Atossa Therapeutics and Quantum Leap Healthcare Announce New Study Arm to Evaluate (Z)-Endoxifen in the Ongoing I-SPY 2 Clinical Trial

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

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Atossa Therapeutics and Quantum Leap Healthcare Announce New Study Arm to Evaluate (Z)-Endoxifen in the Ongoing I-SPY 2 Clinical Trial

SEATTLE and SAN FRANCISCO, March 21, 2023 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology, and Quantum Leap Healthcare Collaborative™ today announce that Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, will be evaluated in a new study arm of the ongoing I-SPY 2 clinical trial. The I-SPY 2 TRIAL evaluates neoadjuvant treatments for locally advanced breast cancer and is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. Approximately 20 patients will be treated with (Z)-endoxifen for up to 24 weeks prior to surgery.

The new study arm evaluating (Z)-endoxifen is part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol (EOP), which targets patients with newly diagnosed estrogen receptor-positive (ER+) invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. These patients have substantial risk for recurrence, often after five years, and need novel agents that are more tolerable and effective than the current standard of care and address the risk of recurrence.

“Atossa is proud to partner with Quantum Leap Healthcare Collaborative and excited that (Z)-endoxifen has been added to their unprecedented I-SPY clinical trial, which is designed to quickly and efficiently bring new drug therapies to breast cancer patients who need them urgently,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Data from this trial will supplement data generated through our ongoing Phase 2 EVANGELINE trial, which is investigating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+ / HER2- breast cancer. There remains a critical need for more effective and tolerable treatment options for this patient population.”

“(Z)-endoxifen is one of the most active metabolites of tamoxifen. Tamoxifen is known to be effective in treating and preventing ER+ breast cancer, but may be most effective in those patients who can adequately metabolize it,” said Dr. Laura Esserman of the University of California San Francisco, founder and leader of the I-SPY TRIAL. “(Z)-endoxifen may overcome some of the shortcomings of tamoxifen, as it is already the active metabolite. Perhaps most exciting is that it may be effective in premenopausal women without the need for ovarian suppression. Ovarian suppression in premenopausal women and aromatase inhibitors in postmenopausal women are associated with both short-term and potential long-term side effects that diminish adherence. (Z)-endoxifen holds promise of being a more effective and tolerable alternative to targeting the estrogen receptor in women with early-stage breast cancer.”

Atossa is currently evaluating (Z)-endoxifen in two ongoing Phase 2 studies:

The EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) trial is a randomized non-inferiority study of (Z)-endoxifen compared to exemestane plus goserelin as a neoadjuvant treatment for premenopausal women with Grade 1 or 2 ER+ / HER2- breast cancer. Participants receive neoadjuvant treatment for up to six months, followed by surgery. The primary objective of the EVANGELINE study is to determine whether the endocrine sensitive disease (ESD) rate, measured by Ki-67 (a proliferation marker prognostic for disease free survival), after four weeks of treatment with (Z)-endoxifen is non-inferior to the ESD rate following treatment with current standard of care, exemestane plus goserelin. Exemestane is an aromatase inhibitor designed to block the synthesis of estrogen and slow the growth of ER+ cancers. Goserelin is a medication given to block the ovaries from making estrogen, which in premenopausal women is associated with significant morbidity and inadequate compliance, which compromises efficacy and increases the risk of mortality.

The Karisma-Endoxifen trial is a randomized, double-blind, placebo-controlled efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density. Participants receive daily doses of (Z)-endoxifen for six months, over the course of which mammograms are conducted to measure reduction in mammographic breast density (MBD). Participants also have a mammogram at 24 months to assess the durability of the MBD changes. MBD affects more than 10 million women in the United States and many millions more worldwide. Increased MBD reduces the ability of mammograms to detect cancer. 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.

Atossa will supply (Z)-endoxifen and provide financial support to Quantum Leap for this study. Quantum Leap, as sponsor, will provide the clinical sites and clinical expertise. Currently, there are 41 open sites, all of which have the EOP program open.

About Premenopausal Patients with ER+ / HER2- Breast Cancer
Breast cancer is the most frequently diagnosed cancer in premenopausal women worldwide and accounts for almost half of the cancers that occur in women aged 15-49. An overwhelming majority (75%) of premenopausal breast cancer falls under luminal A (ER+/HER2-) or B (ER+/HER2+) subtypes. Ovarian function suppression, when combined with either tamoxifen or an aromatase inhibitor, is the standard of care for the endocrine management of stage 2 and 3 premenopausal ER+/HER2- breast cancer. The I SPY Endocrine Optimization Pilot (EOP) specifically targets women of all ages with molecularly low risk stage 2 and 3 breast cancer.

About (Z)-Endoxifen
(Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies by others have demonstrated that the anti-estrogenic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its potent anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKCβ1, a known oncogenic protein.

Atossa has developed a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions converts a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. We are currently studying our (Z)-endoxifen in healthy women with measurable breast density and premenopausal women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by two issued U.S. patents and numerous pending patent applications.

About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing 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

About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate care and research, and to foster high-impact trials with embedded clinical processes and systems technology and improved data management, greater access to clinical trial matching, and greater benefit to patients, providers, and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit https://www.quantumleaphealth.org/

About the I-SPY TRIALs
The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The Endocrine Optimization Pilot (EOP) is developing better endpoints and new endocrine targeted agents for stage 2/3 molecularly low risk breast cancer. The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 30 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org.

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

Eric Van Zanten
VP, Investor and Public Relations
610-529-6219
eric.vanzanten@atossainc.com

Quantum Leap Healthcare Collaborative Media Contact:
Jacqueline Murray
Director, Marketing and Communications
(415) 839-8082
j.murray@quantumleaphealth.org

Forward Looking Statements
Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between interim and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies of (Z)-endoxifen, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, whether reduction in breast density or in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for (Z)-endoxifen, whether Atossa can complete acquisitions, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.


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Mar 21, 2023

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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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Delly Behen, PHR, SHRM-CP

VP, Administration & HR

Delly Behen, PHR, SHRM-CP has served as Atossa’s VP, 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.

Heather Rees

Vice President, Finance and Accounting

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).

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.

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).