Net Revenue of $65.1 million Gross Profit Margin of 52.1% from continuing operations, up 110 basis points from 51.0% in the third quarter of 2024 Net Cash provided from continuing operations of $7.1 million and Free Cash Flow¹ of $4.9 million 13th consecutive quarter of positive Cash Flow from continuing operations and 9th consecutive quarter of positive Free Cash Flow¹ During the quarter, completed a $79 million non-dilutive refinancing of existing debt with an additional uncommitted term loan facility of ...

Urteste S.A. launches European multicenter clinical study of the Panuri test Gdańsk, Poland – 6 November 2025 – Urteste S.A. (Warsaw Stock Exchange: URT), a company specializing in the development of innovative technology for the early detection of cancer from urine samples, has entered into a tripartite agreement with Aurevia Poland and Aurevia Oy, based in Finland, for CRO services, including the organization and management of a European clinical study of the Panuri test — an IVD medical device for the d ...

核心观点 - 公司是一家临床阶段的TechBio公司，专注于利用其AI-Immunology™平台开发疫苗 [1] - 公司在2025年第三季度取得显著进展，包括其主导的个性化癌症疫苗EVX-01在二期临床试验中获得积极数据，以及成功将传染病疫苗候选药物EVX-B3授权给MSD [2][5][8] - 公司财务状况显著改善，实现净利润460万美元，现金状况增强，现金储备可支持运营至2027年下半年 [27][31][32] 研发管线进展 - 主导资产个性化癌症疫苗EVX-01在晚期黑色素瘤二期试验的两年数据显示，客观缓解率(ORR)达到75%，高于第一年的69% [5][6] - 92%的患者在两年随访期仍保持临床应答，且未观察到复发 [6] - 54%的患者在治疗期间出现应答加深，16名患者中有15名观察到肿瘤缩小 [7] - EVX-01在所有患者中均诱导了免疫反应，81%的靶向新抗原产生了强烈的特异性T细胞反应 [9] - EVX-01耐受性良好，二期试验将延长一年以进一步巩固数据包 [10] - 公司研发管线新增EVX-04，一种针对内源性逆转录病毒(ERV)肿瘤抗原的现成疫苗，目前处于针对急性髓系白血病的临床前开发阶段 [12][13] - EVX-02项目已停用并从研发管线中移除 [15] 技术与平台发展 - AI-Immunology™平台新增自动化疫苗设计模块，取代了此前的手动流程，可将设计时间从数月缩短至数天 [8][16][17] - 该平台能够识别患者肿瘤测序数据中的ERV抗原，并选择最佳片段以开发适用于广泛患者的现成疫苗 [14] - EVX-B3是首个被制药公司授权的AI设计疫苗候选物，验证了该平台的能力 [8] 业务发展与合作伙伴关系 - 公司将EVX-B3授权给MSD，已收到750万美元的选择权执行费，并有资格获得未来高达5.92亿美元的付款 [8][21][28] - MSD同时持有针对淋病疫苗候选物EVX-B2的授权选择权，评估期已延长至2026年上半年 [22] - 若MSD执行EVX-B2的选择权，公司将获得250万美元付款，并有资格获得高达5.92亿美元的里程碑付款及销售分成 [23] - 公司正积极进行多项合作讨论，目标是在未来几个月内达成至少一项新的合作伙伴关系 [24] 财务状况与资本 - 2025年第三季度净利润为460万美元，相比2024年同期的净亏损190万美元有显著改善 [27][38] - 第三季度收入为750万美元，主要来自MSD的选择权执行 [28][38] - 通过资本市场活动（ATM发行募资450万美元，权证行权募资270万美元）以及MSD的付款，公司现金状况得到加强 [25][26] - 截至2025年9月30日，现金及现金等价物为1060万美元，较2024年12月31日的600万美元大幅增加 [32][36] - 现金储备可支持运营至2027年下半年，较此前预测的2027年上半年有所延长 [25][31] - 截至2025年9月30日，总权益为1660万美元，相比2024年12月31日的170万美元有显著改善 [32][36] - 研发费用为310万美元，一般及行政费用为140万美元，显示出严格的成本控制 [29][38]

Leading Boston-based bank focused on outstanding client experience unifies multiple legacy systems onto nCino’s comprehensive platformWILMINGTON, N.C., Nov. 06, 2025 (GLOBE NEWSWIRE) -- nCino, Inc. (NASDAQ: NCNO), the leading provider of intelligent, best-in-class banking solutions, today announced that Eastern Bank has expanded its loan origination and operations platform with nCino, selecting the Company's Consumer Banking and Mortgage solutions to complement its existing Commercial Banking Solution, crea ...

- $30 Million Registered Direct Offering Support Next Stage of Development for Zervimesine (CT1812) - - Aligned with U.S. FDA on Registrational Path for Zervimesine - - Expanded Access Program for Dementia with Lewy Bodies Ongoing - PURCHASE, N.Y., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, today reported financial results for the third quarter ended September ...

WAYNE, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that Wes Kaupinen, Founder and Chief Executive Officer of Palvella, will present at the Stifel 2025 Healthcare Conference on Wednesda ...

ORR and preliminary duration of treatment data for the Phase 2 trial of silevertinib in 1L patients with non-classical EGFRm NSCLC on track for this quarter Cash, cash equivalents, and investments of $135.5 million as of September 30, 2025; expected to be sufficient to fund operations into Q4 of 2027 CAMBRIDGE, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations ...

– Generated Record Quarterly Net Revenue of $209.4 Million, Up 31% Year-over-Year – – Generated Record Quarterly Jornay PM® Net Revenue of $41.8 Million; Grew Prescriptions by 20% Year-over-Year – – Generated Record Quarterly Pain Portfolio Net Revenue of $167.6 Million, Up 11% Year-over-Year, with All Three Core Products Growing Year-over-Year – – Raised Full-Year 2025 Net Revenue Guidance to be in the Range of $775 to $785 Million and Adjusted EBITDA Guidance in the Range of $460 to $470 Million – – Ende ...

Leptomeningeal metastases disease session features novel treatments in the horizon, REYOBIQ™ and ReSPECT-LM, and future directions and needsHOUSTON, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces its participation at the 40th Society for Immunotherapy of Cancer (SITC) Annual Meeting, Melanoma Research ...

LOWELL, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- MACOM Technology Solutions Holdings, Inc. (“MACOM”) (Nasdaq: MTSI), a leading supplier of semiconductor products, today announced its financial results for its fiscal fourth quarter and fiscal year ended October 3, 2025. Fourth Quarter Fiscal Year 2025 GAAP Results Revenue was $261.2 million, an increase of 30.1%, compared to $200.7 million in the previous year fiscal fourth quarter and an increase of 3.6% compared to $252.1 million in the prior fiscal quarte ...