Annexin has laid the foundation for continued clinical development

Annexin is developing ANXV, a recombinant protein with anti-inflammatory and vasoprotective properties, for the treatment of diseases where inflammation and vascular dysfunction play a central role. The company's primary focus is on ophthalmology, with a focus on retinal vascular diseases such as retinal vein occlusion (RVO) and diabetic retinopathy (DR).

Clinical milestones in RVO and diabetic retinopathy

During the year, Annexin reached several important milestones in the clinical program for ANXV. Early in the spring, the company announced that the database in the completed phase IIa study in the US in RVO had been locked. According to the company, the analyses confirmed a maintained good safety profile and efficacy signals that provided support for continued development in the indication.

In parallel, the next step in clinical development was prepared through obtaining regulatory approval for a new phase IIa study in diabetic retinopathy and RVO. The study was designed to further evaluate ANXV's potential in retinal vascular diseases, especially DR, and to clarify whether ANXV can be given for fewer days while maintaining efficacy signals. In December, Annexin reported that the first patients had been treated. In connection with this, the company also communicated that the inclusion criteria in the study had been adjusted, with the aim of facilitating patient recruitment.

Together, these events marked a clear step from completed early studies to a more cohesive clinical development strategy within the ophthalmology segment. Annexin has also made it clear that more extensive studies, such as a phase IIb study, should primarily be funded through a strategic partnership.

Medical Advisory Board and increased international visibility

To strengthen the company's scientific and clinical expertise, a Medical Advisory Board has also been established with internationally leading experts in diseases affecting the retina. The board was appointed to provide strategic and medical advice for continued clinical development, including study design, patient selection and future regulatory considerations.

During autumn, the company also increased its international visibility by being selected to present at the Eyecelerator conference in Orlando, USA, and Eyenovator in Florence, Italy, both forums focusing on product innovations in ophthalmology and life science. In conjunction with the conference in Orlando, meetings were also held with the company's Medical Advisory Board, which provided an opportunity for in-depth discussions about the program's future direction.

Focused resource allocation

During the past year, Annexin has also clarified its strategic priorities. Having built a solid foundation in eye diseases, the company is now intensifying its focus on ophthalmology. This means that resources are being concentrated on the ongoing development program with ANXV in RVO and diabetic retinopathy, while certain activities in oncology and sickle cell anemia are being postponed to the future. The same applies to work related to manufacturing processes, especially in preparation for phase III.

As a result of this prioritisation, the company states that cash liquidity has been extended by approximately two months, which means that the existing financing is estimated to last until April 2026.

CEO comments on the future

BioStock had the opportunity to ask Annexin's CEO Anders Haegerstrand a few questions about the past year and what lies ahead in 2026.

Looking back at 2025, what do you see as the most important event for the continued clinical development of ANXV?

– The most important event for the development of our drug candidate ANXV was the promising results from our phase IIa study in the US at the beginning of the year. We identified unique and positive effects on the reduced blood supply to the retina. This prompted the phase IIa study in London within RVO to further elucidate this and it also provided a reason to test ANXV in diabetic retinopathy where we are now starting to treat patients. So far, no safety or tolerability problems in connection with ANXV treatment have been reported, which is of course positive, as we are now studying a new patient group in DR.

Now that the first patients have been treated in the phase IIa study for diabetic retinopathy and RVO, what does the timeline for the study look like — when do you expect to be able to present interim data and any next steps in the development program?

–We plan to enroll up to 12 patients, but this will be decided in stages. We can follow each patient in detail and after treating three patients within each indication, following them for 30 days, an evaluation will be made on what the future holds, in RVO patients where we wish to try a shorter treatment cycle of three days and in DR we will carefully study, among other things, blood flow and the appearance of the blood vessels, and first the vision according to standard clinical practice. The recruitment of additional RVO and DR patients to the study is now underway and with the modifications to the inclusion criteria that we implemented during the autumn, we expect to be able to increase the recruitment rate.

What priorities will be particularly important going forward to translate the progress made in 2025 into the next step in development?

–We will focus on completing the ongoing phase IIa study in RVO and diabetic retinopathy in order to generate more clinical data for further dialogues with potential licensing partners. Business development will remain our top priority in 2026. We are in continuous dialogues with global and regional potential collaboration partners in the field of ophthalmology with the aim of fully or partially out-licensing the ANXV project. At the same time, we will, together with our medical advisory board, conduct dialogues with the US FDA and perhaps other authorities in preparation for planning a phase IIb study in RVO. 2026 will be a very exciting year for the next phase of our drug candidate ANXV and also for Annexin as a whole!