Image Credit: Shutterstock / KingVector In the last decade, the idea of tapping into the gut has attracted much interest from investors and the public, but recent years have showed that a lot more work needs to be done before such treatments enter the mainstream. This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times. Finch Therapeutics’s Phase III PRISM4 trial for recurrent Clostridioides difficile infection (CDI) and MaaT Pharma’s Phase III trial in steroid-resistant acute graft-versus-host disease were both put on hold. While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. In January 2023, Finch announced plans to scrap the PRISM4 trial altogether. The idea behind these treatments relies on altering the gut microbiome by designing therapeutics that contain bacteria derived from donated stool samples. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. But the approval came through after an FDA Advisory Committee meeting. Moreover, the Covid-19 pandemic put a spotlight on microbiome-based therapeutics due to the potential transmission risks in this class. “This whole field has been set back a little bit by the pandemic. We lost three years,” says Dr. Susy Hota, infectious disease specialist at University Health Network, University of Toronto. Coupled with this, the harsh conditions of the biotech market affected some companies. On February 16, the microbiome therapeutics-focused biotech 4D Pharma was pulled from the London Stock Exchange after falling into administration in June 2022. When Finch decided to end the PRISM4 program, it announced plans to reduce its workforce by 95%. Back in April 2022, the microbiome-focused biotech Kaleido Therapeutics folded due to financial and regulatory setbacks. Although there was a lot of hype surrounding the microbiome about five years ago, it is a question if this is still the case, says Hota. Also, microbiome therapies need to work in other indications for continued interest. “If recurrent CDI is the main indication, it is not an extremely attractive area to a lot of people,” says Hota. Regulatory concerns remain Overall, microbiome research has not advanced as much as expected, which is partly due to safety issues, says Hota. Though the pandemic disrupted research in general, it was particularly difficult to conduct research that relied on stool samples, adds Hota. Such caveats centre around the risk of infection caused by different diseases such as Covid-19 and mpox. In March 2020, the FDA shared a safety alert on the use of faecal microbiota transplants (FMTs) due to Covid-19, which added questions identifying those infected with Covid-19 to donor screening protocols. More than two years later, the FDA shared a similar alert that requested additional protections on the use of FMTs due to the mpox virus. These safety concerns froze research, says Dr. Sarah McGill, associate professor of medicine at the University of North Carolina School of Medicine, Chapel Hill. “It will take some time for research to thaw,” she adds. McGill says she does not know of a single confirmed case of Covid-19 transmission through FMTs. The best approach here would be to screen every sample, but that raises questions on the sustainability of such protocols, Hota notes. Wild west of development Currently, the sector is in its “wild west stage,” says Jack Gilbert, PhD, professor in paediatrics and the Scripps Institution of Oceanography, University of California San Diego. Although research here is about 20 years old, it remains new compared to other areas like genomics, says Gilbert. To an extent, the use of FMT in CDI paved the way for microbiome therapies, says Dr. Neilanjan Nandi, associate professor of clinical medicine at the University of Pennsylvania, Philadelphia. While Rebyota was the first to be approved, more could be coming up soon, says Gilbert. Rebyota is a faecal microbiota-based treatment for patients with recurrent CDI that is administered through an enema. In the Phase III PUNCH CD3 trial, Rebyota was superior to placebo in the reduction of CDI recurrence, with a 70.6% treatment success rate after eight weeks compared to 57.5% with placebo. Seres Therapeutics’s SER-109 is under Priority Review and the FDA has set a PDUFA date of April 26, 2023, for its use as a treatment for recurrent CDI. Unlike Rebyota, SER-109 comes in capsule form and is taken over the course of three days. Elsewhere, Vedanta Biosciences aims to bring its oral CDI treatment VE303 into a Phase III trial this year. Vedanta is a subsidiary of Puretech Health. Destiny Pharma’s CDI treatment NTCD-M3 is expected to enter a Phase III next year. Unlike Rebyota and SER-109, Vedanta’s treatment is based on clonal bacteria strains and does not use donated stool samples. CDI should be seen as only the beginning, says Nandi, adding that inflammatory bowel disease (IBD) is also an interesting avenue . However, the results here are quite mixed, say Hota and McGill. For instance, Seres’s Phase IIb study of SER-287 to treat ulcerative colitis did not meet its primary endpoint of clinical remission compared to placebo. Both SER-109 and SER-287 are made from a purified consortium of Firmicutes spores derived from stool samples. According to the company’s website, the biotech is undertaking research to decide on the future of the ulcerative colitis program, which also includes another candidate called SER-301. Last year, Takeda Pharmaceutical ended its deal with Finch in August after a review of its pipeline. Previously, Takeda had licensed the two Finch treatments FIN-524 and FIN-525 for their development in IBD. Still, other companies are keen on exploring IBD further, such as the UK-based company Microbiotica. The start-up expects to start its Phase Ib in ulcerative colitis this year, and focuses on the development of orally administered live therapeutics that are derived from bacterial consortia. The potential use of microbiome therapeutics in cancer comes with its own set of questions. While humans normally encounter microorganisms in their day-to-day activities, their functioning immune systems can handle those, says Hota. But since the immunity of cancer patients is suppressed by treatments like chemotherapy, the risks here are much greater, she explains. Microbiome therapeutics here could be used as adjunct treatments, rather than primary therapies, says Dr. Louis Korman, co-director of Chevy Chase Clinical Research, Chevy Chase, Maryland. A lot of immunotherapies cause side effects in the gastrointestinal tract, says Korman. With that in mind, therapeutics could be used to reduce toxicity, he explains. Although enthusiasm for microbiome therapeutics is broadly quite high, it is slightly waning at expert meetings, says McGill. There is some confusion from the side of the investors due to the field’s broad nature, says Gilbert. This is further emphasised by the current state of the biotech market , he adds. But this could change with the first approvals, notes McGill. In a way, the accessibility could increase enthusiasm and interest, she adds. C,,, ,Ferring ,Rebyota,FDA-approved ,Seres,SER-109,PDUFA Date on April 26 , ,Vedanta,VE303 ,Phase III in 2023 ,Destiny,NTCD-M3 ,Phase III in 2023 ,Ferring ,MyBiotics,MBX-SD-202,Phase I completed in 2022 ,Adiso Therapeutics,ADS024,"Enrollment of Phase Ib complete, awaiting data, potentially ready for Phase II"Company,Product,Indication,Status AOBiome Therapeutics,B244,Pruritus,PhaseIIb complete enrollment AOBiome Therapeutics,B244,Acne,Phase IIb completed AOBiome Therapeutics,B244,Rosacea,Phase Iib completed Mikrobiomik,MBK-01,Nonalcoholic steatohepatitis,Phase II not yet recruiting Mikrobiomik,MBK-01,Klebsiella pneumoniae carpapenemase,Phase II recruiting Microbiotica,Live Bacterial Therapeutics ,Ulcerative colitis,Phase Ib start in 2023 Microbiotica,Live Bacterial Therapeutics ,Immuno-oncology,Phase Ib start in 2023

临床2期临床3期免疫疗法临床结果微生物疗法

2022-12-05

·CPhI制药在线

市场 | 首款粪便疗法获批，国内外肠道微生物玩家还有谁？

关注并星标CPHI制药在线11月30日，美国FDA批准辉凌制药的RBX2660上市，用于降低18岁以上成年人艰难梭菌感染（CDI）后的复发，商品名为Rebyota，这也是FDA批准的首款粪便微生物疗法。攻克抗生素耐药，微生物疗法迎来里程碑式进展艰难梭菌(C. difficile) 是一种可导致CDI的细菌，CDI是一种潜在的危及生命的疾病，可导致腹泻和严重的结肠炎症。在美国，CDI导致每年15000–30000人死亡相关。艰难梭菌感染经常成为复发恶性循环的开始，给患者和医疗系统造成沉重负担。据估计，高达35%的CDI病例在初次诊断后会复发，复发者发生进一步感染的风险显著升高。首次复发后，高达65%的患者可能会再次复发。艰难梭菌反复感染的一个核心原因便是，肠道微生物菌群遭到破坏。众所周知，肠道含有数百万微生物菌群。某些情况下，如服用抗生素治疗感染，可能会改变肠道内微生物的平衡，使艰难梭菌繁殖并释放毒素，进而导致腹泻、腹痛、发烧，甚至器官衰竭和死亡。从CDI恢复后，患者可能会发生多次再感染，这种情况即为复发性CDI。对于CDI复发的患者，目前临床上的治疗选择极为有限。此时，Rebyota便应运而生。Rebyota由符合要求的捐赠的人类粪便制成。其通过单剂量直肠给药的方式，促进患者肠道菌群的恢复，从而防止艰难梭菌感染的进一步发生。11月7日，辉凌制药公布了Rebyota的III期临床试验数据。该研究纳入了267例受试者，接受了盲法治疗（n=180，Rebyota；n=67，安慰剂），主要终点是治疗成功，定义为在完成研究治疗后8周内没有出现CDI腹泻。结果显示，Rebyota在8周时治疗成功率为70.6%，而安慰剂组为 57.5%。Rebyota在标准抗生素治疗后，降低复发CDI方面优于安慰剂的概率为99.1%。超过90%治疗成功的研究参与者在6个月内没有 CDI 复发。Rebyota不良反应多为轻到中度的消化道反应，且无治疗相关的严重不良事件发生。不过，FDA也在官网披露，辉凌制药虽然对捐赠者和捐赠的粪便进行过可传播病原体的检测，但由于Rebyota由人类粪便制成，可能存在传播疾病的风险。此外，Rebyota可能含有食物过敏原；该产品因食物过敏原而引起不良反应的可能性尚不清楚。尽管如此，Rebyota的获批仍给微生物治疗领域注入了一针强心剂。因为，全球数十家公司都未曾在这一领域做出有治疗意义的临床结果。因此，FDA生物制品评估与研究中心主任Peter Marks博士对此表示：“Rebyota的获批对复发性CDI患者来说是一大进步。复发性CDI影响个人的生活质量，也可能危及生命。今天的获批是一个重要的里程碑，作为FDA批准的第一个粪便微生物产品，它为预防复发性CDI提供了新选择。”国内外有哪些玩家在布局？近年来，越来越多的科学研究已证明肠道微生物的诸多作用。美国政府在奥巴马时代就开始资助使用肠道微生物来治疗人类疾病。在政策的推动下，除了Seres、Evelo、Finch等一大批微生物制药明星企业已经在舞台上崭露头角，辉瑞、罗氏、辉凌等跨国制药巨头也纷纷布局微生态制药赛道。其中微生物明星公司Seres Therapeutics曾于10月26日宣布，FDA已接受其在研口服微生物疗法SER-109的生物制品许可申请（BLA），用于预防复发性艰难梭菌感染rCDI，预计于2023年4月26日前完成审查。SER-109由多种厚壁菌门菌种的纯化细菌孢子组成。在两项III期研究中（ECOSPOR III和ECOSPOR IV），试验结果显示，ECOSPOR III研究在8周时，SER-109减少CDI复发的效力优于安慰剂，治疗8周后的持续临床反应率约为88%，而安慰剂组为60%。在ECOSPOR IV试验中，第8周时，有91.3%接受SER-109治疗的受试者展现出持续性的临床疗效，与ECOSPOR III试验中观察到的88%的治疗效率一致。Evelo是一家通过识别针对小肠免疫细胞的特定单克隆菌株，引导全身免疫反应，从而治疗癌症、炎症性等疾病的公司。癌症免疫疗法和微生物组的结合让这家公司成立之初便备受关注。另外，Evelo利用细胞在小肠中的重要作用，开发了一个综合平台，识别微生物的单个菌株，并将其开发为针对小肠细胞的药物。而这一部分小肠细胞往往具有明确的药理特性。基于这个平台，Evelo开发出一系列的候选产品。比如治疗癌症疾病的主要候选产品EDP1503以及针对炎症性疾病的主要候选产品EDP1815，以及Evelo在肿瘤学中领先的微生物细胞外囊泡临床候选产品EDP1908等。Finch是一家临床阶段生物医药公司，专注于使用粪便移植的微生物组研发新型疗法。公司产品管线由专有的Human-First平台驱动，使用反向翻译来识别营养不良的疾病，并设计针对这些疾病的微生物组疗法。利用机器学习和分子表征技术，Finch能够确定微生物组破坏导致疾病的条件，并揭示与成功临床结果相关的关键动态。基于公司专有平台，Finch研发出了针对炎症性肠病 (IBD)的微生物疗法FIN-524和FIN-525（曾获武田合作共同开发，后被武田退回），以及一种口服的微生物组胶囊CP101，该产品旨在提供完整的功能性微生物组，以持久地修复community-level营养不良。把视野拉回国内，目前未知君生物、慕恩生物、知易生物等皆有布局。未知君生物深圳未知君生物科技有限公司（简称未知君生物）成立于2017年，是国内行业专注于肠道微生物治疗的AI制药公司，拥有先进完备的微生物药物研发平台。未知君把肠道微生态视作系统性的对象，通过数据建模、机器学习的方法去找出哪些菌与疾病治疗间存在因果关系，找到以后再定向地把这些菌分离出来，最后成药。其研发的代号为XBI-302的粪菌移植药物，获得了FDA的新药临床试验（IND）批准，可正式进入治疗急性移植物抗宿主病的临床试验阶段，这是中国微生态制药企业首次获FDA批准的IND申请，标志着中国制药企业正式开拓出一条国内微生态药物向FDA递交审批的完整路径，实现了粪菌移植从治疗形式向药物形态的转化。慕恩生物慕恩（广州）生物科技有限公司（简称慕恩生物），是国内专注于将微生物资源商业化的创新型生物技术公司，已搭建起了从发现、筛选、改造微生物到应用微生物的完整微生物组产业化技术体系。公司建立了生物多样性与全球规模数一数二的肠道微生物、植物微生物菌种库和基因库，发现、保存和鉴定了超18万株具有自主知识产权的微生物菌株。其研发的活菌生物药MNC-168可通过提升抗肿瘤功能与肿瘤免疫疗法的响应力，能够多靶点激活机体中免疫激活型抗原呈递细胞-树突细胞、M1巨噬细胞、IFN-γ+阳性辅助型CD4+ T淋巴细胞与IFN-γ+阳性毒杀型CD8+T淋巴细胞等免疫细胞，同时能显著上调IL-1β、TNF-α、IFN-γ、CXCL9与CXCL10与等抗肿瘤活性免疫细胞因子与趋化因子。通过长期作用于肠道粘膜微环境，重新激活免疫系统的抗肿瘤能力，从而达到治疗多种恶性实体瘤的目的。目前，MNC-168单药在晚期恶性实体瘤受试者中的安全性、耐受性、药代动力学特征及初步有效性I期临床研究，于11月8日完成中国受试者的首次用药。知易生物广州知易生物科技有限公司（简称知易生物），是中国活体生物药（LBPs）与二代益生菌研发公司。拥有微生物与致病菌谱、新功能菌株分离与靶标确定、新活菌药物、活性成分药物开发的完整技术体系，以及从发现、临床前到NDA的产业化平台。2019年11月，知易生物的原创新药SK08活菌散获批进入临床，目前处于针对腹泻型肠易激综合征（IBS-D）的II期临床试验阶段。另外用于化疗相关性腹泻（CID）的SK10也已进入IND阶段。同时，知易生物管线上的多个源自微生物组的新型药物也正在快速有序地推进中。随着人体微生物组研究的深入，人们越来越注意到，多数疾病的发生和发展跟人体微生物关系密切。如今，人体微生态已被证实与多种慢性疾病密切相关，如肥胖症、炎症性肠病、糖尿病、代谢综合征、动脉粥样硬化、非酒精性脂肪性肝病等。于是在近几年，微生态菌群在全球范围内获得了前所未有的关注。目前在全球范围内，有超过 50多家企业，纷纷布局肠道微生物相关的活菌药物，其中90%左右在美国，相对而言国内的活菌药物处于滞后状态。市场分析认为，到2026年全球微生态药物市场空间有望达到100亿美元。无论是在国内还是国外，这一赛道仍处于刚起步阶段，是名副其实的朝阳产业。当前胃肠道疾患和胃肠道感染依然是微生物治疗的主要潜在临床适应症。如何在其他领域体现肠道微生物的疗效依然有着巨大的想象空间。参考来源：1、https://www.businesswire.com/news/home/20221026005415/en/Seres-Therapeutics-Announces-FDA-Acceptance-of-Biologics-License-Application-for-Investigational-Microbiome-Therapeutic-SER-109-for-Recurrent-C.-Difficile-Infection-for-Priority-Review；2、Dizman, N., Meza, L., Bergerot, P. et al. Nivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial. Nat Med (2022). https://doi-org.libproxy1.nus.edu.sg/10.1038/s41591-022-01694-6；3、Sepich-Poore GD. , Zitvogel L., Straussman R., Hasty J., Wargo JA., Knight R. The microbiome and human cancer. Science (2021). https://doi-org.libproxy1.nus.edu.sg/10.1126/science.abc4552;4、Lin CS., Jiang X., Li B., Xian Y. et al., Preclinical monotherapeutic and anti-PD-1 synergistic anti-tumor efficacy of MNC-168, a novel human-derived live biotherapeutic product. 2021 ASCO Annual Meeting (e14581). Journal of Clinical Oncology (2021). https://ascopubs-org.libproxy1.nus.edu.sg/doi/abs/10.1200/JCO.2021.39.15_suppl.e14581.【企业推荐】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

微生物疗法临床3期临床结果

2022-11-10

·GlobeNewswire-Health Care

Finch Therapeutics Provides Corporate Updates and Reports Third Quarter 2022 Financial Results

Patient dosing underway in PRISM4 Phase 3 trial of CP101 in recurrent CDITopline PRISM4 data anticipated in H1 2024 Anticipated cash runway into Q2 2024 SOMERVILLE, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today provided corporate updates and reported financial results for the third quarter ended September 30, 2022. “We are pleased with the tremendous progress our team has made recently to advance the development of our lead program, with patient dosing now underway in our PRISM4 Phase 3 trial of CP101, a product candidate that we believe holds the potential to fulfill the need for a convenient, one-time oral therapy to prevent recurrent C. difficile infection,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “In an effort to accelerate our timeline to topline PRISM4 data and conserve capital, we are evaluating possible modifications to PRISM4 for future discussion with FDA, such as a reduction in the size of the randomized portion of the trial, an approach that may be informed in part by regulatory insights from the recent FDA advisory committee meeting for an enema-based microbiome product candidate. We look forward to providing additional updates as we continue to advance this important program.” Recent Program Highlights Proceeded with Patient Dosing in PRISM4 Recurrent CDI Trial, with Topline PRISM4 Data Anticipated in H1 2024: In October 2022, Finch announced that it had proceeded with patient dosing in PRISM4, a Phase 3 trial of CP101 for the prevention of recurrent C. difficile infection (CDI). The PRISM4 trial has two parts: a randomized, double-blind, placebo-controlled portion and an open-label portion for eligible participants who experience a recurrence during the randomized portion of PRISM4. Topline data from the randomized portion of PRISM4 is anticipated in the first half of 2024. To expand the safety database for CP101 in support of a potential Biologics License Application (BLA), Finch plans to allow direct entry into the open-label portion of PRISM4 following the completion of enrollment in the randomized portion of PRISM4.Presented CP101 PRISM-EXT Biomarker Data at ACG 2022: In October 2022, Finch announced the presentation of biomarker data from the PRISM-EXT open-label trial of CP101 in recurrent CDI at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting. Following open-label administration of CP101 after standard-of-care (SOC) CDI antibiotics, there was a significant increase in microbiome diversity from baseline through week 8 and week 24 in PRISM-EXT participants. Higher engraftment of CP101-associated taxa and improvement in diversity were both associated with prevention of CDI recurrence through week 8 in PRISM-EXT participants. As previously reported, 80.3% and 78.8% of participants who received CP101 following SOC antibiotics in PRISM-EXT were without CDI recurrence through week 8 and week 24, respectively (n=132).Conducted Strategic Portfolio Review: Following a recent strategic review of its portfolio, which includes wholly-owned microbiome product candidates for recurrent CDI, inflammatory bowel disease (IBD) and autism spectrum disorder (ASD), Finch is prioritizing the development of CP101 in recurrent CDI and exploring opportunities to potentially advance the development of its pre-clinical candidates for IBD through strategic partnerships. In connection with the strategic review, Finch has suspended efforts to initiate a Phase 1 trial of FIN-211 in ASD while the Company explores opportunities to leverage clinical data generated by ongoing third-party studies to inform its autism program strategy going forward, as previously announced. Recent Corporate Highlights Appointed Howard Franklin, MD, MBA, as Chief Medical Officer: Dr. Franklin, a general surgeon and biopharmaceutical executive with more than 20 years of experience spanning clinical practice, clinical development, medical affairs, regulatory strategy, and product commercialization, previously served as Interim Chief Medical Officer for Finch. Prior to Finch, Dr. Franklin served as Chief Medical Officer at Salix Pharmaceuticals, where he provided leadership and expertise to program teams focused on the development of GI therapeutics. Prior to Salix, he held leadership roles within early-stage biotechnology companies as well as large pharmaceutical companies, including Icon Bioscience, Oceana Therapeutics, The Medicines Company, and Esprit Pharma. Third Quarter 2022 Financial Results Finch reported a net loss of $40.4 million for the third quarter of 2022, compared to a net loss of $10.0 million for the same period in 2021. The net loss was driven by a charge of $18.1 million for the full impairment of the Company’s goodwill during the current quarter. Additionally, there was a decrease in revenue of $11.2 million due to changes under Finch’s collaboration agreement with Takeda, including Takeda’s election in August 2022 to terminate the agreement. Finch also reported an increase in restructuring expenses of $1.3 million quarter-over-quarter.Research and development (R&D) expenses were $11.9 million for the third quarter of 2022, compared to $15.5 million for the same period in 2021. The decrease in R&D expense was driven by a decrease in expenses related to the CP101 program, primarily due to a decrease in external clinical research organization costs, in addition to a decrease in IBD program expenses due to Takeda’s election in August 2022 to terminate its collaboration agreement with Finch. Additionally, there was a decrease in expenses associated with both the hepatitis B (HBV) and ASD programs, due to the Company's decision to suspend its HBV program, announced on March 31, 2022, and its subsequent decision, announced on September 1, 2022, to suspend its Phase 1 clinical trial in ASD.General and administrative (G&A) expenses were $9.6 million for the third quarter of 2022, compared to $5.7 million for the same period in 2021. The increase in G&A expense was primarily due to an increase in professional fees, in addition to an increase in facility-related costs and stock-based compensation expense. This increase was partially offset by a decrease in employee-related expenses due to reduced headcount.Finch’s cash and cash equivalents as of September 30, 2022 were $85.3 million, compared to $133.5 million as of December 31, 2021. Finch believes its cash and cash equivalents on hand as of September 30, 2022, together with anticipated cash inflows from executed subleases for one of the Company’s office and lab facilities, will fund its operations into Q2 2024. About the PRISM4 Phase 3 Trial PRISM4 is a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial evaluating the efficacy and safety of a one-time oral administration of CP101 for the prevention of recurrent C. difficile infection (CDI). After completing standard-of-care CDI antibiotics for their most recent CDI recurrence, eligible participants will be randomized in a 2:1 ratio to receive either CP101 or placebo. Participants will be evaluated for CDI recurrence and safety through week 8, the primary endpoint, as well as through week 24. Participants who qualify may enroll in the optional open label arm and receive CP101 if they experience a CDI recurrence through week 8 of the trial. To learn more about the trial, visit clinicaltrials.gov (Identifier: NCT05153499) or the study website at https://prism4trial.com/. About Finch Therapeutics Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs. Finch’s lead candidate, CP101, is in late-stage clinical development for the prevention of recurrent C. difficile infection and has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration. Finch is exploring strategic options to potentially advance the development of its pre-clinical candidates FIN-524 for ulcerative colitis and FIN-525 for Crohn's disease and its pre-clinical program in autism spectrum disorder. Finch routinely posts information that may be important to its investors on its website at www.finchtherapeutics.com. Finch encourages investors to consult the “Investors & News” section of its website regularly. Human-First Discovery® is a registered trademark of Finch Therapeutics Group, Inc. Forward-Looking Statements This press release includes “forward-looking statements.” Words such as “will,” "anticipates," "believes," "expects," "intends," “plans,” “potential,” "projects,” “would” and "future" or similar expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding: the therapeutic potential of Finch’s product candidates, including the potential of CP101 to fulfill the need for a convenient, one-time oral therapy for the prevention of recurrent CDI; possible modifications to PRISM4 and Finch’s ability to leverage regulatory insights from a recent FDA advisory committee meeting; Finch’s ability to accelerate its timeline to topline PRISM4 data and conserve capital; the anticipated timing for topline data from PRISM4; Finch’s plans to allow direct entry in the open-label portion of PRISM4 to expand the safety database for CP101; potential strategic partnerships to advance Finch’s product candidates; opportunities to leverage clinical data generated by third-party studies to inform Finch’s ASD program strategy; Finch’s cash runway; and Finch’s ability to develop a novel class of orally administered biological drugs. 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, among others, those related to: Finch’s limited operating history and historical losses; Finch’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Finch’s dependence on the success of its lead product candidate, CP101; the possibility that Finch may be delayed in initiating, enrolling or completing any clinical trials, including PRISM4; results of clinical trials may not be indicative of final or future results from later stage or larger clinical trials (or in broader patient populations once the product is approved for use by regulatory agencies) or may not be favorable or may not support further development; Finch’s product candidates may not generate the benefits to patients that are anticipated; results of clinical trials may not be sufficient to satisfy regulatory authorities to approve Finch’s product candidates in their targeted or other indications (or such authorities may request additional trials or additional information); Finch’s ability to comply with regulatory requirements; ongoing regulatory obligations and continued regulatory review may result in significant additional expense to Finch and Finch could be subject to penalties for failure to comply; competition from third parties that are developing products for similar uses; Finch’s ability to maintain patent and other intellectual property protection and the possibility that Finch’s intellectual property rights may be infringed, invalid or unenforceable or will be threatened by third parties; Finch’s ability to qualify and scale its manufacturing capabilities; Finch’s lack of experience in selling, marketing and distributing its product candidates; Finch’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact and duration of the COVID-19 pandemic on Finch’s business. These and other risks are described more fully in Finch’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in Finch’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 31, 2022, as supplemented by Finch’s Quarterly Reports on Form 10-Q filed with the SEC on May 16, 2022 and August 11, 2022, as well as discussions of potential risks, uncertainties, and other important factors in Finch’s other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Finch undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact: Stephen Jasper Gilmartin Group (858) 525-2047 stephen@gilmartinir.com Media Contact: Jenna Urban Berry & Company Public Relations (212) 253-8881 jurban@berrypr.com Finch Therapeutics Group, Inc.Condensed Consolidated Statements of Operations (Unaudited)(in thousands, except share and per share data) FOR THE THREE MONTHSENDED SEPTEMBER 30, FOR THE NINE MONTHSENDED SEPTEMBER 30, 2022 2021 2022 2021 Revenue: Collaboration revenue $138 $11,343 $853 $17,726 Total revenue 138 11,343 853 17,726 Operating expenses: Research and development 11,859 15,537 41,312 42,476 General and administrative 9,584 5,739 27,152 16,173 Impairment of goodwill 18,057 — 18,057 — Restructuring expense 1,270 — 2,173 — Total operating expenses 40,770 21,276 88,694 58,649 Loss from operations (40,632) (9,933) (87,841) (40,923)Other income (expense) 261 (22) 203 1,818 Net loss $(40,371) $(9,955) $(87,638) $(39,105)Net loss per share attributable to common stockholders—basic and diluted $(0.85) $(0.21) $(1.84) $(1.07)Weighted-average common stock outstanding—basic and diluted 47,728,130 47,445,195 47,611,872 36,408,506 Finch Therapeutics Group, Inc.Condensed Consolidated Balance Sheet Data (Unaudited)(in thousands) SEPTEMBER 30,2022 DECEMBER 31,2021 Assets: Cash and cash equivalents $85,292 $133,481 Other assets 102,676 91,888 Total assets $187,968 $225,369 Liabilities, redeemable convertible preferred stock and stockholders' equity Liabilities 67,102 23,145 Stockholders' equity 120,866 202,224 Total liabilities and stockholders' equity $187,968 $225,369

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