Hexavalent Recombinant Norovirus vaccine (Kanghua Biological)

裁员仍在持续。 据药研网统计，8月宣布减员的药企数量仍高达22家，与去年持平。 其中，不仅有因主要候选药物临床失败而裁员过半的多家生物药企，更有CRISPR基因编辑先驱张锋两位学生创立但迅速陨落新型基因编辑公司。 2024年8月裁员汇总 新型基因编辑公司的迅速陨落 8月23日，据马萨诸塞州政府官网，基因编辑公司Tome Biosciences 将于11月裁员 131人。该公司员工数正好超过130 人，但发言人未对裁员一事发表评论。 Tome Biosciences 由CRISPR基因编辑先驱—张锋教授的2位学生于2021年创立，8个月前筹集了 2.13 亿美元的两轮融资，但这家初创公司却已经耗尽资金，用于支持其IND的C轮融资困难。目前，该公司表示将停止实验室工作，专注于寻找收购方或合作伙伴以继续开发基因编辑技术。 首席执行官Kakkar将这归因于投资者对整个基因编辑公司的情绪普遍恶化。据PitchBook的数据，细胞和基因治疗领域的投资情绪低迷。自2024年初以来，专注于CRISPR基因编辑的六家生物技术公司的股价下跌了25%至65%。 临床加速无望，研发人员遭裁撤80% 8月22日，精准肿瘤公司Aadi Bioscience宣布，将裁员80%研发人员，将现金运行时间延长到2026年下半年。其核心管线白蛋白结合型西罗莫司的II期临床数据未达到批准所需疗效阈值。将暂停TSC1或者TSC2基因突变的实体瘤患者的白蛋白结合型西罗莫司试验PRECISION1。 放射治疗药物公司破产清算 8月14日，专注于放射治疗药物的Galera Therapeutics公司宣布，董事会已批准一项破产清算计划，停止所有临床试验活动和候选产品的开发，将解雇22名员工，占总数的70%。 Grail大规模裁员 6月底从Illumina剥离后，Grail于8月13日发布Q2财报时宣布重组，将更新产品战略，专注于核心多癌早期检测业务，集中开发Galleri产品。同时调整公司的架构，进行大规模裁员约 350人（比例高达30%），预计调整后现金将支持运营至2028年。 核心管线失败，FibroGen解雇75%美国员工 8月13日，据悉，FibroGen在核心管线Pamrevlumab后期试验失败后，终止该项目，实施成本削减，预计在2025年Q1前裁减美国员工127人（75%）。 Pamrevlumab是一款靶向CTGF的first-in-class抑制剂。其两项临床皆未能达到预先指定的总生存期主要终点：一项为pamrevlumab联合吉西他滨用于转移性胰腺导管腺癌（mPDAC）患者的一线和二线治疗的II/III期试验，另一项为评估pamrevlumab联合吉西他滨或 folfirinox 治疗胰腺癌的III期试验。 百时美施贵宝继续执行裁员计划 百时美施贵宝正在执行今年春天宣布的裁员 2,200 名员工的计划，在新泽西州劳伦斯维尔解雇 117 名员工 。这是继今年3月和5月裁员之后进行的最新一轮裁员。   UniQure 8月2日，基因治疗公司 UniQure宣布将裁员65%，共计 300 人，包括首席运营官 Pierre Caloz。该公司将此次裁员归因于：将马萨诸塞州工厂出售给Genezen。  HilleVax 8月1日，从武田分拆出来的HilleVax周三宣布，将裁员 41 名员工，约占员工总数的40%。该公司表示，此次减产“旨在保留现金，继续探索核心产品诺如病毒疫苗潜力。 7月份该公司已宣布, 二价诺如病毒疫苗婴儿2b期临床NEST-IN1试验未能达到主要或次要疗效终点，将终止HIL-214在婴儿的临床试验，继续进行HIL-214、HIL-216在成人群体的临床探索。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。 转载/商务/投稿 | 联系微信 wfj_GM 商务合作 稿件征集 点击了解详情 往期回顾 1 5月| 20家药企裁员（附名单） 2 18亿美元，ADC又出海! 宜联生物宣布新授权 3 2024 ASCO| 默沙东/科伦TROP2 ADC、信达、礼新CLDN18.2 ADC数据公布

$245.0 million of cash, cash equivalents and marketable securities as of June 30, 2024 The company is exploring the potential for continued development of its HIL-214 and HIL-216 norovirus vaccine candidates in adults BOSTON, Aug. 08, 2024 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today reported financial results for the quarter ended June 30, 2024 and highlighted recent progress. Recent Business Highlights In Q3 2024, HilleVax announced that the NEST-IN1 clinical study did not meet its primary or secondary efficacy endpoints and that the company would discontinue further development of HIL-214 in infants.In Q3 2024, HilleVax announced a workforce reduction of approximately 40% of its workforce to reduce operating expenses while maintaining core capabilities as the company explores the potential for continued development of its HIL-214 and HIL-216 norovirus candidates as well as business development-related activities for these vaccine candidates. Second Quarter 2024 Financial Results As of June 30, 2024 and December 31, 2023, the company had cash, cash equivalents and marketable securities totaling $245.0 million and $303.5 million, respectively. Research and development expenses for the second quarter 2024 were $26.6 million, compared to $23.0 for the second quarter 2023. The increase was primarily due to the growth in the number of R&D employees. General and administrative expenses for the second quarter 2024 were $8.1 million, compared to $7.2 million for the second quarter 2023. The increase was primarily due to the growth in the number of G&A employees. Other income for the second quarter 2024 and second quarter 2023 was $2.3 million. Net loss for the second quarter 2024 was $40.7 million, compared to $27.9 million for the second quarter 2023. About HilleVax HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Its initial programs, HIL-214 and HIL-216, are virus-like particle (VLP) based vaccine candidates in development for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. Globally, norovirus is estimated to result in over approximately 700 million cases of AGE and 200,000 deaths per year, resulting in over $4 billion in direct health system costs and $60 billion in societal costs per year. The burden of norovirus falls disproportionately on young children and older adults. For more information about HilleVax, visit the company’s website at http://www.HilleVax.com. Forward-Looking Statements The company cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on the company’s current beliefs and expectations and include, but are not limited to, the company’s plans to explore continued development efforts on, and advance the development of, HIL-214 and HIL-216 in adults and the potential opportunity for and benefits of HIL-214 and HIL-216, and intended objectives and benefits of the workforce reduction. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the company’s business, including, without limitation: to-date the company has depended primarily on the success of HIL-214, and the company may be unable to identify a viable development path forward for HIL-214 or HIL-216; if the company does identify a development path forward for its vaccine candidates, the company may require additional capital and other resources, including business development partnerships or other strategic collaborations, and the company may be unable to secure partnerships, other strategic collaborations or other resources on acceptable terms or at all; topline results are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the NEST-IN1 study and such topline data may not accurately reflect the complete results of a clinical trial; to the extent the company pursues future studies, the company may experience potential delays in the commencement, enrollment, data readouts and completion of clinical trials and preclinical studies; the company depends on third parties in connection with manufacturing, research and clinical and preclinical testing; unexpected adverse side effects or inadequate immunogenicity or efficacy of HIL-214, HIL-216 or any future vaccine candidates that may limit their development, regulatory approval, commercialization and/or business development potential; further unfavorable results from clinical trials; results from prior clinical trials and studies are not necessarily predictive of future results; the company relies on intellectual property rights under its license agreements with Takeda Vaccines, Inc. and Kanghua Biological Products Co., Ltd.; the company may be unable to obtain, maintain and enforce intellectual property protection for its vaccine candidates; the company may use its capital resources sooner than it expects; and other risks described in the company’s prior press releases and the company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the company’s annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Shane MaltbieIR@hillevax.com+1-617-213-5054 HilleVax, Inc.Condensed Consolidated Statement of Operations Data(in thousands, except share and per share data)(unaudited) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Operating expenses: Research and development $26,601 $22,953 $52,579 $46,117 In-process research and development — — 15,325 — General and administrative 8,127 7,231 16,621 13,026 Impairment charges 8,235 — 8,235 — Total operating expenses 42,963 30,184 92,760 59,143 Loss from operations (42,963) (30,184) (92,760) (59,143)Total other income 2,295 2,282 5,263 4,352 Net loss $(40,668) $(27,902) $(87,497) $(54,791)Net loss per share, basic and diluted $(0.83) $(0.74) $(1.79) $(1.45)Weighted-average shares of common stock outstanding, basic and diluted 49,179,109 37,951,735 48,819,729 37,853,176 HilleVax, Inc.Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) June 30,2024 December 31,2023 Cash, cash equivalents and marketable securities $245,040 $303,483 Total assets 276,931 344,434 Total liabilities 72,001 78,909 Total stockholders’ equity 204,930 265,525 Total liabilities and stockholders’ equity 276,931 344,434