Sirona Biochem Releases CEO Letter to Shareholders – Clinical trial results expected Q1 2019

Vancouver, British Columbia – January 30, 2019 – Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (the “Company”) is pleased to provide a corporate update today from the Company’s CEO, Dr. Howard Verrico regarding its plans for the current calendar year.

Dear Shareholders,

I am pleased to provide the following update on Sirona’s current activities and anticipated developments for 2019.

Sirona’s skin lightening compound TFC-1067

Clinical Trial

The proof of concept clinical trial for Sirona’s skin lightening compound TFC-1067 began on 26th November 2018 at a center in North Carolina under the supervision of top dermatologist, Dr. Zoe Draelos. The double-blinded trial will assess the safety and efficacy of TFC-1067 in lightening the skin of patients with melasma as well as balancing overall skin tone. The study will end late February. Sirona management expect to receive results 1-2 weeks after the trial is completed.

Global Licensing Strategy

One of the largest US cosmetic companies has invested significant time and resources to evaluate TFC-1067. Their due diligence has included months of research and a substantial investment of resources. We have met with, and presented to, the management and founders of the company and they remain excited about incorporating Sirona’s compound into their existing product line.

With this progress to date, we anticipate licensing discussions to follow the clinical trial. However, to mitigate risk and maximize opportunity, we have maintained communication with a number of leading cosmetic companies around the world and have developed many new contacts. We have established and continue to build a list of companies eagerly awaiting the results of our clinical trial. This includes our efforts in Japan through our Tokyo based consultant.

China Licensing Strategy

The global skin lightening market is estimated to grow to US$31.2 billion by 2024. Of this, Asia makes up the largest and fastest growing market[1]. However, there remain health concerns over many of the currently available lighteners due to the sensitivity of Asian skin. Accordingly, we have chosen to enter this market separately from the global licensing strategy so we can maximize the commercial opportunity while providing a safe, effective product for the Asian skin-type.

After many months in China exploring numerous opportunities, our advisor, PRC Partners, has established, and greatly progressed, a relationship in China with a large cosmetic distribution company. We have signed a memorandum of understanding to work with this distribution company.

This company is currently managing and funding a 3-site, 60-person, clinical trial for TFC-1067 which is well underway with preliminary results anticipated mid-February. The trial is comparing TFC-1067 to brands local to the Chinese market and will provide an assessment of the effects of TFC-1067 on Asian skin. Based on our scientific knowledge of TFC-1067, we believe our skin lightener will avoid sensitivity and efficacy issues currently associated with existing skin lighteners. The distributor is contemplating making a significant equity investment in Sirona pending positive results of their testing.

We are very pleased with the work that PRC has done in China and we will continue to update our shareholders as the trial and agreements advance.

Sirona’s Diabetic drug candidate SGLT-2 inhibitor, TFC039: Clinical & Animal Trials

China also represents the largest market for diabetes with approximately 114 million adults now with the disease[2]. Our partner, Wanbang Biopharmaceuticals, continues to progress the development of TFC-039 for the treatment of type 2 diabetes. We will meet with them shortly and anticipate a joint announcement on their progress regarding the status of CFDA testing after the Chinese New Year.

Our companies have agreed to coordinate all news releases on this project. We remain very pleased with the ongoing progress and our close relationship with Wanbang.

TFC-039 is also being tested for companion animals. The company doing testing is currently consolidating data from the first study. Based on these results, a decision will be made on how to move forward.

Many of our initiatives will reach a critical point in 2019 and we expect it to be a watershed year for Sirona Biochem. We thank you for your continued support and are looking forward to reporting our continued progress.

Sincerely,
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 located 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.

For more information regarding this press release, please contact:

Christopher Hopton, CFO
Sirona Biochem Corp.
Phone:  1.604.282.6064
Email: chopton@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.

 

 

[1] Global Industry Analysts(2018, March). Obsession with Lighter Skin Tones in Asia, the Middle East & Africa Drives Opportunities in the Global Skin Lighteners Market

Retrieved from https://www.strategyr.com/MarketResearch/Skin_Lighteners_Market_Trends.asp

[2] Zhang, J. (2018, July 19). The Diabetes Market in China. Retrieved from http://www.pharmexec.com/diabetes-market-china

Product Development

While carbohydrate-based molecules offer immense commercial potential, we are focusing on three programs at this time.