Sirona Biochem CEO Quarterly Update Q2 2021
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.
- Published in News Home, Sirona Biochem
Sirona Biochem Reports Excellent Results in New Clinical Study on TFC-1067
Sirona Biochem Corp. (TSXV: SBM) (FSE: ZSB) (US-OTC: SRBCF) (“Sirona“) is pleased to announce that the second clinical trial of the active ingredient, TFC-1067, has been completed with excellent results.
The trial, which concluded on January 22nd, 2021, was managed by Dermscan (a division of Eurofins), a global leader in cosmetic clinical trials. The study’s endpoint was to determine the compound’s ability to selectively reduce areas of hyperpigmentation and dark spots of the skin while not creating a “halo” around the spot, which is a known side effect of other treatments. Multiple parameters were measured including the added effects of the higher concentration of TFC-1067 and a boosted formulation.
Results of the trial included:
- A significant decrease in spot intensity
- A significant decrease in spot size
- A significant decrease in dark spots versus surrounding skin tone
Optimal results were obtained with the higher concentration and improved formulation:
- 100% of participants agreed their complexion was illuminated
- 100% of participants agreed their complexion was brighter
- 100% of participants agreed their skin was more even in tone
- 100% of participants agreed the product blurred imperfections
- 100% of participants agreed the product prevented new dark spots from occurring
- 100% of participants agreed the spot size and mark was reduced
- 100% of participants agreed the intensity of dark spots was reduced
- 100% of participants would purchase the product
Due to contractual obligations, further disclosures will not be made at this time.
The Company also reports an increase in international interest in the project since the commercial launch of TFC-1067.
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.
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.
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Contact:
Investor Enquiries: Jonathan Williams, Managing Director, Momentum PR, Canada, Phone: 1.450.332.6939, Email: jwilliams@momentumpr.com; Corporate Enquiries: Dr. Howard Verrico, CEO, Chairman of the Board, Sirona Biochem Corp., Phone: 1.604.641.4466, Email: info@sironabiochem.com
- Published in News Home, Sirona Biochem
Sirona Biochem Announces Launch of First Commercial Product Containing TFC-1067
VANCOUVER, BC, March 10, 2021 /CNW/ –Sirona Biochem Corp. (TSXV: SBM) (FSE: ZSB) (US-OTC: SRBCF) is pleased to announce the launch of the first commercial product containing the Company’s proprietary ingredient, TFC-1067. TFC-1067 will debut as the active ingredient in New Rodan + Fields REVERSE Targeted Dark Spot Corrector. It will precisely target stubborn discoloration for a brighter, even-looking skin tone.
Rodan + Fields licensed TFC-1067 from Sirona in 2019.
In Rodan + Fields clinical trials*, REVERSE Targeted Dark Spot Corrector had the following results:
- After 4 Weeks: 77% had less visible dark spots
- After 8 Weeks: 72% didn’t feel like their dark spots were the first thing people noticed
Rodan + Fields additional claims:
- Diminishes the appearance of stubborn dark spots without leaving a halo
- Stubborn dark spots look smaller, less defined, less intense
- Skin tone looks more uniform and even
- Stubborn dark spots are less visible, less noticeable
- Skin looks clearer, more translucent
Sirona also recently partnered with a top-ten pharmaceutical company to conduct a European clinical trial to assess the efficacy of TFC-1067 at .4%. The 12-week study was completed successfully in February. Results are being consolidated into a final report to be released within the next few weeks.
“Rodan + Fields’ use of TFC-1067 in their new REVERSE Targeted Dark Spot Corrector after extensive testing is the strongest validation of our technology to date. Rodan + Fields demand product excellence and innovation for their customers. TFC-1067 is the basis for a product that can uniquely brighten dark spots without leaving a halo effect,” said Dr Howard Verrico, CEO of Sirona Biochem. “Our long-term goal is to provide an effective alternative to hydroquinone for those seeking a solution for skin discoloration. With this launch, we have proven that we can take a compound from the laboratory through clinical trials to large-scale production and integration into a commercial product. This validates our business model and we aim to follow the same path exactly for our entire pipeline. This transformative event is only the beginning as Sirona Biochem evolves into a profitable broadly diversified large company.”
*Based on an 8-week U.S. clinical and consumer study. Results may vary depending on multiple factors: age, gender, skin type and condition, concomitant products used, health history, location, lifestyle and diet. |
About TFC-1067
TFC-1067, Sirona’s proprietary compound, is proving to be superior to current actives on the market, safe and free of hydroquinone. The compound has undergone extensive testing, both clinical and preclinical, including a double blinded study for dyschromia in the USA and a recent trial in the EU for higher dose. Clinical results have shown the compound to be superior to hydroquinone in the treatment of dyschromia with no adverse side effects.
About Rodan + Fields
Founded by Stanford-trained dermatologists Dr. Katie Rodan and Dr. Kathy Fields, Rodan + Fields was launched in 2002 with the mission of giving consumers the best skin of their lives. The brand is a result of the Doctors’ belief that healthy skin empowers people to feel confident. Born in the digital era and designed to directly reach consumers where they live and shop via mobile and social networks, Rodan + Fields is disrupting the industry with its regimen-based skincare and powerful Independent Consultant community.
For more information, please visit www.rodanandfields.com.
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.
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.
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Sirona Biochem CEO Quarterly Update Q1 2021
Sirona Biochem Corp. (TSXV: SBM) (FSE: ZSB) (OTC: SRBCF) (“Sirona“) is pleased to provide the following update to shareholders.
We continue to make substantial progress with core deliverables.
TFC-1067
Rodan + Fields (R+F) is completing the final stages in preparation to launch one of their newest skin care products incorporating TFC-1067. The dates are tightly guarded at this time and shareholders will be updated as soon as we are able to do so. We can report that everything is still progressing on schedule. As this will be our first project to reach commercial sales, we are looking forward to a successful launch.
Manufacturing of commercial quality TFC-1067 is ongoing in both China and France and shipments have been completed from both countries to the USA. As is the case with most new manufacturing, we continue to invest in optimizing the process. The development of an optimal production is an initial investment and a necessary condition to ensure we can sustainably serve a growing demand.
Our second clinical trial for TFC-1067, utilizing a higher dose, has been successfully completed and preliminary results have been received from Dermscan. We expect the final report within 4 weeks at which time we will review the results with our pharmaceutical partner (see news Oct 2020). We anticipate being able to release a portion of the results that are independent of our partner after a period of due diligence.
Several multinational companies have approached Sirona with interest in TFC-1067. Once the first product is available for purchase and we can release the latest data, we anticipate that number to grow. The data package now contains many in vitro studies, clinical safety data, two clinical trials and manufacturing. Additionally, we have a partner who independently tested the product providing further support for its performance.
After completing our due diligence, we made the decision not to pursue an agreement with HuaxiPharm. They have experienced internal challenges and delays and we do not feel their goals align with Sirona at this time. We have been working on developing a relationship with another company that can manage all aspects of commercialization of TFC-1067 in China. Our board and senior team are in regular discussion with this company on moving forward with an agreement. Extensive due diligence has already occurred.
TFC-039
TFC-039 for a type 2 diabetes pharmaceutical has completed another major phase in development and material information is pending.
TFC-039 for animal health continues to progress. We are in discussions with two international companies on this project and as such it has taken more time than expected to coordinate. Sirona and its consultants have structured and negotiated this unique partnership. We have closed binding terms on one side of this deal with the partner and we anticipate the other partner closing soon. Until such time that both partners have agreed to all terms, the details must remain confidential.
In addition, the team at TFChem are currently investigating further indications for TFC-039.
Anti-Aging
Our team has recently completed further studies for our anti-aging project to analyze our library of compounds and determine a lead. While we had previously done studies on some of these compounds, the lab was successful in developing further compounds for the library which we believe may have additional potential. These compounds must be patented and to do so, it is a requirement to fulfill a set of in-vitro studies. The studies are now complete, and we can begin the next steps of preparing a lead for further investigative studies in safety prior to the clinical trial. The project was introduced to several companies at BIO JPM (https://www.bio.org/events/bio-partnering-jpm) and we are developing the information package to share with them. We also anticipate further discussions with our current partners about this project.
Antiviral
With recent developments in other projects as well as the lab’s dedication to scale-up and managing the clinical trials of this project, the antiviral project remains less of a priority at the moment, but very much on the agenda for 2021 and 2022. We will update as progress is made.
Sirona continues to thrive in a world which has become increasingly virtual and has been conducting business daily on four continents. With a well-seasoned and experienced team, including multiple locally based consultants, travel has become unnecessary to maintain our progress. We will continue to support and grow our pipeline technology developed by our dedicated team of TFChem scientists based in Rouen, France.
We also continue to focus our efforts to create significant value for our shareholders. We realize that some investors had hoped for more progress. However, once again, we are moving forward and we are very confident that we will reach further significant milestones and continue to develop Sirona as a commercially successful company.
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.
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.
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Sirona Biochem Releases CEO Letter to Shareholders
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (US-OTC: SRBCF) (“Sirona”) is pleased to provide an update from the Company’s CEO, Dr. Howard Verrico.
Dear Shareholders,
This year, we decided to provide our investor community with a FAQ format as an update on some of the progress and activities currently underway at Sirona.
Q: Will we have any news before the end of 2020?
Sirona’s projected milestones will occur within the next 7 months. As per our Investor PowerPoint, we have provided a list of items we feel are within our control and our goal remains to announce them within that timeframe. Estimating timelines is difficult for two reasons. One is that many of our milestones rely on partner organizations and we cannot control their progress or what they choose to make public, and two, research and development can often take unexpected pathways. There are times when we need to switch strategies based on results and/or resources available, but our decisions are always in the best interest of increasing shareholder value. While we do our best to estimate project outcomes and timelines, they are based on variable factors and can change without notice.
Q: In your interview with Smallcap-Investor, you said there would be news in early 2020 from Wanbang. Is this still expected?
The Wanbang trial was delayed due to COVID-19 early in the pandemic. The delay was relatively brief as the infections were quickly brought under control, but it did have an impact on the timing of the studies. Wanbang have restarted and we have been informed that the trial is currently meeting expectations of efficacy and safety. Wanbang is in full control of publicly released information on their trials and advancement of the SGLT2 inhibitor. When they choose to announce, we will immediately inform our investors. If they reach a milestone which triggers a payment to Sirona, then Sirona can issue an independent release as required by stock exchange rules. Consultation with Wanbang would always be part of the process as we maintain our excellent working relationship.
Q: What is happening with the Huaxi deal?
We have been actively performing due diligence on Huaxi with the assistance of Sirona’s consultants on the ground in China. We have found that Huaxi has experienced internal delays so, in parallel, we have decided to talk to other potential partners in China. Over the past month, we have executed several confidentiality agreements and begun introductory meetings as well as due diligence. Huaxi may still proceed or the company may become a participant in a larger group. The interest in Sirona and TFC-1067 remains high. We must spend the time and effort to secure the right partner. China is too important to make a strategic misstep with a partner in an effort to rush the product to market. We will secure the right group or groups to move this forward.
Q: What is happening with the Tinyi deal? Will they still be our distribution partner in China?
Tinyi is still expecting to be a distribution partner for TFC-1067 in China. They are also potentially looking to be part of a larger transaction. As in the above response, Sirona is ideally looking for an integrated team based in China to manage all aspects of commercialization. We are actively moving toward this plan with the due diligence of several competent partner groups. This will maximize our growth potential and free up resources to expand into other countries. This aligns with Sirona’s business model to partner and licence our technology with leading industry companies that have established abilities in all aspects of commercialization including manufacturing, regulatory, distribution and sales in local markets around the world. Sirona will grow by doing what it does best, innovation of new cosmetic and therapeutic agents using its proven platform technology.
Q: How long will it take to get CFDA approval for TFC-1067?
We anticipate updates on this issue as regulations are undergoing a major reform. This is something we are planning for our partner to manage but are also actively talking to leading experts on the regulatory landscape.
Q: Why is the Rodan + Fields launch taking so long?
Rodan + Fields spend a great deal of time preparing the introduction of their products and regimes. They are strong advocates of good science and take the necessary time to complete compound studies, formulations, and appropriate marketing analyses. The launch date for TFC-1067 was established early in the program and R+F have not altered that date. We have been informed last week that they are still on track for the scheduled launch. Our established manufacturing will ensure that enough product will be produced to meet the demand for TFC-1067 without delays.
Q: Is the antiviral program on hold?
The antiviral program is not formally on hold, but resources have been temporarily shifted to the anti-aging program as the team in France works on testing various compounds in the library. We have had good results that require further investigation and we felt that shifting the strategy to this program made sense for now. We are actively seeking partnerships while we confirm results. We have new anti-aging compounds which we believe are even more commercially promising both in ease of manufacturing as well as effectiveness. Testing of these new compounds became a priority to secure the patents.
Q: Has COVID-19 had an impact on deal progress?
Yes. COVID-19 has not impacted our ability to work internally but has impacted the ability of our team to travel. Much of our business in China traditionally relies on face-to-face meetings that simply cannot take place so we have adapted. Fortunately, we do have consultants in China who are able to progress our business development. We will resume travel as soon as possible but will not delay business development in the meantime.
Q: What is happening with the diabetic therapy for animals?
Our partner completed extensive due diligence that went beyond the initially set timeline. They have reported to us they are at the very final stages of that process and will be moving to the next level of engagement. We expect an update on this project soon, however, we caution that due to holidays, we cannot be certain that news will be released prior to year-end.
Q: Is Sirona going to improve investor communications?
We are actively working to improve communications. This FAQ sheet is part of that process. You will see more changes over the next few months as we work to keep our shareholders informed of our latest developments. This includes a stronger social media presence and quarterly shareholder updates.
Best Regards,
Dr. Howard Verrico
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.
- Published in News Home, Sirona Biochem
Sirona Biochem Announces Acceptance of Clinical Study for TFC-1067 in the Journal of Cosmetic Dermatology
Sirona Biochem Corp. (TSXV: SBM) (FSE: ZSB) (USOTC: SRBCF) (“Sirona“) is pleased to announce that the clinical study using .2% TFC-1067 and conducted by Dr. Zoe Draelos of Dermatology Consulting Services, North Carolina, has been peer reviewed and accepted for publication in the Journal of Cosmetic Dermatology.
The study abstract can be found at the following link: https://doi.org/10.1111/jocd.13771
“The acceptance of a peer-reviewed study in a prestigious dermatology journal shows the dedication and credibility of our team and unwavering support of our innovative compound TFC-1067,” said Dr. Geraldine Deliencourt-Godefroy, Chief Scientific Officer of Sirona Biochem. “While we continue to foster our global partnerships, this publication will provide tremendous of commercial value as consumers increasingly demand clinical validation of products. With the unique benefits of TFC-1067 demonstrated in this trial, we are very excited about the next clinical trial currently underway using a higher concentration and improved formulation” she added.
The 12-week double blinded study involving 48 participants, completed in 2019, showed that TFC-1067 successfully achieved the endpoint of lightening dyschromic areas (dark spots) on the skin. With the application of TFC-1067, areas of hyperpigmentation were significantly lightened while preserving overall skin tone. TFC-1067 demonstrated the ability to lighten dark spots to blend into surrounding skin while preserving overall complexion. In this study, TFC-1067 achieved this goal while Hydroquinone did not, which is a tremendous consumer benefit and commercial advantage.
Further studies are planned, with one currently underway. Exploring the potential of TFC-1067 on different skin types, formulations and concentrations will further unlock the consumer and commercial unique benefits.
Hydroquinone has remained the gold standard for skin lightening despite known toxicity which is an ongoing concern for the FDA and the dermatology community. Hydroquinone is banned or has restricted dosing in an increasing number of countries. Despite the fact that many non-hydroquinone alternative lightening compounds are either toxic or ineffective, unfortunately millions of people still resort to toxic treatments for hyperpigmentation despite poor aesthetic results. There is a clear unmet need for a safe and effective treatment in this 20-Billion-USD skin lightening market.1
About the Journal of Cosmetic Dermatology
The Journal of Cosmetic Dermatology is the official journal of the International Academy of Cosmetic Dermatology (IACD) and the Canadian Association of Aesthetic Medicine (CAAM). The Journal publishes high quality, peer-reviewed articles on all aspects of cosmetic dermatology with the aim to foster the highest standards of patient care in cosmetic dermatology. Published quarterly, the Journal of Cosmetic Dermatology facilitates continuing professional development and provides a forum for the exchange of scientific research and innovative techniques.
For more information about the Journal of Cosmetic Dermatology, please visit: https://onlinelibrary.wiley.com/page/journal/14732165/homepage/productinformation.html
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.
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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1Fact.MR (July 2018) Retrieved from: https://globenewswire.com/news-release/2018/07/10/1535161/0/en/Key-Insights-on-Skin-Lightening-Products-Market-through-2022-by-Fact-MR.html
SOURCE Sirona Biochem Corp.
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Contact:
regarding this press release, please contact: Investor Enquiries: Jonathan Williams, Managing Director, Momentum PR, Canada, Phone: 1.450.332.6939, Email: jwilliams@momentumpr.com; Marcus Kaemper, Germany, Phone: +49 160 920 340 25, Email: mk@sironabiochem.com; Corporate Enquiries: Dr. Howard Verrico, CEO, Chairman of the Board, Sirona Biochem Corp., Phone: 1.604.641.4466, Email: info@sironabiochem.com
- Published in News Home, Sirona Biochem
Sirona Biochem Signs Agreement with Global Pharmaceutical Company for Clinical Trial of its Novel Skincare Compound TFC-1067
Sirona Biochem Corp. (TSXV: SBM) (FSE: ZSB) (US-OTC: SRBCF) (“Sirona“) is pleased to announce that it has signed an agreement with a top 10 global pharmaceutical company (“Company”) to jointly test Sirona’s novel skin care, dark spot remover, TFC-1067, in a new clinical study. TFC-1067 will be tested using a new higher concentration (0.4%) and advanced formulation.
The clinical trial, launched October 5th, will run for a period of 12 weeks and include a minimum of 125 participants. It will be managed by Dermscan (a division of Eurofins), a global leader in cosmetic clinical trials. The study’s endpoint is to determine the compound’s ability to reduce hyperpigmentation or “dark spots” of the skin.
Multiple parameters will be measured including the added effects of the higher concentration of TFC-1067 and a boosted formulation. The study is expected to complete in early 2021 with results in February 2021. The study protocol was established through a collaboration of the scientific teams of TFChem, Sirona’s wholly owned subsidiary and the Company’s skincare scientific team.
Following the study, the Company will have first access to the clinical study results to assess potential use by its subsidiary dermatology company.
“To have a partner of this magnitude assisting in the design and financing of our clinical trial is a testament to the potential of TFC-1067,” said Dr. Howard Verrico, CEO of Sirona Biochem. “We look forward to continuing our relationship with their clinical team through the study as we evaluate the higher dose and improved formulation of the compound. TFC-1067 has been clinically proven to selectively lighten dark spots and blend them into surrounding skin tone. The ability to lessen visibility of dark spots while preserving underlying skin tone safely is a unique consumer benefit.”
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.
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.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/October2020/13/c0146.html
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Sirona Biochem Contracts WuXi AppTec for Large-Scale Manufacturing of TFC-1067
Sirona Biochem Corp. (TSXV: SBM) (FSE: ZSB) (US-OTC: SRBCF) (“Sirona“) is pleased to announce it has signed an agreement with Contract Manufacturing Organization (CMO) WuXi AppTec (“WuXi”), Shanghai, to launch large-scale production of TFC-1067, a novel skin dark spot remover, for global commercialization.
WuXi has spent four months developing their manufacturing process for commercial grade TFC-1067. This process was recently completed, resulting in a highly pure production of TFC-1067 with the ability to scale to any quantity needed by Sirona.
Sirona anticipates the need for multi-kilogram production of TFC-1067 through the remainder of 2020 with sustained large-scale quantities for commercialization required in 2021. To prevent gaps in manufacturing, and minimize risk, the compound will be produced in multiple locations. Roowin, the current CMO in France, will remain a producer in addition WuXi.
Given the high potency of TFC-1067, each kilogram of Sirona’s active ingredient will produce up to ten thousand consumer size (fifty milliliters) containers of finished product.
“With our current agreement, as well as potential new global organizations developing interest in TFC-1067 as an active ingredient, we anticipate needing significant quantities of product. WuXi AppTec is one of the most highly regarded CMOs in China and have been excellent to work with thus far”, said Dr. Howard Verrico, CEO of Sirona Biochem. “We’ve taken our time choosing a manufacturer in China to ensure we have the most qualified company for the job. We look forward to our relationship with WuXi and are confident about meeting further milestones near-term.”
About WuXi AppTec
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions.
With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.”
For more information, please visit: www.wuxiapptec.com
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.
- Published in News Home, Sirona Biochem
Sirona Biochem Ships First Batch of TFC-1067 to Rodan + Fields
Sirona Biochem Corp. (TSXV: SBM) (FSE: ZSB) (US-OTC: SRBCF) (“Sirona“) is pleased to announce that it has made its first shipment of compound, TFC-1067, to industry leader Rodan + Fields, LLC (“Rodan + Fields”) formulation team. Rodan + Fields will be the first to market for a consumer product utilizing TFC-1067 for the treatment of dyschromia (hyperpigmentation or “dark spots” of the skin).
Using the services and expertise of Contract Research Organization, Roowin SA, Sirona scaled-up production to the multi-kilogram level. The synthetic process was refined to yield a large supply of high purity TFC-1067 to meet the exacting standards for a high-quality product. Roowin will be providing a further supply of TFC-1067 near term as production continues. Sirona management is currently in advanced negotiations with Chinese producers regarding large scale manufacturing of TFC-1067 and expects to sign an agreement in this regard within the next quarter. Part of the strategic plan is to build up an inventory of commercially ready TFC-1067 through two manufacturing sites. This will enable a quick response to anticipated demands from other companies using a diversified supply channel. Further details of the product launch will remain confidential for strategic reasons.
Sirona also announces a successful attendance at BIO Digital, June 8-12, 2020. Interest in TFC-1067 and anti-aging from international cosmetic companies was high during the virtual conference. The advancement of TFC-1067 through clinical and manufacturing has established a significant level of interest as the compound is much more attractive to companies. Having a ready supply of inventory and established manufactures vastly decreases the risk for organizations looking to add TFC-1067 to their product lines.
About Rodan + Fields
Founded by Stanford-trained dermatologists Dr. Katie Rodan and Dr. Kathy Fields, Rodan + Fields was launched in 2002 with the mission of giving consumers the best skin of their lives. The brand is a result of the Doctors’ belief that healthy skin empowers people to feel confident. Born in the digital era and designed to directly reach consumers where they live and shop via mobile and social networks, Rodan + Fields is disrupting the industry with its regimen-based skincare and powerful Independent Consultant community.
For more information, please visit www.rodanandfields.com.
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.
- Published in News Home, Sirona Biochem
Sirona Biochem shareholders elect five directors at AGM
Sirona Biochem Corp.’s annual general meeting was held at the offices of Sirona Biochem at Suite 1600, Room 16D, 595 Burrard St., Vancouver, B.C., on May 22, 2020, at 9 a.m. Pacific Time. All resolutions presented to the shareholders at the AGM were passed, as discussed in the meeting proxy materials published and mailed to the shareholders and posted at SEDAR.
Voting results:
- The number of directors of the company was set at five.
- All directors were elected with more than 96 per cent of votes in favour, being the following directors elected at the AGM: Howard J. Verrico, Christopher D. Hopton, Geraldine Deliencourt-Godefroy, Alex Marazzi and Jason Tian.
- The ordinary resolution to ratify and approve the stock option plan for continuation was passed by more than 97 per cent of votes in favour.
- The ordinary resolution to ratify and approve the shareholder rights plan agreement was passed by more than 97 per cent of votes in favour.
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona Biochem’s subsidiary lab, TFChem, specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential. Sirona Biochem’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and continuing royalty payments.
We seek Safe Harbor.
- Published in News Home, Sirona Biochem