Paris & New York, October 3, 2017
- Positive results from Phase IIa trial of QGC001 for the treatment of arterial hypertension
- Launch of NEW-HOPE Phase II targeted clinical trial in the United States
- Continuation of research programs, particularly in heart failure
- Strengthening of cash position and financial visibility
Quantum Genomics (Euronext Growth - FR0011648971 – ALQGC), a biopharmaceutical company specializing in the development of a new class of proprietary drugs directly acting on the brain to treat unmet medical needs in the field of cardiovascular diseases, released its financial results for the first half of the year, approved by the Board of Directors at its meeting on October 2, 2017.
The half-year financial report, including the financial statements for the period ended June 30, 2017, associated Notes and external auditor's report are available on the Company's website: www.quantum-genomics.com.
Lionel Ségard, Chairman and Chief Executive Officer of Quantum Genomics, states:
"The financial results for the first half of the year show the acceleration of our drug development programs on our pipeline. The successful capital increase in July substantially increases our financial visibility and provides us with the resources required to pursue our roadmap.
Presented at the Congress of the European Society on Hypertension (ESH) Annual Meeting, held in June, the full results of our Phase IIa study are encouraging for our drug candidate QGC001. This is an important milestone bringing us closer to our objective, which aims to provide a new class of drugs to the millions of patients suffering from complicated or resistant hypertension, and for whom treatment has failed in part or in full.
At the end of August, we received approval from the US Food and Drug Administration (FDA) to continue our clinical investigations of QGC001 in the US. At the end of September, we launched our NEW-HOPE study in the United States, a Phase II clinical trial that will enable us to evaluate our molecule on 250 hypertensive patients with higher cardiovascular risks. We are also continuing our other clinical development programs, particularly in heart failure."
Positive results from Phase IIa trial of QGC001: a major milestone achieved and the launch of the larger Phase II study in the United States
- Phase IIa of the study: greater decrease in blood pressure in the most hypertensive patients
In June, Quantum Genomics published the detailed results of the first Phase IIa clinical trial with the QGC001 product for the treatment of hypertension. This study confirmed the positive trend of the first results and emphasized several promising elements:
- QGC001 is an antihypertensive drug; the higher the blood pressure, the higher its antihypertensive effect.
- QGC001 is well-tolerated, particularly with regard to renal function (no creatinine nor kalemia increase),
- QGC001 does not affect the hormones involved in cardiovascular regulation (renin, angiotensin, aldosterone), which demonstrates the particularly innovative side of QGC001's mechanism of action.
QGC001 is the first Brain Aminopeptidase A Inhibitor (BAPAI). It uniquely targets a previously unexplored metabolic pathway in the brain, which plays a key role in regulating blood pressure and in protecting the heart. The central and the longer peripheral action of the drug is indeed a new and radically innovative pharmacological approach.
- Launch of NEW-HOPE Phase II study
As an extension of Phase IIa results, the US FDA approved Quantum Genomics' Investigational New Drug (IND) application for the launch of a targeted Phase II clinical trial in arterial hypertension in the United States with drug candidate QGC001. This clinical study, titled NEW-HOPE, will be conducted across 25 major hospitals in the United States on 250 hypertensive or overweight patients, with the majority from minority ethnic groups (African-American, Hispanic, Asian). The first patient will be recruited in the last quarter of 2017 and the first results of the NEW-HOPE study are expected in the first quarter of 2019. Following this trial, a Phase III clinical study could then be initiated with QGC001.
Continuation of combined drug treatment for arterial hypertension and heart failure development programs
- Strengthening of the QGC001 combined drug treatment program intellectual property
In February 2017, the company's patent portfolio was expanded with a key patent protecting in Europe the therapeutic use of drug candidate QGC001 until December 2032 in combination with several other approved and highly prescribed drugs for treating hypertension and heart failure.
- Continuation of QUID HF study in heart failure
Throughout the first half of the year, Quantum Genomics has continued its multi-center Phase IIa study in heart failure, with the clinical trial part finishing by the end of the current financial year.
Consolidation of the management team and the Scientific Advisory Board
- Appointment of Bruno Besse as Chief Medical Officer
Bruno Besse joined Quantum Genomics as Chief Medical Officer. A cardiologist at the Georges-Pompidou hospital in Paris, France, he brings more than 20 years of experience working in Medical Affairs departments in leading pharmaceutical companies, thus strengthening Quantum Genomics' cardiology expertise.
- Appointment of Professor Toshiro Fujita to the Scientific Advisory Board
Professor Toshiro Fujita joined the company's Scientific Advisory Board. His internationally renowned expertise in resistant arterial hypertension and his knowledge of the Japanese pharmaceutical market are definite assets for Quantum Genomics.
Strengthening of financial visibility
- Key figures as of June 30, 2017
|Data in €k (French standards)||30/06/2017||30/06/2016|
|Revenue (expense transfer)||8.4||4.7|
|Other operating expenses||(3,224.6)||(2,018.7)|
|Earnings before taxes||(4,634.7)||(3,095.7)|
|Research tax credit||624.9||417.0|
On June 30 2017, the operating income was -€4.5 million versus -€3.1 million one year earlier. The increase in expenses reflects the ongoing clinical trials, particularly the QUID HF study and the preparation of the NEW-HOPE study. The consumption of active substance inventory has reached €0.6 million and external expenses related to R&D activities have increased by €0.5 million.
Free cash flow (net cash flow from operating activities) was -€4 million for the period.
After accounting for net financial expenses of €0.1 million and the research tax credit of €0.8 million, Quantum Genomics reports a net income of -€4 million versus -€2.8 million for the first half of 2016.
As of June 30, 2017, shareholders' equity was €6.7 million and available cash flow reached €7.3 million versus €11.2 million on December 31, 2016. The company has no financial debt.
- Strengthening of financial structure through a capital increase of €8.2 million
In July, Quantum Genomics increased its capital by €8.2 million through a private investment of 2,191,698 shares with equity warrants attached (ABSA). This capital increase could rise to €16 million if the redeemable equity warrants (BSA) attached to the new shares are exercised in full. This increase would support the company's new drug development programs, particularly the NEW-HOPE study.
Taking into account this operation and the cash flow available on June 30, the Company has the funds required to pursue its drug development programs until mid-2019.
Upcoming 2017 meetings
- October 4 & 5 European Large & Midcap Event (Paris)
- 25 & 26 MedStartUp and Galien Forum (New York)
- November 18 & 19 Shareholder's Forum/Salon Actionaria (Paris)
- November 28 & 29 Midcap Event (Geneva)
- December 7SFAF Presentation (Paris)
- December 19Biomed Event (Paris)
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, it relies on its 20 years of academic and clinical research in some of the largest French laboratories (The French National Institute of Health and Medical Research (INSERM), the National Center for Scientific Research (CNRS), the Collège de France, and the Paris-Descartes University). Quantum Genomics thus aims to develop innovative treatments for complicated or resistant arterial hypertension (among 30% of patients are poorly-controlled or under unsuccessful treatment), and heart failure (one in two patients die within five years of being diagnosed).
Based in Paris and New York, the company is listed on the Euronext Growth market in Paris (FR0011648971 - ALQGC) and is trading on OTCQX in the United States (symbol: QNNTF).
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