Hyloris FIRST LOOK: Positive IDMC recommendation for Alenura phase 2 in IC/BPS
Hyloris announced that the independent data monitoring committee (IDMC) reviewed the phase 2 trial of Alenura (bladder instillation combining lidocaine and heparin) in interstitial cystitis/bladder pain syndrome (IC/BPS) and concluded that there were no safety concerns and that the efficacy signals observed justified continued investigation. The recommendation is a positive sign for the program particularly as the IDMC saw unblinded data, though we note that they also recommended that the enrolment target is adjusted (likely upwards). We model peak sales of € 165m in the US by 2036 booked by partner Vaneltix, with Hyloris' share being € 33m. Beyond Alenura, we look forward to the company's FY24 results for an update on Hyloris' broader pipeline and funding plans (we est. a YE24 cash position of € 13.5m). We reiterate our € 5 TP and Hold rating.