ATOS Atossa Therapeutics Inc.

7.02
+1.13  (+19%)
Previous Close 5.89
Open 6.25
52 Week Low 0.81
52 Week High 6.82
Market Cap $848,187,063
Shares 120,824,368
Float 120,772,146
Enterprise Value $508,844,789
Volume 76,667,274
Av. Daily Volume 15,167,213
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Drug Pipeline

Drug Stage Notes
Endoxifen
Breast cancer
Phase 2
Phase 2
Phase 2 final data presented June 9, 2021. Primary endpoint met.
AT-301 Nasal Spray
COVID-19
Phase 1
Phase 1
Phase 1 final data released February 25, 2021 - safe and well tolerated.
Endoxifen
Mammographic breast density (MBD)
Phase 2
Phase 2
Phase 2 initiation due in 2020 (Sweden).
Endoxifen
Male breast cancer and Gynecomastia
Phase 1
Phase 1
Phase 1 preliminary data September 13, 2018 noted drug met safety and tolerability objectives. Final data January 9, 2019 confirmed objectives met. Program will not be advanced in 2020.
Endoxifen
Mammographic breast density (MBD)
Phase 2
Phase 2
Phase 2 data met primary endpoint - June 27, 2019. High dropout rate noted.

Latest News

  1. SEATTLE, June 16, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, today announced it is set to be added to the Russell 2000 and Russell 3000 Indexes This milestone will take place at the conclusion of the 2021 Russell Indexes' annual reconstitution, effective after the U.S. market opens on June 28, 2021, according to a preliminary list of additions posted June 4, and June 14, 2021.

    "Atossa's inclusion in both the Russell 2000 and Russell 3000 Indexes present an important opportunity for us to further expand Atossa's awareness among a…

    SEATTLE, June 16, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, today announced it is set to be added to the Russell 2000 and Russell 3000 Indexes This milestone will take place at the conclusion of the 2021 Russell Indexes' annual reconstitution, effective after the U.S. market opens on June 28, 2021, according to a preliminary list of additions posted June 4, and June 14, 2021.

    "Atossa's inclusion in both the Russell 2000 and Russell 3000 Indexes present an important opportunity for us to further expand Atossa's awareness among a broader group of investors, which we expect will also further enhance its liquidity," said Kyle Guse, Atossa's CFO and General Counsel.

    Membership in the Russell 2000 and Russell 3000 Indexes, which remains in place for one year each, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell Indexes primarily by objective, market-capitalization rankings, and style attributes.

    Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's U.S. Indexes. Russell Indexes are part of FTSE Russell, a leading global index provider.

    About Atossa Therapeutics

    Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

    Forward-Looking Statements Disclaimer Statement

    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, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering, 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 AT-H201, AT-301 and 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 Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, 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.

    Company Contact:

    Atossa Therapeutics, Inc.

    Kyle Guse, CFO and General Counsel

    Office: 866 893-4927

    Investor Relations Contact:

    Core IR

    Office:(516) 222-2560



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  2. SEATTLE, June 11, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious disease with a current focus on breast cancer and COVID-19, announces that it has received approval from the Swedish Medical Product Agency (MPA) to initiate a Phase 2 clinical study of its oral Endoxifen for the reduction of mammographic breast density (MBD). MBD is an emerging public health issue affecting more than 10 million women in the United States and many more worldwide. Studies conducted by others have shown that MBD reduces the ability of mammograms to detect cancer (sensitivity) and increases the risk of developing breast cancer…

    SEATTLE, June 11, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious disease with a current focus on breast cancer and COVID-19, announces that it has received approval from the Swedish Medical Product Agency (MPA) to initiate a Phase 2 clinical study of its oral Endoxifen for the reduction of mammographic breast density (MBD). MBD is an emerging public health issue affecting more than 10 million women in the United States and many more worldwide. Studies conducted by others have shown that MBD reduces the ability of mammograms to detect cancer (sensitivity) and increases the risk of developing breast cancer. Additional studies show a correlation between reducing MBD and a reduction in the incidence of breast cancer.

    "This is a critical milestone in the development of our oral Endoxifen," commented Steven Quay, M.D., Ph.D., Atossa's Chairman and CEO. "We now plan to commence the study as soon as restrictions for COVID-19 in Stockholm allow and we are encouraged that daily and weekly average COVID-19 cases have been steadily declining in Sweden over the past six weeks. If this trend continues, we expect to initiate the study in the next quarter. We have also received useful input from the MPA about the development path for Endoxifen. Based in part on that input we will consider conducting future studies to measure the treatment effect of Endoxifen not only on MBD reduction but also on the reduction of the incidence of breast cancer. In addition to clinical data, regulators will require that we also develop preclinical information including toxicology studies and information about manufacturing oral Endoxifen prior to regulatory approval. We have now established two manufacturing sources of Endoxifen for clinical and potential future commercial use and we have initiated a significant portion of the preclinical studies needed for a New Drug Application."

    The primary objective of the MBD study is to determine the dose-response relationship of daily oral Endoxifen on mammographic breast density reduction, with secondary endpoints assessing safety and tolerability. The Phase 2 study will be randomized, double-blinded and placebo-controlled. It will be conducted in Stockholm and will include approximately 240 pre-menopausal women with measurable MBD who will receive daily doses of oral Endoxifen or placebo for six months. South General Hospital in Stockholm will be conducting the study. The study is being led by principal investigator Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. The study is also subject to approval by the institutional ethics committees and enrollment will not begin unless and until all approvals are obtained and COVID restrictions are lifted in Sweden.

    About Atossa Therapeutics

    Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious diseases with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.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 AT-H201, AT-301 and 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 Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, 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.

    Company Contact:

    Atossa Therapeutics, Inc.

    Kyle Guse CFO and General Counsel

    Office: (866) 893-4927

     

    Investor Relations Contact:

    Core IR

    Office: (516) 222-2560

     

    Source: Atossa Therapeutics, Inc.



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  3. SEATTLE, June 09, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, today announced the following final data from its Phase 2 clinical study of oral Endoxifen administered in the "window of opportunity" between diagnosis of breast cancer and surgery.

    • Primary Endpoint Met: Reduction in Ki-67 was achieved. Ki-67, a common measure of tumor cell activity, was reduced from an average of 25.6% at screening to 6% on the day of surgery, a 65.1% reduction. Ki-67 was reduced below 25% for all patients, which is potentially clinically meaningful…

    SEATTLE, June 09, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, today announced the following final data from its Phase 2 clinical study of oral Endoxifen administered in the "window of opportunity" between diagnosis of breast cancer and surgery.

    • Primary Endpoint Met: Reduction in Ki-67 was achieved. Ki-67, a common measure of tumor cell activity, was reduced from an average of 25.6% at screening to 6% on the day of surgery, a 65.1% reduction. Ki-67 was reduced below 25% for all patients, which is potentially clinically meaningful because studies by others have shown that a reduction below 25% improves long term survival.



    • Secondary Endpoints Were as Follows:



      Safety and tolerability: All adverse events were mild and considered related to the study drug. There were no abnormal laboratory findings (serum chemistry, hematology, coagulation, urinalysis) and no differences in vital signs, physical examinations and ECGs. Based on these results, Endoxifen was considered safe and well tolerated in this study. No adverse events led to discontinuation of the study.



      Other Results: Estrogen receptor expression decreased from 100% at screening to 88.6% on the day of surgery and progesterone receptor expression increased from 84.3% at screening to 92.9% on the day of surgery. No correlation between Ki-67 expression and Endoxifen levels was observed.

    "Based on these favorable results, we are taking a number of steps to quickly advance our development of Endoxifen," commented Steven Quay, M.D., Ph.D., Atossa's President and Chief Executive Officer. "We have begun the formal non-clinical toxicology program that will be needed for a New Drug Application to seek marketing approval for Endoxifen and plan to apply to the U.S. FDA for approval to conduct a clinical study here in the United States as soon as possible. We expect the next clinical study to measure pathological complete response in the neoadjuvant setting. Although there are several FDA-approved neoadjuvant therapies for breast cancers that are not estrogen receptor positive (ER+), currently there are very few approved therapies for the approximately 78% of breast cancers, which are ER+ that we believe creates a significant unmet need for our Endoxifen."

    Atossa will hold a webinar at 8:00 am Pacific Time today to discuss the study results. To register to join the complimentary ZOOM-based webinar event, please visit Tribe Public LLC at ATOS.TribePublic.com. Registered participants may email questions for Atossa's management to Tribe Public prior to the event at  or share their questions via the ZOOM chat feature during the event. Tribe Public's Managing Member, John F. Heerdink, Jr., will host the event and relay questions to management.

    The study enrolled seven newly-diagnosed patients with ER+ and human epidermal growth factor receptor 2 negative (HER2-) stage 1 or 2 invasive breast cancer, requiring mastectomy or lumpectomy. Patients received the Atossa proprietary oral Endoxifen for at least 14 days from the time of diagnosis up to the day of surgery. The primary endpoint was to determine if the administration of oral Endoxifen reduces the tumor activity as measured by Ki-67. The secondary endpoints were safety and tolerability and assessment of the study drug on expression levels of both estrogen and progesterone receptors, and correlation between Ki-67 and Endoxifen levels. The Phase 2 study was conducted on behalf of Atossa by Avance Clinical, a leading Australian CRO.

    The American Cancer Society (ACS) estimates that in 2021, 281,550 women will be diagnosed with breast cancer in the U.S. and 43,600 will die. ER+ breast cancer makes up approximately 78% of all women diagnosed with breast cancer.

    Atossa is evaluating a number of potential clinical benefits and potential indications for its oral Endoxifen in the window of opportunity, or neoadjuvant, setting. These may include avoidance of surgery in some patients, such as older and/or frail patients, allowing for breast conservation surgery, and use of Endoxifen in place of other neoadjuvant therapies such as chemotherapy, aromatase inhibitors and other endocrine therapies like tamoxifen.

    About Atossa Therapeutics

    Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

    Forward-Looking Statements Disclaimer Statement

    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, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering, 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 AT-H201, AT-301 and 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 Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, 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.

    Company Contact:

    Atossa Therapeutics, Inc.

    Kyle Guse, CFO and General Counsel

    Office: 866 893-4927

    Investor Relations Contact:

    Core IR

    Office:(516) 222-2560

     



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  4. SEATTLE, June 07, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious disease with a current focus on breast cancer and COVID-19, announces that it will hold a webinar at 8 am Pacific Time on June 9, 2021 to release and discuss final data from its Phase 2 study of Endoxifen administered to breast cancer patients prior to surgery. The webinar will be attended by Dr. Steven Quay, CEO and President, Kyle Guse, CFO and General Counsel, and Dr. B. Heather Fraser, VP Clinical, Regulatory and CMC.

    To register to join the complimentary ZOOM-based webinar event, please visit Tribe Public LLC at ATOS.TribePublic.com

    SEATTLE, June 07, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious disease with a current focus on breast cancer and COVID-19, announces that it will hold a webinar at 8 am Pacific Time on June 9, 2021 to release and discuss final data from its Phase 2 study of Endoxifen administered to breast cancer patients prior to surgery. The webinar will be attended by Dr. Steven Quay, CEO and President, Kyle Guse, CFO and General Counsel, and Dr. B. Heather Fraser, VP Clinical, Regulatory and CMC.

    To register to join the complimentary ZOOM-based webinar event, please visit Tribe Public LLC at ATOS.TribePublic.com. Registered participants may email questions for Atossa's management to Tribe Public prior to the event at  or share their questions via the ZOOM chat feature during the event. Tribe Public's Managing Member, John F. Heerdink, Jr., will host the event and relay questions to management.

    About Atossa Therapeutics

    Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in oncology and infectious diseases with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

    About Tribe Public LLC

    Tribe Public LLC is a San Francisco, CA-based organization that hosts complimentary worldwide webinar & meeting events in the U.S. Tribe's events focus on issues that the Tribe's members care about with an emphasis on hosting management teams and experts from publicly traded companies from all sectors & financial organizations that are seeking to increase awareness of their products, progress, and plans. Tribe members primarily include Institutions, Family Offices, Portfolio Managers, Registered Investment Advisors, Accredited Investors, Sell Side Analysts, and members of media. Tribe Members are encouraged to express their interest in speakers at the Tribe Public website via the Tribe's FREE "Wish List" process. Visit Tribe Public's Website http://www.tribepublic.com/ to join the Tribe and express your interests today.

    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 AT-H201, AT-301 and 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 Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, 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.

    Company Contact:

    Atossa Therapeutics, Inc.

    Kyle Guse CFO and General Counsel

    Office: (866) 893-4927

    Investor Relations Contact:

    Core IR

    Office: (516) 222-2560

    Source: Atossa Therapeutics, Inc.



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  5. SEATTLE, May 27, 2021 /PRNewswire/ -- DRASTIC Investigator Gilles Demaneuf and Physician-Scientist Dr. Steven C. Quay, M.D., Ph.D., CEO of Atossa Therapeutics (NASDAQ:ATOS), have published new research that addresses the question of whether the claim that there were no COVID cases at the Wuhan Institute of Virology (WIV) is legitimate. Given that it has been reported there were about 590 staff members working at the WIV at that time and the documented prevalence of COVID in Wuhan during the first half of 2020 of 4.4%, it is statistically impossible that there were no cases. The research can be read here.

    "The purpose of our analysis was to try to reconcile the reports from the U.S. State Department of early COVID cases in the fall of 2019 at…

    SEATTLE, May 27, 2021 /PRNewswire/ -- DRASTIC Investigator Gilles Demaneuf and Physician-Scientist Dr. Steven C. Quay, M.D., Ph.D., CEO of Atossa Therapeutics (NASDAQ:ATOS), have published new research that addresses the question of whether the claim that there were no COVID cases at the Wuhan Institute of Virology (WIV) is legitimate. Given that it has been reported there were about 590 staff members working at the WIV at that time and the documented prevalence of COVID in Wuhan during the first half of 2020 of 4.4%, it is statistically impossible that there were no cases. The research can be read here.

    "The purpose of our analysis was to try to reconcile the reports from the U.S. State Department of early COVID cases in the fall of 2019 at the Wuhan Institute of Virology with the pronouncements by the WIV that they had no cases whatsoever," stated Dr. Quay. "We determined that with 4.4% of the general population of Wuhan testing positive at about the same time, the probability that nobody would have tested positive at the WIV is extremely small, unless so few people were tested there that the testing exercise itself was largely flawed and irrelevant. An island of uninfected people at the WIV could not have existed in Wuhan at that time."

    "This study cannot address directly the timing of early cases," continued Mr. Demaneuf. "But whether infected from the laboratory or from the community, you can be sure that a properly designed testing of staff and students would have returned many positive cases."

    About Steven Quay, M.D., Ph.D.

    Dr. Steven Quay has 360+ published contributions to medicine and has been cited over 10,000 times, placing him in the top 1% of scientists worldwide. He holds 87 US patents and has invented seven FDA-approved pharmaceuticals which have helped over 80 million people. He is the author of the best-selling book on surviving the pandemic, Stay Safe: A Physician's Guide to Survive Coronavirus, available here.  He is the CEO of Atossa Therapeutics Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics for treating breast cancer and COVID-19.

    He received his M.D. and Ph.D. from The University of Michigan, was a postdoctoral fellow in the Chemistry Department at MIT with Nobel Laureate H. Gobind Khorana, a resident at the Harvard-MGH Hospital, and spent almost a decade on the faculty of Stanford University School of Medicine. A TEDx talk he delivered on breast cancer prevention has been viewed over 220,000 times.  For more information, visit www.DrQuay.com

    About Gilles Demaneuf

    Gilles Demaneuf (MScEng, Applied Maths) is a data scientist and analyst within DRASTIC, a multi-disciplinary community of scientists, data specialists, and biologists who have been working on the possible origins of SARS-CoV-2 since early 2020. For more information, visit Gilles Demaneuf

    Public Relations Contact:

    Dunn Pellier Media| t: 323.481.2307

    11620 Wilshire Blvd., 9th Floor, Los Angeles, CA 90025

      

     

    Cision View original content:http://www.prnewswire.com/news-releases/new-research-demonstrates-claims-that-the-wuhan-institute-of-virology-had-no-cases-of-covid-19-are-not-credible-301301156.html

    SOURCE Dr. Steven Quay

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