Financial Data and Key Metrics Changes - Total operating expenses for 2024 were $27.6 million, down from $31.4 million in 2023, a decrease of $3.8 million [29] - R&D expenses declined by $3.2 million from $17.3 million in 2023 to $14.1 million in 2024, primarily due to reduced spending on (Z)-endoxifen trials [30] - Net loss for 2024 was $25.5 million or $0.20 per share, compared to $30.1 million or $0.24 per share in 2023 [34] - The company closed the year with $71.1 million in cash and cash equivalents, providing a healthy runway for advancing (Z)-endoxifen and other research initiatives [34] Business Line Data and Key Metrics Changes - The focus remains on the lead program (Z)-endoxifen, which is positioned as a next-generation anti-estrogen therapy for breast cancer [12][17] - The company aims to address significant unmet needs in endocrine therapy for breast cancer, including patient adherence and drug resistance [10][11] Market Data and Key Metrics Changes - The company is prioritizing the metastatic breast cancer indication for (Z)-endoxifen, which is a clinical setting of high unmet need [19] - Clinical investigations have shown a clinical benefit rate of approximately 26% in patients with endocrine refractory ER-positive HER2-negative metastatic breast cancer [21] Company Strategy and Development Direction - The company plans to advance (Z)-endoxifen in metastatic breast cancer first, potentially leading to a more streamlined path to regulatory approval [19][26] - There is a commitment to continue dialogue with the FDA regarding the potential for (Z)-endoxifen in earlier disease settings [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of (Z)-endoxifen to transform breast cancer treatment, especially in metastatic disease where new options are urgently needed [36] - The company remains focused on executing research and regulatory strategies to meet clinical milestones [27] Other Important Information - The company reported a write-off of $1.7 million related to its investment in dynamic cell therapies, which ceased operations in Q4 2024 [33] - Professional fees increased by $1.8 million year-over-year, primarily due to higher legal and investor relation costs [32] Q&A Session Summary Question: Timing for initiating a study in the metastatic setting - Management is consulting with key opinion leaders and plans to discuss details with the FDA over the next four to six months [39][40] Question: Update on EVANGELINE trial enrollment and data - Updates on enrollment and interim data results will be provided at upcoming meetings; the primary endpoint difference is due to requirements for early Ki-67 value assessments [43] Question: Pursuing global markets for metastatic breast cancer - The focus is currently on the U.S. FDA process, with plans to consider other major markets in early 2026 [48]

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].

Core Viewpoint - Atossa Therapeutics is focusing on advancing its lead product candidate, (Z)-endoxifen, for the treatment of metastatic breast cancer, which is an area with significant unmet medical needs. The company believes that this approach may provide a more efficient regulatory pathway to bring the therapy to patients sooner [3][5]. Financial Performance - For the year ended December 31, 2024, Atossa reported total operating expenses of $27.6 million, a decrease of $3.8 million from $31.4 million in 2023 [7]. - Research and Development (R&D) expenses totaled $14.1 million in 2024, down from $17.3 million in 2023, reflecting a decrease in spending on (Z)-endoxifen trials [8]. - General and Administrative (G&A) expenses were $13.5 million for 2024, compared to $14.0 million in 2023, indicating a slight reduction [10]. Cash Position - Atossa ended 2024 with $71.1 million in cash and cash equivalents and no debt, positioning the company favorably for future developments [1][19]. Clinical Development - The company is advancing (Z)-endoxifen as a potential next-generation therapy for metastatic breast cancer, supported by promising results from previous clinical trials [3][5]. - The Phase 2 EVANGELINE trial showed substantial tumor suppression with (Z)-endoxifen, achieving a Ki-67 response rate above 85% across dosing levels [5]. - Data from the Phase 2 KARISMA-Endoxifen study indicated that low-dose (Z)-endoxifen significantly reduced mammographic breast density, with a 1 mg dose reducing it by 17.3 percentage points and a 2 mg dose by 23.5 percentage points [5]. Strategic Focus - Atossa plans to continue engaging with the U.S. Food and Drug Administration (FDA) to pursue additional indications for (Z)-endoxifen, including breast cancer prevention and neoadjuvant therapy [5]. - The company is committed to transforming breast cancer treatment through innovative science and patient-focused solutions, with (Z)-endoxifen being central to this strategy [16][17].

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]

Core Viewpoint - Atossa Therapeutics expresses disappointment over the Patent Trial and Appeal Board's (PTAB) decision to find all challenged claims in U.S. Patent No. 11,572,334 unpatentable, but the decision does not affect the formulations currently in clinical development [2][5] Patent Developments - Atossa will not appeal the PTAB decision due to cost and time considerations, and will instead focus on obtaining patent protection for its current formulations through a new Continuation Patent Application [2] - A new patent, U.S. Patent No. 12,201,591, was issued on January 21, 2025, covering sustained release compositions of endoxifen with 31 claims [3] - Atossa's patent estate includes several patents: U.S. Patent No. 11,261,151 (21 claims), U.S. Patent No. 11,680,036 (22 claims), U.S. Patent No. 12,071,391 (44 claims), and the newly issued U.S. Patent No. 12,201,591 (31 claims), providing a comprehensive coverage for its formulations [4] Product Development - Atossa is developing a proprietary oral formulation of (Z)-endoxifen designed to bypass stomach acidity, which can convert a significant portion of (Z)-endoxifen to an inactive form [6] - (Z)-endoxifen has shown good tolerability in Phase 1 studies and is currently being evaluated in five Phase 2 trials targeting various breast cancer conditions [6] - The company aims to provide better treatment options for breast cancer patients through its innovative (Z)-endoxifen formulations [5][7]

Core Viewpoint - Atossa Therapeutics expresses disappointment over the Patent Trial and Appeal Board's decision to invalidate claims in U.S. Patent No. 11,572,334, but this decision does not affect its current clinical formulations [2][5] Patent Developments - The company is evaluating options following the PTAB's ruling but will not appeal due to cost and time considerations, opting instead to pursue additional patent protection through a new Continuation Patent Application [2] - A new patent, U.S. Patent No. 12,201,591, was issued on January 21, 2025, focusing on sustained release compositions of endoxifen, adding to Atossa's patent estate [3][4] Clinical Development - Atossa is developing a proprietary oral formulation of (Z)-endoxifen, which is designed to bypass stomach acidity that deactivates the drug [6] - (Z)-endoxifen is currently undergoing five Phase 2 clinical trials targeting various breast cancer conditions, demonstrating well-tolerated results in earlier studies [6] Company Mission - Atossa Therapeutics is committed to providing innovative treatment options for breast cancer, focusing on (Z)-endoxifen as a potential preventive and therapeutic agent [7]

Core Insights - Atossa Therapeutics has made significant progress in 2024, particularly with (Z)-endoxifen, which shows promise in breast cancer prevention and treatment [1][4][16] Clinical Program Updates - The completion of the KARISMA-Endoxifen Phase 2 Study demonstrated significant reductions in mammographic breast density (MBD), with decreases of 17.3 percentage points in the 1 mg arm and 23.5 percentage points in the 2 mg arm, both statistically significant (p<0.01) [2][3] - The EVANGELINE trial has shown promising initial results, achieving the primary endpoint with 50% of patients in the 80 mg (Z)-endoxifen with goserelin group meeting target plasma concentrations [5][6] - Significant tumor suppression was observed across all dosing levels in the EVANGELINE trial, with a Ki-67 ≤10% response rate consistently above 85% [7] Intellectual Property and Financial Position - The company secured two additional U.S. patents for (Z)-endoxifen, enhancing its intellectual property portfolio and pipeline value [14] - Atossa maintains a strong cash position, allowing for efficient funding of research and development efforts while ensuring operational stability [15] Future Directions - The company aims to advance (Z)-endoxifen into registrational clinical trials in 2025, focusing on expediting its market entry [18] - Ongoing business development efforts will be amplified to ensure global access to (Z)-endoxifen [18] - Collaborations with industry leaders and advocacy groups will be deepened to broaden the impact of Atossa's work [18]