Lugano, Switzerland – October, 2026 – Helsinn is pleased to announce its renewed support to AnaCardio in the successful completion of a €62.5 million Series B financing to fund the continued development of AC01. AC01 (formerly HM01) is an investigational therapy for heart failure originated and brought to clinical development by Helsinn and then licensed to its partner AnaCardio in 2022.
The financing 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 proceeds will fund the Phase 2b clinical development of AC01 in patients with chronic advanced heart failure with reduced ejection fraction (HFrEF), with the objective of advancing the program toward Phase 3 readiness by 2028.
Heart failure remains a major global health challenge and a significant area of unmet medical need. Despite advances in treatment, approximately one-third of patients with HFrEF do not respond adequately to, or cannot tolerate, current guideline-directed medical therapies and are at risk of progressing to advanced disease.
AC01 is a first-in-class oral ghrelin receptor agonist designed to improve cardiac contractility through a differentiated calcium-sensitizing mechanism. This approach aims to enhance cardiac performance while potentially avoiding some of the safety concerns associated with conventional inotropic therapies, including arrhythmias, ischemia and hypotension.
The program has generated encouraging clinical data to date. In the Phase 1b/2a GOAL-HF1 study, AC01 demonstrated improvements in measures of cardiac function together with a favorable safety and tolerability profile. Results published in The Lancet showed a 22% increase in cardiac output among patients receiving the 3 mg dose of AC01, alongside a 4.8 percentage point improvement in left ventricular ejection fraction after 28 days of treatment. No evidence of tachycardia, new-onset sustained arrhythmias, ischemia or symptomatic hypotension was observed.
AnaCardio expects to initiate the Phase 2b GOAL-HF2 study in the fourth quarter of 2026. The randomized, double-blind, placebo-controlled trial is expected to enroll approximately 400 patients across around 100 sites in North America and Europe and will further evaluate the safety and efficacy of AC01 in patients with chronic advanced heart failure.
For Helsinn, the financing represents an important milestone in the continued advancement of AC01. Licensed to AnaCardio in 2022, the program is now progressing into its next phase of clinical development, supported by a strong syndicate of life science investors and encouraging clinical evidence generated to date.
The successful financing highlights the continued progress of AC01 and the importance of collaboration across the healthcare and life sciences ecosystem in advancing innovative therapeutic approaches for patients living with heart failure.
