Atossa Therapeutics Announces Year-End 2022 Financial Results and Provides Corporate Update

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

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Atossa Therapeutics Announces Year-End 2022 Financial Results and Provides Corporate Update

SEATTLE, March 22, 2023 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in cancer, today announced financial results for the fiscal quarter and fiscal year ended December 31, 2022 and provided an update on recent company developments.

Key developments from Q4 2022 and year to date include:

Initiation and First Patient Dosed in Phase 2 EVANGELINE Study – EVANGELINE (Endoxifen Versus exemestANe GosEreLIn), is our Phase 2 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. Several FDA-approved neoadjuvant therapies exist for ER- breast cancers, but few exist for 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.

Continued Enrollment in Phase 2 Karisma-Endoxifen Study – The Karisma-Endoxifen study is our 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 mammographic breast density (MBD). Patients will also be given 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. We expect to fully enroll the study by the end of 2023.

Initiation of New Study Arm in the Ongoing Phase 2 I-SPY 2 Clinical Trial – (Z)-endoxifen is being 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.

Additional Intellectual Property Protection for (Z)-endoxifen – The United States Patent and Trademark Office granted a new patent (No. 11,572,334) directed to (Z)-endoxifen encapsulated in an enteric capsule. Enteric capsules have an acid resistant coating to prevent them from dissolving when they pass through the stomach. Enteric capsules are dissolved when they pass through an alkaline environment, which is usually when they reach the small intestine. Delivering oral (Z)-endoxifen via an enteric capsule prevents breakdown of the endoxifen in the stomach. This patent further reinforces Atossa’s broad Intellectual Property portfolio related to (Z)-endoxifen.

Investment in Dynamic Cell Therapies, Inc. (DCT) – DCT is a privately held, venture capital backed developer of CAR-T therapies 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. Our investment totaled $4.7 million and resulted in Atossa owning approximately 19% of the outstanding capital stock of DCT.

“Our focus remains on both helping reduce the incidence of breast cancer and changing the treatment paradigm for patients who are not benefiting from, or are unable to tolerate, currently approved therapies,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “With a strong balance sheet and three Phase 2 trials underway, we are well positioned to continue accelerating the development of (Z)-endoxifen, which we feel has the potential to address significant unmet needs across the continuum of breast cancer.”

YEAR ENDED DECEMBER 31, 2022, FINANCIAL RESULTS (IN THOUSANDS)

As of December 31, 2022, we had cash, cash equivalents and restricted cash of $111,000.

Results of Operations

Comparison of Years Ended December 31, 2022 and 2021

Revenue and Cost of Revenue:

For the years ended December 31, 2022 and 2021, we have no source of sustainable revenue and no associated cost of revenue.

Operating Expenses:

The following table provides a breakdown of major categories within Research and Development (R&D) and General and Administrative (G&A) expenses for the years ended December 31, 2022 and 2021, together with the dollar change in those categories:

2022 2021 Period-Period
Change
Research and Development
Clinical trials $ 10,225 $ 4,656 $ 5,569
Compensation 1,875 1,482 393
Stock-based compensation 2,393 1,591 802
Professional fees 1,242 454 788
Exclusivity agreements (700 ) 1,000 (1,700 )
Other 48 27 21
Research and Development Total $ 15,083 $ 9,210 $ 5,873
General and Administrative
Compensation $ 3,034 $ 2,371 $ 663
Stock-based compensation 4,395 3,676 719
Professional fees 1,625 2,317 (692 )
Legal 1,135 534 601
Insurance 1,640 1,576 64
Other 779 837 (58 )
General and Administrative Total $ 12,608 $ 11,311 $ 1,297

Total operating expenses were $27,691 for the year ended December 31, 2022, which was an increase of $7,170, or 35% from the year ended December 31, 2021. Operating expenses for 2022 consisted of R&D expenses of $15,083 and G&A expenses of $12,608. Operating expenses for 2021 consisted of R&D expenses of $9,210 and G&A expenses of $11,311. Factors contributing to the increased operating expenses in the year ended December 31, 2022 are explained below.

R&D Expenses: R&D expenses for the year ended December 31, 2022, were $15,083, an increase of $5,873 or 64% from total R&D expenses for the year ended December 31, 2021 of $9,210. Key changes were as follows:

  • The increase in R&D expense was attributed primarily to increased spending on clinical and non-clinical trials of $5,569 compared to the prior year period due to additional pre-clinical toxicology studies in our (Z)-endoxifen and AT-H201 programs as well as increased trial costs and manufacturing expenses for (Z)-endoxifen.
  • R&D compensation increased $393 in 2022 compared to the prior year period due to increased headcount, salary, bonuses and benefits during 2022.
  • Stock-based compensation, which is a non-cash charge, increased $802 due to the increased number of options being expensed as well as the weighted average fair value of options amortizing in 2022 was higher compared to the prior year period.
  • Professional fees increased $788 compared to the prior year period, due primarily to a CAR-T technology market analysis performed during 2022.
  • In 2022, the Company received a refund of $1,000 from the research institution with which the Company had an exclusive right to negotiate for the acquisition of the worldwide rights to two oncology R&D programs. In 2021, R&D expenses included $1,000 attributable to the same one-time exclusivity fee. Finally, in 2022, we paid $300 for the exclusive right to negotiate with another CAR-T Company. Net, the exclusivity agreements caused a decrease in expenses of $1,700 compared to the prior year period.

    G&A Expenses: G&A expenses were $12,608 for the year ended December 31, 2022, an increase of $1,297, or 11% from total G&A expenses for the year ended December 31, 2021 of $11,311. Key changes were as follows:

  • The increase in G&A expense for the year ended December 31, 2022 compared to the prior year period, was in part attributable to the increase in compensation expense of $663 in 2022 due to an increase in headcount, hourly wages, salaries and bonus accruals.
  • Non-cash stock-based compensation expense also increased by $719 due to the increased number of options being expensed as well as the weighted average fair value of options amortizing in 2022 was higher compared to the prior year period.
  • Professional fees decreased by $692 in 2022 compared to the prior year period, due primarily to a decrease in proxy costs for investor outreach.
  • Legal fees increased $601 in 2022 compared to the prior year period, due to higher patent activity in 2022 for (Z)-endoxifen and our immunotherapy research.

    Interest Income: Interest income was $877 for the year ended December 31, 2022 compared to the prior year period of $6. The increase is due to the investment of an additional $50,000 in a money market account during 2022 and higher average interest rates for the year ended December 31, 2022 compared to 2021.

ATOSSA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except for par value)
As of December 31,
2022 2021
Assets
Current assets
Cash and cash equivalents $ 110,890 $ 136,377
Restricted cash 110 110
Prepaid expenses 4,031 2,488
Research and development tax rebate receivable 743 1,072
Other current assets 2,423 1,193
Total current assets 118,197 141,240
Investment in equity securities 4,700
Other assets 635 22
Total Assets $ 123,532 $ 141,262
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable $ 2,965 $ 1,717
Accrued expenses 1,059 204
Payroll liabilities 1,525 1,184
Other current liabilities 19 21
Total current liabilities 5,568 3,126
Total Liabilities 5,568 3,126
Commitments and contingencies
Stockholders’ equity
Series B convertible preferred stock – $0.001 par value; 10,000 shares authorized; 1 shares issued and outstanding as of December 31, 2022 and December 31, 2021
Additional paid-in capital – Series B convertible preferred stock 582 582
Common stock – $0.18 par value; 175,000 shares authorized; 126,624 shares issued and outstanding as of December 31, 2022 and December 31, 2021 22,792 22,792
Additional paid-in capital – common stock 250,784 243,996
Accumulated deficit (156,194 ) (129,234 )
Total Stockholders’ Equity 117,964 138,136
Total Liabilities and Stockholders’ Equity $ 123,532 $ 141,262

ATOSSA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except for per share amounts)
For the Year Ended
December 31,
2022 2021
Operating expenses
Research and development $ 15,083 $ 9,210
General and administrative 12,608 11,311
Total operating expenses 27,691 20,521
Operating loss (27,691 ) (20,521 )
Interest income 877 6
Other expense, net (146 ) (91 )
Loss before income taxes (26,960 ) (20,606 )
Income taxes
Net loss (26,960 ) (20,606 )
Loss per share of common stock – basic and diluted $ (0.21 ) $ (0.18 )
Weighted average shares outstanding – basic and diluted 126,624 116,950


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. For more information, please visit www.atossatherapeutics.com

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

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 22, 2023

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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.

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.

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 Controller from 2017 through early 2021. 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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. 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. 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).