First BrainTransporter technology agreement signed
 

• Leqembi® was approved for the treatment of Alzheimer's disease in China - launch planned for July 2024
• The European Medicines Agency (EMA) announced that its deliberations on lecanemab regarding the Marketing Authorisation Application has been rescheduled due to procedural reasons

• BioArctic's partner Eisai submitted a supplemental Biologics License Application (sBLA) for less frequent intravenous (IV) maintenance dosing with lecanemab to the U.S. Food and Drug Administration (FDA)
• BioArctic was included in Nasdaq Stockholm's new ESG Responsibility Index
• BioArctic and Eisai entered into a research evaluation agreement regarding BAN2802, a potential new treatment combining BioArctic's proprietary BrainTransporter™ technology with an Alzheimer drug candidate

• Eisai initiated a rolling Biologics License Application (BLA) to the FDA for subcutaneous maintenance dosing of Leqembi

• Eisai published sales projection for Leqembi for fiscal year 2024 (April 2024 - March 2025) of JPY 56.5 billion

• Net revenues for the period amounted to SEK 29.6 M (393.4), of which SEK 21.3 M (-) in royalties for Leqembi
• Operating profit amounted to SEK -73.1 M (300.6)
• Profit for the period amounted to SEK -57.6 M (293.9)
• Earnings per share before dilution was SEK -0.65 (3.33) and after dilution -0.65 (3.31)
• Cash flow from operating activities amounted to a negative SEK 114.4 M (299.0)
• Cash and cash equivalents and short term investments at the end of the period amounted to SEK 991 M (1,106)

Comments from the CEO
"It's an important milestone that we have now signed our first research evaluation agreement, where our BrainTransporter technology will be used with a drug candidate against Alzheimer's disease."

Step by step, Leqembi (lecanemab) for early Alzheimer's disease is being rolled out in the US and Japan. It is encouraging to see the continuous increase in sales and that the drug is helping more and more patients. Total sales of Leqembi in the first quarter amounted to JPY 2.83 billion (approx. SEK 200 M), which means that BioArctic received royalty of SEK 19 M net, less royalties granted. For the coming 12 months, Eisai is projecting sales of JPY 56.5 billion (approx. SEK 4 billion), which corresponds to around SEK 360 M in net royalty to BioArctic.

In January, lecanemab was approved in China and Eisai estimates that there are 17 million patients with early Alzheimer's disease in China, and it is preparing the market launch in July 2024.

Unfortunately, patients in the EU will have to wait for the treatment as the European Medicines Agency postponed the approval process based on potential conflicts of interest among the members of its Scientific Advisory Group. Delays of this type are very trying, but it is important to emphasize that this is a delay that has nothing to do with the lecanemab application.

In the US, Eisai's systematic launch is starting to pay off and they have declared that the patient pathway has been established and that they are now transitioning into a prescription expansion phase. Eisai is also working hard to simplify the treatment. They recently submitted a supplementary Biologics License Application for maintenance treatment with lecanemab in the form of monthly intravenous dosing. Currently, both the initiation phase and maintenance treatment involve treatment every other week. If the application is granted, patients will be able to switch to monthly intravenous treatment after an initiation phase with treatment every other week. The next major improvement opportunity is the subcutaneous formulation with an autoinjector where Eisai have now received Fast Track designation and started a rolling submission for maintenance dosing. If approved, the treatment can be administered weekly in the patient's home environment instead of in healthcare facilities.

It's an important milestone that we have now signed our first agreement, where our BrainTransporter technology will be used with a drug candidate against Alzheimer's disease. The research evaluation agreement with Eisai regarding BAN2802 is a potential new treatment combining our technology with an undisclosed Alzheimer drug candidate. In parallel, we are increasing the investments in our other Alzheimer's project with BrainTransporter, BAN2803. The BrainTransporter platform has tremendous potential for improving many different drug projects, which will give BioArctic opportunities to form strategic partnerships with external partners. 

In March, this year's international AD/PD™ congress was held in Lisbon. The atmosphere was very positive with a strong forward-looking spirit. The lecanemab presentations at the meeting highlighted the long-term treatment benefit and the extra time that patients can gain by extending the earlier stages of the disease and postponing the more severe stages when they become more dependent on others. Additional data was presented that indicate even better efficacy if the treatment is initiated early on in the disease. The development of blood-based biomarkers, which are important for identifying the patients that can benefit from the treatment, continues progress well. These biomarkers will over time permit more patients to gain access to treatment at earlier stages. Moreover, I was able to draw two further distinct conclusions from the congress. Firstly, the field of antibodies against synucleopathies such as Parkinson's disease, Lewy body dementia and multiple system atrophy (MSA) is evolving rapidly, both as regards treatment and biomarkers. Secondly, we are hearing more and more that the next major advance in the CNS field will be based on developments in active transport of drugs across the blood-brain barrier. With BioArctic's significant initiatives in both fields, we are well positioned in the field.

As far as we are aware, BioArctic has the world's most selective antibodies against the pathological forms of the protein alpha-synuclein, which is a driver in several synucleopathies. We are now preparing for a Phase 2a trial with Exidavnemab in Parkinson's disease, which we plan to initiate in the autumn. The study is designed to create opportunities in several diseases such as Parkinson's disease, Parkinson's disease dementia, Lewy body dementia and multiple system atrophy. Once the trial has concluded, we will be able to make a well-founded decision based on the findings and careful analyses to develop Exidavnemab within the indication or indications where the treatment can be of the greatest benefit.

We are also happy to see that BioArctic's sustainability focus is receiving attention. Recently, we were included in the new Nasdaq OMX Sweden Small Cap 30 ESG Responsibility Index, based on our sustainable innovation strategy, which combines scientific advances with responsible business practices. Our most important contribution to a sustainable future is innovation and development of safe and efficacious drugs against neurodegenerative diseases, an effort that we remain deeply engaged in every day.

Gunilla Osswald
CEO, BioArctic AB

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Invitation to presentation
BioArctic invites investors, analysts and media to an audiocast with teleconference (in English) today, May 17, at 9:30-10:30 a.m. CET. CEO Gunilla Osswald and CFO Anders Martin-Löf will present BioArctic, comment on the first quarter report and answer questions.

If you wish to participate via webcast, please use the link below. Via the webcast you are able to ask written questions.

Webcast: https://ir.financialhearings.com/bioarctic-q1-report-2024/register

If you wish to participate via teleconference, please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference.

https://conference.financialhearings.com/teleconference/?id=50047206

The webcast will afterwards also be available on demand at BioArctic's corporate website

https://www.bioarctic.se/sv/investerare/finansiella-rapporter-och-presentationer/

For more information, please contact
Anders Martin-Löf, CFO, anders.martin.lof@bioarctic.se,phone + 46 70-683 79 77
Oskar Bosson, VP Communications & Investor Relations, oskar.bosson@bioarctic.se,phone +46 70 410 71 80

The interim report is such information as BioArctic AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, though the agency of the named contact persons, at 8:00 a.m. CET on May 17, 2024.

About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) - the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.