Descartes-08

Enrollment continues to progress in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Phase 2 TRITON trial of Descartes-08 in dermatomyositis and antisynthetase syndrome, expected to initiate in 1H26 Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis actively enrolling Approximately $126.9 million cash, cash equivalents and restricted cash as of December 31, 2025 , expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., March 09, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“we”, the “Company” or “Cartesian”), a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the year ended December 31, 2025, and outlined recent business updates. “Building on a productive year, we look forward to a potentially transformative 2026 as we advance Descartes-08 across several autoimmune indications,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Our top priority remains delivering on our Phase 3 AURORA trial in myasthenia gravis (MG), for which we are on track to enroll approximately 100 patients. This trial represents a crucial opportunity to demonstrate the potential of Descartes-08 to improve patient outcomes and redefine the standard-of-care for MG. Descartes-08’s ease of use, including, flexible, convenient outpatient administration with no preconditioning chemotherapy, combined with deep and durable responses observed through 12 months following a single course of treatment, and a favorable safety profile, underscore our belief that Descartes-08 holds significant promise to deliver meaningful benefit to patients.” Dr. Brunn continued, “Beyond MG, we are working to activate sites for our Phase 2 TRITON trial of Descartes-08 in myositis, which we plan to initiate in the first half of 2026. In parallel, we are also excited to explore potentially enhanced cell therapy delivery options of existing product candidates and next generation agents in development through in-vivo platforms with multiple feasibility studies underway. With an upcoming year of focused clinical execution, we believe we are well-positioned to fill the significant unmet need that remains within the autoimmune treatment landscape.” Pipeline Progress and Anticipated Milestones Enrollment Continues to Progress in the Phase 3 AURORA Trial of Descartes-08 in Participants with MG. The randomized, double-blind, placebo-controlled Phase 3 AURORA trial is designed to assess Descartes-08, Cartesian’s autologous anti-B cell maturation antigen (BCMA) chimeric antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 patients with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo. In December 2025, the AURORA trial was named to Nature Medicine’s “ Eleven clinical trials that will shape medicine in 2026 ” list. Phase 2 TRITON Trial Initiation in Myositis Anticipated in 1H26. In January 2026, Cartesian announced that the U.S. Food and Drug Administration (FDA) accepted the investigational new drug (IND) application for its planned Phase 2 TRITON trial in myositis. The randomized, double-blind, placebo-controlled Phase 2 trial in myositis is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six weekly outpatient infusions without preconditioning chemotherapy in up to 50 patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome. The primary endpoint is expected to assess safety and efficacy of Descartes-08 compared to placebo added to standard of care in participants with myositis at Week 24. The Company currently intends to conduct a blinded interim analysis through the Data Safety Monitoring Board (DSMB) after ten patients reach the primary endpoint, at which point Cartesian may revise sample size assumptions to what could be necessary to support the trial becoming pivotal, pending FDA review. Phase 1/2 HELIOS Pediatric Trial of Descartes-08 in Juvenile Dermatomyositis (JDM) Remains Ongoing. In January 2026, Cartesian announced the initiation of its Phase 1/2 (HELIOS) pediatric trial of Descartes-08 in children and young adults with autoimmune diseases, including JDM. JDM is a rare pediatric autoimmune disorder marked by pathognomonic skin rash and muscle inflammation affecting multiple organ systems. The FDA previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM. Descartes-08’s Mechanism of Action and Phase 2b 12-Month Data in MG Highlighted in Nature Medicine . In January 2026, Cartesian announced the publication of two peer reviewed journal articles in Nature Medicine detailing the mechanism of action of Descartes-08 and outlining deep and durable response data observed throughout 12 months after a single course of therapy in the Phase 2b trial of Descartes-08 , consistent with previously announced 12-month data. Continuing Evaluation of the Potential for Enhanced Delivery Platforms for Cell Therapies. The Company continues to evaluate the potential for enhanced delivery platforms for its cell therapies with multiple agreements in place to explore optimizing in-vivo delivery of Descartes-08 and next generation agents currently in development. Corporate Updates Adrian Bot Appointed to Cartesian’s Board of Directors. Adrian Bot, M.D., Ph.D., was appointed to the Company’s Board of Directors in December 2025. Dr. Bot is a biopharma executive with three decades of experience in research and development with a focus on immune, cell, gene therapy and nanomedicines. His appointment to the Board of Directors supports the Company’s strategic expansion to explore potential enhanced delivery platforms for cell therapies. Carsten Brunn Named Cartesian’s Chairman of the Board of Directors. Dr. Brunn was appointed Cartesian’s Chairman of the Board of Directors in October 2025 following the departure of Carrie S. Cox who stepped down to focus on other responsibilities, including her recent appointment as Executive Chair of another publicly-traded company. In connection with Dr. Brunn’s assumption of the role of Chairman of the Board, Patrick Zenner, M.B.A., was named as Lead Independent Director of the Board of Directors. Full Year 2025 Financial Results Cash, cash equivalents and restricted cash as of December 31, 2025 was $126.9 million and is expected to support planned operations, including completion of the ongoing Phase 3 AURORA trial and initiation of its Phase 2 TRITON trial in myositis, into mid-2027. Research and development expenses were $58.0 million for the year ended December 31, 2025, compared to $45.1 million for the year ended December 31, 2024. The increase in expenses was primarily a result of increased expenses associated with the ongoing Phase 3 AURORA trial coupled with an increase in employee expenses as a result of headcount growth. General and administrative expenses were $31.5 million for the year ended December 31, 2025, compared to $30.1 million for the year ended December 31, 2024. The increase in expenses was primarily the result of increased facilities and stock-based compensation expenses. Net loss was $130.3 million, or $5.02 net loss per share allocable to common stockholders (basic), for the year ended December 31, 2025, compared to net loss of $77.4 million, or $4.48 net loss per share allocable to common stockholders (basic), for the year ended December 31, 2024. About Descartes-08 Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous CAR-T product targeting BCMA in clinical development for generalized MG and myositis, specifically dermatomyositis and antisynthetase syndrome. In contrast to conventional DNA-based CAR T-cell therapies, Cartesian’s CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis. About Cartesian Therapeutics Cartesian Therapeutics is a late clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a CAR-T in Phase 3 clinical development for patients with generalized myasthenia gravis and in Phase 1/2 clinical development of juvenile dermatomyositis with plans to initiate a Phase 2 trial in myositis, specifically dermatomyositis and antisynthetase syndrome in the first half of 2026. For more information, please visit or follow the Company on LinkedIn or X. Forward-Looking Statements Any statements in this press release about the future expectations, plans and prospects of the Company, including without limitation, statements regarding the Company’s expected cash resources and cash runway, the ability of the Company’s product candidates to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the potential of Descartes-08, or any of the Company’s other product candidates to treat MG, juvenile MG, myositis, JDM, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, including the ongoing Phase 3 AURORA trial of Descartes-08 in MG, the planned Phase 2 TRITON trial of Descartes-08 in myositis, and the planned Phase 2 pediatric HELIOS trial of Descartes-08 in autoimmune diseases, including JDM, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, including the number of trials that may be necessary in order to obtain marketing approval, the potential for in-vivo delivery of the Company’s product candidates, the Company’s ability to conduct its clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the ability of the Company to enter into and maintain potential collaborations or partnerships, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, and enrollment in the Company’s clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, political uncertainty, the Company’s reliance on third parties to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts, pandemics, and macroeconomic impacts, and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law. Cartesian Therapeutics, Inc. and Subsidiaries Consolidated Balance Sheets (Amounts in thousands, except share data and par value) December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 125,139 $ 212,610 Accounts receivable 1,115 872 Prepaid expenses and other current assets 3,022 3,144 Total current assets 129,276 216,626 Property and equipment, net 12,185 9,912 Right-of-use assets, net 5,601 5,535 In-process research and development assets 93,900 150,600 Goodwill 48,163 48,163 Long-term restricted cash 1,735 1,669 Investment — 2,000 Long-term prepaid expenses and other assets 5,551 518 Total assets $ 296,411 $ 435,023 Liabilities and stockholders’ deficit Current liabilities: Accounts payable $ 1,288 $ 288 Accrued expenses and other current liabilities 9,498 12,076 Lease liabilities 4,151 2,851 Contingent value right liability — 7,761 Total current liabilities 14,937 22,976 Lease liabilities, net of current portion 8,525 11,133 Warrant liability 141 3,836 Contingent value right liability, net of current portion 392,100 387,739 Deferred tax liabilities, net 6,948 16,141 Total liabilities 422,651 441,825 Stockholders’ deficit: Series A Preferred Stock, $0.0001 par value; 134,904.563 shares authorized as of December 31, 2025 and 2024; 120,790.402 shares issued and outstanding as of December 31, 2025 and 2024 — — Series B Preferred Stock, $0.0001 par value; 437,927 shares authorized, issued and outstanding as of December 31, 2025 and 2024 — — Preferred stock, $0.0001 par value; 9,427,168.437 shares authorized as of December 31, 2025 and 2024; no shares issued and outstanding as of December 31, 2025 and 2024 — — Common stock, $0.0001 par value; 350,000,000 shares authorized as of December 31, 2025 and 2024; 26,011,106 and 25,767,369 shares issued and outstanding as of December 31, 2025 and 2024, respectively 3 3 Additional paid-in capital 700,706 689,887 Accumulated deficit (822,373 ) (692,071 ) Accumulated other comprehensive loss (4,576 ) (4,621 ) Total stockholders’ deficit (126,240 ) (6,802 ) Total liabilities and stockholders’ deficit $ 296,411 $ 435,023 Cartesian Therapeutics, Inc. and Subsidiaries Consolidated Statements of Operations and Comprehensive Loss (Amounts in thousands, except share and per share data) Year Ended December 31, 2025 2024 Revenues: Collaboration and license $ 400 $ 38,275 Grant 2,397 638 Total revenues 2,797 38,913 Operating expenses: Research and development 58,034 45,105 General and administrative 31,468 30,126 Impairment of indefinite-lived intangible and long-lived assets 56,700 7,579 Total operating expenses 146,202 82,810 Operating loss (143,405 ) (43,897 ) Other income (expense): Interest income 6,579 7,386 Gain on change in fair value of warrant liabilities 3,695 2,558 Loss on change in fair value of contingent value right liability (4,354 ) (36,900 ) Loss on change in fair value of forward contract liabilities — (6,890 ) Other (expense) income, net (2,010 ) 606 Total other income (expense), net 3,910 (33,240 ) Loss before income taxes (139,495 ) (77,137 ) Income tax benefit (expense) 9,193 (287 ) Net loss $ (130,302 ) $ (77,424 ) Other comprehensive income (loss): Foreign currency translation adjustment 45 (21 ) Total comprehensive loss $ (130,257 ) $ (77,445 ) Net loss $ (130,302 ) $ (77,424 ) Net loss per share allocable to common stockholders: Basic $ (5.02 ) $ (4.48 ) Diluted $ (5.02 ) $ (4.49 ) Weighted-average common shares outstanding: Basic 25,973,329 17,276,822 Diluted 25,973,329 17,357,943 Investor Contact Megan LeDuc Associate Director of Investor Relations megan.leduc@cartesiantx.com Media Contact David Rosen Argot Partners david.rosen@argotpartners.com

点击蓝字 关注我们 2月28日世界罕见病日，我们聚焦一种隐匿却致命的疾病——全身型重症肌无力。它不是普通疲劳，而是免疫系统“内乱”，错误攻击自身神经肌肉接头，让患者眼皮下垂、咀嚼困难、呼吸费力，甚至连起身都成奢望，更要面对终身服药的困境。 传统疗法如同“大炮打蚊子”，抑制病情的同时削弱正常免疫，而《Nature Medicine》刊登的重磅研究，为患者带来救赎——Descartes-08 mRNA CAR-T疗法，无需化疗、不用住院，83%患者治疗后1年无复发，已进入III期临床，有望终结终身服药噩梦。 💔 绝境困局：终身服药，传统疗法两难全 对于重症肌无力患者而言，治疗就是一场漫长的煎熬：传统免疫抑制剂易伤肝肾，生物制剂需长期维持，一旦停药病情就反弹。他们渴望的，是能“重置”免疫系统、实现长期缓解的治愈性疗法，而Descartes-08的出现，正是为了打破这一困局。 这款由Cartesian Therapeutics公司研发的疗法，是全球首个完成重症肌无力随机对照试验的mRNA CAR-T，用硬核数据，改写了自免病治疗的格局。 🎯 三大颠覆性突破，改写治疗规则 Descartes-08能引发学术界震动，核心在于它实现了三大突破，彻底摆脱传统疗法的局限： ✅ 安全革命：门诊即可完成，告别化疗与病毒风险。采用非整合mRNA技术，CAR-T细胞完成任务后自然消亡，无基因突变风险，无需化疗预处理，轻中度输液反应24小时内可缓解。 ✅ 疗效奇迹：83%患者1年无复发。26例患者临床试验显示，3个月时66.7%患者症状显著改善，1年后83%仍保持有效应答，一个疗程即可实现长期稳定。 ✅ 生活重生：33%患者近乎无症状。治疗6个月后，三分之一患者达到“最小症状表达”，吃饭、上楼等日常活动恢复正常，未用生物制剂的患者这一比例高达55.6%。 📢 权威报道+真实案例：见证生命逆转 Descartes-08的疗效，不仅有顶级期刊背书，更有权威媒体报道的真实案例佐证，每一个故事都充满希望： 据中国新闻网报道，33岁的谢女士确诊重症肌无力4年，多种药物治疗无效，严重时需插管靠呼吸机维持，连简单动作都无法完成。2022年接受CAR-T疗法后，她停用所有免疫药物，不仅病情持久缓解，还在2023年顺利生下健康宝宝，18个月随访中始终无药正常生活，创造了医学奇迹。 另有临床案例显示，一名52岁全身型重症肌无力患者，长期依赖激素控制病情，接受Descartes-08治疗后，6周便摆脱激素，12个月无复发，重新回归正常工作与生活。 🔍 精准“拆弹”：不摧毁免疫，只清除病灶 Descartes-08的核心优势的是精准：瞄准BCMA靶点，像“定向扫雷”般清除产生致病抗体的浆细胞，从根源掐断病因；同时保留正常免疫功能，不会让患者变成“无菌人”，彻底解决传统疗法“杀敌一千、自损八百”的痛点。 💛 致重症肌无力病友：你不是孤军奋战 亲爱的病友，我知道你曾因肌肉无力沮丧，因终身服药迷茫，因病情反复绝望。但请相信，罕见病从不是“无药可医”，Descartes-08的突破、权威媒体报道的真实案例，都在为你点亮希望之光。科技的光芒，从不因患者数量而黯淡，III期临床的推进，正在让“门诊治愈”从梦想照进现实。想了解Descartes-08的适用人群、临床进展、相关细节，点击阅读原文，专业医疗团队为你一对一解答，陪你共赴无药新生之路。 END