Sirona Biochem Inc.

Overview

Sirona Biochem Inc. (TSXV:SBM) is a biotechnology company with an innovative platform for developing safer, more effective cosmetic and pharmaceutical active ingredients. Its strategy is to license or sell its patented compounds to leading global companies in return for up-front fees, milestone fees and ongoing royalty payments.

Sirona’s technology is based on proprietary fluorination chemistry developed by the company’s wholly owned French subsidiary research and development (R&D) laboratory TFChem. This fluorination chemistry can improve the safety and efficacy of carbohydrate-based molecules, which 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™.

Carbohydrate-based molecules are extremely challenging to develop due to their inherent instability. Sirona’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 line includes an SGLT2 inhibitor for the treatment of type 2 diabetes as well as a range of compounds for skin-care and cell preservation and repair. The company has an exclusive global licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), to develop and commercialize topical skin care treatments based on active ingredients derived from certain Sirona patents for TFC-1067 and related family of compounds.

Sirona also has a non-exclusive licensing agreement with Rodan + Fields, a leading skin care brand in the United States, for Sirona’s skin lightening compound TFC-1067, which has been proven safe and effective in clinical trials. Rodan + Fields has since launched its first dark spot corrector product based on TFC-1067.

Sirona 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.

Technology Platform

Sirona’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’s fluorination platform has multiple applications. It improves the properties of drugs in development or discontinued drugs that may have been shelved for stability reasons. It can also be used for the development of new products for cosmetics and biological manufacturing. Sirona is exploring multiple commercial opportunities and partnerships for its fluorination technology platform and currently has two streams of product line: cosmetics and pharmaceuticals.

Company Highlights

• Proven technology platform based on proprietary fluorination chemistry leading to a pipeline of products across a broad range of applications in cosmetics and pharmaceuticals.
• Signed global exclusive licensing deal with Allergan Aesthetics, an AbbVie [NYSE: ABBV] company, for TFC-1067 and library of cosmetic compounds.
• Ongoing royalty payments for compound discoveries, including upcoming royalties on net sales generated by AbbVie product line based on licensed patented ingredients. Cooperating on additional products with AbbVie. Seventeen years duration for TFC-1067 patents.
• Disruptive proprietary carbohydrate-bonding platform based on 20 years of research and development.
• Strong worldwide IP portfolio, including North America, European Union and Asia.
• Cosmetics - Developing disruptive solutions for anti-aging (US$271 billion), cell preservation (US$7.5 billion), and cellulite treatment (US$1.4 billion).
• Pharmaceutical
  • TFC-039, first-in-market ingestible tablet to treat animal diabetes. In advanced partnership talks with three major animal health companies.
  • Developing antiviral TBD compound for US$36 billion antiviral market.
• State-of-the-art, multi-million dollar laboratory in France with top scientific team, strong global manufacturing partners for pharmaceutical (Wanbang Pharma, China) and cosmetics (Wuxi AppTec, China).

Key Business Segments

Cosmetics

Sirona is developing disruptive solutions for the skin-care market in categories of anti-aging, cell preservation and cellulite treatment. These markets combined are worth nearly US$280 billion. Sirona’s TFC-1326 proprietary compound is an active ingredient for anti-aging and anti-wrinkle skin-care products. The company has signed an agreement with WuXi AppTec, a contract manufacturing organization in Shanghai, for the small-scale development of TFC-1326 for a clinical trial commencing in 2022.

The company’s library of breakthrough compounds, including the TFC-1067 are used for dark-spot correction. These compounds are part of separate licensing agreements with Rodan + Fields and AbbVie.

Pharmaceuticals

Sirona’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. Wanbang has completed Phase I clinical studies with SGLT2 Inhibitor TFC-039, and while the compound has performed well in the study, recent developments that created a generic environment for SGLT2 inhibitors in China led Wanbang to make a business decision to discontinue the development of TFC-039 as a treatment for Type 2 diabetes. Sirona received a total of US$1.5 million in upfront and milestone payments from Wanbang.

Sirona is currently in advanced discussions with four major interested parties from the animal health sector for further development of TFC-039.

The company is also finalizing a partnership for the development of a compound that can be used for antiviral drugs. The antiviral and diabetes health market is estimated to be more than US$44 billion.

Management Team

Dr. Howard J. Verrico, MD - CEO and Chairman of the Board

Dr. Howard Verrico obtained his medical degree from the University of Toronto in 1985 and has been a member of the College of Physicians and Surgeons of British Columbia since July 1986. Dr. Verrico is currently a practicing emergency room physician. In addition, Dr. Verrico has extensive experience as a venture capitalist in the junior capital markets.

Géraldine Deliencourt-Godefroy, PhD - Chief Scientific Officer

Dr. Géraldine Deliencourt-Godefroy is an award-winning synthetic chemist and the founder of French-based biotechnology company TFChem. Since the acquisition of TFChem by Sirona Biochem in March 2011, Dr. Deliencourt-Godefroy has assumed the role of Chief Scientific Officer. 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. Previous to founding TFChem, Dr. Deliencourt-Godefroy was a scientific leader at INSA (National Institute of Applied Sciences) in Rouen, France, where she developed a new technology on stabilized carbohydrates. Previous roles also include a post-doctoral position at the University College London and doctoral research at the Research Institute of Fine Organic Chemistry in Rouen, France. Dr. Deliencourt-Godefroy received a PhD and Masters in Organic Chemistry as well as her business degree from the University of France. She is the author of several publications and patents and is also the recipient of the acclaimed Francinov Research and Innovation Medal, French Ministry of Research Award and the French Senate Award.

Christopher Hopton, CGA - Chief Financial Officer

Christopher Hopton brings 25 years of expertise in financial management and operations. His extensive experience covers areas of financial planning, accounting policy and business process improvement. As a business investment and finance consultant, Hopton has worked with several public and privately-held companies. Most recently, Hopton was the Chief Financial Officer of Central Resources Corp., a junior mineral exploration company. Formerly, he held the position of Division Controller at Canadian Airlines where he was responsible for an annual operating budget of $200M. Hopton was also involved in the restructuring of 360 Networks, a network communications company, which led to a buyout by Bell Canada. Hopton earned his Bachelor of Business Administration from Simon Fraser University in British Columbia, Canada and received his professional designation as a Certified General Accountant.

Michelle Seltenrich, MBA - Vice President, Operations

Michelle Seltenrich brings 19 years of expertise in public biotech companies. Her experience ranges from both academic and industry R&D lab management to corporate mergers and acquisitions. Seltenrich was previously the Manager of Business Development at Forbes MediTech and was responsible for international business development, in-licensing and M&A. She played a key role in the successful acquisition of a US based biotech company. Seltenrich holds a BSc from the University of British Columbia and an MBA in Technology Management from Simon Fraser University.