Feb 08, 2019
October – December 2018 in brief
›› To better reflect its evolution and long-term aspirations, Hansa Medical AB changed its name to Hansa Biopharma AB. The new name represents the next stage in the Company’s lifecycle and emphasizes Hansa’s focus on the development and commercialization of biopharmaceuticals. This refinement of Hansa’s profile is particularly salient as the Company continues the international expansion of its business and investor base.
›› In November, Hansa raised SEK 453 /$50 million in a directed share issue of 1.8 million ordinary shares. The share issue was significantly oversubscribed due to high demand from U.S., UK, Swiss and Swedish institutional investors including Consonance Capital, Redmile Group, Polar Capital and HBM Partners. This funding will enable the Company to accelerate commercial preparations for launch of imlifidase in kidney transplantation and to continue advancing the development of its other pipeline projects.
›› The U.S. Food and Drug Administration (FDA) granted imlifidase Fast Track Designation for the investigation of imlifidase for kidney transplantation. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs which demonstrate the potential to address an unmet medical need, in treating serious or life-threatening conditions.
›› The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) issued a positive opinion on Orphan Drug Designation for imlifidase for the treatment of anti-glomerular basement membrane (anti-GBM) antibody disease. Subsequently, the European Commission officially designated imlifidase as an orphan drug in this indication.
Significant events after the end of the reporting period
›› The Company provided an update on its interactions with regulatory agencies regarding imlifidase in kidney transplantation. Hansa expects to file a Marketing Authorisation Application with the EMA in the first quarter of 2019. The Company’s dialogue with the FDA to determine the path forward for regulatory filing and approval in the U.S. is ongoing and Hansa will provide updated guidance regarding the timeline for a potential Biologic License Application (BLA) following a subsequent meeting with the agency in the coming months.
›› Anne Säfström Lanner joined Hansa as Vice President, Global Human Resources. Mrs. Lanner has over 15 years of broad human resources experience in international growth companies, including developing and implementing strategies for talent acquisition and management, organizational culture and employer branding, compensation and benefits, and employee training and development.
›› Donato Spota appointed new Chief Financial Officer. Mr. Spota is a senior executive with more than 20 years of international pharmaceutical industry experience, including strategic finance, investor relations and international capital markets transactions. Prior to joining Hansa, Mr. Spota was with Basilea Pharmaceutica AG, a Swiss listed biopharmaceutical company, for 16 years where he served as CFO for the past five years.
January – September 2018 in brief
›› Hansa successfully completed two Phase 2 clinical studies evaluating imlifidase for kidney transplantation in highly sensitized patients. Imlifidase met all primary and secondary endpoints in each study. Treatment with imlifidase enabled transplantation in all 35 highly sensitized patients and at study completion, six months post-transplantation, graft survival was 91%.
›› Hansa initiated a long-term observational prospective follow-up study evaluating graft survival in patients who have undergone kidney transplantation after treatment with imlifidase. The objective of the study is to collect long-term outcome data to provide further support to future prescribers, payers and patients.
›› The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to imlifidase for the treatment of the rare and acute kidney disease anti-GBM antibody disease, also known as Goodpasture’s disease.
›› Vincenza Nigro was appointed as Vice President, Global Medical Affairs. Ms. Nigro has more than two decades of international life sciences industry experience in medical affairs, clinical development and commercial leadership roles, including significant expertise in transplantation and orphan diseases.
›› The board of directors strengthened its expertise in biopharma commercialization and R&D through the appointments of Anders Gersel Pedersen and Andreas Eggert.
›› Anders Gersel Pedersen, MD, Ph.D, previously served as Executive Vice President, Research & Development at H.Lundbeck A/S and is a member of the boards of Genmab A/S and Bavarian Nordic A/S.
›› Andreas Eggert, MBA has more than 20 years of cross-functional leadership experience in biopharma commercialization, including Senior Group Vice President, Global Product Strategy & Portfolio Development at H. Lundbeck A/S and Vice President & Global Business Manager at Wyeth/Pfizer in the U.S.
›› Hansa formed a U.S. subsidiary. for the continued build-up of a U.S. organization and presence.
›› Søren Tulstrup was appointed President and CEO of Hansa, effective March 20, 2018. He has over 25 years of broad senior leadership experience in the life sciences industry, including as a CEO of a high-growth, global biopharma company.
›› The FDA granted Orphan Drug Designation to imlifidase for the treatment of Guillain-Barré syndrome (GBS).
›› Clinical results from Hansa’s first Phase 2 study of imlifidase were published in the American Journal of Transplantation (AJT), the monthly peer reviewed medical journal published by the American Society of Transplant Surgeons and the American Society of Transplantation. The publication describes the results from Hansa’s initial clinical study in sensitized patients, which evaluated the first transplantation enabled by treatment with imlifidase. To date, stable kidney function has been maintained in this very first patient for more than four years.
Financial summary for the Group (KSEK)
|KSEK, unless otherwise stated||October – December||Year|
|Earnings per share before and after dilution (SEK)||-2.07||-1.35||-6.47||-4.96|
|Cash flow from operating activities||-57,466||-29,142||-204,560||-150,105|
|Cash and cash equivalents including short term investments||858,187||616,061||858,187||616,061|
When I joined Hansa in the spring of 2018, I was eager to be part of this highly regarded company pursuing the opportunity to radically improve the lives of people living with rare immuno-pathologies. With a clear focus on filling unmet medical needs, Hansa’s proprietary enzymology platform had already demonstrated early success, setting expectations high for our lead candidate imlifidase to make a difference for tens of thousands of patients. I’m extremely proud of all we accomplished this past year to prove the potential of the Company’s immunomodulatory enzyme technology and imlifidase.
Imlifidase in kidney transplantation
Imlifidase is a novel enzyme that specifically and rapidly degrades immunoglobulin G (IgG) antibodies, thereby eliminating immunological barriers and enabling treatment of immune-mediated diseases. Our lead clinical program is developing imlifidase as a treatment to enable kidney transplantation in highly sensitized patients. These patients carry high levels of anti-HLA antibodies, which can target and significantly compromise a transplanted organ. The more anti-HLA antibodies, the lower the likelihood of finding a donor organ that will be a match. The unmet medical need in sensitized patients is high with many patients indefinitely remaining in a debilitating disease state on long-term dialysis treatment, which is associated with high cost, a poor quality of life and an increased mortality rate.
We further advanced the clinical development of our lead program in 2018, most notably in the third quarter, when we announced sixmonth
follow up data from two Phase 2 clinical studies of imlifidase for kidney transplantation in highly sensitized patients. These results demonstrated that treatment with imlifidase enabled transplantation in all 35 highly sensitized patients and at study completion, six months post-transplantation, graft survival was 91%. Imlifidase has the potential to create equality on the organ donor waiting list by improving access to organs for highly sensitized patients. The outcomes of the Phase 2 studies are described in greater detail on pages 7–8 in this report.
In 2018, imlifidase also continued to receive further validation from the scientific community. In May, clinical results from our first Phase 2 study of imlifidase were published in the American Journal of Transplantation, the peer-reviewed medical journal of the American Society of Transplant Surgeons and the American Society of Transplantation. In June, at the prestigious American Transplant Congress, Stanley Jordan, M.D., Director of Kidney Transplantation and Transplant Immunology at the Kidney and Pancreas Transplant Center at Cedars-Sinai Medical Center, Los Angeles, USA, presented additional data and conclusions from his investigator-initiated Phase 2 study of imlifidase. In October at the American Society of Nephrology’s Kidney Week, Dr. Jordan highlighted graft survival and stable renal function at up to 24 months following transplantation enabled by imlifidase.
In October, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to imlifidase in kidney transplantation. Much like the European Medicines Agency’s (EMA) PRIME designation, which was granted to imlifidase for kidney transplantation in 2017, Fast Track designation is designed to facilitate the development and expedite the review of new drugs to treat serious or life-threatening conditions. This designation is further endorsement of imlifidase’s potential to address the significant unmet medical need for highly sensitized patients, for whom transplantation is extremely difficult or impossible and otherwise face high mortality rates associated with long-term dialysis. The FDA’s Fast Track program provides more frequent communication with the agency regarding drug development and eligibility for priority review.
We are actively engaged with the European and U.S. regulatory agencies regarding the path to approval for imlifidase in kidney transplantation. We expect to file a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) in the first quarter of 2019. In addition to the six-month follow-up data announced in September, the filing will include positive data collected across all four Phase 2 clinical studies demonstrating the efficacy and safety of imlifidase to enable kidney transplantations; the validation of the manufacturing process for imlifidase; and evidence of the significant medical need for these highly sensitized patients who today have very limited opportunity for transplantation.
Our dialogue with the FDA to determine the path forward for regulatory filing and approval in the U.S. is ongoing and we will provide updated guidance regarding the timeline for a potential Biologic License Application following a subsequent meeting with the agency in the coming months. We are determined to bring imlifidase to market in kidney transplantation as soon as possible.
Imlifidase in additional indications
Imlifidase also has potential applications in other solid organ transplantation and an array of acute autoimmune indications.
We are evaluating imlifidase in a Phase 2 clinical study for the treatment of anti-glomerular basement membrane (anti-GBM) antibody isease. Anti-GBM, also known as Goodpasture’s disease, is a rare autoimmune disorder where the immune system mistakenly develops IgG-antibodies, resulting in an acute immune attack on the kidneys and, in some patients, the lungs. There are no effective treatment options and severe anti-GBM disease may progress to renal failure or death, with less than one third of patients surviving with preserved kidney function after six months.
In early July, the FDA granted Orphan Drug Designation to imlifidase for the treatment of anti-GBM disease. In November, following the EMA’s Committee for Orphan Medicinal Products (COMP) positive opinion, the European Commission also officially designated imlifidase as an orphan drug for the treatment of anti-GBM. These designations both confirm the high unmet medical need of patients with this devastating disease, and recognize the potential for imlifidase to help prevent acute kidney damage and the progression to kidney failure and dialysis.
We have currently enrolled seven of the targeted 15 patients with this ultra-rare disease in the Phase 2 study, which aims to evaluate the safety and tolerability of imlifidase, and assess efficacy based on renal function at six months after treatment. Thus far, all seven patients have responded favorably and imlifidase seems to be well tolerated. We anticipate completing enrollment in this study during 2019. The next two indications in which we will evaluate imlifidase are Guillain-Barré syndrome (GBS) and Acute Kidney Antibody Mediated Rejection (AMR) post transplantation. Guillain-Barré syndrome (GBS) is a rare, acute neurological disease in which the peripheral nervous system is attacked by the immune system and IgG-antibodies.
Last year, the FDA granted Orphan Drug Designation for imlifidase for the treatment of GBS. During the first quarter of 2019, we expect to begin enrollment in a Phase 2 study in GBS and a separate Phase 2 study in AMR, each of which is designed to enroll approximately 30 patients. To support imlifidase’s clinical development across these indications, we have continued to expand Hansa’s research and development team.
Next generation of immunomodulatory enzymes
We believe that our unique and proprietary capabilities in immunomodulatory enzymes extend beyond imlifidase to other novel IgG-cleaving enzymes. In our next generation program, NiceR, we are developing candidates with lower immunogenicity that potentially will enable repeat dosing. This program has the potential to apply to a broad array of indications, including relapsing autoimmune diseases and oncology. In 2018, we made significant advancements in our research and development work and we expect to select a candidate for clinical development in 2019.
Hansa’s progress across our platform of immunomodulatory enzymes has been well received by investors. In November, we raised SEK 453 m ($50 m) in a directed share issue, which was significantly oversubscribed due to high demand from U.S., UK, Swiss and Swedish institutional investors. This funding will enable us to accelerate our commercial preparations for the potential launch of imlifidase and continue advancing the development of our other pipeline projects.
As part of the expansion of our commercial organization, in September, we were fortunate to appoint Vincenza Nigro as Vice President, Global Medical Affairs. Vincenza brings more than two decades of international life sciences industry expertise in medical affairs, clinical development and commercial leadership roles, including deep experience in transplantation and orphan diseases. With her extensive background building and leading high-performance medical affairs teams, and in lifecycle management for innovative transplant-related and immunology products, she is a valuable asset to our team as we transform Hansa into a global, commercial-stage biopharma company.
To better reflect this evolution and our long term aspirations, we decided to change the name of the company to Hansa Biopharma. The new name represents the next stage in our lifecycle and emphasizes our focus on the development and commercialization of biopharmaceuticals. This refinement of our profile is particularly salient as we continue the international expansion of our business and investor base. The new name, which will be fully implemented during 2019, was approved at an Extraordinary General Meeting held on December 4 and has since been cleared by the Swedish Companies Registration Office (“Bolagsverket”).
At Hansa, we are driven by a passion to deploy our unique enzymology platform as a means to radically improve the lives of people living with rare immuno-pathologies. We are poised for success in 2019, with a growing body of clinical evidence supporting the efficacy of imlifidase, multiple opportunities in additional indications, and a potential pipeline of next-generation candidates. I am grateful for the talented team at Hansa for their outstanding work, our distinguished partners for their collaboration, the patients in our clinical studies for their trust in us, and our shareholders for their continued support. I look forward to updating you on our continued progress.
President and CEO of Hansa Biopharma
Lund, Sweden, February 8, 2019