Sirona Biochem Announces Positive Efficacy Results for Skin Lightening Library
Sirona Biochem Announces Positive Efficacy Results for Skin Lightening Library
Momentum Public Relations
Press Release: July 6, 2017
VANCOUVER, BC–(Marketwired – July 06, 2017) – Sirona Biochem Corp. (TSX VENTURE: SBM) (FRANKFURT: ZSB)(XETRA: ZSB) (the “Company“) announced positive preclinical efficacy data for its library of skin lightening compounds.
The study was conducted at Bioalternatives in France, a contract research organization specializing in cellular and molecular pharmacology. The study looked at each of six compounds’ ability to inhibit melanin synthesis induced by L-tyrosine for 10 days in normal human epidermal melanocytes. Results showed a significant decrease in melanin synthesis with a similar efficacy across the library. Inhibiting melanin production is the principal mechanism of action for the majority of skin lighteners in clinical use.
“In December 2016, we announced the completion of our skin lightening library, with plans to begin testing in 2017,” said Dr. Howard Verrico, CEO. “The positive efficacy of these compounds adds value to a licensing transaction as it increases the opportunity for commercialization in various markets and therapeutic areas. Moreover, this data will be used to support and strengthen our IP in this area.”
Sirona has shared these results with the multinational companies currently working towards a license to commercialize 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.
For more information regarding this press release, please contact:
Christopher Hopton
CFO
Sirona Biochem Corp.
Phone: 1.604.282.6064
Email: chopton@sironabiochem.com
- Published in Life Sciences, News Home, Sirona Biochem
Sirona Biochem Announces Convertible Note Financing
VANCOUVER, BC–(Marketwired – January 31, 2017) – Sirona Biochem Corp. (TSX VENTURE: SBM) (FRANKFURT: ZSB) (XETRA: ZSB) announced today a non-brokered private placement (the “Private Placement”) of convertible notes (“Notes”) for gross proceeds of up to $600,000. Each Note will be convertible at the option of the holder into one common share of the company at a conversion price of $0.18 per share during the 18 month term of the Notes.
The Notes will mature in 18 months from the date of issuance and bear interest at the rate of 12{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} per annum, payable quarterly, until the Notes are converted or repaid. The company will be entitled to repay the principal amount of the Notes, together with accrued and unpaid interest, at any time commencing four months after the date of issuance, subject to giving the holders prior notice thereof to permit holders to convert during the notice period. The Notes are unsecured and transferable, subject to resale restrictions under applicable securities laws and TSX Venture Exchange requirements.
Sirona Biochem intends to use the net proceeds from the Private Placement for general working capital, and to support the company’s efforts to secure a licensing agreement for its skin lightening compound, TFC-1067. The company is expecting to receive a term sheet for a licensing transaction for TFC-1067 in Q1 2017 but there can be no assurances that a licensing agreement will be entered into on terms acceptable to Sirona Biochem or at all. The Company may pay fees of 7{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} in cash to qualified finders.
All securities issued in connection with the private placement will be subject to a statutory hold period of four months commencing from the date of issuance of the Notes. Closing of the private placement is subject to customary conditions, including TSX Venture Exchange acceptance.
This news release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of any of the Shares in any jurisdiction in which such offer, solicitation or sale would be unlawful. The Shares have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to, or for the benefit of, U.S. persons (as defined in Regulation S under the U.S. Securities Act) unless registered under the U.S. Securities Act and applicable state securities laws or pursuant to an exemption from such registration requirements.
In addition, the Company announces an extension to the term of 8,865,970 common share purchase warrants (the “Warrants”) originally issued on March 6, 2014. The warrants were issued as part of a private placement. The expiry dates will be extended as follows:
March 6, 2014
Number of Warrants: | 8,865,970 |
Original Expiry Date of Warrants: | March 6, 2017 |
New Expiry Date of Warrants: | April 30, 2017 |
Exercise Price of Warrants: | $0.20 |
All other terms of the Warrants will remain unchanged.
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: a third party potential licensees of TFC-1067 may not deliver a term sheet to the company in Q1 2017 or at all; the company may not be able to negotiate a license agreement with a potential licensees of TFC-1067 on terms acceptable to Sirona Biochem; the progress and timing of its clinical trials are uncertain; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing products; unexpected adverse side effects or inadequate therapeutic efficacy of the company’s or licensed products that could delay or prevent product development or commercialization; the scope and validity of patent protection for the company’s or licensed 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.
CONTACT INFORMATION
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For more information regarding this press release, please contact:
Christopher Hopton
CFO
Sirona Biochem Corp.
Phone: 1.604.282.6064
Email: chopton@sironabiochem.com
- Published in Bio technology, News Home, Sirona Biochem
Sirona Biochem (SBM:tsxv) CEO’s Report on Progress
Sirona Biochem CEO’s Report on Progress
– Momentum Public Relations –
Press Release: December 8, 2016
Sirona Biochem Corp. (TSX VENTURE: SBM) (FRANKFURT: ZSB) (XETRA: ZSB) today provided a business update.
Dear Shareholders,
The following is an update on our progress in 2016 and our plans for 2017.
Skin Lightener, TFC-1067
Throughout 2016, we have remained focused on completing a licensing agreement for our skin lightening compound, TFC-1067. It was our plan to finalize this transaction earlier in the year. However, it is not a timeline we have full control over. We have multiple companies engaged and progressing through due diligence at their own speed. Despite contrary market rumors, no party has left the negotiation table. At this time, we expect to receive one or more term sheets from interested parties before the end of Q4 2016. We remain very confident that one or more of these global entities will move forward with a definitive licensing agreement in early 2017.
Should the circumstances be that no potential licensing partner can complete the deal in a reasonable time frame, or for what we consider to be an appropriate value, then we will proceed with the full development of the skin lightener on our own. This would include GMP scale-up, toxicology, formulation and an early clinical trial. We already have consultants in France building the full development plan. We are aware that building a development plan may seem unnecessary but we take seriously our commitment to minimize risk and maximize opportunity for our shareholders. It is important that we are not dependent on a partner to complete a development plan and remain in a position of strength during negotiations.
SGLT2 Inhibitor, SBM-TFC-039 (Wanbang)
Wanbang Biopharmaceuticals recently provided a project update on the SGLT2 Inhibitor. We are very pleased to announce that they have completed most of the preclinical studies, the scale-up optimization and pharmaceutical grade manufacturing of the product. They will formulate the product in January 2017 to prepare for a clinical trial. Following that, they will conduct an additional pharmacology as well as toxicology study and file the “investigational new drug” (IND) package with the Chinese FDA (CFDA). This filing will trigger the next escalating milestone payment. Approval of the IND package by the CFDA will trigger another milestone payment and indicate the start of clinical studies.
The data that has been generated by Wanbang is currently being used in licensing discussions with a potential partner in India that recently approached us.
Skin Lightener, TFC-849 (Valeant) and Library
Our skin lightener, TFC-849 remains in scale-up at a French CRO for clinical studies. We did anticipate that this would be finalized earlier in 2016, however, the CRO experienced some complications and therefore it has been delayed until January. Valeant is aware of the delays in scale-up and has not altered plans to commercialize.
In 2016 we also completed the development of several other skin lighteners. This group contains potential lead compounds which can be licensed with TFC-1067 or separately in multiple markets. We have begun preliminary testing to determine the most effective new compounds, and expect results in Q1 2017.
Cell Preservation and Regenerative Compounds
We have now concluded testing of our glycoprotein compound library. We showed a protective effect in human fibroblasts (skin cells) under various stress conditions. Our subsidiary, TFChem has developed a comprehensive report of the data to be shared with potential partners. While the compounds have very interesting properties, they are still considered early stage, which means that the partnerships we seek will be considered “Research and Development” (R&D) collaborations. The compounds also have numerous potential applications and we need to take time to evaluate the best path to market. This is something we will advance with partner organizations.
One potential application is in storage of various cells and tissues. In May, we entered into a research program with Dr. Caigan Du’s laboratory (Vancouver Coastal Health Research Institute) on red blood cell storage and preservation. Results showed that while the compounds did not improve total blood cell count, they did improve the health of the cells that survived. This could result in more cells remaining viable in transfusions (where many typically die). Testing in commercial storage protocols will begin in 2017.
Dr. Du also carried out a study on oxidative stress in skin cells. The results confirmed what our previous CROs have found, which is a significant preservation under stress conditions. This data is currently being compiled and will be used for partnering discussions.
Acne Compound
Our acne compound is in chemistry development and expected to be completed and ready for testing in mid-2017. It will likely be our next major pipeline candidate. This project utilizes our successful business model of applying our proprietary technology to a known compound with stability issues. There is an excellent opportunity to produce a new therapy in this market which is estimated to be $8 Billion USD worldwide annually. Acne is the most common skin condition in the United States affecting some 50 million Americans and costing $3 Billion USD annually.
Keloid
We have developed a compound that we believe could have properties in preventing the formation of keloid scars. This is a significant unmet need as there are currently no effective therapies available. Early In vitro studies show a down-regulation of genes involved in the Extracellular Matrix (ECM) deposit which occurs in keloid scars and an up-regulation of genes involved in ECM degradation. Early safety tests have also been completed.
We have also uncovered mechanisms of action favourable to the target therapy and started to build a development plan for this project. Moreover, we are exploring CRO’s and universities in Europe with expertise in keloid research to assist us. The current market for global scar therapy is estimated at $16 Billion USD annually.
Like all biotech companies, we have experienced some delays in the development of our pipeline. We understand the apprehension that this can create for our investors and we want to assure you that we have a strong technology platform, a strong development pipeline, excellent patent protection and a dedicated management team. We are doing everything we can to sustainably increase shareholder value. We thank you for your continued support and look forward to what 2017 will bring.
Wishing you and your families Happy Holidays and all the best for 2017.
Sincerely,
Dr. Howard Verrico, CEO
- Published in News Home, Sirona Biochem