QUANTUM GENOMICS : 2015 annual report : acceleration of clinical trials, secured financing and internationalisation in progress

information fournie par Actusnews •14/04/2016 à 18:00

Quantum Genomics (Alternext - FR0011648971 - ALQGC) , a biopharmaceutical company whose mission is to develop new therapies for unmet medical needs in the field of cardiovascular diseases, announces that its 2015 annual report, including the 2015 financial accounts, approved by the Board of Directors at a meeting held on 13 April 2016, their appendices and the auditors reports, is available online (www.quantum-genomics.com).

Quantum Genomics is also taking this opportunity to issue a report on the highlights from 2015 and the start of 2016.

Lionel Ségard, CEO of Quantum Genomics, states:

“2016 is a very promising year, in particular due to the start of the phase IIA clinical trial on heart failure, an ambitious Pan-European study, but also due to the end of the phase IIA clinical trial on high blood pressure. We are also preparing to implement two new phase IIB trials on high blood pressure in 2017: one on a targeted population that will take place in the United States and the other in Europe with specific work on biomarkers.”

The 2015 accounts reflect the progress of the Quantum Genomics programmes during the year: a phase IIA clinical trial on the drug candidate QGC001 for high blood pressure and the acceleration of developments in the field of heart failure.

In this context, cash consumption has continued to be well-managed and the balance sheet structure has been strengthened following the capital increase relating to the 12.9M€ public offering carried out in February 2015.
Operating result stands at -4.3 M€ in contrast to -2.4 M€ in 2014.

Net result stands at -3.8 M€ in contrast to -2.2 M€ in 2014, taking into account a financial result of - 0.2 M€ and a research tax credit (RTC) of 0.7 M€.

Free cash flow (value of net disbursements linked to operations) was limited to -3.5 M€ for the entire year.

This resulted in a cash position of 8.7 M€ on 31 December 2015 in contrast to 3.3 M€ at the end of 2014, to which should be added the 8.6 M€ capital increase carried out in March 2016.

At the end of 2015, the company had no financial debt and its equity stood at 8.0 M€.

Capital increase via public offering: 12.9M€ raised
In February 2015, Quantum Genomics carried out a capital increase via public offering, which was a resounding success, oversubscribed 3.4 times, with significant participation from individual investors. This operation raised 12.9 M€ and greatly opened up the company's capital.

Key progress in the QGC001 programme on high blood pressure
The phase IIA clinical trial started in March 2015 with the recruitment of the first patients at four clinical investigation centres (Paris, Lyon, Lille and Dinard), under the supervision of Professor Michel Azizi (Clinical Investigation Centre of the Hôpital Européen Georges Pompidou in Paris). Analysis of the mid-trial clinical and biological monitoring criteria by the Monitoring Committee has shown a satisfactory safety profile among patients, enabling the trial to continue with no change of protocol. At the start of 2016, all patients had been recruited and the clinical part of the trial will be completed in April 2016. Results will be available in the 3 ^rd quarter of 2016.

Key progress in the QGC101 programme on heart failure
Following the encouraging results obtained in June 2015 in the trial on heart failure in dogs, at the end 2015, Quantum Genomics received a letter of intent from its partner in animal health, to guarantee the rights of both parties while waiting to sign the final agreement. Quantum Genomics and this major player in the field of animal health are currently in discussions to jointly define the outline and protocol of the next clinical trials with a view, in due course, to marketing of a future drug for use in animal health.

Quantum Genomics has also announced its intention to launch a phase IIA clinical trial among men from for its drug candidate QGC101, starting summer 2016, initial planning for which has been ongoing for more than six months. In view of this, Quantum Genomics has recruited Professor Faiez Zannad as the main expert in the preparation of these multi-centre clinical trials, which will be carried out in several European countries.

Furthermore, Quantum Genomics signed a research collaboration agreement in July 2015 with the University of Ottawa Heart Institute. This agreement aims to complete non-clinical trials further demonstrating the therapeutic value of centrally acting aminopeptidase A inhibitors (BAPAIs) in the prevention and treatment of heart failure.

Creation of a joint INSERM-Quantum Genomics laboratory, at the Collège de France, with the financial backing of the French National Agency for Research (ANR)
In terms of basic research on the therapeutic platform of BAPAIs, in 2015, Quantum Genomics announced the creation of a joint INSERM-Quantum Genomics laboratory, at the Collège de France, backed by the ANR, which has granted this laboratory a subsidy of 300 K€ over the 2015-2017 period.

Broadening the scope of the next clinical trials in Europe and the United States
Lastly, Quantum Genomics' Scientific Committee met in November 2015 in Paris. It carried out a review of the various trials underway and recommended subjects for subsequent stages of development. In particular, it discussed broadening the scope of the next clinical trials in Europe and the United States, based on a multi-centre approach, both for high blood pressure (QGC001 programme) and heart failure (QGC101 programme).

Increasing Quantum Genomics' presence in the United States
In January 2016, Quantum Genomics was granted a new patent for the United States, protecting the industrial manufacturing process of the drug candidate QGC001 until October 2031. The granting of this new patent by the US Patent and Trademark Office considerably enhances the company's intellectual property portfolio in relation to its flagship product and enables it to provide and protect the industrial manufacturing of this drug candidate in one of its main target markets.

In terms of its development on the other side of the Atlantic, and in view of the next multi-centre clinical trials to be carried out in the United States, Quantum Genomics has set up a US Clinical Committee, comprising Doctor Keith C. Ferdinand, Doctor Henry Black and Doctor Howard Dittrich, leading clinicians in high blood pressure and cardiology.

Quantum Genomics also opened a New York office on 1 March 2016 and the first meeting of the US Clinical Committee was held there on 3 March.

8.6 M€ capital increase which may be increased to 14.1 M€
To maintain the progress made and accelerate its development programmes, in March 2016, Quantum Genomics increased its capital by 8.6 M€ via a 5.5 M€ private placement with US institutional investors and a 3.1 M€ public offering to its shareholders. This capital increase could be increased to 14.1 M€ should all share purchase warrants attached to the new shares be exercised.