BioArctic AB Series B

Eisai announced that Japan has approved the subcutaneous autoinjector formulation of Leqembi, known as Leqembi Pen, as a new route of administration for the treatment of early Alzheimer's disease, making Japan the third country globally to approve the subcutaneous formulation. The Leqembi Pen allows patients or care partners to self-administer two injections totaling 500 mg once weekly, with each injection taking approximately 15 seconds, complementing the existing intravenous formulation that is given every two weeks in a hospital setting. The approval is based on integrated results and modeling from the 18-month core study of the Phase 3 Clarity AD study and multiple subcutaneous administration sub-studies in its long-term extension, which showed similar exposure to intravenous dosing given once every two weeks and supported comparable efficacy. The overall safety profile of subcutaneous administration was generally similar to intravenous administration, while systemic injection or infusion-related reactions occurred less frequently at 1.4 percent. Leqembi is approved in 53 countries and is under regulatory review in 6 countries and regions, and BioArctic, which invented the drug and partners with Eisai, is entitled to sales milestone payments and royalties on global sales.

BioArctic AB's partner Eisai announced that Canada's Drug Agency has issued a final positive recommendation supporting public reimbursement of Leqembi (lecanemab) for eligible patients in Canada with mild cognitive impairment or mild dementia due to Alzheimer's disease. The recommendation follows a reconsideration and marks a step toward broader access, with next steps including negotiations through the pan-Canadian Pharmaceutical Alliance and subsequent reimbursement decisions by provincial and territorial drug plans. More than 770,000 people in Canada were estimated to be living with dementia in 2025, a number projected to rise to 1.7 million by 2050. Leqembi is approved in 53 countries and under review in 6, with maintenance dosing approved in 8 countries including the US, Japan, China, and the UK.

BioArctic AB (publ) announced today that it issued 20,200 Class B shares during August for delivery to participants in the 2019/2028 stock option program, following the exercise of 20,200 stock options of that series. As of August 31, 2026, the total number of shares in the company amounts to 88,744,685, comprising 74,344,689 listed Class B shares and 14,399,996 unlisted Class A shares. Each Class A share carries ten votes, while each Class B share carries one vote, bringing the total number of votes to 218,344,649. The disclosure was made pursuant to the Financial Instruments Trading Act and released on August 31, 2026, at 5:30 pm CEST.

BioArctic reported its interim results for the second quarter of 2026, highlighting new approvals for Leqembi and strategic partnerships. The company entered into a research collaboration with Eli Lilly, receiving an upfront payment of USD 30 million, with the agreement worth up to USD 800 million plus royalties. Additionally, the FDA approved Leqembi Iqlik subcutaneous autoinjector for weekly initiation treatment in early Alzheimer's disease, leading to a US launch in August. BioArctic also entered into a research collaboration in oncology with the Swedish biotech company Mesenkia Therapeutics to explore a novel antibody-based treatment for glioblastoma. Net revenues for the quarter amounted to SEK 247.5 million, with royalty income from Leqembi at SEK 179.4 million, while operating profit was SEK -6.5 million and earnings per share before dilution were SEK -0.13.

Global sales of Leqembi totaled 29.3 billion yen in the second quarter of 2026, generating a royalty of 179 million Swedish kronor for BioArctic, an increase of approximately 10 percent compared to the second quarter of 2025. The prior-year quarter included a one-time stockpiling effect in the Chinese market of around 5.3 billion yen; excluding that effect, royalty revenues grew approximately 43 percent year-over-year. The figures were reported by BioArctic's partner Eisai alongside Biogen's second-quarter results.

The US Food and Drug Administration has approved a once-weekly subcutaneous injection of Leqembi Iqlik as a starting dose for early Alzheimer's disease, with a US launch planned for late August 2026. The approval, announced by BioArctic's partner Eisai, makes Leqembi Iqlik the first anti-amyloid treatment worldwide to offer at-home dosing for both initiation and maintenance via an autoinjector. The initiation regimen is 500 milligrams once weekly, delivered as two 250-milligram injections each taking about 15 seconds. Leqembi Iqlik was already approved for maintenance dosing at 360 milligrams once weekly after 18 months of intravenous or subcutaneous treatment, and patients can now receive the drug subcutaneously throughout the entire treatment course and switch between administration methods. Clinical data from the Phase 3 Clarity AD long-term extension showed that once-weekly subcutaneous administration achieved exposure equivalent to intravenous dosing, with a comparable safety profile and expected similar efficacy and amyloid removal benefits.

Leerink raised its price target on Eli Lilly and Company to $1,232 from $1,119 and maintained an Outperform rating on June 25. Separately, Eli Lilly and BioArctic AB announced a research and collaboration agreement on June 22 for a potential new treatment combining BioArctic's BrainTransporter technology with an undisclosed Lilly drug candidate in neurodegeneration. BioArctic will receive a $30 million upfront payment and is eligible for up to $770 million in additional milestone payments, plus tiered mid-single-digit royalties on future global product sales if the product reaches the market.

Eli Lilly has entered new research and license agreements with Abbisko Therapeutics and BioArctic, adding multi-target discovery work worth up to about US$1.90 billion in milestones for Abbisko and up to US$770 million for BioArctic, alongside royalties on any future product sales. These alliances are part of Lilly's strategy to broaden its pipeline beyond its flagship GLP‑1 franchise, which continues to drive growth with Q1 2026 results and a raised full-year revenue guidance of US$82 billion to US$85 billion. While the partnerships support diversification, the key short-term catalyst remains execution and access on GLP‑1s, with the biggest risk being pricing pressure and reimbursement pushback on obesity drugs. Some analysts project around US$102 billion of revenue and US$40 billion of earnings by 2029, yet they remain cautious due to potential obesity pricing reforms and tighter safety scrutiny.

BioArctic has entered into a research and collaboration agreement with Eli Lilly and Company to combine its proprietary BrainTransporter technology with an undisclosed Lilly drug candidate in neurodegeneration. BioArctic will receive an upfront payment of USD 30 million and is eligible for additional milestone payments of up to USD 770 million, plus tiered mid-single digit royalties on future global product sales. Under the deal, BioArctic will generate a new drug candidate using the BrainTransporter technology with a Lilly molecule, while Lilly assumes full responsibility for global development and commercialization. This is the fourth collaboration BioArctic has signed involving the BrainTransporter platform, following agreements with Eisai, Bristol Myers Squibb, and Novartis, and BioArctic retains all rights for uses outside these four deals.