14:11:06 EDT Sun 15 Sep 2019
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Sirona Biochem Corp
Symbol C : SBM
Shares Issued 179,825,982
Close 2019-01-30 C$ 0.095
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Sirona expects TFC-1067 licensing talks after trial

2019-01-30 06:21 ET - Shareholders Letter

Dr. Howard Verrico reports

SIRONA BIOCHEM RELEASES CEO LETTER TO SHAREHOLDERS

Sirona Biochem Corp. has provided a corporate update from the company's chief executive officer, 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 Nov. 26, 2018, at a centre 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 expects to receive results one to two weeks after the trial is completed.

Global licensing strategy

One of the largest U.S. cosmetic companies has invested significant time and resources to evaluate TFC-1067. Its 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 $31.2-billion (U.S.) by 2024. Of this, Asia makes up the largest and fastest-growing market. 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 adviser, 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 financing a three-site, 60-person, clinical trial for TFC-1067 which is well under way with preliminary results anticipated mid-February. The trial is comparing TFC-1067 with 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, TFC-039: clinical and animal trials

China also represents the largest market for diabetes with approximately 114 million adults now with the disease. 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 co-ordinate all news releases on this project. We remain very pleased with the continuing 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, chief executive officer.

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.

We seek Safe Harbor.

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