Spero Therapeutics, Inc.

受全球经济下行压力和生物制药资本寒冬影响，生物医药行业裁员现象日益普遍。裁员原因包括被并购、产品开发失利、业务重组、降低管理成本等多方面。2024年10月，寒气更甚，裁员公司数量有增加趋势，有21家公司宣布裁员。其中辉瑞在半个月内进行了2次裁员。 10月 30日 10月29日，Spero Therapeutics宣布，由于其候选抗生素SPR720（一种正在研究的非结核分枝杆菌肺病治疗方法）的 IIa 期研究的中期分析未达到主要终点。公司暂停该项目，内部重组裁员约39%。根据 10 月 29 日提交给美国证券交易委员会的文件，这家处于临床阶段的生物制药公司预计将在今年年底前基本完成裁员。截至2023年 12 月 31 日，Spero 有 46 名员工，其中 30 人主要从事研发活动，按照这个数量计算，裁员会影响大约 18 人。 根据公告，Spero 的重组预计将延长公司的现金流并支持运营至 2026 年年中。在此期间，这家生物制药公司将专注于在正在进行的全球 III 期试验中推进替比培南 HBr，并为 SPR206 的 II 期试验做准备。 10月28日 据Fierce Biotech报道，总部位于都柏林的合同研究组织（CRO）ICON首席执行官Steve Cutler在投资者电话会议上表示，该公司正在“查看某些地区人员过多的地方”并“采取相当果断的行动”。ICON在45个国家/地区设有办事处，美国11个州设有办事处。 根据公司的财报公告，ICON第三季度收入为203万美元，同比下降1.2%，未能达到预期.。原因有三：两个大客户削减预算开发模式发生变化;疫苗相关结果低于预期;生物技术客户“持续谨慎”，以及研究计划延迟。 10月25日 总部位于宾夕法尼亚州拉德诺的Marinus Pharmaceuticals宣布，在加奈索酮治疗与结节性硬化症（TSC）相关的癫痫发作的III期试验令人失望后，为削减成本该公司将裁员。此外，为实现“为股东实现价值最大化”的目标，公司还将停止该药物的进一步临床开发，并探索战略替代方案。 公司未明确裁员人数也没有说明裁员何时生效。截至2023年12月31日，该公司有165名全职员工。Marinus在5月份宣布裁员约20%。因此，目前员工人数可能更少。 Marinus 在其 10 月 24 日的公告中指出，评估口服加奈索酮的 III 期 TrustTSC 试验未达到 28 天 TSC 相关癫痫发作频率百分比变化的主要终点。虽然癫痫发作频率的降低有利于加奈索酮组，但主要终点未能达到统计学意义。 10月23日 四个月前，辉瑞的III期杜氏肌营养不良症（DMD）试验中未能达到主要疗效终点。受此影响，辉瑞将要裁员。此次裁员将影响辉瑞北卡罗来纳州桑福德工厂的75名员工。在此之前，辉瑞Sanford工厂在III期DMD读数后立即取消了 150个职位。 此次裁员是辉瑞在10月16日和10月17日在其堪萨斯州麦克弗森工厂发出80份裁员通知后，几周内的第二轮裁员，本月的第三轮裁员。 10月22日 据多家当地媒体报道，辉瑞在其位于堪萨斯州麦克弗森的工厂发出了80份裁员通知，该工厂约有1,800名员工。裁员影响了管理和工程职位，但不会影响生产职位。 根据2024年5月的利润率评估计划，辉瑞进行了一系列评估，重点是运营效率和网络优化。根据这些评估，目前已将员工人数与工厂容量设计保持一致，以满足业务需求。 这是辉瑞本月的第二轮裁员。10月初，《爱尔兰时报》报道称，该公司在爱尔兰Grange Castle、Newbridge和Ringaskiddy的工厂裁减多达210个制造业工作岗位。 10月21日 根据10月15日的WARN通知，武田将在2024年9月下旬至2025年3月期间在其剑桥工厂裁员45名员工，在其列克星敦工厂再裁员34名员工。在宣布这一消息的同时，该公司决定终止WVE-003临床阶段亨廷顿病项目上的工作——这是一个潜在的50亿美元的商业机会。 7月，该公司解雇了马萨诸塞州的220名员工（剑桥189名员工和列克星敦31名员工）。5月，该公司分别宣布在该州裁员641人（剑桥495人，列克星敦146人），并关闭圣地亚哥的一个研发中心，该中心拥有324名员工。今年3月，武田表示，由于奥地利多瑙河畔奥尔特的一家工厂的研发和制造业务关闭，将有190名员工失去工作。 到目前为止，武田总共已经裁员或宣布计划在2024年裁员1,300多名员工。 10月17日 在宣布停止开发dalzanemdor治疗阿尔茨海默病大约一周后，有消息称Sage Therapeutics将裁员超过165名员工，约占其员工总数的33%。 根据Sage在10月17日的公告中，裁员是公司业务运营战略重组的一部分。裁员将包括大约55%的马萨诸塞州剑桥生物技术公司研发人员及其领导团队的五名成员。该公司预计将在2024年底前基本完成裁员。 据Sage称，此次重组旨在支持Zurzuvae在产后抑郁症中的上市，并在预计今年晚些时候进行临床研究。Sage 于 2023 年底与 Biogen 合作推出了 Zurzuvae，Zurzuvae 于 2023 年获得批准，是第一种被批准用于治疗产后抑郁症的药丸。并销售额达160 万美元。此外，将候选药物dalzanemdor的亨廷顿病管线开发作为工作重点。6 月，FDA批准的 II 期 SURVEYOR 研究显示dalzanemdor在亨廷顿舞蹈症-认知评估电池综合评分有统计学上的显著改善。 参考文献： Layoff Tracker: https://www.biospace.com/

Matinas BioPharma first reported in August that it had signed a non-binding term sheet for global licensing rights to MAT2203 for all future treatment indications. Image credit: Yellow_man / Shutterstock. Matinas BioPharma has halted all product development activities and fired 80% of its staff, including three members of senior management, in an effort to save resources after the partnership negotiations for its lead antifungal therapy were terminated. The company noted that the workforce reductions would occur with immediate effect. According to a Matinas press release, the company’s board is evaluating all alternatives, including the asset sale of MAT2203 (oral formulation of amphotericin B) and the potential wind-down and dissolution of the company. The company’s stock took a nosedive following the news. It is currently trading at $0.67, down by 65.2% compared to the market close yesterday (30 October). Martinas BioPharma’s market cap currently stands at $3.5m, with the company reporting cash reserves of $14.3m as of 30 June, as per the company’s Q2 financials. In August, Martinas reported that it had signed a non-binding term sheet for global licensing rights to MAT2203 for all future treatment indications. The company did not disclose the partner’s name or the financial details of the deal, only that it was preparing to start a Phase III registrational trial for the therapy following the partnership announcement. The study was expected to evaluate the therapy as an oral step-down monotherapy for patients with invasive aspergillosis following treatment with AmBisome (liposomal amphotericin B). MAT2203 was designed using the company’s lipid nanocrystal (LNC) platform to overcome the safety and toxicity limitations of intravenous amphotericin B. Despite being indicated to treat invasive fungal infections, intravenous amphotericin B is known to be toxic to kidneys and liver, with approximately 80% of patients developing infusion-related adverse effects or nephrotoxicity. Although there is an increased need for antimicrobial therapies , the field has not seen much success in recent years. Spero Therapeutics’ prodrug antibiotic SPR720 failed to meet the primary endpoint in a Phase IIa trial in patients with non-tuberculous mycobacterial pulmonary disease. AN2 Therapeutics also had to suspend development for its lead antibiotic, epetraborole, after it failed to show efficacy in the Phase II/III trial (NCT05327803). Itreum Therapeutics was able to receive approval from the US Food and Drug Administration (FDA) for its antibiotic Orlynvah (sulopenem etzadroxil and probenecid) for treating uncomplicated urinary tract infections (uUTIs). The agency approved the therapy’s use for treating uUTIs caused by E. coli, Klebsiella pneumoniae or Proteus mirabilis in women who have limited or no alternative antibacterial treatment options.

Plus, news about Zai Lab, Spero Therapeutics and EyePoint Pharmaceuticals: Leal Therapeutics raises $45M: The biotech, which emerged from stealth earlier this year, said the financing was led by Newpath Partners. Other investors included Chugai Venture Fund and OrbiMed. It’s developing CNS treatments, with plans to file INDs for two therapies by the end of this year. — Jaimy Lee SynOx raises $17M in Series B extension: The UK biotech plans to use the funds to support a Phase 3 test of its monoclonal antibody, called emactuzumab, in tenosynovial giant cell tumor, a form of rare, non-malignant growth. SynOx has already dosed the first few patients in the trial. The extension brings the company’s total Series B proceeds to $92 million. — Ayisha Sharma Zai Lab passes Phase 3 test for KarXT in China: Bristol Myers Squibb’s schizophrenia drug appears poised to reach the Chinese market after partner Zai Lab reported positive Phase 3 data there . A Phase 3 bridging study met the primary endpoint, demonstrating a statistically significant 9.2 reduction in a measurement of schizophrenia symptoms compared to placebo. — Max Bayer Spero fails proof-of-concept Phase 2a trial, lays off staff: The company ended development of the asset after an interim analysis of SPR720 found it did not meet the primary endpoints of a mid-stage trial for patients with nontuberculous mycobacterial pulmonary disease. Spero said the drug did not show “sufficient separation from placebo” and potential dose-limiting issues at the 1,000 mg dose level, exemplified by three grade 3 cases of hepatotoxicity that were eventually reversed. The company, which had 46 employees as of Dec. 31, is now laying off 39% of its workers. — Max Bayer EyePoint upsized its public offering. It now expects to raise $140 million instead of $100 million . — Jaimy Lee