ALQGC.PA: First Half Results
EPA:ALQGC
READ THE FULL ALQGC.PA RESEARCH REPORT
Quantum Genomics S.A. (EPA:ALQGC) reported first half 2022 results in an October 5th press release. During the period, Quantum enrolled its final patient in the FRESH study and has scheduled the release of topline results to be presented at the American Heart Association November conference in Chicago, Illinois. Other important events during the reporting period were the raise of additional capital in April and the generation of €2.9 million in revenues.
Since the beginning of the year, Stéphane Cohen was appointed as Chief Operating Officer, Sarah Merlen Boulenger as the Head of Regulatory Affairs and new members were added to 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 first half 2022 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 €2.9 million in 1H:22 and incurred operating expenses of (€12.5) million yielding net loss of (€8.9) million or approximately (€0.26) per share.1
For the six-month period ending June 30, 2022 and versus the comparable six-month period ending June 30, 2021:
➢ Revenue was €2.9 million, up 7% from €2.7 million, mainly comprising milestones from South Korea and Taiwan related to the REFRESH study. The amount also includes €0.6 million from Biolab for the FRESH study in Brazil;
➢ Personnel costs were €1.3 million, comparable with €1.1 million;2
➢ Research and development costs were €10.6 million vs. €6.7 million with the increase attributable to continued progress in clinical studies;
➢ Other operating costs were €0.7 million vs €0.5 million, driven by higher depreciation and other expenses partially offset by lower taxes;
➢ Tax represented a (€1.2) million contribution to income reflecting a research and development tax credit;
➢ Net loss was (€8.9) million versus (€6.2) million, or (€0.26) and (€0.23),3 respectively.
As of June 30, 2022, cash and equivalents totaled €19.4 million. Cash burn for the first half was (€11.4) million. Financial debts stand at €3.0 million and relate 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. The presentation featuring FRESH results is scheduled for 3 pm on November 7th.
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.
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
Upcoming Milestones
➢ AHA Scientific Sessions, FRESH topline – November 7, 2022
➢ Preparation of Phase III protocol in heart failure – 2022
➢ Seeking partners in US, EU China & Japan for hypertension & heart failure – 2022/2023
➢ Firibastat Type C meeting for heart failure with FDA – 1Q:23
➢ Efficacy results for REFRESH study – June 2023
➢ Phase I PK study, firibastat 1x per day – 2H:23
➢ FDA submission of firibastat – End of year 2023
➢ Firibastat approval and commercialization – 2024/2025
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1. Calculation uses end of period share count to calculate earnings per share
2. Amounts include social security charges
3. Calculation uses end of period share count to calculate earnings per share
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 October 2022 Corporate Presentation
