Lund, Sweden October 20, 2022, 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 2022.

Highlights for the third quarter 2022

• Total Q3 revenue of SEK 67m including SEK 23m in product sales and SEK 44m under our agreements with Sarepta and AskBio
• Positive reimbursement decisions received in Poland and Scotland for Idefirix^® in highly sensitized kidney transplant patients. Market access has now been secured in nine European countries and procedures are ongoing in eight countries, including Spain, Italy and Belgium.
• First patient treated in the post-authorization efficacy study (PAES) of imlifidase in highly sensitized kidney transplant patients, at the Vall d’Hebron University Hospital in Barcelona.
• $70 million non-dilutive financing executed with NovaQuest to support continued development of the company’s antibody-cleaving enzyme technology platform. The transaction extends Hansa’s cash runway through 2024.
• The European Society for Organ Transplantation’s (ESOT) guidelines for desensitization treatment of highly sensitized kidney transplant patients published in Transplant International in August 2022. Guidelines include imlifidase and provide a new clinical practice tool for healthcare professionals and represents the first international consensus on a management pathway for highly sensitized patients.
• Hansa received Great Place to Work^® certification for the third consecutive year. The 2022 certification is based on a company-wide survey completed by 99% of Hansa employees.

Clinical pipeline update

• U.S. ConfIdeS: 39 out of the targeted 64 patients have been enrolled for randomization in the pivotal U.S. open label, randomized, controlled trial of imlifidase in kidney transplant with the aim of completing enrollment by the end of this year, as previously guided. The aim is to complete randomization in the first half 2023, while a BLA submission is expected in 2024 under the accelerated approval path.
• AMR: After completing enrollment in Q2-22, the first data read out is expected toward end of 2022 as previously guided. The AMR study is a randomized, open-label, multicenter, active control study designed to evaluate efficacy of imlifidase in eliminating donor specific antibodies (DSA) in the treatment of active episodes of acute and chronic acute AMR in kidney transplant patients, in comparison to plasma exchange.
• GBS: In the Guillain Barré Syndrome (GBS) phase2 trial, 20 out of a target of 30 patients have been enrolled. Several initiatives have been implemented to support enrollment including simplifying the protocol and increasing capacity at the center level. New centers were also added before and over the summer with further measures being taken to accelerate recruitment in the coming months. The aim is to complete enrollment of GBS patients H2 2022/H1 2023.
• Anti-GBM: Preparations to commence a phase 3 study later this year, as previously guided, are on track with a protocol in place and approved by FDA. Selection of investigators and site set up activities are now ongoing.

Financial summary

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

“In July, we executed a $70 million non-dilutive financing transaction, strengthening our existing cash position to support the continued development of transformative drug candidates based on our unique antibody-cleaving enzyme technology platform and the commercial launch of Idefirix^® in Europe.

So, I am pleased to see continued good execution of our market access and commercial launch activities across Europe. During the third quarter, we secured reimbursement in Scotland and Poland, and market access has now been secured in nine European countries, including Germany, France, and the UK, while market access procedures continue to progress in eight additional countries, including Spain, Italy and Belgium.

We also welcome the publication in Transplant International of the first international guidelines for desensitization treatment of highly sensitized kidney transplant patients by the European Society for Organ Transplantation (ESOT). These guidelines, which are the first to include imlifidase, represent the first supranational consensus on a management pathway for highly sensitized patients and articulate the variability in definitions, approaches, outcomes as well as the perceived success of HLA-related transplantations. It is our expectation that these guidelines can help improve access to lifesaving kidney transplants for highly sensitized patients across Europe.

In the U.S., our pivotal ConfIdeS trial in kidney transplantation is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney through the U.S. kidney allocation system. Enrollment is progressing according to plan, with 39 out of a target of 64 patients now enrolled across the U.S. Randomization of all patients is aimed for completion in the first half of 2023 with BLA submission under the accelerated approval pathway in 2024.

As for our AMR clinical development program, we look forward to the first data read-out from our phase 2 study later this year, following the completion of enrolment in May 2022. Acute AMR episodes post kidney transplantation occur in 5-7% of patients, with significant risk of patients losing graft function. There is currently no approved treatment for AMR.

With respect to our GBS phase 2 program, we have implemented several significant initiatives to increase the enrolment rate and are taking further measures to increase the enrolment rate as the trial has been impacted by the pandemic in various ways, including shortage of IVIg as well as reduced availability of staff across a number of trial centers. We believe we will see an acceleration in recruitment due to these initiatives as well as higher infection rates as we approach the winter season. Completion of enrollment in the GBS trial is anticipated H2 2022/H1 2023.

In anti-GBM, we plan to commence a pivotal phase 3 study of imlifidase following FDA’s acceptance of Hansa’s Investigational New Drug (IND) application earlier this year. The new study will enroll 50 patients across the EU and U.S. and will be initiated later this year, as previously guided.

Lastly, I also want to highlight that Hansa Biopharma AB was recently certified as a Great Place to Work^® for the third 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.

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

Upcoming milestones and news flow

2022                             Anti-GBM:  Initiation of phase 3 study

2022                             NiceR: Completion of GLP tox studies

H2 2022                        AMR Phase 2 study: First data read out

H2 2022                        U.S. Kidney transplantation: Complete enrollment

H2 2022/H1 2023         GBS Phase 2 study: Complete enrollment

H1 2023                       U.S. Kidney transplantation: Complete randomization

H2 2023                       GBS Phase 2 study: First data read out

2023                             Long-term follow-up data 5-years out in kidney transplantation

2024                             Kidney transplantation US: BLA submission

Updated financial calendar 2022/2023

February 2, 2023          Year-end Report for January-December 2022

March 30, 2023             2022 Annual Report

April 20, 2023                Interim Report for January-March 2023

June 14, 2023                2023 Annual General Meeting

July 20, 2023                 Half-year Report for January-June 2023

October 18, 2023           Interim Report for January-September 2023

Conference call details

Hansa Biopharma will host a telephone conference today Thursday October 20 2022, 14:00 CET / 8:00am EST.

The presentation will be held in English and be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota. Slides used in the presentation will be live on the company website during the call under ”Events & Presentation” 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 (Local): 010 884 80 16

United Kingdom (Local): 020 3936 2999

United States (Local): +1 646 664 1960

Participant Access code: 178360

The webcast will be available on https://streams.eventcdn.net/hansa/interim-report-for-january-september-2022/

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

Interim report January to September 2022 https://www.hansabiopharma.com/investors/financial-reports/

Investor road show presentation Q3, 2022 https://www.hansabiopharma.com/investors/presentations/

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