AnaCardio raises USD 19 million to advance first-in-class drug candidate AC01 for heart failure

Reports positive results from phase 1b study of AC01 in patients with heart failure and reduced ejection fraction (HFrEF)

• USD 19 million (SEK 205 million) financing round closed with new international investors Novo Holdings, Pureos Bioventures and Sound Bioventures
• AC01, a selective oral ghrelin receptor (GHSR1a) agonist was well tolerated in patients with chronic, stable HFrEF
• Clear target engagement demonstrated and exploratory pharmacodynamic measurements indicated increased contractility

January 9, 2025, Stockholm, Sweden - AnaCardio, a clinical-stage biopharmaceutical company developing novel contractile agents to treat patients with heart failure today announced the completion of a USD 19 million (SEK 205 million) Series A extension financing round, co-led by Novo Holdings, Pureos Bioventures and Sound Bioventures. Current investors Flerie, Industrifonden, and Fredrik and Ann-Helene Ljungström, also participated to complete the round. The raised funds will be used to complete the phase 1b/2a GOAL-HF1 study, and to prepare and initiate start-up activities for the subsequent phase 2b study.

The investment follows the successful completion of the first part of the Company’s phase 1b/2a GOAL-HF1 study in patients with HFrEF. GOAL-HF1 is the first clinical study in patients with AC01, the Company's novel, selective oral ghrelin receptor (GHSR1a) agonist molecule, which is in development to improve contractility in patients with heart failure. AnaCardio licensed AC01 from the Helsinn Group in February 2022.

In the present study, AC01 was well-tolerated with no Treatment Emergent Adverse Event (TEAE) resulting in treatment discontinuation, and no severe TEAEs. One Serious Adverse Event (SAE) occurred in a patient receiving placebo. No clinically significant changes in blood pressure, arrhythmias or laboratory safety variables were observed. The systemic exposure of AC01 increased in direct proportion to dose and an AC01 concentration-dependent target engagement, expressed as immediate increases in systemic Growth Hormone levels, was demonstrated. Exploratory pharmacodynamic measurements of Cardiac Index and Stroke Volume showed signs of increased contractility, which will be further evaluated in the second part of GOAL-HF1, a phase 2a cohort expansion where patients will be treated for 28 days. This final part of GOAL-HF1 is due to start Q1, 2025, with results expected by the end of the year.

“The study results demonstrate that AC01 is a promising novel inotrope showing signs of increased contractility without adverse effects, such as tachycardia, arrhythmias, ischemia or hypotension which are typically seen with conventional inotropes when administered to patients with heart failure. AC01 proved to be well-tolerated and showed convincing target engagement meriting advancement to the next development stage testing the drug for 28 days to establish proof-of-concept and enable progress to late-stage clinical development”, commented Professor Lars Lund, CSO and Founder of AnaCardio.

AnaCardio’s CEO Patrik Strömberg commented, “This is a landmark day for AnaCardio, where we report a significant financing round, welcome three prominent new investors, and announce the positive outcome of the first study with AC01 in patients. We now have the data and funding to accelerate the further clinical development of our first-in-class inotrope to improve the lives of patients with heart failure”.

“Heart failure with reduced ejection fraction remains a major unmet medical need, affecting millions of lives worldwide. We are thrilled to be part of this groundbreaking initiative and proud to support the development of a new therapeutic option that has the potential to significantly improve outcomes for patients facing this challenging condition,” said Johan Kördel, Managing Partner, Sound Bioventures. 

In connection with the new investment, Johan Kördel (Managing Partner, Sound Bioventures), Jørgen Søberg Petersen (Senior Partner, Novo Holdings) and Veronica Gambillara Fonck (Partner, Pureos Bioventures) will join AnaCardio’s Board of Directors. In addition, Viktor Drvota (CEO, Karolinska Development) will replace Per Aniansson on the AnaCardio board. As part of the transaction, Karin Hehenberger, Advisor, 3BFuture Health will transition to a board observer role.

About AnaCardio

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 program AC01, a first-in-class calcium sensitizing inotrope, is an oral ghrelin mimetic small-molecule, which was in-licensed from Helsinn and is now being developed as a contractile agent in heart failure patients. The company has raised over USD 35 million to date. AnaCardio is based in Stockholm, Sweden.

Find more information about AnaCardio at www.anacardio.com and follow us on LinkedIn.

Media contacts:

Patrik Strömberg, CEO

Telephone: +46 704 156 159

E-mail: patrik.stromberg@anacardio.com

About the GOAL-HF1 HFrEF study

The GOAL-HF1 study is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AC01 in patients with heart failure with reduced ejection fraction (HFrEF). The now completed first part of GOAL-HF1 included a phase 1b multiple-dose-escalation, and a total of 32 patients, 8 in each of 4 sequential dose cohorts, were treated orally, twice daily with ascending doses of AC01 (0.3 to 3.0 mg) or placebo for 7 days; all patients completed the study according to plan. All patients had  New York Heart Association (NYHA) class II or III, an ICD for primary prevention and were treated with optimal guideline-based medical therapy for HFrEF. More information about the study is available at www.clinicaltrials.gov (NCT05642507).

About Helsinn

Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and an extensive network of long-standing trusted partners enabling a commercial presence in more than 90 countries.

Established in 1976, Helsinn is a fourth-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality.  The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision.

To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and X.

About Novo Holdings A/S

Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.

Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk and Novonesis and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Planetary Health Investments and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development.

As of year-end 2023, Novo Holdings had total assets of EUR 149 billion.

For more information, please visit Novo Holdings.

About Pureos Bioventures

Pureos Bioventures are a series of venture capital funds advised by Swiss-based Pureos Partners that invest exclusively in private innovative drug development companies, with a special emphasis on the next generation of biological drugs and drug formats. The funds’ portfolio companies are built on scientific excellence to develop therapies across a broad indication spectrum including oncology, cardiometabolic, ophthalmology, infectious disease, and neuroscience. Pureos has built a team with in-depth investment, operating and clinical expertise, that strives to impact patients’ lives by advancing innovative treatments for devastating diseases. For further information, please visit www.pureosbio.com.

About Sound Bioventures

Sound Bioventures is a specialist life sciences venture capital fund investing in about-to-be clinical or clinical stage private companies in Europe and the USA developing therapeutics in areas of significant clinical unmet need. The founding team has an active approach to investing and brings considerable operational and VC investment experience, including working together on over 40 investments over the past 15 years. 

Sound Bioventures operates from Malmö and Stockholm (Sweden), Copenhagen (Denmark) and Washington DC (USA). For more information, see Sound Bioventures.