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Atossa Therapeutics, Inc. (ATOS)

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1.8400-0.0600 (-3.16%)
At close: 4:00PM EDT

1.8300 -0.01 (-0.54%)
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Neutralpattern detected
Previous Close1.9000
Open1.8600
Bid1.8100 x 3200
Ask1.8200 x 4000
Day's Range1.7500 - 1.8700
52 Week Range0.8100 - 5.0800
Volume5,692,163
Avg. Volume24,629,023
Market Cap222.316M
Beta (5Y Monthly)2.22
PE Ratio (TTM)N/A
EPS (TTM)-1.9750
Earnings DateMay 11, 2021 - May 17, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est6.38
  • Atossa Therapeutics Announces Ovarian Cancer Patient has Begun Treatment with Oral Endoxifen under FDA’s Expanded Access Pathway
    GlobeNewswire

    Atossa Therapeutics Announces Ovarian Cancer Patient has Begun Treatment with Oral Endoxifen under FDA’s Expanded Access Pathway

    SEATTLE, April 08, 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 in oncology and infectious diseases, today announced that an ovarian cancer patient has begun treatment with Atossa’s proprietary oral Endoxifen. The FDA previously issued a “Safe to Proceed” letter under their expanded access pathway, permitting the use of Atossa’s oral Endoxifen in this patient. The patient is being treated at the University of Washington Medical Center by Dr. Barbara Goff, Surgeon-in-Chief. “The patient has recurrent ovarian cancer and did not tolerate tamoxifen, which is sometimes prescribed for ovarian cancer as well as breast cancer,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO. “The patient recently underwent functional molecular genomic testing using 3D tumor organoid cultures grown in the laboratory from the patient’s tumor to help determine potential therapies. This testing revealed that the combination of Endoxifen and alpelisib produced an exceptional tumor response. We will follow the progress of this patient and consider additional clinical studies in patients with ovarian cancer.” Under the FDA expanded access program, the use of Atossa's proprietary oral Endoxifen is restricted solely to this patient. About FDA Expanded Access Sometimes called "compassionate use," expanded access is a potential pathway for a patient with serious disease or condition, or an immediately life-threatening condition, to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. For more information about this process, please see the FDA website: FDA Expanded Use Website About Atossa's Proprietary Endoxifen Endoxifen is an active metabolite of tamoxifen, which is an FDA-approved drug to treat ovarian and breast cancer. Tamoxifen itself must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. In third party preclinical studies, endocrine-sensitive and letrozole-resistant breast tumors, Z-endoxifen resulted in robust antitumor and antiestrogenic activity compared to tamoxifen and aromatase inhibitor monotherapy. Atossa has been developing its proprietary oral Endoxifen for breast cancer and other breast conditions and has successfully completed five clinical studies with this drug, including an expanded access study of a female breast cancer patient who has been taking oral Endoxifen for over two years, with no recurrence to date. About Ovarian Cancer In 2021 ovarian cancer will be diagnosed in about 21,400 women in the United States and about 13,770 women will die from the disease. Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. About Alpelisib Alpelisib was approved in the United States in 2019 for use in combination with the endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. PIK3 is a family of lipid kinases and one of them, PIK3CA, has mutations or gene amplification detected in 30.5% of all ovarian cancers and 45% of the endometrioid and clear cell subtypes. Alpelisib is marketed by Novartis under the brand name of Piqray. About Atossa Therapeutics Atossa Therapeutics, Inc. (Nasdaq: ATOS) 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. 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 development plans, any variation between interim, preliminary 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, whether change in mammographic breast density is an approvable end point 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 CounselOffice: (866) 893-4927kyle.guse@atossainc.com Investor Relations Contact:Core IROffice:(516) 222-2560ir@atossainc.com Source: Atossa Therapeutics, Inc.

  • Atossa Therapeutics Announces Year End 2020 Financial Results and Provides Corporate Update
    GlobeNewswire

    Atossa Therapeutics Announces Year End 2020 Financial Results and Provides Corporate Update

    SEATTLE, March 31, 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, today announced financial results for the fiscal year ended December 31, 2020, and provided an update on recent company developments. Key recent developments and from Q4 2020 include: Demonstrated positive interim results of the Company’s open-label Phase 2 clinical study of oral Endoxifen administered in the “window of opportunity” between diagnosis of breast cancer and surgery and, based on those results, Atossa concluded the study early and is accelerating its Endoxifen program in the United StatesAnnounced updated findings following 24 months of an Expanded Access (or “compassionate use”) single-patient study of Endoxifen. The patient in the study had no cancer recurrence and suffered no side effects. Endoxifen did not cause other safety and tolerability concerns in this patientReceived a “Safe to Proceed” letter from the FDA permitting the use Atossa’s oral Endoxifen as a treatment in an ovarian cancer patient (expanded access)Announced final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered to be safe and well tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19Completed financing transactions with net proceeds of approximately $136 million in December 2020 and Q1 2021 “We believe that in 2020 Atossa rose to meet the challenges of a pandemic through innovation and rapid response to the global events impacting economies, institutions, and pharmaceutical research and development,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Despite these challenges, 2020 was the year our proprietary Endoxifen programs began to show the potential breadth and depth of its medical and ultimate commercial value. Three recent Endoxifen-related events stand out: the reporting of two-year experience in the adjuvant setting in breast cancer in a single patient, Expanded Access study in which Endoxifen was well tolerated and cancer recurrence was not seen clinically;the better-than-expected response in the breast cancer window-of-opportunity study, allowing that study to be closed early based on success, accelerating that program almost one year; andthe initiation of an Expanded Access treatment program in an ovarian cancer patient, based on sensitivity to Endoxifen of laboratory cancer organoids from this patient. “Our nasal spray AT-301 being developed for COVID-19 patients to use at home showed encouraging results in preclinical and Phase 1 studies. We believe that AT-301 has the potential to provide an important and necessary component of a broader global response to COVID-19. Although it is encouraging that traditional vaccines are becoming available, there are many people who won’t take a vaccine, and current vaccines may not protect against future variants. “Finally, the ability to strengthen our balance sheet over the last few months, even in these challenging times, places Atossa in a good position to execute on business opportunities, both internal and potentially external, during the remainder of 2021 and beyond,” concluded Dr. Quay. Year Ended December 31, 2020 Financial Results For the year ended December 31, 2020, Atossa has no source of sustainable revenue and no associated cost of revenue. Operating Expenses Total operating expenses were $14,607,000 for the year ended December 31, 2020, which is a decrease of $2,658,000 or 15%, from the year ended December 31, 2019. Operating expenses for 2020 consisted of research and development ("R&D") expenses of $6,608,000 and general and administrative ("G&A") expenses of $7,999,000. Operating expenses for 2019 consisted of R&D expenses of $6,645,000, and G&A expenses of $10,620,000. Research and Development Expenses R&D expenses for the year ended December 31, 2020, were $6,608,000, a decrease of $37,000 or 1% from total R&D expenses in 2019 of $6,645,000. The decrease in R&D expense is attributed primarily to a decrease in stock-based compensation of approximately $2,214,000, which is a non-cash charge, offset by an increase in salaries of approximately $428,000, and an increase in professional fees and clinical trials expenses of approximately $1,696,000, as compared to the same period in 2019. We expect our R&D expenses to increase into 2021 as Atossa seeks to commence a study of AT-H201, complete a preclinical and commence a clinical study of AT-301, launch a Phase 2 clinical trial of Endoxifen in women with high breast density, and continue the development of other indications and therapeutics. General and Administrative Expenses G&A expenses were $7,999,000 for the year ended December 31, 2020, a decrease of $2,621,000, or 25% from the total G&A expenses for the year ended December 31, 2019, of $10,620,000. The decrease in G&A expenses for the year ended December 31, 2020, is mainly attributed to a decrease in stock-based compensation of approximately $3,610,000, which is a non-cash charge, offset by an increase in legal fees of approximately $507,000, professional fees of approximately $169,000 and insurance costs of approximately $268,000 compared to the same period in 2019. G&A expenses consist primarily of personnel and related benefit costs, facilities, professional services, insurance, and public company related expenses. As of December 31, 2020, the Company had cash, cash equivalents and restricted cash of $39.7 million. 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 CounselOffice: (866) 893-4927kyle.guse@atossainc.com Investor Relations Contact:Core IROffice: (516) 222-2560ir@atossainc.com Source: Atossa Therapeutics, Inc. ATOSSA THERAPEUTICS, INC.CONSOLIDATED BALANCE SHEETS As of December 31, Assets 2020 2019 Current assets Cash and cash equivalents $39,553,671 $12,581,136 Restricted cash 110,000 110,000 Prepaid expenses 1,813,902 862,344 Research and development tax rebate receivable 634,940 739,656 Other current assets 657,662 26,130 Total current assets 42,770,175 14,319,266 Furniture and equipment, net 20,632 34,350 Intangible assets, net 13,375 68,542 Right-of-use asset 18,053 50,479 Other assets 17,218 17,218 Total Assets $42,839,453 $14,489,855 Liabilities and Stockholders' Equity Current liabilities Accounts payable $1,588,613 $293,171 Accrued expenses 93,367 77,888 Payroll liabilities 963,665 899,420 Common stock warrant liability 13,003,075 - Lease liability 18,053 39,371 Other current liabilities 4,748 12,892 Total current liabilities 15,671,521 1,322,742 Long term liabilities Lease liability long term - 11,108 Total Liabilities 15,671,521 1,333,850 Commitments and contingencies Stockholders' equity Preferred stock - $0.001 par value; 10,000,000 shares authorized; 621 and 671 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively 1 1 Additional paid-in capital - Series B convertible preferred stock 620,999 670,999 Common stock - $0.18 par value; 175,000,000 shares authorized; 47,548,835 and 9,130,984 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively 8,558,778 1,643,565 Additional paid-in capital 129,887,146 104,912,480 Accumulated deficit (111,898,992) (94,071,040)Total Stockholders' Equity 27,167,932 13,156,005 Total Liabilities and Stockholders' Equity $42,839,453 $14,489,855 ATOSSA THERAPEUTICS, INC.CONSOLIDATED STATEMENTS OF OPERATIONS For the Year Ended December 31, 2020 2019 Operating expenses Research and development $6,608,392 $6,645,417 General and administrative 7,999,000 10,620,008 Total operating expenses 14,607,392 17,265,425 Operating loss (14,607,392) (17,265,425)Change in fair value of common stock warrants (2,332,567) - Warrant financing expense (938,794) - Other income 50,801 25,648 Loss before income taxes (17,827,952) (17,239,777)Income taxes - - Net loss $(17,827,952) $(17,239,777)Deemed dividend attributable to preferred stock (4,502,799) - Net loss applicable to common shareholders $(22,330,751) $(17,239,777)Loss per common share - basic and diluted $(1.97) $(2.03)Weighted average shares outstanding - basic and diluted 11,308,532 8,496,964

  • Physician-Scientist Steven Quay Provides Open Letter Response to WHO Report: Five Undisputed Facts Support the Laboratory Origin of the COVID Virus
    PR Newswire

    Physician-Scientist Steven Quay Provides Open Letter Response to WHO Report: Five Undisputed Facts Support the Laboratory Origin of the COVID Virus

    An Open Letter concerning the WHO Report was published today by Dr. Steven Quay, M.D., PhD., CEO of Atossa Therapeutics, Inc. (NASDAQ: ATOS), entitled, "To Stop the Next Pandemic, Evidence that is Undisputed Favoring Lab Origin of COVID Needs to Be Acknowledged." The Open Letter can be downloaded from Zenodo, a general-purpose open-access repository operated by CERN, here: Open Letter to the WHO. A short 'explainer' video about the paper can be found here: Open Letter - Video Explainer