Immedica Pharma AB

Stockholm, September 20, 2024 – KKR, a leading global investment firm, and Impilo, a Nordic healthcare investment firm, have today announced the completion of their joint acquisition of Immedica Pharma, a pharmaceutical company headquartered in Stockholm and focused on the commercialization of medicines for rare diseases and specialty care products. Having announced the strategic partnership in April this year, KKR and Impilo will continue to work together with Immedica’s experienced management team to support the business’ growth, as it continues to build on its position as a leader in the European rare disease space. Kugan Sathiyanandarajah, Partner and Head of KKR’s Health Care Strategic Growth business in Europe, commented: “We are excited to close the transaction with Immedica, alongside Impilo. We remain committed to supporting Immedica’s future growth as a rare disease player with a highly promising pipeline and attractive international expansion prospects.” Magnus Edlund, Partner at Impilo, commented: “We are eager to now embark on the next phase of Immedica’s growth journey together with KKR and management, making innovative medicines available to more patients with high unmet medical needs.” Anders Edvell, CEO of Immedica, commented: “This collaboration with KKR and Impilo marks an exciting step forward in our mission to deliver innovative treatments to more patients with rare diseases. With their support, we are well-positioned to enhance our growth and continue addressing critical unmet medical needs across the globe”. Since its founding in 2018 by Impilo, Immedica has built an impressive portfolio and pipeline of drugs primarily within hematology, oncology and genetic & metabolic diseases for rare conditions with high unmet medical needs, generating revenues of EUR 100m and annual growth of more than 50%. KKR invested in Immedica through its KKR Health Care Strategic Growth Fund II, a $4.0 billion fund focused on investing in high-growth health care companies. KKR has a long track record of supporting health care companies globally, having invested approximately $20 billion in the sector since 2004. Impilo re-invested into Immedica through a continuation fund which will enable Impilo to continue supporting Immedica with additional equity alongside KKR. About KKR KKR is a leading global investment firm that offers alternative asset management as well as capital markets and insurance solutions. KKR aims to generate attractive investment returns by following a patient and disciplined investment approach, employing world-class people, and supporting growth in its portfolio companies and communities. KKR sponsors investment funds that invest in private equity, credit and real assets and has strategic partners that manage hedge funds. KKR’s insurance subsidiaries offer retirement, life and reinsurance products under the management of Global Atlantic Financial Group. References to KKR’s investments may include the activities of its sponsored funds and insurance subsidiaries. For additional information about KKR & Co. Inc. (NYSE: KKR), please visit KKR’s website at www.kkr.com. For additional information about Global Atlantic Financial Group, please visit Global Atlantic Financial Group’s website at www.globalatlantic.com. About Impilo Impilo is a Nordic investment company focused solely on investments in companies operating in the pharmaceutical, medical technology, healthcare services and other health related industries. Our starting point is that our portfolio companies must contribute to a positive and sustainable development of the societies and markets in which they operate in order to remain successful in the long term. Impilo strives to increase value of its investments through long-term active ownership. Impilo has a well-diversified portfolio of healthcare investments and manages c. EUR 1 billion of capital from leading Nordic and international investors. Learn more about Impilo at www.impilo.se. About Immedica Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care products. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory, medical affairs and market access, as well as a global distribution network serving patients in more than 50 countries. Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need. Immedica’s therapeutic areas are within genetic & metabolic diseases, hematology & oncology and specialty care. Immedica was founded in 2018 and employs today more than 120 people across Europe, the Middle East and the U.S. The main owners are the investment firms KKR and Impilo. For more information visit www.immedica.com Contacts Immedica Linda Holmström Global Head of Communication linda.holmstrom@immedica.com KKR Nordics Fogel & Partners Ludvig Gauffin kkr@fogelpartners.se UK FGS Global Alastair Elwen KKR-Lon@FGSGlobal.com Impilo Magnus Edlund, Partner magnus.edlund@impilo.se We believe we have an important role to fill in society – bringing new, innovative treatments to patients with rare diseases. Focus areas are within genetic & metabolic diseases, hematology & oncology and specialty care. We operate products from phase 2 and all the way to mature products. ESG is an integrated part of our business model. Stay up to date with our latest news. Telephone: +46 (0) 8 533 39 500 E-mail: info@immedica.com

▲10月26-27日成都中国临床试验产业发展大会免费报名 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。 药融圈之前和大家分享了Paragon Therapeutics孵化的第一家Biotech——ApogeeTherapeutics（相关阅读：自免高热赛道“毛头小司”，一年股价涨幅曾超300%：主打长效），今天想与大家一起聊聊其孵化的第二家公司——Spyre Therapeutics。值得一提的是，虽然Paragon Therapeutics是投资机构Fairmount在2021年才创立的，但是截止2024年8月底，其已经成功孵化了四家公司，其采取的策略简单粗暴，直接针对成熟靶点开发迭代的长效抗体药物，技术上也多采用专利过期的YTE改造策略。不得不说，直到目前为止，从孵化公司的融资情况来看该策略还是比较奏效。 药融云数据，www.pharnexcloud.com：公司信息 从药融云数据库获悉，Spyre Therapeutics的成立时间可以追溯到2013年（具体缘由下面会分享），目前主要专注于开发炎症性肠病的新型单克隆抗体。Spyre Therapeutics可以说是成立于2013年底的Aeglea BioTherapeutics（专注于开发罕见代谢疾病）的救司手段，2023年6月，Aeglea宣布以换股交易的方式收购Spyre Therapeucs，交易完成后，Aeglea BioTherapeutics的股东拥有合并后公司约5.5%的股份，新公司由Aeglea和Spyre高管共同领导。在此交易之前，Aeglea BioTherapeutics正在经历临床失利和濒临破产的情况，股价从高位下跌超过95%，于是公司只得大量裁员。 药融云数据库：融资信息 合并后公司便将之前的针对罕见代谢疾病精氨酸酶1缺乏症的pegzilarginase的全球权利出售给了 Immedica Pharma，也算是正式表示其专注炎症性肠病的决心。随后公司宣布更名为Spyre Therapeucs，股价连续大涨，且在2023年和2024年分别完成了一笔1.8亿美元的融资（总计3.6亿美元）。 当前研发管线主打长效 Spyre Therapeutics的管线主要专注于炎症性肠病（IBD），IBD是一种以胃肠道炎症为特征的慢性疾病，包括溃疡性结肠炎（UC）和克罗恩病（CD）两种主要疾病。在研管线中SPY001、SPY002和SPY003均采用半衰期延长工程技术设计，SPY004则是与上述几条管线不同作用机制的单克隆抗体。目前各管线具体进展情况如下： 01 SPY001 药融云数据，www.pharnexcloud.com显示：SPY001是一种研究性新型皮下延长半衰期单克隆抗体，专为高浓度配制，可最大限度地提高诱导暴露和潜在缓解率，并实现不频繁的皮下维持给药，主要靶向整合素α4β7。整合素作为一类重要的细胞表面粘附分子，是直接介导白细胞迁移运动的重要蛋白，与炎症反应关系密切。整合素α4β7主要表达在淋巴细胞表面，负责介导淋巴细胞从血液循环进入肠道和中枢神经系统，其功能的异常与人类自身免疫疾病密切相关，如溃疡性结肠炎、克罗恩病等。在头对头的临床前研究中，SPY001在阻断MadCAM-1粘附方面显示出与vedolizumab（注射用维得利珠单抗）相当的效力，并且显示出明显更长的半衰期，有可能每两三个月才需要给药一次。 2024年6月18日，Spyre Therapeutics宣布已开始SPY001的临床试验1期研究，该临床试验1期研究是一项针对健康志愿者的双盲、安慰剂对照试验，预计将招募48名健康志愿者，包括至少四个单次递增剂量（SAD）队列和两个多次递增剂量（MAD）队列，主要终点是安全性，次要终点是药代动力学。预计该研究的中期安全性和药代动力学数据会在2024年年底前公布，并且在等待临床试验1期研究的数据之前，公司可能会在2025年开始该管线的临床试验2期研究。 前面提到的注射用维得利珠单抗是武田制药的重磅IBD治疗药物，可特异性地抑制MAdCAM-1与α4β7整合素的结合，从而阻止免疫细胞定向迁移到肠道黏膜，缓解炎症性肠病的症状。2014年在美国和欧洲上市以来销售增长强劲，是武田最畅销的产品之一。 截图自：武田财报 从武田2023年4月~2024年3月的财年年报来看，消化道是公司营收的主要来源，Entyvio（注射用维得利珠单抗）作为消化道产品管线的支柱产品，全年营收8009亿日元（约合美元55亿），占公司合并收入的19%。 02 SPY002 阻断TL1A与其同源受体DR3的相互作用已被证明可以改善CD和UC患者的疾病进程。SPY002是一种靶向TL1A的新型延长半衰期的全人lgG1单抗，对TL1A各种亚型都具有亚纳摩亲和力，可以有效抑制TL1A介导的信号传导。 2024年2月，Spyre Therapeutics在第19届年度ECCO大会上公布了SPY002主要开发候选药物的临床前数据，证明了其在非人灵长类动物（NHP）中的亚纳摩尔结合亲和力和效力，以及24天的药代动力学半衰期，与临床阶段的抗TL1A相比增加了两到三倍。预计在2024年下半年开始对两个SPY002候选药物进行FIH（首次人体试验），2025年上半年获得健康志愿者的中期数据。如果成功，公司预计一个SPY002候选药物将进入进一步的临床开发。 2023年4月，默克通过以108亿美元的价格收购了自免公司Prometheus Biosciences，以进军免疫疾病治疗市场，通过该收购也获得了靶向TL1A的药物——MK-7240，此外，Roivant Sciences（RVT-3101）和梯瓦制药（TEV-48574）也在加紧自家管线的研发进程。与上述三种临床阶段的管线相比，SPY002在NHP中的半衰期延长，也具有不需要频繁通过皮下给药的优势。 03 SPY003 SPY003是一种靶向IL-23的p19亚基的高效选择性的研究性单克隆抗体。预计在2024年下半年启动IND赋能研究，并于2025年上半年启动FIH试验。值得一提的是，IL-23也是艾伯维的Skyrizi（利生奇珠单抗）和强生公司的Tremfya（古塞奇尤单抗）靶向的蛋白质。 基于现有优质管线开展联合用药 α4β7抑制是胃肠病学家首选的一线治疗选择，因为它具有良好的安全性和肠道选择性作用机制，并且在VARSITY研究中显示出优于TNF抑制的疗效，Deanna Nguyen博士（Spyre Therapeutics临床开发高级副总裁）表示这种独特的安全性和有效性特征，结合更方便的给药频率，可以使SPY001成为IBD联合治疗的理想骨干，同时抑制其他高活性机制，包括T1LA和IL-23。 注：VARSITY研究是武田开展的一项随机双盲双模拟全球多中心的临床试验3b期研究，旨在比较维多珠单抗（静脉注射）与阿达木单抗（皮下注射）在治疗中度-重度活动性溃疡性结肠炎患者中，在第52周时的有效性与安全性。 根据最近关于与第三方产品联合疗法治疗IBD的研究结果，公司目前正在开展下一代单克隆抗体的联合治疗研究，目前正在临床前研究的联合疗法包括：（1）SPY120：SPY001和SPY002联合；（2）SPY130：SPY001和SPY003联合；（3）SPY230：SPY002和SPY003联合。 财务状况 2023年度Spyre Therapeutics研发费用为8950万美元，而上年同期只有5858万美元，这一增长主要与公司IBD产品线的临床前开发和生产费用的增加有关；一般和行政费用为3995万美元，上年同期为2853万美元；其他费用为9651万美元；2023年度净亏损6320万美元。 2024年上半年研发费用为6760万美元；一般和行政费用2440万美元；其他收入930万美元；净亏损8270万美元。分季度来看，2024年第二季度研发费用总额为3260万美元，上年同期为1740万美元，这一增长是由公司IBD产品线的临床前和临床开发和生产费用推动的，部分被与公司传统罕见病产品线相关的费用减少以及Paragon Therapeutics与SPY003开发成本相关的非经常性损益所抵消。一般和行政费用总额为1150万美元，上年同期为1210万美元。其他收入共计530万美元，主要受公司现金和有价证券所赚取的利息推动。净亏损3880万美元，而上年同期则高达2.171亿美元。 截至2024年6月30日，Spyre Therapeutics的可用现金和现金等价物、有价证券和限制性现金为4.263亿美元，当前的资金状况预计将足以支持公司继续运营到2027年。截止2024年8月26日，Spyre Therapeutics公司市值13.71亿美元。8月30日，收盘市值为14.60亿美元。 参考： NMPA/CDE； 药融云数据，www.pharnexcloud.com； FDA/EMA/PMDA； 相关公司公开披露（除标注外，正文图片均来自企业官网）； https://spyre.com/； https://mp.weixin.qq.com/s/qkg1Cd55pgHvqPGJVORKwQ； https://mp.weixin.qq.com/s/rKoixewPMhk32GT0Z2Ab2A； https://assets-dam.takeda.com/image/upload/Global/Investor/ASR/Y2023/E_FY23_ASR.pdf； https://www.medsci.cn/article/show_article.do?id=29ed18026114； https://mp.weixin.qq.com/s/8d_bNiG15Q_HySJJDEugeQ；等等。  本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐 【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。

The SIERRA results demonstrate Iomab-B's ability to overcome the negative impact of a TP53 mutation in patients who otherwise would have limited treatment options and dismal prognosis Represents the eleventh oral presentation of the Phase 3 SIERRA results demonstrating continued recognition of the high potential for Iomab-B led allogeneic bone marrow transplant by the bone marrow transplant community NEW YORK, April 1, 2024 /PRNewswire/ --Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today announced that results from the Phase 3 SIERRA trial of Iomab-B in patients with a TP53 mutation have been accepted for oral presentation at the 50th Annual meeting of the European Bone Marrow Transplant Society (EBMT) being held April 14 – 17, 2024, in Glasgow, Scotland. Iomab-B is a targeted radiotherapy conditioning agent comprised of an anti-CD45 monoclonal antibody and Iodine-131 radioisotope payload. The Phase 3 SIERRA trial enrolled 153 patients with active relapsed or refractory acute myeloid leukemia (r/r AML) and compared outcomes of patients receiving Iomab-B and a bone marrow transplant (BMT) to those of patients receiving physician's choice of care in the control arm. In total, 24% of patients (37/153) in the SIERRA trial had a TP53 mutation, which is associated with poor outcomes, and 27 of the TP53 positive patients received Iomab-B. Iomab-B met the primary endpoint of durable Complete Remission (dCR) in the SIERRA trial with high-statistical significance (p<0.0001) and 100% of patients receiving a therapeutic dose of Iomab-B achieved BMT access and engagement. Dr. Hannah Choe, Assistant Professor of Medicine at Ohio State University and SIERRA trial investigator will present the SIERRA results. Details of the oral presentation are as follows: Title: I-131-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Demonstrates Survival Benefit and Overcomes High-Risk TP53 Mutations in Patients with R/R AML Date and Time: Wednesday, April 17, 2024, 12:39 PM GMT Session: OS17-02 Location: Scottish Event Campus (SEC Centre) Dr. Avinash Desai, Actinium's Chief Medical Officer, said, "In addition to demonstrating unprecedented 100% access to BMT in Iomab-B treated patients with active r/r AML and achieving the primary endpoint of dCR with high statistical significance, we are excited by the compelling outcomes in patients with a TP53 mutation in the SIERRA trial. We look forward to returning to EBMT and once again highlighting the positive results from the Phase 3 SIERRA trial to the European bone marrow transplant community. We are particularly focused on Europe as it represents the largest bone marrow transplant market performing 40% of the BMT transplants globally. We also look forward to continuing to work with our European, Middle East and North African commercial partner, Immedica Pharma Ab, to bring Iomab-B to patients globally." About the EBMT Annual Meeting The Annual Meeting of the EBMT is attended by more than 5,500 participants, including physicians, nurses, data managers, statisticians, quality managers, cell therapists, paediatricians, pharmacists, psychologists, psychiatrists and psychoanalysts, transplant coordinators, lab scientists, trainees, patients. This important congress ensures and encourages dialogues and information exchange, education and scientific productivity. The full annual meeting program is available online at: . About Actinium Pharmaceuticals, Inc. Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B (pre-BLA & MAA (EU)), an induction and conditioning agent prior to bone marrow transplant, and Actimab-A (National Cancer Institute CRADA pivotal development path), a therapeutic agent, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia. Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes. Actinium holds more than 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron. For more information, please visit: Forward-Looking Statements This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. Investors: investorrelations@actiniumpharma.com View original content to download multimedia: SOURCE Actinium Pharmaceuticals, Inc. Company Codes: AMEX:ATNM, NYSE:NYSE, AMEX:NYSE