The last quarter of 2022 was extremely intensive with a focus on business development and negotiations. We are therefore thrilled to report that we have reached the goal of a license agreement and an exciting collaboration with Merck.

In early 2022 we had two prioritized objectives: we would try to reach an early deal in the Alnitak program and we would initiate the Phase 1 clinical trial in the Regulus program. As I look back at an exciting year of intensive work, I am pleased and proud of what the Aqilion team has achieved.

Alnitak program delivers

The license and collaboration agreement with Merck is extremely important for Aqilion. It acknowledges that our business model and research focus on chronic inflammation and autoimmune diseases delivers the quality and news value that our potential customers, the pharmaceutical companies, demand.

The deal covers know-how and all intellectual property rights within both Alnitak and Alnitak CNS. The joint development work will begin immediately, and we have high expectations for both the exchange of knowledge and the results of the collaborative effort.

The total value of the deal could amount to more than EUR 950 million in milestone payments, plus future royalties. The milestone payments include both early development milestones and sales milestones. An upfront payment of EUR 10 million was made at the time of signing of the agreement.

Clinical trials in the Regulus program

During the quarter we mainly focused on activities that strengthen planning of a Phase 2 clinical trial in the Regulus program. We are working on the design of the study and preparatory activities for the production and formulation of study drugs.

The Phase 1 clinical trial, ARIA-1, which began in August, will continue during the spring. The primary objective is to establish the safety and tolerability of the drug candidate AQ280. The study is largely on schedule, with the exception of a delay at the end of the year, but we still expect a final report according to plan during the third quarter of 2023.

A resilient and cohesive team

The focus on Aqilion as a biotech company with an innovative pipeline in chronic inflammation has now begun to deliver results. This achievement is largely thanks to my incredible coworkers, but also to a strategically skilled Board of Directors and persevering shareholders who have shown that they have great confidence in us.

I would therefore like to take this opportunity, before we take on new exciting challenges, to thank you all for a fabulous and inspirational 2022!

Helsingborg, Sweden, on February 16, 2023

Sarah Fredriksson, CEO and President, AQILION AB