Atossa Therapeutics(ATOS)
icon
搜索文档
Atossa Therapeutics(ATOS) - 2024 Q3 - Quarterly Report
2024-11-12 21:35
公司业务与药物研究 - 公司是临床阶段生物制药公司专注于女性乳腺癌等乳腺疾病[79] - 公司主要药物(Z)-endoxifen已完成多项临床研究并具备临床制造能力[80] - (Z)-endoxifen针对乳腺密度研究初步数据显示积极结果1mg和2mg剂量组乳腺密度分别降低19.3%和26.5%[80] - 该研究每组80名女性共240名研究持续6个月[80] - 因药物副作用退出研究的女性人数在安慰剂1mg和2mg组分别为4、5和11名[80] - 基于监管机构意见公司可能开展更多研究评估(Z)-endoxifen与乳腺癌风险相关性[80] - (Z)-endoxifen相关研究中初步数据显示95%患者接受超75%计划治疗[81] 公司财务状况 - 营收与成本 - 公司在2024年三、九月无营收及相关成本[85] - 2024年三、九月总运营费用分别为640万美元和2050万美元较2023年同期下降[85] - 2024年三、九月研发费用分别为341.2万美元和1071.4万美元较2023年同期下降[86] - 临床和非临床试验费用在2024年三、九月较前一年分别下降90万美元和40万美元[87] - 2024年三、九月研发薪酬费用较前一年分别下降6.2万美元和69万美元[88] - 2024年三、九月一般和管理费用分别为297.3万美元和975.6万美元较2023年同期下降[90] - 2024年三、九月一般和管理薪酬费用较前一年分别下降19.2万美元和245.5万美元[90] - 2024年三、九月一般和管理专业费用及其他较前一年分别增加29.8万美元和187.2万美元[90] - 2024年三、九月一般和管理保险费用较前一年分别下降13.4万美元和33.9万美元[92] 公司财务状况 - 其他财务数据 - 2024年前三季度利息收入320万美元较上一年同期增加10万美元[93] - 2024年前三季度权益性证券投资减值170万美元2023年前三季度为300万美元[93] - 2024年前三季度净亏损1920万美元运营活动使用现金1400万美元[94] - 2024年前三季度运营活动现金使用较2023年同期减少140万美元[94] - 2024年前三季度投资活动现金使用1.9万美元[94] - 2024年前三季度融资活动现金流入30万美元[94] - 2023年前三季度融资活动现金使用1475美元[94] - 截至2024年9月30日不可取消的合同承诺估计为1050万美元[96] - 2023年6月董事会授权回购至多1000万美元普通股但2024年前三季度未回购[97] - 公司预计在可预见未来持续运营亏损[95] 疾病相关数据 - 导管原位癌每年美国约有6万新病例[80]
Atossa Therapeutics(ATOS) - 2024 Q3 - Quarterly Results
2024-11-12 21:30
现金及债务情况 - 2024年第三季度末现金及现金等价物为7480万美元且无债务[1] - 2024年9月30日现金及现金等价物为74766000美元2023年12月31日为88460000美元[17] - 2024年9月30日总负债为5796000美元2023年12月31日为5236000美元[17] - 2024年9月30日股东权益为73681000美元2023年12月31日为91016000美元[18] 临床试验进展 - KARISMA - Endoxifen二期研究中1毫克和2毫克治疗组在6个月内分别使乳腺密度显著降低19.3%和26.5%[1] - I - SPY 2 EOP二期试验中95%(19/20)的患者完成了超过75%的计划治疗[1] - 与Quantum Leap Healthcare Collaborative合作的临床试验已对第一名患者用药[1] 专利情况 - 获得新专利涵盖(Z) - endoxifen的某些成分及给药方法[1] 运营费用情况 - 2024年第三季度总运营费用为640万美元较2023年同期减少110万美元[4] - 2024年前三季度总运营费用为2050万美元较2023年同期减少190万美元[4] - 2024年三季度研发费用较2023年同期减少105.5万美元[5] - 2024年前三季度研发费用较2023年同期减少96.6万美元[5] - 2024年三季度管理费用较2023年同期减少28000美元[8] - 2024年前三季度研发费用为10714000美元2023年为11680000美元[19] - 2024年前三季度一般和管理费用为9756000美元2023年为10678000美元[19] 财务亏损情况 - 2024年前三季度运营亏损20470000美元2023年为22358000美元[19] - 2024年前三季度净亏损19157000美元2023年为22340000美元[19] - 2024年9月30日每股净亏损为0.15美元2023年为0.18美元[19] 资产情况 - 2024年9月30日总资产为79477000美元2023年12月31日为96252000美元[17]
Atossa Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update
GlobeNewswire News Room· 2024-11-12 21:30
Announced positive topline results from KARISMA-Endoxifen Phase 2 study which demonstrated that low doses of (Z)-endoxifen significantly reduced mammographic breast density (MBD), addressing a key breast cancer risk factorReleased a preliminary analysis from I-SPY 2 Endocrine Optimization Pilot (EOP) Phase 2 trial of (Z)-endoxifen which met the primary endpoint with 95 percent (19/20 patients) receiving > 75 percent of planned treatmentAnnounced the dosing of the first patient in a clinical trial conducted ...
Atossa Therapeutics Reports Positive KARISMA-Endoxifen Trial Results:
GlobeNewswire News Room· 2024-11-04 19:30
文章核心观点 - 公司开发的(Z)-endoxifen在预防性试验中显著降低了女性乳腺密度,这可能为创新的乳腺癌预防策略铺平道路 [1][2][3] - (Z)-endoxifen是一种高效的选择性雌激素受体调节剂(SERM),具有强大的抗雌激素作用,并可能导致雌激素受体降解 [5] - 公司正在开发一种口服的(Z)-endoxifen制剂,以避免胃酸对其的转化 [6] - 公司正在进行多项(Z)-endoxifen的临床试验,包括预防和治疗乳腺癌的研究 [6] 根据目录分别总结 试验结果 - 试验共纳入240名女性,分为安慰剂组和1mg、2mg两个剂量组,为期6个月 [2] - 1mg和2mg剂量组乳腺密度相比安慰剂组分别下降19.3%和26.5% [2] - 试验期间未发现重要的安全性问题,仅出现轻微的血管运动症状 [2] - 1mg和2mg剂量组的平均内生内酚浓度分别为5.18ng/mL和10.87ng/mL [2] - 有4、5和12名受试者因副作用退出了安慰剂、1mg和2mg组 [2] 公司和产品信息 - 公司正在开发(Z)-endoxifen作为预防和治疗乳腺癌的创新药物 [4][6] - (Z)-endoxifen具有多种潜在优势,包括更强的抗肿瘤作用和更好的骨骼效果 [5] - 公司已获得(Z)-endoxifen的4项美国专利,并有多项专利申请 [6] - 公司计划在12月的圣安东尼奥乳腺癌研讨会上发布试验详细结果,并于明年在同行评议期刊上发表 [4]
Atossa Therapeutics to Present at the 2024 Maxim Healthcare Virtual Summit
GlobeNewswire News Room· 2024-10-15 05:08
SEATTLE, Oct. 14, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), today announced that Michael Parks, Vice President, Investor and Public Relations, will participate in a virtual fireside chat on Wednesday, October 16, 2024 at 12:00 p.m. EDT at the 2024 Maxim Healthcare Virtual Summit. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer. Interes ...
Atossa Therapeutics Commemorates Breast Cancer Awareness Month, Highlighting the Need for Innovation Across the Breast Cancer Treatment Continuum
GlobeNewswire News Room· 2024-10-01 20:30
SEATTLE, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), today announced its recognition and support of Breast Cancer Awareness Month this October; highlighting the importance of increasing awareness, advancing research, and driving progress toward innovative treatments for breast cancer. Approximately one in eight women will be diagnosed with breast cancer in their lifetime, so this annual campaign serves as a powerful reminder of the ongoing need for ...
Is Atossa Genetics (ATOS) Stock Outpacing Its Medical Peers This Year?
ZACKS· 2024-09-19 22:46
For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Is Atossa Genetics Inc. (ATOS) one of those stocks right now? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Atossa Genetics Inc. is one of 1016 companies in the Medical group. The Medical group currently sits at #5 within the Zacks Sector Rank. The Zacks Sector Rank considers 16 differen ...
Atossa Therapeutics Announces Support of Final Rule from FDA Requiring Patient Notification of Breast Density, a Critical Step in Addressing a Known Risk Factor for Breast Cancer
GlobeNewswire News Room· 2024-09-10 20:30
SEATTLE, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), today announced its support of the U.S. Food and Drug Administration (FDA) for issuing a final rule to update the mammography regulations issued under the Mammography Quality Standards Act of 1992 (MQSA), which becomes effective today. Among the updates, the final rule requires mammography facilities to provide patients with an assessment of breast density in patient friendly terms. Atossa is a ...
Is Atossa Genetics (ATOS) Outperforming Other Medical Stocks This Year?
ZACKS· 2024-09-03 22:40
The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Is Atossa Genetics Inc. (ATOS) one of those stocks right now? Let's take a closer look at the stock's year-to-date performance to find out.Atossa Genetics Inc. is one of 1017 companies in the Medical group. The Medical group currently sits at #4 within the Zacks Sector Rank. The Zacks Sector Rank considers 16 different sector groups. The average Zacks Rank of the individual ...
Are You Looking for a Top Momentum Pick? Why Atossa Genetics Inc. (ATOS) is a Great Choice
ZACKS· 2024-08-31 01:01
Momentum investing revolves around the idea of following a stock's recent trend in either direction. In the 'long' context, investors will be essentially be "buying high, but hoping to sell even higher." With this methodology, taking advantage of trends in a stock's price is key; once a stock establishes a course, it is more than likely to continue moving that way. The goal is that once a stock heads down a fixed path, it will lead to timely and profitable trades.While many investors like to look for moment ...