Hansa Biopharma

Lund, Sweden, April 18, 2024, 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 March 2024.

Highlights for the first quarter of 2024

• Strong commercial performance. Total Q1 revenue of SEK 56m including product sales of SEK 47m - sales growth during Q1 2024 was driven by product sales in our largest European markets including France, UK, and Germany, as well as initial sales in Belgium. Represents first time Company has delivered two consecutive quarters of strong growth.
• IDEFIRIX has achieved pricing and reimbursement in 75% of the European kidney transplant market; Ongoing HTA processes in 11 countries including, most recently, in Ireland.
• Evan Ballantyne joined Hansa Biopharma as Chief Financial Officer effective March 1, 2024. Previously served as CFO of Gain Therapeutics, Inc., a U.S. based biotech company. Evan brings to Hansa more than 30 years of international experience as a senior financial executive in both public and private life science companies.

Clinical pipeline update

• US ConfIdeS trial (kidney transplantation): 122 patients have been enrolled with 49 of 64 targeted patients randomized in this pivotal, Phase 3 U.S. open label, randomized, controlled trial of imlifidase in kidney transplantation.
• Post Approval Study (kidney transplantation): 36 patients have been treated (72% completion). The study will support full marketing authorization in Europe and is expected to be completed by 2025.
• Phase 3 (anti-GBM disease): 25 of 50 targeted patients enrolled in global pivotal Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. Completion of enrollment is expected in 2025.
• Investigator-initiated phase 2 trial (ANCA-associated vasculitis): 3 of 10 targeted patients enrolled.

Events after closing period

• Cash runway extended into 2026: Raised SEK ~372m (USD ~34.6m) in a directed share issue targeting mainly high-quality international healthcare specialist investors.

Financial summary

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

"I am very pleased with the strong commercial performance in the first quarter of 2024, the second consecutive quarter with solid product sales and a promising start to 2024. This strong sales performance is a continuation of the traction we saw at the end of last year where key large markets such as UK and Germany started to contribute.  Our performance continues to be driven by our largest markets underpinned by new and repeat use of IDEFIRIX at leading transplant centers. We have now achieved pricing and reimbursement in 75% of the European kidney transplant market and expect to see utilization in new centers resulting in additional sales growth in 2024.

Our clinical programs in kidney transplantation continue to progress at pace. Enrolment and randomization in our pivotal US Phase 3 trial (ConfIdeS) is advancing as expected. During the first quarter of 2024 four new sites have been activated and both screening and randomization of eligible patients have recently accelerated. We expect randomization to complete in mid-2024, as previously guided.

We have also made significant progress in the European post approval study - PAES - with more than a doubling of the number of patients treated in the trial in the last couple of quarters. This post approval study is an obligation under the European conditional marketing authorization and will be used to further investigate the long-term graft survival in 50 highly sensitized kidney transplant patients treated with IDEFIRIX. The study will also help generate important clinical experience in leading transplant centers in using IDEFIRIX as a new transformative desensitization therapy in highly sensitized patients.

Beyond kidney transplantation, we continue to advance our imlifidase clinical programs in autoimmunity. In the Phase 3 trial in anti-GBM disease, our lead autoimmune indication, we have reached 50% enrolment in the trial and expect completion in 2025 as previously guided.  We also expect to share contextualized efficacy data later this year in our 15-HMedIdeS-09 Phase 2 study in Guillain-Barré Syndrome (GBS). This follows promising first high-level data shared in December 2023.

On April 12, 2024, we announced that additional financing had been secured - extending our cash runway into 2026 through a SEK ~372m (USD ~34.6m) directed share issue targeting mainly U.S. and European healthcare specialist investors. I am very pleased to see the strong interest in the Hansa equity story from leading international health specialist investors. This transaction will help finance the preparation of a potential U.S. launch of imlifidase in kidney transplantation, strengthen ongoing product development in autoimmune indications and allow for the continued clinical development of HNSA-5487, the lead candidate from the NiceR program for repeat dosing.

Lastly, I am delighted to welcome Evan Ballantyne as Chief Financial Officer. With his deep international experience and successful track record as a CFO at public and private life science companies I am confident that Evan will be a strong addition to our team and will help drive our financial strategy, deliver on key strategic priorities, and build shareholder value.

We 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

2024     GBS Phase 2: Outcome of the comparative efficacy analysis

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 in FIH trial incl. lead indication

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

2024     First high level data read-out from phase 1b study in DMD with Sarepta

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

2025     Anti-GBM disease Phase 3: Completion of enrollment

Updated financial calendar 2024

Apr 18, 2024                   Interim Report for January - March 2024

June 27, 2024                 2024 Annual General Meeting in Lund, Sweden

July 18, 2024                  Half-year Report January - June 2024

Oct 24, 2024                   Interim Report for January - September 2024

Conference call details

Hansa Biopharma will host a telephone conference today Thursday, April 18, 2024, 14:00 CET / 8:00am EST.

The event will be hosted by Søren Tulstrup, President and CEO, Matthew Shaulis, CCO and US President, Evan Ballantyne, CFO, and Hitto Kaufmann, CSO. 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. Link to presentation

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

Sweden: +46 812 410 952

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/interim-report-january-march-2024

For the full financial calendar and list of events in 2024 please visit https://www.hansabiopharma.com/investors/calendar/

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

For more information:

Klaus Sindahl, VP Head of Investor Relations
M: +46 (0) 709 298 269
E: klaus.sindahl@hansabiopharma.com

Stephanie Kenney, VP Global Corporate Affairs
M: +1 (484) 319 2802
E: stephanie.kenney@hansabiopharma.com

About Hansa Biopharma

Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life altering treatments for patients with rare immunological conditions. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa has a rich and expanding research and development program, based on the Company's proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. Hansa Biopharma is based in Lund, Sweden and has operations in Europe and the U.S. The Company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at hansabiopharma.com.