Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to provide the following update to shareholders.
We provide this update with conviction that value-driving developments ahead will open a new chapter in Sirona's history. Admittedly, we expected it in 2021, but some events with our partners could not be foreseen.
We thank everyone for their continued support and remain committed to creating value for shareholders with expanding partnerships globally.
We are in the negotiation phase with a global top 10 pharmaceutical company for the rights to TFC-1067. We are completing final legal due diligence and they are advancing on the project as expected. They remain transparent on their steps and timelines.
We are very pleased to have the engagement of Linda Pullan and Pullan Consulting team to assist with this negotiation Linda has successfully closed many pharma/biotech deals and is a renowned professional in the field. She will provide strategic direction negotiating and closing this deal.
We continue to discuss TFC-1067 with other potential global and regional partners and will highlight the compound at BIO JPM January 10th – 14th. Partnering the compound remains a top priority for the company.
Our partnership with Rodan + Fields (R+F) remains strong. We expect to receive their forecasted 2022 requirements for TFC-1067within the next month and currently maintain a sufficient inventory of product.
Individual countries have regulatory requirements which can differ from the rest of the world. The full library of compounds (which includes TFC-1067 as well as TFC-1394) will provide a path to navigate various regions and offer partnerships beyond just the initial compound.
In the event that the licensee of TFC-1067 wishes to also license the whole library, the value of the transaction will reflect this.
As recently announced, Wanbang Biopharmaceuticals has notified us of their decision to discontinue the development of TFC-039 for the treatment of type 2 diabetes in China. While this is disappointing, we still see opportunity ahead for TFC-039 and value added by the work completed to date.
We have refocused our efforts on TFC-039 and have adjusted our strategy to develop the drug for a patentable new indication that addresses unmet needs in valuable markets. Unlike the current indication of diabetes, the new target will put us ahead of any competition. We also have scientific reason to believe there is strong advantages for TFC-039 compared to other compounds of the same class.
We have begun studies on this new indication to determine the preclinical activity and are securing the necessary intellectual property. Details of the new indication cannot be disclosed, but the opportunity as a valuable therapeutic exists and is an area of great need.
This month, we will continue our meetings with two global companies in animal health. Our original party was impacted significantly by a merger, which concluded with the shuffling of senior management, R&D and the external innovation experts. We have re-engaged with a new senior person in the company and will revisit the project in January. Having excellent data already obtained, we remain hopeful to get this project partnered.
The lead compound for anti-aging is currently entering into the development of the analytical method by our manufacturing partner. This is a necessary step in order to qualify the profile of the batch produced for the clinical trial. Once this is established, we will begin with a small scale-up in house to develop the formulation that can be used in a clinical trial as well as for stability studies. A small scale up will also be initiated at a contract manufacturer. Simultaneously, we are speaking with potential partners for R&D collaborations.
At present, we anticipate the clinical trial to take place in the second half of 2022.
We are excited to report that we now have 20 compounds that entered testing for anti-COVID activity. These can take up to 6 weeks to complete and we expect results by the end of February 2022.
In terms of partnering, we seek partners at any stage of development. However, the company will move forward with testing regardless of having a partner. If development advances beyond the preclinical stage, we will likely require a partner to share the cost of clinical trials. With enough preclinical activity to move to clinical, we do not anticipate difficulty in finding that partner.
We are currently in discussions with another biotech company that possesses a high level of expertise in developing antivirals. We are also exploring non-dilutive government funding, which has become more readily available in the current pandemic.
The anti-cellulite project is early stage, but exciting in that there's no competition that offer real treatment potential currently in the market. This makes it a desirable target for skincare companies. At this time, we are in discussions with a top pharmaceutical company and the next step will be a presentation to their R&D team on the development plan. This will occur within the next weeks.
We are very much looking forward to participating in "BIO Partnering at JPM" by Biotechnology Innovation Organization from January 10-14, 2022. Meetings have been arranged and preparations are underway. JPM is the perfect forum to present each of the above projects.
Grant of Incentive Stock Options
Sirona announces that it has granted an aggregate of 4,000,000 incentive stock options to management, independent directors and consultants of the Company. The options may be subject to performance-based vesting provisions as determined by the board of directors. The options, to purchase common shares in the capital of the Company, at a price of $0.17 per common share, will be for periods ranging from 5 to 10 years. The options have been granted under the terms of the Company's stock option plan.
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 .
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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.