The first quarter of 2025 has been an important period for Annexin Pharmaceuticals, characterized by both promising clinical results and secured financing. The full data analysis from the company's Phase IIa study with ANXV in the eye disease retinal vein occlusion (RVO) confirms previously reported efficacy signals and strengthens the drug candidate's favorable safety profile.
Particularly noteworthy is that retinal blood flow analyses showed clear improvements in 6 out of 10 patients shortly after treatment – effects that in several cases have been shown to be lasting over time.
– In addition to the analysis showing that the main objectives of the phase IIa study have been achieved, the promising results strengthen our belief that ANXV can offer a new unique treatment paradigm to treat both the cause and consequences of RVO – and thereby reduce the need for today's standard treatment, writes CEO Anders Haegerstrand in the Q1 report.
Today's standard treatment consists of repeated injections of anti-VEGF drugs directly into the eye, which only treat the symptoms. The drug candidate ANXV mimics the body's own protein Annexin A5 and binds to a fatty substance that is thought to be part of the cause of the disease – a clot in a vein in the retina of the eye – and thus attacks the disease in a new way.
Financing enables continued development
In order to take the next step in the development of ANXV, Annexin carried out a rights issue in March that raised approximately SEK 50 million for the company. The issue was subscribed to 79 percent with and without the support of subscription rights, while the remaining 21 percent was subscribed through top guarantee commitments. The issue was thus fully subscribed.
The issue proceeds will primarily be used to prepare a Phase IIb study in RVO, start a Proof-of-Concept study in diabetic retinopathy and deepen partnership discussions.
The capital is deemed sufficient to finance operations until the middle of the first quarter of 2026, according to a previous interview with Anders Haegerstrand. Annexin's Q1 report shows that the company's cash and cash equivalents amounted to SEK 45,2 million at the end of the period. Cash flow from operating activities during the quarter amounted to SEK -8,25 million.
Next indication: diabetic retinopathy
ANXV's potential in eye diseases extends beyond RVO alone. The company is now planning a proof-of-concept study in diabetic retinopathy – a serious complication of diabetes that can lead to blindness. The disease has certain similarities to RVO, both in terms of the fatty substance phosphatidylserine being linked to the disease and current treatments, which means that the company sees promising potential for ANXV here as well. The application for the study has been submitted and the start of the study is expected during the summer.
The positive study results within RVO have also given impetus to the company's ongoing licensing discussions with international players, with the goal of securing an agreement that enables continued development.
In parallel, Annexin continues to explore ANXV's potential in oncology, as well as sickle cell anemia through analyses of the lipid component in blood plasma to better select patients and dose in potential future patient studies.
CEO comments
BioStock contacted CEO Anders Haegerstrand to gain deeper insight into the company's plans going forward and progress in 2025.
Looking back at the first quarter of 2025 – what milestones would you highlight as particularly significant for Annexin Pharmaceuticals?
– That we have verified our clinical data from the phase II study and confirmed the positive findings regarding safety and efficacy signals. In-depth analyses show rapid improvements in retinal blood flow in many patients and this is a differentiating factor compared to anti-VEGF and may explain why our patients were assessed to need fewer anti-VEGF injections than one would expect. That we can also see reduced levels of the fatty substance phosphatidylserine in blood plasma after ANXV treatment is very positive and a strength in our partnership discussions.
You are currently preparing a Phase IIb study with ANXV in retinal vein occlusion. Could you tell us a little more about the potential design and focus of the study?
– The study, which we want to conduct in collaboration with a licensing partner who will also finance it, will provide a statistically reliable basis for ANXV's effects in comparison with today's standard treatment. Among other things, we want to see whether ANXV's effects on blood flow in the retina can be linked to a lower risk of swelling in the retina, with accompanying visual improvements or no deterioration. This way, we can hope to see a lower need for anti-VEGF injections and that the disease does not risk becoming chronic, which is currently the case for many patients. The design will be discussed with potential licensing partners and regulatory authorities during the year.
In parallel, you are planning a Proof-of-Concept study in diabetic retinopathy. What makes this particular indication particularly interesting to pursue?
– There is a high risk of blindness in patients with diabetes and no good treatment other than the same anti-VEGF injections used for RVO. The fatty substance that ANXV binds to and that we have shown to affect in RVO has been suggested to contribute to vascular damage and blindness also in diabetes. If we can demonstrate positive effects on the retinal blood vessels, and in the best case also vision, in diabetic patients who are threatened with blindness in this limited PoC study, a new very important market opens up for which many companies are looking for good licensing opportunities.
You also mention that you have deepened your contacts with international players regarding licensing agreements. What components weigh most heavily when you evaluate a potential licensing agreement?
– It is difficult to say anything other than the value of the deal, both in terms of initial up-front, milestone payments and royalties, but of course we hope for a partner who takes great account of our ideas and knowledge in the continued development. We see a deal in the area of eye diseases as the main track and that we can continue to develop ANXV in other important diseases so that the very broad potential that ANXV has benefits as many patients as possible.
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