16:07:45 EDT Fri 23 Aug 2019
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Callitas Health Inc
Symbol C : LILY
Shares Issued 32,462,095
Close 2017-09-21 C$ 0.55
Recent Sedar Documents

Callitas Health to launch ToConceive Sept. 29

2017-09-22 06:47 ET - Shareholders Letter

Mr. Gary Thompson reports

CALLITAS HEALTH INC. PROVIDES REPORT TO SHAREHOLDERS HIGHLIGHTING PRODUCT DEVELOPMENT AND STRATEGIC ADVANCEMENTS

Gary Thompson, president and chief executive officer of Callitas Health Inc., has issued a comprehensive update letter to shareholders.

Dear shareholders of Callitas Health,

The summer of 2017 officially ends this week and so closes the summer of our shift and 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 fourth quarter.

Updates on specific company projects

Corporate structure and strategy

  • July and August saw a significant number of warrants exercised, providing additional working capital to maintain the company's growth initiatives.
  • On Aug. 1, 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 on Sept. 15.
  • On Sept. 15, the company converted $2.50-million of vendor debt into 62,500,003 common shares at a conversion price of five cents and announced a share consolidation of one new Callitas share for each 10 old M Pharma shares.
  • In July, the company created three subsidiary limited liability companies to hold development projects to silo its assets in preparation for partnership opportunities for each.

ToConceive

  • Callitas has continued to target third quarter as the launch date for the newly reformulated and rebranded ToConceive. Our launch date is Friday, Sept. 29.
  • The new marketing website will be moved from development to live status on Sept. 29, with anticipated sales and fulfilment 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.

Extrinsa

  • With assistance from Camargo Pharmaceutical Services, the Extrinsa pre-IND meeting information package was submitted to the Food and Drug Administration with a response date of Oct. 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 U.S. Patent and Trademark Office (USPTO) trademark protection in May.
  • The Extrinsa opportunity is targeted to be $1-billion annually in North America assuming FDA approval.

C-103 reformulated 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 under way 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 an $800-million/year drug, we have targeted $500-million in the U.S. market alone as first year revenues, once approved by the FDA.
  • Discussions for exclusive rights outside of the U.S. and Canada have begun with potential partners.

Addition of orphan drug to research and development pipeline

  • Joint venture with third party investors established and financed 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 and 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 labelled 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 per cent 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, European Union, 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 and 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 and 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 under way 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 labelling 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 chief operating officer, chief financial officer, director of brand management, and 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.

About Callitas Health Inc.

Callitas is a clinical-stage company developing innovative technologies for obesity, weight management, and female health and wellness. In addition to its recent acquisitions of C-103, a reformulation of Orlistat, and assets from 40 J's LLC, Callitas is scheduled to launch its Food and Drug Administration-cleared fertility product branded as ToConceive some time in September, 2017.

We seek Safe Harbor.

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