CERo Therapeutics Holdings, Inc.

CAR-T cell therapy startup Arsenal Biosciences has reeled in a $325 million Series C as it works through two early-stage trials in solid tumors. But even after securing the fifth-largest private biotech financing round so far in 2024, ArsenalBio is also prioritizing, joining the likes of many other well-funded startups in the industry. The lead program, AB-1015, is not expected to move beyond a Phase 1 in ovarian cancer. “[AB-1015] was the first program that we put into the clinic, and it gave us incredible insight into the novelty of our product design that we could then evolve into the second- and third-generation programs,” CEO Ken Drazan said in an interview with Endpoints News . The Series C came about two years after ArsenalBio’s last major raise of $220 million . With the new megaround, which Drazan said is not tranched, ArsenalBio will focus on its second clinical-stage autologous cell therapy, dubbed AB-2100. The programmable cell therapy entered the clinic earlier this year for kidney cancers, and the startup expects to have a clinical progress update by year’s end, the CEO said. The biotech also plans to bring a third cell therapy into the clinic, in prostate cancer, in late 2025 or early 2026. ArsenalBio manufactures its cell therapies in-house and uses synthetic biology, computation and other technologies to genetically adjust a patient’s own T cells to thwart solid tumors. Cell therapies have dramatically changed the treatment landscape for blood cancers, but the move into solid tumors has been fraught with more challenges. The latest round included a cohort of first-time ArsenalBio backers, including ARCH Venture Partners, Milky Way Investments Group (also behind cell therapy developers Lyell and CERo), newly-launched Regeneron Ventures , Nvidia’s VC arm, T. Rowe Price and Rock Springs Capital. Existing investors also took part in the new round, including partner Bristol Myers Squibb, Westlake Village BioPartners, SoftBank Vision Fund 2, the Parker Institute for Cancer Immunotherapy and others. Drazan said the round’s “diversity of investors” includes a few buckets: traditional specialists, firms that typically come in for crossovers or IPOs, and strategics with specific interests. “I would just encourage you to look at that list of individual corporations, and you can probably see that some are interested in medicines and some that are interested in other things,” Drazan said, “and those other things, we hope to have more news about before the end of the year.” Drazan was previously president of Grail before co-founding ArsenalBio in January 2019. His leadership team includes experienced cell therapy developers and manufacturers, including CMO Susie Jun, who was the chief development officer at Allogene; and technical operations chief Tim Sirichoke, who’s been at Kite Pharma, Novartis and Genentech. The biotech has expanded to 265 employees across locations in South San Francisco and Hayward, CA. It’s also working on two solid tumor CAR-T cell therapies with Bristol Myers and research in undisclosed areas with Genentech, which is pulling back in certain cancer immunology areas. Multiple large pharmaceutical companies and nimbler biotechs are also moving cell therapies into the autoimmune field . While ArsenalBio doesn’t plan to develop autoimmune cell therapies internally, its technology platform could “enable autoimmune drug developers, and we’re hoping to provide that capability through business development,” Drazan said. “Hopefully, we’ll have some news on that front later this year,” the CEO added.

SOUTH SAN FRANCISCO, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Cero Therapeutics Holdings, Inc., (NASDAQ:CERO) (“CERo”) an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic and innate immune system mechanisms, announces it is presenting preclinical data on its lead product candidate CER-1236 at the Stanford Drug Discovery Symposium, which is being held April 29-30, 2024 in Palo Alto, Calif. The poster, titled, “TIM-4-L-targeting CER-1236 Engineered T cells Eliminate Adverse-Risk AML Xenografts and Exhibit Favorable Manufacturing Product Attributes for Clinical Translation,” outlines key attributes of the program. Specifically, the data highlights the capabilities of CER-1236 engineered T cells in eliminating adverse-risk p53mutated AML cell lines in vivo and low risk of off-tumor toxicity to hematopoietic progenitor stem cells (HSPCs). The poster also highlights manufacturing data demonstrating the Company’s capacity to generate high yields of CER-1236 drug product exhibiting naïve and central memory phenotypes, which enhance the activity of the therapy. Details of the poster can be found here. CERo Founder and CTO Daniel Corey comments, “CER-1236 engineered T cells targeting TIM-4-L are a novel and differentiated therapeutic approach for leukemia with encouraging pre-clinical data. We have demonstrated the capacity to manufacture high yields of CER-1236 with favorable memory and immunophenotypic pro We are diligently working on an IND submission in the near term. We look forward to continuing to provide appropriate updates to shareholders as they develop.” About CERo Therapeutics, Inc. CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body’s full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells (“CER-T”). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor (“CAR-T”) cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo anticipates initiating clinical trials for its lead product candidate, CER-1236, in 2024 for hematological malignancies. Forward-Looking Statements This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo’s management. Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo’s filings with the Securities and Exchange Commission, including its Current Report on Form 8-K, as amended, filed on February 27, 2024, and the documents incorporated by reference therein. The risks described in CERo’s filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contact: Brian Atwood Chief Executive Officer batwood@cero.bio Investors: CORE IR investors@cero.bio

▲5月30-31日 第八届广州生物医药创新者峰会 扫码立即报名 注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。2024年1-3月，据不完全统计，共6家CGT公司上市，其中4家通过IPO上市，2家通过与SPAC公司合并上市。4家IPO上市募资金额超9亿美元，其中超亿美元的有3家，CG Oncology IPO金额最高，达3.8亿美元。2家通过与SPAC合并上市的CGT公司分别是：CERo Therapeutics、Tevogen Bio。2月15日，SPAC公司PBAX宣布与细胞疗法公司CERo Therapeutics合并，上市代码为"CERO"，估值约为1.45亿美元。2月15日，细胞免疫疗法开发商Tevogen Bio与SPAC公司LGST合并上市，上市代码为“TVGN”，估值约为12亿美元。除此之外，放眼国内，1月22日，香港证券交易所网站公示显示，九源基因已向港交所递交IPO申请并获得受理。该公司致力于将基因工程应用于医药行业，专注于骨科、代谢疾病、肿瘤及血液四大治疗领域，并已经拥有8款已上市产品，超过10款在研产品。CG Oncology1月25日，CG Oncology不仅成为首家于2024年成功IPO的CGT公司，也成为2024Q1募资规模最大的CGT公司。此次IPO募集3.8亿美元，超出了原先1.81亿美元的预期。CG Oncology是一家溶瘤免疫疗法公司，其核心管线Cretostimogene（CG0070）是一种经静脉内给药的靶向溶瘤免疫疗法药物，已经进入三期临床，有望造福膀胱癌患者。与此同时，1月份CDE官网公示，CG Oncology公司的溶瘤病毒产品“CG0070注射液”获得临床默示许可。适应症为：非肌层浸润性膀胱癌。研发管线Fractyl Health2月1日，Fractyl Health宣布完成1.1亿美元IPO。Fractyl Health于2010年成立，是一家专注于开发2型糖尿病和肥胖症基因疗法的公司。与诺和诺德Semaglutide、礼来Tirzepatide等减肥药停用易反弹不同，Fractyl Health开发了1款AAV基因疗法GLP-1 PGTx，旨在减肥后体重维持时间长，且不需要持续治疗。该疗法通过使用失活的腺相关病毒，传递刺激胰腺细胞中GLP-1表达的基因，从而导致胰岛素释放，以帮助患者永久产生自己的GLP-1激动剂，预计今年进行临床前研究。研发管线Kyverna Therapeutics2月8日，Kyverna Therapeutics在纳斯达克交易所上市，IPO金额达3.19亿美元，是计划募资（1亿美元）的3倍。Kyverna于2020年1月完成2500万美元A轮融资，2022年1月完成8500万美元 B 轮融资，2023年8月完成6000万美元B+轮融资；累计融资1.7亿美元，均获吉利德投资。Kyverna Therapeutics 是一家处于临床阶段的细胞治疗公司，开发自体（KYV-101）和同种异体（KYV-201）CAR-T细胞疗法，用于自身免疫疾病和炎症性疾病。其核心管线KYV-101是一种新型的全人源CD19 CAR-T 细胞疗法，其特性尤其适用于治疗B细胞驱动的自身免疫性疾病，如狼疮性肾炎、系统性硬化症和炎性肌病。而KYV-201 是同种异体版的 CD19 CAR-T，这是一种现货型治疗方法，通过基于 CRISPR/Cas9 的同种异体平台进行了基因组编辑，可用于 B 细胞介导的自身免疫疾病。研发管线Metagenomi2月9日，Metagenomi 在纳斯达克交易所上市，募资募资9375万美元，成为今年首个IPO的临床前生物技术公司。Metagenomi成立于2018年，是一家通过宏基因组学挖掘新编辑工具、开发基因药物的生物技术公司，曾入选Fast Company公布的“全球最具创新力的10家生物科技公司名单”。自2018年成立以来，Metagenomi 获得了30多家投资机构和制药商近4亿美元的资金支持。投资人包括拜耳、诺和诺德、Moderna、BMS、 等知名企业。2020年7月，Metagenomi完成6500万美元的A轮融资。2021年4月，Metagenomi完成1000万美元的A+轮融资。2022年2月，Metagenomi完成1.75亿美元B轮融资。2023年1月，Metagenomi完成1亿美元的B+轮融资。目前，Metagenomi 已开发多款研发管线，除血友病、囊性纤维化外，还布局心血管、肿瘤学、代谢疾病等疾病。值得注意的是，其所有候选产品均处于临床前阶段。研发管线总结相比于2023年的3家CGT公司进行IPO，2024年短短一季度就有4家公司IPO，由1月份CG Oncology募资高达3.8亿引领行业浪潮，对于试图从2023年低迷市场中反弹的CGT公司来说，这是一个积极的信号。而Metagenomi的IPO代表投资者对临床前生物技术公司投资的升温。参考资料：各公司官网版权声明：本文转自细胞基因治疗前沿，如不希望被转载的媒体或个人可与我们联系，我们将立即删除 活动推荐  5月 • 第八届大湾区生物医药创新者峰会  关键词：  小分子，XDC，多肽及GLP-1热点话题，80+行业专家（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。