CEO Gunilla Osswald presents BioArctic

CEO comments on November 8, 2018 (Interim Report January-September 2018):

In early July BioArctic reported positive topline 18 months results of the BAN2401 Phase 2b study in 856 early Alzheimer’s disease patients. More detailed results were presented later in July by our partner Eisai. BAN2401 demonstrated a dose-dependent effect on clinical and biomarker endpoints. The highest BAN2401 dose showed clinically meaningful effect compared to placebo. All doses of BAN2401 strongly reduced amyloid in the brain as measured by PET techniques. 81% of patients, in the highest BAN2401 dose group, converted from Alzheimer positive to Alzheimer negative status. That is, an improvement in which the former disease-related degree of amyloid has disappeared. BAN2401 was well tolerated across the
dose-range.

In October, Eisai presented additional results that further support the positive effects of BAN2401 in all sub-groups of early Alzheimer patients. A correlation was shown between the dose-dependent amyloid reduction in the brain and the clinical effects of BAN2401, and the clinical effects were shown to increase over time. The positive clinical results were further supported by consistent biomarker data indicating that BAN2401 reduces neurodegenerative processes in Alzheimer’s disease.

Eisai is currently discussing the next steps for BAN2401 with regulatory authorities and preparing for further clinical studies. The patients who participated in the Phase 2b study are offered continued treatment with BAN2401. The results mark an important advancement in the future treatment of Alzheimer’s disease and give new hope for the patients and their families.

I am also very pleased with how well BioArctic’s research collaboration with AbbVie has developed. During the period, the work

has been intense delivering the projects and preparing for an IND-application to start the first clinical study with BAN0805 in the US next year. It is; therefore, very exciting that AbbVie earlier than expected announced that they exercise their option to license our alpha-synuclein antibody portfolio, pending clearance under the U.S. antitrust legislation.

In the project for treatment of complete spinal cord injury, the inclusion of patients in the first of three panels in the company’s ongoing Phase 1/2 study has been completed. BioArctic has regulatory approvals to include patients from Sweden, Estonia, Norway and Finland. The first patients from Estonia are currently in screening phase. An interim analysis of the first panel is planned for Q4 2019/Q1 2020.

BioArctic’s ambition is to improve the quality of life for patients with disorders in the central nervous system. Our project portfolio is progressing well, and I am pleased to notice yet another period with a positive financial result. The company is well positioned to advance the projects towards our goals and new potential collaborations, in line with the company’s strategy. I am looking forward to continue to progress our innovative projects in our three disease areas each with high unmet medical need.