Interim Report for the period January – March 2021

New data continues to strengthen lecanemab

Events during the first quarter 2021

• BioArctic presented findings at the AD/PD conference suggesting that lecanemab could be developed into a disease modifying treatment for individuals with Down’s syndrome with dementia.
• New preliminary results presented from the ongoing open-label extension of the Phase 2b study in early Alzheimer’s disease continued to support the effect of the drug candidate lecanemab on brain amyloid levels.

Events after the period

• Lecanemab Phase 2b study results in early Alzheimer’s disease published in peer-reviewed journal, Alzheimer’s Research and Therapy, and lecanemab confirmatory Phase 3 Clarity AD clinical trial completed enrollment with 1,795 patients.

Financial summary January – March 2021

• Net revenues for the period amounted to MSEK 7.2 (36.4)
• Operating profit amounted to MSEK -29.1 (3.8)
• Profit for the period amounted to MSEK -29.1 (3.6) and earnings per share were SEK -0.33 (0.04)
• Cash flow from operating activities amounted to MSEK -37.5 (-36.3)
• Cash and cash equivalents at the end of the period amounted to MSEK 960.5 (1,077.3)

Comments from the CEO
“Lecanemab continues to prove effective in reducing amyloid-beta in the brain.”

The 15th International Conference on Alzheimer’s and Parkinson’s diseases and related neurological disorders was held in March. The conference is one of the year’s most important scientific forums in neurological diseases, gathering researchers and companies from around the globe. The new developments and analyses that were presented provided important information about developments in the field. In summarizing our impressions from this year’s conference, we can confirm that scientific support has further increased for anti-amyloid beta antibodies that reduce harmful forms of amyloid in the brain, alleviate the symptoms, and slow the progress of the disease in patients with Alzheimer’s disease. Today, there are four antibodies against amyloid-beta that are in the late clinical development phase. Of these, lecanemab and two others have already demonstrated clinical effect.

At the same time, understanding of how crucial the binding profiles of individual antibodies are for achieving a positive clinical effect and reducing the risk of side effects is increasing. Lecanemab, the drug candidate generated by BioArctic and developed by Eisai, stands out with its unique and highly specific binding profile. By binding selectively to the soluble aggregated forms of amyloid-beta — oligomers and protofibrils, the forms most toxic to nerve cells — lecanemab has been shown to remove amyloid-beta quickly and effectively from the brain.

During the conference, Eisai presented new data from the open-label extension study of the Phase 2b study in early Alzheimer’s disease that further strengthens lecanemab. We can now state that more than 80 percent of the patients who received the highest dosage of lecanemab, both in the core study and in the open-label extension study, showed reduction of amyloid-beta to non-pathological levels when their brains were studied using diagnostic imaging. This effect can be seen after only 12 months of treatment. Lecanemab also has a continued low occurrence of ARIA-E compared to such side effects reported by competitors’ antibody therapy under development. At the same time as the promising results from the open-label extension study are being presented, the large global Phase 3 study of lecanemab in 1,795 patients with early Alzheimer’s disease is under way, and according to Eisai the results of the study are expected in September 2022.

During the AD/PD Conference, we were able to present results for the first time from our own research concerning Down’s syndrome with dementia. Persons with Down’s syndrome suffer from dementia to a much greater extent than others, and our research has now confirmed that these individuals have significantly elevated levels of the soluble aggregated forms of amyloid-beta (oligomers and protofibrils) compared with the control group. In other words, the pathology is similar to that seen in Alzheimer’s disease. Treatment with lecanemab therefore has the potential to slow the development of dementia in these individuals.

The latest developments in Parkinson’s disease were also in focus during the AD/PD Conference. New clinical data from the Parkinson’s projects of other pharma companies provided important learnings concerning the design of the Phase 2 study that our partner, AbbVie, is now preparing for ABBV-0805, the drug candidate outlicensed by BioArctic. In Parkinson’s disease as well, it is clear that the binding profile is crucial to how well an antibody will function.

Our research into the blood-brain barrier and the technology which we call Brain Transporter and is intended to facilitate the transport of antibodies into the brain, continues to perform well and we now have two Alzheimer’s projects in progress linked to our technology.

When I hear about all the research being conducted into the central nervous system, it strengthens my conviction that BioArctic’s research is on the global leading edge. It was therefore particularly gratifying recently to have the honor of presenting BioArctic and our vital research at a digital meeting, arranged by the Confederation of Swedish Enterprise, with the Swedish Royal Family. The royal family showed an impressive level of engagement in these crucial questions.

In summary, the research being conducted by our fantastic employees holds great promise and has the potential to make a big difference for patients around the world.

Gunilla Osswald
CEO, BioArctic AB

Invitation to presentation
BioArctic invites investors, analysts and media to an audiocast with teleconference (in English) today, April 21, at 9:30–10:30 a.m. CET. CEO Gunilla Osswald and CFO Jan Mattsson will present BioArctic, comment on the interim report and answer questions.

Webcast: https://tv.streamfabriken.com/bioarctic-q1-2021

To participate in the conference, please call:
Sweden: +46 8 505 583 51
Denmark: +45 781 501 08
Netherlands: +31 107 129 162 
Norway: +47 239 639 38
Switzerland: +41 225 675 632
UK: +44 333 300 90 32
Germany: +49 692 222 203 77
USA: +1 833 249 8405

The webcast will afterwards also be available on demand at BioArctic’s corporate website https://www.bioarctic.se/en/section/investors/presentations/

For more information, please contact
Gunilla Osswald, CEO, gunilla.osswald@bioarctic.se, phone +46 8 695 69 30
Jan Mattsson, CFO, jan.mattsson@bioarctic.se, phone + 46 70 352 27 72
Oskar Bosson, VP Communications & Investor Relations, oskar.bosson@bioarctic.se, phone +46 70 410 71 80

The information was submitted for publication, though the agency of the named contact persons, at 08:00 a.m. CET on April 21, 2021.

About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on disease-modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease. BioArctic focuses on innovative treatments in areas with high unmet medical needs. The company was founded in 2003 based on innovative research from Uppsala University, Sweden. Collaborations with universities are of great importance to the company together with its strategically important global partners in the Alzheimer (Eisai) and Parkinson (AbbVie) projects. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market and out-licensing potential. BioArctic’s Class B share is listed on Nasdaq Stockholm Mid Cap (ticker: BIOA B). For more information about BioArctic, please visit www.bioarctic.com.

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