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  Communiqué de la société QUANTUM GENOMICS du 06/10/2021

  06/10/2021 - 18:00

Quantum Genomics Publishes 2021 Half-year Results and Reviews its Clinical Activity


Quantum Genomics Publishes 2021 Half-year Results and Reviews its Clinical Activity

  • Firibastat expected to launch in late 2023 for difficult-to-treat/resistant hypertension.
  • Gross cash of €24.9 million at June 30, 2021.

Quantum Genomics (Euronext Growth - FR0011648971 - ALQGC), a biopharmaceutical company specializing in the development of a new drug class that directly targets the brain to treat difficult-to-treat/resistant hypertension and heart failure, today reported its 2021 half-year results.

Jean-Philippe Milon, Chief Executive Officer at Quantum Genomics, said in a statement:

“In the first half of 2021, we enrolled the first patient in our phase III REFRESH trial, continued the phase III FRESH trial and completed the Phase IIb QUORUM trial, the results of which were presented at the end of the August and pave the way for a new treatment for heart failure following myocardial infarction in severe patients. Despite a severely disrupted healthcare environment, Quantum Genomics is forging ahead with determination and discipline. Our stated objective is to start marketing firibastat for difficult-to-treat or resistant hypertension by the end of 2023. In the meantime, we remain fully committed to finding new partners to help us move into phase III in heart failure, and are continuing to explore new therapeutic areas, building on our teams' expertise and on the potential of our technology platform developed around brain aminopeptidase inhibitors”

Continuation of research programs: launch of firibastat expected by end 2023

Quantum Genomics is continuing its research programs despite the pandemic's impact on hospital services.

In difficult-to-treat/resistant hypertension, Quantum Genomics confirmed that it plans to launch firibastat in late 2023 as a once-daily dose, a regimen that improves treatment compliance. In line with discussions with the FDA (U.S. Food and Drug Administration), the marketing application, which is expected to be submitted in Q3 2023, will be based on interim data from the Phase III REFRESH trial, and after six months of follow-up.

The REFRESH trial is a pivotal phase III trial of firibastat in patients with difficult-to-treat and resistant hypertension anad aims to demonstrate the long-term safety and three-month efficacy of the product after a once-daily dose of 1000mg. The first patient was enrolled last July. This study is being conducted jointly with DongWha and Orient EuroPharma, in accordance with the partnership agreements entered into for South Korea, South-East Asia, Australia and New Zealand respectively. The interim data from this trial, which will support the marketing application filed with the FDA, should be available by mid-2023.

The FRESH trial is a randomised, double-blind, placebo-controlled trial initiated shortly before REFRESH and conducted in partnership with Biolab Pharma. Patient enrolment in Brazil fell behind due to the considerable impact of the COVID-19 pandemic on the Brazilian healthcare system. The situation is now stable and the outcomes of FRESH will be presented in Q2 2022.

The timelines of these two trials align with the the Company's plan to launch firibastat in late 2023.

In heart failure, Quantum Genomics presented the results of the phase IIb QUORUM trial at the end of August. These results demonstrated the efficacy and good tolerance of firibastat, particularly in severe patients with an ejection fraction lower than 50%. These results pave the way for a phase III clinical trial in severe patients. The protocol for this trial is currently being developed with the Quantum Genomics committee of experts. It will then be discussed and approved with the pharmaceutical laboratory that will be partnering Quantum Genomics in phase III and in launching firibastat for this indication.

2021 half-year results: controlled cash flow of €24.9 million

In the first half of 2021, Quantum Genomics continued to receive payments under partnership agreements announced in 2020. Over the six-month period from January 2021 through June 2021, Quantum Genomics billed and collected €2.3 million in royalties, corresponding to upfront payments under partnership contracts signed in South Korea, Greece and Canada. Total payments received in 2020 and 2021 amounted to €4.3 million.

For the first six months of 2021, operating income amounted to €2.7 million compared with €0.4 million a year earlier. The operating result amounted to -€7.2 million, compared with -€5.9 million at the end of June 2020. Personnel costs remained under control, while the progress of clinical studies logically led to an increase in operating costs.

After recognition of the research tax credit of €1.2 million, net income was -€6.2 million at June 30, 2021. Free cash flow was -€5.7 million over the period.

At the end of the first half of 2021, the company's equity amounted to €21.8 million, plus €0.3 million in other equity capital, which include conditional advances from Bpifrance. At the beginning of the year, Orient EuroPharma Co. Ltd (OEP) acquired a stake in Quantum Genomics in a reserved capital increase of €0.9 million, strengthening the ties between the two companies in South-East Asia and Oceania.

Available cash stood at €24.9 million at June 30, 2021, compared with €27.2 million at 31 December 2020, while financial debt stood at €3 million. The latter consisted of a €1.5 million government-guaranteed loan from BNP and a €1.5 million R&D innovation loan from BPIFrance.

In the second half of 2021, Quantum Genomics should receive its first milestone payments following the expected inclusion of the first patients in South Korea and Taiwan in REFRESH.

Summary of financial information at June 30, 2021:

Data in €k (French standards) 30/06/2021 30/06/2020
Products 2,711.7 377.3
Personnel costs (1,109.7) (1,134.0)
Other operating costs (8,824.8) (5,198.5)
Operating result (7,222.9) (5,955.2)
Financial result 4.9 (2.2)
Profit before tax (7,218.0) (5,957.4)
Extraordinary income (130.6) 16.5
Research tax credit 1,168.3 860.0
Net income (6,180.2) (5,081.0)

Release of the half-year financial report

The half-year financial report, including the financial statements at June 30, 2021, the management report and the statutory auditor's report, will be published on the Company's website on October 6, 2021.The half-year financial statements were approved by the Board of Directors on October 4, 2021. They were subject to a limited review by the statutory auditor.

About Quantum Genomics

Quantum Genomics is a biopharmaceutical company specialising in the development of a new class of cardiovascular drugs based on the Brain Aminopeptidase A Inhibition (BAPAI) mechanism. It is the only company in the world to explore this innovative approach that directly targets the brain, drawing on more than twenty years of research by Paris-Descartes University and the INSERM/CNRS laboratory headed by Dr. Catherine Llorens-Cortès at the Collège de France. Quantum Genomics aims to develop innovative treatments for complicated or even resistant hypertension (approximately 30% of patients are inadequately controlled or failing treatment), and heart failure (half of the patients diagnosed die within five years).

Based in Paris, the company is listed on Euronext Growth Paris (FR0011648971 - ALQGC) and on the OTCQX market in the United States (symbol: QNNTF).

For more information, please go to www.quantum-genomics.com, or follow us on Twitter and LinkedIn

Contacts

Quantum Genomics  
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Edifice Communication (EUROPE)  
Financial communication and media
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LifeSci (USA)  
Mike Tattory
Media communication
+1 (646) 751-4362 - [email protected]
 

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  Original Source : QUANTUM GENOMICS