OMEICOS Therapeutics Appoints Dr Simon Russell as Chief Business Officer

Berlin, Germany, April 29, 2019

OMEICOS OMEICOS strengthens management team with the appointment of biopharma business development veteran

Berlin, Germany, September 03, 2019 – OMEICOS Therapeutics, a Berlin-based biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular and ophthalmic diseases, today announced that Dr Simon Russell has been appointed as Chief Business Officer. Creating this new leadership role reflects the growing importance of OMEICOS’ product pipeline with its lead program OMT-28 progressing towards clinical proof-of-concept and final dose-finding in Atrial Fibrillation patients as a prerequisite for a fast transition into pivotal trials.

Commenting on the appointment, Dr Robert Fischer, CEO/CSO of OMEICOS Therapeutics said: “I’m delighted to welcome Simon to the OMEICOS team at such an important and exciting time in the growth of the company. His extensive industry experience of unlocking the full commercial potential of scientific innovation makes him a perfect fit for OMEICOS as we advance our lead compound in Atrial Fibrillation and continue expanding our development pipeline of synthetic epoxyeicosanoid analogs.”

Dr Russell has over thirty years of experience in the biopharma sector and has a strong track record of leading teams through key business decisions and strategic milestones across a range of therapy areas.

Following his early career in R&D at AstraZeneca, he held a number of senior commercial and brand leadership roles at both AstraZeneca and Novartis Pharma AG including Head of Strategic Marketing, Biologics.

In 2012 he was appointed Chief Business Officer of Creabilis Ltd and was responsible for commercial and business development activities for this VC-backed biotech including negotiating term sheets, raising finance, and preparation for a potential IPO. In 2016 he played a key role in the negotiation and sale of Creabilis to Sienna Biopharmaceuticals, Inc. in the US and the subsequent IPO of the company on the NASDAQ in 2017.

As Entrepreneur-in-Residence with BaseLaunch, the incubator group in Basel, he advised local start-up companies and as a result, co-founded a new biotech company in 2019.

Dr Russell has a PhD in organic chemistry from Southampton University and an MA (Hons) in Chemistry from the University of Oxford. He is a member of the Royal Society of Chemistry.

Dr Russell added: “OMEICOS has a very promising therapeutic platform targeting one of nature’s most important cell-protective pathways and I’m thrilled to be joining them in their journey to bring this family of first-in-class therapeutics to market. I look forward to leveraging my business development and commercial experience to support the Company’s strategic vision.”

About OMEICOS

OMEICOS OMEICOS Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine (MDC) in Berlin. The company has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat inflammatory, cardiovascular and other diseases. Epoxyeicosanoids, as a newly described class of bioactive lipid mediators, activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. OMEICOS’ technology is based on ground-breaking scientific results in the field of omega-3 fatty acid metabolism and physiology obtained by the companies’ founders, Dr. Wolf-Hagen Schunck, Prof. John. R. Falck, Prof. Dominik Mueller and Dr. Robert Fischer. The companies’ research activities are supported by a grant from the German Ministry of Education and Research (BMBF). www.omeicos.com

Contacts

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

MacDougall Biomedical Communications
Mario Brkulj or Amanda Whelan
Phone: +49 89 2424 3494 or +1 781-235-3060
E-Mail: omeicos@macbiocom.com

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OMEICOS Therapeutics Announces First-Dosing in Phase 2 Clinical Study Evaluating its Lead Program OMT-28 in Patients with Persistent Atrial Fibrillation

Berlin, Germany, April 29, 2019

PROMISE-AF trial to deliver clinical proof-of-concept and determine Phase 3 dosing regimen for novel approach to stabilize the heart rhythm.

OMEICOS Therapeutics, a Berlin-based biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular and ophthalmic diseases, today announced the dosing of a first patient in a Phase 2 clinical study for the company’s OMT-28 development program. The placebo-controlled, double-blind, randomized PROMISE-AF study will evaluate the efficacy, safety, and population pharmacokinetics in patients with persistent Atrial Fibrillation (AF). The study is expected to enroll up to 120 patients via centers in four European countries. The completion of the PROMISE-AF trial is expected for H1 2020 and should enable OMEICOS to transition OMT-28 into Phase III clinical evaluation.

“In our first-in-man study, OMT-28 was shown to be safe with results strongly supporting OMT-28’s claim to have a low risk for pro-arrhythmia. We are thus very excited to further substantiate our clinical data set for OMT-28 in AF patients addressing a significant unmet medical need with a novel therapeutic approach,” said Dr. Robert Fischer, Chief Executive Officer and Chief Scientific Officer of OMEICOS Therapeutics. “OMT-28 targets the process of intracellular calcium regulation and mitochondrial function to stabilize the heart’s rhythm and in addition provides a cardioprotective effect. This mechanism sets it apart from currently marketed anti-arrhythmic drugs with the potential to make a real difference for the millions of patients suffering from AF. Since our therapeutic platform targets one of nature’s most important cell-protective pathways, clinical evaluation of OMT-28 in cardiovascular diseases could very well act as the cornerstone to branch out into multiple other indications.”

OMT-28 is a stable synthetic small molecule analog of the natural omega-3 fatty acid metabolite 17,18-EEQ, which has a structure optimized to provide high efficacy, safety and oral bioavailability. The compound has already proven its anti-arrhythmic, cardioprotective and anti-fibrotic potential in different in vivo models.

The primary goal of the PROMISE-AF trial is to evaluate the efficacy and safety of three different dose levels of OMT-28 administered once daily versus placebo and the drug’s impact on the maintenance of normal sinus rhythm in patients with persistent AF. To accurately detect and monitor arrhythmias and assess the AF burden for patients, data will be collected via an implantable cardiac monitor provided by Berlin-based medical device specialist Biotronik.

More information on the PROMISE-AF study is available on https://www.clinicaltrials.gov.

About OMEICOS

OMEICOS Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine (MDC) in Berlin. The company has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat inflammatory, cardiovascular and other diseases. Epoxyeicosanoids, as a newly described class of bioactive lipid mediators, target one of nature’s most important cell-protective pathways, promoting organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. OMEICOS’ technology is based on ground-breaking scientific results in the field of omega-3 fatty acid metabolism and physiology obtained by the companies’ founders, Dr. Wolf-Hagen Schunck, Prof. John. R. Falck, Prof. Dominik Mueller and Dr. Robert Fischer. The companies’ research activities has been supported by a grant from the German Ministry of Education and Research (BMBF). www.omeicos.com

Contacts

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

MacDougall Biomedical Communications
Mario Brkulj or Kara Mazey
Phone: +49 89 2424 3494 or +1 781-235-3060
E-Mail: omeicos@macbiocom.com

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Leonardo Caló, MD

Chief of the Department of Cardiology at Policlinic Casillino, Rome and Professor of Medicine at University Cattolica, Rome (Italy)
Dr. Leonardo Caló is focused on studying cardiac arrhythmias, electrophysiology and ablation and is an expert in the functional role played by omega-3 fatty acids in the prevention of arrhythmias in different settings. He is a Fellow of the European Society of Cardiology and has participated in several international clinical trials. He is associated Editor of Journal of Cardiovascular Interventional Electrophysiology and European Journal of Preventive Cardiology, has authored or co-authored numerous papers and more than 20 book chapters. Prof. Caló has participated in several international clinical trials.

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John Camm, MD, FRCP

Professor of Clinical Cardiology at St. George’s Hospital, University of London and at Imperial College, London (United Kingdom)

Dr. John Camm is focused on cardiac arrhythmias, atrial fibrillation, stroke prevention, clinical cardiac electrophysiology, heart failure and cardiomyopathy patients. He is President of the European Heart Rhythm Association and Founder of the Atrial Fibrillation Association and in addition, a Fellow of the Royal College of Physicians (London, Edinburgh and Glasgow), the American College of Cardiology, the American Heart Association and the European Society of Cardiology (ESC). Prof. Camm has written or edited more than 40 books and has authored or co-authored almost 1300 peer reviewed papers and over 500 book chapters in the field of cardiology and has been involved in the production of numerous guidelines, including the ESC guidelines for the management of atrial fibrillation. In 2010 and 2012, he was the recipient of the ESC Gold Medal and the British Cardiovascular Society’s Mackenzie Medal.

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Dobromir Dobrev, MD

Professor and Director of Institute of Institute of Pharmacology, University of Duisburg-Essen (Germany)

Dr. Dobromir Dobrev is an internationally recognized expert in understanding the cellular and molecular mechanisms underlying development, progression and maintenance of cardiac arrhythmias, particularly atrial fibrillation. He has authored over 200 peer reviewed articles and is on the editorial board of numerous cardiovascular journals. He is currently Chairman of ESC Working Group on Cardiac Cellular Electrophysiology and co-authored the 2016 ESC guidelines for the management of atrial fibrillation.

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Andreas Götte, MD, FEHRA

Professor and Head of Department of Cardiology and Intensive Care Medicine at St. Vincenz Hospital, Paderborn (Germany)

Dr. Andreas Götte is a specialist in interventional cardiology as well as clinical and experimental electrophysiology. The main focus of his research is on molecular mechanisms and molecular biology of atrial fibrillation. Since 2015 he is one of the Chairman of the German Atrial Fibrillation NETwork (AFNET). He was the Chair of the Scientific Program Committee of the European Heart Rhythm Association (EHRA), co-authored various international guidelines in atrial fibrillation treatment and published more than 150 peer reviewed papers.

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Gerald Naccarelli, MD, FACC, FAHA, FHRS, Bernard Trabin Chair in Cardiology

Professor of Medicine and Chief of the Division of Cardiology at Pennsylvania State University College of Medicine/Milton S Hershey Medical Center, Pennsylvania (USA)

Dr. Gerald Naccarelli Dr. Gerald Naccarelli is a cardiologist and arrhythmia expert who has been in clinical practice for 36 years. He is past-president of the Heart Rhythm Society (HRS) and served on the Board of Trustees of the American College of Cardiology and HRS. He is a recipient of the American Heart Association’s Paul Dudley White Award. Prof. Naccarelli has published over 600 peer reviewed papers, book chapters and reviews in addition to authoring four books related to cardiac arrhythmia. He is currently on the steering committee of multiple clinical trials and has vast experience in the development and approval of multiple anti-arrhythmic agents in the USA.

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Max Delbrück Center in the Helmholtz Association

As a spin-off from MDC Berlin, OMEICOS has continued a close collaboration with the working groups of OMEICOS’ co-founders Dr. Wolf-Hagen Schunck and Dr. Dominik Müller since its foundation. Joint research activities helped to further elucidate the molecular mode of action of OMEICOS compounds.

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University of Alberta

OMEICOS is working closely together with the research group of John Seubert to investigate the effect of OMEICOS’ compounds in indications, associated with mitochondrial dysfunction.John’s research is focused on investigating the role of CYP epoxygenase metabolites in maintaining tissue homeostasis and reducing injury with a special focus on cardioprotection, ischemia-reperfusion, mitochondria, toxicology, the cytochrome P450 system and mechanisms of cellular death.

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Lipidomix

Lipidomix GmbH is a specialized lipid analysis lab which conducts high-throughput lipidomic analysis, in particular eicosanoids. It is based on rapid-resolution-HPLC in combination with triple quad tandem mass spectrometry. Lipidomix develops and validates analysis methods for areas in the life sciences, food monitoring, forensics and others.

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Omegametrix

Omegametrix is an international reference laboratory for the determination of the so called HS-Omega-3 Index®, a standardized method for erythrocyte fatty acid analysis. Dr. Clemens von Schacky, Head of Preventive Cardiology at the LMU Munich, together with Prof. W.S. Harris, Sanford University established the HS-Omega-3 Index® and founded Omegametrix in Martinsried, Germany, in 2007.

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Wolf-Hagen Schunck

Wolf is biochemist at the Max Delbrück Center for Molecular Medicine. He has over 30 years of research experience in the field of cytochrome P450 (CYP)-derived bioactive lipid mediators. Wolf’s laboratory identified 17,18-EEQ laying the scientific basis for the foundation of OMEICOS. In collaboration with fellow co-founder John R. Falck, he developed robust synthetic analogues for in vivo administration. The current work of Wolf is focused on further elucidating the cellular and molecular mechanisms underlying the unique biological properties of 17,18-EEQ and developing new fields of clinical application in collaboration with academic partners and OMEICOS.

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John R. Falck

John is the Welch Distinguished Chair of Chemistry and Professor at the University of Texas Southwestern Medical Center and has over 40 years of research experience in the field of medicinal and synthetic chemistry. He has pioneered the identification, preparation and chemical synthesis of a number of epoxyeicosatrienoic acids and is one of the foremost experts in the application of chemistry and pharmacology of CYP eicosanoids.

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Dominik N. Müller

Dominik is pharmacist and group leader at the Experimental and Clinical Research Center and Max Delbrück Center for Molecular Medicine. He has over 25 years of research experience in the field. His current work is focused on the crosstalk between immune cells, vasculature and target organs of hypertension. His research group’s major research interests are beside the understanding of pathomechanisms leading to cardiovascular disease, the identification of cardiovascular risk factors and new target for treatment.

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Robert Fischer

Robert’s passion is to transform excellent science into novel treatments for diseases with high unmet medical need. Prior to taking the lead at OMEICOS, he worked as a clinical cardiologist at the Charité – Universitätsmedizin Berlin and led or participated in many clinical and preclinical research in activities together with the Max-Delbrück-Center for Molecular Medicine. Robert holds a PhD in cardiovascular physiology from the Freie Universität zu Berlin and received Board-certification for Internal Medicine.

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Karen Uhlmann

Karen has more than 20 years’ experience in IP Asset Management, building and running organizations and being instrumental in raising funds, executing all different routes of commercialization. She holds a Master and a PhD in Biology from Freie Universität zu Berlin and Humboldt-Universität zu Berlin, and has earned a business degree from the Chamber of Commerce Berlin.

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Bernhard Kirschbaum

Chairman

Bernhard Kirschbaum studied biochemistry and physiological chemistry at the University of Konstanz and received his PhD in 1989. He moved on to work at the Rockefeller University and the Pasteur Institute before making a career in the pharmaceutical industry where he covered a broad range of technological and disease areas. In his most recent position, Dr. Kirschbaum served as head of Global Research and Early Development at Merck Serono where he was a member of the board.

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Christian Schneider

Christian Schneider, Managing Partner of Vesalius Biocapital, has been a venture capital executive for 20 years. He gained extensive experience in the areas of diagnostics, medtech, and therapeutics in the corporate life science and venture capital industry. Previously he held positions of increasing responsibility at Boehringer Mannheim, Centocor, and Johnson&Johnson. As a managing partner of VC firm PolyTechnos, he was responsible for OncoMethylome (IPO, 2006), Devgen (IPO, 2005) and Jerini (IPO, 2005). He was support partner for Addex (IPO, 2007) and BiPar (USD 500m sale to Sanofi-Aventis, 2009). He joined Vesalius in 2008 and is responsible for the portfolio companies Skyline (write-off), Activaero (EUR 130m sale to Vectura, 2014), Ventaleon, OMEICOS, Humedics and Mecuris where he serves on the boards. Dr. Schneider holds a doctorate degree in veterinary medicine (1992) and a PhD in immunology (1995), both from the University of Munich, Germany, and an MBA with focus on healthcare administration from Penn State University, Pennsylvania (1999).

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Peter Seiler

Head of Treasury Vice President SMS GmbH

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Taro Inaba

Taro Inaba is Founder and Managing Partner at Remiges Ventures. He has over 29 years of business experience including 19 years in start-up financing and company creation. At Remiges, Taro is engaged in technology sourcing, company creation, leading negotiation for investments and serving as director for seven of the Remiges’ portfolio companies. Prior to establishing Remiges Ventures, he spent 13 years at divisions of Mitsui & Co., Ltd. engaged in venture investment activities where he built and managed the biopharma investment team and investment portfolio. He served as President & CEO of Mitsui & Co. Venture Partners in Menlo Park, California from 2008 to 2009. Taro holds a B.E. in Polymer Chemistry, Kyoto University and MBA from European University. Taro is a CFA charter holder.

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Wolf-Hagen Schunck

Wolf-Hagen Schunck is biochemist at the Max Delbrück Center for Molecular Medicine in Berlin-Buch. He has over 30 years of research experience in the field of cytochrome P450 (CYP)-derived bioactive lipid mediators. Dr. Schunck’s laboratory identified 17,18-epoxyeicosatetraenoic acid (17,18-EEQ) laying the scientific basis for the foundation of OMEICOS. In collaboration with fellow co-founder Dr. John R. Falck, he developed robust synthetic analogues for in vivo administration. The current work of Dr. Schunck is focused on further elucidating the cellular and molecular mechanisms underlying the unique biological properties of 17,18-EEQ and developing new fields of clinical application in collaboration with academic partners and OMEICOS.

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Robert Fischer

CEO/CSO
Co-Founder

Robert’s passion is to transform excellent science into novel treatments for diseases with high unmet medical need. Prior to taking the lead at OMEICOS, he worked as a clinical cardiologist at the Charité – Universitätsmedizin Berlin and led and participated in many clinical and preclinical research in activities together with the Max-Delbrück-Center for Molecular Medicine. Robert holds a PhD in cardiovascular physiology from the Freie Universität zu Berlin and received Board-certification for Internal Medicine.

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Simon Russell

CBO, Consultancy

Simon’s career began in R&D before gaining over 20 years’ experience in senior commercial and business roles in AstraZeneca, Novartis AG and biotech. Following his last role as Head of Strategic Marketing for Biologics at Novartis, he became CBO of Creabilis Ltd leading commercial, corporate and business development ultimately negotiating its sale to Sienna Biopharmaceuticals with its subsequent IPO on NASDAQ. He is a co-founder of a biotech emerging from the Basel incubator initiative. Dr Russell studied Chemistry at the University of Oxford and received a PhD from Southampton University.

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Karen Uhlmann

Vice President Operations & IP
Co-Founder

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Edita Bade

Head of Finance
& Controlling

Edita has gained more than 20 years of experience in various Finance, Controlling & Project Leader roles across a broad range of industries. Prior to joining OMEICOS, she supported the leadership team of an international Real Estate development company with the valuation and long-term value development projections of real estate opportunities, due diligence and acquisition/sales of these assets.

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Henk Streefkerk

Clinical Development, Consultancy

Henk, MD PhD, joined OMEICOS as Consultant ‘Clinical Development’ in September 2020. Henk is a medical doctor with a PhD in neurosurgery from University of Utrecht. He held multiple medical roles in large companies (Organon, Novartis) and biotech (Actelion, PIQUR), in translational medicine, safety, and clinical development in cardiovascular, oncology, and orphan diseases. Most recently, he was CMO of an Oncology Biotech in Basel. Henk supports OMEICOS in the overall clinical development of OMT-28.

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Markus Henrich

Medicinal Chemistry and CMC, Consultancy

Markus has more than 20 years of experience in various roles in the pharmaceutical industry, amongst them Executive Director Drug Discovery and Development at Merz Pharmaceuticals GmbH. In his current role as management consultant he constantly supports OMEICOS in the field of drug discovery and development. Areas of special expertise are innovation productivity and CMC.

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OMEICOS Therapeutics Strengthens Board of Directors with the Appointment of Christian Schetter

Berlin, Germany, and Boston, MA, USA, February 11, 2019

– Addition of 2nd independent board member positions OMEICOS well for future value creation –

OMEICOS Therapeutics, a biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular and ophthalmic diseases, today announced the appointment of Christian Schetter, Ph.D., as an independent Board Member.

Christian has over 20 years’ industry experience across the life sciences sector, and most recently joined venture capital firm Arix Bioscience plc as an Entrepreneur in Residence. Before that he was instrumental in building German immuno-oncology company Rigontec GmbH as their CEO and managed the integration process after Rigontec was acquired by MSD in 2017. His appointment adds a second independent board member to the OMEICOS board complementing the position of Dr. Bernd Kirschbaum as Chairman of the Supervisory Board.

Dr. Bernd Kirschbaum, Chairman of the Supervisory Board commented: “Bringing Christian on board, an experience leader who has gone through the process of building up biopharmaceutical start-ups, delivering on the important value inflection points in R&D and taking the next steps in corporate development, adds valuable expertise to the OMEICOS board. With two independent board members, in addition to the experienced board representation from our investors already in place, OMEICOS is well equipped for the next corporate development steps.”

“We welcome Christian to our Supervisory Board and are looking forward to working with him as OMEICOS enters a very exciting stage in its development. Christian’s appointment adds a second independent board member to our team, following Bernd Kirschbaum’s addition to the board in 2015 whose years of R&D leadership at pharmaceutical companies have been and will continue to be essential as we advance our lead compound in Atrial Fibrillation towards proof-of-concept in patients and continue expanding our development pipeline with our subsidiary OMEICOS Ophthalmics in Boston. Taken together, Bernd and Christian bring two unique sets of experience and expertise to OMEICOS,” added Robert Fischer, MD, CEO/CSO of OMEICOS Therapeutics.

Prior to his role at Rigontec GmbH, Christian was President and CEO of Neovii Biotech (previously Fresenius Biotech). During his tenure, one antibody product was brought to market and the indication for another product expanded. Christian was also instrumental in selling Fresenius Biotech to the Neopharm Group, Israel, to form Neovii Biotech and positioning it as a successful standalone business. He was SVP of European Operations at Coley Pharmaceutical Group and Managing Director of Coley GmbH. Christian was part of the leadership team which built Coley Pharmaceuticals from inception through multiple financing rounds, a NASDAQ IPO and, following several significant pharma deals, to a trade sale to Pfizer in 2007. Before entering the life science industry, Christian was successfully performing academic research at the Max Planck Institute in Martinsried, Germany. He received his undergraduate degree and PhD from the University of Cologne and did postdoctoral research in oncology and virology at the Scripps Research Institute in La Jolla, California.

ABOUT OMEICOS

OMEICOS Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine (MDC) in Berlin. The company has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat inflammatory, cardiovascular and other diseases. Epoxyeicosanoids, as a newly described class of bioactive lipid mediators, activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. OMEICOS’ technology is based on ground-breaking scientific results in the field of omega-3 fatty acid metabolism and physiology obtained by the companies’ founders, Dr. Wolf-Hagen Schunck, Prof. John. R. Falck, Prof. Dominik Mueller and Dr. Robert Fischer. The companies’ research activities are supported by a grant from the German Ministry of Education and Research (BMBF). www.omeicos.com

CONTACTS

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

MEDIA REQUESTS

MacDougall Biomedical Communications
Mario Brkulj or Amanda Whelan
Main: +49 89 2424 3494 or +1 781-235-3060
E-Mail: omeicos@macbiocom.com

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OMEICOS Therapeutics Closes €17m Series C Financing to Advance Lead Candidate OMT-28 Towards Pivotal Trials in Atrial Fibrillation

Berlin, Germany, and Boston, MA, USA, November 2, 2018

Proceeds provide OMEICOS with the financial runway to conduct the Phase II Study PROMISE-AF and continue expansion into ophthalmology through US subsidiary

OMEICOS Therapeutics, a Berlin-based biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular and ophthalmic diseases, today announced the closing of a EUR 17 million (approx. USD 19.5 million) Series C financing led by new investor Forbion.

Existing investors Vesalius Biocapital II S.A. SICAR, Remiges BioPharma Fund, SMS Group GmbH, KFW Group, VC Fonds Technologie Berlin, High-Tech Gründerfonds II GmbH & Co. KG and The Falck Revocable Trust participated as well. The proceeds from this round will finance PROMISE-AF, a placebo controlled, double-blinded, randomized, dose finding Phase II study on OMT-28 in maintenance of sinus rhythm after electrical cardioversion in patients with persistent atrial fibrillation. Additionally, OMEICOS will continue to drive the expansion of its pipeline into novel indications including ophthalmology, led by its US-based subsidiary OMEICOS Ophthalmics. “This financing arrives in a particularly exciting time for the OMEICOS team as we accelerate plans to initiate our Phase II study of OMT-28, OMEICOS’ novel safe rhythm stabilizer developed for patients with atrial fibrillation. The investment of Forbion confirms the excellent work of the entire team and supports our ambitious plans in atrial fibrillation and other indications,” commented Robert Fischer, MD, CEO/CSO of OMEICOS Therapeutics. Holger Reithinger, Ph.D. General Partner at Forbion added: “We’ve been following the OMEICOS story for some time and are very positive about the progress. The unique concept of a novel treatment for atrial fibrillation together with the excellent safety data of OMT-28 convinced us to invest and support the future growth of the company.” Christian Schneider, Ph.D. Managing Partner at Vesalius Biocapital commented: “The addition of Forbion is another consequent step in the successful development of OMEICOS. The shareholders highly welcome Forbion’s commitment to join forces in order to accelerate the company’s development pipeline in indications with high unmet medical need.” OMEICOS is developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular and ophthalmic diseases. The compounds are synthetic analogs of naturally occurring, but metabolically unstable, metabolites of omega-3 fatty acids that can activate anti-arrhythmic, cardio protective and anti-inflammatory pathways. OMEICOS’ first-in-class small molecules can be administered orally and have shown improved biological activity and pharmacokinetic properties compared to their natural counterparts. Atrial fibrillation is the most common type of heart arrhythmia affecting an estimated 33.5 million people worldwide. Incidence is expected to increase over the next decade as life expectancy increases. The disease is associated with significant health risks and current therapies have limited efficacy and safety. OMEICOS Ophthalmics was established in Boston, MA, USA in August 2017 to focus on a clinical development program for OMEICOS’ ophthalmological drug indications. OMEICOS’ compounds are currently in preclinical development for macular edema disease, including wet age-related macular degeneration (AMD) and diabetic retinopathy. New treatments for wet AMD are needed to reduce the burden of repeated, frequent injections of therapeutics into the eye, and to offer more convenient routes of administration.

Meet OMEICOS Therapeutics at BIO-Europe 2018 in Copenhagen: Dr. Robert Fischer, CEO of OMEICOS will give a company presentation on Tuesday, November 6th, 4:45 pm, Cardiovascular track, Room B1

About OMEICOS

OMEICOS Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine (MDC) in Berlin. The company has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat inflammatory, cardiovascular and other diseases. Epoxyeicosanoids, as a newly described class of bioactive lipid mediators, activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. OMEICOS’ technology is based on ground-breaking scientific results in the field of omega-3 fatty acid metabolism and physiology obtained by the companies’ founders, Dr. Wolf-Hagen Schunck, Prof. John. R. Falck, Prof. Dominik Mueller and Dr. Robert Fischer. The companies’ research activities are supported by a grant from the German Ministry of Education and Research (BMBF). www.omeicos.com

Contacts

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

MacDougall Biomedical Communications
Mario Brkulj or Kara Mazey
Main: +49 89 2424 3494 or +1 781-235-3060
E-Mail: omeicos@macbiocom.com

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OMEICOS Therapeutics Announces Compelling First-in-Human Data on Lead Compound OMT-28 and Prepares Phase 2 Trial in Atrial Fibrillation

Berlin, Germany, July,17 2018

High-resolution electrocardiography strongly supports OMT-28’s claim for low pro-arrhythmic risk

The study met its primary goal with OMT-28 exhibiting an excellent tolerability profile and showing no safety signals in vital signs or safety laboratory parameters up to the maximum dose tested, which was 60 mg. High-resolution electrocardiography recordings were used to detect any heart beat anomalies such as QT-prolongations and changes in the PR and QRS intervals. OMT-28 did not have a clinically relevant effect on these heart rate parameters or on cardiac conduction at all doses tested in the trial which strongly supports OMT-28’s claim to have a low risk for pro-arrhythmia. With the Phase 1 trial concluded, OMEICOS has accelerated its plans to initiate a subsequent Phase 2 trial focused on maintenance of sinus rhythm in patients suffering from non-permanent Atrial Fibrillation. “It is very encouraging to see that even at the highest dose tested for OMT-28, the regular heart beat physiology in healthy volunteers remained intact, since the tendency of existing antiarrhythmic drugs to lead to the emergence of potentially life threatening arrhythmias is a well-documented paradox”, said Robert Fischer, MD, CEO of OMEICOS Therapeutics. “We believe this further supports our claim that OMT-28 could become the first example of a complete novel class of drugs combining anti-arrhythmic, cardioprotective and anti-remodelling effects for long-term rhythm maintenance. With this data, the swift execution of our development plan for OMT-28 remains a top priority for OMEICOS and we are eager to initiate the subsequent Phase 2 trial in patients suffering from a common form of atrial fibrillation. Additionally, the results of our first-in-human study put us in a great position to unlock the tremendous potential of OMT-28 and the entire new molecule class in several other indications”. OMEICOS’ lead compound, OMT-28, is a stable synthetic small molecule analog of the natural omega-3 fatty acid metabolite 17,18-EEQ, which has a structure optimized to provide high efficacy, safety and oral bioavailability. OMT-28 has already proven its anti-arrhythmic, cardioprotective and anti-fibrotic potential in different in vivo models. The now concluded randomized, double-blind, placebo-controlled Phase 1 study was conducted at two centers in Germany and enrolled 75 subjects. The results of the first-in-human trial demonstrate that OMT-28’s pharmacokinetic profile allows a once daily oral treatment. Additional parameters analyzed in the trial were the impact of the subject’s gender or diet on the uptake and metabolism of OMT-28.

For more information on the trial (NCT03078738) please visit https://clinicaltrials.gov.

Contacts

OMEICOS Therapeutics GmbH Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

MacDougall Biomedical Communications
Mario Brkulj or Kara Mazey
Main: +49 89 2424 3494 or +1 781-235-3060
E-Mail: omeicos@macbiocom.com

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Alexander Gebauer Joins Executive Board of OMEICOS Therapeutics and Named CEO and Chairman of OMEICOS Ophthalmics

Berlin, Germany, and Boston, MA, USA, April 27, 2018

Appointment marks further progress in ramping-up US-based subsidiary as validation of OMEICOS’ lead compound also progresses through clinical trials in atrial fibrillation

Dr. Gebauer will lead the clinical development efforts of OMEICOS Therapeutics GmbH. He has also been appointed to Chief Executive Officer and Chairman of the Board of the recently founded US-based subsidiary, OMEICOS Ophthalmics. Dr. Gebauer joins the OMEICOS leadership team with over 25 years of R&D experience within the biotechnology and pharmaceutical industry.

“Alexander’s impressive track record of accomplishments, most notably his success with leading regulatory organizations resulting in numerous approvals, provides OMEICOS with additional experienced leadership to mature our diverse pipeline,” said Robert Fischer, MD, CEO of OMEICOS Therapeutics. “As the development of our lead compound progresses through the clinic and our US subsidiary OMEICOS Ophthalmics accelerates its pace, adding breadth to the management team of OMEICOS is a crucial step in building the organization’s global footprint.”

“OMEICOS is entering a very exciting and promising phase of its corporate development. With Robert as CEO and today’s addition of Alexander as Managing Director we feel the OMEICOS team is very well positioned to progress its growing pipeline steadily towards its next value inflection point,” commented Dr. Bernd Kirschbaum, Chairman of the Board of OMEICOS.

In his role as Managing Director, Dr. Gebauer will oversee the clinical development of OMEICOS’ lead compound OMT-28 for rhythm control in patients with atrial fibrillation. Together with the team, he will steer the planning and clinical trial design for the upcoming Phase II trial in atrial fibrillation for which OMEICOS is currently raising additional capital. As Chief Executive Officer of OMEICOS Ophthalmics Inc., Dr. Gebauer is responsible for the advancement of OMEICOS’ drug discovery prospects in ophthalmology.

This includes establishing further preclinical proof of concept with an external network of renowned experts in the field.

Dr. Gebauer commented, “OMEICOS has tremendous potential to make a fundamental change in the treatment of cardiovascular and ophthalmic diseases. I look forward to building on the company’s successes that have been achieved to date, capitalizing on expertise in the cardiology and ophthalmology fields which I gained in my previous roles.”

Prior to joining OMEICOS Therapeutics, Dr. Gebauer served in a multitude of R&D roles, including Managing Director, President of Global R&D, Chief Scientific Officer and other executive committee positions at several international pharmaceutical companies such as Sun Pharmaceuticals, Ranbaxy Laboratories Ltd., Merz Pharmaceuticals Hoechst AG, Aventis and Sanofi. Dr. Gebauer studied medicine at Johann Gutenberg University, Mainz/Germany, where he completed his thesis in pharmacology.

About OMEICOS OMEICOS Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine (MDC) in Berlin. The company has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat inflammatory, cardiovascular and other diseases. Epoxyeicosanoids, as a newly described class of bioactive lipid mediators, activate cell type-specific endogenous pathways that promote organ and tissue protection.

OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. OMEICOS’ technology is based on ground-breaking scientific results in the field of omega-3 fatty acid metabolism and physiology obtained by the companies’ founders, Dr. Wolf-Hagen Schunck, Prof. John. R. Falck, Prof. Dominik Mueller and Dr. Robert Fischer. The companies’ research activities are supported by a grant from the German Ministry of Education and Research (BMBF). www.omeicos.com

Contacts

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, CEO, CSO
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

MacDougall Biomedical Communications
Mario Brkulj or Kara Mazey
Main: +49 89 2424 3494 or +1 781-235-3060
E-Mail: omeicos@macbiocom.com

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OMEICOS Announces Formation of Inaugural Clinical Advisory Board

Berlin, Germany, November 13, 2017

Leading Experts in Atrial Fibrillation to Complement the Company’s Key Focus Area

OMEICOS Therapeutics, a Berlin-based biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular and ophthalmic diseases, today announced the appointment of leading experts in the field of cardiac arrhythmias to the company’s Clinical Advisory Board (CAB). The multinational group of specialists will serve as a strategic resource to OMEICOS as it continues to advance its lead compound, OMT-28, currently in a Phase I clinical trial. The CAB will provide counsel to the company as OMEICOS starts to design a Phase II program for maintenance of sinus rhythm in patients with atrial fibrillation.

The inaugural CAB meeting was held adjacent to the American Hearts Associations’ Scientific Sessions 2017 in Anaheim, CA. The initial members of OMEICOS’ Clinical Advisory Board include:

Leonardo Caló, MD, Chief of the Department of Cardiology at Policlinic Casillino, Rome and Professor of Medicine at University Cattolica, Rome (Italy)

John Camm, MD, FRCP, Professor of Clinical Cardiology at St. George’s Hospital, University of London and at Imperial College, London (United Kingdom)

Dobromir Dobrev, MD, Professor and Director of Institute of Institute of Pharmacology, University of Duisberg-Essen (Germany)

Andreas Goette, MD, FEHRA, Professor and Head of Department of Cardiology and Intensive Care Medicine at St. Vincenz Hospital, Paderborn (Germany)

Gerald Naccarelli, MD, FACC, FAHA, FHRS, Bernard Trabin Chair in Cardiology, Professor of Medicine and Chief of the Division of Cardiology at Pennsylvania State University College of Medicine/Milton S Hershey Medical Center, Pennsylvania (USA)

“We are extremely pleased to have attracted a group of world-renowned leaders to one of our key focus areas, atrial fibrillation” said Robert Fischer, MD, CEO of OMEICOS. “The addition of these seasoned experts to OMEICOS’ Clinical Advisory Board is a testament to the potential of our program and we look forward to their invaluable scientific and clinical development expertise as we shape our strategy to develop an effective therapeutic to achieve long term rhythm control in patients with AF.”

Dr. Leonardo Caló is focused on studying cardiac arrhythmias, electrophysiology and ablation and is an expert in the functional role played by omega-3 fatty acids in the prevention of arrhythmias in different settings. He is a Fellow of the European Society of Cardiology and has participated in several international clinical trials. He is associated Editor of Journal of Cardiovascular Interventional Electrophysiology and European Journal of Preventive Cardiology, has authored or co-authored numerous papers and more than 20 book chapters. Prof. Caló has participated in several international clinical trials.

Dr. John Camm is focused on cardiac arrhythmias, atrial fibrillation, stroke prevention, clinical cardiac electrophysiology, heart failure and cardiomyopathy patients. He is President of the European Heart Rhythm Association and Founder of the Atrial Fibrillation Association and in addition, a Fellow of the Royal College of Physicians (London, Edinburgh and Glasgow), the American College of Cardiology, the American Heart Association and the European Society of Cardiology (ESC). Prof. Camm has written or edited more than 40 books and has authored or co-authored almost 1300 peer reviewed papers and over 500 book chapters in the field of cardiology and has been involved in the production of numerous guidelines, including the ESC guidelines for the management of atrial fibrillation. In 2010 and 2012, he was the recipient of the ESC Gold Medal and the British Cardiovascular Society’s Mackenzie Medal.

Dr. Dobromir Dobrev is an internationally recognized expert in understanding the cellular and molecular mechanisms underlying development, progression and maintenance of cardiac arrhythmias, particularly atrial fibrillation. He has authored over 200 peer reviewed articles and is on the editorial board of numerous cardiovascular journals. He is currently Chairman of ESC Working Group on Cardiac Cellular Electrophysiology and co-authored the 2016 ESC guidelines for the management of atrial fibrillation.

Dr. Andreas Goette is a specialist in interventional cardiology as well as clinical and experimental electrophysiology. The main focus of his research is on molecular mechanisms and molecular biology of atrial fibrillation. Since 2015 he is one of the Chairman of the German Atrial Fibrillation NETwork (AFNET). He was the Chair of the Scientific Program Committee of the European Heart Rhythm Association (EHRA), co-authored various international guidelines in atrial fibrillation treatment and published more than 150 peer reviewed papers.

Dr. Gerald Naccarelli is a cardiologist and arrhythmia expert who has been in clinical practice for 36 years. He is past-president of the Heart Rhythm Society (HRS) and served on the Board of Trustees of the American College of Cardiology and HRS. He is a recipient of the American Heart Association’s Paul Dudley White Award. Prof. Naccarelli has published over 600 peer reviewed papers, book chapters and reviews in addition to authoring four books related to cardiac arrhythmia. He is currently on the steering committee of multiple clinical trials and has vast experience in the development and approval of multiple anti-arrhythmic agents in the USA.

About Atrial Fibrillation Atrial fibrillation (AF) is the most common cardiac arrhythmia in humans. More than 30 million patients are affected worldwide and this number is increasing by 2% per year due to the aging population. AF is characterized by an irregular heart rhythm originating from the heart’s upper chambers, resulting in inefficient blood pumping. AF leads to a significant reduction in quality of life, increases the risk of stroke, raises the risk of heart failure and doubles the risk of death. Marketed anti-arrhythmic drugs have limited efficacy and often severe adverse effects, which together with the huge number of affected patients accounts for a high unmet medical need for a safe and efficacious medical treatment of AF.

About OMEICOS

OMEICOS Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine (MDC) in Berlin. The company has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat inflammatory, cardiovascular and other diseases. Epoxyeicosanoids, as a newly described class of bioactive lipid mediators, activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. OMEICOS’ technology is based on ground-breaking scientific results in the field of omega-3 fatty acid metabolism and physiology obtained by the companies’ founders, Dr. Wolf-Hagen Schunck, Prof. John. R. Falck, Prof. Dominik Müller and Dr. Robert Fischer. The companies’ research activities are supported by a grant from the German Ministry of Education and Research (BMBF). www.omeicos.com

Contact

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, Chief Scientific Officer and Managing Director
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

MacDougall Biomedical Communications
Mario Brkulj or Dr. Jacob Verghese
Main: +49 89 2424 3494 or +49 175 501 0575
E-Mail: mbrkulj@macbiocom.com

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OMEICOS Secures Extension of Series B Financing Round to Expand its Technology into Ophthalmology

Berlin, Germany, and Boston, MA, USA, October 04, 2017

OMEICOS adds REMIGES Ventures as new investor and announces the incorporation of U.S. subsidiary OMEICOS Ophthalmics, Inc.

OMEICOS Therapeutics, a Berlin-based biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular diseases, today announced that it has secured an extension of its recently closed Series B financing round. The financing by US-based REMIGES Ventures will help to expand the development of OMEICOS’ technology into the field of ophthalmological disorders. The company’s novel technology is based on stable synthetic small molecules which mimic natural highly bioactive lipid mediators derived from omega-3 fatty acids. REMIGES Ventures joins the existing investor consortium including Vesalius Biocapital II S.A. SICAR, a SMS Group company, VC Fonds Technologie Berlin, Hightech Gründerfonds II GmbH & Co. KG (HTGF) and KfW Group. Financial details of the additional investment were not disclosed.

In conjunction with the Series B financing round extension, OMEICOS establishes an US-based subsidiary, OMEICOS Ophthalmics, in Cambridge Massachusetts. The financing allows OMEICOS to expand its proprietary technology into a new field and to test pre-clinically a range of compounds and different routes of administration for different types of eye diseases, like age-related macular degeneration.

“The fact that omega-3 fatty acids play a crucial role in the health and disease of the brain including the retina, and the fact that the improved drug-like properties of our compounds bypass limitations of omega-3 fatty acid supplementation – that’s driving our excitement about this new development opportunity,” said Robert Fischer, Dr. med., CSO and co-founder of OMEICOS. “Our expansion into a new indication and being part of Boston’s vibrant biotech community will provide additional benefits for our Berlin-based startup in terms of expertise, diversity and future patient population.”

Taro Inaba, Founder and Managing Partner at Remiges Ventures will join the Board at OMEICOS. He brings over 25 years of business development and venture investment experience at Remiges Ventures and Mitsui Ventures, a Japan and US based global investment company.

Taro Inaba commented: “We are very pleased to have joined the OMEICOS’ Series B financing round, which allows the company to expand its technology into the new area. We have a strong belief, based on the recent scientific discoveries, that the OMEICOS’ unique technology opens the door to a new era of treatment in ophthalmology. The entire Remiges team is excited to actively participate in the effort of building the firm’s new operation in the United States.”

About OMEICOS

OMEICOS Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine (MDC) in Berlin. The company has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat inflammatory, cardiovascular and other diseases. Epoxyeicosanoids, as a newly described class of bioactive lipid mediators, activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. OMEICOS’ technology is based on ground-breaking scientific results in the field of omega-3 fatty acid metabolism and physiology obtained by the companies’ founders, Dr. Wolf-Hagen Schunck, Prof. John. R. Falck, Prof. Dominik Müller and Dr. Robert Fischer. The companies’ research activities are supported by a grant from the German Ministry of Education and Research (BMBF). www.omeicos.com

Contact

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, Chief Scientific Officer and Managing Director
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

MacDougall Biomedical Communications
Mario Brkulj or Dr. Jacob Verghese
Main: +49 89 2424 3494 or +49 175 501 0575
E-Mail: mbrkulj@macbiocom.com

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OMEICOS Secures Continued BMBF Support with New €1.7M Research Grant to Advance its Novel Approach to Treat Cardiovascular Diseases

Berlin, Germany, June 07, 2017

Clinical Trial in Atrial Fibrillation Ongoing as OMEICOS Evaluates Therapeutic Paradigm in Additional Indication Areas

OMEICOS Therapeutics, a biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular diseases including atrial fibrillation, today announced the approval of a new grant by the German Ministry of Education and Research (BMBF). The grant of approximately €1.7 million covers half of the investment needed to advance an OMEICOS research project with the other half coming from the funds secured in a Series B round from an investor consortium including Vesalius Biocapital II S.A. SICAR, a SMS Group company, VC Fonds Technologie Berlin, Hightech Gründerfonds II GmbH & Co. KG (HTGF), KfW Group and The Falck Revocable Trust, Ascenion GmbH and members of the management team earlier this year. The project will facilitate further research activities into OMEICOS’ novel approach to treat cardiovascular diseases and to explore its potential in other areas of high unmet medical need. With this renewed support from the German government as part of the Ascenion Spinnovator program, OMEICOS has secured so far roughly €4 million non-dilutive funding.

“With the Series B closed earlier this year and continued support by the BMBF, OMEICOS is well positioned to enter the next stage of its corporate development. While clinical development of our lead development candidate OMT-28 advances through the clinic in atrial fibrillation, we will continue exploring other potential applications of the unique mode of action in other areas within the cardiovascular space and beyond,” commented Dr. Robert Fischer, CSO and co-founder of OMEICOS.

OMEICOS’ lead compound, OMT-28, is a stable synthetic small molecule analog of a natural occurring omega-3 fatty acid metabolite, which has a structure optimized to provide high efficacy, safety and oral bioavailability. OMT-28 has demonstrated anti-arrhythmic and cardioprotective potential in different in vivo models and is currently being evaluated in a randomized, double-blind, placebo-controlled Phase 1 study in Germany.

About Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia in humans. AF is characterized by an irregular heart rhythm originating from the heart’s upper chambers, resulting in inefficient blood pumping. AF leads to a significant reduction in quality of life, increases the risk of stroke, raises the risk of heart failure, and doubles the risk of death.

About OMEICOS

OMEICOS Therapeutics is a spin-off company from the Max Delbrück Center for Molecular Medicine (MDC) in Berlin. The company has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids, that have the potential to treat inflammatory, cardiovascular, and other diseases. Epoxyeicosanoids as a newly described class of bioactive lipid mediators activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. OMEICOS’ technology is based on ground-breaking scientific results in the field of omega-3 fatty acid metabolism and physiology obtained by the companies’ founders Drs. Wolf-Hagen Schunck, John. R. Falck, Dominik Müller and Robert Fischer. www.omeicos.com

Contact

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, Chief Scientific Officer and Managing Director
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

MacDougall Biomedical Communications
Gretchen Schweitzer or Mario Brkulj
Phone: +49 (0) 89 2423 3494 or +49 175 5010575
E-Mail: mbrkulj@macbiocom.com

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OMEICOS Announces First Closing of €8.3 Million Series B Financing Round and the Initiation of Phase 1 Clinical Trial

Berlin, Germany, March 1, 2017

Financing Provides Runway Beyond Completion of First-in-man Trial with Lead Compound OMT-28 for Treatment of Atrial Fibrillation

OMEICOS Therapeutics, a biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular diseases, today announced the first closing of a Series B financing round of €8.3 million and the initiation of a Phase 1 clinical trial with lead compound OMT-28 for the treatment of atrial fibrillation. The financing was led by Vesalius Biocapital II S.A. SICAR and SMS Company Group, along with existing investors KFW Group, VC Fonds Technologie Berlin, High-Tech Gründerfonds II GmbH & Co. KG (HTGF), The Falck Revocable Trust, Ascenion GmbH and members of the management team. The funding will be used to support the newly initiated clinical program and to further leverage the therapeutic potential of the technology.

In addition to the financing, OMEICOS today announced the dosing of the first subject in the first-in-human clinical study for its lead candidate, OMT-28. The goal of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of OMT-28 in healthy volunteers. The randomized, double-blind, placebo-controlled Phase 1 study is being conducted in a single center in Germany and aims to enroll up to 100 subjects.

“The successful closing of the Series B financing round in combination with the initiation of the first clinical trial with our lead compound, OMT-28, marks the beginning of a new stage of corporate development for OMEICOS,” said Dr. Robert Fischer, CSO and co-founder of OMEICOS. “We are grateful for the ongoing support of our investors and anticipate this financing to fully fund the company throughout the duration of the Phase 1 clinical study, which will set the stage for a swift transition into a subsequent Phase 2 trial.”

“We believe in the potential of OMEICOS’ distinctive small molecules to treat atrial fibrillation and other inflammatory and cardiovascular diseases,” said Vesalius Biocapital’s Dr. Christian Schneider. “We look forward to seeing progress with the Phase 1 clinical trial and are pleased to continue and strengthen our financial investment in the company.”

OMEICOS’ lead compound, OMT-28, is a stable synthetic small molecule analog of the natural omega-3 fatty acid metabolite 17,18-EEQ, which has a structure optimized to provide high efficacy, safety and oral bioavailability. OMT-28 has already proven its anti-arrhythmic and cardioprotective potential in different in vivo experimental models. OMEICOS’ synthetic analogs of omega-3 fatty acid epoxides are currently focused on cardiovascular diseases, although they have the potential to be applied across a wide range of diseases.

More information on the trial (Eudra-CT 2016-003445-28) will be provided via the European Union Clinical Trials Register.

About Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia in humans. More than 30 million patients are affected worldwide and this number is increasing by 2% per year due to the aging population. AF is characterized by an irregular heart rhythm originating from the heart’s upper chambers, resulting in inefficient blood pumping. AF leads to a significant reduction in quality of life, increases the risk of stroke, raises the risk of heart failure and doubles the risk of death. Marketed anti-arrhythmic drugs have limited efficacy and often severe adverse effects, which together with the huge number of affected patients accounts for a high unmet medical need for a safe and efficacious medical treatment of AF.

About OMEICOS

OMEICOS Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine (MDC) in Berlin. The company has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids that have the potential to treat inflammatory, cardiovascular and other diseases. Epoxyeicosanoids, as a newly described class of bioactive lipid mediators, activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. OMEICOS’ technology is based on ground-breaking scientific results in the field of omega-3 fatty acid metabolism and physiology obtained by the companies’ founders, Dr. Wolf-Hagen Schunck, Prof. John. R. Falck, Prof. Dominik Müller and Dr. Robert Fischer. The companies’ research activities are supported by a grant from the German Ministry of Education and Research (BMBF). www.omeicos.com

Contact

OMEICOS Therapeutics GmbH
Dr. Ulrich Dauer, Chief Executive Officer and Managing Director
Dr. Robert Fischer, Chief Scientific Officer and Managing Director
Phone: +49 (0) 30 9489 4810
E-Mail: u.dauer@omeicos.com, r.fischer@omeicos.com
www.omeicos.com

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MacDougall Biomedical Communications
Gretchen Schweitzer or Mario Brkulj
Phone: +49 (0) 89 2423 3494 or +49 175 5010575
E-Mail: mbrkulj@macbiocom.com

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OMEICOS Receives BMBF Research Grant to Advance its Novel Approach to Treat Atrial Fibrillation

Berlin, Germany, November 2, 2015

OMEICOS Therapeutics, a biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular diseases including atrial fibrillation, today announced the approval of an approximately €1.7 million grant by the German Ministry of Education and Research (BMBF). The grant covers half of the investment needed to advance an OMEICOS’ research project with the other half coming from the funds secured in a Series A round from an investor consortium including Vesalius Biocaptial II S.A. SICAR, a SMS Group company, VC Fonds Technologie Berlin, Hightech Gruenderfonds II GmbH & Co. KG (HTGF) and KfW Group earlier this year. The project will facilitate further research activities into OMEICOS’ novel approach to treat atrial fibrillation using orally available small molecule drug candidates and to explore their potential in other areas of high unmet medical need.

OMEICOS’ novel therapeutic approach is based on the discovery of highly potent synthetic analogues of natural-occurring omega-3 fatty acid metabolites which activate a novel endogenous organ-protective pathway. The drug candidates show beneficial pharmacological activity in preclinical models, including the ability to protect normal sinus rhythm in hearts prone to develop arrhythmia. OMEICOS’ drug candidates are metabolically much more stable than their natural counterparts and have ideal drug-like characteristics. These properties suggest that they can be delivered orally as therapeutics which, together with the novel mode of action, promises a significant improvement in the treatment of patients.

“With this additional funding secured, we feel well positioned to achieve our three main objectives within the 18 months’ project runtime: to complete the preclinical package for our lead development candidate, to extend our research into its unique mode of action and to explore new therapeutic opportunities for our platform technology,” commented Dr. Robert Fischer, CSO and co-founder of OMEICOS.

“This renewed support from the German government further acknowledges the excellent research by OMEICOS’ team and its collaborators and the potential of our novel approach. In combination with the funding received as part of the Ascenion Spinnovator program today’s news brings the total amount of grant money we were able to secure so far to roughly €2.2 million,” Dr. Ulrich Dauer, CEO of OMEICOS added.

About Atrial Fibrillation

About OMEICOS

OMEICOS Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine (MDC) in Berlin. The company has discovered a series of metabolically robust synthetic analogues of omega-3 fatty acid-derived epoxyeicosanoids, that have the potential to treat inflammatory, cardiovascular, and other diseases. Epoxyeicosanoids as a newly described class of bioactive lipid mediators activate cell type-specific endogenous pathways that promote organ and tissue protection. OMEICOS’ small molecules are orally available and show improved biological activity and pharmacokinetic properties compared to their natural counterparts. OMEICOS’ technology is based on ground-breaking scientific results in the field of omega-3 fatty acid metabolism and physiology obtained by the companies’ founders Drs. Wolf-Hagen Schunck, John. R. Falck, Dominik Müller and Robert Fischer. www.omeicos.com

Contact

Media requests

MacDougall Biomedical Communications
Gretchen Schweitzer or Mario Brkulj
Phone: +49 (0) 89 2423 3494 or +49 175 5010575
E-Mail: mbrkulj@macbiocom.com

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OMEICOS Therapeutics Raises EUR 6.2 Million in Series A to Advance Lead Candidate in Atrial Fibrillation

Berlin, Germany, April 15, 2015

OMEICOS Therapeutics, a biopharmaceutical company developing first-in-class small molecule therapeutics for the prevention and treatment of cardiovascular diseases including atrial fibrillation (AF), today announced that it has raised EUR 6.2 million in a Series A round. Participating in the round were Vesalius Biocapital II S.A. SICAR, acting as lead; a SMS Group Company; VC Fonds Technologie Berlin; Hightech Gruenderfonds II GmbH & Co. KG (HTGF); and KfW Group. As part of the financing round, the company has received subsidies of EUR 550,000 via Ascenion’s Spinnovator, a grant program supported by the German Ministry of Education and Research (BMBF).

“The growing population of AF patients is faced with outdated and extremely limited medical treatment options. Current treatments have insufficient efficacy, risk of severe side effects, and are unable to reduce patient mortality,” said Dr. Robert Fischer, Chief Scientific Officer of OMEICOS Therapeutics. “We are grateful for the recognition from our investors that OMEICOS has the potential to develop truly novel drugs to prevent and treat severe cardiovascular diseases such as AF.”

The company’s novel therapeutic strategy is based on synthetic derivatives of natural metabolites of omega-3 fatty acids that have a strong antiarrhythmic effect. So far, approaches to make omega-3 fatty acids therapeutically effective have not been particularly successful due to the instability of their bioactive metabolites. OMEICOS has managed to overcome this hurdle by developing synthetic molecules that are equally potent as natural metabolites, but much more stable, making them suitable as orally available therapeutics.

Unlike other antiarrhythmic drugs, OMEICOS’ compounds activate an endogenous cardio-protective signaling pathway that stabilizes heart rhythm. In addition, the compounds are expected to provide curative effects to diseased hearts by preventing electrical and structural remodeling, a common cause of heart disease and sudden cardiac death. OMEICOS’ proprietary platform has high potential for further development in additional therapeutic indications in the cardiovascular area as well as in chronic inflammatory diseases.

“With their unique technology and seasoned team of experts, we believe that OMEICOS will fill the existing gap in AF treatment,” added Dr. Christian Schneider of Vesalius Biocapital Partners. “We are happy to support OMEICOS by leading such a strong syndicate of private and public investors and look forward to working with the company to advance its lead candidate through the pre-clinic into clinical development.”

Following the closing of the financing round, Christian Schneider and Gaston Matthyssens of Vesalius Biocapital Partners, Peter Seiler of SMS Group, Ute Mercker of VC Fonds Technologie Berlin, Martin Pfister of Hightech Gruenderfonds II GmbH & Co. KG, and co-founder Wolf-Hagen Schunck have joined the OMEICOS Supervisory Board.

About Atrial Fibrillation

About OMEICOS

OMEICOS Therapeutics is a spin-off company from the Max Delbrueck Center for Molecular Medicine (MDC) in Berlin, co-founded and managed by Dr. Robert Fischer (Managing Director) and Dr. Karen Uhlmann. The company is developing oral, first-in-class, small molecules for the prevention and treatment of cardiovascular diseases, initially focusing on AF. The company’s novel, small molecule AF therapy is based on proprietary synthetic analogues of omega-3 fatty acid metabolites. The technology was originally discovered and developed by a research team under the supervision of Dr. Wolf Schunck and Dr. Dominik Mueller at MDC and Dr. John R. Falck at the University of Texas Southwestern Medical Center. OMEICOS’ lead candidate is envisioned for oral, once-daily treatment for patients with paroxysmal and persistent AF, with and without structural heart disease, for maintenance of sinus rhythm. www.omeicos.com

About Vesalius Biocapital Partners

Vesalius Biocapital Partners invests in companies active in human health through venture capital funds raised since 2007. With over EUR 150 million under management in two funds, Vesalius Biocapital Partners plays the role of lead investor in the large majority of its financing rounds. We invest in European life science companies in all stages of development with a sound proprietary technology and corresponding IP, unique team skills and a clear competitive edge based on solid data. Our investment strategy focuses on therapeutics, medical devices, and diagnostics. www.vesaliusbiocapital.com

About IBB Beteiligungsgesellschaft mbH

The IBB Beteiligungsgesellschaft provides venture capital to innovative Berlin enterprises and has established itself as a market leader in the field of early stage financing in the location Berlin. The funds are used primarily for the development and market launch of innovative products or services, as well as for business concepts of creative industries. Currently two of the funds managed by the IBB Beteiligungsgesellschaft are in the investment phase, the VC Fonds Technologie Berlin with a fund size of EUR 60 million and the VC Fonds Kreativwirtschaft Berlin with a fund size of EUR 40 million. Both VC funds are financed by means of the Investitionsbank Berlin (IBB) and the European Fund for Regional Development (EFRE) administered by the State Berlin. Since 1997 the IBB Beteiligungsgesellschaft Berlin, in consortia with partners, has made EUR 1.006 million available to creative and technology-orientated companies; thereof, the portion invested by IBB Beteiligungsgesellschaft itself, as lead, co-lead or co-investor, was approximately EUR 141 million. www.ibb-bet.de

About KfW Group

KfW is one of the world’s leading promotional banks. With its decades of experience, KfW is committed to improving economic, social and ecological living conditions across the globe on behalf of the Federal Republic of Germany and the federal states. To do this, it provided funds totaling EUR 74.1 billion in 2014 alone; and of this, 36 % went into measures for protecting the environment and combating climate change. KfW does not have any branches and does not hold customer deposits. It refinances its promotional business almost entirely through the international capital markets. In 2014 KfW raised EUR 57.4 billion for this purpose. In Germany, the KfW Group is represented in Frankfurt, Berlin, Bonn and Cologne. Its network includes 80 offices and representations around the world. www.kfw.de

About High-Tech Gruenderfonds (HTGF)

High-Tech Gruenderfonds invests in young, high potential high-tech start-ups. The seed financing provided is designed to enable start-ups to take an idea through prototyping and to market launch. Typically, High-Tech Gruenderfonds invests EUR 500,000 in the seed stage, with the potential for up to a total of EUR 2 million per portfolio company in follow-on financing. Investors in this public/private partnership include the Federal Ministry of Economics and Energy, the KfW Banking Group, as well as strategic corporate investors including ALTANA, BASF, Bayer, B. Braun, Robert Bosch, CEWE, Daimler, Deutsche Post DHL, Deutsche Telekom, Evonik, Lanxess, media + more venture Beteiligungs GmbH & Co. KG, METRO, Qiagen, RWE Innogy, SAP, Tengelmann and Carl Zeiss. High-Tech Gruenderfonds has about EUR 576 million under management in two funds (EUR 272 million HTGF I, EUR 304 million HTGF II).

www.high-tech-gruenderfonds.de

About Ascenion

Ascenion GmbH is an IP asset management company with particular expertise in the life sciences. Ascenion advises and supports public research institutions in all aspects of technology transfer. The company places particular emphasis on coaching company founders and on active equity management and holds equity in 25 life-science companies. Ascenion is technology transfer partner of 22 research institutes in the Helmholtz and Leibniz Associations, as well as of the Charité, the Hannover Medical School, the research institute TWINCORE and the Universität zu Lübeck. www.ascenion.de

Contact

OMEICOS Therapeutics GmbH
Dr. Robert Fischer, Chief Scientific Officer and Managing Director
Robert-Rössle-Straße 10
13125 Berlin
Phone: +49 (0) 30 9489 4810
E-Mail: r.fischer@omeicos.com
www.omeicos.com

Media requests

MacDougall Biomedical Communications
Gretchen Schweitzer or Blair Atkinson
Phone: +49 (0) 89 2424 3494 or +49 (0) 151 2348 2513
E-Mail: batkinson@macbiocom.com