Sirona Biochem Inc. (TSXV:SBM) is a biotechnology company with an innovative platform for developing safer, more effective cosmetic and pharmaceutical active ingredients. The technology is based on proprietary fluorination chemistry developed by the company’s wholly-owned French subsidiary, research and development (R&D) laboratory TFChem. Sirona Biochem’s business model centers on leveraging its technology platform and chemistry expertise to build strategic R&D partnerships with leading global companies through contract services, licensing and royalty agreements as well as joint ventures.TFChem has developed a fluorination chemistry that can improve the safety and efficacy of carbohydrate-based molecules. Carbohydrate-based molecules are valuable in that they have broad application potential for the development of pharmaceuticals and cosmeceuticals.
Examples of commercially available carbohydrate-based drugs include viral neuraminidase inhibitor Tamiflu, and Johnson & Johnson’s (NYSE:JNJ) SGLT2 inhibitor Invokana™. However, carbohydrate-based molecules are extremely challenging to develop due to their inherent instability. Sirona Biochem’s proprietary chemistry technique overcomes that challenge by stabilizing carbohydrates, allowing the company to explore commercial opportunities for these valuable molecules.Sirona Biochem’s product pipeline includes an SGLT2 inhibitor for the treatment of type 2 diabetes as well as cosmeceuticals such as compound libraries for safe and effective skin lighteners and anti-aging compounds. The company has completed two successful licensing agreements. The first, for its SGLT2 inhibitor to Wanbang/Fosun Pharmaceutical in China, which is now in advanced Phase I clinical trials.
The second was a non-exclusive license to Rodan + Fields, the leading skin care brand in the United States, for Sirona’s skin lightening compound TFC-1067. The compound has proven safe and effective in clinical trials.Sirona Biochem is led by a highly experienced team of finance and biotechnology professionals. The company’s Chief Scientific Officer Dr. Géraldine Deliencourt-Godefroy is an award-winning synthetic chemist and the founder of the French biotechnology company TFChem. Her scientific research in carbohydrate chemistry has led to the discovery of new drug families and the development of drug candidates for diabetes and obesity, cosmetic ingredients and biological adjuvants. She is the recipient of the acclaimed Francinov Research and Innovation Medal, the French Ministry of Research Award and the French Senate Award.
Sirona Biochem’s Company Highlights
Proven technology platform based on a proprietary fluorination chemistry leading to a pipeline of products across a broad range of applications, including therapeutics, cosmeceuticals and biological ingredients.Diabetes drug TFC-039 has been licensed to Wanbang/Fosun Pharmaceutical and is currently in advanced Phase 1 clinical studies. Fosun Pharma is one of the largest healthcare companies in China.China represents the world’s largest population of diabetic patients.Skin lightener product TFC-1067 has had positive results from efficacy and safety trials in the United States and was shown to be better than 2 percent hydroquinone for treating skin discoloration.Sirona Biochem has licensed its skin lightener product TFC-1067 to Rodan + Fields under a non-exclusive agreement and is seeking further partnering opportunities for the product.Several potential multinational licensing deals are expected in 2020.Has an experienced management team of capital market and biotechnology professionals.
Sirona Biochem’s Technology Platform
Sirona Biochem’s technology platform is based on a fluorination chemistry that stabilizes carbohydrate-based molecules to improve their cosmeceutical and pharmaceutical qualities. Carbohydrate molecules play a central role in cell to cell communication and have the ability to interact with proteins, hormones, viruses, toxins and bacteria. In this way, carbohydrates perform a variety of essential biological functions in the human body, making them valuable components for the development of therapeutics and cosmeceuticals.While they have broad application potential, carbohydrates are extremely challenging to develop due to their inherent instability. Using chemistry techniques originally developed by TFChem, Sirona has overcome the challenge of stabilizing carbohydrates to develop safer, more effective cosmetic and pharmaceutical active ingredients.
This proprietary chemistry method involves strengthening the bond of a carbohydrate molecule by strategically placing fluorine atoms with the molecule. The result is enhanced stability and bioavailability of carbohydrate-based molecules.Sirona Biochem’s fluorination platform has multiple applications, including improving the properties of drugs in development or discontinued drugs that may have been shelved for stability reasons as well as for the development of new products for cosmetics and biological manufacturing.
Sirona Biochem’s Product Pipeline and Partnerships
Sirona Biochem is exploring multiple commercial opportunities and partnerships for its fluorination technology platform and currently has three high-value programs in development. Each program was chosen for its high market potential and attractive development timeline.Therapeutics – Diabetes, anti-inflammatories and anti-infectivesCosmeceuticals – Anti-aging and depigmenting agents (skin lighteners)Biological Ingredients – Inducers and adjuvants for biological development and preservationThe three most advanced products on this platform include diabetes therapeutics, cosmetic skin lighteners and anti-aging cream.
Therapeutics: Diabetes Drug TFC-039
Sirona Biochem’s diabetes drug TFC-039 is a sodium-glucose co-transporter SGLT2 Inhibitor compound developed using the company’s proprietary fluorination technology. SGLT2 Inhibitors act in the kidneys to reduce the reabsorption of glucose into the bloodstream. TFC-039 has achieved positive results in head-to-head preclinical studies, performing better than Johnson & Johnson’s canagliflozin (Invokana™), which was given US FDA market approval in March 2013 and in European market approval in November 2013.Globally, diabetes caused 4.2 million deaths in 2019 and at least US$760 billion in health expenditures. The number of adults living with diabetes in 2019 totaled approximately 463 million, and that figure is projected to rise to 700 million by 2045.In 2014, Sirona licensed SGLT2 Inhibitor TFC-039 to Wanbang Biopharmaceuticals for development and commercialization exclusively in the People’s Republic of China, the largest population of diabetes patients in the world. In exchange for this license, Wanbang Biopharma has provided an upfront payment and will give milestone payments of up to US$9.5 million in addition to royalty payments for product sales. Wanbang is currently in Phase I clinical studies with SGLT2 Inhibitor TFC-039.