Hansa Biopharma公布2023年1-9月业务更新和中期报告-动脉网

Hansa Biopharma Interim Report January-September 2023

PR Newswire 等信源发布 2023-10-26 14:09



可切换为仅中文







• Encouraging high-level results for first-in-human trial of HNSA-5487• Well attended Hansa-sponsored symposium at ESOT focusing on first patient experiences• Dr. Hitto Kaufmann appointed new CSO

•鼓励HNSA-5487首次人体试验的高水平结果•参加了由Hansa赞助的ESOT研讨会，重点关注首次患者体验•Dr。希托·考夫曼任命了新的CSO

LUND, Sweden, Oct. 26, 2023 /PRNewswire/ -- Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for January to September 2023.

瑞典隆德，2023年10月26日/PRNewswire/-Hansa Biopharma，罕见IgG介导疾病免疫调节酶技术的先驱，今天宣布其2023年1月至9月的业务更新和中期报告。

Highlights for the third quarter of 2023

2023年第三季度的亮点

Total Q3 revenue of SEK 22.8m including SEK 16.5m in product sales and SEK 5.7m under our agreement with Sarepta

根据我们与Sarepta达成的协议，第三季度总收入为2280万新加坡元，其中包括产品销售为1650万新加坡元和570万新加坡元

Several new agreements secured with leading transplantation centers in key markets such as U.K. and Germany. Ongoing patient identification through organ allocation systems such as Eurotransplant, which should translate into increased commercial sales in Q4 2023, as previously guided.

与英国和德国等主要市场的领先移植中心签订了几项新协议。通过器官分配系统（如Eurotransplant）进行持续的患者识别，这应该转化为2023年第四季度的商业销售增加，如前所述。

European Society of Organ Transplantation (ESOT) Congress in Athens: Held well-attended Hansa-sponsored symposium 'Crossing DSA Barriers to Transplant Today' focusing on patient experiences with Idefirix.

雅典欧洲器官移植学会（ESOT）大会：举办了由Hansa赞助的研讨会“跨越DSA今天移植障碍”，重点关注Idefirix的患者体验。

First patients treated with imlifidase in an investigator-initiated Phase 2 study in ANCA-associated vasculitis.

在ANCA相关性血管炎的研究者发起的第二阶段研究中，第一批接受伊米非达酶治疗的患者。

Dr. Hitto Kaufmann appointed Chief Scientific Officer (CSO) of Hansa Biopharma responsible for all research, early development, translational and manufacturing activities.

Hitto Kaufmann博士任命了Hansa Biopharma的首席科学官（CSO），负责所有研究，早期开发，转化和制造活动。

Great Place to Work® certification received for the fourth consecutive year. The 2023 certification is based on a company-wide survey completed with 100% participation from Hansa employees.

连续第四年获得工作认证的好地方。2023认证基于全公司调查完成，Hansa员工100%参与。

Clinical pipeline update

临床管道更新

Anti-GBM disease: Positive momentum in the pivotal phase 3 study in anti-GBM disease, five patients were enrolled during Q3, while number of active sites expanded from 12 to 25 in the past quarter. A total of 9 patients out of a target of 50 patients have been enrolled across centers in the U.S., U.K.

抗GBM疾病：积极势头在抗GBM疾病的关键3期研究中，5名患者在第3季度入组，而活动部位的数量在过去一个季度从12个增加到25个。在英国的各个中心共招募了50名患者中的9名患者。

and EU..

和欧盟。。

U.S. ConfIdeS trial: As of October 26, 2023, 87 patients have been enrolled at 16 centers in this pivotal U.S. open label, randomized, controlled trial of imlifidase in kidney transplant. Despite an acceleration in the number of patients being randomized this summer following the initiation of more centers, the allocation of organs to patients on the study remain highly variable and difficult to predict.

U、 S.ConfIdeS试验：截至2023年10月26日，87名患者已在美国这项关键的imlifidase肾移植开放标签，随机对照试验的16个中心就诊。尽管今年夏天在更多中心启动后随机分配的患者数量有所增加，但研究中患者的器官分配仍然高度可变且难以预测。

Randomization is expected to complete by mid 2024 with, a BLA submission expected in 2025..

随机化预计将在2024年中期完成，预计在2025年提交BLA。。

ANCA-associated vasculitis: An investigator-initiated single center, single arm study was launched in the first half 2023 by Charité Universitätsmedizin in Berlin. The study is targeting 10 patients with pulmonary haemorrhage due to severe ANCA-associated vasculitis. As of October 26, three patients have been treated with imlifidase..

ANCA相关性血管炎：由CharitéUniversitätsmedizin于2023年上半年在柏林发起了一项由研究者发起的单中心单臂研究。该研究针对10例因严重ANCA相关性血管炎引起的肺出血患者。截至10月26日，已有3例患者接受了咪唑烷酶治疗。。

Events after closing period

结束后的事件

On October 9, 2023, Hansa announced first high-level results from the first-in-human trial for HNSA-5487. Data showed the molecule was safe and well tolerated with fast and complete depletion of immunoglobulin G (IgG) antibodies observed in all subjects with increasing doses.

2023年10月9日，汉萨公布了HNSA-5487首次人体试验的高水平结果。数据显示该分子是安全的并且耐受性良好，随着剂量增加，在所有受试者中观察到免疫球蛋白G（IgG）抗体的快速和完全消耗。

On October 17, 2023, Hansa announced results from the 5-year long-term study demonstrating 90% patient survival and 82% graft survival. The 5-year extended pooled analysis is a continuation of the analysis at 3-years of crossmatch positive only patients published in the American Journal of Transplantation..

2023年10月17日，Hansa公布了这项为期5年的长期研究结果，显示90%的患者存活率和82%的移植物存活率。为期5年的扩展汇总分析是对美国移植杂志上发表的仅限交叉配型阳性患者3年的分析的延续。。

Financial summary

财务摘要

SEKm, unless otherwise stated - unaudited

SEKm，除非另有说明-未经审计

Q3 2023

第三季度2023

Q3 2022

第三季度2022

9M 2023

9月2023日

9M 2022

9月2022日

Revenue

收入

22.8

67.1

83.7

123.8

SG&A expenses

SG＆A费用

(111.7)

(83.5)

(344.5)

(254.2)

R&D expenses

研发费用

(95.6)

(90.4)

(303.1)

(254.0)

Loss from operation

操作损失

(202.2)

(139.5)

(613.0)

(442.3)

Loss for the period

期间损失

(250.7)

(154.0)

(707.3)

(462.5)

Net cash used in operation

经营中使用的净现金

(193.8)

(128.7)

(582.7)

(392.6)

Cash and short-term investments

现金和短期投资

908.2

1,215.3

908.2

1,215.3

Shareholders' equity

股东权益

(62.2)

344.8

(62.2)

344.8

EPS before and after dilution (SEK)

稀释前后的EPS（SEK）

(4,78)

(3.45)

(13.49)

(10.39)

Number of outstanding shares

已发行股份数目

52,443,962

44,588,118

52,443,962

44,588,118

Weighted avg. number of shares before and after dilution

加权平均数稀释前后的股份数量

52,443,962

44,588,118

52,443,962

44,517,974

Number of employees at the end of the period

期末的雇员人数

168

145

168

145

Søren Tulstrup, President and CEO of Hansa Biopharma, comments;

Hansa Biopharma总裁兼首席执行官SørenTulstrup评论；

'Our commitment to creating paradigm shifts in clinical care resulting in significantly better patient outcomes remains strong. Ongoing progress with the commercialisation of Idefirix continues, and our pipeline of drug candidates, underpinned by exciting science, is progressing steadily.

“我们致力于在临床护理中创造范式转变，从而显着改善患者预后。随着Idefirix商业化的不断进步，我们的候选药物管道在令人兴奋的科学基础上稳步发展。

We continue to see steady growth in the number of key transplant centers readied for utilisation of Idefirix and patients identified and waitlisted for desensitization across Europe. We are also encouraged by the fact that a growing number of transplant centers now have experience with Idefirix and that positive first outcomes have led to repeat usage in a number of hospitals.

我们继续看到关键移植中心的数量稳步增长，这些移植中心重新利用了Idefirix，并确定了患者并等待在欧洲脱敏。我们也感到鼓舞的是，越来越多的移植中心现在有使用Idefirix的经验，积极的第一个结果导致在一些医院重复使用。

Idefirix is a disrupter in the kidney transplant and desensitization treatment ecosystem requiring significant changes in both transplant protocols and organ allocation systems. With this in mind, the adaptation of new approaches to care takes time. While, given the significant unmet need and the demonstrated ability of Idefirix to enable potentially lifesaving kidney transplants, we would like to see a faster uptake, we are pleased with the progress of the launch against key launch metrics and in particular seeing centers gain valuable clinical experience through both the commercially available product and the Post Approval Efficacy Study utilising imlifidase as a desensitization therapy for highly sensitized patients..

Idefirix是肾移植和脱敏治疗生态系统中的破坏者，需要移植方案和器官分配系统发生重大变化。考虑到这一点，适应新的护理方法需要时间。虽然，鉴于重大未满足的需求以及Idefirix能够实现潜在的挽救生命的肾脏移植的能力，我们希望看到更快的摄取，我们对关键发射指标的推出进展感到高兴，特别是看到中心通过商业上可获得的产品和使用伊姆利福酶作为高度敏感患者的脱敏疗法的批准后功效研究获得宝贵的临床经验。。

During the third quarter we have secured several new agreements with leading transplant centers in Europe and do expect this to translate into increased commercial sales in the coming period, supported by new markets such as U.K., Germany and Belgium where patient identification is ongoing as organs become available..

在第三季度，我们已经与欧洲领先的移植中心达成了几项新协议，并且预计这将在未来一段时间内转化为商业销售的增加，并得到英国，德国和比利时等新市场的支持，这些市场随着器官的出现正在进行患者识别。。

On September 16-17 the European Society of Organ Transplantation (ESOT) hosted its annual International Transplant Congress in Athens. At the congress, a Hansa-sponsored symposium 'Crossing DSA Barriers to Transplant Today' was attended by more than 600 members of the transplantation clinical community - validating the continued interest in Idefirix as a transformative desensitization therapy.

9月16日至17日，欧洲器官移植学会（ESOT）在雅典举办了年度国际移植大会。在大会上，Hansa赞助的研讨会“跨越DSA今天移植障碍”参加了600多名移植临床社区成员-验证了对Idefirix作为转化性脱敏疗法的持续兴趣。

The symposium featured KOLs from multiple centers with clinical experience utilizing Idefirix in kidney transplant patients. In some instances, the KOLs had transplanted multiple patients using Idefirix..

研讨会的特色是来自多个中心的KOL，具有在肾移植患者中使用Idefirix的临床经验。在某些情况下，KOLs使用Idefirix移植了多名患者。。

I am also pleased to see positive data from our 5-year long follow-up study further supporting the clinical benefit of imlidase in kidney transplantation. Data five years out demonstrate graft survival of 82%, which is in line with outcomes seen at 3-years post-transplant.

我也很高兴看到我们为期5年的随访研究的积极数据进一步支持imlidase在肾移植中的临床益处。五年的数据显示移植物存活率为82%，这与移植后3年的结果一致。

In the U.S. we continue to carry out key initiatives to accelerate randomization in the pivotal phase 3 trial, ConfIdeS, in kidney transplantation. Despite several new centers being activated in the last 4-6 months and an acceleration in the number of patients being randomized over the summer, the allocation of organs to patients on the study remain highly variable and difficult to predict.

在美国，我们继续在关键的3期试验中开展关键举措，加速随机化，ConfIdeS，肾移植。尽管在过去的4-6个月中有几个新的中心被激活，夏季随机分配的患者数量也在加速，但研究中器官分配给患者仍然高度可变且难以预测。

We are expecting randomization to complete by mid 2024 with a BLA submission expected in 2025..

我们预计随机化将在2024年中期完成，预计2025年将提交BLA。。

In anti-GBM disease, we have recently seen good uptake in patient enrolment in the global pivotal phase 3 study, with nine patients enrolled out of a target of 50 patients, while our newly started investigator-initiated phase 2 study in ANCA-associated vasculitis now has three patients enrolled out of a target of ten patients..

在抗GBM疾病中，我们最近在全球关键性3期研究中看到了患者入选的良好吸收，其中9名患者入选了50名患者的目标，而我们新开始的研究者发起的ANCA相关性血管炎2期研究现在有三名患者入选了十名患者的目标。。

We are also very pleased to report encouraging high-level data from the first-in-human trial for HNSA-5487, the lead candidate from our NiceR program focused on developing next generation IgG-cleaving enzymes. Results demonstrated the molecule was safe and well tolerated with fast and complete depletion of immunoglobulin G (IgG) antibodies observed at increasing doses in all subjects.

我们也非常高兴地报告了HNSA-5487首次人体试验的令人鼓舞的高水平数据，HNSA-5487是我们NiceR计划的主要候选人，专注于开发下一代IgG切割酶。结果表明，该分子安全且耐受性良好，在所有受试者中以增加的剂量观察到免疫球蛋白G（IgG）抗体的快速和完全消耗。

These data are highly encouraging as we continue to explore the potential for our next generation enzymes and better understand how this powerful new enzyme could benefit patients with diseases where a prolonged IgG-free window is needed and where repeat dosing would be beneficial..

这些数据非常令人鼓舞，因为我们继续探索下一代酶的潜力，并更好地了解这种强大的新酶如何使需要延长无IgG窗口且重复给药有益的疾病患者受益。。

Further, I am happy to welcome Dr. Hitto Kaufmann as Hansa's new Chief Scientific Officer (CSO), effective December 1, 2023. Dr. Kaufmann brings more than 20 years' experience in R&D from both large pharma and small biotech.

此外，我很高兴欢迎Hitto Kaufmann博士作为Hansa新首席科学官（CSO），于2023年12月1日生效。考夫曼博士带来了大型制药和小型生物技术20多年的研发经验。

Last, I want to highlight that Hansa Biopharma AB was recently certified as a Great Place to Work® for the fourth consecutive year. This certification reflects our successful efforts over the past years to not only build and maintain a high-performance team, but also to create a rewarding and stimulating workplace for our employees, enabling us to continue to attract and retain the very best people in the industry..

最后，我想强调的是，Hansa Biopharma AB最近被认证为连续第四年工作的好地方。该认证反映了我们过去几年的成功努力，不仅要建立和维护一支高绩效团队，还要为员工创造一个有价值和激励的工作场所，使我们能够继续吸引和留住行业中最优秀的人才。。

I look forward to keeping you updated on our continued progress, with several upcoming important milestones to be achieved across our platform and franchises in the coming period, as we continue our efforts to develop new, transformative medicines for patients suffering from serious, rare immunologic diseases.'.

我期待着让您了解我们的持续进展，在未来一段时间内，我们的平台和特许经营将实现几个即将到来的重要里程碑，因为我们继续努力为患有严重，罕见免疫疾病的患者开发新的变革性药物疾病“。

Upcoming milestones and news flow

即将到来的里程碑和新闻流

Q4 2023 GBS Phase 2: First data readout

Q4 2023 GBS阶段2：第一次数据读出

Q4 2023 AMR Phase 2: Full data readout

Q4 2023 AMR阶段2：完整的数据读出

Q4 2023 Sarepta DMD pre-treatment Phase 1b: Commence clinical study

Q4 2023 Sarepta DMD预处理阶段1b：开始临床研究

2024 GBS Phase 2: Outcome of the comparative efficacy analysis to IGOS data

2024 GBS阶段2：对IGOS数据进行比较效力分析的结果

2024 Genethon Crigler-Najjar Phase 1/2: Initiate clinical study with imlifidase prior to GNT-0003

2024年Genethon-Crigler-Najjar 1/2期：在GNT-0003之前开始使用imlifidase进行临床研究

2024 HNSA-5487 (Lead NiceR candidate): Further analysis around endpoints to be completed in 2024 incl. lead indication

2024 HNSA-5487（领先的候选人）：围绕终点的进一步分析将于2024年完成，包括主导适应症

2024 U.S. ConfIdeS (Kidney tx) Phase 3: Complete randomization

2024年美国ConfIdeS（Kidney tx）第3阶段：完全随机化

2025 U.S. ConfIdeS (Kidney tx) Phase 3: BLA submission

2025年美国ConfIdeS（Kidney tx）第3阶段：BLA提交

Updated financial calendar 2023/2024

更新财务日历2023/2024

Feb 2, 2024 Full-year Report for January - December 2023

Mar 20, 2024 Annual Report 2023

2024年3月20日年度报告2023

Apr 17, 2024 Interim Report for January - March 2024

2024年4月17日2024年1月至3月的临时报告

July 17, 2024 Half-year Report January - June 2024

Oct 23, 2024 Interim Report for January - September 2024

2024年10月23日2024年1月至9月临时报告

Conference call details

电话会议详情

Hansa Biopharma will host a telephone conference today Thursday, October 26, 2023, 14:00 CET / 8:00am EST.

Hansa Biopharma将于2023年10月26日星期四，美国东部时间14:00/上午8:00主持电话会议。

The event will be hosted by Hansa Biopharma's CEO, Søren Tulstrup, CCO and U.S. President, Matthew Shaulis and CFO, Donato Spota. The presentation will be held in English.

该活动将由Hansa Biopharma的首席执行官sørenTulstrup，CCO和美国总裁Matthew Shaulis和CFO Donato Spota主持。演示文稿将以英文举行。

Slides used in the presentation will be live on the company website during the call under 'Events & Presentations' and will also be made available online after the call.

演示文稿中使用的幻灯片将在“事件和演示文稿”下的呼叫期间生活在公司网站上，并在呼叫后在线提供。

To participate in the telephone conference, please use the dial-in details provided below:

要参加电话会议，请使用下面提供的拨号详情：

Sweden: +46 31 311 51 03

瑞典：+46 31 311 51 03

United Kingdom: +44 203 769 6819

英国：+44 203 769 6819

United States: +1 646 787 0157

美国：+1 646 787 0157

Participant access code: 765135

参与者访问代码：765135

The webcast will be available on https://hansabiopharma.eventcdn.net/events/q3-2023-conference-call