About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

SEATTLE, Feb. 07, 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 announced that the (Z)-endoxifen arm of the ongoing Phase 2 I-SPY 2 clinical trial has fully enrolled. In the study, (Z)-endoxifen, Atossa's proprietary Selective Estrogen Receptor Modulator (SERM), is being evaluated as a neoadjuvant treatment for newly diagno ...

For many biotech stocks, price and performance hinges on the success of a drug in testing. This means most biotech companies rely on one market opportunity to succeed financially. Testing usually takes several years, with many different criteria to meet before applying for review by regulators. Even after successful tests, the survival of these stocks relies on approval by the U.S. Food and Drug Administration (FDA). Still, many companies continue to innovate to meet stringent checkpoints to put the next li ...

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 ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements](index=3&type=section&id=ITEM%201.%20Condensed%20Consolidated%20Financial%20Statements%20%E2%80%93%20Unaudited) Atossa's Q3 2023 unaudited financials reveal decreased assets and equity, increased net losses, and negative operating cash flows Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $94,031 | $110,890 | | Total current assets | $97,648 | $118,197 | | Total Assets | $101,695 | $123,532 | | **Liabilities & Equity** | | | | Total current liabilities | $3,444 | $5,568 | | Total Liabilities | $3,444 | $5,568 | | Total Stockholders' Equity | $98,251 | $117,964 | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,467 | $5,160 | $11,680 | $10,097 | | General and administrative | $3,001 | $3,045 | $10,678 | $9,456 | | Total operating expenses | $7,468 | $8,205 | $22,358 | $19,553 | | Operating loss | $(7,468) | $(8,205) | $(22,358) | $(19,553) | | Net loss | $(6,229) | $(8,011) | $(22,340) | $(19,469) | | Loss per share | $(0.05) | $(0.06) | $(0.18) | $(0.15) | Condensed Consolidated Statements of Cash Flows Highlights (Nine Months Ended, in thousands) | Cash Flow Activity | Sep 30, 2023 | Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(15,370) | $(16,237) | | Net cash used in investing activities | $(14) | $(2,719) | | Net cash used in financing activities | $(1,475) | $0 | | **Net decrease in cash** | **$(16,859)** | **$(19,010)** | - The company has a history of net losses and negative operating cash flows, with a **net loss of $22.3 million** and **$15.4 million cash used in operations** for the nine months ended September 30, 2023[21](index=21&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses (Z)-endoxifen clinical development, mixed operating expense trends, an impairment charge, liquidity, and Nasdaq non-compliance [Company Overview and Leading Programs](index=17&type=section&id=Company%20Overview%20and%20Leading%20Programs) Atossa focuses on oral (Z)-endoxifen development for breast cancer and density, with multiple Phase 2 trials, discontinuing the AT-H201 program - The company's primary focus is on its lead drug candidate, **oral (Z)-endoxifen**, for neoadjuvant treatment of ER+/HER2- breast cancer and reduction of dense breast tissue[84](index=84&type=chunk) - Key clinical trials for (Z)-endoxifen include **Karisma** (breast density), **EVANGELINE** and **I-SPY 2** (neoadjuvant breast cancer), and **RECAST** (Ductal Carcinoma in Situ)[88](index=88&type=chunk)[90](index=90&type=chunk)[94](index=94&type=chunk)[96](index=96&type=chunk) - In December 2022, the company invested in Dynamic Cell Therapies, Inc. (DCT), acquiring approximately **19% of its outstanding capital stock**[98](index=98&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) Q3 2023 operating expenses decreased 9%, while nine-month expenses rose 14% due to clinical trials and G&A, including a $3.0 million impairment charge Operating Expenses Comparison - Three Months Ended Sep 30 (in thousands) | Expense Category | 2023 | 2022 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and Development | $4,467 | $5,160 | $(693) | (13%) | | General and Administrative | $3,001 | $3,045 | $(44) | (1%) | | **Total Operating Expenses** | **$7,468** | **$8,205** | **$(737)** | **(9%)** | Operating Expenses Comparison - Nine Months Ended Sep 30 (in thousands) | Expense Category | 2023 | 2022 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and Development | $11,680 | $10,097 | $1,583 | 16% | | General and Administrative | $10,678 | $9,456 | $1,222 | 13% | | **Total Operating Expenses** | **$22,358** | **$19,553** | **$2,805** | **14%** | - For the nine months ended September 30, 2023, the company recorded a **$2.99 million impairment charge** on its investment in Dynamic Cell Therapies, Inc. (DCT)[121](index=121&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) Atossa has $94.0 million cash, sufficient for 12 months, but faces future funding needs and a Nasdaq non-compliance notice - As of September 30, 2023, the company had **$94.0 million in unrestricted cash and cash equivalents** and believes this is sufficient to fund operations for at least the next 12 months[123](index=123&type=chunk) - Net cash used in operating activities decreased to **$15.4 million** for the nine months ended Sep 30, 2023, from $16.2 million in the same period of 2022[124](index=124&type=chunk) - On September 26, 2023, the company was notified by Nasdaq for not maintaining a minimum closing bid price of **$1.00 per share**, with a deadline of March 25, 2024, to regain compliance[130](index=130&type=chunk) - The company initiated a share repurchase program in June 2023, repurchasing approximately **1.32 million shares for $1.475 million** in the nine months ended September 30, 2023[49](index=49&type=chunk)[132](index=132&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=24&type=section&id=ITEM%203%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Atossa Therapeutics is exempt from providing market risk disclosures - The company is exempt from providing quantitative and qualitative disclosures about market risk as it qualifies as a smaller reporting company[134](index=134&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes in internal control - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of September 30, 2023[137](index=137&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended September 30, 2023, that have materially affected, or are reasonably likely to materially affect, the company's internal controls[137](index=137&type=chunk) [PART II. OTHER INFORMATION](index=25&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=25&type=section&id=ITEM%201.%20Legal%20Proceedings) Atossa is contesting a Petition for Post Grant Review filed by Intas Pharmaceuticals LTD. seeking to invalidate a key Endoxifen patent - On August 18, 2023, Intas Pharmaceuticals LTD. filed a Petition for Post Grant Review (PGR) seeking to invalidate the company's U.S. Patent No. 11,572,334, titled "Methods for Making and Using Endoxifen"[71](index=71&type=chunk) - The company intends to contest the petition, believing the patent was properly granted and is valid and enforceable[71](index=71&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=ITEM%201A.%20Risk%20Factors) The company faces significant risks including operating losses, capital needs, IP challenges, regulatory hurdles, and Nasdaq non-compliance - The company has a history of operating losses, incurring a **net loss of approximately $22.3 million** for the nine months ended September 30, 2023, and expects to continue incurring losses[152](index=152&type=chunk)[155](index=155&type=chunk) - A Petition for Post Grant Review (PGR) was filed by Intas Pharmaceuticals LTD. to invalidate one of the company's key patents for Endoxifen, and a Pre-Grant Opposition was filed in India, posing risks to its intellectual property protection[197](index=197&type=chunk)[198](index=198&type=chunk) - The company is not in compliance with Nasdaq's minimum bid price rule, which could lead to delisting if not resolved, adversely affecting stock liquidity and the ability to raise capital[238](index=238&type=chunk)[239](index=239&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q3 2023, the company repurchased 1.2 million shares under its program, with $8.5 million remaining available until December 31, 2023 Common Stock Repurchases (Q3 2023) | Period | Total Shares Purchased | Average Price Paid Per Share | Approx. Dollar Value Remaining Under Program | | :--- | :--- | :--- | :--- | | Jul 2023 | 719,528 | $1.18 | $8,980,020 | | Aug 2023 | 481,136 | $0.91 | $8,524,761 | | Sep 2023 | 0 | — | $8,524,761 | | **Total** | **1,200,664** | | **$8,524,761** | - The share repurchase program, authorized in June 2023 for up to **$10.0 million**, expires on December 31, 2023[251](index=251&type=chunk) [Item 3. Defaults upon Senior Securities](index=41&type=section&id=ITEM%203.%20Defaults%20upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[253](index=253&type=chunk) [Item 4. Mine Safety Disclosures](index=41&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[253](index=253&type=chunk) [Item 5. Other Information](index=41&type=section&id=ITEM%205.%20Other%20Information) The company reported no other information for this item - None[253](index=253&type=chunk) [Item 6. Exhibits](index=42&type=section&id=ITEM%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including SOX certifications and Inline XBRL documents

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 ...

PART I. FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - UNAUDITED](index=3&type=section&id=ITEM%201.%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS%20-%20UNAUDITED) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining the company's financial position, performance, and accounting policies for the periods ended June 30, 2023, and December 31, 2022 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity as of specific dates | Assets/Liabilities & Equity (in thousands) | As of June 30, 2023 | As of December 31, 2022 | | :----------------------------------------- | :------------------ | :---------------------- | | Cash and cash equivalents | $99,390 | $110,890 | | Total current assets | $106,003 | $118,197 | | Total Assets | $108,355 | $123,532 | | Total current liabilities | $3,478 | $5,568 | | Total Liabilities | $3,478 | $5,568 | | Total Stockholders' Equity | $104,877 | $117,964 | | Total Liabilities and Stockholders' Equity | $108,355 | $123,532 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section outlines the company's financial performance over specific periods, detailing revenues, expenses, and net loss | Operating Expenses (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $3,705 | $3,433 | $7,213 | $4,937 | | General and administrative | $4,088 | $3,162 | $7,678 | $6,411 | | Total operating expenses | $7,793 | $6,595 | $14,891 | $11,348 | | Operating loss | $(7,793) | $(6,595) | $(14,891) | $(11,348) | | Impairment charge | $(2,990) | $- | $(2,990) | $- | | Interest income | $983 | $11 | $1,833 | $13 | | Net loss | $(9,830) | $(6,672) | $(16,111) | $(11,457) | | Loss per share (basic and diluted)| $(0.08) | $(0.05) | $(0.13) | $(0.09) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section details changes in the company's equity, including common stock, additional paid-in capital, and accumulated deficit | Stockholders' Equity (in thousands) | Balance at December 31, 2022 | Balance at June 30, 2023 | | :---------------------------------- | :--------------------------- | :----------------------- | | Common Stock Amount | $22,792 | $22,792 | | Additional Paid-in Capital | $250,784 | $253,960 | | Treasury Stock | $- | $(152) | | Accumulated Deficit | $(156,194) | $(172,305) | | Total Stockholders' Equity | $117,964 | $104,877 | - The company repurchased **119 shares** of common stock for **$152 thousand** as of June 30, 2023, which are recorded as treasury stock[11](index=11&type=chunk)[45](index=45&type=chunk) - Stock-based compensation cost for stock options granted totaled **$1,603 thousand** for the three months ended June 30, 2023, and **$3,176 thousand** for the six months ended June 30, 2023[11](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the cash inflows and outflows from operating, investing, and financing activities over specific periods | Cash Flows (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :------------------------ | :----------------------------- | :----------------------------- | | Net loss | $(16,111) | $(11,457) | | Net cash used in operating activities | $(11,487) | $(10,827) | | Net cash used in investing activities | $(13) | $(13) | | Net cash used in financing activities | $- | $- | | Net decrease in cash | $(11,500) | $(10,840) | | Ending cash, cash equivalents and restricted cash | $99,500 | $125,647 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [NOTE 1: NATURE OF OPERATIONS](index=7&type=section&id=NOTE%201:%20NATURE%20OF%20OPERATIONS) This note describes the company's primary business activities as a clinical-stage biopharmaceutical company focused on oncology - Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing proprietary innovative medicines in oncology, specifically breast cancer and other breast conditions[16](index=16&type=chunk) [NOTE 2: LIQUIDITY AND CAPITAL RESOURCES](index=7&type=section&id=NOTE%202:%20LIQUIDITY%20AND%20CAPITAL%20RESOURCES) This note discusses the company's financial liquidity, cash position, and future capital funding requirements - The company has incurred net losses and negative operating cash flows since inception, with a net loss of **$16,111 thousand** and **$11,487 thousand** cash used in operating activities for the six months ended June 30, 2023[17](index=17&type=chunk) - As of June 30, 2023, the company had **$99,390 thousand** in unrestricted cash and cash equivalents and working capital of **$102,525 thousand**[17](index=17&type=chunk) - Management believes current cash and cash equivalents are sufficient to finance operations for at least one year, but the company will need to raise substantial additional capital for its business plan[17](index=17&type=chunk) [NOTE 3: SUMMARY OF ACCOUNTING POLICIES](index=8&type=section&id=NOTE%203:%20SUMMARY%20OF%20ACCOUNTING%20POLICIES) This note outlines the significant accounting principles and methods used in preparing the financial statements - The financial statements are prepared in accordance with GAAP for interim information, with all amounts presented in thousands except for par value and per share data[19](index=19&type=chunk) - The company operates as a single segment and measures non-marketable equity investments at cost less impairment, performing assessments for impairment at each reporting period[21](index=21&type=chunk) - Research and development costs are generally expensed as incurred, including manufacturing, preclinical studies, clinical trials, and associated compensation[25](index=25&type=chunk) [NOTE 4: INVESTMENT IN EQUITY SECURITIES](index=9&type=section&id=NOTE%204:%20INVESTMENT%20IN%20EQUITY%20SECURITIES) This note details the company's investment in Dynamic Cell Therapies, Inc. and related impairment charges - On December 23, 2022, the company invested **$4,700 thousand** in Dynamic Cell Therapies, Inc. (DCT), a preclinical CAR T-cell therapy developer, acquiring approximately **19%** of its outstanding shares[30](index=30&type=chunk) - An impairment charge of **$2,990 thousand** was recorded as of June 30, 2023, due to adverse market conditions and concerns about DCT's going concern ability, reducing the investment's value to **$1,710 thousand**[31](index=31&type=chunk)[33](index=33&type=chunk) [NOTE 5: RESTRICTED CASH](index=10&type=section&id=NOTE%205:%20RESTRICTED%20CASH) This note explains the nature and amount of cash held for specific purposes, such as security for credit cards - Restricted cash remained at **$110 thousand** as of June 30, 2023, and December 31, 2022, serving as security for commercial credit cards[34](index=34&type=chunk) [NOTE 6: PREPAID EXPENSES](index=10&type=section&id=NOTE%206:%20PREPAID%20EXPENSES) This note provides a breakdown of various prepaid expenses, including research and development and insurance | Prepaid Expenses (in thousands) | As of June 30, 2023 | As of December 31, 2022 | | :------------------------------ | :------------------ | :---------------------- | | Prepaid research and development| $4,918 | $3,480 | | Prepaid insurance | $509 | $387 | | Professional services | $191 | $130 | | Other | $141 | $34 | | Total prepaid expenses | $5,759 | $4,031 | [NOTE 7: RESEARCH AND DEVELOPMENT REBATE RECEIVABLE](index=10&type=section&id=NOTE%207:%20RESEARCH%20AND%20DEVELOPMENT%20REBATE%20RECEIVABLE) This note details the R&D rebate received by the Australian subsidiary and the total rebate receivable - The company's Australian subsidiary incurred **$34 thousand** and **$86 thousand** in qualified R&D expenses for the three and six months ended June 30, 2023, respectively, receiving a rebate that reduced R&D expense by **$10 thousand** and **$37 thousand** for the same periods[37](index=37&type=chunk) - Total R&D rebate receivables were **$737 thousand** as of June 30, 2023, down from **$743 thousand** at December 31, 2022[37](index=37&type=chunk) [NOTE 8: ACCRUED EXPENSES](index=10&type=section&id=NOTE%208:%20ACCRUED%20EXPENSES) This note presents a breakdown of accrued liabilities, including research and development and professional services | Accrued Expenses (in thousands) | As of June 30, 2023 | As of December 31, 2022 | | :------------------------------ | :------------------ | :---------------------- | | Research and development | $559 | $1,038 | | Professional Services | $244 | $21 | | Total accrued liabilities | $803 | $1,059 | [NOTE 9: PAYROLL LIABILITIES](index=10&type=section&id=NOTE%209:%20PAYROLL%20LIABILITIES) This note details the company's payroll-related liabilities, such as accrued bonuses and vacation | Payroll Liabilities (in thousands) | As of June 30, 2023 | As of December 31, 2022 | | :--------------------------------- | :------------------ | :---------------------- | | Accrued bonuses | $50 | $1,060 | | Accrued vacation | $23 | $224 | | Accrued payroll liabilities | $1,382 | $241 | | Total payroll liabilities | $1,455 | $1,525 | [NOTE 10: FAIR VALUE OF FINANCIAL INSTRUMENTS](index=12&type=section&id=NOTE%2010:%20FAIR%20VALUE%20OF%20FINANCIAL%20INSTRUMENTS) This note provides information on the fair value measurements of financial assets, specifically money market accounts | Financial Assets (in thousands) | As of June 30, 2023 (Level 1) | As of December 31, 2022 (Level 1) | | :------------------------------ | :---------------------------- | :-------------------------------- | | Money market account | $97,182 | $102,681 | - The company had no financial liabilities subject to fair value measurements on a recurring basis as of June 30, 2023, and December 31, 2022[42](index=42&type=chunk) [NOTE 11: STOCKHOLDERS' EQUITY](index=12&type=section&id=NOTE%2011:%20STOCKHOLDERS'%20EQUITY) This note details the components of stockholders' equity, including authorized shares, repurchase programs, and outstanding warrants - The company is authorized to issue **175,000 shares** of common stock (**$0.18 par value**) and **10,000 shares** of preferred stock (**$0.001 par value**)[43](index=43&type=chunk) - A share repurchase program was authorized on June 27, 2023, to repurchase up to **$10,000 thousand** of common stock, expiring December 31, 2023. As of June 30, 2023, **119 shares** were purchased for **$152 thousand**[45](index=45&type=chunk) | Warrants Outstanding (shares) | Exercise Price Per Share | Expiration Date | | :---------------------------- | :----------------------- | :-------------- | | December 2020 warrants (6,490)| $1.00 | Dec 11, 2024 - Jun 21, 2025 | | January 2021 warrants (4,500) | $1.055 | July 8, 2025 | | March 2021 warrants (10,525) | $2.88 | Sep 22, 2025 | | Total (21,515) | | | [NOTE 12: NET LOSS PER SHARE](index=14&type=section&id=NOTE%2012:%20NET%20LOSS%20PER%20SHARE) This note explains the calculation of basic and diluted net loss per share and the impact of anti-dilutive securities - Basic and diluted net loss per share are the same due to the anti-dilutive effect of potential common shares from stock options, Series B convertible preferred stock, and warrants[59](index=59&type=chunk)[60](index=60&type=chunk) | Common Share Equivalents Excluded (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :----------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Options to purchase common stock | 17,828 | 13,337 | 16,294 | 12,219 | | Series B convertible preferred stock | 165 | 165 | 165 | 165 | | Warrants to purchase common stock | 21,515 | 22,009 | 21,515 | 22,142 | | Total | 39,508 | 35,511 | 37,974 | 34,526 | [NOTE 13: INCOME TAXES](index=15&type=section&id=NOTE%2013:%20INCOME%20TAXES) This note discusses the company's income tax position, including deferred tax assets and valuation allowances - A full valuation allowance is provided against net deferred tax assets due to cumulative losses, and no income tax liabilities existed as of June 30, 2023, and December 31, 2022[63](index=63&type=chunk) [NOTE 14: CONCENTRATION OF CREDIT RISK](index=15&type=section&id=NOTE%2014:%20CONCENTRATION%20OF%20CREDIT%20RISK) This note highlights the company's exposure to credit risk, particularly regarding cash and cash equivalents exceeding insured limits - The company had **$99,208 thousand** and **$110,647 thousand** in cash and cash equivalents exceeding FDIC insured limits as of June 30, 2023, and December 31, 2022, respectively[64](index=64&type=chunk) [NOTE 15: COMMITMENTS AND CONTINGENCIES](index=15&type=section&id=NOTE%2015:%20COMMITMENTS%20AND%20CONTINGENCIES) This note outlines the company's contractual obligations, including lease agreements and CRO contracts - The company terminated its existing office lease and entered a new 12-month operating lease for **$3 thousand** monthly rent, commencing July 1, 2023[65](index=65&type=chunk) - Lease expense for the three and six months ended June 30, 2023, was **$3 thousand** and **$7 thousand**, respectively[66](index=66&type=chunk) - As of June 30, 2023, the company had an estimated non-cancellable contractual commitment of **$908 thousand** related to a CRO contract[67](index=67&type=chunk) [NOTE 16: STOCK-BASED COMPENSATION](index=15&type=section&id=NOTE%2016:%20STOCK-BASED%20COMPENSATION) This note details the stock options granted and the associated compensation expense recognized by the company - The company granted **4,230** and **6,691 options** to purchase common stock during the three and six months ended June 30, 2023, respectively, with weighted average grant date fair values of **$0.74** and **$0.69**[69](index=69&type=chunk) | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative | $1,156 | $1,140 | $2,211 | $2,323 | | Research and development | $447 | $631 | $965 | $1,254 | | Total stock compensation expense | $1,603 | $1,771 | $3,176 | $3,577 | - The company recorded **$320 thousand** in compensation expense related to accelerated unvested options for the former CFO and is obligated to pay an additional **$554 thousand** for salary and bonus severance[72](index=72&type=chunk) [NOTE 17: SUBSEQUENT EVENT](index=16&type=section&id=NOTE%2017:%20SUBSEQUENT%20EVENT) This note reports on significant events occurring after the reporting period, specifically further share repurchases - From July 1, 2023, to August 10, 2023, **720 shares** were purchased for a total cost of **$868 thousand** under the share repurchase program[76](index=76&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=17&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's perspective on the company's financial condition and operational results, highlighting key developments in its clinical programs, investment activities, and financial performance for the three and six months ended June 30, 2023, compared to the prior year. It also discusses liquidity, capital resources, and critical accounting policies [Forward-Looking Statements](index=17&type=section&id=Forward-Looking%20Statements) This section cautions readers about statements regarding future business, clinical, and financial performance, which are subject to inherent risks - The report contains forward-looking statements regarding future business, clinical and commercialization activities, operating costs, supply chain, regulatory approvals, and financial performance, which are subject to risks and uncertainties[77](index=77&type=chunk)[78](index=78&type=chunk) [Company Overview](index=18&type=section&id=Company%20Overview) This section introduces Atossa Therapeutics as a clinical-stage biopharmaceutical company focused on breast cancer and related conditions - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative medicines for breast cancer and other breast conditions[81](index=81&type=chunk) - The lead drug candidate is oral (Z)-endoxifen, being developed for ER+ HER2- breast cancer treatment prior to surgery and for reducing dense breast tissue[81](index=81&type=chunk) - The company holds two U.S. patents and one international patent for (Z)-endoxifen, with protection through **November 17, 2038**, and numerous pending applications[82](index=82&type=chunk) [Summary of Leading Programs](index=18&type=section&id=Summary%20of%20Leading%20Programs) This section provides an overview of the company's key drug development programs, including (Z)-endoxifen and AT-H201 [(Z)-endoxifen](index=19&type=section&id=(Z)-endoxifen) This subsection describes (Z)-endoxifen as a proprietary oral SERM under development for breast cancer and breast density reduction - (Z)-endoxifen is a proprietary oral Selective Estrogen Receptor Modulator (SERM) being developed for breast cancer and breast density reduction, having completed four Phase 1 and two Phase 2 clinical studies[84](index=84&type=chunk) [(Z)-endoxifen for Women with Breast Density](index=19&type=section&id=(Z)-endoxifen%20for%20Women%20with%20Breast%20Density) This subsection details the Phase 2 Karisma-(Z)-endoxifen study for reducing breast density in premenopausal women - A Phase 2, randomized, double-blind, placebo-controlled Karisma-(Z)-endoxifen study in premenopausal women with measurable breast density commenced in December 2021 in Stockholm, Sweden, aiming to enroll approximately **240 participants**[86](index=86&type=chunk) - The primary objective is to determine the dose-response relationship of daily (Z)-endoxifen on breast density reduction, with secondary endpoints assessing safety and tolerability[86](index=86&type=chunk) - FDA input suggests that MBD reduction may require demonstration of breast cancer incidence reduction for approval, potentially necessitating additional studies[87](index=87&type=chunk) [(Z)-endoxifen for Neoadjuvant Treatment of Breast Cancer](index=19&type=section&id=(Z)-endoxifen%20for%20Neoadjuvant%20Treatment%20of%20Breast%20Cancer) This subsection outlines the Phase 2 EVANGELINE and I-SPY 2 studies for (Z)-endoxifen in neoadjuvant breast cancer treatment - The company received FDA IND authorization in October 2022 and Health Canada authorization in June 2023 for the Phase 2 EVANGELINE study of oral (Z)-endoxifen for neoadjuvant treatment of premenopausal women with ER+/HER2- breast cancer[88](index=88&type=chunk) - The first PK Run-in Cohort of the EVANGELINE study was fully enrolled in June 2023, with **six patients** treated at **40 mg/day**. The **80 mg/day** dose level will commence as the initial dose did not achieve optimal plasma concentrations[91](index=91&type=chunk) - A second Phase 2 trial investigating oral (Z)-endoxifen as a neoadjuvant treatment for locally advanced ER+ breast cancer was initiated in March 2023 as part of the I-SPY 2 clinical trial, with **six patients** dosed as of June 30, 2023[92](index=92&type=chunk) [Inhaled HNAC(AT-H201)](index=20&type=section&id=Inhaled%20HNAC(AT-H201)) This subsection discusses the shift in focus for AT-H201 development and its current status after a healthy volunteer study - Development of AT-H201 for COVID-19 was shifted in late 2022 to focus on lung function compromised by cancer treatment, and the program is not expected to advance further after concluding a healthy volunteer study in Q1 2023[93](index=93&type=chunk) [Investment in CAR-T Company](index=20&type=section&id=Investment%20in%20CAR-T%20Company) This section details the company's strategic investment in Dynamic Cell Therapies, Inc., a preclinical CAR-T therapy developer - On December 23, 2022, the company invested in Dynamic Cell Therapies, Inc. (DCT), a preclinical CAR-T therapy developer, acquiring approximately **19%** of its outstanding capital stock[94](index=94&type=chunk) [Research and Development Phase](index=20&type=section&id=Research%20and%20Development%20Phase) This section clarifies that the company is in the R&D phase and does not anticipate generating revenue until product launch - The company is currently in the research and development phase and does not anticipate generating revenue until its pharmaceutical programs are developed and launched[95](index=95&type=chunk) [Commercial Lease Agreements](index=20&type=section&id=Commercial%20Lease%20Agreements) This section describes the termination of an old office lease and the commencement of a new 12-month operating lease - On June 26, 2023, the company terminated its existing office lease and entered a new 12-month operating lease for a larger office space at the same location for **$3 thousand** monthly rent, commencing July 1, 2023[96](index=96&type=chunk) [Critical Accounting Policies and Significant Estimates](index=20&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Estimates) This section highlights key accounting policies and estimates, including investment impairment and R&D expense recognition - The company's investment in DCT Series Seed Preferred Stock is measured at cost less impairment, with a **$2,990 thousand** impairment charge recorded for the three and six months ended June 30, 2023, due to adverse market conditions and going concern concerns[99](index=99&type=chunk) - Research and development expenses are estimated based on open contracts, work orders, and communication with personnel, with costs generally expensed as incurred[101](index=101&type=chunk) - Stock option awards are measured at fair value on the grant date using the Black-Scholes model and recognized as compensation expense over the vesting period[104](index=104&type=chunk)[105](index=105&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, comparing operating expenses and net loss for current and prior periods [Comparison of the Three Months Ended June 30, 2023 and 2022](index=22&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202023%20and%202022) This subsection compares the company's operating expenses and financial results for the three-month periods - Total operating expenses increased by **$1,198 thousand (18%)** to **$7,793 thousand** for the three months ended June 30, 2023, compared to **$6,595 thousand** in the prior year[108](index=108&type=chunk) | Expense Category (in thousands) | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | Change ($) | Change (%) | | :------------------------------ | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and Development | $3,705 | $3,433 | $272 | 8% | | General and Administrative | $4,088 | $3,162 | $926 | 29% | | Clinical and non-clinical trials| $2,538 | $1,821 | $717 | 39% | | G&A Compensation | $2,534 | $1,826 | $708 | 39% | | Legal and professional fees | $964 | $676 | $288 | 43% | | Interest income | $983 | $11 | $972 | 8836% | | Impairment charge | $2,990 | $- | $2,990 | N/A | - G&A compensation increased due to **$554 thousand** in severance costs for the CFO and **$138 thousand** for new employees, partially offset by a decrease in non-cash stock-based compensation[110](index=110&type=chunk) [Comparison of the Six Months Ended June 30, 2023 and 2022](index=23&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202023%20and%202022) This subsection compares the company's operating expenses and financial results for the six-month periods - Total operating expenses increased by **$3,543 thousand (31%)** to **$14,891 thousand** for the six months ended June 30, 2023, compared to **$11,348 thousand** in the prior year[114](index=114&type=chunk) | Expense Category (in thousands) | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | Change ($) | Change (%) | | :------------------------------ | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and Development | $7,213 | $4,937 | $2,276 | 46% | | General and Administrative | $7,678 | $6,411 | $1,267 | 20% | | Clinical trials | $4,874 | $3,109 | $1,765 | 57% | | G&A Compensation | $4,619 | $3,831 | $788 | 21% | | Legal and professional fees | $1,891 | $1,346 | $545 | 40% | | Interest income | $1,833 | $13 | $1,820 | 14000% | | Impairment charge | $2,990 | $- | $2,990 | N/A | - R&D expense increased primarily due to **$1,765 thousand** higher spending on clinical and non-clinical trials, API, and drug product formulation[115](index=115&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations and funding needs - As of June 30, 2023, the company had **$99,390 thousand** in unrestricted cash and cash equivalents and working capital of **$102,525 thousand**, believing it has sufficient funds for at least the next 12 months[119](index=119&type=chunk) - The company incurred a net loss of **$16,111 thousand** and used **$11,487 thousand** in operating activities for the six months ended June 30, 2023[119](index=119&type=chunk) [Cash Flows](index=24&type=section&id=Cash%20Flows) This section analyzes the sources and uses of cash from operating, investing, and financing activities - Net cash used in operating activities increased by **$660 thousand (6.1%)** to **$11,487 thousand** for the six months ended June 30, 2023, primarily due to increased clinical trial activity[120](index=120&type=chunk) - Net cash used in investing activities remained consistent at **$13 thousand** for both periods, mainly for computer purchases[120](index=120&type=chunk) - No cash was used in financing activities during the six months ended June 30, 2023, or June 30, 2022[121](index=121&type=chunk) [Funding Requirements](index=24&type=section&id=Funding%20Requirements) This section discusses the company's anticipated need for additional capital to support ongoing operations and development - The company expects ongoing operating losses and will need to raise additional capital through equity offerings, debt financings, or collaborations, which may not be available on acceptable terms[122](index=122&type=chunk)[124](index=124&type=chunk) - Stockholders have not approved proposals to increase authorized common stock, which may limit the company's ability to raise capital when needed[126](index=126&type=chunk) [Contractual Obligation](index=25&type=section&id=Contractual%20Obligation) This section outlines the company's significant non-cancellable contractual commitments, such as CRO contracts - As of June 30, 2023, the company had an estimated non-cancellable commitment of **$903 thousand** related to one CRO contract[128](index=128&type=chunk) [Share Repurchase Program](index=25&type=section&id=Share%20Repurchase%20Program) This section details the board-authorized program for repurchasing common stock and its terms - The Board authorized a share repurchase program in June 2023 to buy back up to **$10,000 thousand** of common stock, expiring December 31, 2023[129](index=129&type=chunk) - The program does not obligate the company to acquire a specific number of shares, with timing, manner, price, and amount determined at the company's discretion[129](index=129&type=chunk) [Off-Balance Sheet Arrangements](index=25&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of any off-balance sheet arrangements or relationships with unconsolidated entities - The company does not have any off-balance sheet arrangements or relationships with unconsolidated entities or financial partnerships[130](index=130&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=25&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a smaller reporting company, Atossa Therapeutics is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Atossa Therapeutics is exempt from providing quantitative and qualitative disclosures about market risk[131](index=131&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=25&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) This section details the evaluation of the company's disclosure controls and procedures and reports on any changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=25&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section confirms management's conclusion on the effectiveness of disclosure controls and procedures - Management, with CEO and CFO participation, concluded that disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2023[132](index=132&type=chunk)[134](index=134&type=chunk) [Changes in Internal Control Over Financial Reporting](index=25&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) This section reports on the absence of material changes in internal control over financial reporting during the quarter - There have been no material changes in internal control over financial reporting during the quarter ended June 30, 2023[134](index=134&type=chunk) PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, and other required disclosures not included in the financial statements [ITEM 1. LEGAL PROCEEDINGS](index=26&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not currently a party to any material legal proceedings and believes that any existing claims will not have a material adverse effect on its financial position or operations - The company is not currently a party to any material legal proceedings and believes that existing claims will not materially affect its financial position, results of operations, or cash flows[135](index=135&type=chunk) [ITEM 1A. RISK FACTORS](index=26&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section outlines various risks that could adversely affect the company's business, including operational losses, funding challenges, clinical trial failures, regulatory hurdles, intellectual property issues, industry competition, and risks related to its securities and market listing [Summary of Risk Factors](index=26&type=section&id=Summary%20of%20Risk%20Factors) This section provides a concise overview of the key risks impacting the company's business, operations, and financial performance - The company's business is subject to risks including operating losses, funding needs, clinical trial success, regulatory approvals, intellectual property protection, third-party dependencies, competition, and stock market volatility[136](index=136&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk) [Risks Relating to our Business](index=28&type=section&id=Risks%20Relating%20to%20our%20Business) This section details operational and financial risks, including historical losses, funding needs, and dependencies on third parties - The company has a history of operating losses and has not established ongoing revenue sources, requiring substantial additional capital to fund future operations, which may not be available on acceptable terms[144](index=144&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk) - Successful development and commercial market acceptance of products are uncertain, with potential delays or failures in clinical trials due to safety, efficacy, regulatory approvals, manufacturing, or patient enrollment issues[152](index=152&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk) - The company is highly dependent on third-party service providers for manufacturing, testing, supply chain, and clinical trial activities, and any failure or delay by these parties could harm the business[167](index=167&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) [Risks Related to our Intellectual Property](index=34&type=section&id=Risks%20Related%20to%20our%20Intellectual%20Property) This section addresses challenges in protecting proprietary technology, potential infringement claims, and reliance on trade secrets - The company's commercial success depends on protecting its proprietary technology through patents and licenses, but obtaining and enforcing patents is uncertain, costly, and subject to challenges and changes in patent law[189](index=189&type=chunk)[190](index=190&type=chunk)[192](index=192&type=chunk)[193](index=193&type=chunk)[199](index=199&type=chunk) - Third-party claims of intellectual property infringement could prevent or delay drug development, incur substantial costs, and require licenses that may not be available on commercially reasonable terms[204](index=204&type=chunk)[206](index=206&type=chunk)[207](index=207&type=chunk) - The company relies on trade secret protection and confidentiality agreements, but cannot guarantee prevention of disclosure or independent development by competitors, which could impair its competitive position[210](index=210&type=chunk) [Risks Related to Our Industry](index=37&type=section&id=Risks%20Related%20to%20Our%20Industry) This section covers risks from legislative changes, regulatory compliance, and intense competition within the biopharmaceutical industry - Legislative or regulatory reforms, including changes in FDA policies or healthcare initiatives, could increase costs, lengthen review times, or make it more difficult to obtain approvals and commercialize products[211](index=211&type=chunk)[212](index=212&type=chunk)[213](index=213&type=chunk)[227](index=227&type=chunk) - Failure to comply with complex government regulations concerning patient privacy (HIPAA, GDPR, UK GDPR) could result in significant fines, penalties, litigation, and reputational harm[215](index=215&type=chunk)[216](index=216&type=chunk)[217](index=217&type=chunk)[218](index=218&type=chunk)[219](index=219&type=chunk)[220](index=220&type=chunk)[221](index=221&type=chunk) - The company faces intense competition from larger biotechnology and pharmaceutical companies with greater resources and experience, which could limit market share, pricing, and commercial opportunities[228](index=228&type=chunk)[229](index=229&type=chunk) [Risks Related to the Securities Markets and Investment in our Securities.](index=40&type=section&id=Risks%20Related%20to%20the%20Securities%20Markets%20and%20Investment%20in%20our%20Securities.) This section discusses risks associated with stock market volatility, Nasdaq listing compliance, and anti-takeover provisions - The company faces risks of not satisfying Nasdaq listing standards, including minimum bid price and independent director requirements, which could lead to delisting and adverse consequences for its stock[233](index=233&type=chunk)[234](index=234&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk) - The trading price of the common stock is highly volatile due to various factors, and substantial sales of shares could cause dilution and price decline[237](index=237&type=chunk)[238](index=238&type=chunk)[240](index=240&type=chunk) - Anti-takeover provisions in governing documents and Delaware law, along with a concentrated ownership, could delay or prevent a change in control or influence management and operations[243](index=243&type=chunk)[244](index=244&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=42&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section reports on the company's share repurchase activities for the three months ended June 30, 2023, detailing the number of shares purchased and the remaining value under the authorized program | Period | Total Number of Shares Purchased | Average Price Paid Per Share | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs | Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs | | :--------------------------- | :------------------------------- | :--------------------------- | :------------------------------------------------------------------------------- | :--------------------------------------------------------------------------------------- | | April 1, 2023 to April 30, 2023 | — | — | — | $10,000,000 | | May 1, 2023 to May 31, 2023 | — | — | — | $10,000,000 | | June 1, 2023 to June 30, 2023| 119,382 | $1.27 | 119,382 | $9,847,597 | | Total | 119,382 | | 119,382 | | - All repurchases were made pursuant to the publicly announced Share Repurchase Program, authorized in June 2023 for up to **$10.0 million** of common stock, expiring December 31, 2023[248](index=248&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=42&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) The company reported no defaults upon senior securities for the period - There were no defaults upon senior securities[250](index=250&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=42&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the company - Mine Safety Disclosures are not applicable to the company[250](index=250&type=chunk) [ITEM 5. OTHER INFORMATION](index=42&type=section&id=ITEM%205.%20OTHER%20INFORMATION) The company reported no other information for the period - No other information was reported[250](index=250&type=chunk) [ITEM 6. EXHIBITS](index=43&type=section&id=ITEM%206.%20EXHIBITS) This section lists the exhibits filed with the Form 10-Q, including certifications from the CEO and CFO, and XBRL-related documents - Exhibits include certifications from the Chief Executive Officer and Chief Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[252](index=252&type=chunk) - The filing also includes Inline XBRL Instance Document, Taxonomy Extension Schema Document, Calculation Linkbase Document, Definition Linkbase Document, Labels Linkbase Document, Presentation Linkbase Document, and Cover Page Interactive Data File[252](index=252&type=chunk) [SIGNATURES](index=44&type=section&id=SIGNATURES) The report is duly signed on behalf of the registrant by the President and Chief Executive Officer, Steven C. Quay, and the Executive Vice President, Chief Financial Officer, and Secretary, Greg Weaver - The report was signed on **August 14, 2023**, by Steven C. Quay, President and Chief Executive Officer, and Greg Weaver, Executive Vice President, Chief Financial Officer, and Secretary[253](index=253&type=chunk)

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 ...