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Sirona Biochem Corp . (TSXV: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to provide the following Q3 update to shareholders.
Dear shareholders,
We are providing this quarterly update with a particular focus on our TFC-1067 compound for skin lightening as it advances towards a second commercial license agreement.
The individual project updates are as follows:
TFC-1067
North America
As previously reported, our second clinical trial for TFC-1067 was supported by a top 10 pharmaceutical company, which included the right to complete due diligence in the months following. Our partner has successfully completed their analyses of the compound and we have moved into the next stage of licensing discussions. A global license with a highly respected partner is our preferred outcome for TFC-1067.
Rodan + Fields (R+F) continue sales of the add-on product, REVERSE Targeted Dark Spot Corrector which contains TFC-1067 as the active ingredient. R+F orders for raw material have been forecast for the remainder of 2021.They remain an excellent partner, successfully advancing the commercial use of TFC-1067 in their product. A first for Sirona.
Our manufacturing partner, WuXi AppTec has prepared an inventory of TFC-1067 that will be held in storage in China . This inventory will allow for zero delays in requests for orders as we move forward with anticipated partnerships. We are also maintaining manufacturing capabilities in France and exploring new manufacturing processes as we continually evolve our platform technology for this and all projects.
We believe, based on safety and efficacy data, that we possess the industry leading compound for lightening dark spots and balancing skin tone. We are confident TFC-1067 will have a strong commercial future.
Asia
Our business strategy for Asia continues to evolve due to challenging regulatory requirements. We will still advance and offer a second compound, TFC-1394, from our patented library for countries that have differing needs. Having either a global or regional partner will be critical to navigate commercialization in China and other Asian countries. With advanced discussions ongoing for a global license, we will scale back pursuing regional opportunities.
TFC-039
Human Diabetes
Wanbang Biopharmaceuticals has completed Phase I studies for diabetes drug candidate TFC-039 and is currently in the data analysis phase. We are awaiting further information for their plan to move forward. Some logistical challenges have caused delays and we will update shareholders as soon as we have material information on the project.
Animal Health
We have received clinical data from the cat studies which show TFC-039 to be safe and well tolerated. There is concern regarding manufacturing and the final cost of goods which are not yet fully defined. Our team is addressing this challenge with assistance from Wanbang and we have their full commitment.
Other Indications
The team at TFChem is investigating further indications for TFC-039 and have identified target diseases. We are putting in place the contract research organizations to evaluate these targets as well as developing the patents.
Anti-Aging
The lead compound from our anti-aging library is advancing to scale-up. This first batch will be developed for stability testing, formulation, and the clinical study. Preliminary results for some studies will be available in Q4 of 2021, however, due to the need to keep information confidential while patents are being written, only select information will be released.
Discussions with potential partners remain preliminary.
Antiviral
Our team in France has synthesized 16 novel antiviral compounds for testing. Information is currently limited as we develop IP around these compounds. We are encouraged by the recent successful Phase 3 clinical trial of a new antiviral from Merck & Co in the treatment of COVID-19 ( Merck pill seen as 'a huge advance', raises hope of preventing COVID-19 deaths | Reuters ).
Anti-Cellulite
Our recently announced discovery of a potential cellulite therapy is still in early-stage development. This discovery represents another major market opportunity for our company and has already garnered interest from a global pharmaceutical company.
Financing
Sirona's last private placement financing was over 2 years ago, a similar financing is not being planned. Management will execute a strategy which will include non-dilutive sources.
With the completion of the due diligence of our top 10 global pharma partner, a decisive phase is approaching. While our scientists in France are making excellent progress in advancing our pipeline, management is fully focused on closing concrete agreements and sustainably increasing shareholder value.
Dr. Howard Verrico, CEO
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.
Sirona's compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona's laboratory, TFChem, is in France and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com .
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem's forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem's business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.
SOURCE Sirona Biochem Corp.
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