$QBIO News: NEW YORK, Oct. 25, 2021 /PRNewswire/ -- Q BioMed Inc. (OTCQB: QBIO), a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector is pleased to provide an update to its shareholders.
On October 5th the company closed an additional $2 million funding to support its planned uplisting and operations. The capital raise is a bridge to the planned uplisting transaction which is expected to provide sufficient capital for the next 12 months at a minimum.
The Company is focused on our current approved radiopharmaceutical product and is assessing additional assets within the same vertical to grow the future revenue opportunities. We have also learned that as of Oct 19th with immediate effect, our direct competitor in the cancer pain palliation space is no longer producing QUADRAMET® (Samarium Sm 153 Lexidronam Injection).We have already seen an uptick in product enquiry as result. In addition, together with Mannin Research we have de-risked the Mannin platform with successful proof of concept data and fully funded clinical trials expected to start in early 2022. Continued success in this platform opens the opportunity for over $200 million in potential license revenues in several indications including infectious diseases (COVID19), kidney disease, cardiovascular disease, and glaucoma.
Strontium-89 - FDA Approved Drug Launched
In January 2021, we announced that treatment with Strontium-89 (Strontium Chloride Sr-89 Injection, USP) in the hospital out-patient setting is fully reimbursed by Medicare. In March, we were approved as a federal supplier which will allow us to sell into federal hospital systems, notably the U.S. Department of Veteran Affairs and the U.S. Department of Defense. We have deployed a VA sales force and we are preparing to launch an institutional contract sales force to increase our presence and uptake in non-government hospitals by the end of the year.
We have been working with large regional and national oncology organizations to bring Strontium-89 to all of their radionuclide qualified clinics. Agreements and contracting are ongoing. We have continued to deploy a multi-channel marketing campaign, driving awareness among our target audiences, both on the physician and the patient side. Virtual and live sales calls have been ongoing since June 2020 within the confines of COVID-19 access. We have seen an uptick in Strontium89 sales starting in the 4th Quarter and expect revenue in that quarter to likely double the prior quarter. In addition, the Company has received its first order from the VA health care system under its federal supply contract. Repeat orders from clinics also indicate adoption and confidence in the product and as mentioned, with the discontinuation of QUADRAMET® (Samarium Sm 153 Lexidronam Injection) we believe we will see increased demand from that patient population.
In mid-2020, we began the regulatory registration process for full commercial access in the European Union, with pan-EU approval expected in the first quarter of 2022. These efforts have seen some delay due to Brexit related regulatory requirements. In parallel, we are midway through the registration process in many other countries. Due to some legacy data from previous owners not being available in current reporting standards to complete the filings, we have begun the process of creating our own source documents to complete the filings in non-US jurisdictions. We also expect this to be completed in the first quarter of 2022.
We are assessing several potential clinical trial programs that may expand the use in the current palliation market and additional indications beyond palliation into a therapeutic use that may increase utilization in years to come.
Launching Strontium-89 distinguishes us from publicly traded biotech companies that have yet to launch a regulatory approved commercial product and generate revenues.
Mannin Technology Collaboration – COVID-19, Glaucoma and Others – More Government Funding
In March 2021, our technology partner Mannin Research Inc. (Mannin) was granted an additional CAD$1.7 million from the Canadian governments COVID response budget, adding to the approximate $7.7 million granted in Europe, which together will fund 65-75 percent of every dollar incurred to advance the Acute Respiratory Distress Syndrome therapy for COVID patients as well as a portfolio of therapeutic assets for vascular diseases currently in development at Mannin, including: glaucoma, cardiovascular diseases, acute kidney disease, and other infectious diseases.
The MAN-19 therapeutic is a recombinant fusion protein that treats the patient, instead of targeting the virus. It is not a cure for COVID-19, but it strengthens a patient's blood vessels and protects them against ARDS, breathing problems, sepsis and other infections that may cause the body's organs to begin shutting down. It is designed to keep COVID-19 patients out of the ICU and off a ventilator. Initial manufacturing and preclinical testing has shown promise, and pending upcoming toxicology testing, the drug is poised for clinical trials to start in 2022. If the drug proves both safe and effective, our goal is to have it available for use by patients by early 2023.
We, along with Mannin, are very encouraged by our progress and the results of the preclinical work to date. Our next steps are to complete the final toxicology studies, data aggregation and achieve approval of a Phase 1 clinical trial. With proof-of-concept complete and clinical trials planned in 2022, we believe there is a significant return on investment in the near term and major milestones to be achieved. The market for this kind of treatment in the current pandemic climate is substantial and global. COVID-19 is not going away any time soon. As a result, there is a need to develop more effective treatments. We believe that this technology will play a role in the broader treatment landscape and not only for COVID-19, but also for other infectious diseases that cause ARDS.
We believe that licensing and milestone revenue opportunities for this and related indications in kidney and ophthalmological diseases are possible in the next few months. Conservative estimates based on milestones could reach $200M over the next 24 months.
A successful infectious disease application in COVID-19 would 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 support the development of therapeutics for other vascular diseases such as sepsis, acute kidney injury and glaucoma. All of these are large markets with significant potential.
GDF 15 Diagnostic for Glaucoma - In Clinical Trial and Product Development and FDA approval anticipated early 2022
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 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). With appropriate funding, we anticipate completion of the IVD device and submission to the FDA (510K) for in vitro diagnostic approval in 2022.
Uttroside-B - Liver Cancer Chemotherapeutic
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 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 and have recently been awarded Orphan Drug designation. Manufacturing and scale-up of the drug for use in preclinical testing and IND application has begun. Pre-clinical testing is underway and early results are encouraging.
Corporate Strategic Goals
Our mission is to solve problems by accelerating the development of important therapies and availability of those therapies to patients. We believe we are creating value for our shareholders as we approach some milestones and catalysts. In particular we are very encouraged by the de-risking of the Mannin platform with significant non-dilutive funding to support the clinical program and potential for licensing opportunities in multiple therapeutic areas over the next 12 months. This along with the growth in the Strontium revenue and addition of potential products in the same vertical could provide meaningful revenue opportunities over the next 6 – 24 months.
The funding we have raised to date has allowed us to settle some outstanding payables, prepare for an uplisting on a senior exchange and to continue developing our current assets. The uplisting will coincide with a proposed capital raise that, in the minimum, will satisfy our next 12 month capital needs. Our priority is to continue to support and expand a contract sales force for Strontium-89 in commercial and federal settings and possibly increase the product offering in this nuclear medicine vertical. We will also focus on advancing our rare disease portfolio in liver cancer, and leveraging the now almost $20,000,000 in committed non-dilutive government funding for the Mannin platform of vascular therapeutics for Acute Respiratory Distress Syndrome for COVID-19 patients as well as Glaucoma, Kidney diseases and others.
We believe our current valuation is not reflective of the opportunity within our pipeline. The pandemic environment has certainly made our job much harder, but that does not allow us to avoid blame for some missteps along the way. We have learned much about our business and the 'new normal' in which we have to operate and what we think will make our current opportunities more valuable to the market. We continue to believe that we have created a valuable and exciting company and expect to see that translate over the next 12 months as we approach several significant milestones. We are resilient and better prepared for our future than ever before.
On October 5th the company closed an additional $2 million funding to support its planned uplisting and operations. The capital raise is a bridge to the planned uplisting transaction which is expected to provide sufficient capital for the next 12 months at a minimum.
The Company is focused on our current approved radiopharmaceutical product and is assessing additional assets within the same vertical to grow the future revenue opportunities. We have also learned that as of Oct 19th with immediate effect, our direct competitor in the cancer pain palliation space is no longer producing QUADRAMET® (Samarium Sm 153 Lexidronam Injection).We have already seen an uptick in product enquiry as result. In addition, together with Mannin Research we have de-risked the Mannin platform with successful proof of concept data and fully funded clinical trials expected to start in early 2022. Continued success in this platform opens the opportunity for over $200 million in potential license revenues in several indications including infectious diseases (COVID19), kidney disease, cardiovascular disease, and glaucoma.
Strontium-89 - FDA Approved Drug Launched
In January 2021, we announced that treatment with Strontium-89 (Strontium Chloride Sr-89 Injection, USP) in the hospital out-patient setting is fully reimbursed by Medicare. In March, we were approved as a federal supplier which will allow us to sell into federal hospital systems, notably the U.S. Department of Veteran Affairs and the U.S. Department of Defense. We have deployed a VA sales force and we are preparing to launch an institutional contract sales force to increase our presence and uptake in non-government hospitals by the end of the year.
We have been working with large regional and national oncology organizations to bring Strontium-89 to all of their radionuclide qualified clinics. Agreements and contracting are ongoing. We have continued to deploy a multi-channel marketing campaign, driving awareness among our target audiences, both on the physician and the patient side. Virtual and live sales calls have been ongoing since June 2020 within the confines of COVID-19 access. We have seen an uptick in Strontium89 sales starting in the 4th Quarter and expect revenue in that quarter to likely double the prior quarter. In addition, the Company has received its first order from the VA health care system under its federal supply contract. Repeat orders from clinics also indicate adoption and confidence in the product and as mentioned, with the discontinuation of QUADRAMET® (Samarium Sm 153 Lexidronam Injection) we believe we will see increased demand from that patient population.
In mid-2020, we began the regulatory registration process for full commercial access in the European Union, with pan-EU approval expected in the first quarter of 2022. These efforts have seen some delay due to Brexit related regulatory requirements. In parallel, we are midway through the registration process in many other countries. Due to some legacy data from previous owners not being available in current reporting standards to complete the filings, we have begun the process of creating our own source documents to complete the filings in non-US jurisdictions. We also expect this to be completed in the first quarter of 2022.
We are assessing several potential clinical trial programs that may expand the use in the current palliation market and additional indications beyond palliation into a therapeutic use that may increase utilization in years to come.
Launching Strontium-89 distinguishes us from publicly traded biotech companies that have yet to launch a regulatory approved commercial product and generate revenues.
Mannin Technology Collaboration – COVID-19, Glaucoma and Others – More Government Funding
In March 2021, our technology partner Mannin Research Inc. (Mannin) was granted an additional CAD$1.7 million from the Canadian governments COVID response budget, adding to the approximate $7.7 million granted in Europe, which together will fund 65-75 percent of every dollar incurred to advance the Acute Respiratory Distress Syndrome therapy for COVID patients as well as a portfolio of therapeutic assets for vascular diseases currently in development at Mannin, including: glaucoma, cardiovascular diseases, acute kidney disease, and other infectious diseases.
The MAN-19 therapeutic is a recombinant fusion protein that treats the patient, instead of targeting the virus. It is not a cure for COVID-19, but it strengthens a patient's blood vessels and protects them against ARDS, breathing problems, sepsis and other infections that may cause the body's organs to begin shutting down. It is designed to keep COVID-19 patients out of the ICU and off a ventilator. Initial manufacturing and preclinical testing has shown promise, and pending upcoming toxicology testing, the drug is poised for clinical trials to start in 2022. If the drug proves both safe and effective, our goal is to have it available for use by patients by early 2023.
We, along with Mannin, are very encouraged by our progress and the results of the preclinical work to date. Our next steps are to complete the final toxicology studies, data aggregation and achieve approval of a Phase 1 clinical trial. With proof-of-concept complete and clinical trials planned in 2022, we believe there is a significant return on investment in the near term and major milestones to be achieved. The market for this kind of treatment in the current pandemic climate is substantial and global. COVID-19 is not going away any time soon. As a result, there is a need to develop more effective treatments. We believe that this technology will play a role in the broader treatment landscape and not only for COVID-19, but also for other infectious diseases that cause ARDS.
We believe that licensing and milestone revenue opportunities for this and related indications in kidney and ophthalmological diseases are possible in the next few months. Conservative estimates based on milestones could reach $200M over the next 24 months.
A successful infectious disease application in COVID-19 would 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 support the development of therapeutics for other vascular diseases such as sepsis, acute kidney injury and glaucoma. All of these are large markets with significant potential.
GDF 15 Diagnostic for Glaucoma - In Clinical Trial and Product Development and FDA approval anticipated early 2022
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 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). With appropriate funding, we anticipate completion of the IVD device and submission to the FDA (510K) for in vitro diagnostic approval in 2022.
Uttroside-B - Liver Cancer Chemotherapeutic
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 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 and have recently been awarded Orphan Drug designation. Manufacturing and scale-up of the drug for use in preclinical testing and IND application has begun. Pre-clinical testing is underway and early results are encouraging.
Corporate Strategic Goals
Our mission is to solve problems by accelerating the development of important therapies and availability of those therapies to patients. We believe we are creating value for our shareholders as we approach some milestones and catalysts. In particular we are very encouraged by the de-risking of the Mannin platform with significant non-dilutive funding to support the clinical program and potential for licensing opportunities in multiple therapeutic areas over the next 12 months. This along with the growth in the Strontium revenue and addition of potential products in the same vertical could provide meaningful revenue opportunities over the next 6 – 24 months.
The funding we have raised to date has allowed us to settle some outstanding payables, prepare for an uplisting on a senior exchange and to continue developing our current assets. The uplisting will coincide with a proposed capital raise that, in the minimum, will satisfy our next 12 month capital needs. Our priority is to continue to support and expand a contract sales force for Strontium-89 in commercial and federal settings and possibly increase the product offering in this nuclear medicine vertical. We will also focus on advancing our rare disease portfolio in liver cancer, and leveraging the now almost $20,000,000 in committed non-dilutive government funding for the Mannin platform of vascular therapeutics for Acute Respiratory Distress Syndrome for COVID-19 patients as well as Glaucoma, Kidney diseases and others.
We believe our current valuation is not reflective of the opportunity within our pipeline. The pandemic environment has certainly made our job much harder, but that does not allow us to avoid blame for some missteps along the way. We have learned much about our business and the 'new normal' in which we have to operate and what we think will make our current opportunities more valuable to the market. We continue to believe that we have created a valuable and exciting company and expect to see that translate over the next 12 months as we approach several significant milestones. We are resilient and better prepared for our future than ever before.
