- Strontium89 launched; contract manufacturer now producing commercial scale quantities; sales revenue expected to be booked this quarter
- $25 million in annual sales anticipated in 2022 based on the current potential market size
- COVID-19 Investigational New Drug application (or similar clinical trial proposal) to regulators planned for late 2020
Dear Fellow Shareholders,
We are extremely pleased to have reached our initial goal of becoming a commercial pharmaceutical company. As mentioned on February 13th, we launched Strontium89 (Strontium Chloride Sr-89 Injection, USP), our FDA approved non-opioid drug which has been shown to relieve the pain associated with cancer that has metastasized to bone. Our contract manufacturing facility, which is FDA approved to produce Strontium89, is manufacturing commercial-scale quantities now. Our new Strontium89 website has been launched and outreach to health care professionals and patients has commenced. The response has been positive thus far and it is very gratifying to have already impacted those suffering from cancer bone pain.
We expect to book revenues in the current quarter, even as COVID restrictions have limited our access to hospitals and physicians. We anticipate exceeding $25 million in annual sales in 2022 based on the current potential market size.
In several multicenter, placebo-controlled trials in cancer patients with pain from bone metastases, pain relief occurred in more patients treated with a single injection of Strontium89 than in patients treated with an injection of placebo. Strontium89 is administered intravenously once every three months and for some patients can reduce or even eliminate the need for opioid analgesics. (Please see Important Safety Information and the full Prescribing Information on our website www.strontium 89.com.)
The opioid crisis is pervasive, and clinicians worldwide are being asked to re-examine opioid use. Over 10 million people around the world suffer from pain associated with metastatic cancer in the bone and can benefit from Strontium89.
Through our distribution partner, Jubilant RadiopharmaTM, we have the capability to reach patients in all 50 U.S. states. Commercial and marketing activities, including marketing at conferences and direct sales, have commenced concurrent with commercial availability. Strontium89 is reimbursed by Medicare, Medicaid and most insurance companies.
Near term, this opportunity will provide meaningful revenue for the Company. We also plan to launch the drug in several substantial international markets during 2020 and 2021. Looking to the future, we are assembling a world class scientific advisory board to assist in market access and plan Phase 4 clinical trial programs that may expand the indication beyond palliation into a therapeutic use that may increase patient survival, accessing the much larger therapeutic market. A comparative drug in the radiopharmaceutical space was purchased by Bayer for $2.9 billion in 2013 with peak sales projected by Bayer exceeding $1 billion a year.
As we reflect on our mission of finding undervalued assets and advancing them to increased value, we are proud to say that we are accomplishing that goal.
Launching Strontium89 distinguishes QBioMed from publicly traded biotech companies that have yet to launch a regulatory approved commercial product and generate revenues. Building a robust pipeline, we continue to work closely with our technology partners to develop treatments for unmet needs in multi-billion-dollar markets.
Our technology partner Mannin Research Inc. (Mannin) was recently granted up to $7.7 million in Europe, which will fund 65 percent of every dollar incurred to advance a portfolio of therapeutic assets for vascular diseases currently in development at Mannin, including: glaucoma, cardiovascular diseases, acute kidney disease, and infectious diseases such as influenza and coronavirus, among others.
Given the urgent need for therapeutics to treat COVID-19, Mannin is 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 are planned for late 2020. It is important to note that 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 would position MAN-19 very well as a potential government stockpile drug for inevitable 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 very 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 have seen very promising preliminary data that inspires confidence in the program and the market it addresses. Again, as we assess this against our mission, we have found a unique opportunity in a neglected market with significant potential and are advancing it towards real value.
Our next steps for the MAN-01 and MAN-11 programs are to initiate toxicology studies in 2021, with the goal of initiating a Phase 1 proof of concept trial in late 2021. These successful data points should command a significant value proposition with potential partner companies that have a specific interest in ophthalmology.
In addition, in early 2019, we licensed a diagnostic marker 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 very important and novel tool for practicing ophthalmologists and drug developers, because it allows them to assess the efficacy of the treatment or disease progression in their practice. This product represents a unique opportunity and current clinical trials are yielding promising results. In partnership with Mannin Research Inc. and McMaster University, we 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 2020 with submission to the FDA for in vitro diagnostic approval in early 2021.
We are innovating in the treatment of liver cancer, a disease indication that currently has a high unmet need. Currently, there are only two approved first-line therapies. We licensed and have advanced Uttroside-B, a new molecule that showed ten times the potency of the current standard of care in early pre-clinical investigation. Uttroside-B was discovered in the leaf of the Black Nightshade plant in India. As it is not feasible to use the plant as the source for a drug, we successfully synthesized the molecule thereby creating an exact replica of the naturally occurring chemical compound. We are now preparing to advance this into a pre-clinical program leading to an orphan drug application and IND application with the FDA and a proof of concept clinical program. If we are successful in achieving a positive proof of concept, we would expect the commercial market to recognize the additional value created in this billion-dollar market.
While our immediate focus is on the above-mentioned assets, we are also developing a new drug candidate to treat young children with pediatric 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 U.S. We are working on a discovery and development program to address this highly unmet need. In that regard, we recently filed an Orphan Drug application with the FDA based on a collaboration that resulted in a breakthrough discovery examining 1,953 autistic biomarkers that could identify the condition in a narrow patient population. We are in communication with the FDA's Office of Orphan Products Development and hope to be successful in the orphan designation.
Since Q BioMed's inception 5 years ago, we have been busy building significant value ranging from blockbuster potential drugs to imminent revenue producing opportunities. Our mission is to solve problems by accelerating the development of important therapies and availability of those therapies to patients. As we successfully accomplish this, we believe we are creating value for our shareholders as we approach some significant milestones and catalysts.
Finally, I will be presenting at Proactive Investors One2One Forum which is taking place today, Tuesday 30th June 2020 at 1pm EST. You are invited to register and attend the event https://event.webinarjam.com/register/458/xyy9gs6l
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.
Please visit http://www.QBioMed.com and sign up for regular updates.
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.
Q BioMed Media Contact: