Q BioMed has a winner in cancer bone pain drug Strontium89 and a deep pipeline of biomedical assets

Acquires undervalued biomedical assets to accelerate their development Developing drugs and therapies to treat pediatric nonverbal autism, liver cancer, and glaucoma Produces cancer bone-pain drug Strontium89 for sale in all 50 US states What Q BioMed does: Q BioMed Inc (OTCMKTS:QBIO) is a biotech company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. The New York City-based company has a pipeline of drugs and therapies to treat metastatic cancer bone pain, pediatric non-verbal autism, liver cancer, and glaucoma. Q BioMed’s commercialized flagship drug candidate is Metastron, which it purchased from GE Healthcare, to treat metastatic bone pain. The drug is administered intravenously once every three months as an alternative to opioid analgesics. The company also has a US Food and Drug Administration (FDA) approved generic version called Strontium89 Chloride USP. The company is developing QBM-001 to treat toddlers with pediatric non-verbal autism who suffer from non-verbal or minimally verbal capabilities. The company says there is no effective treatment available to help an estimated 250,000 children born with the affliction worldwide each year (20,000 in the US). Q BioMed is also working on two candidates to detect and treat glaucoma. In early 2019, it exercised its option to license from Washington University in St. Louis a diagnostic marker known as GDF15, for determining the severity of glaucoma. The company and technology partner Mannin Research Inc are developing MAN-01, a small-molecule therapeutic in eye-drop form, to treat primary open-angle glaucoma. The company also is developing a biologic, MAN-11, to treat glaucoma.  Q BioMed also has two drug candidates in the preclinical stages. MAN-03 and MAN-04, respectively, which are designed to treat acute kidney injury and cardiovascular diseases. And it has been working with Mannin on a therapeutic to treat coronavirus (COVID-19) patients. It is also targeting ways to fight liver cancer, with the company involved in a joint research program with India-based Chemveda Life Sciences since early 2017 to synthesize the compound uttroside-B, a type of chemical compound found in the Black Nightshade shrub, and study its use. How is it doing: It has been a busy spell so far in 2021 for Q BioMed and its Canadian technology partner Mannin Research, with which it is developing drugs for the treatment of complications caused by COVID-19.  The two companies are pursuing a treatment for Acute Respiratory Distress Syndrome (ARDS), the condition that causes the most severe symptoms in COVID-19 patients. A production contract has been initiated for MAN-19, a clinical-grade therapeutic.  The two firms plan to submit an Investigational New Drug (IND) application to regulators during the first quarter of Q BioMed’s fiscal 2021, with trials expected to begin in the second half of 2021. The accelerated development is being backed in part by funding from the Canadian and German governments. In fact in April, Mannin received up to C$1.7 million worth of R&D funding from the National Research Council of Canada Industrial Research Assistance Program. Q BioMed has partnered with Mannin since 2015 and has an exclusive option on all its portfolio assets. Q BioMed is continuing to support the development of Mannin's MAN-01 and MAN-11 therapeutics for glaucoma, with the next steps to initiate toxicology studies in 2021 while aiming for a Phase 1 proof of concept trial to begin later in the year. The company is also completing the development of an in-vitro diagnostic (IVD) using the biomarker 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 US Food & Drug Administration (FDA) for in vitro diagnostic approval in late 2021 or early 2022. Meanwhile, Q BioMed’s potential breakthrough chemotherapy for the most common type of liver cancer called cellular carcinoma (HCC) was granted orphan drug designation by the FDA in January. Uttroside-B has shown ten times the potency against HCC as compared to the current standard of care. Currently, there are only two approved first-line therapies for HCC. Testing is expected to begin sometime in 2021. The FDA endorsement would provide a fully approved uttroside-B product with seven years of market exclusivity following marketing approval. Also on offer for Q BioMed are grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. While it advances MAN-19 and uttroside-B, Q BioMed is also moving ahead with commercial sales of its flagship metastatic cancer bone pain drug Strontium89. In March, the company announced a supply contract with the US Department of Defense and Veterans Affairs (VA), which will make the drug available to over 9 million VA beneficiaries. Strontium89 also has been included on the Federal Supply Schedule (FSS) for eligible patients. The company in May hired WSI PBG LLC to promote further the drug within 76 VA and military medical centers. 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. The five-year contract includes a VA sales force, formulary and market access, medical education, and marketing -- efforts that will expand as the FSS agreement is translated to clinical use.  The company also recently signed a contract with UroGPO, the largest group purchasing organization for urology private practice clinics in the US, to make Strontium89 available to doctors. UroGPO members represent 650 urology group practices and 167 ambulatory surgery centers with more than 3,400 urologists. Through the partnership, UroGPO will support the establishment of Strontium89 injections as an added radionuclide therapeutic choice for patients with painful bone metastases from prostate and other urological cancers.  Look ahead, Q BioMed sees Strontium89 generating revenue of $25 million to $50 million annually in the next three years based on the current market size. An estimated 10 million people are living with bone metastases. Under a distribution relationship with Jubilant Radiopharma, Strontium89 can reach patients in all 50 US states and is reimbursed by Medicare, Medicaid, and most insurance companies. And the company is also developing a new drug candidate to treat young children with minimally verbal autism. To help fund its operations, Q BioMed in May announced that Aedesius Holdings Ltd (AedesiusOne), a privately held global disruption aggregator, is investing up to $30 million in the company via a securities agreement. It's the company's largest single investment so far. AedesiusOne is run by Geoffrey Fatzinger, Q BioMed's global head of regulatory affairs. Inflection points: Expects revenues from Strontium89 injections to ramp up during 2021 Submit IND application for MAN-19 to treat ARDS in COVID-19 patients Launch Phase 1 proof-of-concept trial in late 2021 for MAN-01 and MAN-11 to treat glaucoma Initiating process to up-list to the NASDAQ What the boss says: "Obviously this is a very impactful investment for Q BioMed,” said CEO Denos Corin, commenting on the $30 million investment from AedesiusOne. “Not only does it come from an insider, but it is the largest single investment we have ever had. It allows us to move forward with our pre-Covid commercial roll-out plans for Strontium89 on a worldwide basis." Corin added: "This funding also gives us the ability to advance our therapeutic development and pipeline opportunities and reduce the financing risk that typically overhangs small-cap biotech companies with 18 months of cash before taking into account the income that we expect from our Strontium89 revenues. "Further, we will be in a position to extinguish all remaining debt and convert all outstanding preferred shares, thereby increasing our shareholder equity and positioning the company for an uplisting. Strategically, we also expect to review our pipeline, specifically with regards to adding one or more late-stage assets through acquisition or licensing." Contact the author: patrick@proactiveinvestors.com Follow him on Twitter @PatrickMGraham