• Lecanemab was granted Fast Track designation by the US Food and Drug Administration (FDA), which is a program that is intended to support and expedite the development of new treatments for serious illnesses with significant medical need, such as Alzheimer's disease.
• The clinical section and proposed label, the second of three parts in the rolling submission for lecanemab under the accelerated approval pathway, was submitted to the FDA.
• BioArctic announced that the company's ND3014 drug project is focused on developing antibody drugs against TDP-43, a protein that is considered to play a key role in the development of the rare neurodegenerative disease ALS.
• BioArctic and the company's partner, Eisai, gave several presentations at the CTAD congress, which provided further support for lecanemab and clarified the similarities and key differences in the binding profile of lecanemab compared with other anti-amyloid antibodies.

• Net revenues for the period amounted to MSEK 4.7 (8.4)
• Operating profit amounted to MSEK -39.4 (-30.2)
• Profit for the period amounted to MSEK -19.0 (-13.2) and earnings per share before and after dilution were SEK -0.22 (-0.15)
• Cash flow from operating activities amounted to MSEK -39.3 (-26.8)
• Cash and cash equivalents at the end of the period amounted to MSEK 848 (1,000)

• Net revenues for the period amounted to MSEK 23.1 (62.3)
• Operating profit amounted to MSEK -139.7 (-85.0)
• Profit for the period amounted to MSEK -119.8 (-68.5) and earnings per share before and after dilution were SEK -1.36 (-0.78)
• Cash flow from operating activities amounted to MSEK -140.5 (-92.3)
• Cash and cash equivalents at the end of the period amounted to MSEK 848 (1,000)

Comments from the CEO
"Lecanemab has the potential to be the first disease-modifying drug that obtains full approval in the US, and the first to reach the market in Europe. "

On Christmas Eve, the holiday mood for BioArctic got an extra boost with the announcement that the US FDA had granted Fast Track designation to lecanemab. Lecanemab had obtained Breakthrough Therapy designation earlier in the year, and the drug candidate is thus now covered by two FDA programs intended to support and expedite the development of new treatments for serious illnesses with significant medical need. Our partner Eisai has already submitted two of the three parts of the rolling submission under the accelerated approval pathway that the FDA will use in its assessment of a potential approval of lecanemab. BioArctic contributed to the first part of the application, which covers all preclinical documentation. Now only the part of the documentation that focuses on the production of the drug candidate remains to be submitted. The regulatory procedure for lecanemab thus made great strides in 2021, and we can state that lecanemab now has the potential of becoming the first disease-modifying drug for Alzheimer's disease to obtain full approval in the US, and the first to reach the market in Europe.  

At the CTAD Alzheimer's disease conference in November, Eisai and BioArctic presented new data from the open-label extension study with lecanemab that reinforces and confirms the earlier results from the Phase 2b study, which demonstrated a profound elimination of amyloid plaque in the brain, decreased cognitive impairment in persons with early Alzheimer's disease and a low frequency of the ARIA-E side effect. In a presentation held by Professor Lars Lannfelt, founder of BioArctic, the binding profiles of the antibodies lecanemab, aducanumab and gantenerumab were compared against different types of amyloid beta. Lecanemab distinguished itself through its strong binding to protofibrils and oligomers, the soluble aggregated forms of amyloid beta that research indicates leads to Alzheimer's disease. Moreover, data was presented at the conference that demonstrates the potential for using the biomarkers p-tau181 and Aβ42/40 in the blood to monitor the treatment effect of lecanemab.

We received further recognition of the unique properties of lecanemab when DIAN-TU, a US-based network for clinical studies of dominant hereditary Alzheimer's disease, chose to include lecanemab in competition with other antibodies as the backbone anti-amyloid treatment in a clinical trial in combination with potential tau treatments in patients with dominant hereditary Alzheimer's disease. The purpose of the Tau NexGen trial is to evaluate whether different treatments or combinations thereof could slow the cognitive decline and improve disease-related biomarkers in the patients. The choice of lecanemab emphasizes the value of the results from the Phase 2b study. The first patient in the study was included in January of 2022.

BioArctic is deeply involved in the development of new drugs against neurodegenerative disorders, and during the past quarter we presented our efforts at developing a drug against amyotrophic lateral sclerosis (ALS). A central protein in the development of the disease is TDP-43, which is found in nearly all patients with ALS. When this protein folds incorrectly, toxic aggregates are formed that cause a gradual breakdown of motor nerve cells in the brain, brain stem and spinal cord. As part of our ND3014 drug project, we are developing selective antibodies against TDP-43 for the purpose of extending and improving life for people suffering from ALS.

2022 will be the most exciting year in the company's history. It is the year we expect the results from the Phase 3 study of lecanemab in patients with early Alzheimer's disease, the completion of the rolling submission under the accelerated approval pathway in the US and AbbVie's commencement of the Phase 2 program with drug candidate ABBV-0805 against Parkinson's disease. At the same time, we look forward to continuing the development of our own expanded project portfolio. Our blood-brain barrier technology demonstrates a drastically increased and improved exposure of antibodies in the brain. With our world-class research, we are doing our utmost, in collaboration with our partners, to develop drugs that could give patients with neurodegenerative disorders a better life. 
Gunilla Osswald
CEO, BioArctic AB

Invitation to presentation
BioArctic invites investors, analysts and media to an audiocast with teleconference (in English) today, February 3, 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-q4-2021

To participate in the conference, please call:
Sweden: +46 8 505 583 75
Denmark: +45 823 331 94
Netherlands: +31 207 219 496 
Norway: +47 235 002 36
Switzerland: +41225675 632 
UK: +44 333 300 92 64
Germany: +49 692 222 391 66
USA: +1 646 722 4902

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

This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the Swedish Securities Market Act. The information was submitted for publication, though the agency of the named contact persons, at 08:00 a.m. CET on February 3, 2022.

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.