Welcome to Atossa Therapeutics
Atossa Therapeutics is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need. Atossa’s current focus is on breast cancer and COVID-19. We believe our innovative therapies and delivery methods can benefit COVID-19 patients and transform breast cancer treatment with the goals of preventing breast cancer from developing in the first place, to increasing the odds of surviving for those who do develop this deadly disease.
For example, we are developing a drug “endoxifen” and a new way to deliver therapies, such as “CAR-T” cells, through our microcatheters directly to the site of the breast cancer. Approximately one in eight women and one in 1,000 men will be diagnosed with breast cancer during their lifetime. Every two minutes an American woman is diagnosed with breast cancer; 40,000 die each year. The American Cancer Society (ACS) estimates that approximately 250,000 women will be diagnosed with breast cancer in the United States this year. It is the second leading cause of cancer death in American women.
View Dr. Quay’s TedX Talk “How to Be Smart When You’re Dense: Preventing Breast Cancer by 2030.”
Atossa’s COVID-19 HOPE Program
Our COVID-19 HOPE Program involves developing a therapy to improve lung function and reduce the amount of time that COVID-19 patients are on ventilators. This program uses a novel combination of two drugs that have been previously approved by the FDA for other diseases.
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The Promise of Endoxifen
We are developing an oral formulation of endoxifen for breast cancer patients. For newly diagnosed patients, taking oral endoxifen before surgery may “turn down” the cancer cell activity. For breast cancer survivors, although tamoxifen is the most commonly recommended FDA-approved drug to reduce the risk of cancer recurrence, it does not work for up to 50% of these patients.
Endoxifen has been identified as a key tamoxifen metabolite that helps reduce the risk of getting future breast cancer. Studies have shown that increasing the levels of endoxifen in breast cancer patients reduces the risk of future recurrence.
We are also developing a topical formulation, to be applied to the breast skin like a lotion, to reduce breast density. Studies have shown that women with highly dense breast tissue have a 4-fold risk of developing breast cancer.
Our proprietary Oral and Topical forms of Endoxifen were the subject of a 2017 comprehensive Phase 1 clinical study in healthy women in Australia. In 2018 we completed a comprehensive Phase 1 study of our proprietary Topical Endoxifen in healthy men in Australia. All objectives from these studies were successfully met.
The Promise of Local Treatment
We are developing a new way to deliver pharmaceuticals and genetically modified, or “CAR-T” cells – through microcatheters (small tubes that can be inserted with anesthetic, through the nipple) so that therapeutics can be targeted to the tissue where breast cancer actually grows.
Our patented microcatheter technology is in a Phase 2 clinical study using a drug called fulvestrant that is also currently enrolling patients.
COVID-19 HOPE Program
In April 2020 Atossa launched a new drug development program called COVID-19 HOPE. The goal of the COVID-19 HOPE program is to develop a therapy to improve lung function and reduce the amount of time that COVID-19 patients are on ventilators. The program uses a novel combination of two drugs that have been previously approved by the FDA for other diseases.
The program is called “COVID-19 HOPE,” which is an acronym for AT-H201in COVID-19 patients for Pulmonary Evaluation. The intended primary function of the Atossa’s proprietary drug combination AT-H201 is to essentially mimic the function of the antibodies formed from a vaccine by blocking the ability of the virus to enter the target cells; a vaccine that may not be available for more than a year. There are five known key steps the coronavirus must take to signal the cell to open up and let the virus in. AT-H201 is being designed to function like a “chemical vaccine” by blocking all five of those steps, similar to what antibodies would be expected to do when a vaccine is administered. With AT-H201, the virus should be unable to enter the cell because its “keys” that would otherwise open the door into the cell surface, are disabled. Atossa expects that its AT-H201 drug combination can be developed more quickly than a traditional vaccine.
“The rapidly increasing number of COVID-19 patients needing mechanical ventilation is deeply worrisome, as more than one-third of these patients will never recover lung function and will die on the ventilator,” stated Dr. Steven Quay, President and CEO. “The problem is confounded by the fact that hospitals may soon be facing a ventilator shortage and a vaccine could take more than a year to develop. The two drugs we intend to combine, which we call AT-H201, have been approved by the FDA for other diseases and are supported by a dozen clinical studies in close to 800 patients. We plan to quickly initiate and complete clinical studies so that we can obtain FDA approval to bring this treatment to market as soon as possible.”
Breast Cancer Overview & Risk Factors
Intense research has resulted in a great deal of knowledge about breast cancer. The factors that increase breast cancer risk include lifestyle (e.g., poor diet, sedentary, moderate to excessive alcohol consumption), certain genetic factors and dense breast tissue. Many of these factors can be reduced by taking steps before cancer strikes (risk mitigation) by adopting a healthier life-style and getting routine screening (e.g., mammograms, tomeography) that is proportional to one’s risk. Although tamoxifen has been used to reduce breast cancer risk, it is not a widely accepted practice due to safety concerns.
Once breast cancer is diagnosed, treatment plans can include surgery, radiation and/or chemotherapy. After the initial treatment, long term drug therapy can reduce the risk of new or recurrent cancer.
Endoxifen
Endoxifen has the potential to work in all three areas of the Breast Cancer Paradigm: to mitigate breast cancer risk (by reducing the density of breast tissue); to reduce the cancer cell activity before surgery; and to reduce the risk of recurrent or new breast cancer after the initial treatment.
At Atossa Therapeutics, we are working hard to realize the promise of endoxifen in all three phases: prevention, between diagnosis and surgery; and for the long term.
Gynecomastia
We are developing Topical Endoxifen to prevent a condition called gynecomastia, which is male breast enlargement and accompanying pain. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone levels are lower than estrogen. According to the Mayo Clinic, gynecomastia affects 25% of men in the U.S. between the ages of 50-69, or approximately 10 million men, and can be triggered by any number of commonly prescribed medications. Gynecomastia is a common side-effect of androgen deprivation therapy which is used to treat prostate enlargement and prostate cancer.
Microcatheter
We are developing our patented microcatheter technology to deliver therapeutics through the nipple directly to the site of early breast cancer. The goals of this direct delivery method are to increase the amount of the therapy getting to the targeted area while likely reducing the side effects that would otherwise be caused by delivering the drug through the blood stream.
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.
Director
Mr. Weaver has served as a director of the Company since October 2013. Mr. Weaver currently serves as Chief Financial Officer of Eloxx Pharmaceuticals, Inc,.a publically traded biotech company. From October 2015 to August 2017 he served as Chief Financial officer of ProMetic Life Science, a publicly traded pharmaceutical company.
From January to October 2015 he served as Global Chief Financial Officer of Oryzon Genomics, a public biotech company. From August 2013 to October 2014, Mr. Weaver served as Chief Financial Officer, Senior Vice President, Treasurer and Corporate Secretary of Fibrocell Science, Inc., a public biotech company. From June 2011 to July 2013, Mr. Weaver served as Chief Financial Officer and Senior Vice President of Celsion Corp., Mr. Weaver received his B.S. degree from Trinity University and his M.B.A. degree from Boston College. Mr. Weaver 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 current and prior experience as a Chief Financial Officer, director and committee member of public companies. Mr.Weaver serves on the board of directors of Egalet Corp., a public biotech company.
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.
Mr. Remmel served on the Board of Advisors of CytoDel, LLC, an early stage bio-pharmaceutical company developing products for bio-defense, neuronal drug delivery, and musculoskeletal and aesthetic medicine. In February 2018, he became a director of CytoDel, Inc., the successor to CytoDel LLC. He was an associate of the law firm Reboul, MacMurray, Hewitt, Maynard & Kristol from 1984 to 1988, and began his legal career at Carter, Ledyard & Milburn, where he was an associate from 1979 to 1984. He was admitted to the New York bar in 1980 and is a member of the New York State Bar Association. He received his J.D. from the Washington & Lee University School of Law in 1979 and his B.A. from Princeton University in 1975. He currently is a doctoral candidate in the Graduate School of Life Sciences of the University of Utrecht, in the Department of Clinical and Translational Oncology, with a thesis project in hyperplasia and early stage breast cancer. Mr. Remmel has been selected to serve on the Company’s Board of Directors because of his substantial experience as a corporate attorney advising biotechnology companies and his familiarity with the fiduciary duties and the regulatory requirements affecting publicly traded companies.
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.
He is past president of the American Society for Investigative Pathology and past president of the Collegium Internationale Allergologicum. In addition to receiving several awards for his research, he was recognized with the 2010 Stanford University President’s Award for Excellence through Diversity for his recruitment and support of women and underrepresented minorities at Stanford University. He received his B.A. degree in biology, magna cum laude, from Harvard College in 1968 and his M.D. degree from Harvard Medical School in 1973 and completed a residency in anatomic pathology at the Massachusetts General Hospital in 1977. Dr. Galli has been selected to serve on the Company’s Board of Directors because of his qualifications as a professor and physician, and his specialized expertise as a pathologist.
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.
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.
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.
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.
Senior Vice President, Regulatory, Quality, Clinical Affairs
Ms. Rea has nearly 35 years of industry leadership experience in regulatory affairs and quality. A Washington native, she obtained her B.S. degree in Microbiology from the University of Washington and was conferred a Master’s of Science of Public Health from the same institution. Her career in the healthcare industry started with Miami, FL-based Dade Division of then American Hospital Supply Corporation (now Baxter), followed by Genetic Systems, and she was an early employee of Seattle-based Immunex Corporation where she played a key role in the company’s first licensed product, LEUKINE®.
She held positions with increasing levels of responsibility with MDS Pharma, Targeted Genetics, and executive positions with AVI BioPharma (now Sarepta), Poniard Pharmaceuticals and Protein Sciences Corporation (Meriden, CT), and Therapeutic Proteins International (Chicago, IL). She has also operated a consulting practice of both small and large organizations, and she has lectured at both Shoreline Community College and the University of Washington – Biomedical Regulatory Affairs Certificate and Master Program, where she was also appointed as an Assistant Clinical Professor.
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. Cuzick is one of the foremost authorities in the field of breast cancer prevention and has led some of the most important clinical studies involving chemoprevention drugs. He is Director of Wolfson Institute of Preventive Medicine in London and head of Centre for Cancer Prevention and the John Snow Professor of Epidemiology at Queen Mary, University of London. He is a Fellow of the Royal Society, the Academy of Medical Sciences, the Royal Statistical Society, the Institute of Mathematical Statistics and he is an Honorary Fellow of the Royal College of Physicians.
Dr. Cuzick was chosen by Thompson Scientific as one of the twelve hottest researchers in all of science in 2007. He was awarded the AACR Cancer Prevention Prize in 2012 and the American Cancer Society Medal of Honor in 2015. Dr. Cuzick is the author of more than 500 peer-reviewed papers and has published in all the major medical journals. In 2014, the Cancer Research UK’s Translational Cancer Research Prize was awarded to Dr. Cuzick’s research team for their trials of tamoxifen and aromatase inhibitors for chemoprevention of breast cancer in women with a high risk of developing the disease.
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.
