Q BioMed Inc (OTCQB:QBIO) reported Tuesday that it anticipates revenues from its Strontium89 injection, a palliative treatment for metastatic bone cancer, to continue ramping up during fiscal 2021.
In a year-end update to shareholders, the company also said it expects treatment with Strontium89 in the hospital out-patient setting will be fully reimbursed by Medicare in January, following which Q BioMed will launch a hospital-focused marketing initiative and expect to see hospitals more actively treat appropriate patients using its injection.
Q BioMed added that it is assessing several potential clinical trial programs that may expand the indication beyond palliation into a therapeutic use, which it believes may increase utilization in years to come.
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The company also said it is expecting to have additional international markets available to potential patients as it continues to work through the registration of Strontium89 in multiple jurisdictions throughout the world.
Q BioMed noted that it anticipates being approved as a federal supplier in January 2021, which will allow the company to sell into federal hospital systems, notably the US Department of Veteran Affairs (VA) and the US Department of Defense.
It added that the VA is potentially Q BioMed’s 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.
Q BioMed also said it has 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.
Q BioMed expects to have group purchasing contracts in place in early January and have begun to negotiate with national and regional oncology organizations.
As well, Q BioMed revealed its other initiatives for 2021, which include:
- Pursuing a treatment for Acute Respiratory Distress Syndrome, the condition that causes the most severe symptoms in COVID-19 patients, with its technology partner Mannin Research Inc. The two companies plan to submit an Investigational New Drug (IND) application (or similar clinical trial proposal) to regulators during 1Q of its Fiscal 2021 with trials expected to begin in 1H 2021.
- Completing the development of an in-vitro diagnostic (IVD) using the biomarker known as GDF-15 for determining the severity of glaucoma with both point-of-care as well as an external laboratory-based detection by the end of June 2021, with submission to the FDA (510K) for in vitro diagnostic approval in late 2021.
- Developing an innovative treatment for liver cancer through the advancement of a pre-clinical program and IND application with the FDA in 2021, followed by a proof-of-concept clinical trial and;
- Developing a new drug candidate to treat young children with minimally verbal autism.
Q BioMed also announced that it has begun the process to up-list its shares to NASDAQ, which it expects will enhance its valuation through the participation of a larger group of investors and institutions.
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