Vancouver, British Columbia – February 24, 2021 – Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (US-OTC: SRBCF) (“Sirona”) is pleased to provide the following update to shareholders.
We continue to make substantial progress with core deliverables.
TFC-1067
Rodan + Fields (R+F) is completing the final stages in preparation to launch one of their newest skin care products incorporating TFC-1067. The dates are tightly guarded at this time and shareholders will be updated as soon as we are able to do so. We can report that everything is still progressing on schedule. As this will be our first project to reach commercial sales, we are looking forward to a successful launch.
Manufacturing of commercial quality TFC-1067 is ongoing in both China and France and shipments have been completed from both countries to the USA. As is the case with most new manufacturing, we continue to invest in optimizing the process. The development of an optimal production is an initial investment and a necessary condition to ensure we can sustainably serve a growing demand.
Our second clinical trial for TFC-1067, utilizing a higher dose, has been successfully completed and preliminary results have been received from Dermscan. We expect the final report within 4 weeks at which time we will review the results with our pharmaceutical partner (see news Oct 2020). We anticipate being able to release a portion of the results that are independent of our partner after a period of due diligence.
Several multinational companies have approached Sirona with interest in TFC-1067. Once the first product is available for purchase and we can release the latest data, we anticipate that number to grow. The data package now contains many in vitro studies, clinical safety data, two clinical trials and manufacturing. Additionally, we have a partner who independently tested the product providing further support for its performance.
After completing our due diligence, we made the decision not to pursue an agreement with HuaxiPharm. They have experienced internal challenges and delays and we do not feel their goals align with Sirona at this time. We have been working on developing a relationship with another company that can manage all aspects of commercialization of TFC-1067 in China. Our board and senior team are in regular discussion with this company on moving forward with an agreement.
TFC-039
TFC-039 for a type 2 diabetes pharmaceutical has completed another major phase in development and material information is pending.
TFC-039 for animal health continues to progress. We are in discussions with two international companies on this project and as such it has taken more time than expected to coordinate. Sirona and its consultants have structured and negotiated this unique partnership. We have closed binding terms on one side of this deal with the partner and we anticipate the other partner closing soon. Until such time that both partners have agreed to all terms, the details must remain confidential.
In addition, the team at TFChem are currently investigating further indications for TFC-039.
Anti-Aging
Our team has recently completed further studies for our anti-aging project to analyze our library of compounds and determine a lead. While we had previously done studies on some of these compounds, the lab was successful in developing further compounds for the library which we believe may have additional potential. These compounds must be patented and to do so, it is a requirement to fulfill a set of in-vitro studies. The studies are now complete, and we can begin the next steps of preparing a lead for further investigative studies in safety prior to the clinical trial. The project was introduced to several companies at BIO JPM (https://www.bio.org/events/bio-partnering-jpm) and we are developing the information package to share with them. We also anticipate further discussions with our current partners about this project.
Antiviral
With recent developments in other projects as well as the lab’s dedication to scale-up and managing the clinical trials of this project, the antiviral project remains less of a priority at the moment, but very much on the agenda for 2021 and 2022. We will update as progress is made.
Sirona continues to thrive in a world which has become increasingly virtual and has been conducting business daily on four continents. With a well-seasoned and experienced team, including multiple locally based consultants, travel has become unnecessary to maintain our progress. We will continue to support and grow our pipeline technology developed by our dedicated team of TFChem scientists based in Rouen, France.
We also continue to focus our efforts to create significant value for our shareholders. We realize that some investors had hoped for more progress. However, once again, we are moving forward and we are very confident that we will reach further significant milestones and continue to develop Sirona as a commercially successful company.
Dr. Howard Verrico, CEO