Hansa Biopharma

Lund, Sweden, October 26, 2023, 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.

Highlights for the third quarter of 2023

• Total Q3 revenue of SEK 22.8m including SEK 16.5m in product sales and SEK 5.7m under our agreement with Sarepta
• 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.
• 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.
• First patients treated with imlifidase in an investigator-initiated Phase 2 study in ANCA-associated vasculitis.
• Dr. Hitto Kaufmann appointed Chief Scientific Officer (CSO) of Hansa Biopharma responsible for all research, early development, translational and manufacturing activities.
• 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.

Clinical pipeline update

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

Events after closing period

• 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.
• 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.

Financial summary

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

"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.

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. 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.

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.

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. 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.

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.

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

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.

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. 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.

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.

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.

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."

Upcoming milestones and news flow

Q4 2023 GBS Phase 2: First data readout

Q4 2023 AMR Phase 2: Full data readout

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

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

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

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

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

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

Updated financial calendar 2023/2024

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

Mar 20, 2024                  Annual Report 2023

Apr 17, 2024                   Interim Report for January - March 2024

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

Oct 23, 2024                   Interim Report for January - September 2024

Conference call details

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

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.

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.

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

Sweden: +46 31 311 51 03

United Kingdom: +44 203 769 6819

United States: +1 646 787 0157

Participant access code: 765135

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

The interim report and latest investor presentation can be downloaded from our web:

Interim report January to September 2023 https://www.hansabiopharma.com/investors/financial-reports/

Investor road show presentation Q3, 2023 https://www.hansabiopharma.com/investors/presentations/

This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.