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Hansa Biopharma interim report Jan-Mar 2020. EMA process on track; an opinion from the CHMP is expected in the second quarter 2020.

28 Apr 2020, 08:00
Regulatory information
•    A formal adoption of outstanding questions, incl. definition of patients and design of the post approval study, expected at the CHMP April session. 
•    The study protocol for a new US trial is expected to be submitted in Q2 2020.

Lund April 28, 2020. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and interim report for the first quarter 2020.

Highlights for the first quarter 2020

  • The ongoing review of the MAA for imlifidase in Europe by EMA is on track. Responses to Day 180 questions were submitted for EMA review at the end of Q1. A formal adoption of outstanding questions, including definition of patients and design of the post approval study, is expected at CHMP April session. CHMP Opinion expected at a subsequent CHMP meeting in Q2 2020. 
  • Discussions with the FDA on the design of a randomized, controlled trial in kidney transplantation in the US is progressing according to plan. Submission of the study protocol is expected in Q2, and recruitment of the first patient is targeted for the fourth quarter of this year. 
  • Long-term follow-up data from patients in the Phase 2 trials was presented at the Cutting Edge of Transplantation Summit on March 6, 2020 demonstrating two-year graft survival of 89% after imlifidase treatment and transplantation.  
  • Enrollment in the investigator initiated Anti-GBM study was completed at the end of January 2020. The completion marks an important milestone for Hansa Biopharma’s expansion beyond transplantation. In the Phase 2 studies in Guillain Barré Syndrome (GBS) and Antibody Mediated Rejection (AMR) four patients were enrolled in each of the studies by end of March 2020.
  • The COVID-19 pandemic may impact parts of Hansa Biopharma’s business, namely: recruitment timelines of ongoing clinical studies, start of recruitment into the US trial, the potential European launch of imlifidase in kidney transplantation and the financing strategy.
  • CSO Christian Kjellman has assumed an expanded responsibility as CSO and COO effective February 2020 as the Company prepares to implement a focused launch strategy through leading transplantation clinics across Europe.
  • Consonance Capital Management LP, reported being a new major shareholder in Hansa Biopharma as per March 9, 2020 with shareholdings greater than 5% of total shares outstanding.
  • Investments in R&D and SG&A increased in the first quarter to SEK 53m (Q1’19: SEK 43m) and SEK 39m (SEK 29m), respectively. Cash position was SEK 477m at the end of March 2020. Cash flow from operating activities for the first quarter ended at SEK -121m (SEK -102m).

Søren Tulstrup, President and CEO of Hansa Biopharma, comments
“Hansa Biopharma’s strategy to transform the organization into a fully integrated, commercial stage global biopharmaceutical company continues according to plan. Our top priority is to get our lead compound, imlifidase, to market to enable lifesaving kidney transplants for highly sensitized patients, who currently cannot receive this standard of care treatment

In Europe, our MAA for imlifidase in kidney transplant is currently under review by EMA. I am pleased that the review process is progressing according to plan and that we can expect an opinion from the CHMP in the second quarter, as previously guided. 

Throughout the review process, we have had positive and constructive discussions with EMA with frequent interactions over the past year. We are now in the final process of addressing the outstanding questions, including definition of patients and design of the post approval study.

If approved, imlifidase for kidney transplantation will be the first of the drug candidates in our internal pipeline addressing conditions with high unmet medical need to receive regulatory approval, enabling the Company to transform itself into a commercial-stage biopharmaceutical company.” 

Hansa Biopharma will host a telephone conference today Tuesday April 28 at 2:00 p.m. CET. 
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 & Webcast” and will also be made available online after the call. 

To participate in the telephone conference, please use the dial-in details provided below:
SE: +46 8 50 55 83 54 
UK: +44 333 300 92 69 
US: +1 833 249 84 06

The webcast will be available on

For further information, please contact:
Klaus Sindahl, Head of Investor Relations
Hansa Biopharma
Mobile: +46 (0) 709-298 269

About Hansa Biopharma
Hansa Biopharma is leveraging its proprietary immunomodulatory enzyme technology platform to develop treatments for rare immunoglobulin G (IgG)-mediated autoimmune conditions, transplant rejection and cancer. The Company’s lead product candidate, imlifidase, is a unique antibody-cleaving enzyme that potentially may enable kidney transplantation in highly sensitized patients with potential for further development in other solid organ transplantation and acute autoimmune indications. Imlifidase is currently under review for marketing authorization by EMA. Hansa’s research and development program is advancing the next generation of the Company’s technology to develop novel IgG-cleaving enzymes with lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden and also has operations in Europe and US.