- Sound balance sheet: €13.2 M cash and no financial debt at 30 June
- 18-month financial visibility
PARIS and NEW YORK, Oct. 13, 2016 (GLOBE NEWSWIRE) -- 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 financial results for the first half of the year, approved by the Board of Directors at its meeting of 12 October 2016. The half-year financial report, including the financial statements for the period ended 30 June 2016, associated Notes and in external auditor's report are available on the Quantum Genomics website. In addition, the Company provided a business update for the first nine months of 2016.
Lionel Ségard, Chairman & CEO of Quantum Genomics, says:
"Our strong financial position, positive topline Phase IIa results from the arterial hypertension study, launch of Phase IIa trial in heart failure and issuance of key patents have allowed us to optimistically continue our drug development strategy, along with financial visibility in the order of 18 months.
Our goal remains to sign, during Phase II, a licence agreement or partnership with the best possible partner to ensure continuing clinical development and commercialization of our drug-candidates.”
Key Figures 1st half 2016
The first-half 2016 results reflect the ongoing R&D programs at Quantum Genomics, during which the Company completed a Phase IIa clinical trial of QGC001 in hypertension (high blood pressure) and accelerated development of its lead product in a second indication with the initiation of a Phase IIa pan-European study of QGC001 in heart failure.
During the first-half 2015, expenses were tightly controlled and the balance sheet was strengthened following a capital raise of €8.6 million capital, potentially rising to €14.1 million if the redeemable equity warrants (BSAR) are exercised in full.
Half-year operating income was -€3.1 million, versus -€1.9 million in the same period 2015.
Net income was -€2.8 million, versus -€1.8 million in the same period 2015, after taking into account net financial income of -€20k and a €417k research tax credit.
Free cash flow (net cash flow from operating activities) was -€3.2 million in the period.
In balance sheet terms, the financial structure was strengthened by the capital increase in March 2016, raising shareholders' equity to €13.0 million as of June 30, 2016.
Available cash amounted to €13.2 million at June 30, 2016, versus €8.7 million at the end of 2015.
The company has no financial debt.
Highlights First Half 2016
- Capital increase of €8.6 million in the United States and Europe, potentially rising to €14.1 million
In March 2016, Quantum Genomics increased its capital by €8.58 million via a €5.54 million private placement with U.S. institutional investors and a €3.04 million public offering to its shareholders in Europe. This capital increase could rise to €14.12 if the redeemable equity warrants (BSAR) attached to the new shares are exercised in full.
- Strengthened presence in the United States
Early in the year, Quantum Genomics was granted a new patent in the United States protecting the industrial manufacturing process for its drug candidate QGC001 in one of its key target markets until October 2031. The U.S. Patent and Trademark Office also granted two new patents in May 2016, protecting the crystalline trihydrate form of QGC001 until November 2031 with a possible additional five-year extension, and a new crystalline form of QGC001 in combination with L-lysine until October 2033 with a possible five-year extension as well.
To support the upcoming clinical trials in the United States, Quantum Genomics has also formed an American Clinical Advisory Board comprised of Dr Keith C. Ferdinand (New Orleans), Henry Black (New York) and Howard Dittrich (San Diego), respected and prominent clinicians in arterial hypertension and cardiology.
Furthermore, Quantum Genomics opened an office in New York, NY on March 1st 2016.
- Completion of Phase IIa clinical trial for hypertension (high blood pressure)
The Phase IIa clinical trial for high blood pressure with the drug candidate QGC001, conducted at four clinical investigation centres in France under the leadership of Prof Michel Azizi (Georges Pompidou European Hospital, Paris), was completed in April 2016. In total, 34 patients with moderate Grade I and II hypertension were included and randomised in a double-blind crossover study including two 28-day sequences alternating the tested product against a placebo, separated by a 14-day washout (no treatment) period.
The topline results from this clinical trial were released on September 29, 2016 (read the release below).
- Regulatory authorisations received and the first centres opened for the Phase IIa multicentric pan-European clinical trial for heart failure
After receiving the regulatory authorisations, Quantum Genomics opened the first three clinical centres – in France (Louis Pradel Hospital in Lyon and Laennec Hospital in Nantes) and Norway (Stavanger University Hospital in Stavanger) – for the QUID HF (QUantum Genomics Incremental Dosing in Heart Failure) Phase IIa multicentric European trial for the treatment of chronic heart failure in humans.
Led by Prof. Faiez Zannad, Professor of Therapeutic Cardiology at the University of Lorraine (Nancy CHU teaching hospital), QUID HF is a randomised double-blind study of 75 patients to assess the effects of multiple doses of QGC101, in chronic heart failure sufferers with altered cardiac ejection fraction.
The trial will be conducted in approximately 10 university hospitals across six European countries.
In the animal health field, Quantum Genomics announced at the end of June, that it had extended the cooperation agreement with its partner, one of the world leaders in animal health. The two companies will continue their close cooperation with a view to launching further clinical trials with the drug candidate developed by Quantum Genomics for the treatment of heart failure in dogs. The financial terms of this agreement remain confidential.
Events after the reporting period and recent news
- Positive topline data reported from the Phase IIa clinical trial of QGC001 for high blood pressure
In late September, Quantum Genomics reported positive topline results for its Phase IIa trial in high blood pressure with its drug candidate QGC001. The data displayed 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 a placebo. This positive result was confirmed by an in-depth multivariate analysis.
- IND application to be filed in the first half of 2017 to launch in the United States a Phase II clinical trial for high blood pressure in a target population
At the Pre-Investigational New Drug (IND) meeting with the U.S. Food & Drug Administration (FDA) in Washington DC, the FDA reviewed and analysed the entire QGC001 application, including all preclinical and clinical data available to date. Based on these factors, the FDA advised the company on how to conduct the trial in the United States on a targeted population of hypertensive patients. Quantum Genomics plans to file the IND application for this trial in the first half of 2017.
The company is also studying the possibility of conducting future Phase II trials in Europe and Asia.
- €800k financing obtained from Bpifrance (French Public Investment Bank)
In August 2016, the company received an €800k "innovation advance" (zero-rate loan for innovation) from Bpifrance. This advance will be used to support the Phase IIa clinical trial for heart failure. The first instalment of €480k was received at the end of September.
Next meetings
| October 26-28, 2016 | MedStartUp and Galien Forum (New York, USA) |
| November 8, 2016 | Biotech Agora (Paris, France) |
| November 12-16, 2016 | American Heart Association - Scientific Sessions 2016 (New Orleans, USA) |
| November 18-19, 2016 | Shareholders Forum / Salon Actionaria (Paris, France) |
| Nov 30-Dec 1, 2016 | Midcap Event (Geneva, Switzerland) |
| December 6, 2016 | Midcap Day, French society of financial analysts (SFAF) (Paris, France) |
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 high blood pressure and heart failure.
Quantum Genomics 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.