(AGENPARL) – gio 20 aprile 2023 8.00 AM CEST / 20-Apr-2023 / Hansa Biopharma AB (STO:HNSA)
Hansa Biopharma interim report January–March 2023
– Positive reimbursement decision in Spain expands market access to include the five largest European markets
– Enrollment in phase 2 study of imlifidase in Guillain-Barré Syndrome (GBS) completed
– HNSA-5487: Phase 1 clinical study started in healthy volunteers
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
Revenue
30.3 154.5
SG&A expenses
(103.3)
(80.4) (337.9)
R&D expenses
(92.8)
(70.9) (346.2)
Loss from operation
(182.3)
(135.0) (588.6)
Loss for the period
(205.4)
(138.4) (611.1)
Net cash used in operations
(207.0)
(130.5) (502.7)
Cash and short-term investments
1,286.8
753.7 1,496.2
Shareholders’ equity
414.7
636.0 602.9
EPS before and after dilution (SEK)
(3.92)
(3.11) (13.60)
Number of outstanding shares
52,443,962
44,473,452 52,443,962
Weighted avg. number of shares before and after dilution
52,443,962
44,473,452 44,923,998
Number of employees at the end of the period
141 150
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
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:
Participant access code: 574936
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.
For further information, please contact:
Klaus Sindahl, VP Head of Investor Relations
M: +46 (0) 709–298 269
Stephanie Kenney, VP Global Corporate Affairs
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](https://publish.ne.cision.com/l/aneyrjuje/hansabiopharma.com).
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