Data recently presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer Treatment with Annamycin results in statistically significant inhibition of tumor growth and extension of survival in orthotopic lung cancer models Annamycin continues to be 100% non-cardiotoxic HOUSTON, Sept. 23, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug can ...

Wally Klemp, CEO of Moleculin, discusses the Company's recent update on the Phase 2 clinical trial of STAT3 inhibitor in combination with radiation for the treatment of glioblastoma Watch the "What This Means" video here HOUSTON, Sept. 16, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a Phase 3 clinical-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that Walter Klemp, Chairman an ...

– Investigator-initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin – Funding for study provided by NIH and BrainUp® – Trial combines WP1066 and radiation, which demonstrated both significant therapeutic response and immune memory in glioblastoma animal models HOUSTON, Sept. 9, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a Phase 3 clinical-stage pharmaceutical company with a broad portfolio of drug candidates targ ...

文章核心观点 - 公司完成了2,466,368股普通股(或等同普通股)、2,466,368份A系列认股权证和2,466,368份B系列认股权证的公开发行,每股/份发行价格为2.23美元[2] - 公司拟使用本次发行所得资金推进Annamycin和其他两个药物组合的临床开发,推进现有组合的临床前研究并进入IND申报,以及用于公司运营资金[5] - 公司已修改之前发行的895,834份认股权证,将行权价格从9.60美元降至2.23美元,并将行权期限延长至获得股东批准后5年[7] 公司概况 - 公司是一家处于III期临床阶段的制药公司,拥有一系列针对难治肿瘤和病毒的药物候选物[9] - 公司的主要项目包括Annamycin(用于复发/难治急性髓系白血病和软组织肉瘤肺转移)、WP1066(用于脑瘤、胰腺癌等)以及一系列代谢拮抗剂[10][11] 本次融资 - 本次公开发行募集资金总额约5.5亿美元,如果认股权证全部行权还可额外获得约1.1亿美元[5] - 本次发行由H.C. Wainwright & Co.担任独家配售代理,Roth Capital Partners LLC和Maxim Group LLC担任财务顾问[4] - 本次发行已于2024年8月15日在SEC注册生效,发行完成后公司股票继续在纳斯达克上市交易[6]

临床试验进展 - 公司正在推进一项关键的适应性第三阶段临床试验(MIRACLE试验),旨在获得Annamycin联合细胞毒性药物阿糖胞苷用于治疗复发/难治性急性髓系白血病(R/R AML)的加速批准[1][2] - 在公司正在进行的MB-106临床试验中,Annamycin联合阿糖胞苷(AnnAraC)治疗的总体完全缓解率(CRc)为41%,其中2线治疗的CRc为60%[7][8] - 公司计划于2025年第一季度开始MIRACLE试验的首例受试者入组,并于2026年中期进行75例受试者的中期数据分析和最佳剂量的确定[9][10] 监管进展 - 公司与FDA进行了EOP1B/2会议,取得了积极的讨论结果,为Annamycin在AML治疗中的发展道路提供了重要支持[4][6] - 公司目前拥有Annamycin在治疗R/R AML和软组织肉瘤肺转移方面的FDA快速通道地位和孤儿药资格认定,以及欧盟EMA的R/R AML孤儿药资格认定[11] 财务状况 - 截至2024年6月30日,公司现金及现金等价物为1080万美元,预计现有现金加上计划融资12百万美元可为公司运营提供资金支持至2025年第二季度[14]

- Positive outcome from End of Phase 1B/2 Meeting with FDA - Company proceeding with a pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of R/R AML - Webcast replay of the Company's recent MIRACLE trial update available here HOUSTON, Aug. 14, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a Phase 3 clinical stage pharmaceutical company with a bro ...

临床试验进展 - 公司正在进行一项名为"MIRACLE"的全球性第三期临床试验,用于治疗复发/难治性急性髓系白血病(R/R AML),预计2025年第一季度开始首例受试者入组[92] - 公司正在进行的MB-106临床试验显示,无论之前接受过多少线治疗,Annamycin联合细胞毒素阿糖胞苷(AnnAraC)的总体完全缓解率(CR)为36%,总体完全缓解复合率(CRc)为41%[99] - 在2线及2-3线AML患者中,AnnAraC的CR率分别为50%和43%,CRc率分别为60%和50%,优于目前已批准用于2线AML的任何药物[99] - 9例CRc患者的缓解持续时间中位数约为7个月,目前仅有1例死亡(由肺炎引起)和2例复发[100] 药物安全性 - 在84例接受Annamycin治疗的患者中,即使大多数患者已超过终生最大累积蒽环类药物剂量,也未发现心脏毒性信号[101,102] 知识产权保护 - 公司获得美国专利11,951,118号和11,980,634号,涵盖Annamycin的制备和重建配方,专利期限延长至2040年[103,104] - 欧洲药品管理局(EMA)授予Annamycin治疗急性髓性白血病的孤儿药资格,与美国的孤儿药资格相结合,进一步保护了Annamycin的商业独占地位[105,106] 临床前数据 - 在美国癌症研究协会(AACR)年会上,公司展示了Annamycin的高抗癌活性和无心肌毒性的临床前数据[107] 其他研发项目 - 公司与美国和外国学术机构就使用WP1066治疗神经胶质瘤和儿童脑瘤进行合作,其中与西北大学的试验已经开始招募受试者[108] - 公司正在推进WP1122的静脉注射剂型,并计划在近期提交专利申请和获得许可[109] 财务情况 - 公司2024年上半年的研发费用为8.342百万美元,较2023年同期下降13.7%,主要由于2023年终止了WPD的许可协议[120] - 公司2024年上半年的管理费用为4.457百万美元,较2023年同期下降13.1%,主要由于监管和法律费用的减少[121] - 公司2024年第二季度和上半年分别实现了169.6万美元和315.1万美元的衍生工具公允价值变动收益,主要由于股价下降所致[118,122] - 公司预计现有现金和预期的股权融资将可为其运营提供资金支持至2025年第二季度[128,129]

Based on an encouraging discussion in the End of Phase 1B/2 Meeting with FDA the Company plans to: Proceed with a pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML; Run such future studies globally and in the US above the lifetime maximum allowable anthracycline dose; and Provide the FDA with additional data supporting the selection of the optimal dosing level v ...

HOUSTON, July 10, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the completion of its End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ar ...

– 89% of CRc's were subjects with "poor prognosis" cytogenetics and/or mutations – Current median durability of response (mDOR) of CRc's = 6 months and increasing (n=9) – In 2nd line subjects (n=10) Annamycin in combination with Cytarabine (AnnAraC) achieved an estimated median overall survival (mOS) of 6 months and increasing plus 5 CR's (50%) and 6 CRc's (60%)– Recruitment increased to 22 subjects and CRc's in all subjects evaluable for efficacy (n=20) was 45%– Annamycin continues to demonstrate no cardio ...