Novo Holdings co-leads AnaCardio’s €62.5 million Series B financing to advance transformational novel therapy in heart failure

• Financing co-led by Novo Holdings and the Ljungström family office, with participation from the originator Helsinn, existing investors Pureos Bioventures, Sound Bioventures, Industrifonden, Flerie, LLD Nybohov Invest AB and new investor Innovestor Life Science

• Proceeds will fund Phase 2b development of AC01, a first-in-class oral therapy designed to improve cardiac contractility and outcomes in patients with advanced heart failure

• Phase 1b/2a GOAL-HF1 study demonstrated clinical proof of concept, with a 22% increase in cardiac output and a 4.8 percentage point improvement in ejection fraction after only four of weeks treatment, alongside a favourable safety and tolerability profile

• If confirmed in later-stage trials, GOAL-HF1’s findings suggest AC01 could meaningfully improve clinical outcomes, including mortality and morbidity, in advanced heart failure

• Phase 2b GOAL-HF2 study is expected to enrol the first participant in Q4 2026, with the aim of advancing AC01 towards Phase 3 readiness by 2028

AnaCardio, a clinical-stage biopharmaceutical company developing novel therapies for heart failure, today announced the successful completion of a €62.5 million Series B financing. The round was co-led by Novo Holdings and the Ljungström family office, with participation from the originator Helsinn, existing investors Pureos Bioventures, Sound Bioventures, Industrifonden, Flerie and LLD Nybohov Invest AB, alongside new investor Innovestor Life Science.

The financing will fully fund the advancement of AnaCardio's lead candidate, AC01, through Phase 2b clinical development in patients with chronic advanced heart failure with reduced ejection fraction (HFrEF), with the aim of establishing a Phase 3-ready asset by 2028.

Heart failure remains a significant global health challenge, with substantial unmet need. Despite advances in treatment, approximately one-third of patients with HFrEF do not respond adequately to, or cannot tolerate, standard of care guideline-directed medical therapy (GDMT) and risk progressing to advanced disease, where two-year mortality can reach 50%. Conventional inotropic therapies increase cardiac contractility, but safety concerns, including arrhythmias, ischaemia and increased mortality, generally restrict their use to short-term treatment.

AC01 is a first-in-class oral ghrelin receptor agonist designed to improve cardiac contractility through a differentiated calcium-sensitising mechanism, without the safety concerns associated with conventional inotropes. The programme builds on pioneering research led by Professor Lars Lund at Karolinska Institutet, which demonstrated that activation of the ghrelin signalling pathway could improve cardiac function in patients with HFrEF.

Patrik Strömberg, Chief Executive Officer of AnaCardio, said: “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, ischaemia 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.”

Jørgen Søberg Petersen, Senior Partner at Novo Holdings, said: “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.”

AC01 demonstrated clinical proof of concept in the Phase 1b/2a GOAL-HF1 study, with results published in The Lancet in June 2026. The study showed a favourable safety and tolerability profile alongside encouraging improvements in cardiac function. On Day 28, patients receiving AC01 3 mg twice daily showed a 22% increase in cardiac output from baseline and a 4.8 percentage point improvement in left ventricular ejection fraction, compared with 1.6 percentage points in the placebo group. The improvement in ejection fraction (the heart’s ability to pump) was comparable to or greater than improvements reported with established heart failure therapies over considerably longer treatment periods. Although based on separate trials, these findings support AC01’s potential to meaningfully improve clinical outcomes, including mortality and morbidity, in advanced heart failure. No evidence of tachycardia, new-onset sustained arrhythmias, ischaemia or symptomatic hypotension were observed.

The Phase 2b GOAL-HF2 study is expected to enrol the first participant in Q4 2026. The randomised, double-blind, placebo-controlled study will evaluate the safety and efficacy of two dose levels of AC01 over 12 weeks in approximately 400 patients with chronic, advanced HFrEF across approximately 100 sites in 12 countries in North America and Europe. The AC01 development programme has been informed by feedback from the FDA and EMA, and regulatory clearance has now been received to begin the GOAL-HF2 study. More information about the study is available at www.clinicaltrials.gov (NCT07584967).

About the GOAL-HF1 HFrEF study
GOAL-HF1 was a Phase 1b/2a multicentre, randomised, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AC01 in 58 patients with HFrEF across 14 sites in the Netherlands, United Kingdom, Sweden, and Italy. All patients had NYHA class II–III HFrEF (mean ejection fraction 31.4%), a transvenous implantable cardioverter-defibrillator (ICD) for primary prevention and were on maximum tolerated guideline-directed medical therapy. Phase 1b consisted of multiple ascending dose escalation in 32 patients across four sequential dose cohorts (0.1–3 mg twice daily, 7 days). In Phase 2a, 26 patients were equally randomised to 1 mg AC01, 3 mg AC01, or placebo orally twice daily for 28 days. More information about the study is available at www.clinicaltrials.gov (NCT05642507).

About AnaCardio and AC01
AnaCardio AB is a privately held clinical-stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. The Company’s lead programme, AC01, a first-in-class oral calcium-sensitising contractile agent, is a ghrelin mimetic small-molecule that was in-licensed from Helsinn and is now being developed in heart failure patients. With proof-of-concept now published in The Lancet and positive scientific advice received from the FDA and EMA establishing a favourable development path, AnaCardio is advancing AC01 into Phase 2b clinical development. The company has raised around €100 million to date. AnaCardio is based in Stockholm, Sweden.

Find more information about AnaCardio at www.anacardio.com.