Atossa Therapeutics(ATOS) - 2023 Q3 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Condensed Consolidated Financial Statements 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] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses (Z)-endoxifen clinical development, mixed operating expense trends, an impairment charge, liquidity, and Nasdaq non-compliance Company Overview and Leading Programs 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] - 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][90][94][96] - In December 2022, the company invested in Dynamic Cell Therapies, Inc. (DCT), acquiring approximately 19% of its outstanding capital stock[98] Results of Operations 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] Liquidity and Capital Resources 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] - 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] - 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] - 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][132] Item 3. Quantitative and Qualitative Disclosures about Market Risk 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] Item 4. Controls and Procedures 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] - 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] PART II. OTHER INFORMATION Item 1. Legal Proceedings 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] - The company intends to contest the petition, believing the patent was properly granted and is valid and enforceable[71] Item 1A. Risk Factors 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][155] - 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][198] - 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][239] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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] Item 3. Defaults upon Senior Securities The company reported no defaults upon senior securities - None[253] Item 4. Mine Safety Disclosures This item is not applicable to the company - Not applicable[253] Item 5. Other Information The company reported no other information for this item - None[253] Item 6. Exhibits This section lists exhibits filed with Form 10-Q, including SOX certifications and Inline XBRL documents