Lund, Sweden February 2, 2023, Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and Year-end report for January to December 2022.

Highlights for the fourth quarter 2022

• Total Q4 revenue of SEK 31m including SEK 20m in product sales and SEK 11m, mainly under the agreements with Sarepta and AskBio.
• Positive reimbursement decisions received in Italy and Czech Republic for Idefirix^® in highly sensitized kidney transplant patients. Market access now secured in 11 European countries including four of the five largest European markets.
• Hansa and partner Sarepta Therapeutics announced plans to initiate a clinical study with imlifidase as a pre-treatment to Sarepta’s SRP-9001 gene therapy in DMD during 2023.
• Positive topline data from the imlifidase phase 2 study in antibody mediated rejection (AMR) post kidney transplantation announced, showing statistical superiority over plasma exchange.
• Raised SEK 416m (USD ~40m) in a directed share issue expanding cash runway into 2025.

Clinical pipeline update

• U.S. ConfIdeS: As of February 1, 2023, 51 patients, out of a target of 64 patients, have been enrolled in our pivotal U.S. open label, randomized, controlled trial of imlifidase in kidney transplantation. Hansa aims to complete enrollment in the first half 2023, while completion of randomization is expected in the second half 2023 targeting a Biologics License Application (BLA) submission under the accelerated approval pathway in 2024, as previously guided.
• AMR: Topline data from the imlifidase phase 2 study in antibody mediated rejection (AMR) post kidney transplantation demonstrates a statistically significantly superior capacity of imlifidase to rapidly reduce levels of donor-specific antibodies (DSAs) compared to plasma exchange (standard of care) in the five days following the start of treatment. Hansa plans to publish the full dataset in the second half of 2023.
• Anti-GBM: Hansa’s pivotal phase 3 study in anti-Glomerular Basement Membrane (anti-GBM) disease commenced mid-December 2022 with the first sites activated.
• GBS: As of February 1, 2023, 25 patients, out of a target of 30 patients in the Guillain Barré Syndrome (GBS) Phase 2 trial, have been enrolled and Hansa expects to complete enrollment in the first half of 2023, as previously guided, with the first high level data read-out expected H2 2023.
• NiceR program (lead candidate HNSA-5487) progressing, with Investigational New Drug (IND) enabling toxicology studies completed and Clinical Trial Application (CTA) approved to initiate clinical study in the first half of 2023.
• Gene Therapy: Following successful pre-clinical work completed by Hansa and Sarepta, plans were announced to initiate a clinical study with imlifidase as a pre-treatment to Sarepta’s SRP-9001 gene therapy in Duchenne Muscular Dystrophy (DMD) during 2023.

Events after the closing period

• On January 30, 2023, it was announced that Christian Kjellman, Chief Scientific Officer (CSO) and Chief Operating Officer (COO), has decided to leave the company in 2024. Effective immediately, Commercial Operations will report directly to President and CEO Søren Tulstrup and a search is underway for a new CSO.

Financial summary

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

2022 was a successful year at Hansa with solid performance and strong progress across the organization. I’m pleased with the forward momentum we continue to make across R&D, Commercial and Operations. In Europe, we are very pleased to have secured Market Access in 11 countries including four of the five largest markets.

In August, the first medical guidelines for desensitization treatment of highly sensitized kidney transplant patients were published. These guidelines are the first to include Idefirix^® and represent the first international consensus on a management pathway for kidney transplant patients with high unmet need. This underscores the important role that Idefirix^® can play as a new, transformative therapy to enable kidney transplantation and is an important step in ensuring its use as a potential new Gold Standard in desensitization protocols.

On the development side, we continued to drive progress across our pipeline. In November, we presented topline data from our Phase 2 program in AMR, post transplantation, demonstrating significantly superior capacity of imlifidase to rapidly reduce DSA levels in comparison to plasma exchange in the five days following the start of the treatment.

In 2022 we initiated two new Phase 3 studies, namely the European Post Approval Efficacy Study in kidney transplantation and the pivotal, global Phase 3 study in anti-GBM disease. Both studies will target 50 patients and involve a significant number of clinics as we broaden our experience with imlifidase to become a potential new standard of care in both transplantation and acute autoimmune diseases.

Patient enrolment continues to progress in the ConfIdeS trial - our pivotal, phase 3 trial in kidney transplantation in the US - with 51 out of a target of 64 patients enrolled. In the GBS Phase 2 program, 25 out of a target of 30 patients have been enrolled. We aim to add more clinics to increase capacity and accelerate enrollment in both trials. Enrollment completion for both trials is expected in the first half 2023, while completion of randomization in the US ConfIdeS trial is expected in the second half 2023. We are targeting submission of a Biologics License Application (BLA), under the accelerated approval pathway, in 2024, as previously guided.

I am also very pleased with the achievements made in the preclinical development programs, specifically, in the DMD program with Sarepta in gene therapy and in the NiceR program, which is exploring utilization of second-generation enzymes for repeat dosing. In DMD, imlifidase is being investigated as a potential pre-treatment in patients with pre-existing IgG antibodies to Sarepta’s SRP-9001. To date, the data looks promising, and plans have been announced to initiate a clinical study in 2023. We completed IND enabling toxicology studies at the end of last year in the NiceR program for the lead candidate HNSA 5487. A CTA approval has since been obtained and we expect to start a clinical trial in the first half 2023.

An important pillar in our overall strategy is to progress select collaborations. I’m pleased to share that we announced our second collaboration in gene therapy with AskBio, in Pompe disease. Meanwhile, we continue to receive a steady flow of interest from other gene therapy companies, looking to collaborate with us, using our antibody cleaving enzyme technology platform. 

We are pleased to have secured financing – giving us runway into 2025 -- through two financing events in 2022. In July, we raised USD 70m through a non-dilutive financing transaction with NovaQuest and in December, raised USD 40m in a directed share issue targeting U.S. and other international healthcare specialist investors. Together these transactions will help finance preparations for a potential U.S. launch of imlifidase in kidney transplantation, strengthen ongoing product development activities and expand the Company’s R&D pipeline.

We anticipate an exciting year ahead, with several key milestones across our platform and therapy areas, as we continue the development of new, transformative medicines for patients suffering from serious, rare immunologic diseases.”

Upcoming milestones and news flow

H1 2023             GBS Phase 2: Complete enrollment

H1 2023             Anti-GBM Phase 3: First patient enrolled

H1 2023             U.S. Kidney transplantation (ConfIdeS): Complete enrollment

H1 2023             HNSA 5487 (Lead NiceR candidate): Initiate Phase 1 study

2023                 Sarepta DMD pre-treatment: Commence clinical study

H2 2023             Long-term follow-up study in kidney transplantation: 5-year data readout

H2 2023             AMR Phase 2: Full data readout

H2 2023             GBS Phase 2: First data readout

H2 2023             U.S. Kidney transplantation (ConfIdeS): Complete randomization

2024                 U.S. Kidney transplantation (ConfIdeS): BLA submission

Updated financial calendar 2023

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 February 2 2023, 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: +46 10 884 80 16

United Kingdom: +44 020 3936 2999

United States: +1 646 664 1960

Participant access code: 031372

The webcast will be available on https://events.q4inc.com/attendee/195504216

The Year-end report and latest investor presentation can be downloaded from our web

Year-end report January to December 2022 https://www.hansabiopharma.com/investors/financial-reports/

Investor road show presentation Q4, 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.