CARA Therapeutics, Inc.

STAMFORD, Conn., July 11, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that it has engaged Piper Sandler & Co. to act as its financial advisor for the process of exploring and reviewing strategic alternatives. “We are committed to evaluating a range of strategic options to maximize value for our shareholders,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “As part of this effort, our Board of Directors has approved a streamlined operating plan focused on cost-containment and cash conservation.” There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such agreements or transactions. Cara Therapeutics does not intend to discuss or disclose further developments regarding the exploration of strategic alternatives unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate or required by law. As of March 31, 2024, the Company had approximately $70 million in cash, cash equivalents, and marketable securities. About Cara Therapeutics Cara Therapeutics is a biopharmaceutical company focused on transforming the way pruritus is treated. The Company developed an IV formulation of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. For more information, visit . Forward-looking Statements 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. Examples of these forward-looking statements include statements concerning the Company’s exploration and review of strategic alternatives, its ability to identify and complete a transaction as a result of the strategic review process, and its plans to reduce costs and conserve cash. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include the risk that the Company may not be successful in exploring strategic alternatives and consummating one or more strategic transactions on attractive terms, if at all; the Company’s actual reductions in spending as compared to anticipated cost reductions; the Company’s costs of continuing to operate as a public company; and the other risks described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ending December 31, 2023 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics 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. INVESTOR CONTACT investor@caratherapeutics.com

来源：药渡 撰文：五月     编辑：哦呼 六月药企裁员潮渐退，相较于之前数月的密集发布，本月约有7家药企公布了减员计划，如下表所示。 6月药企裁员名单 6月24日 近期，G1 Therapeutics公布了其用于评估化疗前给药的曲拉西利（吉西他滨和卡铂；GCb）在转移性TNBC患者中疗效的3期PRESERVE 2试验结果，研究结果显示在风险比（HR）为0.91（p=0.884）的ITT人群（n=187）中未显示出具有统计学意义的治疗效果（图1）。 曲拉西利加GCb组的中位总生存期（OS）为17.4个月，而对照组为17.8个月。在两个PD-L1亚组（阳性和阴性）中，中位OS在数值上都有利于曲拉西利组，尽管两者都没有达到统计学意义。不同地区和接受不同类型后续治疗的患者观察到不同的效果;这些发现将进一步评估。 在试验中观察到的含GCb的曲拉西利的安全性与先前的研究一致，并且没有发现新的安全信号。与其他曲拉西利研究一致，观察到骨髓保护的证据，包括严重中性粒细胞减少的发生率降低，在接受曲拉西利治疗的患者中，有8%的患者发生严重中性粒细胞减少症，而对照组为29%[1]。 图1. G1 Therapeutics公布3 期 PRESERVE 2 试验结果 与此同时，G1还宣布将“停止预期雇用员工”。为了坚持到2025年下半年实现盈利的雄心壮志，这家生物技术公司还将“在现有商业组织之外有针对性地裁员，以精简公司”。该新闻稿没有提供关于有多少员工可能受到影响的线索。 6月24日 肿瘤生物技术公司eFFECTOR Therapeutics宣布已经开始裁员，包括eFFECTOR首席执行官Stephen Worland博士、首席财务官Michael Byrnes、首席医疗官Douglas Warner医学博士，他们都在上周末停止了他们的职位[2]。 根据美国证券交易委员会的文件，该公司预计到6月30日将花费约60万美元用于与裁员相关的一次性费用和现金支出。 与此同时，董事会已任命Craig Jalbert担任eFFECTOR的首席执行官、总裁、财务主管、秘书和唯一董事会成员。Jalbert是会计师事务所 Verdolino & Lowey， P.C. 的负责人，拥有三十多年帮助公司倒闭的经验。 接下来的部分步骤包括为eFFECTOR的开发计划寻找战略替代方案。这家生物技术公司的主要资产是zotatifin，这是一种选择性的eIF4A抑制剂，正在几项针对实体瘤的中期试验中进行测试。 今年4月，eFFECTOR的另一家全资资产tomivosertib在一项针对非小细胞肺癌（NSCLC）患者的2b期试验中未能改善无进展生存期。根据初步分析中提供的所有数据，该公司表示，在一线NSCLC中继续开发该资产没有明显的前进道路。 eFFECTOR还与大型制药公司辉瑞合作开发了一种名为eIF4Ei的临床前资产，该资产也旨在治疗实体瘤。2019年，辉瑞公司在一项独家许可协议中预先支付了1500万美元，与eFFECTOR合作开发真核起始因子4E（eIF4E）的小分子抑制剂，这笔价值5.07亿美元的交易被搁置。 6月21日 上个月宣布削减高达25%的劳动力成本Ginkgo Bioworks这个月继续裁员，宣布将裁员158人[3]。 Ginkgo的一位发言人告诉该媒体，这家总部位于波士顿的公司将在下周披露更多的裁员，但没有透露裁员人数。 Ginkgo于2014年成功从硅谷Y Combinator孵化，并拿到风险投资。2021年，Ginkgo通过SPAC（特殊目的收购公司）成功上市，是一家致力于成为开发细胞编程技术的生物合成领域的横向“平台型”企业。 6月20日 Cara Therapeutics在6月14日提交给美国证券交易委员会的文件中披露，该公司将在本月底前裁员70%。 就在两天前，Cara Therapeutics宣布了KOURAGE-1研究的剂量探索A部分的结果，该研究评估了口服地非利福林治疗成年感觉异常（NP）患者中度至重度瘙痒的疗效和安全性。与安慰剂相比，口服地非利福林在任何剂量下均未显示出有意义的临床益处，导致公司决定终止其临床项目（图2）[4]。 图2. Cara Therapeutics公布KOURAGE-1研究结果 截至2024年3月31日，公司拥有约7000万美元的现金、现金等价物和有价证券。在最新的裁员之前，Cara在1月份宣布裁员高达50%。根据其LinkedIn个人资料，总部位于康涅狄格州斯坦福德的公司拥有51-200名员工。 6月13日 总部位于英国牛津的Barinthus Biotherapeutics在周三的一份新闻稿中表示，遵循“管道优先权”原则，Barinthus Biotherapeutics将裁员约25%，并估计将现金跑道延长至2026年第二季度。 Barinthus正在将其资源投入到慢性乙型肝炎和乳糜泻的项目上，降低前列腺癌候选者的优先级（图3）。 Barinthus最近在欧洲肝脏研究协会（EASL）大会上公布了其乙型肝炎候选药物VTP-300正在进行的两项II期试验的积极中期数据：VTP-300具有显着降低和维持乙型肝炎表面抗原（HBsAg）水平的潜力，并在慢性乙型肝炎（CHB）患者中达到无法检测到的HBsAg水平。 Barinthus还指出，其主要候选药物VTP-1000的乳糜泻药物的临床前发现“令人鼓舞”，这是将该资产与VTP-300一起优先考虑的原因。 图3. Barinthus Biotherapeutics的研发管线 据LinkedIn称，Barinthus正在开发新型T细胞免疫治疗候选药物，拥有51至200名员工。 VTP-1000旨在通过诱导麸质特异性T调节细胞和减少麸质特异性T效应细胞反应来平衡免疫反应。在疾病模型的临床前研究证明“作用方式和疾病改善”之后，Barinthus表示，它正准备在第三季度将VTP-1000带入临床。 6月12日 根据WARN通知，安捷伦科技公司将于8月9日起裁员近200名加州员工，裁员包括CDMO圣克拉拉总部的156名员工，圣巴巴拉县的7名员工，圣地亚哥县的17名员工和佛森的4名员工。 公司发言人Sarah Litton告诉SFGATE，裁员是“跨业务和地区”裁员3%的一部分，安捷伦的目标是“适应市场复苏的步伐”。 安捷伦报告称，今年第一季度的收入与去年同期相比下降了5.6%。在此之前，该公司在2023年底报告了加州裁员，并于2024年1月生效。 6月6日 根据Fierce Pharma报道的一个警告通知，BMS将在2024年剩余的几个月里在新泽西州劳伦斯维尔裁员863人。这家制药巨头在4月份宣布，它将实施一项全面的“战略生产力计划”，以期到2025年节省约15亿美元的成本，包括到今年年底减少约2200个工作岗位。新泽西州裁员的新披露是在3月份 WARN 通知劳伦斯维尔裁员75人之后发布的。 据BMS 2024Q1财报，其Q1营收增长了5%，至119亿美元，超过此前115亿美元的预期，但是其Opdivo（纳武利尤单抗）的销售额下降6%，为21亿美元。低于2023年同期22亿美元的收入。此外，CAR-T疗法Abecma受”持续竞争”和“不利的定价压力”影响，销售额也下降了44%，仅为8200万美元，而去年为1.47亿美元（图4）[5]。  图4. 2024Q1 BMS主要肿瘤产品销售额 参考文献 1. G1 THERAPEUTICS PROVIDES UPDATE ON PHASE 3 PRESERVE 2 TRIAL IN PATIENTS RECEIVING TRILACICLIB PRIOR TO FIRST LINE CHEMOTHERAPY IN METASTATIC TRIPLE NEGATIVE BREAST CANCER (MTNBC) 2. The end of eFFECTOR Therapeutics: Oncology biotech winds down after mid-stage fail 3. Biopharma Layoff Tracker 2024:Ginkgo, Cara, Barinthus and MoreCut Staff 4. Cara Therapeutics Announces Outcome of Part A of KOURAGE-1 Study Evaluating Oral Difelikefalin in Notalgia Paresthetica 5. Bristol Myers Squibb Q1 2024 Results April 25, 2024 编者按： 在医药竞争的浪潮中，现金流稳定是药企稳健前行的关键。通过缩减人员、精简产品线等方式来缓解资金压力虽能短期内止血，却难以根治深层次的资金问题。药企需要更全面、更长远的策略来确保资金链的健康与持续。 专栏作者 五月 药物化学硕博，国外博士后，现从事药物研发工作，热爱医药行业，愿与各位同行互相学习、进步，共同见证创新药的发展。 *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！ 点击下方“药渡“，关注更多精彩内容 股价飙升39%：RNAi疗法时代来临 武田制药药物交易风云：近年数据透视其战略布局新动向 100%预防艾滋！吉利德科学创新药物Lenacapavir 3期临床结果喜人 点击下方关注，聚焦医药创新一手资讯

– Oral difelikefalin did not demonstrate meaningful clinical benefit compared to placebo – – Company will discontinue clinical program in NP and explore strategic alternatives – STAMFORD, Conn., June 12, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the outcome from the dose-finding Part A of the KOURAGE-1 study evaluating the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in adult patients with notalgia paresthetica (NP). Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo, resulting in the Company’s decision to discontinue the clinical program in NP. “Given our strong proof-of-concept results in NP and the significant unmet need in this sensory neuropathy, we are disappointed that oral difelikefalin did not demonstrate a meaningful improvement in pruritus compared to placebo in the KOURAGE-1 Part A study,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “We are grateful for the patients and investigators who participated in this study. We will be winding down the Phase 2/3 clinical program in NP and exploring strategic alternatives focused on maximizing shareholder value.” KOURAGE-1 Part A was a multicenter, randomized, double-blind, placebo-controlled study designed to inform the dose and sample size for the pivotal portions of the Phase 2/3 clinical program. In Part A, 214 patients were randomized to one of four arms: oral difelikefalin 2 mg twice a day (BID), 1 mg BID, 0.25 mg BID or placebo BID for 8 weeks. The primary endpoint was the proportion of patients achieving a ≥4-point improvement from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 8. Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The drug was generally well tolerated with a safety pro to prior trials. As of March 31, 2024, the Company had approximately $70 million in cash, cash equivalents, and marketable securities. About Cara Therapeutics Cara Therapeutics is a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company developed an IV formulation of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. For more information, visit and follow the company on X (Twitter), LinkedIn and Instagram. Forward-looking Statements 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. Examples of these forward-looking statements include statements concerning the winding down of the Company’s Phase 2/3 clinical program in NP, the exploration of strategic alternatives and other statements that are not historical facts. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ending December 31, 2023 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics 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. MEDIA CONTACT: Annie Spinetta 6 Degrees 973-768-2170 aspinetta@6degreespr.com INVESTOR CONTACT: Iris Francesconi, Ph.D. Cara Therapeutics 203-406-3700 investor@caratherapeutics.com