ADVANCE moves towards patient enrolment - Q3 review

Alzinova reported a Q3 loss after financial items of SEK5m vs. SEK7m in Q3 2025, while operating cash flow was SEK-4m. The key development was the operational start-up of the Phase IIa ADVANCE study of ALZ-101, with company targeting first patient enrolment around the turn of 2026/2027. We reiterate our fair value range of SEK1.2–1.8 per share.

Study start-up progressing. Alzinova has selected seven US sites and submitted updated FDA documentation and an ethics application covering these sites. The company also plans to submit its EU application through CTIS in November. We view progress towards first patient enrolment as the key near-term catalyst and await further updates from the company.

Rights issue provides near-term funding, but, as we mentioned in our previous updates, not full Phase II financing. Quarter-end cash was SEK0.7m, although the recently completed rights issue adds cSEK38m after costs. The TO5 and TO6 warrants could provide up to a further SEK189m before costs during 2027, subject to exercise. We continue to expect that Alzinova will require additional funding to complete the Phase II programme absent a partnership.

Diagnostics remains early stage. The Amsterdam UMC collaboration produced supportive technical findings for the blood-based diagnostic programme, while discussions with Fujirebio continue. However, substantial further validation is required before its clinical utility or commercial potential can be assessed. We therefore assign no value to the diagnostics programme in our valuation of Alzinova at this stage.

We make no material changes to our estimates or assumptions. Our SOTP valuation is based on ALZ-101, with a 12% likelihood of approval (LoA), and assigns no value to ALZ-201 or the diagnostics programme. Following the Q3 results, we reiterate our fair value range of SEK1.2–1.8 per share.