<p><em>新专利进一步加强了全球知识产权体系，支持 Atossa 在乳腺癌领域及其他激素驱动疾病的领先项目</em></p>
<p>, /PRNewswire/ -- Atossa Therapeutics, Inc. (纳斯达克：ATOS)（&#34;Atossa&#34;或&#34;公司&#34;）是一家临床阶段的生物制药公司，致力于开发在乳腺癌领域具有重大未满足需求的创新疗法，今天宣布美国专利商标局（USPTO）授予美国专利号 12,479,790 B2，标题为《制备和使用 Endoxifen 的方法》。</p>
<p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2685652/Atossa1_Logo.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2685652/Atossa1_Logo.jpg"/></p>
<p>新授予的专利包括 100 项针对高纯度 (Z)-endoxifen 游离碱的肠溶口服制剂的权利要求，以及使用这些组合物治疗一系列激素依赖性乳腺疾病和其他雌激素相关疾病的方法。该专利还涵盖了特定的固体口服剂型和稳定配方，提供具有治疗意义的持续系统性暴露于 (Z)-endoxifen。</p>
<p>&#34;我们相信这项专利显著延伸并加强了我们已经强大的 endoxifen 专利组合，&#34;Atossa 的总裁兼首席执行官 Steven Quay 博士表示。&#34;通过涵盖可扩展的生产工艺和关键的使用方法，这项专利支持我们长期战略，将 (Z)-endoxifen 定位为乳腺癌领域的差异化疗法，从风险降低和新辅助治疗到辅助治疗和转移性疾病，同时也为其他激素驱动疾病提供机会。</p>
<p>&#34;结合之前授予的涵盖储存稳定和缓释 endoxifen 制剂的美国专利，以及今年早些时候授予的更广泛的配方专利，这项新专利进一步巩固了我们在 endoxifen 治疗领域的领导地位。强大而持久的知识产权基础对于我们投资于晚期临床试验和未来潜在商业化至关重要，&#34;Quay 博士总结道。</p>
<p>Atossa 目前正在多个临床环境中推进其专有的 (Z)-endoxifen，包括：</p>
<ul>
<li><strong>转移性乳腺癌（MBC）：</strong> 一项剂量范围研究正在准备中，作为公司支持注册开发的战略的一部分。</li>
<li><strong>新辅助 ER+/HER2-乳腺癌：</strong> 在第 2 阶段 EVANGELINE 试验中继续招募和数据生成。</li>
<li><strong>乳腺癌风险降低：</strong> 开发包括针对乳腺密度和整体乳腺癌风险的低剂量策略。</li>
</ul>
<p>公司的专利组合不断增长，目前包括多个已授予的美国专利和全球相应申请，旨在为 (Z)-endoxifen 制剂、生产工艺和乳腺癌治疗及风险降低的关键治疗用途提供长期独占权。</p>
<p><strong>关于美国专利号 12,479,790</strong></p>
<p>美国专利号 12,479,790 B2，《制备和使用 Endoxifen 的方法》，归属于 Atossa Therapeutics, Inc. 该专利有 100 项权利要求，针对高纯度 (Z)-endoxifen 游离碱的肠溶口服制剂，以及使用这些组合物治疗一系列激素依赖性乳腺疾病和其他雌激素相关疾病的方法。该专利还涵盖了特定的固体口服剂型和稳定配方，提供具有治疗意义的持续系统性暴露于 (Z)-endoxifen。</p>
<p><strong>关于 (Z)-Endoxifen</strong></p>
<p>(Z)-endoxifen 是最强效的选择性雌激素受体调节剂（SERM）之一，具有抑制雌激素受体的作用，并可能促进雌激素受体的降解。它在肿瘤对其他激素疗法产生耐药的情况下显示出活性，并已被证明在临床可达浓度下靶向已知的致癌蛋白 PKCβ1。Atossa 继续优化其专有的 (Z)-endoxifen 口服制剂，旨在最小化胃部暴露并保持活性 Z 异构体，并确保在一系列乳腺癌预防和治疗适应症中保持一致的系统性暴露。</p>
<p><strong>关于 Atossa Therapeutics</strong></p>
<p>Atossa Therapeutics, Inc.（纳斯达克：ATOS）是一家临床阶段的生物制药公司，致力于开发在乳腺癌领域具有重大未满足需求的创新疗法。公司的主要产品候选药物 (Z)-endoxifen，正在作为一种高效的 SERM 开发，适用于乳腺癌的整个治疗过程。有关更多信息，请访问 www.atossatherapeutics.com。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含某些适用证券法意义上的&#34;前瞻性声明&#34;，包括但不限于我们对公司发展和监管战略及相关里程碑的预期，公司可能追求的 (Z)-endoxifen 潜在适应症，(Z)-endoxifen 获得监管批准的潜力及其时机，公司专利组合的强度，以及公司潜在市场和增长机会。诸如&#34;预期&#34;、&#34;潜在&#34;、&#34;继续&#34;、&#34;可能&#34;、&#34;将&#34;、&#34;应该&#34;、&#34;可以&#34;、&#34;会&#34;、&#34;寻求&#34;、&#34;打算&#34;、&#34;计划&#34;、&#34;估计&#34;、&#34;预期&#34;、&#34;相信&#34;、&#34;设计&#34;、&#34;预测&#34;、&#34;未来&#34;或其他类似表达或关于意图、信念或当前预期的声明，均为前瞻性声明。</p>
<p>本新闻稿中的前瞻性声明受到风险和不确定性的影响，这可能导致实际结果、结果或实际结果或结果的时间与预期或预测的结果有重大差异，包括但不限于与以下事项相关的风险和不确定性：我们成功执行缩短临床开发时间表并追求转移性乳腺癌适应症或其他适应症（Z）- 恩多昔芬的能力；我们预期的前临床研究、临床试验和研发项目的时间、完成和结果；前临床研究结果与临床研究结果之间不可预测的关系；监管申请和批准的时间或可能性；必要监管批准的结果或时间；我们恢复并维持符合纳斯达克上市要求的能力；我们建立和维护覆盖我们产品的知识产权的能力；一般宏观经济条件对我们业务的影响；我们筹集资金的能力；以及不时在 Atossa 向 SEC 提交的文件中详细说明的其他风险和不确定性，包括但不限于其 10-K 表格的年度报告和 10-Q 表格的季度报告。</p>
<p>前瞻性声明以本新闻稿发布之日为准。除法律要求外，我们不打算更新任何前瞻性声明。</p>
<p>来源：Atossa Therapeutics Inc</p>

ATOS

<p>Atossa Therapeutics 宣布获得美国专利号 12,479,790 B2，该专利涵盖了 (Z)-endoxifen 的肠道口服制剂及治疗激素依赖性乳腺疾病的方法。该专利增强了 Atossa 在乳腺癌治疗和激素驱动疾病方面的知识产权，支持其将 (Z)-endoxifen 作为差异化疗法的战略。该专利包含 100 项权利要求，涵盖可扩展的生产工艺和治疗用途，进一步巩固了 Atossa 在 endoxifen 治疗领域的领导地位</p>

<p><em>New patent further strengthens global intellectual property estate supporting Atossa's lead program across the breast cancer spectrum and other hormone-driven conditions</em></p>
<div class="lb-trans"><p><em>新专利进一步加强了全球知识产权体系，支持 Atossa 在乳腺癌领域及其他激素驱动疾病的领先项目</em></p>
</div><p>, /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (&#34;Atossa&#34; or the &#34;Company&#34;), a clinical-stage biopharmaceutical company developing innovative therapies in areas of significant unmet need in breast cancer, today announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 12,479,790 B2, titled, &#34;Methods for Making and Using Endoxifen.&#34;</p>
<div class="lb-trans"><p>, /PRNewswire/ -- Atossa Therapeutics, Inc. (纳斯达克：ATOS)（&#34;Atossa&#34;或&#34;公司&#34;）是一家临床阶段的生物制药公司，致力于开发在乳腺癌领域具有重大未满足需求的创新疗法，今天宣布美国专利商标局（USPTO）授予美国专利号 12,479,790 B2，标题为《制备和使用 Endoxifen 的方法》。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2685652/Atossa1_Logo.jpg" alt="" original-src="https://mma.prnewswire.com/media/2685652/Atossa1_Logo.jpg"/></p>
<p>The newly issued patent includes 100 claims directed to enteric oral formulations of highly pure (Z)-endoxifen free base, as well as methods of using those compositions to treat a range of hormone-dependent breast disorders and other estrogen-related conditions. The patent also covers specific solid oral dosage forms and stable formulations providing therapeutically meaningful and sustained systemic exposure to (Z)-endoxifen.</p>
<div class="lb-trans"><p>新授予的专利包括 100 项针对高纯度 (Z)-endoxifen 游离碱的肠溶口服制剂的权利要求，以及使用这些组合物治疗一系列激素依赖性乳腺疾病和其他雌激素相关疾病的方法。该专利还涵盖了特定的固体口服剂型和稳定配方，提供具有治疗意义的持续系统性暴露于 (Z)-endoxifen。</p>
</div><p>&#34;We believe this patent meaningfully extends and reinforces our already robust endoxifen patent estate,&#34; said Steven Quay, M.D., Ph.D., Atossa's President and Chief Executive Officer. &#34;By covering both scalable manufacturing processes and key methods of use, this patent supports our long-term strategy to position (Z)-endoxifen as a differentiated therapy across the breast cancer spectrum, from risk-reduction and neoadjuvant treatment through adjuvant and metastatic disease, while also enabling opportunities in other hormone-driven conditions.</p>
<div class="lb-trans"><p>&#34;我们相信这项专利显著延伸并加强了我们已经强大的 endoxifen 专利组合，&#34;Atossa 的总裁兼首席执行官 Steven Quay 博士表示。&#34;通过涵盖可扩展的生产工艺和关键的使用方法，这项专利支持我们长期战略，将 (Z)-endoxifen 定位为乳腺癌领域的差异化疗法，从风险降低和新辅助治疗到辅助治疗和转移性疾病，同时也为其他激素驱动疾病提供机会。</p>
</div><p>&#34;Together with previously issued U.S. patents covering storage-stable and sustained-release endoxifen formulations, and broader formulation patents granted earlier this year, this new patent further consolidates our leadership position in endoxifen therapeutics. A strong and durable intellectual property foundation is essential as we invest in late-stage clinical trials and potential future commercialization,&#34; concluded Dr. Quay.</p>
<div class="lb-trans"><p>&#34;结合之前授予的涵盖储存稳定和缓释 endoxifen 制剂的美国专利，以及今年早些时候授予的更广泛的配方专利，这项新专利进一步巩固了我们在 endoxifen 治疗领域的领导地位。强大而持久的知识产权基础对于我们投资于晚期临床试验和未来潜在商业化至关重要，&#34;Quay 博士总结道。</p>
</div><p>Atossa is currently advancing its proprietary (Z)-endoxifen in multiple clinical settings, including:</p>
<div class="lb-trans"><p>Atossa 目前正在多个临床环境中推进其专有的 (Z)-endoxifen，包括：</p>
</div><ul>
<li><strong>Metastatic breast cancer (MBC):</strong> A dose-ranging study is in preparation as part of the Company's strategy to support registrational development.</li>
<li><strong>Neoadjuvant ER+/HER2- breast cancer:</strong> Enrollment and data generation continue in the Phase 2 EVANGELINE trial.</li>
<li><strong>Breast cancer risk-reduction:</strong> Development includes a low-dose strategy targeting mammographic breast density and overall breast cancer risk.</li>
</ul>
<div class="lb-trans"><ul>
<li><strong>转移性乳腺癌（MBC）：</strong> 一项剂量范围研究正在准备中，作为公司支持注册开发的战略的一部分。</li>
<li><strong>新辅助 ER+/HER2-乳腺癌：</strong> 在第 2 阶段 EVANGELINE 试验中继续招募和数据生成。</li>
<li><strong>乳腺癌风险降低：</strong> 开发包括针对乳腺密度和整体乳腺癌风险的低剂量策略。</li>
</ul>
</div><p>The Company's growing patent portfolio, which now includes multiple issued U.S. patents and corresponding applications worldwide, is intended to provide long-term exclusivity for (Z)-endoxifen formulations, manufacturing processes, and key therapeutic uses in breast cancer treatment and risk reduction.</p>
<div class="lb-trans"><p>公司的专利组合不断增长，目前包括多个已授予的美国专利和全球相应申请，旨在为 (Z)-endoxifen 制剂、生产工艺和乳腺癌治疗及风险降低的关键治疗用途提供长期独占权。</p>
</div><p><strong>About U.S. Patent No. 12,479,790</strong></p>
<div class="lb-trans"><p><strong>关于美国专利号 12,479,790</strong></p>
</div><p>U.S. Patent No. 12,479,790 B2, &#34;Methods for Making and Using Endoxifen,&#34; is assigned to Atossa Therapeutics, Inc. The patent has 100 claims directed to enteric oral formulations of highly pure (Z)-endoxifen free base, as well as methods of using those compositions to treat a range of hormone-dependent breast disorders and other estrogen-related conditions. The patent also covers specific solid oral dosage forms and stable formulations providing therapeutically meaningful and sustained systemic exposure to (Z)-endoxifen.</p>
<div class="lb-trans"><p>美国专利号 12,479,790 B2，《制备和使用 Endoxifen 的方法》，归属于 Atossa Therapeutics, Inc. 该专利有 100 项权利要求，针对高纯度 (Z)-endoxifen 游离碱的肠溶口服制剂，以及使用这些组合物治疗一系列激素依赖性乳腺疾病和其他雌激素相关疾病的方法。该专利还涵盖了特定的固体口服剂型和稳定配方，提供具有治疗意义的持续系统性暴露于 (Z)-endoxifen。</p>
</div><p><strong>About (Z)-Endoxifen</strong></p>
<div class="lb-trans"><p><strong>关于 (Z)-Endoxifen</strong></p>
</div><p>(Z)-endoxifen is one of the most potent selective estrogen receptor modulators (SERMs) for estrogen receptor inhibition and may also promote estrogen receptor degradation. It has demonstrated activity in settings where tumors have developed resistance to other hormonal therapies and has been shown to target PKCβ1, a known oncogenic protein, at clinically achievable concentrations. Atossa continues to optimize its proprietary oral formulation of (Z)-endoxifen, which is designed to minimize stomach exposure and maintain the active Z-isomer, and ensures consistent systemic exposure across a range of breast cancer prevention and treatment indications.</p>
<div class="lb-trans"><p>(Z)-endoxifen 是最强效的选择性雌激素受体调节剂（SERM）之一，具有抑制雌激素受体的作用，并可能促进雌激素受体的降解。它在肿瘤对其他激素疗法产生耐药的情况下显示出活性，并已被证明在临床可达浓度下靶向已知的致癌蛋白 PKCβ1。Atossa 继续优化其专有的 (Z)-endoxifen 口服制剂，旨在最小化胃部暴露并保持活性 Z 异构体，并确保在一系列乳腺癌预防和治疗适应症中保持一致的系统性暴露。</p>
</div><p><strong>About Atossa Therapeutics</strong></p>
<div class="lb-trans"><p><strong>关于 Atossa Therapeutics</strong></p>
</div><p>Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative therapies in areas of significant unmet need in breast cancer. The Company's lead product candidate, (Z)-endoxifen, is being developed as a highly potent SERM for use across the breast cancer continuum of care. For more information, please visit www.atossatherapeutics.com.</p>
<div class="lb-trans"><p>Atossa Therapeutics, Inc.（纳斯达克：ATOS）是一家临床阶段的生物制药公司，致力于开发在乳腺癌领域具有重大未满足需求的创新疗法。公司的主要产品候选药物 (Z)-endoxifen，正在作为一种高效的 SERM 开发，适用于乳腺癌的整个治疗过程。有关更多信息，请访问 www.atossatherapeutics.com。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>This press release contains certain &#34;forward-looking statements&#34; within the meaning of applicable securities laws, including but not limited to, our expectations regarding the Company's development and regulatory strategy and related milestones, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval and timing thereof, the strength of the Company's patent portfolio, and the potential market and growth opportunities for the Company. Words such as &#34;expect,&#34; &#34;potential,&#34; &#34;continue,&#34; &#34;may,&#34; &#34;will,&#34; &#34;should,&#34; &#34;could,&#34; &#34;would,&#34; &#34;seek,&#34; &#34;intend,&#34; &#34;plan,&#34; &#34;estimate,&#34; &#34;anticipate,&#34; &#34;believe,&#34; &#34;design,&#34; &#34;predict,&#34; &#34;future,&#34; or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements.</p>
<div class="lb-trans"><p>本新闻稿包含某些适用证券法意义上的&#34;前瞻性声明&#34;，包括但不限于我们对公司发展和监管战略及相关里程碑的预期，公司可能追求的 (Z)-endoxifen 潜在适应症，(Z)-endoxifen 获得监管批准的潜力及其时机，公司专利组合的强度，以及公司潜在市场和增长机会。诸如&#34;预期&#34;、&#34;潜在&#34;、&#34;继续&#34;、&#34;可能&#34;、&#34;将&#34;、&#34;应该&#34;、&#34;可以&#34;、&#34;会&#34;、&#34;寻求&#34;、&#34;打算&#34;、&#34;计划&#34;、&#34;估计&#34;、&#34;预期&#34;、&#34;相信&#34;、&#34;设计&#34;、&#34;预测&#34;、&#34;未来&#34;或其他类似表达或关于意图、信念或当前预期的声明，均为前瞻性声明。</p>
</div><p>Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: our ability to successfully execute our strategy to shorten our clinical development timelines and pursue a metastatic breast cancer indication or other indications for our lead program, (Z)-endoxifen; expected timing, completion and results of our preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to regain and maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa's filings with the SEC, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.</p>
<div class="lb-trans"><p>本新闻稿中的前瞻性声明受到风险和不确定性的影响，这可能导致实际结果、结果或实际结果或结果的时间与预期或预测的结果有重大差异，包括但不限于与以下事项相关的风险和不确定性：我们成功执行缩短临床开发时间表并追求转移性乳腺癌适应症或其他适应症（Z）- 恩多昔芬的能力；我们预期的前临床研究、临床试验和研发项目的时间、完成和结果；前临床研究结果与临床研究结果之间不可预测的关系；监管申请和批准的时间或可能性；必要监管批准的结果或时间；我们恢复并维持符合纳斯达克上市要求的能力；我们建立和维护覆盖我们产品的知识产权的能力；一般宏观经济条件对我们业务的影响；我们筹集资金的能力；以及不时在 Atossa 向 SEC 提交的文件中详细说明的其他风险和不确定性，包括但不限于其 10-K 表格的年度报告和 10-Q 表格的季度报告。</p>
</div><p>Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements.</p>
<div class="lb-trans"><p>前瞻性声明以本新闻稿发布之日为准。除法律要求外，我们不打算更新任何前瞻性声明。</p>
</div><p>SOURCE Atossa Therapeutics Inc</p>
<div class="lb-trans"><p>来源：Atossa Therapeutics Inc</p>
</div>

Atossa Therapeutics Announces Issuance of U.S. Patent Covering Enteric Oral (Z)-Endoxifen Formulations and Methods of Treating Patients Using (Z)-Endoxifen | ATOS Stock News

Atossa Therapeutics 宣布美国专利的发布，该专利涵盖肠道口服 (Z)-Endoxifen 配方及使用 (Z)-Endoxifen 治疗患者的方法 | ATOS 股票新闻