Malaria

DUBLIN, March 28, 2024 /PRNewswire/ -- The "Molecular Diagnostics at the Point of Care. By Application, Technology, Place, Product and by Country. With Executive Guides and Customization 2023 - 2027 " report has been added to ResearchAndMarkets.com's offering. Infectious disease Dx is changing and will change more in the future. Can a rapidly growing market expand even faster? Find out all about it in this comprehensive report on Molecular Diagnostics at the Point of Care. Are targeted tests for specific pathogens going to be obsolete? Will diagnostics replace physicians? Will Point of Care testing move into the Physician's Office or even the Home? Point of Care testing is proving itself in the market. Players are reporting double-digit growth. Lowering costs, improving outcomes and even helping in the battle against Anti Microbial Resistance. Learn about this market including the issues and outlooks. The two key trends of Point of Care Testing and Molecular Diagnostics are merging with spectacular success. It could possibly displace most frontline test protocols AND save money at the same time. The report forecasts the market size for five years. Key Topics Covered: 1 Market Guides 1.1 Strategic Situation Analysis 1.2 Guide for Executives, Marketing and Business Development Staff 1.3 Guide for Management Consultants and Investment Advisors 2 Introduction and Market Definition 2.1 What are Molecular Diagnostics at the Point of Care? 2.2 The Diagnostics Revolution 2.3 Market Definition 2.3.1 Revenues 2.4 Methodology 2.4.1 Methodology 2.4.2 Sources 2.4.3 Authors 2.5 Perspective: Healthcare and the IVD Industry 2.5.1 Global Healthcare Spending 2.5.2 Spending on Diagnostics 2.5.3 Important Role of Insurance for Diagnostics 3 Instrumentation, Automation and Diagnostic Trends 3.1 Instrumentation and Automation 3.1.1 Traditional Automation and Centralization 3.1.2 The New Automation, Decentralization and Point Of Care 3.1.3 Instruments Key to Market Share 3.1.4 Bioinformatics Plays a Role 3.1.5 PCR Takes Command 3.1.6 Next Generation Sequencing Fuels a Revolution 3.1.7 NGS Impact on Pricing 3.1.8 Whole Genome Sequencing, A Brave New World 3.1.9 Companion Diagnostics Blurs Diagnosis and Treatment 4 Industry Overview 4.1 Players in a Dynamic Market 4.1.1 Academic Research Lab 4.1.2 Diagnostic Test Developer 4.1.3 Instrumentation Supplier 4.1.4 Chemical/Reagent Supplier 4.1.5 Pathology Supplier 4.1.6 Independent Clinical Laboratory 4.1.7 Public National/regional Laboratory 4.1.8 Hospital Laboratory 4.1.9 Physicians Office Lab (POLS) 4.1.10 Audit Body 4.1.11 Certification Body. 4.2 The Clinical Laboratory Market Segments 4.2.1 Traditional Market Segmentation 4.2.2 Laboratory Focus and Segmentation 4.3 Industry Structure 4.3.1 Hospital Testing Share 4.3.2 Economies of Scale 4.3.2.1 Hospital vs. Central Lab 4.3.3 Physician Office Lab's 4.3.4 Physician's and POCT 5 Profiles of Key MDx Companies 5.1 Abacus Diagnostica 5.2 Abbott Laboratories 5.3 Accelerate Diagnostics 5.4 Access Bio 5.5 Ador Diagnostics 5.6 ADT Biotech 5.7 Akonni Biosystems 5.8 Alveo Technologies 5.9 Anitoa 5.10 Antelope Dx 5.11 Applied BioCode 5.12 Aureum Diagnostics 5.13 Aus Diagnostics 5.14 Autonomous Medical Devices 5.15 Baebies 5.16 Beckman Coulter Diagnostics 5.17 Becton, Dickinson and Company 5.18 Binx Health 5.19 Biocartis 5.20 BioFire Diagnostics (bioMerieux) 5.21 bioMerieux Diagnostics 5.22 Bio-Rad Laboratories, Inc. 5.23 Bosch Healthcare Solutions GmbH 5.24 Cepheid (Danaher) 5.25 Credo Diagnostics Biomedical 5.26 Cue Health 5.27 Curetis N.V./Curetis GmbH 5.28 Detect 5.29 Diagenode Diagnostics 5.30 Diasorin S.p.A. 5.31 Domus Diagnostics 5.32 Enzo Biochem 5.33 Eurofins Scientific 5.34 Fluxergy 5.35 Fusion Genomics. 5.36 Genedrive 5.37 Genetic Signatures 5.38 GenMark Dx (Roche) 5.39 Genomadix 5.40 Getlabs 5.41 Grip Molecular Technologies 5.42 Hibergene Diagnostics 5.43 Hologic 5.44 Immunexpress 5.45 Inflammatix 5.46 Invetech 5.47 Iollo 5.48 Janssen Diagnostics 5.49 Karius 5.50 LightDeck Diagnostics 5.51 Lucira Health 5.52 Luminex Corp (DiaSorin) 5.53 LumiraDx 5.54 Maxim Biomedical 5.55 Meridian Bioscience 5.56 Mesa Biotech (Thermo Fisher) 5.57 MicroGem 5.58 Millipore Sigma 5.59 Minute Molecular 5.60 Mobidiag (Hologic) 5.61 Molbio Diagnostics 5.62 NanoDx 5.63 Nanomix 5.64 Novacyt 5.65 Novel Microdevices 5.66 OnsiteGene 5.67 Operon 5.68 Oxford Nanopore Technologies 5.69 Panagene 5.70 Perkin Elmer 5.71 Prenetics 5.72 Primerdesign (Novacyt) 5.73 Prominex 5.74 Proof Diagnostics 5.75 Qiagen 5.76 QuantuMDx 5.77 QuidelOrtho 5.78 Roche Molecular Diagnostics 5.79 Salignostics 5.80 Saw Diagnostics 5.81 SD Biosensor 5.82 Seegene 5.83 Siemens Healthineers 5.84 Sona Nanotech 5.85 SpeeDx 5.86 T2 Biosystems 5.87 Talis Biomedical 5.88 Thermo Fisher Scientific Inc. 5.89 Veramarx 5.90 XCR Diagnostics 5.91 Zhejiang Orient Gene Biotech 6 Market Trends 6.1 Factors Driving Growth 6.1.1 New Genotypes Creating New Markets 6.1.2 Aging Population a Boon for All Diagnostics 6.1.3 Developing World Driving ID Dx Growth 6.1.4 Point of Care - Why Centralization is Losing Steam 6.1.5 Self Testing 6.1.6 The Need for Speed 6.2 Factors Limiting Growth 6.2.1 Lower Costs 6.2.2 Infectious Disease is Declining 6.2.3 Wellness Hurts 6.2.4 Economic Growth improves Living Standards 7 Molecular Dx - Infectious Disease Recent Developments 7.1 Recent Developments - Importance and How to Use This Section 7.1.1 Importance of These Developments 7.1.2 How to Use This Section 7.2 Domus Diagnostics Wins NIH RADx Tech Contract 7.3 Llusern Scientific to Launch POC MDx UTI Panel 7.4 Altratech Enters POC MDx Testing Space with Unique Tech 7.5 BioMerieux SpotFire MDx POC System Leverages Novel Approach 7.6 Katalyst Labs to Distribute ProtonDx Dragonfly Rapid IVD System 7.7 LEX Diagnostics Developing Ultra-Fast Low-Cost PCR 7.8 Sherlock Biosciences Adds to Infectious Disease Dx Toolkit 7.9 NanoDx Prepares for Point-of-Care Commercialization 7.10 Paragraf to Study New POC Test to Guide Antibiotic Selection 7.11 MicroGEM to Expand 30-Minute RT-PCR System 7.12 Startup Detect to Roll Out Next-Gen Molecular Instrument 7.13 Diagnostics for the Real World Third-Generation POC Platform 7.14 Salignostics Closes Funding Round 7.15 Cue Health Targets DTC Market in 2022 7.16 Grip Molecular Developing Home Respiratory Panel 7.17 Mainz Biomed Developing Home ColoAlert Assay 7.18 MFB Fertility Closes Series A Financing Round 7.19 Home Test Company Prenetics to go Public 7.20 Roche to Acquire TIB Molbiol to Expand Infectious Disease Portfolio 7.21 BforCure Preparing Multiple Panels for Point-of-Care qPCR Platform 7.22 Talis Biomedical Discusses Point-of-Care 7.23 Roche to Acquire GenMark Diagnostics for $1.8B 7.24 Pandemic Pushes Handheld qPCR Devices Closer to Commercialization 7.25 Hologic to Acquire Mobidiag 7.26 Lucira Health Focuses on User Friendly Approach to Home Testing 7.27 Infectious Disease Dx Firm Talis Biomedical Raises $254M in IPO 7.28 Fluidigm Plans 'Durable' Diagnostics, Clinical Business 7.29 Thermo Fisher Scientific to Acquire Mesa Biotech for Up to $550M 7.30 Mammoth Biosciences Developing Pathogen Detection Tech 7.31 Illumina, IDbyDNA Developing Sequencing-Based Respiratory Tests 7.32 Scanogen Developing 90 Minute Infection Test 7.33 Malaria Assays Use CRISPR for Point-of-Care Multispecies Detection 7.34 FDA Provides Self Testing SARS-CoV-2 EAU Guidance 7.35 Mammoth Biosciences Announces Rapid, CRISPR-Based COVID-19 Diagnostic 7.36 Genetic Signatures Gets CE Mark for Coronavirus Molecular Test 7.37 Qiagen Respiratory Panel with Coronavirus Receives CE Mark 7.38 Lumos Diagnostics Closes $15M Series A Funding For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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中国企业面对周期挑战时的韧性和孜孜不倦的探索精神，一直在医药行业上演。站在当下，中国医药处于一个历史转折点，面临的挑战不仅是如何在周期调整中坚定创新，更是如何跨出国门，开辟新的篇章。这不仅是一场技术与资本的竞赛，更是对企业担当与意志的考验。当下，需要那些敢于担当、愿意引领变革的企业站出来。它们的使命，不仅是成就自身的荣光，更在于引领并塑造产业的未来生态，推动人类医药科学的进步与突破。有着30年产业积累的复星医药，正在成为这样的存在。作为传统医药巨头，在变革中不断进化，坚定的创新转型，稳健的全球化布局，使其成为了中国医药产业高速发展的见证与缩影。与此同时，透过2023年财报来看，作为医药行业创新“灯塔”，复星医药的底盘依旧稳健，创新转型持续推进，重点创新产品如汉斯状、汉曲优和苏可欣的收入依旧保持增长，全球运营能力更是得到进一步夯实，包括达芬奇手术机器人、CAR-T药物奕凯达在内的创新产品本土化落地接踵而至。过去30年，复星医药在每一个发展阶段的战略布局，一并构成了一次次经典跨周期战役，体现了一家中国公司对于周期的深刻理解，这也是产业走向专业与成熟的标志。当下，全球性的经济新周期处于将张未张之际，复星医药这艘创新航母已经蓄势待发，正全面航向更高质量的新周期。1创新灯塔创新，早已刻入复星医药的基因。成立30年以来，其通过自主研发、合作开发、许可引进、深度孵化等多元开放式创新模式，推动了多款全球领先、中国首个的创新技术和产品的开发和转化落地，实现了国内多个领域从0到1的突破。如果细究，复星医药的创新之路，应当是始于2009年，其生物药平台复宏汉霖的成立。彼时的中国医药领域，几乎是创新“荒漠”，复星医药则毅然转向创新。医药产业是长周期，起码要耐得住10年寂寞才能看到曙光。直到2019年，由复星医药自主研发的中国首款生物类似药汉利康（利妥昔单抗）获批上市，填补了国内生物类似药市场空白；后续上市的首个中欧双批国产单抗生物类似药汉曲优（曲妥珠单抗），已在全球40多个国家和地区获批上市，惠及超18万名患者；全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状（斯鲁利单抗）则攻克“治疗荒漠”。在复星医药的护航之下，复宏汉霖实现了飞跃式增长，成为“18A”阵营中第一家盈利的创新药企，2023年净利润达5.46亿元。复宏汉霖的成功也是对复星医药坚守创新最好的褒奖。事实上，随着国内医改深入，作为创新领航员的复星医药，布局早已全面铺开，自研产品持续落地的同时，还积极将国际领先技术和产品引入中国市场，本土化进程不断提速。2017年，复星医药和Kite Pharma成立合资公司复星凯特，引进CAR-T细胞产品奕凯达（阿基仑赛注射液），并依托复星医药专业高效的临床及商业化能力，迅速转化落地。2021年，奕凯达成为中国首个获批准上市的CAR-T产品。CAR-T细胞疗法是近年来癌症治疗领域的重大突破之一，凭借强大的治疗效果让无数淋巴瘤患者的生存期得到了显著改善。根据最新研究数据，奕凯达最佳总缓解率达到79.2%，客观缓解率83%、完全缓解率58%，4年总生存率达44%，显著提高了患者总生存期及生活质量。2023年6月，奕凯达又新增获批二线适应症，为更多一线免疫化疗无效或复发的淋巴瘤患者带来生的希望。当然，与疗效同样突出的是，CAR-T细胞疗法在国内的商业化困境。为了提高可及性，复星凯特推动奕凯达获纳入超过100款省市惠民保和超过75项商业保险，备案的治疗中心覆盖全国超25个省市、数量超160家。2024年1月，奕凯达在国内率先推出按疗效价值支付的创新方案，如果在3个月没有达到完全缓解指标，将会退还患者支付费用的一半。不仅在创新药领域突破不断，复星医药在外科手术机器人的精准治疗领域，同样引领行业不断向前。2023年10月，首台国产达芬奇Xi系统下线，标志着全球领先的达芬奇手术机器人正式实现国产化，这将进一步提升可及性，惠及更多患者；日前，复星医药合营企业直观复星宣布，lon支气管导航操作控制系统获批。这是其继达芬奇机器人后获批的第二个本土生产的产品，有望对早期肺癌的诊疗路径带来革命性的变化。生物科技大航海时代，深度创新带来的突破、跌宕起伏的市场、风起云涌的出海，深刻改变着行业格局。作为灯塔型企业，不仅需要扎实的产业基础，更离不开敏锐洞察力和前瞻性视野。2019年以来创新成果的持续兑现，让我们见识到复星医药从跟随到引领，作为创新灯塔型企业的实力。2筑巢引凤，稳健创新底盘源头创新不易，涉及的基础研究与底层技术转化，更是需要“政、产、学、研、医、资”等多方联动。为提前布局新产品、新技术，复星医药结合自身国际化优势，摸索出投资与孵化联动的新模式，积极转化全球前沿技术。复星医药产业及资本整合能力已经备受认可，旗下的复健资本在深圳50亿生物医药产业基金的全球遴选中脱颖而出，便是例证。3月12日，复星医药宣布，控股子公司复鑫深耀、复星医药(深圳)、复健基金管理公司与深圳市引导基金等其他7方投资人拟共同出资设立目标基金，计划募资50亿元，其中深圳市引导基金认缴份额达50%。可以预见，复星医药将继续加大源头创新转化的投入，促进更多创新项目的转化落地。这也将进一步夯实其创新灯塔的地位。事实上，不论是自主研发、合作开发、还是深度孵化，在创新药的研发过程中，复星医药始终专注于以临床需求为导向、疗效确切、符合现代医学发展导向的疾病及技术领域。前述革命性创新疗法如此，在面对重大公共卫生事件时，复星医药更是扛起大旗，打造了从预防、检测到治疗的产品矩阵，积极抗击疫情，履行社会责任。在这一过程中，复星医药也收获了相应的商业回报。而当疫情消散，抗疫产品行将淡出“舞台”，复星医药也面临着“填坑”的挑战。目前看，复星医药已在短时间内熨平了新冠产品收入下滑造成的业绩波动，根据2023年年报，不含新冠相关产品，其营收同比增长约12.43%。其中，抗肿瘤及免疫调节领域年收入达76.38亿元，同比增长37.99%，很好弥补了新冠产品收入下滑带来的影响。这得益于其稳健的创新底盘，以及创新产品差异化优势带来的回报。时至今日，复星医药已形成开放式、全球化的创新研发体系，聚焦肿瘤、免疫、中枢神经、慢病等核心治疗领域，重点强化小分子、抗体/ADC、细胞治疗、RNA等核心技术平台。多款新产品及新适应症陆续获批上市，收入结构持续优化的背后，是其多年来坚持研发投入。2023年，复星医药研发投入共计59.37亿元，位列国内医药企业第一梯队，主要在研创新药、生物类似药项目超过70项（按适应症计算）。复星医药董事长吴以芳表示，创新是公司发展的核心驱动力，未来将继续加大研发投入，整体管线也将更呈体系化，聚焦的核心领域在管线生命周期的分布上保持合理，且更强调管线价值，更关注和聚焦大品种产品，优选高价值管线并集中资源推进核心管线研发，更好地实现公司价值，惠及更多患者。回望过去十余年间医药行业的巨变，在国内医药改革的红利下，本土药企成长的速度可谓惊人。根据全球医药智库信息平台 Informa Pharma Intelligence发布的《2023年医药研发趋势年度分析》白皮书，复星医药连续第二年入选“全球医药企业研发管线规模Top25”榜单。10年前，看着跨国大药企兼具深度与广度的产品线，可能没人会想到，国内企业能在这么短时间内与它们并驾齐驱，共同角逐全球市场。3全球化的运营能力当出海成为国内创新药企的必答题，复星医药已经率先走向国际化，覆盖美国、欧洲、非洲、印度和东南亚等海外市场。作为中国第一批出海的医药企业，早在2009年复星医药就在非洲自建营销队伍和网络。2010年，复星医药自主研发的注射用青蒿琥酯Argesun成为首个通过世界卫生组织药品资格预认证（WHO PQ）的重症疟疾治疗药物。面对完全陌生的商业环境和文化，复星医药跨过一道道障碍，为“注射用青蒿琥酯”在非洲打开了新的局面，也让当地人对“中国制造”的印象有了改观。经过超15年的运营，复星医药已在非洲40多个国家和地区建立了销售网络。截至2023年末，其抗疟药品已救治了超过6800万重症疟疾患者，其中大部分为5岁以下非洲儿童。去年6月，复星医药自主研发的第二代注射用青蒿琥酯Argesun也通过了WHO预认证，成为首个通过WHO预认证的“一步配制青蒿琥酯注射剂”。第二代药品将青蒿琥酯两步溶解配过程制合为一步，准备时间由3分钟缩减至1分钟，可节省救治重症疟疾患者的宝贵时间。除了抗疟药物，复星医药还在推动实现“非洲本地制造和供应”的愿景。集药品研发、制造及物流配送为一体的科特迪瓦园区已在建设中，未来将实现非洲本地化药品制造及供应。而随着综合能力的提升，复星医药已形成较为完整的全球化运营体系，全球化能力早已今非昔比。具体可以从研发和商业化层面来看。首先，在研发方面，复星医药在集团层面成立了科学顾问委员会（Scientific Advisory Board, 即“SAB”），SAB共有委员12人，为享有国际声望、学术造诣深厚的国内外院士、科学家、临床专家、资深企业家等组成，作为“外部智库”协助公司优化研发战略。在销售体系方面，复星医药不仅在非洲拥有健全网络，在印度拥有Gland Pharma的销售团队，在创新药的“天堂”美国市场，其更是不断寻求新的突破。目前，仿制药自营队伍已初步成熟，与5家大型分销商及16家集中采购组织开展合作，推进制剂产品销售。同时，其已启动美国创新药团队组建，积极开展H药的商业化筹备工作，加速国产创新药“走出去”。对于复星医药而言，2019年之前，更多是通过许可引进别的知识产权和产品，经过本土化运作，转化为自身的创新研发能力和全球运营能力；2019年之后，随着创新成果的涌现，其正加速推动自研药品的出海。尽管国际形势复杂，但吴以芳表示，复星医药将坚定国际化战略，与此同时也将认真研究政策变化，在研发、BD、生产运营及商业化等多维度进一步践行国际化战略。可以预见，国际化的持续推进，将为复星医药这艘巨轮，带来更为强劲的增长动能。4坚持做难而正确的事自1994年创立至今，复星医药穿越了多个周期，不论是宏观周期还是行业周期。30年来，复星医药走过三个发展阶段。1994-2004年，通过并购奠定制药主业根基，通过参股国药控股，重塑医药流通格局；2004-2014年，持续创新探索，率先国际化；2014-2024年，深耕产业布局全球，创新产品加速上市。可以看到，创新是复星医药的核心成长引擎。持续推进研发创新的产品成功商业化是其保持长期竞争力的关键；在此基础上，其在全球各市场的本地化、临床能力、注册能力、营销能力、当地合作伙伴的网络，以及全球化的供应链体系建设等等，更是日积月累下的坚实壁垒，让其有能力抵御更大风浪，驶向更宽广的海域。坚持做难而正确的事情，让复星医药拥有了不断穿越周期的底气。毕竟，在一个创新底盘足够坚实的基础上去实现更高目标，或许不算太难。当然，任何一家企业的命运，既要靠自己奋斗，也要看历史的进程。回看复星医药这30年，是中国医药监管变化最大、最快且最频繁的30年，也是中国医药产业创新生态从贫瘠到丰满、本土药企创新实力大踏步迈进的30年。而复星医药进入市场较早，坚持创新及以临床需求为导向，这使其抓住了中国改革的每一次政策红利，迅速壮大。当下，在技术革命性突破、生产要素创新性配置以及产业深度转型升级背景下，一场新质生产力革命已经拉开序幕。2024年《政府工作报告》提出，要大力推进现代化产业体系建设，加快发展新质生产力。积极培育新兴产业和未来产业，包括加快新材料、创新药等产业发展，积极打造生物制造等新增长引擎。从经济学角度看，新质生产力代表一种生产力的跃迁，它是科技创新发挥主导作用的生产力。本质上，复星医药今日之局面，也正是依靠创新完成的跃迁转变。而其未来，更是深度绑定“创新”二字。作为中国医药产业高速发展的参与者、受益者，享受发展红利之后的复星医药，当前正在积极探寻，如何深耕源头创新、加速技术转化落地，如何帮助中国药企更好地走上国际化这条路。— 总结 —  唯有变革的巨浪袭来时，我们方能逐渐看清价值与成长的真相，即与产业发展保持高度同向性，抗周期特质的公司，才是真正的价值与成长典范。这样的公司注定不甚多，却总在市场逆风时刻显现。面对当下的时代和市场环境给予的挑战和机遇，复星医药这艘巨轮，除了不断加速自身发展，还必须发挥其在产业中的领导力，持续推动创新的深度和广度。这不仅关乎其未来发展的方向和速度，更关乎中国医药创新力量在全球版图中的地位和影响力。更多优质内容，欢迎关注↓↓↓

Phase 2/3 trial (EBO-301) in treatment-refractory Mycobacterium avium Complex (TR-MAC) continues with Phase 2 topline results expected in summer 2024 and Phase 3 enrollment pause in place during continued analysis of incoming data; plan to discuss with FDA Cash, cash equivalents, and investments of $134.5 million at December 31, 2023 MENLO PARK, Calif.--(BUSINESS WIRE)-- AN2 Therapeutics, Inc., (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today reported financial results for the fourth quarter and year ended December 31, 2023. “AN2’s cash position remains strong as we advance our innovative boron-based pipeline. Following the recent meeting of the independent Data Safety Monitoring Board, we continue to believe in the potential of epetraborole to become an important component of the backbone therapy for NTM lung disease,” said Eric Easom, Co-Founder, President and Chief Executive Officer. “Patients enrolled in the epetraborole Phase 2/3 trial in treatment refractory lung disease caused by MAC continue to be dosed while new enrollment in the Phase 3 part of the trial remains paused. Patients in the Phase 2 trial have reached the six-month mark, and we plan to report topline results this summer. Analysis of the baseline patient demographics from the trial show a highly complex and refractory patient population, which we plan to discuss with the FDA in the coming months.” Easom continued, “We are pleased with the momentum across our boron chemistry pipeline. We signed a licensing agreement last fall with the University of Georgia Research Foundation to develop a novel therapy for chronic Chagas disease, which is in late preclinical development and we are also progressing an IV formulation of epetraborole for melioidosis, in addition to advancing other research programs. We believe epetraborole, along with these other promising boron therapy candidates, has the opportunity to help address significant unmet patient need.” Fourth Quarter & Recent Business Updates: Epetraborole Pivotal Phase 2/3 Clinical Study in TR-MAC Lung Disease This double-blind, placebo-controlled trial is comparing epetraborole plus a background regimen versus placebo plus background regimen in patients with TR-MAC lung disease. In February 2024, the Company announced that it had voluntarily paused Phase 3 enrollment in the seamless Phase 2/3 clinical trial, pending further data review. The voluntary pause was instituted following an analysis of blinded aggregate data from the ongoing Phase 2 study, which showed potentially lower than expected efficacy. The aggregate baseline characteristics reveal patients with complex comorbidities, prolonged NTM lung disease, and high levels of cavitary disease, as well as patients who are refractory to Arikayce, the only FDA-approved drug for refractory NTM caused by MAC, as part of their background regimen. The decision to pause Phase 3 enrollment was not due to safety concerns. While the Phase 3 part of the trial is paused for new enrollment (n=97), the Company is continuing to dose existing patients enrolled in the Phase 2/3 trial under the existing protocol. The Company plans to provide further details on the epetraborole development strategy after discussion with FDA and continued review of the accumulated blinded data. The Company expects to announce topline data from the Phase 2 part of the trial in summer 2024. Presented New Epetraborole Data at Infectious Disease Society of America (IDSA) IDWeek 2023 Conference. In October 2023, three poster presentations and two oral presentations were presented at the IDWeek 2023 conference that detailed the potential of epetraborole in treating NTM (nontuberculous mycobacteria) lung disease caused by MAC and Mycobacterium abscessus. The Company also presented data on its melioidosis program. Executed License from University of Georgia Research Foundation to Develop Boron-Containing Product Candidates for Chagas Disease. In October 2023, AN2 announced that it had executed an exclusive license from the University of Georgia Research Foundation to advance the development of a boron-containing small molecule, AN2-502998 (formerly AN15368), for Chagas disease. This boron-based molecule was originally discovered by researchers at Anacor Pharmaceuticals, Inc. (a wholly owned subsidiary of Pfizer), which included some of the current AN2 team, and the University of Georgia, with grant funding from the Wellcome Trust. AN2-502998 has advanced into late preclinical development for chronic Chagas disease. Received Grant from Bill & Melinda Gates Foundation. In September 2023, AN2 announced that it received a grant from the Bill & Melinda Gates Foundation to discover novel, boron containing small molecules for the treatment of tuberculosis and malaria. Selected Fourth Quarter and Full Year 2023 Financial Results Research and Development (R&D) Expenses: R&D expenses for the full year 2023 were $54.9 million, compared to $29.5 million in the prior year. R&D expenses for the fourth quarter of 2023 were $14.9 million compared to $8.8 million for the same period during 2022 due to increased clinical trial expenses, personnel-related expenses, consulting and outside services, and other expenses, partially offset by lower chemistry manufacturing and controls expenses. General and Administrative (G&A) Expenses: G&A expenses for the full year 2023 were $14.8 million, compared to $12.8 million in the prior year. G&A expenses for the fourth quarter of 2023 were $3.9 million, compared to $3.7 million for the same period during 2022 due to increased personnel-related expenses and professional service fees, partially offset by a decrease in insurance expenses. Other Income, Net: Other income, net for the full year 2023 was $4.9 million, compared to $1.3 million in the prior year. Other income, net for the fourth quarter of 2023 was $1.9 million, compared to $0.6 million for the same period in 2022 due to increased interest and investment income based on higher interest rates and higher cash, cash equivalents and investment balances. Net loss: Net loss for the full year 2023 was $64.7 million, compared to $41.0 million in the prior year. Net loss for the fourth quarter of 2023 was $16.9 million, compared to $11.8 million for the same period during 2022. Cash Position: The Company had cash, cash equivalents, and investments of $134.5 million at December 31, 2023. About AN2 Therapeutics, Inc. AN2 Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs. Our initial candidate is epetraborole, which we are studying as a once-daily, oral treatment with a novel mechanism of action for patients with nontuberculous mycobacteria (NTM) lung disease, a rare, chronic, and progressive infectious disease caused by bacteria known as mycobacteria, that leads to irreversible lung damage and can be fatal. For more information, please visit our website at . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: continued analysis of incoming data; continuation of the Phase 2 and 3 parts of the EBO-301 trial; continuation of the enrollment pause in Phase 3 of the EBO-301 trial; FDA meetings and discussions; reporting of topline data from Phase 2 of the EBO-301 trial and other updates; potential of epetraborole, AN-502998, and the Company’s boron chemistry pipeline; timing and initiation of preclinical and clinical studies; the advancement of candidates for Chagas disease and melioidosis; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives, and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the recommendations of the Data Safety Monitoring Board following future reviews of unblinded data; the number of patients who remain enrolled in the Phase 2/3 trial; the ability of AN2 to resume enrollment in the Phase 2/3 trial, in the event the determination to resume enrollment is made; meetings with FDA; the ability of AN2 to effectively and timely make amendments to the Phase 2/3 pivotal trial design based on its analysis of the Phase 2 portion of the study and/or pursuant to additional FDA feedback; possible changes to AN2’s plans or priorities as it assesses study data; potential for protocol modifications, redesign, or study termination; timely enrollment of patients in AN2’s existing and future clinical trials; AN2’s ability to procure sufficient supply of its product candidate for its existing and future clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary, or expected results; significant adverse events, toxicities, or other undesirable side effects associated with AN2’s product candidate; the significant uncertainty associated with AN2’s product candidate ever receiving any regulatory approvals; AN2’s ability to obtain, maintain, or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and current and future product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts; and other risks, including those described under the heading “Risk Factors” in AN2’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, and AN2’s other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2’s website at and on the SEC’s website at . Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. AN2 THERAPEUTICS, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (unaudited) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Operating expenses: Research and development $ 14,919 $ 8,752 $ 54,871 $ 28,511 Research and development—related party — — — 1,000 General and administrative 3,896 3,724 14,764 12,751 Total operating expenses 18,815 12,476 69,635 42,262 Loss from operations (18,815 ) (12,476 ) (69,635 ) (42,262 ) Other income, net 1,917 634 4,903 1,306 Net loss (16,898 ) (11,842 ) (64,732 ) (40,956 ) Accretion to redemption value and cumulative dividends on preferred stock — — — (1,820 ) Net loss attributable to common stockholders $ (16,898 ) $ (11,842 ) $ (64,732 ) $ (42,776 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.57 ) $ (0.61 ) $ (2.74 ) $ (2.79 ) Weighted-average number of shares used in computing net loss per share, basic and diluted 29,735,397 19,352,854 23,600,107 15,340,134 Other comprehensive loss: Unrealized gain (loss) on investments 397 167 649 (347 ) Comprehensive loss $ (16,501 ) $ (11,675 ) $ (64,083 ) $ (41,303 ) AN2 THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands) December 31, 2023 2022 Assets Cash and cash equivalents $ 15,647 $ 27,219 Short-term investments 91,648 68,840 Prepaid expenses and other current assets 3,212 2,562 Long-term investments 27,194 3,219 Other assets, long-term 1,043 720 Total assets $ 138,744 $ 102,560 Liabilities and stockholders’ equity Accounts payable $ 2,676 $ 2,122 Other current liabilities 11,367 5,064 Other liabilities, long-term — 2 Total liabilities 14,043 7,188 Stockholders’ equity 124,701 95,372 Total liabilities and stockholders’ equity $ 138,744 $ 102,560