touche and worked nine years in the audit practice. Ms. Rees earned a Bachelor of Business Administration in accounting from Gonzaga University. She is a CPA in the state of Washington (inactive).

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Eric Van Zanten

VP, Investor & Public Relations

Mr. Van Zanten brings over 25 years of corporate communications experience working within the biopharmaceutical, finance and healthcare industries. He will oversee corporate, executive and digital communications, investor relations, thought leadership, and branding for the Company. Prior to joining Atossa, Mr. Van Zanten led corporate affairs at Faron Pharmaceuticals, a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers via precision macrophage immunotherapy and Urogen Pharma, a commercial stage biotech delivering innovative solutions that treat specialty cancers. 

He was also formerly Head of Commercial and Medical Communications and Director of Oncology Communications at Bristol-Myers Squibb where he helped launch Opdivo, one of the most successful oncology brands ever. Earlier in his career he held communications leadership roles at Deloitte, Booz Allen & Hamilton, Children’s Hospital of Philadelphia and Unisys Corporation. Mr. Van Zanten is a graduate of Franklin and Marshall College, where he received his BA in Political Science and Government.

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Gregory L. Weaver

Chief Financial Officer

Mr. Weaver has more than 30 years of life sciences, financial and operations experience leading corporate finance for several innovative biotechs through IPO and accelerated growth stages. Most recently, he served as CFO of privately held BioIntelliSense, a commercial-stage med-tech company focused on remote patient monitoring.

Earlier in his career, Mr. Weaver served as CFO of rare disease focused Eloxx Pharmaceuticals where he led the reverse merger and Nasdaq IPO including raising $110 million. He also led the atai Life Sciences international corporate finance team and their 2021 Nasdaq IPO, raising over $500M, and managed their acquisition of multiple mental health therapeutics assets. He has been a core executive team member of three Nasdaq oncology businesses with multiple FDA approvals and commercial launches, pre-clinical and global clinical operations and has been responsible for M&A transactions totaling over $200 million. Mr. Weaver has also served as a board director for six life science companies since 2005 in the US and Europe. He began his career as a Certified Public Accountant with Arthur Andersen. Mr. Weaver earned a Master of Business Administration degree from Boston College, and an undergraduate degree in accounting from Trinity University.

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Jonathan F. Finn

cfa

Mr. Finn joined the Company as a director in November, 2023. He is currently Executive Vice President and Chief Investment Officer at Vantage Consulting Group.  In this role, he directs investment strategy, asset allocation, manager selection and portfolio construction. Mr. Finn, who is a Chartered Financial Analyst (CFA), joined Vantage Consulting Group in 1995.

Mr. Finn is also a Founding Partner of Scientia Ventures, a manager of venture capital funds that invest in companies targeting computational biology and chemistry, the digitization of medicine, digital therapies, and traditional drug development businesses at the cutting edge of the life sciences industry. He currently serves as director of Verigraft AB, a regenerative medicine venture, Rose Pharma LLC, a development stage specialty pain company and Solör Bioenergy Holdings AB, a bioenergy business.

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Dr. Paul Wabnitz

BSC (HONS), MD, PHD, MBA, FRACP

Dr. Wabnitz has extensive experience in clinical development with a unique combination of clinical medicine, pharmacology, toxicology, and industry drug development experience. He has acted as an investigator and Medical Monitor on over 50 first in human Phase I/II clinical trials over the last two years, including several Phase I/II first in human oncology studies, as well as previously being the Executive Medical Director of a leading Australian Phase I clinical unit. 

His scientific background includes a Ph.D. in Organic Chemistry, a Post Doc at Parke-Davis (Ann Arbor, MI), 6.5 years of drug development industry experience (Pfizer/Esperion), an M.B.A. from the Stephen Ross School of Business (University of Ann Arbor, MI), and a Drug Development certificate in Regulatory Affairs from Temple University (Philadelphia, PA). His clinical background includes a Doctor of Medicine (M.D.), and he is a qualified Specialist Physician and Clinical Pharmacologist (Fellow of the Royal Australasian College of Physician, Australia).