In April 2022, it was announced that the company received approval to initiate its phase IIa trial (n=20) with ANXV in RVO (“Retinal Vein Occlusion”). We learned later in 2022 that initial recruitment had been slow, partly due to external factors. Annexin later recruited further clinics, and the company announced first-patient-in during November. In yesterday’s report, the company reiterated its goal to present efficacy data by Q2 2023, while initial safety data is expected to be presented during Q1.

In December, Annexin carried out a directed issue of SEK 7 million at SEK 0.95 per share (6% discount) to the five largest shareholders in the company, including Mikael Lönn and Arne Andersson, to finance operations within the field of cancer. Our impression is that the funds will mainly be used to expand the organization and to prepare for a future study within the area, potentially through a partnership. In January, Annexin recruited Dr Alain Thibault, an experience medical oncologist, as Therapeutic Area Head Oncology.  The initial goal is to set up a scientific advisory board and establish expertise, and initiate partnering discussions.
 
We think that the potential of ANXV in cancer is compelling. Annexin has previously in 2022 in-licensed patent rights from Stanford University for the use of Annexin A5 in cancer, specifically relating to increasing the immune response to a tumor by administering Annexin A5 protein, including using Annexin A5 as an immunomodulating anti-cancer agent acting via blocking phosphatidylserine (PS) on cancer cells. External (and independent) researchers have looked into the concept of using Annexin A5 as a checkpoint inhibitor with early positive prospects, a market currently worth double-digit billion dollars. This includes over 10 publications looking at both Annexin A5 as a monotherapy and combination therapy in tumor models.  Annexin will also explore the potential of ANXV as a drug conjugate, ie to deliver a chemotherapy agent specifically to the tumor. Overall, Annexin’s aim is to develop a platform within cancer, although we expect the company to have a targeted focus initially. We are encouraged by the potential in cancer and appreciate Annexin’s step-wise approach to the indication. At this stage, we will likely await further information from regulatory interactions and how the company will fund it before we include it in our valuation. The company hopes to conduct a phase II/proof-of-concept study directly, relying on pre-clinical data and the extensive phase I safety data. We will likely return with a more extensive review of the potential in H1.

Annexin has a history of efficient capital injections, including smaller directed issues/loans from major shareholders before major events (so that the company can raise sufficient cash when it needs to). We think that this has contributed to a more stable share price and valuation. In our base case, we still assume that Annexin will raise some SEK 40 million during Q2/Q3 2023 - but a possible alternative is a smaller injection of roughly SEK 20 million during early 2023 followed by a more significant issue in H2