VANCOUVER, BC, Oct. 6, 2021
/CNW/ - Sirona Biochem Corp. (TSXV: SBM) (FSE: ZSB) (OTC: SRBCF)
("Sirona") is pleased to provide the following Q3
update to shareholders.
Dear shareholders,
We are providing this quarterly update with a particular focus
on our TFC-1067 compound for skin lightening as it advances towards
a second commercial license agreement.
The individual project updates are as follows:
TFC-1067
North America
As previously reported, our second clinical trial for TFC-1067 was
supported by a top 10 pharmaceutical company, which included the
right to complete due diligence in the months following. Our
partner has successfully completed their analyses of the compound
and we have moved into the next stage of licensing discussions. A
global license with a highly respected partner is our preferred
outcome for TFC-1067.
Rodan + Fields (R+F) continue sales of the add-on product,
REVERSE Targeted Dark Spot Corrector which contains TFC-1067
as the active ingredient. R+F orders for raw material have been
forecast for the remainder of 2021.They remain an excellent
partner, successfully advancing the commercial use of TFC-1067 in
their product. A first for Sirona.
Our manufacturing partner, WuXi AppTec has prepared an inventory
of TFC-1067 that will be held in storage in China. This inventory will allow for zero
delays in requests for orders as we move forward with anticipated
partnerships. We are also maintaining manufacturing
capabilities in France and
exploring new manufacturing processes as we continually evolve our
platform technology for this and all projects.
We believe, based on safety and efficacy data, that we possess
the industry leading compound for lightening dark spots and
balancing skin tone. We are confident TFC-1067 will have a strong
commercial future.
Asia
Our business strategy for Asia
continues to evolve due to challenging regulatory requirements. We
will still advance and offer a second compound, TFC-1394, from our
patented library for countries that have differing needs. Having
either a global or regional partner will be critical to navigate
commercialization in China and
other Asian countries. With advanced discussions ongoing for a
global license, we will scale back pursuing regional
opportunities.
TFC-039
Human Diabetes
Wanbang Biopharmaceuticals has completed Phase I studies for
diabetes drug candidate TFC-039 and is currently in the data
analysis phase. We are awaiting further information for their plan
to move forward. Some logistical challenges have caused delays and
we will update shareholders as soon as we have material information
on the project.
Animal Health
We have received clinical data from the cat studies which show
TFC-039 to be safe and well tolerated. There is concern regarding
manufacturing and the final cost of goods which are not yet fully
defined. Our team is addressing this challenge with assistance from
Wanbang and we have their full commitment.
Other Indications
The team at TFChem is investigating further indications for TFC-039
and have identified target diseases. We are putting in place the
contract research organizations to evaluate these targets as well
as developing the patents.
Anti-Aging
The lead compound from our anti-aging library is advancing to
scale-up. This first batch will be developed for stability testing,
formulation, and the clinical study. Preliminary results for some
studies will be available in Q4 of 2021, however, due to the need
to keep information confidential while patents are being written,
only select information will be released.
Discussions with potential partners remain preliminary.
Antiviral
Our team in France has
synthesized 16 novel antiviral compounds for testing. Information
is currently limited as we develop IP around these compounds. We
are encouraged by the recent successful Phase 3 clinical trial of a
new antiviral from Merck & Co in the treatment of COVID-19
(Merck pill seen as 'a huge advance', raises hope of preventing
COVID-19 deaths | Reuters).
Anti-Cellulite
Our recently announced discovery of a potential cellulite
therapy is still in early-stage development. This discovery
represents another major market opportunity for our company and has
already garnered interest from a global pharmaceutical company.
Financing
Sirona's last private placement financing was over 2 years ago,
a similar financing is not being planned. Management will execute a
strategy which will include non-dilutive sources.
With the completion of the due diligence of our top 10 global
pharma partner, a decisive phase is approaching. While our
scientists in France are making
excellent progress in advancing our pipeline, management is fully
focused on closing concrete agreements and sustainably increasing
shareholder value.
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 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.
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.
SOURCE Sirona Biochem Corp.