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今年3月，美国及欧洲的生物医药行业共发生18起融资事件，融资规模达21.8亿美元（约158.96亿人民币），其中值得关注的有：AI制药领域大额融资集中爆发：3月，位居融资额前两位均是AI制药公司，其中，诺奖得主创立的Isomorphic Labs更是单轮完成创纪录的6亿美元融资；前沿技术路线与新靶点受到关注：3月，HDAC6抑制剂公司Augustine 、mGluR5负变构调节剂公司Tempero Bio、KnotBody药物公司Maxion Therapeutics等前沿技术公司均获得大额融资。1、Isomorphic Labs：诺奖得主创办的AI药企3月31日，Isomorphic Labs宣布在第一轮外部融资中筹集了6亿美元。本轮融资由Thrive Capital领投，GV、Alphabet提供后续资金。此次领投的Thrive Capital是如今全球最为炙手可热的风险投资机构之一，以“在少数初创企业押下巨额赌注”的风格著称，曾投出过OpenAI、Instagram、Stripe、Spotify等一众明星项目。Isomorphic Labs成立于2021年，创始人兼CEO为2024年诺贝尔化学奖得主Demis Hassabis。公司致力于利用人工智能技术重新定义药物发现和开发流程，其核心技术包括AlphaFold等革命性AI模型。此前木头姐的《Big Ideas 2025》报告中，将Isomorphic Labs列为AI药物研发领域的少数关键公司。AlphaFold是一种能够预测蛋白质三维结构的AI模型，将预测误差从传统方法的10Å级别压缩至原子尺度（1.6Å）。基于AlphaFold的技术基础，Isomorphic Labs开发了PhoenixAI平台，该平台通过图神经网络（GNN）与扩散模型（Diffusion Model）的融合架构，能够模拟药物分子与蛋白质口袋的原子级相互作用，显著缩短了先导化合物优化周期。2024年5月，Isomorphic Labs与谷歌DeepMind共同开发的AlphaFold 3模型发布，能够准确预测所有生命分子的结构和相互作用，能够显著降低新药研发成本，并提高临床成功率。据摩根士丹利预测，该技术若完全落地，可将新药研发成本从当前平均26亿美元压缩至1.7亿美元，同时将临床成功率从9.6%提升至34%。公司优异的技术，斩获了多家大药企的合作，合作金额高达30亿美元：2024年1月7日，Isomorphic Labs宣布与礼来达成战略研究合作，合作开发针对多个靶点的小分子疗法，公司将获得4500万美元的预付现金，以及潜在高达17亿美元的里程碑付款和净销售额高达两位数的分成；2024年1月7日，Isomorphic Labs宣布与诺华达成战略研究合作，合作开发针对三个未公开靶点的小分子疗法。公司获得3750万美元的预付款，以及潜在高达12亿美元的里程碑付款和从中单到低两位数的净销售额的分成；除了这些合作伙伴关系外，Isomorphic 还在推进多个治疗领域和药物模式的设计项目，包括肿瘤、自身免疫疾病等。公司计划今年年底前将一些人工智能设计的药物投入临床试验。公司的科学顾问委员会包括2020年诺贝尔化学奖获得者、CRISPR先驱 Jennifer Doudna，2021年诺贝尔化学奖获得者David MacMillan，2001年诺贝尔生理学或医学奖得 Paul Nurse，以及阿斯利康前执行副总裁Mene Pangalos等知名人士。近年来，AI制药是资本市场追逐的热点，包括Retro Biosciences（10亿美元A轮）、Xaira Therapeutics（10亿美元初始资金）、EvolutionaryScale（1.42 亿美元种子轮）在内的多家AI制药企业近期获得或正在筹集巨额早期融资。2、Lila Sciences：Flagship Pioneering孵化的AI药物公司3月10日，Lila Sciences宣布完成2亿美元的种子轮融资。本轮融资投资人包括Flagship Pioneering、General Catalyst、March capital、ARK Venture Fund、Altitude Life Science Ventures、Blue Horizon Advisors、State of Michigan Retirement System、Modi Ventures和阿布扎比投资局（ADIA）等知名机构。Lila Science于2023年诞生在Flagship内部实验室。当时，Flagship孵化了两家早期AI公司：一家专注于新材料，另一家专注于生物学，后来两家公司的发展目标趋于一致，招募相同的人才，因此在内部合并。Lila Science致力于在开发一款人工智能程序，该程序经过已发表的实验数据以及科学过程推理的训练。仅仅两年时间，公司平台已在多个领域表现出超越人类和现有人工智能基准的性能，例如：生成优于市售疗法的最佳基因药物结构、发现和验证数百种适用于广泛治疗靶点的新型抗体、肽和结合剂、设计用于工业规模碳捕获的新材料等。在商业模式上，Lila并未像其他AI制药公司那样自己直接下场研发新药，而是与Flagship孵化药企、外部生物技术公司合作，承担 “科研助推器”的角色，加快同行药物研发速度。团队方面，Lila Science集聚了业内众多知名专家：哈佛大学著名遗传学家 George Church担任首席科学家、OpenAI前高管Kenneth Stanley担任高级副总裁、Flagship的普通合伙人Geoffrey von Maltzahn 担任首席执行官。3、Callio Therapeutics：Frazier Life Sciences孵化的ADC药物公司3月3日，Callio Therapeutics宣布完成1.87亿美元的A轮融资。本轮融资由Frazier Life Sciences领投，Jeito Capital、Novo Holdings A/S、Omega Funds、ClavystBio、Platanus、Norwest、Pureos Bioventures、SEEDS Capital和EDBI等知名机构跟投。Callio Therapeutics是一家由Frazier Life Sciences孵化设立的ADC药物公司，致力于开发下一代多载荷ADC。公司的ADC采用差异化的有效载荷和接头技术，能够将多载荷靶向递送至肿瘤细胞，从而最大限度地提高治疗效果。Callio Therapeutics的管线与技术来自Hummingbird Bioscience的授权。公司获得了后者双plyload技术平台、以及两个ADC管线的独家授权。其中一个较快的管线为靶向Her2双payload ADC，第二个管线尚未披露靶点。而Hummingbird则获得Callio的股权，以及两个授权管线的未来里程碑付款。Hummingbird的ADC技术来自著名的ADC技术平台公司Synaffix：2023年1月，Hummingbird以1.5亿美元总额获得了Synaffix三大平台技术GlycoConnect™、HydraSpace™、ToxSYN™的授权。公司的首个项目是靶向HER2的双有效载荷ADC：HMBD-802。根据公司在2024年AACR大会上的介绍，HMBD-802的两个payload分别为拓扑异构酶Ⅰ抑制剂和ATR抑制剂，用以克服单一Topo1i ADC的耐药性。公司联合创始人兼CEOPiers Ingram此前曾是Hummingbird Bioscience的联合创始人，亦曾在此前在赛诺菲等医药企业从事了15年的研发咨询、商业战略和学术工作。首席医疗官Naomi曾担任ProfoundBio（普方生物）的首席医疗官（被Genmab以18亿美元收购），在此之前，她曾担任Silverback Therapeutics的首席医疗官、Acerta Pharma的临床开发和医疗事务副总裁、Seattle Genetics的临床开发副总裁等职务。4、Latigo Biotherapeutics：Vertex镇痛药的潜在挑战者3月17日，Latigo Biotherapeutics宣布完成1.5亿美元的B轮融资，本轮融资由Blue Owl Capital管理的基金领投，卡塔尔投资局、Deep Track Capital、Access Biotechnology、Cormorant Asset Management、赛诺菲风险投资公司、Rock Springs Capital、UPMC Enterprises、Kern Capital、Westlake Village BioPartners、Foresite Capital、5AM Ventures和Alexandria Venture Investments等机构跟投。Latigo Biotherapeutics由生物医药投资机构Westlake Village BioPartners于2020年孵化设立，是一家专注于开发非阿片类止痛药的生物技术公司。目前，公司有四款在研药物，其中最为主要的是LTG-001。这是一款口服选择性Nav1.8抑制剂，目前正在进行临床二期试验，旨在治疗急性和慢性疼痛，预计今年下半年发布数据。NaV 1.8抑制剂为近几年走进医药行业视野的全新机制镇痛药，具有起效快、疗效显著、安全性优于标准护理且不影响中枢神经系统等潜在优势。今年1月底，Vertex Pharmaceuticals旗下药物Journavx成功获批，成为首个获得FDA批准针对 NaV1.8 的止痛药物。虽说Journavx面临着一定程度的商业挑战，疼痛缓解市场一直被廉价的阿片类药物“霸占”，但分析师们还是相当看好药物前景，预测它能够跻身十亿美元药物。Latigo的LTG-001有可能成为有望成为“best-in-class”药物。除了LTG-001，公司还有一系列Nav1.8抑制剂，正处于发现阶段。Westlake运营合伙人Desmond Padhi博士为公司首席执行官。在加入Westlake之前，Padhi博士在安进（Amgen）工作了20年，曾担任药代动力学、药物代谢和临床药理学副总裁一职。在一级市场，2024年2月，Latigo Biotheraputics宣布完成1.35亿美元的A轮融资，本轮融资由Westlake Village BioPartners领投，5AM Ventures和Foresite Capital，Corner Ventures参与跟投。公司的孵化机构Westlake Village BioPartners成立于2018年，致力于与有望为患者带来变革性疗法的企业家共同培育、发展生命科学公司。Westlake的联合创始人Sean Harper博士于2002年进入安进研发部门，并于2012年成为研发执行副总裁，期间领导安进心血管疾病、肿瘤学、神经科学和肾脏疾病领域药物的新品获批。5、Curevo Vaccine：带状疱疹疫苗Shingrix的挑战者3月17日，Curevo Vaccine宣布完成1.1亿美元的B轮融资。本轮融资由Medicxi领投，OrbiMed、HBM Healthcare Investments、赛诺菲风险投资公司、RA Capital Management、Janus Henderson investors、Adjuvant Capital和GC Biopharma等机构跟投。Curevo Vaccine创立于2018年，是一家专注于生产新一代带状疱疹疫苗的药企。公司唯一的管线CRV-101是一款佐剂亚单位疫苗，用于预防老年人带状疱疹。CRV-101被专门设计为在使用少量佐剂的同时产生最佳免疫应答，目的是获得与目前批准的带状疱疹疫苗相似的疗效，但副作用较少。目前，已经上市的带状疱疹疫苗有默沙东的减毒活疫苗Zostavax、以及葛兰素史克的基因重组亚单位疫苗Shingrix。其中，Shingrix凭借90%的有效率，占据市场主导地位。2024年1月7日，公司宣布CRV-101疫苗在对随机、对照、观察者盲法各组的临床二期试验达到了主要终点。CRV-101有效性为100%，而Shingrix为97.9%。此外，CRV-101较Shingrix相比表现出更低的局部或全身不良反应发生率。为了将Shingrix彻底比下去，公司还在进行多达640人的扩展试验，旨在确定临床三期的剂量选择。管理层方面，公司董事会主席Moncef Slaoui博士曾在葛兰素史克工作了近30年，期间为许多新疫苗的开发做出了贡献，包括Shingrix®（带状疱疹）、Cervarix®（HPV诱导的宫颈癌疫苗）、Mosquirix®（疟疾）、Rotarix®）（轮状病毒肠胃炎）和Synflorix®。另外一位董事Tal Zaks 博士在Moderna担任首席医疗官超过六年，期间还负责监督COVID-19的mRNA疫苗Spikevax的开发。在一级市场，公司曾完成两轮融资：2022 年2月，Curevo Vaccine宣布完成6000万美元A轮融资。本轮融资由RA Capital牵头，Aduvant Capital、Janus Henderson investors、EN Investment和创始投资者GC Pharma跟投；2022年11月，Curevo Vaccine宣布完成2600万美元A+轮融资，投资人包括Janus Henderson、RA Capital 、Adverant Capital和GC Biopharma。6、Character Biosciences：博士伦支持的眼科新药公司3月25日，Character Biosciences宣布完成1亿美元的C轮融资。本轮融资由aMoon和Luma Group共同领投，博士伦、Jefferson Life Sciences、Innovation Endeavors、Catalio Capital、S32和KdT Ventures等机构跟投。Character Biosciences成立于2019年，致力于采用资金效率更高的观察性研究来构建患者数据库并开拓多基因疾病的精准医疗解决方案。通过与全美150多家眼科中心合作，公司构建了一个涵盖6500多名患者的基因-临床-影像数据库，实现了AMD的遗传亚型重分类，并以此发现关键致病机制和靶点，结合AI与多组学方法，有望提升复杂眼病精准治疗的成功率。目前，公司有四个在研管线，其中最为重要的有：CTX114：一款补体抑制剂，旨在减缓晚期干性AMD的地图样萎缩的进展。药物设计用于抑制补体系统激活，保护视网膜细胞表面免受免疫攻击；CTX203：一款脂质调节剂，适应症为高风险中期AMD。该药为人工设计的ApoA1类似肽，针对ABCA1脂质转运通道，具有“延缓进展”而非“逆转疾病”的作用方向，定位于尚无药物覆盖的中早期AMD人群（尚未发展至地形萎缩）。CTX203与CTX114预计将于今年进入临床试验阶段。该公司还利用其人工智能驱动的基于基因组学的平台，将其产品线扩展到其他眼科疾病。对外合作方面，2024年1月，公司宣布与博士伦签署协议，共同开发针对AMD的治疗方法，并可能将双方的合作扩展至其他眼科疾病领域。公司创始人兼CEO Cheng Zhang先生拥有丰富的跨行业经验，曾在多家知名公司担任重要职务。在瑞银（UBS）、Oliver Wyman和辉瑞等公司任职期间，他积累了宝贵的战略规划和创新管理经验，参与并推动了多项战略计划的实施。7、Augustine Therapeutics：礼来支持的HDAC6抑制剂药企3月24日，Augustine Therapeutics宣布完成8480万美元的A轮融资。本轮融资由Novo Holdings和Jeito Capital共同领投，Asabys Partners、礼来、AdBio Partners、V-Bio Ventures、PMV、VIB、Gemma Frisius Fund、Charcot Marie Tooth（CMT）研究基金会、Newton Biocapital等机构跟投。Augustine Therapeutics成立于2019年，由比利时弗拉芒生物技术研究所（VIB）与鲁汶大学（KU Leuven）的联合孵化，致力于解决目前缺乏有效治疗方案的重大医疗需求，包括腓骨肌萎缩征等影响周围神经的遗传性疾病，以及其他神经肌肉、神经退行性和心脏代谢性疾病。公司的科学基础源于VIB-KU鲁汶脑与疾病研究中心的Ludo Van Den Bosch教授在胞浆组蛋白脱乙酰酶6（HDAC6）抑制方面的突破性研究，他认为HDAC6抑制剂是治疗CMT和其他神经疾病的有前景的方法。HDAC6是一种II类组蛋白脱酰酶。HDAC6是一种众所周知的分子靶点，对神经系统疾病有很强的生物学基础，对心脏代谢疾病有很高的治疗潜力。2023年，诺华以8000万美元获得了韩国公司Chong Kun Dang Pharmaceutical的1期阶段的HDAC6抑制剂CKD-510。目前，Augustine Therapeutics正在开发HDAC6的同类最佳的小分子抑制剂，适应症为Charcot-Marie Tooth（CMT）。CMT是最常见的外周神经系统遗传性疾病，影响全球约300万人。一级市场，Augustine最初由V-Bio Ventures、AdBio Partners、VIB、PMV和Gemma Frisius Fund组成并提供种子资金，并于2024年6月完成1850万美元的A轮融资，投资人包括Asabys Partners、礼来、Charcot Marie Tooth研究基金会等机构。8、Arbor Biotechnologies：张峰的又一家基因编辑公司3月18日，Arbor Biotechnologies宣布完成7390万美元的C轮融资。本轮融资由ARCH Venture Partners和TCGX领投，QIA、abrdn、Partners Investment、Revolution Partners、Kerna Ventures、Ally Bridge、Arrowmark、Deep Track、Piper Heartland Healthcare、Surveyor、淡马锡、T.Rowe Price Associates和Vertex制药等机构跟投。Arbor Biotechnologies成立于2016年，是一家基因编辑酶开发公司。Arbor联合创始人包括张锋教授、David Walt、David Scott、Winston Yan等业内知名人士。Arbor主要是通过机器学习与人工智能技术来开发新的基因编辑器，截至目前，公司已拥有17种基因编辑器，覆盖90%以上的基因组。还发现了超60多种核酸酶家族和70多种CRISPR转座酶，数量是已发表文献中的6倍和30倍。Arbor的基因编辑器主要包括两大类：CRISPR核酸酶编辑器、CRISPR转座酶编辑器。其中CRISPR核酸酶包括DNA核酸酶（Cas12h，Cas12i）和RNA核酸酶（Cas13d，Cas12g，III-E型）等。2024年5月，Arbor还收购了张锋旗下另一家基因编辑公司Serendipity Biosciences，获得了DNA核酸内切酶基因编辑器Fanzor、基因编辑器IsrB等技术。目前，公司有在研管线8款，最为重要的是ABO-101。ABO-101是一种针对原发性高草酸尿症（PH）的体内基因编辑疗法，于2024年12月获得了FDA的IND批准，目前正在PH1中进行临床I/II期试验，预计2029年初步完成。此前，在2024 ASGCT年会上，Arbor公布了BO-101的临床前数据。在非人灵长类动物（NHP）中，BO-101对HAO1基因实现了有效的体内编辑，多次给药具有良好的耐受性。此外，公司还在推进其首个同类项目的IND/CTA备案，包括一个罕见肝病的RT（逆转录酶）编辑项目和一个针对肌萎缩侧索硬化症（ALS）的项目。对外合作方面，Vertex是公司的长期合作伙伴，于2018年首次达成合作，并于2021年和2023年两次扩大合作协议，尤其是2021年的扩展合作金额高达12亿美元。此外，Arbor分别在2022年和2024年Allogene与博雅辑因达成了授权合作。在一级市场，公司曾完成两轮融资：2017年5月，Arbor宣布完成560万美元A轮融资后走出隐匿模式；2021年11月，Arbor宣布完成2.15亿美元的B轮融资。本轮融资由淡马锡、汇桥资本和TCG Crossover领投，Arrowmark、Deep Track、Great Point Ventures、Illumina Ventures、Janus Henderson investors、Logos Capital、Ono Venture、Piper Heartland Healthcare、Ridgeback Capital、Section 32、Surveyor Capital、T.Rowe Price Associates、Tao等机构跟投。图片来源：123RF版权声明/免责声明本文为授权转载文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn点击这里，查看更多精彩!

ORCA-3 Demonstrated a Significant Increase in Quitting and Reduction in Nicotine Cravings for Cytisinicline-Treated Participants Compared to Placebo Cytisinicline New Drug Application (NDA) Submission to FDA Planned for June 2025 SEATTLE and VANCOUVER, British Columbia, April 21, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced that complete trial results from its ORCA-3 were published in the Journal of the American Medical Association (JAMA) Internal Medicine. ORCA-3 was the second randomized, placebo-controlled Phase 3 clinical trial evaluating cytisinicline for smoking cessation in 792 U.S. adults. The authors concluded that ORCA-3 reaffirms cytisinicline’s efficacy and tolerability for smoking cessation in adult smokers at both 6- and 12-week treatment durations, including reduction in nicotine cravings and extended cessation benefits through 24 weeks. In addition to previously reported topline results announced in May 2023, the published completed trial results provided further evidence of cytisinicline’s highly targeted effect on treating nicotine dependence by binding to specific nicotine receptors. These consistent results, now published from two large, randomized Phase 3 trials, demonstrated that cytisinicline significantly reduced nicotine cravings and increased the likelihood of quitting smoking. In clinical trials, cytisinicline was well tolerated, which is thought to be due to limited other off-target binding effects that can result in side effects known to be associated with currently available treatments. Similar to the first Phase 3 trial, ORCA-3 participants had an average age of 53 years, smoked a median of 20 cigarettes per day at baseline, and had a median smoking history of 36 years with four prior quit attempts. “Most people who smoke want to quit and it often takes multiple attempts to do so successfully. Our trial participants were no exception and had multiple previous quit attempts, although less than half had previously tried varenicline, possibly due to its well-known adverse event profile,” said Cindy Jacobs, MD, PhD, President and Chief Medical Officer of Achieve Life Sciences. “Cytisinicline is very selective in targeting only nicotine receptors and has shown limited binding to other off-target receptors that can cause side effects, like nausea and gastrointestinal disturbances. We believe this leads to a highly tolerable treatment with cytisinicline, as demonstrated in our clinical trial program.” Results from the ORCA-3 study show that cytisinicline significantly increased the odds of smoking cessation compared to placebo. Cytisinicline also reduced nicotine craving which led to decreased nicotine intake, even among those who continued smoking, as evidenced by both lower craving scores and reduced cotinine levels, a well-known metabolite of nicotine. “More deaths each year in the U.S. are attributed to cigarette smoking than to any other preventable cause, and our current smoking cessation treatment options are limited,” said Nancy Rigotti, MD, Professor of Medicine at Harvard Medical School, Director of Tobacco Research and Treatment Center, Massachusetts General Hospital, and ORCA Program Investigator. “The study findings published today suggest that cytisinicline, if approved by the FDA, could help many smokers to quit and reduce the smoking-related risks to their health.” Achieve plans to submit the cytisinicline New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in June 2025. About ORCA-3 The Phase 3 ORCA-3 trial evaluated 792 adults who smoked cigarettes daily and was conducted at 20 clinical trial locations in the U.S. The trial was initiated in January 2022 and completed enrollment in September 2022, with topline results reported in May 2023. ORCA-3 participants received 3mg cytisinicline dosed 3 times daily for either 6 or 12 weeks and were monitored through 24 weeks post randomization. The trial was blinded, placebo-controlled, and all subjects received behavioral support for the duration of the trial. The primary endpoint was biochemically verified continuous abstinence during the last four weeks of treatment. Secondary outcome measures assessed continued abstinence rates through 6 months from the start of study treatment. The full manuscript is published in Journal of the American Medical Association (JAMA) Internal Medicine. About Achieve Life Sciences, Inc. Achieve Life Sciences is a late-stage specialty pharmaceutical company committed to addressing the global smoking health and nicotine dependence epidemic through the development and commercialization of cytisinicline. The company has successfully completed two Phase 3 studies with cytisinicline for smoking cessation and one Phase 2 study with cytisinicline in vaping cessation. The company has fully enrolled its ongoing open-label safety study with cytisinicline and plans to submit its new drug application for smoking cessation in June 2025. Achieve has also conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication. About Cytisinicline There are approximately 29 million adults who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.3 In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.4 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.5 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address this critical need. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, and the successful commercialization of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval in a timely manner or at all, or be successfully commercialized; the risk that new developments in the smoking and vaping cessation landscapes require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic and geopolitical conditions, including fluctuating inflation, interest and tariff rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable. Achieve Contact Nicole Jones ir@achievelifesciences.com 425-686-1510 References 1VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641. 2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014. 4Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483. 5Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924. Released April 21, 2025