VANCOUVER, BC, June 30, 2021 /CNW/ - Sirona Biochem Corp. (TSXV:
SBM) (FSE: ZSB) (OTC: SRBCF) ("Sirona") is pleased to
provide the following update to shareholders.
Dear shareholders,
We are providing this update along with our quarterly results.
We will continue to provide an update each quarter and will update
our milestone list at that time as well.
It is important to appreciate that each of our projects relies
on partners. Whether this is the manufacturing and supply
organizations, the contract research groups that run our studies,
or the potential commercial partners completing their own studies
and reviews as part of due diligence. Our prospective global
partners conduct due diligence that is extremely detailed and often
takes longer than anticipated. Each of these partners has their own
unique organizational structures and schedules and they are often
met with challenges that cause delays. In the best of times this is
the case, but in the past year we have dealt with far more. Sirona
has internally managed recent global challenges with little to no
adversity, but larger organization have been less successful.
We take this opportunity to apologize to our investment
community for our mistakes when it came to estimating some of our
project timelines and we will strive to do better going forward. We
assure you that our projects have not been discontinued, that our
science team is actively working on contributions to partner due
diligence activities as well as expanding our pipeline with new IP,
and that our business teams are continuously meeting with large
global corporations to discuss ongoing and new partnerships.
The individual project updates are as follows:
TFC-1067
North America
We are very pleased that TFC-1067, our active ingredient for dark
spots on or hyperpigmentation of the skin, has now been
commercialized.
On March 10, 2021, we announced
that Rodan + Fields (R+F) had successfully launched TFC-1067 as the
active ingredient in the new REVERSE Targeted Dark Spot Corrector.
We are extremely proud to have contributed to the first
commercialization of the technology developed by our award-winning
CSO Dr. Geraldine Deliencourt-Godefroy. This launch not only
validated our technology but has also opened the door for further
collaborations as global players have increased confidence to add
TFC-1067 to their product portfolios.
Commercial products that include TFC-1067 will have different
levels of efficacy depending on the concentration of our active and
the formula (cream, serum, etc) developed by the commercial
partner. In addition, all spot correctors take time to be effective
and the visible results steadily become more apparent over time.
Even the industry standard, hydroquinone, takes weeks to show an
effect despite achieving results partially through toxicity.
TFC-1067 blocks the formation of new pigment and existing pigment
must degrade over time. Our science team is convinced we developed
an excellent formulation in our clinical trials and remain highly
confident in our product. Participants in our second double blind
clinical trial support this conclusion. This trial demonstrated,
successfully, the powerful effect of our TFC-1067 formulas with
100% of participants seeing an improved complexion and concluding
they would buy this product.
With great results confirmed by consumers, we have again
increased manufacturing in China
and have currently arranged to secure an inventory of product that
will be able to meet the growing demand. Our manufacturing partner,
WuXi AppTec has provided dedicated resources for our compound and
can produce significant quantities with little turnaround time. As
we continue to scale, product supply will not be an issue.
Our second clinical trial for TFC-1067 completed in Feb 2021. At this time, our pharmaceutical
partner continues their due diligence and will do so for a
previously agreed upon time. A successful transaction with the
trial partner is management's goal as it would be transformational
for Sirona. While many global pharmaceutical and dermatological
companies continue to approach Sirona with interest in TFC-1067, we
are obligated to delay in-depth discussions involving the clinical
trial results until our partner has completed analysis of the
clinical results and determined their next steps. Due diligence by
global leaders takes time no matter how confident they are in the
ultimate commercial success since they follow meticulous procedures
with large teams. We observed this with Rodan + Fields as great
care is required to maintain the brand excellence.
Our VP of Operations, Michelle
Seltenrich, attended BIO from June
14th to June
18th and met with 12 organizations from the
following countries/regions: Japan, Korea, China, USA,
Canada, Europe to discuss various programs. Each of
these meetings was pursued by the larger organization and will be
followed up with data exchange.
We will be successful in further commercialization of TFC-1067
globally.
Asia
We continue to implement our Asia
strategy and are in discussions with a China-based company which has established
cosmetic development excellence as discussed in our last news
update. An evolving and varied regulatory landscape for new
compounds throughout Asia has
created challenges. Each country in Asia has enormous commercial potential and we
do not want to miss any of these opportunities. As such, we are
advancing another compound, TFC-1394, from our patented library of
skin lighteners to the same level as TFC-1067. This will occur over
the next 12-18 months and ensure that country regulatory testing,
if required, can be performed by other companies. We will then be
able to launch in every country where a market exists in this
$20 Billion USD industry. Our
scientists have outlined a development path based on the expertise
we have developed which is both efficient and affordable. It will
occur in parallel to commercialization of TFC-1067 and not delay
current plans. The value of our portfolio, which includes TFC-1067
and TFC-1394, will grow as they advance towards becoming a new
industry gold standard as both safe and effective compounds. Having
a regional partner is an important component in successful
achieving our goals in a timely manner.
Tinyi Trading Company remains on board to be a distribution
partner, however, with current discussions ongoing, we wait to see
if the new partner in China seeks
exclusive distribution. Ultimately, we will decide in the best
interests of our company and shareholders.
TFC-039
Human Diabetes
Our partner, Wanbang Biopharmaceuticals, has informed us that our
compound for type 2 diabetes (TFC-039) has completed their Phase I
studies and the data is in the analysis phase. We expected to hear
the results of this before the Chinese New Year in early February,
however, they have experienced delays in the data analysis. We are
now waiting and pushing to have a final report of these results and
will update shareholders as soon as material information is
available for release.
Animal Health
TFC-039 for animal health continues to progress. We are now in
contact with four international companies on this project. Two
additional global animal health companies reached out to our team,
and we have exchanged data that they are currently reviewing.
We are evaluating the best way forward and still anticipate
having both a manufacturing and a commercialization partner for the
animal health product. We have established assistance from Wanbang
in this regard and have their full commitment.
Other Indications
The team at TFChem is investigating further indications for TFC-039
and have identified the target diseases. Once the patents have been
established, we will provide more information. Premature release of
information can prevent the ability to patent a technology and our
company relies on IP as assets, so we ask for patience in this
regard.
Anti-Aging
Our anti-aging library has been completed and a lead compound
has been chosen. These actives target multiple pathways in the
aging process in different layers of the skin, which creates a very
innovative treatment against skin aging and wrinkles. However, the
complexity of this means that the compound will require multiple
and extensive evaluations with different contract research
organizations to identify a mechanism of action. We are now
planning and executing the studies required for clinical testing.
Several studies in this regard, including safety studies have
started and we will announce initial results by Q4 of the calendar
year. New indications for these compounds have been discovered
through the evaluation process and has expanded the potential
target commercial opportunities and will lead to another
specific patent in 2022.
In our last update, we stated that the project was introduced to
several companies at BIO JPM. The team in France put together a very detailed
information package for this project, which contains the
preclinical studies and results. This was distributed to several
companies at the end of May and again following BIO in June.
Discussions with partners remain preliminary at this stage.
Antiviral
Our antiviral compounds are in the chemistry phase, and we will
update as progress is made. Several actives have been already
prepared and we are building our portfolio for evaluation in
different assays. There remains a critical unmet need for drugs
that can halt the extreme progression of some viruses. We have
identified compound structures that fit our platform and have a
clear path of development.
Financing
Sirona's last private placement financing was 2 years ago, a
similar financing is not planned. Management has a strategy on how
to move forward including non-dilutive sources currently being
explored.
Despite our limited recent news flow, we are very excited with
our progress towards future partnerships and licencing deals.
Commercialization of the pipeline is becoming a growing reality
which will ultimately reward our shareholders.
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.
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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.
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SOURCE Sirona Biochem Corp.