Lund, Sweden, July 20, 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 June 2023.

Highlights for the second quarter of 2023

• Total Q2 revenue of SEK 36.7m consisting of SEK 29.6m in product sales and SEK 7.1m in revenue recognition mainly under the agreement with Sarepta.
• Positive reimbursement decision received in Belgium bringing access to Idefirix to a total of 13 European markets.
• Medical guidelines and recommendations including use of Idefirix^® implemented on a national level in U.K., Finland, France, Belgium and the Netherlands.
• New Eurotransplant desensitization program launched as a pilot in June 2023 initially targeting 20 imlifidase-eligible patients under the Acceptable Mismatch Program.
• Hansa and Genethon entered collaboration to develop imlifidase as pre-treatment to gene therapy in Crigler-Najjar syndrome.
• Pre-clinical data in non-human primates presented at ASGCT conference confirms ability of imlifidase to remove antibodies against AAVrh74 and supports the upcoming clinical study combining imlifidase with SRP-9001.
• First patient enrolled in an investigator-initiated phase 2 trial of 10 patients with imlifidase in ANCA-associated vasculitis at Charité - Universitätsmedizin Berlin.

Clinical pipeline update

• U.S. ConfIdeS: As of July 19, 2023, 76 patients have been enrolled at fourteen sites. Hansa will continue to enroll and add additional centers up to a total of approximately 20 in order to accelerate the randomization of 64 patients.
• Guillain-Barré Syndrome (GBS): First high-level data read-out expected H2 2023. Results of a comparative efficacy analysis matched to a cohort from the International GBS Outcome Study (IGOS) expected in 2024.
• Anti-GBM disease: As of July 19, four patients have been enrolled in a pivotal phase 3 trial. The study targets 50 patients with anti-GBM disease across 30-40 sites in the U.S., U.K., and EU.
• HNSA 5487: Enrollment in the phase 1 study in healthy volunteers is completed. Once the Phase 1 data has been analyzed, we will decide on next steps for further clinical development.

Events after reporting period

• On July 11, 2023, Idefirix received provisional approval in Australia as desensitization treatment in highly sensitized patients prior to kidney transplantation from both living and deceased donors. The provisional approval has a duration of two years and was based on data from Hansa's phase 2 studies.

Financial summary

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

“I am pleased with the solid performance in the second quarter. The launch of Idefirix^® in Europe continues to track well against the key launch metrics, and we have also seen good progress in our efforts to advance a valuable pipeline of drug candidates in all our four priority therapy areas. 

Our progress this quarter is underscored by encouraging changes in the transplantation clinical community, including implementation of national medical guidelines in key European markets and a new desensitization program by Eurotransplant targeting Idefirix^®-eligible patients.  The ongoing evolution of the transplantation ecosystem reflects the important role Idefirix^® is playing in advancing transplantation care and potentially helping even more kidney transplant patients.

During the last 15 months, we have received positive reimbursement decisions in several key markets. In June, we secured positive reimbursement in Belgium where more than 1,100 patients are waiting for a kidney transplant and approximately one in ten are classified as highly sensitized, with limited or no access to a suitable donor organ.

In April, we announced an important collaboration with Genethon to develop imlifidase as pre-treatment to gene therapy in Crigler-Najjar syndrome patients with anti-AAV antibodies. Genethon is a pioneer in research and development of gene therapies for rare diseases. This research collaboration further validates our commitment in gene therapy and advancing the science in rare disease to bring better medical care options to patients with unmet medical need.

Additionally, during this year’s American Society of Gene and Cell Therapy Conference, our partner Sarepta presented data in non-human primates confirming the ability of imlifidase to remove antibodies against AAVrh74. This supports the upcoming clinical study combining imlifidase with Sarepta’s product, Elevidys (SRP-9001), which received U.S. FDA approval in June as a one-time treatment in ambulatory paediatric patients aged 4 through 5 years suffering from Duchenne Muscular Dystrophy. In combination with imlifidase, additional treatment may potentially be enabled in up to 14% of patients, who have too high titers of neutralizing antibodies against AAVrh74.

We also continue to drive progress across the early and late-stage pipelines. In the U.S, we will continue enrolment of patients in the pivotal ConfIdeS trial in kidney transplantation. As previously guided, we expect to complete randomization in the second half of 2023. As of July 19, 2023, 76 patients were enrolled at fourteen sites, and we continue to add centers with a goal of approximately 20 in order to accelerate the randomization of 64 patients.

In anti-GBM disease, we have enrolled four patients as of July 19, 2023, in the global pivotal phase 3 study. The study will enroll 50 patients across 30-40 centers in the U.S., U.K., and EU.

We are also happy to report that we successfully completed enrollment of healthy volunteers in a phase 1 study for HNSA-5487, our lead molecule from the second-generation IgG antibody cleaving enzyme program, NiceR. HNSA-5487 may represent an opportunity to substantially expand the number of potential indications for our antibody-cleaving enzyme platform, including in areas where more than one dose of an IgG-modulating enzyme is beneficial. Data is being evaluated to determine relevant indications to pursue in clinical development.

Beyond our exciting programs we are very excited to announce the first patient treated with imlifidase in an investigator-initiated phase 2 trial in ANCA-associated vasculitis to assess efficacy and safety of imlifidase together with standard of care in the treatment of patients with pulmonary haemorrhage due to severe ANCA-associated vasculitis. The trial is a single center, single arm study in 10 patients led by Dr. Adrian Schreiber and Dr. Philipp Enghard, at Charité - Universitätsmedizin Berlin. This is an important step in advancing the science around ANCA-associated vasculitis as there are very few treatment options that can achieve rapid control of disease activity.

Lastly, we applaud the decision from the Australian Therapeutic Goods Administration (TGA) for being the first regulatory body to approve the use of Idefirix^® in transplants from both living and deceased donors, thus ensuring comprehensive access for highly sensitized patients in Australia to this important therapy.

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

H2 2023             U.S. ConfIdeS (Kidney tx) Phase 3: Complete randomization

H2 2023             GBS Phase 2: First data readout

H2 2023             AMR Phase 2: Full data readout

H2 2023             Long-term follow-up (Kidney tx): 5-year data readout

H2 2023             Sarepta DMD pre-treatment Phase 1b: Commence clinical study

H2 2023             HNSA-5487 (Lead NiceR candidate): Completion of Phase 1 study

2024                   U.S. ConfIdeS (Kidney tx): Phase 3: BLA submission

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

Updated financial calendar 2023/2024

October 18, 2023           Interim Report for January - September 2023

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

March 20, 2024              Annual Report 2023

April 17, 2024                 Interim Report January - March 2024

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

October 23, 2024           Interim Report for January - September 2024

Conference call details

Hansa Biopharma will host a telephone conference today Thursday July 20, 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 10 884 80 16
• United Kingdom: +44 20 3936 2999
• United States: +1 646 664 1960

Participant access code: 323180

The webcast will be available on https://events.q4inc.com/attendee/206699686

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

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

Investor road show presentation Q2, 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.