LONDON, Ontario; BOSTON, Massachusetts – June 25, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company, today announces developments in its Phase I/II clinical trial investigating a novel treatment for Type 1 Diabetes (T1D). To date a total of 7 patients across Cohorts 1 and 2 have achieved insulin independence following transplants of human donor islets via Sernova’s proprietary Cell Pouch System™ and a marginal portal vein top up.  Additionally, the study, which is being conducted at the University of Chicago, completed full enrollment of the second cohort of patients with the last patient being enrolled June 24, 2024. .

安大略省伦敦；马萨诸塞州波士顿-2024年6月25日-临床阶段生物技术公司Sernova Corp.（TSX:SVA）（OTCQB:SEOVF）（FSE/XETRA:PSH）今天宣布其I/II期临床试验的进展，该试验研究一种新的1型糖尿病（T1D）治疗方法。迄今为止，第1组和第2组共有7名患者在通过Sernova专有的Cell Pouch System™和边缘门静脉补液移植人类供体胰岛后实现了胰岛素独立性。。

At baseline, all patients in the study were dependent on multiple daily insulin injections with average HbA1c levels (a measure of glucose control over the prior 2 to 3 months) greater than 6.5% across the study population.  In addition, prior to enrollment in the study, patients had a history of severe hypoglycemic events (a potentially life-threatening drop in blood sugar leading to impaired cognition and consciousness) and undetectable plasma levels of C-peptide (a marker of natural insulin production).

在基线时，研究中的所有患者均依赖于每日多次胰岛素注射，整个研究人群的平均HbA1c水平（前2至3个月血糖控制的指标）大于6.5%。此外，在参加研究之前，患者有严重低血糖事件的病史（血糖可能危及生命，导致认知和意识受损）和血浆C肽水平（天然胰岛素产生的标志物）检测不到。

Insulin independence in these first 7 patients has been accompanied by freedom from severe hypoglycemic events, sustained HbA1c levels in the non-diabetic range (HbA1c <6.5%), and persistent transplant-mediated insulin production measured by plasma C-peptide.   .

前7名患者的胰岛素独立性伴随着无严重低血糖事件，持续的HbA1c水平在非糖尿病范围内（HbA1c<6.5%），以及通过血浆C肽测量的持续移植介导的胰岛素产生。。

The trial, which focuses on Sernova’s Cell Pouch technology, demonstrates that insulin independence and additional clinically meaningful patient outcomes were achieved with lower than traditional islet masses infused intra-portally, indicating an important contribution of the islet grafts in Cell Pouch to the observed favorable blood glucose control.  Sernova continues to be the first and only company to announce positive patient outcomes in a clinical trial for T1D that combines donor islets transplanted via an implantable delivery vehicle that also has full payload containment and retrievability capabilities should it be required, as evidenced by the first patient in Cohort 2.

该试验侧重于Sernova的细胞袋技术，表明胰岛素独立性和额外的临床意义患者结果是通过低于传统胰岛肿块的门内输注实现的，这表明细胞袋中的胰岛移植物对观察到的有利血糖控制有重要贡献。Sernova仍然是第一家也是唯一一家在T1D临床试验中宣布阳性患者结果的公司，该试验结合了通过植入式递送载体移植的供体胰岛，如果需要，该载体也具有完整的有效载荷控制和可回收能力，如队列2中的第一名患者所证明的。

Interim data from this study indicates that Cell Pouch is generally safe and well tolerated and, when transplanted with donor islets, contributes to the reversal of T1D, potentially minimizing the long-term comorbidities that include heart and kidney disease, blindness and amputation. The Company anticipates announcing additional trial results for the remaining 5 patients.

这项研究的中期数据表明，细胞袋通常是安全且耐受性良好的，当移植供体胰岛时，有助于T1D的逆转，可能最大程度地减少包括心脏和肾脏疾病，失明和截肢在内的长期合并症。该公司预计将宣布其余5名患者的额外试验结果。

in Cohort 2, later in the year.

在今年晚些时候的队列2中。

Cynthia Pussinen, CEO of Sernova, expressed 'we are excited with and encouraged by the impressive progress of our ongoing Phase I/II clinical trial with donor islets and Cell Pouch. The ability to achieve sustained insulin independence, HbA1c levels in the non-diabetic range and reductions in severe hypoglycemic events in patients, using a retrievable payload device, signifies a transformative step forward in the treatment – and essentially functional cure - of Type 1 Diabetes.

Sernova首席执行官辛西娅·普西宁（CynthiaPussinen）表示，“我们对正在进行的供体胰岛和细胞袋I/II期临床试验取得的令人印象深刻的进展感到兴奋和鼓舞。使用可回收的有效载荷装置，能够实现持续的胰岛素独立性，非糖尿病范围内的HbA1c水平以及患者严重低血糖事件的减少，这意味着在1型糖尿病的治疗（基本上是功能性治愈）方面迈出了变革性的一步。

Sernova remains committed to advancing the potential of our Cell Pouch technology to significantly improve the lives of patients and their families worldwide.” .

Sernova仍然致力于提高我们的细胞袋技术的潜力，以显着改善全球患者及其家人的生活。”。

Sernova Corp continues to collaborate closely with leading academic, pharmaceutical and clinical institutions to expand the scope and impact of its technology. The company anticipates further advancements as it progresses through additional cohorts and trials, with the goal of offering a scalable solution for insulin-dependent diabetes plus other chronic diseases..

Sernova Corp继续与领先的学术、制药和临床机构密切合作，以扩大其技术的范围和影响。该公司预计通过额外的队列和试验将取得进一步进展，目标是为胰岛素依赖型糖尿病和其他慢性疾病提供可扩展的解决方案。。

About Sernova

关于Sernova

Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead technology, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells..

Sernova Corp.是一家临床阶段生物技术公司，正在开发针对慢性疾病的治疗性细胞技术，包括胰岛素依赖型糖尿病，甲状腺疾病和包括血友病a在内的血液疾病。Sernova目前专注于开发胰岛素依赖型糖尿病的“功能性治疗”，其领先技术是细胞袋系统，这是一种具有免疫保护治疗细胞的新型植入式和可扩展医疗设备。。

Sernova partnered with Evotec to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2).

Sernova与Evotec合作开发了一种基于可植入现成iPSC（诱导多能干细胞）的胰岛替代疗法。这种合作关系为Sernova提供了潜在的无限量胰岛素产生细胞，用于治疗数百万胰岛素依赖型糖尿病（1型和2型）患者。

Sernova’s development pipeline that uses its Cell Pouch System also includes: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A..

Sernova使用其细胞袋系统的开发管道还包括：甲状腺切除引起的甲状腺功能减退症的细胞疗法和血友病a的离体慢病毒因子VIII基因疗法。。

On implantation, The Cell Pouch forms a natural, vascularized tissue environment in the body allowing long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago.

植入时，细胞袋在体内形成天然的血管化组织环境，允许治疗细胞的长期存活和功能，释放某些慢性病患者体内不存在或缺乏的必需因子。在芝加哥大学正在进行的1/2期临床研究中，Sernova的细胞袋系统已证明其有潜力成为T1D患者的“功能性治愈”。

The Cell Pouch technology integrates with the body's natural biological processes, creating a biocompatible environment for the delivery of therapeutic cells previously missing from the body including cells, hormones, blood factors and tissues. This innovative approach aims to provide a durable and sustainable treatment option for Sernova’s lighthouse program to treat individuals living with T1D, with additional future therapeutic programs to follow for hypothyroidism and hemophilia A. .

细胞袋技术与身体的自然生物过程相结合，创造了一个生物相容的环境，可以输送以前从身体缺失的治疗细胞，包括细胞、激素、血液因子和组织。这种创新的方法旨在为Sernova的灯塔计划提供持久和可持续的治疗选择，以治疗患有T1D的个体，并为甲状腺功能减退症和a型血友病提供更多的未来治疗方案。。。