Annexin towards completion of phase II study and share issue
After reporting promising efficacy signals in the ongoing phase II study on patients with the eye disease RVO, Annexin Pharmaceuticals now has a stronger position in licensing and partnership discussions. To finance continued activities, the company also plans to conduct a rights issue of approximately SEK 45 million, with parts of both the board and management intending to participate. BioStock reached out to CEO Anders Haegerstrand for a comment.
The eye disease retinal venous occlusion (RVO) often results in severe vision impairment or blindness in the affected eye, and today’s standard treatment typically involves monthly drug injections directly into the eye, often over many years. Annexin‘s drug candidate ANXV aims to fundamentally change how these patients are treated by improving vision long-term after just a few days of treatment via a superficial vein in the arm. This can completely or largely reduce the need for today’s type of treatment.
ANXV could also contribute to treating difficult-to-treat cancer forms that currently lack effective treatments.
Progress in Q1
In Annexin’s main project, the ongoing clinical phase II study with ANXV in RVO includes patients who have recently received their diagnosis but have not yet been treated with the standard anti-VEGF therapy.
In February, promising efficacy signals were confirmed in an additional four patients, without any side effects. Six out of eight patients who received 2 mg and 4 mg of ANXV in 2023 showed improved or unchanged visual acuity at the three-month follow-up from treatment, often in combination with reduced retinal swelling and with little or no need for anti-VEGF therapy. In January 2024, treatment of patients with the planned highest dose of 6 mg began. The company aims to present top-line data from the entire study by mid-2024.
Boosting Annexin’s cash position
According to the Q1 report, the company’s liquid assets amounted to SEK 7.9 million as of March 31. To strengthen its cash position, the company plans to conduct a rights issue of approximately SEK 45 million between May 14-28, subject to approval at the annual general meeting on May 2, 2024. The rights issue is 90 per cent guaranteed by existing shareholders, management, and the Board.
CEO’s comments
BioStock contacted Annexin’s CEO Anders Haegerstrand to learn more about the progress in the RVO study and the cancer initiatives, as well as the upcoming capital raise.
Anders, could you tell us more about the progress in the RVO project, especially regarding the efficacy signals you have observed?
– It is very positive that we have not seen any limiting side effects and that six out of eight patients who received ANXV have shown improved or unchanged visual acuity, often in combination with reduced retinal swelling and with little or no need for the standard anti-VEGF treatment. It will be exciting to follow the results regarding patients treated with the highest dose of 6 mg.
You hope to present top-line data in mid-2024. What are your hopes, given a positive outcome, for the continued development?
– If the trend of no troublesome side effects and improvements continues in more treated patients, we will achieve results in line with our high expectations. The strategy is to try to enter into licensing agreements or partnerships for the continued development of ANXV in RVO, but also in other eye diseases.
Your cancer initiative is divided into two projects – an immunotherapy and a conjugate drug. Could you tell us more about your plans?
– The cancer initiative aims to use ANXV both as an immunotherapeutic drug to help the body’s immune system attack cancer cells and as a conjugate drug where ANXV acts as a transporter of chemotherapy directly to the cancer tumor to kill cancer cells. In the first part, we have concrete plans for patient selection we but need to confirm the technique, and once done, we have a good clinical study design for a first patient study. This is an important part of the business development work because partnerships are our main focus also in the cancer area. In the second part, the ANXV conjugate, we await results from studies in animal models in the middle of the year, and thereafter, we believe interest in our cancer initiative will increase.
How do you view the prospects of entering into licensing or partnership agreements for ANXV?
We have always emphasized that the opportunities for a good deal, especially when working with a new disease mechanism, arise only when promising patient data is available, which the RVO study seems poised to deliver. The prospects are good, but the timing is difficult to predict. A conclusion to the RVO study, i.e., when the last patient is fully evaluated, will be important for a good deal. In cancer, we hope that a way to identify suitable patients for ANXV treatment in immuno-oncology, together with more data on the ANXV conjugate, will contribute to making a deal in that area possible as well.
How do you plan to use the proceeds from the upcoming preferential rights issue?
– The majority is planned to be used to complete the clinical phase II study in the eye disease RVO and to conduct preparatory studies in cancer. Additionally, the funds will be used for business development, regular testing, and some product development work on the drug candidate ANXV itself, as well as to maintain and strengthen patent protections.
