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Date	Title	Alternative
2023-09-21	Resurrection	Show Close
Research \| 21 Sep 2023 \| Guard Therapeutics Resurrection Ph II data from AKITA study On Tuesday, Guard presented data from its ph II study (AKITA) with RMC-035 in CS-AKI. Recruitment was halted earlier this year after a futility analysis showed a low probability of reaching the primary endpoint (occurrence of AKI within 72 hours). The primary endpoint was indeed not reached, which the company argues was because the higher dose of medicine in the study (1.30 mg/kg) triggered AKI in a subset of patients (>60% of the study population). Good effect on key secondary endpoints The results, however, did show that RMC-035 had a good effect on key (long-term) secondary endpoints in the study, including MAKE90, an outcome measure the regulatory authorities want to see in a pivotal phase III study in acute kidney injury. Most interesting to us was the strong delta between RMC-035 and placebo in kidney function (eGFR) after 90 days, particularly in the pre-specified subset of patients with worse kidney function. Justified share price rise During Tuesday’s trading, the share price shot up some 220%, which we consider a justified reaction given the share’s performance since March, trading at a negative enterprise value. We believe the equity market needs some time to process these results and that the share will be revalued over time. We once again include RMC-035 in CS-AKI in our valuation, with an LoA of 35%. Our fair value is SEK 1.9–2.0 per share. We currently model a (risk-adjusted) advance payment from a potential partner during 2024, which explains the large revenue increase that year. We also model a rights issue of SEK 100m during 2024. Should Guard undertake a ph III study in-house, we believe it will require additional capital. Download (EN)