- 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 Strontium-89 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 also is 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.
As it also targets ways to fight liver cancer, the company has been 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.
Lastly, Q BioMed 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.
How is it doing:
It has been a busy spell for Q BioMed which has achieved its goal of becoming a commercial drug company. It has launched a Named Patient Program (NPP) to bring its non-opioid cancer bone pain drug Strontium89 to patients around the world in September. The NPP allows Strontium89 to be given to patients internationally without needing additional regulatory approval in their countries. This will be facilitated by global pharma company Caligor Coghlan Pharma Services.
Q BioMed recently told shareholders that it expects to book revenue in the current quarter for Strontium-89. It expects to generate 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 its distribution relationship with Jubilant Radiopharma, Strontium-89 can reach patients in all 50 US states and is reimbursed by Medicare, Medicaid and most insurance companies. In November 2019, the FDA gave the nod to Q BioMed’s contract manufacturer IsoTherapeutics Group LLC to produce Strontium-89, making Q BioMed the only FDA-approved source for this drug in the western world. As a result, the company now plans to launch the drug in global markets, including Europe, in the coming quarters.
Q BioMed is also planning a Phase 4 clinical trial involving Strontium-89 with the goal of treating metastatic bone cancer, which would potentially generate significantly more in annual revenue.
In April, Q BioMed and its technology partner Mannin Research said they were accelerating the development of drugs for the treatment of complications caused by the deadly coronavirus (COVID-19). They hope to have at least one treatment in human trials this year.
The accelerated development is the result of a joint venture between Mannin, with its Tie2-based small molecule platform that addresses vascular leakage, and Cyclica, a Toronto-based biotech that has an artificial intelligence-augmented drug discovery platform, Ligand Design and Ligand Express. The venture is not aimed at creating a vaccine, but rapidly developing new therapeutics that may boost survival rates by reducing endothelial dysfunction (where the inner lining of the small arteries fails to perform), addressing the respiratory infection caused by viruses such as COVID-19.
Given the need for COVID-19 treatments, Mannin is also steaming ahead with the first clinical milestone for MAN-19, which is equally relevant to other viral diseases like influenza. An investigational new drug application is planned for late 2020. Q BioMed has been partnered with Mannin since 2015 and has an exclusive option on all its portfolio assets.
Q BioMed is also continuing to support the development of Mannin’s MAN-01 and MAN-1 therapeutics — a novel small-molecule and a novel biologic therapeutic for glaucoma — with the next steps to initiate toxicology studies in 2021, aiming for a Phase 1 proof of concept trial to begin in late 2021.
In the liver cancer treatment space, Q BioMed has licensed and advanced Uttroside-B, a new molecule that showed ten times the potency of the current standard of care in an early pre-clinical investigation. As part of the licensing deal, Q BioMed will pay Chemveda a mix of cash and stock as well as a capped royalty on net sales.
Last year, the company launched an Orphan Drug status application with the FDA and the European Medicines Agency for its pediatric autism drug candidate QBM-001. The application is based on its breakthrough discovery of two biomarkers that identify the affliction. The company’s study examined 1,953 autistic biomarkers.
Q BioMed recently launched a financial restructuring plan under which the company’s lead investor Yorkville Advisors Global will convert $3.8 million into stock and may convert an additional $500,000, which would be the total debt held by them. The debt restructuring transforms its balance sheet to create significant positive shareholder equity — a requirement for a Nasdaq listing.
- Planning Phase 4 clinical trial that may expand Strontium-89’s use beyond palliation into treating metastatic bone cancer
- There’s massive upside potential as a comparative drug in the therapeutic space was purchased by drugs giant Bayer for $2.9 billion in 2013, with peak sales projected by the pharma titan exceeding $1 billion a year
- Near-term revenue growth from plans to launch the drug in large global markets, including Europe, in coming quarters
- As Strontium89 becomes available soon through the NPP program, physicians will be able to prescribe it to their metastasis pain patients
- Q Biomed’s partner Mannin Research secured a $7.7 million grant, which will help the firm develop its Glaucoma and vascular disease assets on an expedited timeline
- Scaling-up production of liver cancer treatment Uttroside-B as it gears up for a pre-clinical program leading to an orphan drug application and IND application with the FDA and a proof-of-concept clinical program
- Potential uplist to a national exchange
What the CEO says:
“Since Q BioMed’s inception five years ago, we have been busy building significant value ranging from blockbuster potential drugs to imminent revenue-producing opportunities. We are creating value for our shareholders as we approach some significant milestones and catalysts,” CEO Denis Corin recently told investors.
Published at Fri, 14 Aug 2020 18:15:00 +0000-Q BioMed has a winner in cancer bone pain drug Strontium89 and a deep pipeline of biomedical assets