Sodium Iodide I-131

Theranostics Products Revenues Increased 8% in the Three Months Ended March 31, 2024; Net Cash Provided By Operating Activities Was Approximately $400,000 in the Three Months Ended March 31, 2024; Gross Profit Increased 5% in the Three Months Ended March 31, 2024. IDAHO FALLS, Idaho, May 16, 2024 /PRNewswire/ -- International Isotopes Inc. (OTCQB: INIS) (the "Company" or "INIS") announces its financial results for the three-month period ended March 31, 2024. Revenue for the three months ended March 31, 2024, was $2,904,458 compared to $3,089,535 for the same period in 2023. This was an overall decrease of approximately 6%. The decrease in revenue for the three-month period was largely the result of continued global isotope shortages of Cobalt-57 isotopes impacting our Nuclear Medicine segment. The Company reported a net loss for the three months ended March 31, 2024, of $154,051 compared to net loss of $148,054 for the same period in 2023. This is an increase in net loss of $5,997 that is largely the result of the decrease in revenue in our Nuclear Medicine Standards Products segment partially offset by increased revenue in our Theranostics Products and Cobalt Products segments and increased gross profit percentages for the three months ended March 31, 2024, as compared to the same period in 2023. As of March 31, 2024, cash and cash equivalents of $2,368,496 as compared to $2,688,141 at December 31, 2023. For the three months ended March 31, 2024, net cash provided by operating activities was $412,444 compared to $981,311 for the three months ended March 31, 2023. The following provides a summary of our current business segment performance for the three-month period ended March 31, 2024: Theranostics Products Revenue from the Theranostics Products segment increased approximately 8% for the three-month period ended March 31, 2024, compared to the same period in 2023. The increase was primarily the result of continued growth in demand for our radiopharmaceutical product (generic sodium iodide I-131). This sodium iodide radiopharmaceutical drug is used to treat thyroid cancer and diseases, and we are currently the only domestic manufacturer of this important theranostic radiopharmaceutical drug product. We expect continued growth for our Theranostics Products segment for 2024 due to continued demand for generic sodium iodide I-131 products. We also expect the addition of the EasyFill Automated Iodine Capsule System along with its consumables & accessories in our Medical Devices segment to support our sales in this segment. Nuclear Medicine Segment Revenue from nuclear medicine products for the three months ended March 31, 2024, was $765,408, compared to $1,168,831 for the same period in 2023. This represents a decrease in revenue of $403,423, or approximately 35%. The decrease is due to a global shortage of Cobalt-57 isotopes during the three months ended March 31, 2024. We continue to maintain a growing backlog of orders and we expect a revenue catch-up upon normalization of the global isotope supply chain, anticipated by the end of the third quarter of this year. Overall, we anticipate growth of the Nuclear Medicine Products segment upon normalization of the supply chain and as we continue to add new products, customers, and territories. Cobalt Products Revenue from the sale of Cobalt Products for the three months ended March 31, 2024, was $233,968, compared to $158,308 for the same period in 2023. This represents an increase of $75,660, or approximately 48%. Large value sales of high activity cobalt sources occur at various times throughout the year. Frequently the timing of these sales can have a significant impact on period comparisons. The Company remains the only domestic manufacturer and supplier of high activity cobalt-60 sealed-source products and we anticipate overall yearly growth in this segment in 2024 due to existing orders planned for manufacturing later this year. Medical Devices Medical Devices is a new reportable business segment starting in the first quarter of 2024. While we have not yet commercialized any medical devices, we have invested in this segment throughout 2023 and 2024 and anticipate additional investments for the remainder of 2024 with commercialization of products starting later in 2024. This segment will include The Swirler® and Tru-Fit™ Mouthpiece with related accessories under the RadVent brand. Additionally, the Company has investments in a joint venture arrangement for our EasyFill Automated Iodine Capsule System. Shahe Bagerdjian, President & CEO of the Company, commented, "First quarter results delivered a promising start to 2024, despite continued global isotope constraints impacting our RadQual products. Theranostics Products delivered a promising start to 2024, compounding on last strong growth, and we expect the trend to continue into the next quarter. We remain focused on resolving our raw material shortages impacting the Nuclear Medicine Products segment. We are working with various parties, including the U.S. Department of Energy, to help alleviate the shortage. While we successfully added a new cobalt-57 supplier in the first quarter, demand significantly outpaced our supply." "We are encouraged by the growing demand of our non-Cobalt-57 products and reached various development milestones for new Nuclear Medicine and Medical Device products. We believe the Company will begin commercialization of these new products in the second half of 2024." About International Isotopes Inc. International Isotopes Inc. (INIS), established in 1995, with its headquarters in Idaho Falls, ID, USA, manufactures a wide range of radioisotope-focused products. INIS manufactures and supplies generic sodium iodide I-131 radiopharmaceutical drug product for hyperthyroidism and thyroid cancer. INIS manufactures and distributes a complete line of calibration and reference standards for nuclear pharmacies and SPECT/PET imaging systems as well as industrial calibration standards. The Company also manufactures Cobalt-60 sealed source products and provides contract manufacturing of various drug products as well as radioisotope API supply for 3rd party theranostics clients. International Isotopes Inc. Safe Harbor Statement Certain statements in this press release are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements with respect to the Company's future growth expectations. Information contained in such forward-looking statements is based on current expectations and is subject to change. These statements involve a number of risks, uncertainties and other factors that could cause actual results, performance, or achievements of International Isotopes Inc. to be materially different from any future results, performance or achievements of the Company expressed or implied by these forward-looking statements. Other factors, which could materially affect such forward-looking statements, can be found in the Company's filings with the Securities and Exchange Commission at , including its Annual Report on Form 10-K for the year ended December 31, 2023. Investors, potential investors, and other readers are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements made herein are only made as of the date of this press release and International Isotopes, Inc. and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. FOR MORE INFORMATION, CONTACT: David Drewitz Creative Options Communications Investor and Public Relations [email protected] Phone: 972-814-5723 SOURCE International Isotopes Inc.

为打造全球ADC/RDC未来产业高地，成都医学城拟于2024年4月18日-19日举办首届未来XDC新药大会！大会以“共创偶联药物产业未来”为主题，由同写意策划，安排一场主论坛和九场主题论坛，邀请“政、产、学、研、金、媒”各领域专家，通过“成果发布、主题演讲、热点对话、表彰颁奖、展览展示”五位一体的多元化的组织形式，迸发更多XDC产业新科技、新业态、新模式，构建XDC产业全新生态，触摸医药产业未来脉动。2024年，多家Biotech逆势获得大额的融资，他们之前的共同点是：核药。为什么？1895年，伦琴发现了X射线，这后来被医疗行业用于CT，成为CT诊断技术的核心。1898年，居里夫人发现了放射性元素钋和镭。随后，20世纪初，在居里夫人的指导下，人们第一次将放射性同位素用于治疗癌症。诊断和治疗，两种完全不同的效果，竟然可以来源于同一种药物，这就是日渐“翻红”的放射性核素药物（简称：核药）。近几年，诺华、礼来、默沙东、阿斯利康等跨国药企纷纷通过并购/合作加码核药管线。▲核药的分类（来源：中伦视界）在“翻红”之前，核药经历过漫长的“冰河时代”，尤其在治疗端。1951年，全球首个核药碘[131I]化钠获FDA批准上市，用于甲状腺疾病的诊断和治疗，随后，碘[123I]氟潘、18F-FDG（氟[131F]脱氧葡糖注射液）等产品相继获批，核药在诊断方面的应用进一步加深。但核药治疗端受限于上游核素产能、监管要求过严和安全性存疑等原因，发展停滞不前。2002年和2003年在美国上市的Zevalin（替伊莫单抗，来自日本IDEC公司）和Bexxar（碘[ 131I]托西莫单抗，Corxia与葛兰素史克公司联合研制）即便安全性和疗效都不错，也由于当时市场教育不足、医保报销困难等，商业化难言成功。2013年，拜耳Xofigo（氯化镭[223Ra]）上市用于治疗前列腺癌，其销售额便稳步上升，2017年达到4.71亿美元。虽然这种传统疗法无法迁移运用到其他癌种之上，但并不影响诺华看到核药的潜力。2017年，诺华39亿美元收购法国核药创新公司Advanced Accelerator Applications（AAA），获得了放射性配体疗法Lutathera 和相关技术平台。2018年，诺华又以21亿美元收购Endocyte公司，进而获得更多放射性配体疗法，如治疗前列腺癌的177Lu-PSMA-617和255AC-PSMA-617等。两起并购树立了诺华在核药领域的领先地位。2018年，诺华收购得来的新型靶向放射性疗法（也称放射性核素偶联药物，即RDC）Lutathera（靶点为SSTR）获FDA批准；2022年，诺华又宣布另一RDC产品Pluvicto（靶点为PSMA）上市。自2016年以来，FDA批准了近10款RDC产品，其中8成为诊断药物，唯2款为治疗药物，也就是诺华的这两款。RDC这种新型核药的原理与大热的ADC（抗体偶联药物）基本一致，只不过杀伤癌细胞的小分子毒素等被替换成了放射性核素，通过靶向分子将放射性核素递送至肿瘤细胞组织，近距离精准杀伤癌细胞，不仅高效低毒，还让行业看到了此类产品在其它靶点和适应症拓展的潜力。2023年，Ludera营收6.05亿美元，同比+28%; 上市不到两年的Pluvicto营收爆发，2023年达到惊人的9.80亿美元，同比+262%。核药市场被彻底引爆。1Biotech与MNC的接力游戏当前的环境下，存量资本在寻找最有市场想象力和商业回报的投资方向。核药这一小众赛道颇受制药企业和投资人青睐。根据医药魔方数据库，2023年核药赛道的融资金额已经达到了60亿美元。此外，诺华、礼来、强生等MNC或通过并购合作，或通过股权投资，也在不断加码核药，呈现出一派欣欣向荣的景象。不过，在这场核药翻红过程中，核药Biotech难逃被收购/BD的命运。这其中，除了MNC拥有大量的资金可以通过并购/BD弯道超车以外，也是由核药这个赛道的特殊属性所决定的。居里夫人成功分离出放射性同位素，却也因为过度暴露于辐射中而罹患白血病。这让放射性核素的危险性深入人心。核药的放射性，决定了它既要遵循药品研发生产的一般性规定，也要在从上游生产、中游运输到下游的临床应用遵循关于核药的特殊安全性规定，建设防辐射设施、减少人员的辐射暴露。同时，放射性同位素的活性在特定时间段内减弱，因此需要及时递送和施用给患者。由于给药时间窗口有限，这些药物通常以单人剂量的形式生产，并需要考虑运输包装、运输距离、以及周期的药物递送；使用也需要在有核药临床使用资质的医疗机构，医院也需要为患者配备专门的病房。即便是诺华，也在核药的商业化上遭遇过瓶颈。诺华Pluvicto的有效期从工厂包装好开始计时只有5天；Lutathera更短，只有3天。这让全球分散建厂成为刚需，但核药的放射性原料与生产获批又面临着不同国家的资质审查以及海关限制。2018年上市的Lutathera，前两年销售额增长非常迅猛，在获批的第一年就实现了1.67亿美元的营收，第二年就增长到了4.41亿美元，但是随后便停留在顶峰。究其原因，Lutathera的适应症（胃肠胰腺神经内分泌肿瘤）市场空间本就有限固然是一部分原因，医疗机构资质和生产运输周期限制了Lutathera的大面积推广也是关键因素。为了解决这一问题，诺华已在意大利、西班牙、美国、中国分别设立了多个放射性药物生产基地。其中在中国投资设立的全新放射性药物生产基地落地在浙江省嘉兴市，投资总额预计将超过6亿元人民币，预计在2026年底投入生产。同时，要保证核药在有效期内，配送大多需要用飞机运输，地面运输采用的是高端私人快递。据说诺华专门管物流的团队就有30-40人。诺华预计在解决产能问题之后，2024年以后每年至少供应25万剂Pluvicto，销售峰值将达到20亿美元。种种要求使得核药行业的商业化存在极高的壁垒。成熟、完备的核药上下游产业链，本身就存在极高的壁垒，也都指向了大量的资金投入。做核药的Biotech如果没有办法自己走通这条路，就只有卖给财大气粗的MNC；而并购/合作领先核药公司快速进入核药市场是MNC的常用方式。拜耳、诺华目前已经上市的核药都是通过并购得来；近年来，礼来、BMS也先后通过并购进军核药市场。2023年10月，礼来也以14亿美金收购Point Biopharma进军核药领域。2023年12月，BMS以41亿美金收购成立仅三年多的核药公司RayzeBio，将核药市场推向新的高潮。罗氏、默沙东目前在核药市场的布局主要是合作。其中，默沙东早在2021年就与Fusion达成合作，主要是评估核药与Keytruda的联合疗法；2023年3月，默沙东又与Ratio Therapeuticsd合作推进核药研发。罗氏则通过在2023年9月与PeptiDream达成一项超10亿美金核药研发合作进入核药领域。阿斯利康布局核药的方式是先合作试水，进展良好之后直接收购。近日，阿斯利康斥资24亿美元收购的核药公司Fusion，早在2020年两家公司就已经开展了合作。从合作到并购，Biotech和MNC完成一场核药领域的接力赛。2中国核药双寡头，老牌药企加码破局中国市场上，核药产业是一个方兴未艾的领域。在以中国同辐、东诚药业为核心的双寡头局面之下，老牌药企正在加速进入，双方形成一定的错位竞争。先来看双寡头。据药智数据不完全统计，目前国内上市的核药152个（按品种计），中国同辐和东诚药业两家企业产品数量占比73%。中国同辐的背后是央企中核集团。中国同辐是中国核工业集团的控股子公司，于2011年在原中国同位素有限公司基础上重组设立，该企业是国内少有的集研发、生产、销售、服务于一体的核技术应用龙头企业，包括核药、医学诊断、核医疗装备等七个业务单元，旗下又设有10多个主要子公司，覆盖核医学各环节业务。东诚药业凭借硫酸软骨素和肝素钠两款产品起家，在2015年以7.5亿元收购成都云克药业52%股权，正式进军核药领域。此后，又收购（或通过全资子公司收购）GMS全部股权、中泰生物70%的股权、益泰医药83.5%的股权、安迪科全部股权，进而形成了一个分布于研产供销全链条的核药体系——成都云克药业作为核药生产平台，上海益泰作为核药研发平台，上海欣科作为核药标记与配送平台（核药房），南京安迪科作为正电子药物生产和销售平台。近年来，东诚药业又通过收购布局核药CRO产业链。2020年5月，东诚药业全资子公司安迪科通过收购分子影像CRO公司南京米度生物48%的股权。2022年12月，东诚药业下属米度生物以3020万美元（2.11亿元）的现金收购美国核药转化及临床试验影像CRO服务公司XING IMAGING LLC. 100%股权，收购溢价高达16倍。核药推广关键步骤的核药房上，中国的核药房资源基本也集中在中国同辐、东诚药业两家公司。双寡头之外，老牌制药企业正在加速入局核药市场。国产医药“一哥”恒瑞医药进展快速。恒瑞医药旗下的天津恒瑞在2023年末已有四款核药产品获批临床试验；取得了首个放射性药品生产许可证，标志着恒瑞的核药从研发迈向生产；同时，由天津恒瑞牵头组建的天津市放射性药物创新联合体获批复；依托于天津恒瑞的天津市核素精准诊疗药物重点实验室也获批筹建。远大医药也通过密集收并购来完善产业链布局，百洋集团投资的瑞迪奥也是核药领域的重要参与者。核药领域的新生力量也不容小觑，尤其是先通医药。2023年7月，核药企业先通医药获得了一笔超11亿元的巨额融资，投资机构中包括多个“国家队”。这也是国内医疗健康领域2023年最大一笔融资。2023年9月，先通医药用于测定阿尔茨海默病和其他认知功能下降成年患者脑内Aβ神经炎性斑块的水平的氟[18F]贝他苯注射液获得NMPA正式批准，这是国内核医学领域近20年首个获批上市的新药。虽然获批的新药是用于检测端而非治疗端，但不妨碍资本的热情。2024年初，放射性药物治疗公司辐联医药完成B轮融资，其中包括4730万美元的B轮股权融资和1600万美元的授信额度。此外，智核生物、核欣医药、艾博兹医药、四体康宸等新生代核药公司，逆势斩获高融资。核药领域特点就是：资产资质门槛极高而增长强势。全球市场蓬勃发展，根据Medraysintell数据，2019年全球核药市场规模约60亿美元，其中诊断药物占据主要市场，但随着越来越多的治疗性药物上市，将推动2030年全球核药市场达到300亿美元左右。高速发展的同时，布局的企业也要关注到目前的核药布局倾向于靶点同质化、适应症同质化的苗头，避免“产品真正上市时，市场已成红海”的尴尬局面。参考文献：1. 中伦视界 | 解密核医学之核药行业监管概览及投资合规关注要点2.  药智网 | 中国核药，撕开了一个口 3.  药智网 | 恒瑞给了核药市场一个「小震撼」更多优质内容，欢迎关注↓↓↓