Vancouver, British Columbia – December 8, 2016 – Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (Xetra: ZSB) today provided a business update.
The following is an update on our progress in 2016 and our plans for 2017.
Skin Lightener, TFC-1067
Throughout 2016, we have remained focused on completing a licensing agreement for our skin lightening compound, TFC-1067. It was our plan to finalize this transaction earlier in the year. However, it is not a timeline we have full control over. We have multiple companies engaged and progressing through due diligence at their own speed. Despite contrary market rumors, no party has left the negotiation table. At this time, we expect to receive one or more term sheets from interested parties before the end of Q4 2016. We remain very confident that one or more of these global entities will move forward with a definitive licensing agreement in early 2017.
Should the circumstances be that no potential licensing partner can complete the deal in a reasonable time frame, or for what we consider to be an appropriate value, then we will proceed with the full development of the skin lightener on our own. This would include GMP scale-up, toxicology, formulation and an early clinical trial. We already have consultants in France building the full development plan. We are aware that building a development plan may seem unnecessary but we take seriously our commitment to minimize risk and maximize opportunity for our shareholders. It is important that we are not dependent on a partner to complete a development plan and remain in a position of strength during negotiations.
SGLT2 Inhibitor, SBM-TFC-039 (Wanbang)
Wanbang Biopharmaceuticals recently provided a project update on the SGLT2 Inhibitor. We are very pleased to announce that they have completed most of the preclinical studies, the scale-up optimization and pharmaceutical grade manufacturing of the product. They will formulate the product in January 2017 to prepare for a clinical trial. Following that, they will conduct an additional pharmacology as well as toxicology study and file the “investigational new drug” (IND) package with the Chinese FDA (CFDA). This filing will trigger the next escalating milestone payment. Approval of the IND package by the CFDA will trigger another milestone payment and indicate the start of clinical studies.
The data that has been generated by Wanbang is currently being used in licensing discussions with a potential partner in India that recently approached us.
Skin Lightener, TFC-849 (Valeant) and Library
Our skin lightener, TFC-849 remains in scale-up at a French CRO for clinical studies. We did anticipate that this would be finalized earlier in 2016, however, the CRO experienced some complications and therefore it has been delayed until January. Valeant is aware of the delays in scale-up and has not altered plans to commercialize.
In 2016 we also completed the development of several other skin lighteners. This group contains potential lead compounds which can be licensed with TFC-1067 or separately in multiple markets. We have begun preliminary testing to determine the most effective new compounds, and expect results in Q1 2017.
Cell Preservation and Regenerative Compounds
We have now concluded testing of our glycoprotein compound library. We showed a protective effect in human fibroblasts (skin cells) under various stress conditions. Our subsidiary, TFChem has developed a comprehensive report of the data to be shared with potential partners. While the compounds have very interesting properties, they are still considered early stage, which means that the partnerships we seek will be considered “Research and Development” (R&D) collaborations. The compounds also have numerous potential applications and we need to take time to evaluate the best path to market. This is something we will advance with partner organizations.
One potential application is in storage of various cells and tissues. In May, we entered into a research program with Dr. Caigan Du’s laboratory (Vancouver Coastal Health Research Institute) on red blood cell storage and preservation. Results showed that while the compounds did not improve total blood cell count, they did improve the health of the cells that survived. This could result in more cells remaining viable in transfusions (where many typically die). Testing in commercial storage protocols will begin in 2017.
Dr. Du also carried out a study on oxidative stress in skin cells. The results confirmed what our previous CROs have found, which is a significant preservation under stress conditions. This data is currently being compiled and will be used for partnering discussions.
Our acne compound is in chemistry development and expected to be completed and ready for testing in mid-2017. It will likely be our next major pipeline candidate. This project utilizes our successful business model of applying our proprietary technology to a known compound with stability issues. There is an excellent opportunity to produce a new therapy in this market which is estimated to be $8 Billion USD worldwide annually. Acne is the most common skin condition in the United States affecting some 50 million Americans and costing $3 Billion USD annually.
We have developed a compound that we believe could have properties in preventing the formation of Keloid scars. This is a significant unmet need as there are currently no effective therapies available. Early In vitro studies show a down-regulation of genes involved in the Extracellular Matrix (ECM) deposit which occurs in keloid scars and an up-regulation of genes involved in ECM degradation. Early safety tests have also been completed.
We have also uncovered mechanisms of action favourable to the target therapy and started to build a development plan for this project. Moreover, we are exploring CRO’s and universities in Europe with expertise in Keloid research to assist us. The current market for global scar therapy is estimated at $16 Billion USD annually.
Like all biotech companies, we have experienced some delays in the development of our pipeline. We understand the apprehension that this can create for our investors and we want to assure you that we have a strong technology platform, a strong development pipeline, excellent patent protection and a dedicated management team. We are doing everything we can to sustainably increase shareholder value. We thank you for your continued support and look forward to what 2017 will bring.
Wishing you and your families Happy Holidays and all the best for 2017.
Dr. Howard Verrico, CEO
For more information regarding this press release, please contact:
Christopher Hopton, CFO
Sirona Biochem Corp.
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.