Hansa Biopharma Year-end report January-December 2023

• Strong revenue generation in Q4 2023 including SEK 43m in Idefirix® product sales supported by growth in new markets such as U.K., Germany, and Spain           
• Encouraging results from first-in-human trial of HNSA-5487           
• Initiation of phase 1b trial of imlifidase as pre-treatment to Sarepta's SRP-9001 in DMD

LUND, Sweden, Feb. 2, 2024 /PRNewswire/ -- 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 2023.

Highlights for the fourth quarter of 2023           

• Strong commercial performance. Total Q4 revenue of SEK 50m including SEK 43m in product sales and SEK 7m under our agreement mainly with Sarepta. Idefirix^® sales were driven by growth in new markets such as U.K., Germany, and Spain.
• Medical guidelines and recommendations including use of Idefirix^® implemented on a national level in Italy and Germany.
• NICE-01 phase 1 (HNSA-5487): Following positive results from the first-in-human trial of HNSA-5487, the lead candidate from the NiceR program for repeat dosing, an analysis of additional exploratory endpoints on IgG recovery and immunogenicity is being conducted for completion in 2024.
• AMR (antibody-mediated transplant rejection) phase 2: Full data published in December 2023. Imlifidase met the primary endpoint; explorative secondary outcome measures were not designed nor sufficiently powered to show statistical significance versus the control arm.
• GBS (Guillain-Barré Syndrome) phase 2: Positive high-level data announced in December 2023 as imlifidase demonstrated positive safety, tolerability, and early efficacy outcomes. Further analysis will contextualize the efficacy data.
• SRP-9001-104 phase 1b trial (Duchenne Muscular Dystrophy, DMD): The first clinical study with imlifidase as a pre-treatment to Sarepta's SRP-9001 gene therapy in DMD was initiated mid-December 2023. First patient is expected to be dosed in early 2024.
• On October 17, 2023, Hansa announced 5-year data from the long-term follow-up study of imlifidase, demonstrating 90% patient survival and 82% graft survival in extended pooled analysis with data from the 17-HMedIdeS-14 study.
• On December 5, 2023, Hansa announced plans to restructure the organization to better align and focus on key clinical development and commercial priorities. The planned restructuring should result in an approximately 20-25% reduction in the current workforce and will provide approximately SEK 75-85 million in annual savings, when fully implemented.

Clinical pipeline update           

• US ConfIdeS phase 3 trial (kidney transplantation): 104 patients have been enrolled with 40 of 64 targeted patients randomized in this pivotal U.S. open label, randomized, controlled trial of imlifidase in kidney transplantation.
• GOOD-IDES-02 phase 3 (anti-GBM disease): 18 of 50 targeted patients enrolled in this 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           

• On January 6, 2024, Hansa and NewBridge Pharmaceuticals announced their partnership to enable supply of Idefirix® to kidney transplant patients in the Middle East and North Africa (MENA).
• On February 1, 2024, Hansa Biopharma and Medison Pharma announced positive reimbursement decision in Slovenia for Idefirix^® in highly sensitized kidney transplant patients. With this, commercial access to Idefirix^® has now been obtained in 14 European countries.
• First patient treated in the new Eurotransplant Desensitization Program, under the Acceptable Mismatch Program, which is intended to transform desensitization across eight European member countries including Germany, the Benelux and select Eastern European countries.

Financial summary

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

"Hansa enters 2024 in a strong position to successfully execute on our key priorities. I am encouraged by the performance of Idefirix^® against key launch metrics and the continued progress we have achieved across our pipeline development activities.

I am particularly excited about the encouraging first results from the first-in-human trial of HNSA-5487, Hansa's lead candidate in the NiceR program. It is our aim with this new enzyme to enable repeated infusions and thereby target diseases and conditions where either a prolonged IgG-free window or intermittent therapy is desirable. If successful, this new approach could enable innovative treatment approaches in a broad range of indications, including chronic auto-immune diseases.

In kidney transplantation, we continue to see good commercial progress in Europe, including the implementation of treatment guidelines in both Italy and Germany and continued growth in the number of hospitals with desensitization protocols in place, while sales were supported by growth in key new markets such as U.K., Germany, and Spain.

During the fourth quarter, we also saw increased patient identification through organ allocation systems such as Eurotransplant where both a first and second wave patient assessment took place with the new Desensitization Program. This new pilot program, under the Acceptable Mismatch Program, is intended to transform desensitization across eight European member countries including Germany, the Benelux and select Eastern European countries.

In the U.S., we continue enrollment in the phase 3 ConfIdeS trial in kidney transplantation to accelerate randomization of patients. As previously guided, completion of randomization is expected by mid-2024, with a BLA submission expected in 2025 following a 12-month follow-up on kidney function, measured through the mean estimated glomerular filtration rate (eGFR).

Beyond our core markets, we continue to expand access to imlifidase for highly sensitized kidney transplant patients through a new commercial partnership with NewBridge Pharmaceuticals in the MENA region. The new collaboration is rooted in the existing European conditional marketing authorization for Idefirix® and pending applications for marketing authorization in the respective MENA markets.

Further, I am also pleased to see positive data from our long-term follow-up study further supporting the clinical benefit of imlifidase in kidney transplantation out to year five. The five-year data demonstrate graft survival in line with outcomes seen at 3-years post-transplant.

Beyond kidney transplantation, we shared data read-outs from two phase 2 programs in AMR and GBS. In the AMR phase 2 trial (16-HMedIdes-12), imlifidase met the primary endpoint demonstrating statistically significant reduction in donor-specific antibodies (DSAs) observed among imlifidase patients within five days of treatment as compared to plasma exchange which is a common part of a standard of care treatment. While we are encouraged to have met the primary endpoint, it is important to note that the secondary endpoints were not met as the trial was not designed nor sufficiently powered to show a statistically significant difference between the two arms given the heterogeneity of patients, involving many patients with an additional cellular component of the immune rejection, and the small number of patients enrolled. Patients with an acute AMR may be best placed to benefit from a rapid and significant reduction in DSA levels.

In the GBS phase 2 study (15-HMedIdeS-09), high level data was announced in December 2024 demonstrating that imlifidase was safe and well tolerated when administered prior to standard of care, including rapid improvement in disease-related efficacy measures. Further analysis of efficacy data will be conducted this year.

In our pivotal phase 3 program in anti-glomerular basement membrane (anti-GBM) disease (GOOD-IDES-02), we continue to see good progress, with 18 of 50 targeted patients enrolled as of February 2, 2024. Completion of enrollment is expected in 2025.

Further, I am happy to report that the first clinical study with imlifidase in gene therapy was recently commenced by our partners from Sarepta Therapeutics. In the phase 1b study, imlifidase is being investigated as a pre-treatment to Sarepta's FDA approved SRP-9001 (Elevidys) gene therapy in Duchenne Muscular Dystrophy (DMD). First patient is expected to be dosed in due course.

Lastly, we recently announced plans to restructure the organisation to better align and focus on key clinical development and commercial priorities. This is expected to result in an approximate 20-25% reduction in the current workforce and will yield approximately 75-85 million SEK in annual savings when fully implemented.

While we firmly believe this initiative is a necessary action to help us deliver on our important mission, it was obviously a difficult decision to take as it impacts our most valuable asset ? our people. We are grateful for the commitment and relentless efforts of our colleagues who have worked tirelessly to advance potentially lifesaving medicines for people suffering from serious immunological diseases and conditions and we remain committed to supporting those colleagues impacted by the restructure.

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 2024."

Upcoming milestones and news flow

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

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: Further analysis around endpoints in FIH trial

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

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

2025 Anti-GBM disease Phase 3: Completion of enrollment (NEW)

Updated financial calendar 2024

Mar 20, 2024  Annual Report 2023

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 Friday February 2, 2024, 14:00 CET / 8:00am EST.

The event will be hosted by Hansa Biopharma's CEO, Søren Tulstrup, CCO, U.S. President, Matthew Shaulis, CSO Hitto Kaufmann 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 8 12 41 0952
UK: +44 203 769 68 19
USA: +1 646 787 0157

Participant access code: 765135

The webcast will be available on https://hansabiopharma.eventcdn.net/events/fullyear2023 

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

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

Investor road show presentation Q4, 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.

For more information:

Klaus Sindahl, VP Head of Investor Relations
M: +46 (0) 709 298 269
E: [email protected]

Stephanie Kenney, VP Global Corporate Affairs
M: +1 (484) 319 2802
E: [email protected]

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.

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SOURCE Hansa Biopharma AB