Atossa Therapeutics Announces Third Quarter 2020 Financial Results and Provides Corporate Update
Atossa Therapeutics (Nasdaq: ATOS) reported its third-quarter financial results for the period ending September 30, 2020. The company has no sustainable revenue and reported total operating expenses of approximately $3.5 million for Q3 2020, a slight increase from Q3 2019. Significant advancements include the completion of a Phase 1 study of its AT-301 nasal spray for COVID-19, showing safety and tolerability. Atossa also applied for regulatory approval for a Phase 2 study of Endoxifen in Sweden to address mammographic breast density.
- Completion of Phase 1 study for AT-301 nasal spray showing good safety and tolerability.
- Plan to file pre-IND meeting request with the FDA for AT-301 in the next 30 days.
- No cancer recurrence and no side effects in the Expanded Access study of Endoxifen.
- Operating expenses increased by 6% year-over-year for Q3.
- No source of sustainable revenue reported.
SEATTLE, Nov. 13, 2020 (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 financial results for the third quarter ended September 30, 2020, and provided an update on recent company developments.
Key recent developments included:
- Significantly advanced the development of AT-301 proprietary nasal spray as potential at-home treatment against COVID-19, with completion of a randomized, placebo controlled, double-blinded Phase 1 study and a preliminary assessment of the blinded data indicating that AT-301 was safe and well tolerated by participants at two different dose levels in both single and multiple dose forms over 14 days.
- Applied for regulatory approval from the European Medical Product Authority to commence a Phase 2 clinical study of Endoxifen in Sweden to reduce mammographic breast density (MBD).
- Announced interim findings following 18 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 patient.
“Our COVID-19 nasal spray program has progressed very well during the quarter, with our Phase 1 study of AT-301 nasal spray demonstrating good safety and tolerability at two different dose levels in both single and multiple dose forms over a 14-day trial period,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “We are very encouraged by these preliminary results. In the next 30 days we plan to file a pre-IND meeting request with the FDA and, subject to their input, plan to immediately commence a Phase 2 study, either in the U.S. or abroad, in patients recently diagnosed with COVID-19.
“We believe AT-301 nasal spray is unique among the various therapies under development for COVID-19. While other companies are focused on therapies for patients being treated in hospitals, we are developing AT-301 for at-home use for the vast majority of COVID-19 patients who do not require hospitalization. Although great progress has been made by companies developing vaccines, it has become clear that a vaccine won’t provide a complete solution to the pandemic. No vaccine will be 100 percent effective and surveys have shown that many people won’t take a vaccine even when one becomes available. Similar to the seasonal flu where vaccines don’t provide complete community protection and people also rely on therapies, our AT-301 nasal spray therapy should form an important and necessary component of a comprehensive response to the COVID-19 pandemic,” added Dr. Quay.
Upcoming 2020 milestones include the following:
- File pre-IND meeting request with FDA for AT-301 nasal spray for potential at-home treatment of COVID-19.
- Commence Phase 2 study in Sweden for our Endoxifen to reduce MBD.
September 30, 2020 Financial Results
For the three and nine months ended September 30, 2020 and 2019, we have no source of sustainable revenue and no associated cost of revenue.
Operating Expenses: Total operating expenses were approximately
Research and Development Expenses: R&D expenses for the three months ended September 30, 2020, were approximately
General and Administrative Expenses: G&A expenses were approximately
As of September 30, 2020, the Company had approximately
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
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
kyle.guse@atossainc.com
Investor Relations Contact:
Core IR
Office:(516) 222-2560
ir@atossainc.com
Source: Atossa Therapeutics, Inc.
ATOSSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| As of September 30, 2020 | As of December 31, | |||||||
| Assets | (Unaudited) | 2019 | ||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 9,105,950 | $ | 12,581,136 | ||||
| Restricted cash | 110,000 | 110,000 | ||||||
| Prepaid expenses | 1,484,251 | 862,344 | ||||||
| Research and development tax rebate receivable | 439,205 | 739,656 | ||||||
| Other current assets | 178,911 | 26,130 | ||||||
| Total current assets | 11,318,317 | 14,319,266 | ||||||
| Furniture and equipment, net | 25,429 | 34,350 | ||||||
| Intangible assets, net | 45,417 | 68,542 | ||||||
| Right-of-use asset | 31,279 | 50,479 | ||||||
| Other assets | 17,218 | 17,218 | ||||||
| Total Assets | $ | 11,437,660 | $ | 14,489,855 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 682,612 | $ | 293,171 | ||||
| Accrued expenses | 85,173 | 77,888 | ||||||
| Payroll liabilities | 752,847 | 899,420 | ||||||
| Lease liability | 30,063 | 39,371 | ||||||
| Other current liabilities | 14,671 | 12,892 | ||||||
| Total current liabilities | 1,565,366 | 1,322,742 | ||||||
| Long term liabilities | ||||||||
| Lease liability long term | 1,217 | 11,108 | ||||||
| Total Liabilities | 1,566,583 | 1,333,850 | ||||||
| Commitments and contingencies | ||||||||
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FAQ
What were Atossa Therapeutics' Q3 2020 financial results?
Atossa reported total operating expenses of approximately $3.5 million for Q3 2020, with no sustainable revenue.
What is the status of Atossa's AT-301 nasal spray for COVID-19?
The Phase 1 study of AT-301 nasal spray was completed, indicating safety and tolerability, with plans for a Phase 2 study underway.
What application did Atossa Therapeutics file regarding Endoxifen?
Atossa applied for regulatory approval from the European Medical Product Authority to commence a Phase 2 clinical study of Endoxifen in Sweden.
Atossa Therapeutics, Inc.
NASDAQ:ATOSATOS RankingsATOS Latest NewsATOS Stock Data
125.80M
125.73M
0.06%
28.13%
6.52%
Biotechnology
Pharmaceutical Preparations
United States of America
SEATTLE
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