Recruitment completed more than six months ahead of schedule for Phase 2b NEW-HOPE trial of firibastat for treatment of hypertension in the United States
Announced design of Phase 2b QUORUM trial of firibastat for treatment of heart failure
New governance introduced to drive development of brain aminopeptidase A inhibitors (BAPAIs)
Quantum Genomics (Euronext Growth – FR0011648971 – ALQGC), a biopharmaceutical company specializing in the development of a new class of drugs directly acting on the brain to treat unmet medical needs in the field of cardiovascular diseases, has released its half-yearly financial results that were approved by the Board of Directors on October 3, 2018. The half-year financial report, including the financial statements for the period ended June 30, 2018, associated notes and external auditor's report are available on the company's website: www.quantum-genomics.com.
Jean-Philippe Milon, chief executive officer (CEO) of Quantum Genomics, said: “The first half of 2018 was marked by the efficient advancement of our clinical programs, including our lead NEW-HOPE program examining firibastat, formerly known as QGC001, for the treatment of hypertension. With the completion of patient enrolment in this trial more than six-months ahead of schedule, we look forward to presenting top-line results in a late-breaking presentation at the American Heart Association Meeting in November. The speed of the recruitment process in this trial highlights the need for new treatment options for patients with hypertension who are resistant to current therapies. Additionally, the anticipated launch of the QUORUM trial, a Phase 2b clinical study of firibastat for the treatment of heart failure, by the end of 2018 further demonstrates our commitment to continued research and innovation.”
Key events from the first half-year
New governance structure implemented
In April 2018, Quantum Genomics changed its governance structure by separating the roles of chairman and CEO. Jean-Philippe Milon was named CEO, given his extensive international experience in the pharmaceutical industry and cardiovascular diseases, while Lionel Ségard retained his role as chairman of the Board of Directors. Quantum Genomics' diverse management team with complementary expertise in industry, research and cardiology drives the Company's aim to intensify the research of its new class of BAPAI drugs and achieve its commercial potential.
Approval of the generic name 'firibastat' by the World Health Organization
The World Health Organisation (WHO) has approved the generic name 'firibastat' for the active ingredient developed by Quantum Genomics, previously known as both RB150 and QGC001.
Acceleration of research programs
In April 2018, Quantum Genomics initiated a new development phase through its 3-year strategic plan, “BAPAIs Fast Growth.” The plan focuses on accelerating research programs that are currently in progress with the renewed ambition of preparing to market a therapeutic group that is patented worldwide to treat resistant arterial hypertension and heart failure.
Recruitment for the NEW-HOPE study, a Phase 2b clinical trial that aims to assess the efficacy and tolerance of firibastat in the treatment of arterial hypertension in high-risk cardiovascular patients of diverse ethnic origins, was completed more than six months ahead of schedule. The results will be presented at the annual conference of the American Heart Association, which will be held November 10-12, 2018.
In June 2018, Quantum Genomics also announced the design of its Phase 2b trial in heart failure, QUORUM. This study will assess the efficacy and tolerance of firibastat in comparison with ramipril in patients with a reduced ejection fraction after an acute myocardial infarction. The trial is expected to begin by the end of the year.
Finally, Quantum Genomics is developing controlled-release firibastat tablets that can be administered in a single dose. Quantum Genomics plans to initiate a clinical trial in healthy volunteers to evaluate the pharmacokinetic parameters of the new formulation by the end of 2018.
2018 first half financial results
The financial statements for the first half of 2018 reflect the intensification of research and development activities, particularly the acceleration of the NEW-HOPE study.
As of June 30, 2018, operating income was -€6.8 million, compared with -€4.5 million one year earlier. After booking a research tax credit (RTC) of €0.7 million, Quantum Genomics recognised a net income of -€6.2 million as compared to -€4.0 million for the first half of 2017.
Free cash flow (net cash flow relating to business operations) was -€5.7 million for the period.
At the end of June 2018, shareholders' equity stood at €3.3 million, with an additional €1.2 million in other own funds (conditional advances from Bpifrance).
Available cash flow was €6.0 million, compared with €11.1 million at December 31, 2017, plus a €24 million equity line from Kepler Cheuvreux, €0.7 million of which was used over the course of the first half-year.
The company has no financial debts.
Key figures as of June 30, 2018
|Figures in €k (French standards)||30/06/2018||30/06/2017|
|Staff costs||- 1,207.0||- 1,276.4|
|Other operating costs||- 5,668.9||- 3,232.9|
|Operating income||- 6,810.1||- 4,501.0|
|Financial earnings||- 0.1||- 133.7|
|Pre-tax operating earnings||- 6,810.3||- 4,634.7|
|Extraordinary earnings||- 60.9||- 27.7|
|Research tax credit||663.1||624.9|
|Net income||- 6,208.1||- 4,037.6|
November 10-12, 2018 Presentation of the top-line results from the NEW-HOPE trial to be held at the annual conference of the American Heart Association in Chicago
About Quantum Genomics
Quantum Genomics is a biopharmaceutical company specializing in the development of a new class of cardiovascular drugs based on the Brain Aminopeptidase A Inhibition (BAPAI). The only company in the world exploring this innovative approach, which directly targets the brain and relies on 20 years of academic research from the Paris-Descartes University and the laboratory managed by Dr. Catherine Llorens-Cortès at the Collège de France (French National Institute of Health and Medical Research (INSERM)/ the Scientific Centre for National Research (CNRS)). The goal of Quantum Genomics is to develop innovative treatments for complicated, or even resistant, cases of hypertension (around 30% of patients have poor control of their condition or receive ineffective treatment) and for heart failure (one in two patients diagnosed with heart failure dies within five years).
Based in Paris and New York, Quantum Genomics is listed on the Euronext Growth exchange in Paris (FR0011648971- ALQGC) and trades on the OTCQX Best Market in the United States (symbol: QNNTF).
For more information, please visit www.quantum-genomics.com, or follow us on Twitter and LinkedIn
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