Hansa Biopharma

Lund, Sweden, April 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 March 2023.

Highlights for the first quarter of 2023

• Total Q1 revenue of SEK 24.2m including SEK 14.3m in product sales and SEK 9.9m in revenue recognition mainly under the agreement with Sarepta.
• Received positive reimbursement decision in Spain, completing market access in the five largest European markets. Market access has now been secured in 12 European countries. Market Access procedures are ongoing in additional eight countries including Portugal, Belgium, and Switzerland.
• Expanded commercialization partnership with Medison Pharma for Idefirix^® for kidney transplantation to cover the Baltics.
• Announced completion of enrollment in phase 2 study of imlifidase in Guillain-Barré Syndrome (GBS).
• Initiated clinical trial of HNSA-5487 with dosing in the first healthy volunteers.
• Appointed Matthew Shaulis as Chief Commercial Officer and U.S. President of Hansa Biopharma.

Clinical pipeline update

• U.S. ConfIdeS: As of April 20, 2023, 62, 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 continues to see strong interest among clinics and will continue enrollment to accelerate randomization. We expect to add further centers up to a total of 20.
• On March 31, 2023, Hansa announced completion of enrollment in the phase 2 study of imlifidase in GBS. The first high level data read-out is expected in the second half of 2023.
• Anti-GBM: Hansa's pivotal phase 3 study in anti-GBM disease has been initiated with the first sites being activated at end of 2022 and several more sites to be activated before summer 2023. The study will target 50 patients with anti-GBM disease across the U.S., U.K. and EU, as previously communicated.
• HNSA-5487, the second-generation lead molecule, is progressing. A new clinical phase 1 trial has started with dosing of the first healthy volunteers.

Financial summary

Søren Tulstrup, President and CEO of Hansa Biopharma, comments

"Hansa's commercial efforts for Idefirix^® in Europe continue to progress as planned. During the first quarter of 2023, we were pleased to announce a positive reimbursement decision in Spain, where more than 3,000 kidney transplantations are performed annually with approximately 90 percent of transplanted organs coming from deceased donors and where one in five on the kidney waitlist are classified as highly sensitized.

With Spain secured, Idefirix^® now has market access in the five largest markets in Europe, representing approximately 15,000 kidney transplants per year. This is great news for the thousands of people who are in urgent need of more personalized and innovative desensitization options like Idefirix^® which can enable incompatible kidney transplantation.

Our goal in kidney transplantation is to change the approach to desensitization and organ allocation by integrating Idefirix^® into clinical practice as a new standard-of-care (SOC) for highly sensitized patients. With this novel therapy, we are changing the transplantation ecosystem and advancing a treatment regime from one that has been solely focused on compatibility, to one that is more patient-centric - accommodating transplants for incompatible patients, who previously had no other choice than to wait and hope.

On the development side, we continue to drive progress across our pipeline. At the end of March, we announced the completion of enrollment in our phase 2 study of imlifidase in Guillain-Barré Syndrome (GBS). GBS is an acute autoimmune attack on the peripheral nervous system, which affects approximately one to two patients per 100,000 people, annually. The first high-level data read-out is expected in the second half of 2023, while the outcome of the comparative efficacy analysis to an externally matched cohort from the International GBS Outcome Study (IGOS) database is expected to be shared in 2024.

Patient enrollment in the U.S. continues to progress in our pivotal ConfIdeS trial in kidney transplantation. As of April 20, 2023, a total of 62 out of a targeted 64 patients were enrolled. Hansa continues to see strong interest among clinics and will continue enrollment to accelerate randomization and add additional centers up to a total of 20. This will help build valuable, real-world clinical experience in desensitization of highly sensitized patients among key transplantation centers and specialists in preparation for a planned launch in the market. 

Lastly, I am pleased to announce we have dosed the first healthy volunteers with HNSA-5487, our lead molecule from our second-generation IgG antibody cleaving enzyme program. Moving HNSA-5487 into the clinic is a major accomplishment of our R&D team and an important milestone for the Company. HNSA-5487 represents an opportunity to substantially expand the potential indications in rare immunologic diseases that can be targeted, including indications where patients may benefit from more than one dose of an IgG-modulating enzyme.

On the organizational side, we are very excited to welcome Matthew Shaulis as the new Chief Commercial Officer and U.S. President.  Matthew joins Hansa from Pfizer, where he held several senior executive roles including President, Inflammation and Immunology for the International Developed Markets; President, North America Oncology; and, most recently, Senior Vice President responsible for the company's global commercial and medical go-to-market model transformation. With over 20 years of international experience in the pharmaceutical industry, Matthew will further strengthen our commercial and in-market leadership team and create a U.S.-focused organization that will help deliver our goal of bringing imlifidase to patients and clinicians in the U.S.

We continue to make solid strides in delivering on our mission of developing innovative, life-saving and life-altering immunomodulating therapies by leveraging our unique IgG-cleaving enzyme technology platform for people with rare diseases who have limited to no treatment options available."

Upcoming milestones and news flow

H1 2023            Anti-GBM Phase 3: First patient enrolled

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

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                  GBS Phase 2: Outcome of the comparative efficacy analysis to IGOS data

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

Updated financial calendar 2023

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 April 20, 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 20 3936 2999

United States: +1 646 664 1960

Participant access code: 574936

The webcast will be available on  https://events.q4inc.com/attendee/178799671

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

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

Investor road show presentation Q1, 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.