SEATTLE, April 22, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced that the United States Patent and Trademark Office (USPTO) has granted a new patent (U.S. Patent No. 12,275,684) directed to enteric oral formulations comprising (Z)-endoxifen as well as methods of treating subjects with those oral formulations. This newly granted patent further fortifie ...

Atossa Genetics Inc. (ATOS) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.The power ...

Atossa Therapeutics, Inc. (NASDAQ:ATOS) Q4 2024 Earnings Conference Call March 25, 2025 8:30 AM ET Company Participants Michael Parks - VP of Investor and Public Relations Steven Quay - President and CEO Heather Rees - CFO Conference Call Participants Emily Bodnar - H.C. Wainwright Edward Woo - Ascendiant Capital Operator Good morning, everyone, and welcome to the Atossa Therapeutics Fourth Quarter and Full Year 2024 Earnings Conference Call. My name is Joelle, and I will be your conference operator today. ...

Drug Development and Clinical Trials - The company is developing oral (Z)-endoxifen for breast cancer prevention and treatment, with a focus on overcoming the limitations of tamoxifen[27]. - Four Phase 2 clinical trials are currently investigating (Z)-endoxifen, including the EVANGELINE trial, which aims to enroll approximately 190 patients[30]. - In the EVANGELINE trial, approximately 50% of patients in the 80 mg cohort reached the target plasma concentration of 500 to 1000 ng/mL, with an average plasma concentration of 484 ng/mL[31]. - The Karisma-(Z)-endoxifen study showed that the 1 mg dose reduced mammographic breast density by 17.3% and the 2 mg dose by 23.5%, compared to a minimal change of 0.27 percentage points in the placebo group[38]. - The I-SPY 2 trial reported that (Z)-endoxifen reduced Ki-67 by 69% and functional tumor volume by 30.4% after three weeks of treatment[44]. - The company plans to pursue a metastatic breast cancer indication for (Z)-endoxifen to expedite regulatory approval[51]. - The company may encounter delays in clinical trials or may not be able to conduct them in a timely manner, impacting product development[155]. - The company reported that interim clinical trial data may differ from final results, impacting the perceived value and approval of its product candidates[178]. - The company may experience delays in clinical trials due to various factors, including patient enrollment issues and regulatory approvals, which could hinder product commercialization[197]. Financial Performance and Capital Resources - As of December 31, 2024, the company had cash and cash equivalents of approximately $71.1 million[56]. - Research and development (R&D) expenses for the years ended December 31, 2024 and 2023 were approximately $14.1 million and $17.3 million, respectively, indicating a decrease of about 18.9%[62]. - The company has a history of operating losses and has not established sources of ongoing revenue to cover operating costs, which raises concerns about its ability to continue as a going concern[161]. - The company expects to need to raise substantial additional capital in the future to fund operations, as it currently has no sources of revenue[162]. - The company incurred net losses of approximately $25.5 million and $30.1 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of approximately $211.8 million since inception[162]. Market Potential and Competitive Landscape - The global ER+ breast cancer treatment market is projected to reach $33.7 billion by 2030, growing at a CAGR of 7.89% from 2024 to 2030[54]. - The potential U.S. market for (Z)-endoxifen in breast cancer treatment and prevention could be up to $1 billion or more annually[54]. - The company may not achieve significant commercial market acceptance for its products, which could hinder revenue generation[169]. Regulatory Environment and Compliance - The FDA review user fee for submitting a New Drug Application (NDA) is $4.3 million for fiscal year 2025, highlighting the financial requirements for drug approval[82]. - Approval of a New Drug Application (NDA) requires FDA inspection of clinical sites and manufacturing facilities, with concerns potentially delaying approval[85]. - The FDA has various programs to expedite drug review processes, including breakthrough therapy designation and accelerated approval, which may allow for approval based on surrogate endpoints for serious conditions[84]. - The company is subject to rigorous regulation by the FDA and other international agencies, which may delay or prevent product approvals[180]. Intellectual Property and Legal Risks - The company owns and is pursuing 119 pending patent applications and has 13 issued patents as of February 3, 2025, which are crucial for its competitive advantage[212]. - On August 18, 2023, Intas Pharmaceuticals LTD. filed a Petition for Post Grant Review (PGR) to invalidate claims of U.S. Patent No. 11,572,334 titled "Methods for Making and Using Endoxifen"[217]. - On January 29, 2025, the PTAB issued a final decision declaring all claims under the Patent unpatentable[218]. - Litigation related to proprietary technology may lead to substantial costs and distract management, with risks of compromising confidential information during discovery[219]. - The current patent portfolio may not encompass all necessary rights for full product development and commercialization, potentially delaying or preventing product launches[224]. Operational Risks and Challenges - The company is dependent on third-party service providers for critical operational activities, which poses risks to its business[155]. - The company may face challenges in establishing sales, marketing, and commercial supply capabilities if any product candidates are approved[170]. - The company faces challenges in attracting and retaining qualified personnel, particularly in the greater Seattle area, which may lead to increased operating expenses due to labor shortages and high inflation[174]. - Business disruptions, including natural disasters and pandemics, could materially harm the company's financial condition and increase operational costs[202]. Corporate Governance and Management - The company employs two executive officers and thirteen full-time employees, with plans to hire more as current and future programs develop[148]. - The loss of the Chief Executive Officer could adversely affect the company's business, as his experience is critical for executing the business plan[171]. - The company aims to attract, retain, and motivate personnel through stock-based and cash-based compensation awards, aligning interests with stockholders[149].

Financial Performance - Atossa Therapeutics ended 2024 with $71.1 million in cash and cash equivalents and no debt[1]. - Total operating expenses decreased to $27.6 million in 2024, down from $31.4 million in 2023, representing a reduction of approximately 12.1%[7]. - Net loss narrowed from $30,094,000 in 2023 to $25,504,000 in 2024, reflecting an improvement of about 15.1%[20]. - Net loss per share improved from $(0.24) in 2023 to $(0.20) in 2024, indicating a positive trend[20]. - Total stockholders' equity decreased from $91,016,000 in 2023 to $71,477,000 in 2024, a decline of approximately 21.5%[18]. Research and Development - Research and Development (R&D) expenses totaled $14.1 million in 2024, a decrease of 19% from $17.3 million in 2023, primarily due to reduced spending on (Z)-endoxifen trials[8]. - Atossa is currently studying (Z)-endoxifen in four Phase 2 trials targeting various breast cancer indications[13]. - The 4-week Ki-67 ≤ 10% response rate was above 85% across dosing levels in the Phase 2 EVANGELINE trial[2]. - (Z)-endoxifen demonstrated a 17.3 percentage-point reduction in mammographic breast density at a 1 mg dose and a 23.5 percentage-point reduction at a 2 mg dose, both statistically significant (p<0.01)[2]. - The company plans to advance (Z)-endoxifen for metastatic breast cancer, aiming for a more streamlined regulatory pathway[2]. General and Administrative Expenses - General and Administrative (G&A) expenses totaled $13.5 million in 2024, a decrease of 4% from $14.0 million in 2023[9]. - G&A compensation expenses decreased by $1.9 million in 2024, primarily due to lower cash and non-cash stock-based compensation[12]. - General and administrative expenses slightly decreased from $14,043,000 in 2023 to $13,504,000 in 2024, a decline of about 3.8%[20]. Assets and Cash Flow - Total assets decreased from $96,252,000 in 2023 to $76,444,000 in 2024, a decline of approximately 20.6%[18]. - Cash and cash equivalents fell from $88,460,000 in 2023 to $71,084,000 in 2024, representing a decrease of about 19.6%[18]. - Interest income for 2024 was $4.1 million, a decrease of $0.2 million compared to the previous year[10]. - Interest income decreased from $4,343,000 in 2023 to $4,050,000 in 2024, a decline of about 6.7%[20]. - Impairment charge on investment in equity securities decreased from $2,990,000 in 2023 to $1,710,000 in 2024, a reduction of approximately 42.8%[20].

Ended 2024 with $71.1 million of cash and cash equivalents and no debt Conference Call and Webcast Scheduled for Tuesday, March 25, 2025, at 8:30 a.m. Eastern Time SEATTLE, March 25, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced its financial results for the full year ended December 31, 2024 and provided an update on recent company developments. Fourth ...

Financial Performance - Atossa Therapeutics ended 2024 with $71.1 million in cash and cash equivalents and no debt [1] - Total operating expenses decreased to $27.6 million in 2024 from $31.4 million in 2023, a reduction of $3.8 million [7] - The net loss for 2024 was $25.5 million, compared to a net loss of $30.1 million in 2023, indicating an improvement in financial performance [21] Research and Development - Atossa plans to advance its lead program, (Z)-endoxifen, targeting metastatic breast cancer, which is seen as a critical unmet need [3][5] - The Phase 2 EVANGELINE trial showed substantial tumor suppression with (Z)-endoxifen, achieving a 4-week Ki-67 ≤ 10 percent response rate above 85% across dosing levels [5] - The Phase 2 KARISMA-Endoxifen study demonstrated that a 1 mg dose of (Z)-endoxifen reduced mammographic breast density by 17.3 percentage points, while a 2 mg dose achieved a 23.5 percentage-point reduction [5] Strategic Focus - The company is pursuing an initial approval for (Z)-endoxifen in metastatic breast cancer to expedite availability for patients [3][5] - Atossa is also engaging with the FDA to explore additional indications for (Z)-endoxifen, including breast cancer prevention and neoadjuvant therapy [5] Operating Expenses Breakdown - Research and development expenses totaled $14.1 million in 2024, down from $17.3 million in 2023, primarily due to decreased spending on (Z)-endoxifen trials [8] - General and administrative expenses decreased to $13.5 million in 2024 from $14.0 million in 2023, with a notable reduction in compensation expenses [10][11] Cash Flow and Investments - Interest income for 2024 was $4.1 million, a decrease of $0.2 million from the previous year, attributed to reduced funds in the money market account [12] - The company recorded an impairment charge on investment in equity securities of $1.7 million in 2024, down from $3.0 million in 2023 [12]

Core Viewpoint - Atossa Therapeutics, Inc. will host a conference call and live audio webcast on March 25, 2025, to discuss its corporate and financial results for Q4 and full-year 2024 [1] Group 1: Conference Call Details - The conference call is scheduled for 8:30 a.m. Eastern Time [1] - U.S. callers can dial 1-800-836-8184, while international listeners should dial 1-646-357-8785 to join the call [2] - A replay of the conference call will be available for 30 days on the company's investor relations website [3] Group 2: Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on innovative treatments for breast cancer [4] - The lead product candidate, (Z)-endoxifen, is designed for various breast cancer settings, including metastatic and prevention [4] - The company aims to advance clinical research programs to improve patient outcomes and create shareholder value [4]

Core Insights - Atossa Therapeutics congratulates Dr. Tessa Cigler and her team for receiving a $2.3 million grant from the CDC to improve care for young breast cancer patients in New York City [1][2][3] Group 1: Grant and Initiative Details - The CDC grant will fund initiatives aimed at enhancing equitable access to care, quality of life, and survival outcomes for young breast cancer patients [1] - Dr. Cigler will collaborate with Dr. Vered Stearns and a multidisciplinary team to address the unique needs of young breast cancer patients from diverse backgrounds [2] - The program will focus on care coordination, culturally relevant resources, and targeted interventions for the physical, emotional, and mental well-being of patients and caregivers [2] Group 2: Company Support and Vision - Atossa Therapeutics expresses pride in Dr. Cigler's dedication to advancing breast cancer care and addressing health disparities [3] - The company supports innovative and inclusive approaches to breast cancer treatment and survivorship [3] - Atossa looks forward to the positive impact of the initiative on young breast cancer patients and their families [3] Group 3: Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative medicines for significant unmet medical needs in oncology, particularly breast cancer [4]

SEATTLE, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the prevention and treatment of breast cancer, today issued the following statement in response to the Patent Trial and Appeal Board's (PTAB) final written decision in PGR2023-00043 regarding U.S. Patent No. 11,572,334 (the "'334 patent"). Atossa is disappointed with the PTAB's decision finding all challenged claims in the '334 patent unpaten ...