- June 2017: Present full results of the Phase IIa trial in arterial hypertension at the ESH Congress in Milan
- Mid-2017: Submit IND application for Phase II targeted hypertension trial to the U.S. FDA (NEW HOPE study)
- Second half of 2017: Recruit first patient in NEW HOPE clinical trial
- End 2017: Complete clinical part of Phase IIa pan-European trial in heart failure (QUID HF study)
Quantum Genomics (Alternext - FR0011648971 - ALQGC), a biopharmaceutical company with the mission of developing new therapies for unmet medical needs in the field of cardiovascular diseases, today announced its 2016 annual financial results. The audited financial statements were approved yesterday by Quantum's Board of Directors.
Lionel Ségard, Chairman & CEO of Quantum Genomics, issued the following statement:
“2016 was a productive year during which we validated major advances in each of our therapeutic indications.
In September 2016, we published the first positive results of our Phase IIa trial of drug-candidate QGC001 for the treatment of hypertension, which we completed in the first half of the year. The full results will be unveiled this June at the Congress of the European Society of Hypertension.
Regarding heart failure, we initiated a Phase IIa pan-European clinical trial, an ambitious study that we are on track to complete by the end of this year.
2017 will be a year of major developments for Quantum Genomics.
We are currently in the process of finalizing a preclinical toxicology study that will allow us to apply for IND status with the FDA, which we hope to complete by mid-year. This Phase II trial will include 250 targeted patients in more than 25 hospitals around the United States.
Lastly, we continue our discussions with several pharma players in the United States, Europe and Asia, to obtain licensing or partnership agreements for the clinical development and marketing of our drug candidates."
Key figures of fiscal year 2016
2016 financial results reflect the growth of Quantum Genomics programmes in arterial hypertension and in heart failure.
Cash consumption was under control and financial resources increased following the capital raise via public offering of €8.6 million in March 2016, which could rise to €14.1 million if the BSARs (redeemable equity warrants) are exercised in full.
The operating result for the year was a €6.2 million loss versus a loss of €4.3 million in 2015, reflecting R&D expenses increase.
Net income was - €5.2 million, versus - €1.8 million in 2015, after taking into account a €0.7 million research tax credit.
Free cash flow (net outflows for operating activities) was - €5.6 million over the full year.
At 31 December 2016, cash was in line with expectations, amounting to €11.2 million compared to €8.7 million at the end of 2015 (+ €2.5 million).
Shareholders' equity at the end of 2016 was €10.5 million and the Company has no financial debt.
Significant events in 2016
- Positive results for the Phase IIa clinical trial of QGC001 for high blood pressure
The Phase II clinical trial in hypertension was completed in April 2016 and Quantum Genomics was able to report, in September 2016, positive results. The data showed positive results for many parameters of the study, particularly the main indicator, which is a drop in daytime systolic blood pressure measured as ambulatory pressure in hypertensive patients treated with QGC001 compared to placebo. This positive result was confirmed by the multivariate analysis.
The full results will be unveiled at the European Meeting of Hypertension and Cardiovascular Protection organized by the ESH (European Society of Hypertension) from 16 to 19 June 2017, in Milan, Italy, and will be accompanied by a detailed communication from Quantum Genomics.
- Preparation of the NEW HOPE clinical trial in hypertension in the United States
Launching the Phase II trial of QGC001 in the United States in the second half of 2017, on a targeted population of hypertensive patients (NEW HOPE), Quantum Genomics considerably strengthened its presence and development on that side of the Atlantic in 2016. In addition to being granted several patents by the U.S. Patent and Trademark Office (USPTO) protecting QGC001 and its industrial manufacturing process, the Company set up an American Clinical Advisory Board composed of research clinicians respected for their expertise in cardiovascular diseases.
Lastly, in the second half of 2016, the Company held a Pre-Investigational New Drug (Pre-IND) meeting with the Food and Drug Administration (FDA) in Washington. After reviewing and analyzing the entire QGF001 dossier, including all the preclinical and clinical data, the FDA gave the Company its recommendations regarding the study to be carried out in the United States and patient targeting.
- Launch of QUID HF, Phase IIa pan-European clinical trial in heart failure
As part of the QGC101 programme in heart failure, in 2016 Quantum Genomics initiated its Phase IIa trial in humans. This ambitious pan-European trial, named QUID HF (QUantum genomics Incremental Dosing in Heart Failure), involves 75 patients in more than ten hospitals across Europe. By the end of 2016, the Company had opened the six first centres for this study: France (Louis Pradel Hospital in Lyon, Laennec Hospital in Nantes and Charles Nicolle Hospital in Rouen), Norway (Stavanger University Hospital) and the Netherlands (Groningen University Medical Centre and the Maastricht University Medical Centre).
Activity in the first half of 2017
- Key patent obtained in Europe for the combinations programme
In early February, the European Patent Office granted a new patent to Quantum Genomics protecting – until December 2032 – the therapeutic use of the drug candidate QGC001 in association with the main antihypertensive drugs already prescribed on the market (QGC011 programme). Quantum Genomics announced that it had registered this patent with the 37 Member States of the European Patent Organisation.
- Four new centres opened for the Phase IIa clinical trial in heart failure
As part of the QUID HF trial, Quantum Genomics increased the number of clinical centres participating in the trial to ten, with the opening of the Ninewells Hospital in Dundee (United Kingdom), the Wroclaw Military Hospital (Poland), the Hannover School of Medicine (Germany) and the Klinik für Innere Medizin III in Hamburg (Germany).
Next development steps
- Start of the Phase II trial in the United States in hypertension, in the second half of 2017
With a view to launching in the second half of 2017, the Phase II trial in hypertension in the United States on a targeted population of hypertensive patients, Quantum Genomics intends to file an IND application with the FDA in the middle of 2017, after finalizing the toxicology study currently underway. The preclinical genotoxicity study, which will be included in the IND application, has already demonstrated the absence of genotoxicity and the non-phototoxicity of QGC001 in animals.
This large-scale study, led by Keith Ferdinand, M.D., Professor of Medicine at Tulane University (New Orleans), will include around 250 patients across 25 clinical centres throughout the United States. The first clinical centres are expected to open and the first patients enrolled in the second half of 2017.
Based on these parameters and the timeline established, the trial is expected to run until the end of 2018 and the first results should be published in the first half of 2019.
- Completion of the Phase IIa trial in Europe in heart failure in 4Q17
Regarding the QGC101 heart failure programme, Quantum Genomics' objective is to finish the QUID HF Phase IIa pan-European trial in the fourth quarter of 2017. The results of this trial are expected to be available in the first half of 2018.
- 18 & 19 April 2017 Smallcap Event (Paris, France)
- 8 June 2017 Annual General Meeting (Paris, France)
- 16-19 June 2017 European Meeting of Hypertension and Cardiovascular Protection organised by the ESH (European Society of Hypertension) (Milan, Italy)
- 19-22 June 2017 Bio International Convention (San Diego, United States)
- 30 Aug. - 2 Sept. 2017 ISAN 2017 Symposium (Nagoya, Japan)
- 10-12 September 2017 Rodman & Renshaw Conference (New York, United States)
- 3 October 2017 2017 first-half results (after markets close)
- 4 & 5 October 2017 European Large & Midcap Event (Paris, France)
- 11-13 October 2017 Bio Japan (Yokohama, Japan)
- 28 & 29 Nov. 2017 Midcap Event (Geneva, Switzerland)
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|ABOUT QUANTUM GENOMICS
Quantum Genomics is a biopharmaceutical company with the mission of developing new therapies for unmet medical needs in the field of cardiovascular diseases, especially hypertension and heart failure.
The Company is developing a new therapeutic approach based on BAPAI (Brain Aminopeptidase A Inhibition). This is the result of more than 20 years of academic research in the laboratories of the Collège de France, INSERM, CNRS and the University of Paris Descartes.
Quantum Genomics is listed on the Alternext market in Paris (ISIN code FR0011648971, Ticker ALQGC).
The Company has offices in Paris, France, and New York, NY, USA. For more information, please visit www.quantum-genomics.com.
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