On October 1, 2020 Quantum Genomics Corp. (EPA:ALQGC) issued a press release highlighting the company’s financial and operational achievements over the first six months of 2020. Quantum’s clinical programs persisted in light of some pandemic headwinds. The QUORUM study was delayed and the end of recruitment is now expected by year end 2020; however, the FRESH study is on track with no expected delays. FRESH results are expected to be announced by year end 2021. Quantum held €13.2 million in cash on its balance sheet at the end of June. The highlight since our July initiation is the consummation of the Orient EuroPharma (OEP) partnership, which will provide milestones and double digit royalties on sales for commercialization of firibastat for the treatment of difficult to treat/resistant hypertension in South East Asia, Australia and New Zealand.
In the first half of 2020, Quantum Genomics recorded a net loss of (€5.1) million or (€0.25) per share compared to a net loss of (€4.1) million or (€0.24) in the year earlier period. The difference is primarily attributed to research and development expenses of €4.8 million in 1H:20, up from €3.9 million in 1H:19. Wages and salaries and social security charges partially offset the increase in research and development expenses which were down 28% to €1.1 million in 1H:20.
Available cash amounted to €13.2 million as of June 30, 2020, compared to €11.2 million as of December 31, 2019 with financing from other borrowings and debts funding the increase. Financial and other debts amount to €2.4 million. Financial debt with Negma will be converted into shares and as of October 1, less than €1.7 million of financial debt remained.
In January 2019, Quantum announced the launch of QUORUM Phase IIb study for firibastat in post myocardial infarction (MI) heart failure (HF), a 294-patient trial to characterize safety and efficacy of firibastat in patients after acute anterior MI. In the trial, subjects are required to have a diagnosis of first acute anterior MI and a primary percutaneous coronary intervention (PCI) within 24 hours after MI. QUORUM is structured to compare three parallel groups including firibastat at 100 mg BID and 500 mg BID, and ramipril 5 mg BID over a three month treatment period. The primary endpoint of the trial is change in baseline of left ventricular ejection fraction. In mid-April 2019, Quantum received the first of its regulatory approvals from the French authority to initiate QUORUM, to be conducted in seven European countries and in June 2019, Quantum enrolled its first patient. The trial has been conducted at 38 hospitals throughout Europe and was expected to provide topline results in 2H:20. With slight delay from the pandemic, QUORUM expects to be fully recruited by the end of 2020.
Phase IIb Post-MI HF Trial Design (1)
Quantum announced the start of its Phase III FRESH (Firibastat in treatment-RESistant Hypertension) in mid-December 2019, conducted in partnership with Biolab Sanus Pharmaceuticals. FRESH enrolled its first patient in July 2020. The 500-subject trial is designed as a three month, double-blind, placebo-controlled study in difficult-to-treat and resistant hypertension (HTN) as defined by systolic blood pressure above 140 mm Hg and treatment with two or three anti-hypertensive classes including a diuretic. Study treatment is 500 mg of firibastat, administered twice per day in addition to currently mandated therapy. The trial targets 70 sites around the globe, including hospitals in Europe, the US, Canada and Latin America. Biolab will be responsible for 20% of trial costs and will manage the trials in Latin America.
The primary endpoint for the study is change from baseline in systolic automated office blood pressure (AOBP). Secondary outcomes include measurement of diastolic blood pressure, mean 24-hour ambulatory systolic and diastolic blood pressure.
FRESH Study Design (2)
As of October 2020, management announced that the first patient was enrolled in the FRESH trial with top-line results expected to be announced by the end of 2021.
Expected to begin in the second quarter of 2021 (3) and partially concurrent with FRESH is the RE-FRESH trial, a pivotal efficacy and safety Phase III study, also in difficult-to-treat and resistant hypertensive patients. This effort will enroll 750 patients with AOBP above 140 mm Hg. 650 patients will receive firibastat for six months, and 100 patients will receive firibastat for one year. This trial will also be of randomized, double-blind, placebo-controlled design with firibastat administered on top of current treatment for twelve weeks. There will also be an open-label extension for up to 12 months to further evaluate safety. Trial design is still underway; however, the focus will be on long-term safety.
RE-FRESH Study Design (4)
Exclusive Licensing and Collaboration Agreement
On September 22, 2020, Quantum Genomics announced that it had entered into an exclusive licensing and collaboration agreement with Orient EuroPharma (OEP) for the commercialization of firibastat in South East Asia, Australia and New Zealand. In the agreement, Quantum Genomics will receive upfront and milestone payments up to US$19 million plus double-digit royalties on sales, with milestones based both on development and sales. The total up front has not been disclosed.
Quantum Genomics is developing its lead candidate, firibastat, which is currently in Phase III trials for difficult to treat and resistant hypertension. Quantum has already signed a commercialization arrangement with Brazilian pharmaceutical company Biolab Sanus, entered into in late 2019, for the development and commercialization of the lead candidate in the Latin American market. Under the terms of the agreement, OEP will maintain exclusive rights to commercialize firibastat in difficult to treat/resistant hypertension in Taiwan, Malaysia, the Philippines, Singapore, Vietnam, Thailand, Indonesia, Myanmar, Cambodia, Australia and New Zealand. The estimated addressable population in these regions is 10 million. OEP will also fund part of the Phase III study for firibastat in difficult to treat and resistant hypertension in Taiwan.
Quantum’s sole candidate, firibastat, works within the renin-angiotensin-aldosterone system (RAAS). The RAAS regulates blood pressure, fluid and electrolyte balance and systemic vascular resistance and is the system in which angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) act. Specifically, Brain Aminopeptidase A Inhibitors (BAPAIs) target not the peripheral but brain-level (central) RAAS that plays a unique role in regulating blood pressure. Brain-level RAAS was already known to modulate systemic tone, but, until now, a formulation allowing BAPAI to cross into the brain had not existed. Brain-level RAAS is of special interest, as, unlike peripheral RAAS, central RAAS also has neural relevance to systemic tone, making it a critical target for difficult-to-treat, resistant or salt-sensitive hypertension and post-MI HF. Firibastat is a prodrug, comprised of two EC33 moieties dimerized via disulfide bond. The prodrug crosses the blood brain barrier more readily than EC33, where it is then cleaved and activated by brain-level reductases.
Quantum’s firibastat has a triple mechanism of action which may address high blood pressure in resistant populations. The action of the drug prevents the aminopeptidase A enzyme from converting A2 into A3. A3 will normally bind to angiotensin receptor type 1 (AT1), which raises blood pressure. Without A3, vasopressin release is reduced, sympathetic nerve activity declines and baroreflex action increases. Additionally, A2 is converted to angiotensin-(1-7) rather than A3, which has anti-hypertensive effects. Because HTN and HF are related, many drugs used to treat HTN are implemented in the management of post-MI HF. Brain-level RAAS has been implicated in post-MI cardiac remodeling; thus, firibastat can potentially go beyond current therapies to alter the course of post-MI HF.
Quantum is conducting multiple clinical trials for multiple cardiovascular indications. Below we list key milestones that have occurred in the last year and anticipated future events.
‣ First patient enrolled in Phase III FRESH study – July 2Q:20
‣ Final results of PK study in firibastat renal patients – 3Q:20
‣ Final results of PK study with firibastat table formulation – 3Q:20
‣ Licensing and collaboration agreement with OEP – September 2020
‣ Completion of Phase IIb QUORUM (heart failure) study recruitment – 4Q:20
‣ Bridging PK/PD study for 1x/day in hypertension – 1H:21
‣ Pivotal Phase III efficacy and long term safety (REFRESH) study – 1Q:21
‣ Readout from Phase IIb QUORUM study – 1H:21
‣ Launch Phase III study for heart failure – 2H:21
‣ Complete Phase III efficacy (FRESH) study – 2H:22
‣ New drug application for firibastat – 2023
Quantum’s pipleine consists of one drug with various formulations pursuing multiple indications. The drug is being investigated in difficult-to-treat and resistant HTN and HF in once per day formulations. There is also preliminary work being done in renal failure, a common comorbidity with resistant HTN and HF that limits treatment options. Firibastat is currently in one Phase III trial for hypertension, one Phase II trial for HF and Phase I trials for QD formulation HTN and renal failure.
Quantum Development Pipeline (5)
Quantum is advancing its efforts for firibastat with development and commercialization partnerships established in Latin America, Southeast Asia, Australia and New Zealand. We expect additional partnerships to be announced over the next year. The company maintains sufficient cash on the balance sheet to continue clinical trials of €13.2 million and is expected to receive additional funds from milestones in coming quarters.
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1. Source: Quantum Corporate Presentation, June 2020.
2. Source: Quantum Corporate Presentation, June 2020.
3. As guided in the June 2020 corporate presentation.
4. Source: Quantum Corporate Presentation, June 2020.
5. Source: Quantum Corporate Presentation, June 2020.