Sparks - SynAct Pharma

SynAct Pharma’s Q326 results highlight continued progress with lead asset resomelagon. Encouraging post-hoc analysis from the Phase II ADVANCE study support the case for further development in rheumatoid arthritis, despite the missed primary endpoint and we see the planned FDA Type C meeting in Q426 as a key upcoming catalyst, with feedback expected by end-2026 or early 2027. This should clarify whether the existing Phase II dataset is sufficient to support direct progression into Phase III or whether additional Phase II work will be required. A supportive regulatory outcome would also strengthen ongoing partnering discussions, although confirmation of the post-hoc findings remains important.

Meanwhile, dengue is emerging as a tangible second commercial opportunity. The Hipolabor agreement establishes a Brazilian development and commercial pathway, complemented by WHO recognition of resomelagon as one of six promising dengue candidates with evidence supporting further clinical development. Clinical validation remains critical, with RESOVIR-2 Part 1 data expected in Q426, subject to regulatory approval of the protocol amendment.

Financially, Q3 cash stood at SEK42.4m, supported by the SEK50m Fenja convertible gross drawdown. Operating cash outflow moderated to SEK18.7m (Q325: SEK25.8m). Management has guided for a cash runway into Q427 provides flexibility to progress near-term catalysts and partnering discussions, although longer-term funding requirements remain.