About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

SEATTLE, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announces the issuance of the following Letter to Shareholders from Steven Quay, M.D., Ph.D., the Company's President and Chief Executive Officer: To our valued shareholders: 2023 marked another year of significant progress for Atossa. There are now four Phase ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 (Mark One) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-35610 ATOSSA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-4753208 ...

Atossa Therapeutics, Inc. (NASDAQ:ATOS) Q2 2023 Earnings Conference Call August 14, 2023 9:00 AM ET Company Participants Eric Van Zanten - Vice President of Investor and Public Relations Steven Quay - President and Chief Executive Officer Greg Weaver - Executive Vice President and Chief Financial Officer Conference Call Participants Michael Okunewitch - Maxim Group Edward Woo - Ascendiant Capital Operator Good morning, ladies and gentlemen, thank you for standing by and welcome to the Atossa Therapeutics Q2 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-35610 ATOSSA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-4753208 (State ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-35610 ATOSSA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 26-4753208 (State ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2022 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 | --- | --- | |-----------------------------------------------------------------------------------------|-----------------------------------------------------| | | | | For the transition period ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents the company's unaudited Q1 2022 financial statements, management's analysis, and market risk disclosures [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=ITEM%201.%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited Q1 2022 financial statements, showing a net loss of $4.8 million and key balance sheet changes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows total assets of $137.5 million and a decrease in cash and stockholders' equity as of March 31, 2022 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 (Unaudited) | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $131,486 | $136,377 | | Total current assets | $136,848 | $141,240 | | **Total Assets** | **$137,478** | **$141,262** | | **Liabilities & Equity** | | | | Total current liabilities | $2,322 | $3,126 | | **Total Liabilities** | **$2,322** | **$3,126** | | **Total Stockholders' Equity** | **$135,156** | **$138,136** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss of $4.8 million for Q1 2022, driven by a 34% increase in total operating expenses Condensed Consolidated Statements of Operations (Unaudited, in thousands) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $1,499 | $1,379 | | General and administrative | $3,248 | $2,152 | | **Total operating expenses** | **$4,747** | **$3,531** | | **Operating loss** | **($4,747)** | **($3,531)** | | **Net loss** | **($4,786)** | **($3,538)** | | Loss per common share - basic and diluted | ($0.04) | ($0.04) | | Weighted average shares outstanding | 126,624 | 92,587 | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity decreased to $135.2 million, primarily due to the quarterly net loss offset by stock-based compensation - The primary drivers for the change in stockholders' equity during Q1 2022 were the **net loss of $4,786 thousand** and **stock-based compensation expense of $1,806 thousand**[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $4.9 million, with no financing activities, resulting in an ending cash balance of $131.6 million Cash Flow Summary (Unaudited, in thousands) | Cash Flow Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,878) | ($4,408) | | Net cash used in investing activities | ($13) | $0 | | Net cash provided by financing activities | $0 | $102,428 | | **Net (decrease) increase in cash** | **($4,891)** | **$98,020** | | **Cash at end of period** | **$131,596** | **$137,684** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus, liquidity, R&D rebates, and stock-based compensation policies - The company is focused on developing pharmaceuticals for COVID-19, breast cancer, and other breast conditions[19](index=19&type=chunk) - Management believes its current funding of **$131.5 million in cash and cash equivalents is sufficient** to finance operations for at least one year[20](index=20&type=chunk) - The company receives a **43.5% R&D cash rebate** from Australia for qualified activities, which reduced Q1 2022 R&D expenses by $140 thousand[37](index=37&type=chunk) - **Stock-based compensation expense increased to $1,806 thousand** in Q1 2022 from $640 thousand in Q1 2021, with the majority allocated to G&A expenses[76](index=76&type=chunk)[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its clinical programs, a 34% rise in operating expenses, and its current liquidity position - The company's leading programs are **Endoxifen for breast cancer**, **AT-301 nasal spray** for at-home COVID-19 treatment, and **AT-H201 inhalation therapy** for hospitalized patients[85](index=85&type=chunk)[87](index=87&type=chunk)[94](index=94&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2022 | Q1 2021 | Change (%) | | :--- | :--- | :--- | :--- | | Research & Development | $1,499 | $1,379 | +9% | | General & Administrative | $3,248 | $2,152 | +51% | | **Total Operating Expenses** | **$4,747** | **$3,531** | **+34%** | - The increase in R&D expense was mainly due to drug manufacturing costs, while G&A expense rose due to **non-cash stock-based compensation of $734 thousand** and higher legal fees[111](index=111&type=chunk)[112](index=112&type=chunk) - As of March 31, 2022, the company had **$131.5 million in cash and cash equivalents** and believes it has sufficient funds for at least the next twelve months of operations[113](index=113&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=32&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risks are credit risk from its large cash balance and minor foreign currency exposure - The company holds **$131.5 million in cash and cash equivalents**, with the majority in a commercial money market account at one financial institution, exceeding FDIC insured limits[124](index=124&type=chunk) - The company is subject to foreign currency risk from its Australian subsidiary's cash and R&D rebate receivable, but did not recognize significant exchange rate losses[125](index=125&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal controls over financial reporting were effective - The CEO and CFO concluded that the company's **disclosure controls and procedures were effective** as of March 31, 2022[128](index=128&type=chunk) - There were **no material changes in internal control** over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[129](index=129&type=chunk) [PART II. OTHER INFORMATION](index=33&type=section&id=PART%20II.%20OTHER%20INFORMATION) This part covers legal proceedings, risk factors, and other required disclosures for the reporting period [Item 1. Legal Proceedings](index=33&type=section&id=ITEM%201.%20Legal%20Proceedings) The company believes current legal matters will not have a material effect on its financial position or operations - The company believes that current legal proceedings and claims **will not have a material effect** on its financial position, results of operations, or cash flows[131](index=131&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=ITEM%201A.%20Risk%20Factors) The company faces significant risks related to its operating history, capital needs, clinical development, and the COVID-19 pandemic - The company has a **limited operating history**, a history of operating losses, and will need to raise substantial additional capital to fund operations[133](index=133&type=chunk)[136](index=136&type=chunk)[140](index=140&type=chunk) - Development of pharmaceutical products is **highly uncertain**, with risks of regulatory failure, clinical trial delays, and compound failure in later stages[145](index=145&type=chunk)[147](index=147&type=chunk) - The business is **dependent on third-party service providers** for manufacturing, testing, and clinical trial activities, and failure by these parties could harm the business[153](index=153&type=chunk)[154](index=154&type=chunk) - The COVID-19 pandemic could **adversely impact operations**, while its end could make the company's COVID-19 programs obsolete[203](index=203&type=chunk)[204](index=204&type=chunk) - The company faces risks related to **protecting its intellectual property**, potential infringement claims, and changes in U.S. patent law[165](index=165&type=chunk)[173](index=173&type=chunk)[179](index=179&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=51&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities or use of proceeds during the period - This item is **not applicable** for the reporting period[217](index=217&type=chunk) [Item 3. Defaults upon Senior Securities](index=51&type=section&id=ITEM%203.%20Defaults%20upon%20Senior%20Securities) The company reports no defaults upon senior securities occurred during the period - This item is **not applicable** for the reporting period[217](index=217&type=chunk) [Item 4. Mine Safety Disclosures](index=51&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) The company reports this item as not applicable as it is not involved in mining operations - This item is **not applicable** for the reporting period[217](index=217&type=chunk) [Item 5. Other Information](index=51&type=section&id=ITEM%205.%20Other%20Information) The company reports no other material information was required to be disclosed during the period - This item is **not applicable** for the reporting period[217](index=217&type=chunk) [Item 6. Exhibits](index=52&type=section&id=ITEM%206.%20Exhibits) This section lists the required CEO/CFO certifications and Inline XBRL financial data files filed with the report - The exhibits filed with this report include **CEO and CFO certifications** pursuant to Sarbanes-Oxley Sections 302 and 906, and various Inline XBRL documents[220](index=220&type=chunk)[221](index=221&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk) [Signatures](index=53&type=section&id=SIGNATURES) The report was officially signed by the CEO and CFO on behalf of the company on May 9, 2022 - The report was **signed and authorized on May 9, 2022**, by the company's CEO and CFO[229](index=229&type=chunk)