Annexin Q4 2023: Continued RVO progress
Research Update
2024-02-12
10:36
Redeye returns with an update following Annexin’s Q4 report, and the company continued to present advancements from its ongoing phase II study. We slightly raise our base case.
Fredrik Thor
Annexin’s Q4 report offered no surprises. Operating expenses amounted to SEK-14.8m, which aligned with our expectations. The report mentioned that the company (after the period ended) had secured a loan facility from a few significant shareholders of up to SEK15m, which had not yet been utilized. We expect that the Annexin will have a cash runway through Q2, and then expect a capital injection either through a rights issue or licensing agreement.
Redeye has a positive take on the additional information from the company’s ongoing open phase II study in RVO patients with the drug candidate ANXV. The company saw an effect signal in 6 out of 8 patients followed for at least 3 months or longer, showing no need for multiple doses of the standard-of-care anti-VEGFs (either 0 or 1). Overall, we think the additional data presented confirms the previous readout – that there likely is an effect signal.
We are positive about Annexin’s recent fundamental progress and note that the market continues to overlook the company, which now has shown a credible signal of effect in RVO, which we see as a significant market opportunity. We raise our likelihood of approval to 18% (14%), do some model housekeeping related to USD/SEK, and share price assumptions related to the assumed capital injection. We nudge our base case to SEK1.2 (1.1). We will do a more thorough review once the full study is completed.
| SEKm | 2022 | 2023 | 2024e |
| Total Revenue | 0.0 | 0.0 | 0.0 |
| EBIT | -40.7 | -44.2 | -45.1 |
| Net Income | -40.7 | -44.1 | -45.1 |
The second readout confirms the previous signal of effect
Redeye has a positive take on the additional information from the company’s ongoing open phase II study in RVO patients with the drug candidate ANXV. The company saw an effect signal in 6 out of 8 patients followed for at least three months or longer, showing no need for multiple doses of the standard-of-care anti-VEGFs (either 0 or 1). In comparison, patients typically take at least four doses in the first six months of diagnosis. As also stated in the press release, two patients had central retinal vein occlusion (CRVO), which typically requires more frequent dosing. Overall, we think the additional data presented confirms the previous readout – that there likely is an effect signal. Beyond the anti-VEGF dosing, the company reports that “patients show an improvement, or no worsening, of their visual acuity (BCVA) and in several cases a reduced swelling of the retina” – strengthening the mechanistic rationale. The company expects to have evaluated the data by mid-2024 unless safety and signal of effect data motivate further patient enrollments. Overall, we expect the remainder of the study to confirm further what we have already seen, evaluate the strong safety and tolerability data, and then look at the other exploratory endpoints and understand the holistic picture from a mechanistic perspective. Given that the study is open-label (no placebo group) and not powered for statistical analysis, we expect that confirmation of clinical effect will be the focus of upcoming placebo-controlled phase IIb and phase III studies. We nudge our likelihood of approval to 18% (14%) based on the recent progress that we argue motive further studies in RVO with ANXV. We will return with a more thorough review once the full study is completed.
Disclosures and disclaimers