Questions 5 6 7 & 8From the answer to the 5th question, it is clear that accelerated approval is still on the table...
5th question
What is the status of any licensing acquisition, partnering or distribution agreements?
The company's guidance in our corporate PowerPoint presentation on our website is that the company commenced the commercialization phase at the beginning of 2024. These negotiations with various strategic partners can take up to two to three years to come to fruition. So the corporate strategy is to have an acquisition or distribution partner in place by mid to end of 2026. Just as the company is completing the follow up on its phase two bladder cancer clinical study and preparing for submission to Health Canada and the FDA for regulatory marketing approval or preferably has already achieved regulatory marketing approval. Based on the strong interim clinical data compiled to-date the company believes that these are realistic timelines for potential partnership agreements. When deemed material by the Board of Directors and the licensing acquisition, partnering or distribution agreements would be announced via press release.
6th question
Can you provide any updates on brain cancer, lung cancer or blood cancer clinical studies?
Yes we can. The non-good laboratory practices, or GLP Preclinical Research and toxicology has been completed for glioblastoma multiform brain cancer and is currently underway for lung cancer and the blood cancer lymphoma. GLP talks is slated to be completed this summer pending capital funding. This would allow commencement of a phase 1-2 clinical study for these diseases in 2024-2025, subject of course to Health Canada and FDA pre-approval as well as being properly capitalized to commence these clinical studies.
Based on our recent press release this morning, Theralase has demonstrated that Rutherrin is able to significantly enhance the destruction of lung cancer in a Lewis blood model. This is a very aggressive lung model.
When combined with radiation versus radiation alone, this demonstrates that Rutherrin is effective as a radio enhancer, significantly improving the efficacy of radiation with no additional side effects. This now provides thoracic oncologists with a very powerful tool to help destroy lung cancer, one of the leading causes of cancer related death worldwide.
7th question
What do these new indications mean to Theralase?
The impact on Theralase is believed to be significant. Any opportunity for a pharmaceutical company to increase its pipeline for therapies able to safely and effectively treat major diseases such as brain cancer, lung cancer, or blood based cancers would be considered materially significant to both potential revenues and the stock price. As an example, the global market in 2022 for glioblastoma multiform was $2.4 billion US with an annual growth rate of almost 10%. The global market for non small cell lung cancer was estimated at 10 billion US globally. For blood based cancers such as leukemia, lymphoma and multiple myeloma, the global market reached 63 billion US in 2022. Theralase is excited about the possibility of developing safe and effective treatments for the millions of patients inflicted with these cancers annually.
8th question
Any updates on the COVID-19 vaccine?
The company has been diligently working with the University of Manitoba and the National Microbiology Laboratory to complete this work. All petri dish work has been completed by the University of Manitoba and we are currently working with the National Microbiology Laboratory to complete a challenged animal model. This research was recently published in the peer reviewed journal Heliyon, detailing the ability of Ruvidar to inactivate numerous enveloped and non enveloped viruses, both with and without light activation.
As a result of this research, Theralase is currently in development of a topical ointment made with Ruvidar that can be used to treat herpes simplex lesions. In addition, Theralase has gained consensus from the National Microbiology Laboratory to shift their focus from a COVID-19 vaccine to an avian influenza vaccine. We plan to report out on the NML challenge animal model for avian influenza by year end.
Closing Comments
In closing, I would like to state that the company remains focused on commercializing the next standard of care treatment for BCG-unresponsive, non-muscle-invasive bladder cancer, which includes...
One - being properly capitalized using various equity and debt instruments
Two - completing patient enrollment and provision of the primary study procedure by year end
Three - achieving BTD status from the FDA in 2024
Four - achieving Health Canada and FDA regulatory marketing approval by the end of 2026
Five - successfully partnering the technology by 2026.
In addition, the company plans...
- to commence phase one clinical studies for brain cancer, lung cancer and blood based cancers in 2024 and 2025
- research and develop a topical ointment for the treatment of herpes simplex lesions
- develop a vaccine for avian influenza.