READ THE FULL ALQGC RESEARCH REPORT
As the FRESH and REFRESH trials continue to advance, Quantum Genomics S.A. ALQGC is looking forward to November when results from the FRESH study are expected. Other recent highlights for the company include the appointment of Stéphane Cohen as Chief Operating Officer, Sarah Merlen Boulenger as the Head of Regulatory Affairs and the addition of new members of the Scientific Advisory Board. As results from the FRESH study are made public, we expect increased activity from management to reach out to new partners in Asia, the U.S. and E.U. for further licensing deals. We provide an update on Quantum's financial performance and include results from the full year 2021 press release and financial report.
Highlights for 2022 include:
➢ Appointment of François Pelen to the Board of Directors – January 2022
➢ Stéphane Cohen joins as Chief Operating Officer - March 2022
➢ New patents granted for QGC606 - March 2022
➢ Publication of article featuring QGC606 - March 2022
➢ €17.6 million fundraising – April 2022
➢ Appointment of Sarah Merlen Boulenger as Head of Regulatory Affairs – May 2022
➢ Recruitment completion for FRESH study – May 2022
➢ Appointment of new Scientific Advisory Board – June 2022
Financial Results
Quantum generated revenues of €3.2 million in 2021 and incurred operating expenses of (€22.3) million yielding net loss of (€16.6) million or approximately (€0.60) per share.1
For the full year ending December 31, 2021 and versus the same period ending December 31, 2020:
➢ Revenue was €3.2 million, up 40% from €2.3 million, mainly comprising upfronts from South Korea, Greece and Canada;
➢ Personnel costs were €2.7 million, comparable with €2.3 million;2
➢ Research and development costs were €16.7 million vs. €12.3 million with the increase attributable to continued progress in clinical studies;
➢ Other operating costs were €3.0 million vs €1.5 million, driven by increase in raw materials and supply costs, greater depreciation and an increase in other expenses;
➢ Income tax was a (€2.7) million reduction in pre-tax income;
➢ Net loss was (€16.6) million versus (€11.5) million, or (€0.60) and (€0.43),3 respectively.
As of December 31, 2021, cash and equivalents totaled €24.9 million. Cash burn for the first half was (€5.8) million. Financial debts stand at €3.0 million related to the PGE state guaranteed loan and the R&D innovation loan.
End of Patient Recruitment for FRESH
In a May 9th press release, Quantum announced that it had completed patient recruitment for its Phase III pivotal FRESH study. No treatment-related adverse events were reported. The study enrolled an estimated 502 patients in 69 hospitals across Europe, Canada, the United States and Latin America. FRESH is a double-blind, placebo-controlled, multicenter, efficacy and safety study of firibastat administered over 12 weeks in adult subjects, with uncontrolled primary hypertension. Subjects were randomized 1:1 to firibastat or placebo in addition to existing chronic antihypertensive treatments.
We expect a readout of the primary and secondary endpoints of various blood pressure readings to be shared with investors in the coming months and be presented during the American Heart Association (AHA) Congress in Chicago from November 5 to 7, 2022.
Scientific Advisory Board
The direction of the FRESH and REFRESH studies had been guided by a Scientific Steering Committee that consisted of five experts in the field of hypertension that have each served in this role for several years. In June 2022, Quantum formed a Scientific Advisory Board (SAB) which included several of the same members of the committee to advise Quantum on the future disposition of firibastat. The board members include seasoned members Drs. George Bakris, Keith Ferdinand and Alexandre Persu, who are joined by Drs. Gregory Lip and Atul Pathak who are new to Quantum's SAB.
New Capital and New Investors Added
Quantum Genomics S.A. raised €15.6 million gross benefitting from an April deal conducted with several new and existing shareholders. Participants in the raise include Otium Capital, the family office of Pierre-Edouard Stérin and Vatel Capital among others. In parallel, recently added partner Julphar agreed to increase its capital investment by €1.87 million. The Julphar shares have a one-year lockup attached.
Shares associated with the €15.6 million raise were issued at €2.44 per share, a 15% discount to the April 26 Quantum closing price. Subscription rights, which allow a shareholder to maintain his proportional ownership in the company, were rescinded as part of the offering.
Monies from the raise will be used to continue the funding of firibastat development and explore new therapeutic fields based on existing Brain Aminopeptidase A Inhibition (BAPAI) patents. Following the financing, Quantum will hold €23.6 million in cash, which is sufficient to fund operations until 2Q:23.
Recent highlights include:
➢ Exclusive license agreement with Teva Israel - November 2021
➢ Exclusive license and production agreement with Julphar - December 2021
➢ Stéphane Cohen joins as Chief Operating Officer - March 2022
➢ New patents granted for QGC606 - March 2022
➢ Publication of article featuring QGC606 - March 2022
➢ Capital raise of €17.6 million – April 2022
Partnerships
New Appointments, Patents and Publications
Stéphane Cohen – Chief Operating Officer
On March 14, 2022, Quantum announced that Stéphane Cohen joined the firm as Chief Operating Officer. Stéphane Cohen has held operational management and senior leadership positions involving a dozen successful market launches of new treatments in major pharmaceutical companies, particularly at Bayer and Pfizer for eighteen years. Dr. Cohen earned his PharmD from Aix-Marseille University and his master's in marketing from the ESSEC Business School.
Sarah Merlen Boulenger - Head of Regulatory Affairs
On May 4, 2022, Sarah Merlen Boulenger was introduced as the Head of Regulatory Affairs. As Quantum advances through its late-stage trials and moves closer to its New Drug Application (NDA) submission, it is preparing for regulatory interactions. With a background in regulatory affairs at both Sanofi and Ethypharm, Dr. Boulenger will initiate efforts for market registration for firibastat as the product completes clinical trials and is reviewed by the regulatory agencies.
New patents granted for QGC606
On March 28th, 2022, Quantum reported that QGC606 was granted the following patents: US 17/437,862 and AU2020235216. These two new patents protect QGC606 in the United States and Australia until March 2040, including any derivative pharmaceutical compositions, for the treatment of cardiovascular disease.
Quantum published a new scientific article regarding the efficacy of QGC606 in an experimental model of heart failure. The article titled "QGC606, a best-in-class orally active centrally acting aminopeptidase A inhibitor prodrug, for treating heart failure following myocardial infarction" appeared in the Canadian Journal of Cardiology. The research piece found that chronic oral administration of QGC606 in mice after myocardial infarction provided beneficial effects. It improved cardiac function and reduced cardiac remodeling and fibrosis, but did not reduce blood pressure, unlike ramipril.
Clinical Pipeline
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1. Using year end share count to calculate full year earnings per share
2. Amounts include social security charges
3. Using end of period share count as of December 31 for each year
4. Compiled by Zacks Analysts
5. Malaysia, Philippines, Singapore, Vietnam, Thailand, Indonesia, Myanmar, Cambodia
6. Commonwealth of Independent States: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan
7. Source: Quantum Genomics June 2022 Corporate Presentation
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