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Hansa Biopharma Interim Report January–September 2019

Regulatory information
Positive results from a pooled analysis in highly sensitized patients

Highlights for the third quarter 2019

- Positive results from a pooled analysis of Phase 2 trials with imlifidase for desensitization in highly sensitized kidney transplant patients were presented for the first time at the European Society of Organ Transplantation’s (ESOT) Congress on September 17. Imlifidase enabled kidney transplantation in 46 sensitized patients. The data presented was fully in line with previously reported data on transplantation of highly sensitized patients with imlifidase.

- Hansa Biopharma continued to advance imlifidase towards a potential marketing approval in the EU. A Marketing Authorization Application (MAA) for imlifidase for enabling kidney transplantation in highly sensitized patients is currently under review by the European Medicines Agency, EMA. An opinion from the Committee for Medicinal Products for Human Use is expected during the first half of 2020.

- In the United States, a follow-up meeting with the U.S. Food and Drug Administration (FDA) has been scheduled. At the meeting, the Company intends to continue the discussion from the December 2018 meeting regarding the path forward for a regulatory filing for imlifidase in kidney transplantation of highly sensitized patients in the U.S. The meeting will take place on November 20th, 2019. Minutes from the FDA meeting expected by end-of-December 2019.

- Our pipeline has advanced with the first patient treated within our Phase 2 study in acute Antibody Mediated Rejection (AMR). In the Anti-GBM study we enrolled 11 patients at the end of the third quarter.

- Hansa Biopharma continued building its’ medical and commercial organization to support a potential commercial launch of imlifidase in 2020: Investments in R&D and SG&A increased in the third quarter to SEK 47m (Q3’18: SEK 36m) and SEK 46m (SEK 24m) respectively.

- Cash flow from operating activities for the third quarter ended at SEK -80m (SEK -54m); the Company’s cash position was SEK 680m at the end of September 2019. 

Financial Summary

SEKm, unless otherwise statedQ3 2019Q3 20189M 20199M 2018
Net Revenue0.70.52.22.0
SG&A expenses-45.9-23.8-113.9-54.1
R&D expenses-47.2-36.4-135.3-111.9
Other operating income/expenses-0.5-0.7-1.8-1.7
Operating profit/loss-93.2-60.5-249.6-165.9
Net profit/loss-94.3-61.5-249.2-166.7
Cash flow from operating activities-80.2-54.0-259.8-147.1
Cash and short-term investments Sep 30, 2019680.2483.4680.2483.4
Shareholders’ equity, Sep 30, 2019668.1506.3668.1506.3
EPS before and after dilution Sep 30, 2019 (SEK)-2.36-1.61-6.23-4.38
Number of outstanding shares, Sep 30, 201940,026,10738,133,12540,026,10738,133,125
Weighted average number of shares before and after dilution, Sep 30, 201940,026,10738,214,48040,018,51538,047,377
Number of employees, Sep 30, 201964496449


Søren Tulstrup, President and CEO, comments
“Hansa Biopharma’s evolution into a fully integrated, commercial biopharmaceutical company continues according to plan. During the first nine months of 2019 we made solid progress across the organization with the expansion of our global footprint, advancements in our pipeline and continued engagements with the healthcare community in transplantation, autoimmune diseases and beyond.

Our top priority is advancing our lead candidate, imlifidase, through market authorization to enable kidney transplants for highly sensitized patients. At the same time, we continue to develop our proprietary enzyme technology platform in rare autoimmune diseases, where there is a significant unmet medical need.

In September, Hansa Biopharma presented positive imlifidase data at the ESOT Congress in Copenhagen, Denmark. The data was based on a pooled analysis of highly sensitized kidney transplant patients from four single arm, 6-month, open label, Phase 2 trials of imlifidase treatment prior to deceased and living donor transplantation in sensitized patients. The analysis included 46 patients, of which 50% had a cPRA of 100%, 85% were crossmatch positive and 70% were re-transplanted. Following the treatment of imlifidase, the donor specific antibodies (DSA) levels rapidly decreased and all positive crossmatches were converted to negative, thus enabling transplantation of all patients. The data was fully in line with previously reported data on transplantation of highly sensitized patients with imlifidase.

In Europe, the regulatory review process for imlifidase is progressing as planned, following the acceptance of our Marketing Authorization Application end of February. We expect to receive an opinion from the committee for medical products of European Medicines Agency in the first half of 2020.

In the U.S., we recently confirmed a follow-up meeting with the FDA. The purpose of the meeting will be to continue the discussion from our December 2018 meeting regarding the path forward for a regulatory filing of imlifidase in kidney transplantation of highly sensitized patients in the U.S.

Talking about the U.S., we welcome the initiative by the current administration in the United States, who recently issued an executive order to improve the care of people with end stage renal disease (ESRD). Following the executive order, the U.S. Department of Health and Human Services (HHS) set out three specific goals for ESRD:

1) Reducing the number of Americans developing ESRD by 25 percent by 2030
2) Having 80 percent of new ESRD patients in 2025 either receiving a transplant or homecare dialysis
3) Doubling the number of kidneys available for transplant by 2030

In the U.S., approximately 37 million people have chronic kidney disease and more than 700,000 have ESRD. There are nearly 100,000 Americans waiting to receive a kidney transplant, and approximately 20% of the money spent on traditional Medicare in the U.S. are related to kidney disease. If approved, imlifidase may have the potential to help highly sensitized patients getting off dialysis by enabling transplantation.

We have also continued advancing our pipeline during the first 9 months of 2019, with the initiation of two Phase 2 studies in Guillain-Barré Syndrome (GBS) and acute Antibody Mediated Rejection (AMR) in kidney transplantation. In AMR, the first patient has now been treated with imlifidase. Our Anti-Glomerular Basement Membrane (Anti-GBM) program is also progressing as expected, with 11 patients enrolled so far and it’s our aim to complete enrollment in this study by year-end.

With the continued progress across the organization and significant progress for our lead candidate and pipeline activities, we are well-positioned to become a global biopharmaceutical company that brings lifesaving and life altering therapies to patients with rare diseases who need them and generate value to society at large. I look forward to updating you on our continued progress.”

Søren Tulstrup
President and CEO of Hansa Biopharma

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00am CET on October 31, 2019.