Intense Q4 leads Annexin into interesting 2023
Intense and significant – that is how Annexin Pharmaceutical’s CEO Anders Haegerstrand describes the year 2022. Standing out is the company’s big leap forward with drug candidate ANXV within the serious vascular disease retinal vein occlusion. The year ended with the company also taking its first step into the cancer field, which opens up another exciting year.
Annexin Pharmaceuticals is developing the candidate ANXV as a First-in-Class treatment for the vascular disease RVO (retinal vein occlusion), currently in a proof-of-concept phase II clinical trial. In addition, the candidate is being evaluated in an imaging study within the indication. However, ANXV, which is a recombinant (synthetic) variant of the body’s own protein Annexin A5, has shown platform-like potential in a range of indications. Thus, during the fourth quarter, the company added cancer as a second focus for ANXV.
Updates from two studies to come
In the CEO letter for the 2022 Q4 report, CEO Anders Haegerstrand describes the past year as intense and significant. As Haegerstrand lines up the most important events, he points out that Annexin’s biggest focus is still the phase II study in RVO in the US, for which the first patient was recruited in November. To increase the rate of patient recruitment, the company has since involved more eye clinics. The company hopes to be able to present initial safety data during Q1 2023 as well as efficacy data during H1. The study will include a total of approximately 20 patients.
At the same time, the company’s imaging study within RVO is ongoing in collaboration with a Dutch team. Annexin previously chose to extend the inclusion to patients with retinal damage caused by diabetes. The company hopes to be able to present results from the study soon. If the outcome is positive, the study, in addition to demonstrating ANXV’s ability to bind to the retina in RVO, may provide data for ANXV’s potential in diabetes-related retinal damage. Read more about RVO and its market potential here.
The fact that the company has chosen to carry out the RVO study in the USA is strategically important. On the one hand, the US is the largest market, and, on the other hand, it is home to several key opinion leaders. This increases the chances of finding licensees and partners for ANXV, which the company sees as an opportunity when phase II results are in place. When Annexin participated in the Opthalmology Innovation Summit in San Diego in December, the company also received Innovation Award. This can potentially strengthen Annexin’s position in future partnership discussions.
Initiating operations in oncology
Annexin closed the year by announcing that it intends to investigate the possibilities of ANXV in the treatment of cancer. In the long run, this could potentially lower the general level of risk in the company’s portfolio. CEO Anders Haegerstrand believes that the step into the oncology field more than doubles ANXV’s market potential. In a comment to BioStock, Haegerstrand recently said that the company hopes to begin clinical studies in the area based on the preclinical studies already completed, as well as phase I data. Read about ANXV’s mechanism of action in cancer and the interview with Haegerstrand regarding the potential within the indication here.
As part of its strategy in the area, the company has engaged Dr Alain Thibault, an expert in the field. He will, among other things, put together a Clinical Advisory Board of experts in oncology. Annexin believes that this also could strengthen the company on the way to a future partnership, which is also one of the company’s main focuses in 2023.
Continued funding
In the fourth quarter, Annexin reports a result of SEK -10.1 million, to be compared with SEK -15.9 million in the corresponding period last year. The cash flow amounted to SEK -11.7 million (-10.1) and the net cash at the end of the quarter was SEK 31.1 million (49.4). The targeted shares issue of approximately SEK 7 million at the end of the quarter finances the initiation of operations in the cancer area. In general, the company estimates the funds to be sufficient until the end of the second quarter of 2023. Before then, Annexin intends to make public its plans to finance the remaining activities – primarily during the current year.
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