AnaCardio has raised €62.5 million in Series B funding to advance its lead heart failure candidate AC01 through Phase 2b development and toward Phase 3 readiness. The financing was co-led by Novo Holdings and the Ljungström family office, with participation from Helsinn, Pureos Bioventures, Sound Bioventures, Industrifonden, Flerie, LLD Nybohov Invest and new investor Innovestor Life Science.
The financing fully funds AC01 through Phase 2b development in chronic advanced heart failure with reduced ejection fraction, with the goal of producing a Phase 3-ready asset by 2028.
AC01 is a first-in-class oral ghrelin receptor agonist designed to improve cardiac contractility through a calcium-sensitizing mechanism.
In AnaCardio’s Phase 1b/2a GOAL-HF1 study, AC01 produced a 22% increase in cardiac output and a 4.8 percentage point improvement in ejection fraction after four weeks. No tachycardia, new sustained arrhythmias, ischemia or symptomatic hypotension were observed.
The Phase 2b GOAL-HF2 study is expected to enroll approximately 400 patients across about 100 sites in 12 countries, with the first participant expected in the fourth quarter of 2026.
KEY QUOTES:
“This €62.5 million Series B, co-led by Novo Holdings and the Ljungström family office, fully funds GOAL-HF2, AC01’s 400 patient Phase 2b trial across 12 countries, with a design agreed with the FDA and EMA. We’re really excited to move AC01 into Phase 2b development: we believe it’s a potentially transformative opportunity to improve patient outcomes in advanced heart failure. In GOAL-HF1, AC01 demonstrated highly encouraging improvements in cardiac output and ejection fraction over 28 days, with no tachycardia, arrhythmia, ischemia or hypotension observed. This funding round gives us the capital to complete the GOAL-HF2 Phase 2b study and deliver a first-in-class Phase 3-ready asset by 2028.”
Patrik Strömberg, CEO of AnaCardio
“Improving cardiac contractility safely remains a major unmet need in heart failure. AC01 is the first oral agent we have seen with the potential to overcome the safety limitations of traditional inotropes, supported by evidence from GOAL-HF1, the placebo-controlled proof of concept study published in The Lancet. This combination of a differentiated mechanism, clinical evidence and a phase 2b design agreed with the FDA and EMA underpins Novo Holdings’ decision to co-lead this Series B. The round takes AC01 through Phase 2b to deliver a Phase 3-ready dataset by 2028, a pivotal step towards what we believe could be a new category of heart failure treatments.”
Jørgen Søberg Petersen, Senior Partner at Novo Holdings
