Fobrepodacin

Phase 3 PIVOT-PO trial of tebipenem HBr remains on track to complete enrollment in 2H 2025 Reiterate cash runway into mid-2026; Q3 2024 ending cash balance of $76.3M CAMBRIDGE, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced financial results for the third quarter ended September 30, 2024, and provided a business update. “Enrollment in the Phase 3 tebipenem HBr trial is progressing well, and we are on track to complete enrollment in the second half of 2025. Further, our work on the Phase 2 ready SPR206 program continues, contingent on availability of non-dilutive funding,” said Sath Shukla, President and Chief Executive Officer of Spero. “With SPR720 development plans now suspended while we complete a review of the full dataset from the Phase 2a trial, our extended cash runway into mid-2026 and streamlined operations position us well to achieve our ultimate goal of delivering new therapies to patients in need.” Pipeline Update Tebipenem HBr Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI) including acute pyelonephritis (AP) to help patients potentially avoid hospitalizations or reduce duration of in-patient therapy. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories. Enrollment on track in PIVOT-PO, the global Phase 3 clinical trial of tebipenem HBr in patients with cUTI. This randomized, double-blinded trial compares oral tebipenem HBr with intravenous imipenem cilastatin, in hospitalized adult patients with cUTI/AP. The primary endpoint is overall response (a combination of clinical cure and favorable microbiological response) at the Test-of-Cure (TOC) visit. Target enrollment for the trial is approximately 2,648 patients, with enrollment completion expected in the second half of 2025. For more information on PIVOT-PO, refer to ClinicalTrials.gov ID NCT06059846. SPR206 SPR206 is an investigational, intravenously administered next-generation polymyxin that has shown antibiotic activity against MDR Gram-negative pathogens, including carbapenem-resistant Enterobacterales, Acinetobacter baumannii and Pseudomonas aeruginosa in preclinical studies. The U.S. Food and Drug Administration (FDA) has cleared the Company's IND for a Phase 2 trial in patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). The Company maintains its guidance to initiate the trial contingent on availability of non-dilutive funding. SPR720 SPR720 is an investigational oral, chemically stable phosphate ester prodrug that is converted rapidly in vivo to SPR719, the active moiety. SPR719 targets the ATPase site of DNA gyrase B in mycobacteria. In October 2024, a planned interim analysis of the Phase 2a proof-of-concept study of SPR720 for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD) demonstrated that the study did not meet its primary endpoint. While the data showed antimicrobial activity associated with SPR720, the interim analysis did not show sufficient separation from placebo and highlighted potential dose limiting safety issues in patients dosed at 1,000 mg orally once daily, including three cases of reversible grade 3 hepatotoxicity. In evaluating the totality of both the efficacy and safety data, the Company suspended its development program for SPR720 and will evaluate other potential paths forward as the remaining data are collected and analyzed. Corporate Update In October 2024, following suspension of the current SPR720 development plans, Spero underwent a restructuring and reduction in force of approximately 39%, which extended the Company’s cash runway into mid-2026. Third quarter 2024 Financial Results Spero reported a net loss of $17.1 million, or ($0.32) per share of common stock, basic and diluted, for the third quarter ended September 30, 2024, compared with a net loss of $3.2 million, or ($0.06) per share of common stock, basic and diluted, for the third quarter ending September 30, 2023.Total revenue for the third quarter of 2024 was $13.5 million, compared with total revenue of $25.5 million for the third quarter of 2023. The revenue decrease for the third quarter of 2024 was primarily due to lower revenues related to ongoing collaborations.Research and development expenses for the third quarter of 2024 were $26.9 million, compared to $16.4 million of research and development expenses for the same period in 2023. The increase in research and development expenses year-over-year was primarily due to increased clinical trial expenses for PIVOT-PO.General and administrative expenses for the third quarter of 2024 were $5.2 million, compared to $5.7 million of general and administrative expenses for the same period in 2023. This year-over-year decrease was primarily due to decreased consulting and professional expenses.As of September 30, 2024, Spero had cash and cash equivalents of $76.3 million. Following the reduction in force and restructuring described above, Spero estimates that its existing cash and cash equivalents, together with earned and non-contingent development milestone payments from GSK, as well as other non-dilutive funding commitments, will be sufficient to fund its operating expenses and capital expenditures into mid-2026. For further details on Spero’s financials, refer to Spero’s Quarterly Report on Form 10-Q, filed with the U.S. Securities and Exchange Commission (SEC) today. About Spero Therapeutics Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a multi-asset clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and MDR bacterial infections with high unmet need. For more information, visit www.sperotherapeutics.com Government Agency Research Support The views expressed in this press release are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government. Tebipenem HBr Research Support Select tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C. Department of Defense Select SPR206 studies are supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Joint Warfighter Medical Research Program under Award No. W81XWH 19 1 0295. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. National Institute of Allergy and Infectious Disease Select SPR206 studies have been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93021C00022. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing, progress and results of Spero's preclinical studies, clinical trials and research and development programs; the potential benefits of any of Spero’s current or future product candidates in treating patients; and Spero’s strategy, goals and anticipated financial performance, milestones, business plans and focus. In some cases, forward-looking statements may be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms or other similar expressions. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual results to differ materially from those indicated by such forward looking statements, including whether tebipenem HBr, SPR720 and SPR206 will advance through the clinical trial process on a timely basis, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Spero's reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; Spero's need for additional funding; the ability to commercialize Spero's product candidates, if approved; Spero's ability to retain key personnel; Spero's leadership transitions; whether Spero's cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the "Risk Factors" set forth in filings that Spero periodically makes with the SEC. The forward-looking statements included in this press release represent Spero's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Spero explicitly disclaims any obligation to update any forward-looking statements. Investor Relations Contact:Shai Biran, PhDSpero Therapeutics IR@Sperotherapeutics.com Media Inquiries: media@sperotherapeutics.com Spero Therapeutics, Inc.Condensed Consolidated Balance Sheet Data(in thousands)(Unaudited) September 30, December 31, 2024 2023Cash and cash equivalents$76,290 $76,333Other assets 58,871 106,057Total assets$ 135,161 $ 182,390 Total liabilities 69,654 75,496Total stockholder's equity 65,507 106,894Total liabilities and stockholders' equity$ 135,161 $ 182,390 Spero Therapeutics, Inc.Condensed Consolidated Statements of Operations(in thousands, except share and per share data) (unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenues: Grant revenue$5,650 $2,091 $14,893 $5,349 Collaboration revenue - related party 7,754 23,164 17,721 24,200 Collaboration revenue 65 218 319 710 Total revenues 13,469 25,473 32,933 30,259 Operating expenses: Research and development 26,864 16,393 67,921 34,883 General and administrative 5,198 5,708 16,648 19,121 Impairment of long-term asset — 5,306 — 5,306 Total operating expenses 32,062 27,407 84,569 59,310 Loss from operations (18,593) (1,934) (51,636) (29,051)Other income (expense) 1,156 940 3,668 2,877 Net loss (17,437) (994) (47,968) (26,174)Income tax expense 290 (2,211) 290 (2,211)Net loss$(17,147) $(3,205) $(47,678) $(28,385) Net loss per share attributable to common shareholders per share, basic and diluted$(0.32) $(0.06) $(0.89) $(0.54) Weighted average shares outstanding, basic and diluted: 54,124,862 52,710,280 53,869,824 52,603,709

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/