CINCINNATI, OH, USA (September 21, 2017) – Callitas Health Inc. (CSE: LILY, OTCQB: MPHMF, FWB: T3F2), (the “Company” or “Callitas”) Today, Mr. Gary Thompson, President and CEO of Callitas Health Inc., has issued a comprehensive update letter to shareholders.
Dear Shareholders of Callitas Health Inc.,
The summer of 2017 officially ends this week and so closes the summer of our “Shift & Persist” strategy. With an extensive list of initiatives set before us in June, our team worked hard to stay focused on the objectives that mattered most. Our team has worked quietly to position Callitas for growth in the 4th quarter.
Updates on specific company projects:
Corporate Structure & Strategy
- July and August saw a significant number of warrants exercised, providing additional working capital to maintain the Company’s growth initiatives.
- On August 1st, M Pharmaceutical USA announced a name and branding change to Callitas Therapeutics Inc.
- The parent company, M Pharmaceutical Inc., announced a corresponding name change to Callitas Health Inc. on September 15.
- On September 15th, the Company converted $2.50 million of vendor debt into 62,500,003 common shares at a conversion price of $0.05, and announced a share consolidation of one new Callitas share for each 10 old M Pharma shares.
- In July, the Company created three subsidiary LLC’s to hold development projects to silo their assets in preparation for partnership opportunities for each.
- Callitas has continued to target 3rd quarter as the launch date for the newly re-formulated and re-branded ToConceive. Our launch date is Friday, September 29th.
- The new marketing website, www.toconceive.com, will be moved from development to live status on September 29, with anticipated sales and fulfillment to start immediately.
- Media kits, press releases and targeted social media outlets will be notified the week leading up to the launch date.
- Additional distribution channels have been identified and will be activated sometime within October.
- With assistance from Camargo Pharmaceutical Services, the Extrinsa Pre-IND Meeting Information Package was submitted to the FDA with a response date of October 7, 2017.
- Anticipating a quick start to Extrinsa trials, Callitas has begun the process of sourcing vendors for component formulation for trial purposes.
- Extrinsa received USPTO trademark protection in May.
- The Extrinsa opportunity is targeted to be $1 billion annually in North America assuming FDA approval.
C-103 Re-Formulated Orlistat
- We are continuing to work with Camargo Pharmaceutical Services to launch Phase II Activated Charcoal dose finding studies, solidify the chemistry, manufacturing and controls portion of the development and plan the non-clinical testing required by the FDA.
- With our FDA response and Camargo’s gap analysis report in hand, we now have an asset with a significantly increased value and attractiveness. Business plan development is complete and partnership discussions are underway to drive pivotal clinical trials for this promising new weight loss drug formulation. These discussions will remain confidential until a definitive direction has been determined and a public announcement has been released.
- Without the adverse events associated with Orlistat, once a $800 million/year drug, we have targeted $500 million in the US market alone as first year revenues, once approved by the FDA.
- Discussions for exclusive rights outside of the US & Canada have begun with potential partners.
Addition of Orphan Drug to R&D Pipeline
- Joint Venture with third-party investors established and funded through LLC
- Camargo Pharmaceutical has been contracted to develop the PRE-IND Meeting Request Letter for submission to the FDA
- Patent pending status with USPTO
- Potential for “Priority Review” & additional “Priority Review Voucher”
Current Distribution Efforts
- As part of the 40J’s acquisition, Callitas acquired an active contract for its female intimacy gel private labeled and distributed in Asia, expanding to other markets worldwide. We are pleased to announce that this long-term relationship has recently reached a new level by immediately increasing production levels by 50% and including a commitment to expanding the distribution portfolio with up to four additional Callitas products with an anticipated release date sometime before the end of 2017.
- Additionally, Callitas is in active discussions with new distribution partners for these commercialized and pipeline products in the Middle East, EU, Pacific Rim, Brazil and North America. We expect multiple additional partners under contract before the end of the year.
- To advance distribution efforts worldwide, Callitas has filled the position of Director of Sales and Marketing.
Menthol & L-arginine Patented Technology
- The delivery platform developed for a majority of our Callitas products is based on the patent-protected and FDA-cleared topical gel combining Menthol & L-arginine. This innovative formulation has the potential to be paired with many different ingredients to address a multitude of indications. Scientific formulations for several of these are underway with management oversight from our COO.
- Discussions for exclusive rights to several of these technologies have begun with potential partners.
- Other business development opportunities (transfer pricing, private labeling and out licensing) for many of these products have been identified worldwide and offer significant revenue opportunities for Callitas in the near future.
The Callitas brand continues to evolve and build a strong foundation of partnerships, products and R&D to achieve significant growth in the remaining three months of 2017 and long into the future. We have advanced a public identity that reflects our mission to offer our customers realistic solutions based on the principles of reduced invasiveness and enhanced effectiveness.
Callitas has now advanced our mandate over the past 15 months by expanding and diversifying our treatment portfolio within our focus areas, adding significant revenue to the bottom line and attaining FDA pathway approval for our C-103 project, and pending for our Extrinsa product. Our team continues to grow with the restructuring of our Board of Directors in December and the addition of a COO, CFO, Director of Brand Management and now, Director of Sales and Marketing.
It has been exciting to see our plans evolve into a company that truly has an opportunity to make a difference. Thank you for your support and for this opportunity to update you on our Company’s growth initiatives.
Mr. Gary A. Thompson
President & Chief Executive Officer
Callitas Health Inc.
About Callitas Health
Formed in early 2015, Callitas Health Inc. is a clinical-stage company developing innovative technologies for obesity, weight management and Female Health & Wellness. In addition to its recent acquisitions of C-103, a reformulation of Orlistat, Extrinsa and assets from 40J’s LLC, the Company is scheduled to launch their FDA cleared fertility product branded as ToConceive on Friday, September 29th.
Callitas Health Inc. trades on the Canadian Securities Exchange (CSE) under the ticker symbol “LILY” as well as on the OTCQB as “MPHMF” and FWB (Frankfurt Stock Exchange) as “T3F2.”
For more information contact:
Callitas Investor Relations
Phone: +1 (859) 868-3131
Notice regarding Forward Looking Statements: This news release contains forward-looking statements. The use of any of the words “anticipate”, “continue”, “estimate”, “expect”, “may”, “will”, “project”, “should”, “believe” and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because the Company can give no assurance that they will prove to be correct. This news release includes forward-looking statements with respect to the regulatory approval, commercialization of the rights to the Company’s biomedical & drug technologies, and acquisition of new products. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. These statements speak only as of the date of this news release. Actual results could differ materially from those currently anticipated due to a number of factors and risks including various risk factors discussed in the Company’s disclosure documents which can be found under the Company’s profile on www.sedar.com and the Company’s filings to the CSE at www.cnsx.ca. Such risk factors may cause the inability of the Company to successfully commercialize any of its biomedical technologies.
Notice regarding investigational devices: C-103 and Extrinsa are investigational drugs or devices and are not currently available outside of approved clinical trials. Claims regarding the safety and efficacy of these devices have not been evaluated by Health Canada, the U.S. Food and Drug Administration, or any other international regulatory body.