AP-30663

Financing co-led by new investors Canaan and Alpha Wave, and with participation by the Global BioAccess Fund and existing investor Novo Holdings COPENHAGEN, Denmark, Sept. 26, 2023 /PRNewswire/ -- Acesion Pharma ('Acesion' or 'the Company'), a biotech company pioneering first-in-class novel therapies for atrial fibrillation ('AF'), the most common cardiac arrhythmia, today announces that it has successfully closed an oversubscribed €45M Series B financing round. The equity financing was co-led by new US-based investors Canaan and Alpha Wave and with participation by the Global BioAccess Fund, as well as existing investor Novo Holdings. The financing will be used to advance the clinical development of AP31969, an SK ion channel inhibitor optimised for chronic oral treatment of AF. Earlier this year, Acesion demonstrated clinical proof-of-concept with AP30663, its first-in-class SK ion channel inhibitor for conversion of AF to normal sinus rhythm. AP31969 will be developed for chronic oral maintenance treatment to prevent AF recurrence. Following the successful Series B financing, Acesion is well capitalised to progress AP31969 into a phase 1 and completion of a phase 2 trial. AF is the most common type of cardiac arrhythmia and is forecast to affect 25 million people in the US and EU by 2030. Existing drug therapies for AF are associated with the risk of serious cardiac or other adverse effects, resulting in a great need for safer drugs. Yet, there has been a lack of innovation and development with no new chronic AF drug approved for nearly 20 years. With AP31969, Acesion is aiming to develop a safer alternative. In connection with the closing of the financing, the composition of the Acesion board of directors will change to include Tim Shannon, General Partner at Canaan, and Nik Economopoulos, Analyst from Alpha Wave. Jørgen Søberg Petersen, Partner at Novo Holdings, will remain Chairman. Anders Gaarsdal Holst, MD, PhD, Chief Executive Officer of Acesion, said, "The high levels of investor interest and demand that we saw during this financing speak to the strong data we have generated, both on the novel mechanism of SK channel inhibition in general and the AP31969 compound specifically. This is a powerful endorsement for our team and the quality of our science. With the financing in hand, we are focused on progressing AP31969 into a phase 1 clinical trial later this year." Tim Shannon, MD, General Partner in Canaan, said, "Acesion is redefining treatment for patients suffering from atrial fibrillation. The impressive preclinical data from AP31969 shows great promise and we are delighted to support Acesion in taking AP31969 through to Phase 2 completion." Jørgen Søberg Petersen, MD, PhD, MBA, Partner in Novo Holdings, said, " As the founding and largest shareholder, Novo Holdings remains committed in helping Acesion realise the full potential of AP31969. The preclinical data is encouraging and with this series B financing in place Acesion will be able to progress the development to the important milestone of completing a phase 2 trial and thereby being ready for phase 3 programme." About Acesion Pharma Acesion builds on 20 years of know-how with development of small-molecule SK inhibitors and is the world leader in the field of SK channel inhibition, being the only company able to identify and progress SK channel inhibitors into clinical trials. In pre-clinical studies, inhibiting the SK channels has been shown to result in pronounced antiarrhythmic effects in the atria while avoiding effects on the ventricles, the major chambers of the heart and the source of most safety issues with existing drugs. Furthermore, the SK channel has strong genetic validation, with genes encoding the SK channels having one of the strongest associations to AF in human genome-wide association studies. Acesion's AP30663 IV is a short acting conversion therapy for hospitals that has completed a phase 2 trial proving the value of this first-in-class mechanism in AF and thereby de-risking Acesion's broader SK inhibitor pipeline. Acesion's oral program is designed and engineered using in house knowhow to optimise for, and meet, very high hurdles in both efficacy and particularly safety where existing treatments fall short of patient needs. Acesion Pharma is backed by Novo Holdings A/S, Canaan, Alpha Wave Alpha Wave Ventures, Global BioAccess Fund, Wellcome Trust, Broadview Ventures and FC Capital. About Canaan Canaan is an early-stage venture capital firm that invests in entrepreneurs with visionary ideas. With $6.8 billion under management, a diversified fund, and hundreds of exits to date, Canaan partners with entrepreneurs building the next generation of technology and healthcare companies that will transform how we live, work, and thrive. To learn more about our people and our portfolio, please visit: About Alpha Wave Alpha Wave is a global investment company that manages a variety of partnerships that separately focus on three main verticals: private equity (venture and growth), credit, and public markets. It is led by Rick Gerson, Navroz Udwadia, and Ryan Khoury. Alpha Wave has offices in New York, Miami, London, Monaco, Madrid, Abu Dhabi, Tel Aviv, Bangalore, Jakarta, and Sydney. Its flagship global venture and growth fund, Alpha Wave Ventures, aims to invest in best-in-class venture and growth-stage companies and endeavors to be helpful long-term partners to the founders and management teams. For more information, please visit . About the Global BioAccess Fund The Global BioAccess Fund invests in companies developing novel therapeutics and devices to address serious unmet medical needs in oncology, cardiovascular, neurological, and rare diseases. Leveraging the deep life sciences expertise and global reach of its management, scientific advisors, and partners, the Global BioAccess Fund actively supports ventures who are in clinical-stage development, including IND enabling studies and clinical trials. See . About Novo Holdings 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 A/S and Novozymes A/S 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 Seeds, Venture, Growth, and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2022, Novo Holdings had total assets of EUR 108 billion. About atrial fibrillation (AF) AF is the most common type of cardiac arrhythmia mainly affecting the elderly population. Lifetime risk for development of AF is estimated at more than one in three. It is forecast to affect 25 million people in the US and EU by 2030. AF is characterized by chaotic electrical activity in the upper chambers of the heart, the atria, resulting in an irregular and high heart rate. AF is associated with impaired quality of life, increased rate of hospitalization, and a five-fold increased risk of stroke. Increasing evidence suggests that patients with AF also face a higher risk of cognitive dysfunction and dementia. AF is often treated by electrical shock to bring the heart back to its normal rhythm (conversion). This requires general anesthesia in a hospital setting. In addition, many patients are likely to benefit from chronic treatment to prevent AF and maintain normal sinus rhythm. Existing drug therapies for cardioversion or prevention of AF are associated with risk of serious cardiac or other adverse effects, resulting in a great need for safer drugs. Yet, there has been a lack of innovation and development with no new chronic AF drug approved for nearly 20 years. A landmark New England Journal of Medicine published clinical trial () has shown that sinus rhythm maintenance treatment improves survival and long-term outcomes for AF patients. SOURCE Acesion Pharma

COPENHAGEN, Denmark, May 15, 2023 /PRNewswire/ -- Acesion Pharma ("Acesion" or "the Company"), a biotech company pioneering first-in-class novel therapies for atrial fibrillation ("AF"), the most common cardiac arrhythmia, today announces positive data from pre-clinical studies with AP31969, its second-generation oral SK channel inhibitor developed for chronic oral maintenance treatment to prevent AF recurrence. Acesion aims to develop a novel drug for AF that solves the major concern with existing drugs; a high-risk of life-threatening cardiac arrhythmia, also known as proarrhythmia. To refine drug proarrhythmia risk prediction; regulators, academics, and industry have collaborated on developing pre-clinical models with this specific purpose. In two such models, AP31969 has demonstrated a low risk of proarrhythmia with robust differentiation to existing drugs, which have a high risk of proarrhythmia, tested in the same models. Further results from pre-clinical studies showed that AP31969, tested at expected supratherapeutic doses across two in-vivo large animal models, has no prolongations of the corrected QT interval, a well-established marker of proarrhythmia risk. In addition to its promising cardiac safety profile, AP31969 has demonstrated good oral pharmacokinetic properties across different animal species and a low-risk of causing drug-drug interactions, another significant issue with existing drugs. AP30663, Acesion's first-in-class SK ion channel inhibitor for conversion of AF to normal sinus rhythm, recently demonstrated robust efficacy in patients with AF. AP31969 has shown strong and similar efficacy to AP30663 in two animal models, supporting that efficacy can be expected to be shared across the two compounds. Finally, AP31969 has recently completed the toxicology studies required by regulatory authorities, ahead of the phase 1 trial which Acesion plans to start in H2 2023. Anders Gaarsdal Holst, MD, PhD, Chief Executive Officer of Acesion, said, "With a growing number of patients suffering from atrial fibrillation, there is a significant need for treatment. Unfortunately, all existing drugs have major safety issues that endanger patients. Acesion's positive pre-clinical results support that AP31969 has the potential to solve these issues and greatly broaden the use of pharmacological treatment within atrial fibrillation. We are excited to continue the development of AP31969 with a phase 1 clinical trial and look forward to the continued progress we will make in the coming year." Pre-clinical studies have shown pronounced antiarrhythmic effects in the atria while avoiding effects on the ventricles, the major chambers of the heart and the source of most safety issues with existing drugs, when inhibiting the SK channels. Further, the SK channel has strong genetic validation with genes encoding the SK channels having one of the strongest associations to AF in human genome-wide association studies. About Acesion Pharma Acesion builds on 20 years of know-how with development of small-molecule SK inhibitors and is the world leader in the field of SK channel inhibition, being the only company able to identify and progress SK channel inhibitors into clinical trials. In pre-clinical studies, inhibiting the SK channels has been shown to result in pronounced antiarrhythmic effects in the atria while avoiding effects on the ventricles, the major chambers of the heart and the source of most safety issues with existing drugs. Furthermore, the SK channel has strong genetic validation, with genes encoding the SK channels having one of the strongest associations to AF in human genome-wide association studies. Acesion's AP30663 IV is a short acting conversion therapy for hospitals that has completed a phase 2 trial proving the value of this first-in-class mechanism in AF and thereby de-risking Acesion's broader SK inhibitor pipeline. Acesion's oral program is designed and engineered using in house knowhow to optimise for, and meet, very high hurdles in both efficacy and particularly safety where existing treatments fall short of patient needs. Acesion Pharma is backed by Novo Holdings A/S, Wellcome Trust, Broadview Ventures and FC Capital. About atrial fibrillation (AF) AF is the most common type of cardiac arrhythmia mainly affecting the elderly population. Lifetime risk for development of AF is estimated at more than one in three. It is forecast to affect 25 million people in the US and EU by 2030. AF is characterized by chaotic electrical activity in the upper chambers of the heart, the atria, resulting in an irregular and high heart rate. AF is associated with impaired quality of life, increased rate of hospitalization, and a five-fold increased risk of stroke. Increasing evidence suggests that patients with AF also face a higher risk of cognitive dysfunction and dementia. AF is often treated by electrical shock to bring the heart back to its normal rhythm (conversion). This requires general anesthesia in a hospital setting. In addition, many patients are likely to benefit from chronic treatment to prevent AF and maintain normal sinus rhythm. Existing drug therapies for cardioversion or prevention of AF are associated with risk of serious cardiac or other adverse effects, resulting in a great need for safer drugs. Yet, there has been a lack of innovation and development with no new chronic AF drug approved for nearly 20 years. A landmark New England Journal of Medicine published clinical trial () has shown that sinus rhythm maintenance treatment improves survival and long-term outcomes for AF patients. SOURCE Acesion Pharma