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Rain Oncology Provides Company Update and Outlines Strategic Priorities of Milademetan Clinical Programs

Rain Oncology Provides Company Update and Outlines Strategic Priorities of Milademetan Clinical Programs

Rain Oncology 提供公司最新情况并概述了 Milademetan 临床项目的战略重点
GlobeNewswire ·  2023/05/30 08:30

– Company plans to suspend enrollment in the ongoing milademetan Phase 2 MANTRA-2 basket trial and terminate plans for its Phase 1/2 MANTRA-4 combination trial –

— 公司计划暂停正在进行的 milademetan 第 2 期 MANTRA-2 篮子试验的注册,并终止其 1/2 期 MANTRA-4 联合试验的计划 —

– Evaluation of outcomes from the MANTRA Phase 3 milademetan trial in dedifferentiated liposarcoma (DD LPS) are ongoing with data and findings to be presented at a medical conference in 4Q23 –

— 对去分化脂肪肉瘤(DD LPS)的MANTRA 3期milademetan试验结果的评估正在进行中,数据和发现将在23年第四季度的医学会议上公布 —

– Company continuing to evaluate opportunities for expansion of its pipeline across precision oncology strategies –

— 公司继续评估扩大精准肿瘤战略产品线的机会 —

– Overall workforce reduction of approximately 65% of the Company's employees; with a transition of Chief Medical Officer (CMO) responsibilities –

— 公司员工总数裁减了约 65%;随着首席医疗官 (CMO) 职责的移交 —

– Year-end 2023 cash guidance of $75-80mm, with cash runway to year-end 2026 –

— 2023 年年底现金指引为 7.5-80 亿美元,现金流将持续到 2026 年底 —

NEWARK, Calif., May 30, 2023 (GLOBE NEWSWIRE) -- Rain Oncology Inc. (NasdaqGS: RAIN), (Rain), a clinical stage company developing precision oncology therapeutics today announced an update to its clinical strategy for milademetan, its small molecule inhibitor of the MDM2-p53 complex, to optimize Company resources. The Company is focused on reducing its cash burn with the expectation to extend cash runway to year-end 2026.

加利福尼亚州纽瓦克,2023年5月30日(GLOBE NEWSWIRE)——开发精准肿瘤疗法的临床阶段公司Rain Oncology Inc.(纳斯达克股票代码:RAIN)今天宣布更新其mdm2-p53复合物的小分子抑制剂米拉德美坦的临床战略,以优化公司资源。该公司专注于减少现金消耗,预计将现金流延长至2026年底。

"We are working diligently, as additional information continues to come in, to analyze and understand the outcomes in the Phase 3 MANTRA study in DD LPS," said Avanish Vellanki, co-founder and chief executive officer of Rain. "It is imperative we understand those outcomes before allocating further capital to the milademetan program, with corporate expenses to be greatly reduced to maximize optionality for Rain. In the near-term, Rain plans to suspend enrollment in our Phase 2 MANTRA-2 basket trial and terminate plans to initiate the planned Phase 1/2 MANTRA-4 combination trial."

Rain联合创始人兼首席执行官Avanish Vellanki表示:“随着更多信息的不断涌入,我们正在努力分析和了解DD LPS的3期MANTRA研究的结果。”“在向milademetan计划分配更多资金之前,我们必须了解这些结果,同时要大幅减少公司开支,以最大限度地提高Rain的可选性。在短期内,Rain 计划暂停我们的第 2 阶段 MANTRA-2 篮子试验的注册,并终止启动计划中的第 1/2 阶段 MANTRA-4 联合试验的计划。”

Mr. Vellanki continued, "Rain will make meaningful reductions in our workforce. It was the tremendous effort of our Rain colleagues that allowed us to execute on MANTRA ahead of schedule despite the extreme pressures of the pandemic. I want to sincerely thank every Rain colleague who has been impacted by this realignment. Their contributions have, without a doubt, brought us closer to better understanding the milademetan program, and towards Rain achieving its mission for patients."

Vellanki先生继续说:“雨将大幅裁减我们的员工。正是我们的 Rain 同事的巨大努力使我们得以在疫情的极大压力下提前执行 MANTRA。我要衷心感谢每一位受到这次调整影响的 Rain 同事。毫无疑问,他们的贡献使我们更接近于更好地了解milademetan计划,也更接近于Rain实现其为患者服务的使命。”

The Company thanks Dr. Richard Bryce, MBCHB, MRCGP, MFPM, Rain's CMO, for his tremendous efforts with the MANTRA study, and notes a planned transition from CMO to an ongoing advisory role, with Rain's cofounder, President and chief scientific officer, Dr. Robert Doebele, MD, PhD, to assume the role of CMO.

公司感谢Richard Bryce博士、MBCHB、MRCGP、MRCGP、MFPM、Rain的首席营销官为MANTRA研究所做的巨大努力,并注意到计划从首席营销官过渡到持续的咨询职位,Rain的联合创始人、总裁兼首席科学官Robert Doebele博士担任首席营销官。

Strategic Update Summary:

战略更新摘要:

  • Continue evaluation of the totality of the pivotal Phase 3 MANTRA data
    • Planned data presentation at a medical conference in 4Q 2023
  • Suspend enrollment of additional patients into the MANTRA-2 MDM2 amplified basket study
    • Planned MANTRA-2 clinical update at a medical conference in 4Q 2023
  • Terminate plans for the MANTRA-4 clinical study in patients with CDKN2A-loss, p53 wildtype advanced solid tumors
  • Evaluate avenues to enhance the pipeline through precision oncology program acquisition
  • Streamline internal resources to execute on realigned strategy
    • Reducing full-time employees by approximately 65%, combined with careful workforce management, including employee attrition
    • Transitioning CMO responsibilities from Dr. Richard Bryce to Dr. Robert Doebele
  • Year-end 2023 cash guidance of $75-$80 million, and cash runway to year-end 2026
  • 继续评估关键的第 3 阶段 MANTRA 数据的全部情况
    • 计划于 2023 年第四季度在医学会议上发布数据
  • 暂停招收更多患者参加 MANTRA-2 MDM2 扩增篮子研究
    • 计划在 2023 年第四季度的一次医学会议上更新 MANTRA-2 的临床信息
  • 终止针对 cdkn2a-loss、p53 野型晚期实体瘤患者的 MANTRA-4 临床研究计划
  • 评估通过收购精准肿瘤学项目来加强渠道的途径
  • 精简内部资源以执行调整后的战略
    • 将全职员工减少约 65%,再加上谨慎的劳动力管理,包括员工流失
    • 将首席营销官的职责从理查德·布莱斯博士移交给罗伯特·多贝勒博士
  • 2023年年底的现金指导为7500万至8000万美元,到2026年底的现金流向

About Milademetan

关于 Milademetan

Milademetan (also known as RAIN-32) is an oral small molecule inhibitor of the MDM2-p53 complex that reactivates p53. Milademetan has demonstrated antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial. Rain has recently announced topline data of its Phase 3 trial of milademetan (MANTRA) in patients with LPS. Milademetan has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LPS.

Milademetan(也称为 RAIN-32)是一种可重新激活 p53 的 mdm2-p53 复合物的口服小分子抑制剂。在一项1期临床试验中,Milademetan已在脂肪肉瘤(LPS)的mdm2扩增亚型和其他实体瘤中显示出抗肿瘤活性。Rain最近公布了其针对LPS患者的milademetan(MANTRA)3期试验的头条数据。Milademetan已获得美国食品药品监督管理局(FDA)颁发的孤儿药称号,用于治疗LPS。

About Rain Oncology Inc.

关于 Rain Onology

Rain Oncology Inc. is a late-stage precision oncology company developing therapies that target oncogenic drivers to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors' underlying genetics rather than histology. Rain's product candidate, milademetan, is a small molecule, oral inhibitor of the MDM2-p53 complex that reactivates p53.

Rain Oncology Inc. 是一家处于后期阶段的精准肿瘤公司,正在开发针对致癌驱动因素的疗法,对它认为最有可能受益的患者进行基因选择。这种方法包括使用肿瘤不可知策略根据肿瘤的基础遗传学而不是组织学来选择患者。Rain 的候选产品 milademetan 是一种可重新激活 p53 的 mdm2-p53 复合物的小分子口服抑制剂。

Forward Looking Statements

前瞻性陈述

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Rain's clinical strategy, the therapeutic potential of the reactivation of p53 and a potential path forward for milademetan. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "plans," "will", "anticipates," "goal," "potential," "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Rain's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Rain's business in general and limited operating history, Rain's ability to execute on its strategy; the results of preclinical and clinical studies; the FDA regulatory process; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical studies; the sufficiency of Rain's capital resources and its ability to successfully manage its cash resources; and the other risks described in Rain's Annual Report on Form 10-Q for the quarter ended March 31, 2023 and subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Rain undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

本新闻稿中包含的关于非历史事实的陈述是1995年《私人证券诉讼改革法》所指的 “前瞻性陈述”。此类前瞻性陈述包括关于Rain的临床策略、p53重新激活的治疗潜力以及milademetan的潜在前进方向等的陈述。由于此类陈述存在风险和不确定性,因此实际结果可能与此类前瞻性陈述所表达或暗示的结果存在重大差异。诸如 “计划”、“将”、“预期”、“目标”、“潜力”、“期望” 等词语和类似表达方式旨在识别前瞻性陈述。这些前瞻性陈述基于Rain目前的预期,所涉及的假设可能永远无法实现或可能被证明是不正确的。由于各种风险和不确定性,实际结果可能与此类前瞻性陈述中的预期存在重大差异,其中包括但不限于与Rain总体业务相关的风险和不确定性以及有限的运营历史、Rain执行其战略的能力、临床前和临床研究的结果、美国食品药品管理局的监管程序;临床试验的积极结果不一定可以预测未来或正在进行的临床研究的结果;Rain资本资源的充足性及其成功管理现金资源的能力;以及Rain截至2023年3月31日的季度10-Q表年度报告以及随后向美国证券交易委员会提交的文件中描述的其他风险。本新闻稿中包含的所有前瞻性陈述仅代表其发表之日,并且基于管理层截至该日的假设和估计。除非法律要求,否则Rain没有义务更新此类陈述以反映在声明发表之日之后发生的事件或存在的情况。

Media Contact
Jordyn Temperato
LifeSci Communications
jtemperato@lifescicomms.com

媒体联系人
Jordyn Temperato
LifeSci
jtemperato@lifescicomms.com

Investor Contact
Dan Ferry
LifeSci Advisors
+1.617.430.7576
daniel@lifesciadvisors.com

投资者联系人
丹·费里
生命科学顾问
+1.617.430.7576
daniel@lifesciadvisors.com


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