Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, with a current focus on breast cancer and COVID-19. Atossa Therapeutics (NASDAQ: ATOS) President and CEO Dr. Steven C. Quay M.D., Ph.D. issued the following letter to Atossa stockholders today.
To Our Valued Stockholders:
With the onset of COVID-19, the year 2020 will be remembered as one that changed the entire paradigm of business, the way we lead our daily lives and the world. I am deeply saddened by the devastating loss of life and the countless challenges the pandemic has created worldwide. With the ease of transmission, new variants emerging and the current limits of vaccines, we believe COVID-19 will be with us for the foreseeable future and we aim to be a part of the solution.
During the past twelve months, despite the pandemic and the associated global disruptions, we continued to deliver on our corporate and clinical milestones, expanded our pipeline, and significantly strengthened our balance sheet by adding approximately $81 million in net proceeds. We are in a strong position to continue the development of our programs and opportunistically add accretive programs as we move forward.
While much work still lies ahead, we are pleased to report the following highlights of our progress:
AT-301 Nasal Spray for the Treatment of COVID-19. AT-301 is a nasal spray being developed for at-home treatment of patients diagnosed with COVID-19 who do not require hospitalization. During 2020, we completed successful in-vitro testing followed by a Phase 1 clinical study with preliminary data demonstrating safety and tolerability. We recently received written feedback from the FDA from a pre-IND meeting that is informing our clinical and regulatory strategy. We expect to release final data from this study in the first quarter of 2021 and then quickly start additional pre-clinical and clinical studies to support an investigational new drug application (IND) with the FDA. We are in the process of identifying potential partners for this program. For example, an ideal partner may be selling diagnostic tests for COVID-19 so that our nasal spray could be co-promoted with the diagnostic test once all regulatory approvals are obtained.
In addition to developing AT-301 nasal spray for COVID-19 patients recently diagnosed with the disease, we believe a significant opportunity exists for the nasal spray to potentially prevent COVID-19 in high-risk environments, such as people living with an infected patient, people living and working in healthcare facilities, emergency responders or teachers.
While we hope that traditional vaccines will be effective in reducing COVID-19 infections, it is also clear to us that therapies such as AT-301 nasal spray will also play an important role, particularly as it becomes clear that it will take months or years for vaccines to be administered around the world. New deadlier and/or more infective variants of COVID-19 are being reported in the U.S. and in many other countries and it is not clear that current vaccines will be completely effective against these and future variants. Additionally, none of the currently available vaccines are 100% effective, they may have more significant side effects in older people and effectiveness is expected to diminish over time. For these reasons, we believe therapies like ours will provide valuable protection even as vaccines continue to be developed and deployed.
AT-H201 Inhalation Therapy for COVID-19. AT-H201 is a proprietary combination of two drugs previously approved by the FDA to treat other diseases. It is intended to improve compromised lung function for moderate to severely ill, hospitalized COVID-19 patients by inhalation. In May 2020, we completed in vitro testing of AT-H201 that showed that the components of AT-H201 inhibit SARS-CoV-2 infectivity of VERO cells, which is a standard cell type being used to study infectivity of the coronavirus. The AT-H201 components were found to be at least four times more potent than remdesivir and at least 20 times more potent than hydroxychloroquine. Based in part on our success with other clinical studies in Australia, we have applied to the regulatory authorities to conduct the initial clinical study of AT-H201 in Australia, which we anticipate receiving in first quarter 2021.
Oral Endoxifen in the Window of Opportunity Between Diagnosis and Surgery. In 2020, we made tremendous progress developing oral Endoxifen in the window of opportunity between diagnosis of breast cancer and surgical treatment. In May 2020, we reported interim results from our Phase 2 study in Australia showing a statistically significant (p=0.031) reduction of about 74% in tumor cell proliferation was achieved in the initial patients, as measured by Ki-67, over an average 22 days of dosing. Ki-67 is a recognized standard measurement of breast cancer cell proliferation. Six out of the initial six (100%) patients experienced a significant reduction in Ki-67 and each had a Ki-67 below 25% after treatment, which is the threshold identified in research by others for predicting overall survival. Results to date from this open-label study are sufficiently compelling that we have halted the study, shortening our development time-line by approximately one year. In the second quarter 2021, we plan to report final data from the study and obtain input from the FDA to inform our pathway for further development in the U.S.
A breast cancer patient in an FDA-approved, expanded access (or “compassionate use”) study has now received our oral Endoxifen for over two years without recurrence of breast cancer or significant side effects.
Oral Endoxifen to Reduce Mammographic Breast Density (MBD). We have contracted with South General Hospital in Stockholm to conduct a randomized, double-blinded, placebo-controlled Phase 2 study to reduce MBD in pre-menopausal women dosed over six months. This study will be led by principal investigator Dr. Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. This study will evaluate safety, tolerability and efficacy of our oral Endoxifen. The study is subject to approval by the European Medical Product Authority and ethics board. We expect to open this study in Stockholm soon after receiving all necessary regulatory approvals, provided COVID-19 restrictions are lifted to permit patient recruitment.
Fundraising Activities. At the end of this year and moving into the beginning of 2021, Atossa raised in excess of $81 million, which comfortably positions the Company to conduct its current programs through 2021 and beyond.
Moving forward in 2021, we will continue to pursue our mission with vigor and dedication and we have set the following goals and milestones:
COVID-19 Therapies. We expect to release final data from our Phase 1 study of AT-301 in the first quarter of 2021 and then quickly start additional pre-clinical and clinical studies to support an IND with the FDA. We are in the process of identifying potential partners for this program. We expect to receive regulatory approval in the first quarter 2021 to commence additional pre-clinical and clinical studies of AT-H201 in Australia.
Oral Endoxifen. In the second quarter 2021, we plan to report final data from our Australian window of opportunity Phase 2 study and obtain input from the FDA for further development in the U.S. Subject to receiving all regulatory clearances, we plan to commence a Phase 2 study of oral Endoxifen to reduce MBD in Stockholm as soon as COVID-19 restrictions allow.
On behalf of the board of directors, management and employees of Atossa Therapeutics, we thank you for your investment and continued support. The next period of Atossa’s history is just beginning and I cannot wait to report Atossa’s successes as we move forward.
Steven C. Quay, MD, Ph.D.
President and Chief Executive Officer
Recently, Tribe Public hosted a Webinar Presentation and Q&A Event with Steven Quay, MD, PhD, CEO & Founder & Kyle Guse CFO of Atossa Therapeutics (NASDAQ: ATOS) who delivered a presentation titled “The Important Role of COVID-19 Therapeutics In A Post-Vaccine World.” They also addressed Q&A session at the end of the presentation. Please view it here.