Sirona Biochem Corp . (TSXV: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to provide the following update to shareholders.
We are providing this update along with our quarterly results. We will continue to provide an update each quarter and will update our milestone list at that time as well.
It is important to appreciate that each of our projects relies on partners. Whether this is the manufacturing and supply organizations, the contract research groups that run our studies, or the potential commercial partners completing their own studies and reviews as part of due diligence. Our prospective global partners conduct due diligence that is extremely detailed and often takes longer than anticipated. Each of these partners has their own unique organizational structures and schedules and they are often met with challenges that cause delays. In the best of times this is the case, but in the past year we have dealt with far more. Sirona has internally managed recent global challenges with little to no adversity, but larger organization have been less successful.
We take this opportunity to apologize to our investment community for our mistakes when it came to estimating some of our project timelines and we will strive to do better going forward. We assure you that our projects have not been discontinued, that our science team is actively working on contributions to partner due diligence activities as well as expanding our pipeline with new IP, and that our business teams are continuously meeting with large global corporations to discuss ongoing and new partnerships.
The individual project updates are as follows:
We are very pleased that TFC-1067, our active ingredient for dark spots on or hyperpigmentation of the skin, has now been commercialized.
On March 10, 2021 , we announced that Rodan + Fields (R+F) had successfully launched TFC-1067 as the active ingredient in the new REVERSE Targeted Dark Spot Corrector . We are extremely proud to have contributed to the first commercialization of the technology developed by our award-winning CSO Dr. Geraldine Deliencourt-Godefroy. This launch not only validated our technology but has also opened the door for further collaborations as global players have increased confidence to add TFC-1067 to their product portfolios.
Commercial products that include TFC-1067 will have different levels of efficacy depending on the concentration of our active and the formula (cream, serum, etc) developed by the commercial partner. In addition, all spot correctors take time to be effective and the visible results steadily become more apparent over time. Even the industry standard, hydroquinone, takes weeks to show an effect despite achieving results partially through toxicity. TFC-1067 blocks the formation of new pigment and existing pigment must degrade over time. Our science team is convinced we developed an excellent formulation in our clinical trials and remain highly confident in our product. Participants in our second double blind clinical trial support this conclusion. This trial demonstrated, successfully, the powerful effect of our TFC-1067 formulas with 100% of participants seeing an improved complexion and concluding they would buy this product.
With great results confirmed by consumers, we have again increased manufacturing in China and have currently arranged to secure an inventory of product that will be able to meet the growing demand. Our manufacturing partner, WuXi AppTec has provided dedicated resources for our compound and can produce significant quantities with little turnaround time. As we continue to scale, product supply will not be an issue.
Our second clinical trial for TFC-1067 completed in Feb 2021 . At this time, our pharmaceutical partner continues their due diligence and will do so for a previously agreed upon time. A successful transaction with the trial partner is management's goal as it would be transformational for Sirona. While many global pharmaceutical and dermatological companies continue to approach Sirona with interest in TFC-1067, we are obligated to delay in-depth discussions involving the clinical trial results until our partner has completed analysis of the clinical results and determined their next steps. Due diligence by global leaders takes time no matter how confident they are in the ultimate commercial success since they follow meticulous procedures with large teams. We observed this with Rodan + Fields as great care is required to maintain the brand excellence.
Our VP of Operations, Michelle Seltenrich , attended BIO from June 14 th to June 18 th and met with 12 organizations from the following countries/regions: Japan , Korea, China , USA , Canada , Europe to discuss various programs. Each of these meetings was pursued by the larger organization and will be followed up with data exchange.
We will be successful in further commercialization of TFC-1067 globally.
We continue to implement our Asia strategy and are in discussions with a China -based company which has established cosmetic development excellence as discussed in our last news update. An evolving and varied regulatory landscape for new compounds throughout Asia has created challenges. Each country in Asia has enormous commercial potential and we do not want to miss any of these opportunities. As such, we are advancing another compound, TFC-1394, from our patented library of skin lighteners to the same level as TFC-1067. This will occur over the next 12-18 months and ensure that country regulatory testing, if required, can be performed by other companies. We will then be able to launch in every country where a market exists in this $20 Billion USD industry. Our scientists have outlined a development path based on the expertise we have developed which is both efficient and affordable. It will occur in parallel to commercialization of TFC-1067 and not delay current plans. The value of our portfolio, which includes TFC-1067 and TFC-1394, will grow as they advance towards becoming a new industry gold standard as both safe and effective compounds. Having a regional partner is an important component in successful achieving our goals in a timely manner.
Tinyi Trading Company remains on board to be a distribution partner, however, with current discussions ongoing, we wait to see if the new partner in China seeks exclusive distribution. Ultimately, we will decide in the best interests of our company and shareholders.
Our partner, Wanbang Biopharmaceuticals, has informed us that our compound for type 2 diabetes (TFC-039) has completed their Phase I studies and the data is in the analysis phase. We expected to hear the results of this before the Chinese New Year in early February, however, they have experienced delays in the data analysis. We are now waiting and pushing to have a final report of these results and will update shareholders as soon as material information is available for release.
TFC-039 for animal health continues to progress. We are now in contact with four international companies on this project. Two additional global animal health companies reached out to our team, and we have exchanged data that they are currently reviewing.
We are evaluating the best way forward and still anticipate having both a manufacturing and a commercialization partner for the animal health product. We have established assistance from Wanbang in this regard and have their full commitment.
The team at TFChem is investigating further indications for TFC-039 and have identified the target diseases. Once the patents have been established, we will provide more information. Premature release of information can prevent the ability to patent a technology and our company relies on IP as assets, so we ask for patience in this regard.
Our anti-aging library has been completed and a lead compound has been chosen. These actives target multiple pathways in the aging process in different layers of the skin, which creates a very innovative treatment against skin aging and wrinkles. However, the complexity of this means that the compound will require multiple and extensive evaluations with different contract research organizations to identify a mechanism of action. We are now planning and executing the studies required for clinical testing. Several studies in this regard, including safety studies have started and we will announce initial results by Q4 of the calendar year. New indications for these compounds have been discovered through the evaluation process and has expanded the potential target commercial opportunities and will lead to another specific patent in 2022.
In our last update, we stated that the project was introduced to several companies at BIO JPM. The team in France put together a very detailed information package for this project, which contains the preclinical studies and results. This was distributed to several companies at the end of May and again following BIO in June. Discussions with partners remain preliminary at this stage.
Our antiviral compounds are in the chemistry phase, and we will update as progress is made. Several actives have been already prepared and we are building our portfolio for evaluation in different assays. There remains a critical unmet need for drugs that can halt the extreme progression of some viruses. We have identified compound structures that fit our platform and have a clear path of development.
Sirona's last private placement financing was 2 years ago, a similar financing is not planned. Management has a strategy on how to move forward including non-dilutive sources currently being explored.
Despite our limited recent news flow, we are very excited with our progress towards future partnerships and licencing deals. Commercialization of the pipeline is becoming a growing reality which will ultimately reward our shareholders.
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 .
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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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