Allogene Therapeutics, Inc. (ALLO) registered a loss of 38 cents per share in first-quarter 2024, in line with the Zacks Consensus Estimate. In the year-ago quarter, the company reported a loss of 69 cents. ALLO recorded revenues of $0.02 million during the quarter, missing the Zacks Consensus Estimate of $0.04 million. Revenues were down 27% year over year. Quarter in Detail Research & development (R&D) expenses were $52.3 million, down 35% from the year-ago quarter’s level. General and administrative (G&A ...

财务数据和关键指标变化 - 公司2024年第一季度现金、现金等价物和投资总额为3.973亿美元,融资后现金余额将增加至约5亿美元,现金跑道延长至2026年下半年 [29] - 2024年第一季度研发费用为5,230万美元,其中包括380万美元的非现金股票激励费用;管理费用为1,730万美元,其中包括810万美元的非现金股票激励费用 [29] - 2024年第一季度净亏损为6,500万美元或每股0.38美元,包括1,190万美元的非现金股票激励费用 [29] - 2024年全年现金消耗预计约2亿美元,较之前指引增加1,000万美元,主要由于修订与Servier的里程碑付款时间影响,部分被CIRM 1,500万美元补助抵消 [30] - 2024年全年GAAP经营费用预计约3亿美元,其中包括约6,000万美元的非现金股票激励费用 [30] 各条业务线数据和关键指标变化 - 公司将重点发展4个核心项目,包括cema-cel在大B细胞淋巴瘤和慢性淋巴细胞白血病的应用,ALLO-329在自身免疫疾病的应用,以及ALLO-316在实体瘤的应用 [12][15][16] - cema-cel在大B细胞淋巴瘤一线巩固治疗的ALPHA3试验预计2026年读数,有望在2027年提交BLA申请,这可能改变大B细胞淋巴瘤的标准治疗 [14] - cema-cel在复发/难治性慢性淋巴细胞白血病的应用也有潜力成为新的标准治疗 [14] - ALLO-329是公司自主研发的针对CD19和CD70的双靶点CAR-T细胞疗法,旨在通过单次输注重置免疫系统,计划于2025年一季度提交IND并在上半年开始临床试验 [15][44] - ALLO-316在晚期肾细胞癌的TRAVERSE试验进展良好,公司获得了加州再生医学研究所(CIRM)1,500万美元的资助 [16][45] 各个市场数据和关键指标变化 - 公司从Servier获得了欧盟和英国的cema-cel权利,将市场机会从原来的约5亿美元增加到超过95亿美元 [13][25] - 公司还有权在未来获得日本和中国的cema-cel权利,进一步扩大市场机会 [26] 公司战略和发展方向及行业竞争 - 公司将重点发展4个核心项目,包括cema-cel、ALLO-329、ALLO-316等,以差异化和竞争力的产品来满足未满足的临床需求 [12][15][16] - cema-cel有望成为大B细胞淋巴瘤一线巩固治疗的标准,并在慢性淋巴细胞白血病中也有潜力成为新的标准治疗 [14] - ALLO-329旨在通过单次输注重置免疫系统,在自身免疫疾病领域具有差异化优势 [15] - ALLO-316在实体瘤领域展现出治疗潜力,获得CIRM的资助支持 [16] - 公司通过融资和扩大cema-cel权利范围,进一步巩固了其在同种异体CAR-T领域的领导地位 [17][23][24] 管理层对经营环境和未来前景的评论 - 公司专注于推进4个核心项目,相信这些项目有望改变CAR-T治疗格局,造福患者 [18] - 公司获得了来自顶级机构投资者和基金的支持,表明他们对公司同种异体CAR-T战略的信心 [23] - 公司扩大了cema-cel的权利范围,大幅提升了市场机会,为未来的战略合作奠定基础 [24][26][27] - 公司有信心在2026年前完成ALPHA3试验的中期有效性分析和入组,为cema-cel在一线巩固治疗的潜力提供支持 [22] 问答环节重要的提问和回答 问题1 **Michael Yee 提问** 对于ALPHA3试验的入组情况和时间表,公司有何信心?中期分析和最终主要疗效分析之间有何区别? [49][50][51] **Zachary Roberts 回答** 公司已经选定了近乎所有的临床试验中心,包括社区肿瘤中心。试验将随机入组约240名MRD阳性患者,一部分接受cema-cel巩固治疗,另一部分接受观察。中期分析时将评估不同淋巴清除方案的安全性和有效性,以确定最终使用的方案。[50][51] 问题2 **Tyler Van Buren 提问** MRD阳性患者是否意识到复发的风险?为什么他们会选择参与该试验? [53][54] **Zachary Roberts 回答** MRD的概念还没有进入患者的普遍意识,但对于研究者来说,这是一个很有潜力的生物标志物。对于MRD阳性的患者来说,接受cema-cel巩固治疗是一个很有吸引力的选择,因为目前没有批准的治疗方案可以用于这类患者。[54][55] 问题3 **Salveen Richter 提问** 对于cema-cel在慢性淋巴细胞白血病中的数据,公司期望看到什么样的结果?目前的临床bar如何? [57][58] **Zachary Roberts 回答** 对于复发/难治性慢性淋巴细胞白血病患者来说,临床bar还是很低的。最近批准的自体CAR-T疗法在这一人群中的总反应率和完全缓解率分别为45%和20%,这已经是一个不错的基准。我们相信cema-cel作为一种现成的CAR-T疗法,几乎所有符合条件的患者都能够接受输注,这将是一个很大的优势。[58]

Allogene Therapeutics (ALLO) came out with a quarterly loss of $0.38 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.68 per share a year ago. These figures are adjusted for non- recurring items. A quarter ago, it was expected that this immuno-oncology company would post a loss of $0.47 per share when it actually produced a loss of $0.43, delivering a surprise of 8.51%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Allogene Therap ...

SOUTH SAN FRANCISCO, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced the pricing of an underwritten offering of 37,931,035 shares of its common stock at a price of $2.90 per share. The gross proceeds from this offering are expected to be approximately $110 million, before deducting the underwriting discount and comm ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ________________________________________________________ FORM 10-Q ________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0 ...

Exhibit 99.1 Allogene Therapeutics Reports First Quarter 2024 Financial Results and Business Update • Cemacabtagene Ansegedleucel (Cema-Cel) ◦ Expanded CD19 Oncology Rights to Include all EU Member States and the United Kingdom, Reinforcing Company’s Conviction in the Unique Opportunity in Large B Cell Lymphoma (LBCL) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) ▪ Extended Territory Rights Substantially Increase Market Opportunity in 1L Consolidation LBCL and R/R CLL From More Than $6 Bi ...

Cemacabtagene Ansegedleucel (Cema-Cel) Expanded CD19 Oncology Rights to Include all EU Member States and the United Kingdom, Reinforcing Company's Conviction in the Unique Opportunity in Large B Cell Lymphoma (LBCL) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) Extended Territory Rights Substantially Increase Market Opportunity in 1L Consolidation LBCL and R/R CLL From More Than $6 Billion in the US to More Than $9.5 Billion in the Combined U.S., EU Member States and the United Kingdom Co ...

Conference Call and Webcast Scheduled for May 13, 2024 at 2:00 p.m. PT/5:00 p.m. ET SOUTH SAN FRANCISCO, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that it will report first quarter 2024 financial results and provide a business update on May 13, 2024, after the close of the market. The announcement will be foll ...

$15 million CIRM Grant Supports the Ongoing Phase 1 TRAVERSE Trial Evaluating ALLO-316 in Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC) ALLO-316 Illustrates Proof-of-Concept in RCC and the Potential of Dagger® Technology to Optimize CAR T Cell Expansion and Persistence SOUTH SAN FRANCISCO, Calif., April 26, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cance ...

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