Company Expects Several Milestones as Momentum Builds for 2021
Dear Fellow Shareholders,
As 2020 draws to a close, we join the rest of the world in looking forward to a new year with new beginnings and hope for a quick return to whatever the new normal will be. Leaving behind the constant threat of lockdowns and the interruption the COVID-19 pandemic has had on our lives will be a welcome change.
With that in mind we acknowledge that 2020 was not the year we promised and feel even more committed to achieving our stated goals. We learned a great deal about Q BioMed’s place in the fragile world in which we live and operate. With the 20/20 view of hindsight, we are excited about the coming year.
Strontium Chloride Sr89 Injection, USP (Strontium89), a Palliative Treatment for Metastatic Bone Cancer
In January we expect treatment with Strontium89 in the hospital out-patient setting will be fully reimbursed by Medicare. When this occurs, we will launch a hospital-focused marketing initiative and expect to see hospitals more actively treat appropriate patients with Strontium89. We also anticipate being approved as a federal supplier in January 2021 which will allow us to sell into federal hospital systems, notably the U.S. Department of Veteran Affairs (VA) and the U.S. Department of Defense. The VA is potentially our largest target customer, with a significant percentage of its patients suffering from prostate, breast and lung cancer, and at rates higher than the national average.
We have free-standing clinics in at least eight states that are undergoing the required operational steps to become a ‘Strontium89 practice’, including having it on their radioactive materials license, with some clinics already up and running. We also expect to have group purchasing contracts in place in early January and have begun to negotiate with national and regional oncology organizations.
We have been deploying a multi-channel marketing campaign, driving awareness among our target audiences, both on the physician and the patient side. We have exhibited Strontium89 at several conferences including ASTRO (American Society of Therapeutic Radiation Oncology) and ONS (Oncology Nursing Society) and plan to begin speaker programs in the first quarter of 2021. Virtual and live sales calls have been ongoing since June 2020 within the confines of COVID-19 access, and we intend to expand our field force efforts in early 2021 with the addition of a contract sales organization.
We are expecting to have additional international markets available to potential patients as we continue to work through the registration of Strontium89 in multiple jurisdictions around the world.
We anticipate revenues from Strontium89 to continue ramping up in our 2021 fiscal year as we build capacity and demand worldwide. We are assessing several potential clinical trial programs that may expand the indication beyond palliation into a therapeutic use that may increase utilization in years to come.
COVID-19, Glaucoma and Other Mannin Platform Drugs
Even as vaccines for COVID-19 are being rolled out, the infection numbers are soaring around the world. Together with Mannin Research Inc., our technology partner, we are pursuing a treatment for Acute Respiratory Distress Syndrome, the condition that causes the most severe symptoms in COVID-19 patients usually resulting in hospitalizations and worse. Given the urgent need for therapeutics to treat COVID-19, we are rapidly accelerating the time to the first clinical milestone for MAN-19. An Investigational New Drug (IND) application (or similar clinical trial proposal) to regulators is planned for the first quarter of our 2021 fiscal year with trials commencing in the first half of 2021. It is important to note that we believe the MAN-19 therapeutic is virus-agnostic, which makes it relevant to other viral diseases today like influenza and future viral pandemic outbreaks. Therefore, a successful infectious disease application in COVID-19 could position MAN-19 as a potential government stockpile drug for possible future pandemics. Furthermore, a successful proof-of-concept clinical trial with MAN-19 in COVID-19 patients would provide the clinical dataset to quickly support the development of therapeutics for other vascular diseases such as sepsis, acute kidney injury, and of course glaucoma. All of these are large markets with significant potential.
We continue to support the development of Mannin’s MAN-01 and MAN-11 therapeutics, a novel small-molecule, and novel biologic therapeutic for glaucoma, respectively. There are over 60 million patients worldwide with primary open-angle glaucoma. The MAN-01 program is developing topical drops designed to reduce pressure build-up in the eye by assisting with, and correcting, drainage problems in tiny vessels in the eye. We have advanced this asset from ‘concept to compound’, and the preliminary data that we have reviewed has convinced us to continue pursuing these products in earnest.
GDF-15 Diagnostic for Glaucoma - In Clinical Trial and Product Development with FDA Approval anticipated late in 2021
In early 2019, we licensed a diagnostic biomarker known as GDF-15 for determining the severity of glaucoma from Washington University in St. Louis. GDF-15 is a perfect companion diagnostic for the MAN-01 and MAN-11 drugs, as well as a novel tool for practicing ophthalmologists and drug developers, because it is designed to assess the efficacy of the treatment or disease progression in their practice. This product represents a unique opportunity, and we believe that the current clinical trial is yielding promising results that will inform the 510(K) filing. In partnership, Mannin and McMaster University are nearing the completion of development of an in vitro diagnostic (IVD) with both point-of-care (detection in a doctor’s office) as well as an external laboratory-based detection (i.e. for use in existing CLIA laboratories using existing diagnostic equipment). We anticipate completion of the IVD device by the end of June 2021 with submission to the FDA (510K) for in vitro diagnostic approval in late 2021.
Uttroside-B - Liver Cancer Chemotherapeutic
Along with our drug developmental partners, Chemveda Life Sciences, the Ragiv Ghandi Center and Oklahoma Medical Research Foundation, we are developing an innovative treatment for liver cancer, a disease indication that currently has a high unmet need. Currently, there are only two approved first-line therapies. We are now preparing to advance this into a pre-clinical program and IND application with the FDA in 2021 followed by a proof-of-concept clinical trial. Initiation of scale-up and GMP material has begun and is progressing well.
QBM-001 - Early Stage Treatment for Young Minimally Verbal Children on the Autism Spectrum
While our immediate focus is on the above-mentioned assets, we are also developing a new drug candidate to treat young children with minimally verbal autism. The advancement of this program will depend on the availability of funds and resources as we prioritize our clinical development milestones. There is no effective treatment available to help an estimated 250,000 children born with the condition worldwide each year, 20,000 of them in the United States. We are working on a discovery and development program to address this highly unmet need.
Corporate Strategic Goals
Our mission is to solve problems by accelerating the development of important therapies and availability of those therapies to patients. Since Q BioMed's inception 5 years ago, we have been busy building significant value ranging from blockbuster potential drugs to revenue producing opportunities. To that end, we believe that our planned uplist to a senior exchange will result in an enhanced valuation as a larger group of investors and institutions can participate in our equity. We have begun the process to uplist to NASDAQ and look forward to updating our shareholders on this in the very near term. As we move through these milestones, we believe we are creating value for our shareholders as we approach some significant milestones and catalysts in 2021.
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About Q BioMed Inc.
Q BioMed Inc is a biotech acceleration and commercial stage company. Q BioMed is focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need.
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
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