Yesterday morning, Annexin Pharmaceuticals announced top-line results from its open-label phase IIa study with ANXV in RVO: “ Based on visual acuity and retinal swelling, 12 of the 14 patients improved or had stable disease. Of these patients, 7 received none and 5 received a single anti-VEGF injection into the eye.” Furthermore, no safety or tolerability events associated with ANXV were reported. As we have previously argued, we think the effect signal is strong, especially for an open-label study, and indicates that there is a positive effect happening in the treated patients. Furthermore, the safety profile, which is very important in ophthalmology, remains strong in this more representative patient population. The company will also conduct more in-depth analysis of the data and the several additional exploratory endpoints that could give additional insight into the mechanism. We think that the holistic profile and mechanistic rationale will be important to convince potential partners, beyond the already published top-line results.

We think that the results clearly motivates further development, most notably in a randomized study where the results can be assessed with a higher level of evidence, likely a phase IIb trial. This is also likely the stage where the company can determine the optimal dose. The company's main strategy is to outlicense ANXV following the phase IIa results, and the company has a cash position that will extend through Q1 2025, giving the company some time to accelerate its business development efforts. Typically, it takes some time to land a deal following a top-line readout in our view, as the partner will do due dilligence on the new data set.

Following the positive data, we raise the likelihood of approval in RVO to 23% (18%), and the probability of success in phase II to 50%. This as we currently assume that the company will conduct a phase IIb trial followed by a pivotal trial. We thus raise our base case to SEK1.7 (1.2) per share