--- title: "AnaCardio Raises €62.5M Series B to Take Heart Drug AC01 Into Phase 2b" description: "AnaCardio raised €62.5 million to fully fund a roughly 400-patient Phase 2b study of oral heart-failure drug AC01, targeting a Phase 3-ready asset by 2028." date: 2026-10-04T13:22:00.000Z source: https://venturecapitaltracker.com/2026-anacardio-62-5m-series-b-heart-failure-ac01 --- # AnaCardio Raises €62.5M Series B to Take Heart Drug AC01 Into Phase 2b > AnaCardio raised €62.5 million to fully fund a roughly 400-patient Phase 2b study of oral heart-failure drug AC01, targeting a Phase 3-ready asset by 2028. AnaCardio has completed a **€62.5 million Series B** to fund a Phase 2b trial of AC01, an oral drug intended to improve cardiac contractility in people with chronic advanced heart failure. Novo Holdings and the Ljungström family office co-led the round. Helsinn, Pureos Bioventures, Sound Bioventures, Industrifonden, Flerie, LLD Nybohov Invest and new investor Innovestor Life Science also participated. The financing is designed to take AC01 through the roughly 400-patient GOAL-HF2 study and produce a Phase 3-ready dataset by 2028. That makes this more than a discovery-stage biotech round: the capital is tied to a defined, multinational clinical program. ## Financing and trial snapshot | Item | Detail | |---|---| | Financing | €62.5 million Series B | | Co-leads | Novo Holdings and the Ljungström family office | | Other investors | Helsinn, Pureos Bioventures, Sound Bioventures, Industrifonden, Flerie, LLD Nybohov Invest and Innovestor Life Science | | Lead asset | AC01 | | Indication | Chronic advanced heart failure with reduced ejection fraction | | Next study | GOAL-HF2 Phase 2b | | Planned enrollment | Approximately 400 patients | | Sites and countries | About 100 sites across 12 countries | | First patient target | Fourth quarter of 2026 | | Phase 3-ready target | 2028 | | Valuation | Not disclosed | ## What AC01 is trying to change Heart failure with reduced ejection fraction occurs when the heart cannot pump enough blood with each contraction. Modern guideline-directed therapy can slow progression and reduce hospitalization and mortality, but a substantial group of patients remains symptomatic or cannot tolerate full treatment. Doctors can use intravenous inotropes such as dobutamine and milrinone to increase contractility in acute settings. Their use is generally limited because greater contractile force can come with arrhythmia, ischemia, hypotension and worse long-term outcomes. AC01 is designed to approach contractility differently. It is an oral ghrelin-receptor agonist and calcium-sensitizing small molecule licensed from Helsinn. AnaCardio argues that activating the ghrelin pathway can improve the force of contraction without the tachycardia and oxygen-demand penalties associated with conventional inotropes. If that hypothesis survives larger trials, AC01 could address a difficult gap between chronic heart-failure medicines and short-term hospital inotropes. ## What the early data show—and do not show AnaCardio's GOAL-HF1 Phase 1b/2a study enrolled 58 patients with heart failure with reduced ejection fraction. In the Phase 2a portion, 26 patients were randomized to two doses of AC01 or placebo for 28 days. The company reported a 22% increase in cardiac output from baseline and a 4.8 percentage-point improvement in left ventricular ejection fraction for patients receiving 3 mg twice daily, compared with a 1.6-point improvement in the placebo group. It also reported no tachycardia, new sustained arrhythmia, ischemia or symptomatic hypotension. Those findings are encouraging, and the study was published in The Lancet. They are still early evidence from a small sample and a short treatment period. Cross-trial comparisons with established therapies cannot prove superior efficacy. The Phase 2b study must show that the physiological signal is reproducible, clinically meaningful and durable in a much broader population. ## Why the Series B is clinically significant Biotech financings often fund several intermediate milestones. AnaCardio says this round fully funds GOAL-HF2, a randomized, double-blind, placebo-controlled trial evaluating two dose levels over 12 weeks. The study is expected to enroll patients across North America and Europe. AnaCardio says the design incorporates feedback from both the U.S. Food and Drug Administration and the European Medicines Agency, and regulatory clearance has been received to begin. That does not mean either regulator has endorsed the drug's efficacy. It means the development path and study design have advanced far enough to support the next trial. Investors are financing a clearer regulatory and clinical plan than is typical for an early biotech round. ## Why Novo Holdings co-led Novo Holdings invests across the life-sciences company lifecycle and can support capital-intensive clinical development. Its decision to co-lead points to three features that specialist investors value: 1. a mechanism differentiated from conventional inotropes; 2. randomized proof-of-concept data rather than only preclinical evidence; 3. a Phase 2b design intended to produce a registrationally useful package. The Ljungström family office adds a second co-lead, while returning investors preserve continuity. Helsinn's participation is strategically relevant because it originated AC01 and licensed the program to AnaCardio. ## The competitive and treatment context AnaCardio is not competing only with another startup. The real benchmark is the combination of modern heart-failure drugs, implanted devices and hospital therapies already used in clinical practice. AC01 would need to demonstrate benefit on top of guideline-directed therapy. It also has to show that improving contractility translates into outcomes that matter to patients—function, symptoms, hospitalization or survival—without creating cardiovascular safety liabilities. Programs from companies such as Cytokinetics have explored cardiac myosin activation, while Windtree Therapeutics has pursued istaroxime-based approaches for acute heart failure. These programs differ in setting, mechanism and development stage, but they illustrate how difficult it has been to improve contractility safely. ## Principal risks The Series B removes an immediate financing constraint, but not the core development risks: - **Small early study.** The strongest efficacy observations come from a limited Phase 2a sample. - **Short exposure.** Twenty-eight days cannot establish long-term safety or clinical outcomes. - **Endpoint translation.** Better cardiac output and ejection fraction may not automatically reduce hospitalization or mortality. - **Patient heterogeneity.** Advanced heart failure includes patients with different causes, comorbidities and treatment tolerance. - **Execution.** A 400-patient, 12-country study introduces enrollment, site-quality and operational risk. - **Future capital.** A successful Phase 2b result would likely require substantially more funding for Phase 3 and commercialization. ## What to watch The next milestones should be judged in sequence: - first-patient enrollment in GOAL-HF2; - pace and geographic quality of recruitment; - dose selection and safety-monitoring disclosures; - completion of the 12-week treatment period; - whether improvements extend beyond imaging and hemodynamic measures; - the design and funding of a Phase 3 program. AnaCardio now has capital to test AC01 at meaningful scale. The investment case rests on whether a promising short-term contractility signal can become a durable, safe and clinically useful heart-failure therapy. **By:** [Venture Capital Tracker](https://venturecapitaltracker.com/editorial-policy) **Editorial note:** AI tools assisted with research, structure, or drafting. Venture Capital Tracker retains human editorial responsibility for factual accuracy, relevance, and source quality before publication.