CINCINNATI, OH, Dec. 19, 2018 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Callitas Health Inc. (CSE: LILY, OTCBB: MPHMF, FWB: T3F3), today announced that President and Chief Executive Officer, James Thompson, has issued the following letter to shareholders.
Dear Shareholders:
We would like to thank you for your continuing commitment as we strive to build Callitas Health into a strong player in the health, wellness and cannabis pharmaceutical delivery industry. We started 2018 with ambitious goals and ended the year overcoming many challenges, achieving many accomplishments, all while setting the stage for a stronger, successful 2019 and future.
With the close of fiscal year 2018, and acknowledging the overall decline in the stock value, we wanted to provide some insight to shareholders including: some challenges that occurred in 2018, summarize some key achievements, and detail what we anticipate for 2019. Our foremost priority is creating significant shareholder value, over time, through new IP development/in-licensing, new product R&D, sales, marketing and licensing. Some of these operations, which cannot be disclosed until finalized, take significant time to realize revenues without creating a competitive disadvantage to ourselves (or partners) or violating non-disclosure agreements. In 2018, we set the stage for significant revenue growth by quickly advancing partnerships and sales operations, while adding new products, continuing R&D and licensing our technology, which will begin in early 2019. Additionally, in 2018, we spent a considerable amount of time and resources improving and enhancing our Over-The-Counter (“OTC”) product pipeline, our CannaPharma delivery technologies portfolio, and advancing our pipeline of drug candidates, while adding new business partners and increasing our overall visibility with the financial community.
2018 Challenges
- In January 2018, we announced that Gary Thompson was temporarily stepping down as President & CEO due to ongoing health issues. Unfortunately for the entire Callitas family, Gary passed in mid-September after a valent struggle against brain cancer. His loss is still felt by employees and our partners.
- In late August 2018, Erin Thompson, wife of James Thompson, President & CEO, suffered a ruptured aneurism and massive hemorrhagic stroke while exercising; she survived, spent two plus months in Neurosurgery ICU and is now recovering in a Skilled Nursing/Stroke Rehab Center in Cincinnati, OH. This devastating event, paired with the hospice stay and passing of Gary Thompson mid-September, were dual contributing factors to the delay in filings mentioned below, and the advancement/closing of some business development milestones on the OTC and cannabis businesses.
- In early September 2018, the Company was notified by the British Columbia Securities Commission of regulatory deficiencies for failure to file second quarter 2018 financial statements and management discussion and analysis prior to the August 30, 2018 deadline. This deficiency was cured early October and the shares resumed trading October 19, 2018. The trading halt negatively impacted the company perception in the short run and delayed some operations and capital raising discussions. The delay in the Q2 filing were due specifically to the aforementioned personal tragedies.
Pipeline & Partnering Progress
OTC Health & Wellness-
· October 2017: We successfully launched ToConceive, our proprietary FDA cleared fertility enhancement product via a multi-channel direct-to-consumer strategy. (ToConceive is a vaginal gel, lubricant and moisturizer, clinically shown to help increase a woman’s own natural conception lubrication, called transudate, which helps aid in conception). As we continue to expand ToConceive’s presence in the U.S. we are evaluating additional retail opportunities and investigating global expansion.
· February 2018: We began a partnership and co-branding opportunity for our ToConceive fertility lubricant with NFI Consumer Healthcare’s e.p.t®, the OTC pregnancy test kit brand that includes promotional opportunities on shelf, product samples and new product inclusion at major food, drug and mass retailers throughout the United States. This partnership should begin generating revenue from US retail marketing in early 2019 and provide a fertility channel retail partner for additional products in our pipeline.
· We have renewed our partnership with Lifestyles® for the licensing of our female enhancement gel brand Excite by SKYN. We commenced product development for Lifestyles on a new item for 2019 which, should be released to major U.S. food, drug and mass retailers.
· Callitas is evaluating International Expansion of OTC products in direct sales, MLM, online and retail in select international markets; specifically targeting Canada, Europe, India, Asia, Latin America, where we have begun discussions with local consultants to advance these sales initiatives.
· Callitas has begun and advanced new products R&D for the following products to support our OTC partners pipelines in the US and international:
— Fertility oral supplement
— Prenatal oral vitamins
— Weight loss/metabolism oral supplement
— Female enhancement oral supplement
— Male enhancement gels
· Callitas is evaluating new business acquisitions and licensing of additional products and assets for the US markets, specifically a medical foods company targeting bariatric patients, older adults and obese individuals.
CannaPharma Delivery Technologies
We continue to see momentum and significant revenue potential in developing for our Cannabis Pharmaceutical (CannaPharma) Delivery Technologies through partnering with local, regional, national and international partners. As the CannaPharma industry rapidly expanded, we entered the market and have quickly achieved several milestones. We have co-developed or in-licensed the following IP and technologies in the Cannabis (THC and/or CBD) delivery field:
· Novel Oral THC/CBD strip delivery technology, developed to enhance oral/mucosal delivery of THC/CBD.
· Novel Topical Formulations for CBD/THC delivery (Sexual Wellness, Pain Management & Skincare)
· Biphasic Release Candy Tech
· Sustained Release Oral Delivery Tech
· Business Methods IP & Proprietary Equipment for precise dosing
· Novel Vapor & Decarboxylation Tech
· Novel Patch Delivery Tech
We are excited about our recent partnering discussions and hope to be able to share additional updates on this critical sector of our overall business.
Rx Development
· Callitas temporarily paused the Rx development projects in August 2018 due to the personal challenges mentioned above. However, we have restarted these programs and are currently evaluating partners for C-103, Extrinsa and Orphan Drug. In early 2018, we:
— Continued our Phase II study on C-103, our reformulated version of orlistat for weight loss.
— Began our preliminary Phase II work on Extrinsa™, a reformulated topical tadalafil for female sexual dysfunction.
— Advanced our Orphan Drug product development, through submission of an Orphan Drug Designation and Rare Pediatric Disease Designation(s). We received feedback from the FDA, will perform some planned, requested testing, and resubmit our application to the FDA. Product manufacturing is underway and should be available for required studies in Q1 2019.
Management and Advisory Board Enhancement
- In January 2018, we announced that Gary Thompson was temporarily stepping down as President & CEO due to ongoing health issues (ultimately a brain tumor that took his life in September) and that the Board appointed me as Interim President & Chief Executive Officer. Subsequently, I was promoted to President & CEO when Gary retired in June. The focus of the management team remains unchanged; to accelerate the numerous initiatives already underway, as well as, developing new partnerships, products and opportunities that will enhance overall shareholder value. With new initiatives in the cannabis space accelerating and the OTC business expanding, we will look to add additional members to our team to further advance our products, marketing, sales, and additional partners.
- Following my appointment, we were delighted to announce that Dr. Laura Berman was appointed to the role of Chief Health Advisor. Dr. Berman is a world-renowned sex and relationship educator, researcher and therapist, as well as TV, radio and internet host, and a New York Times best-selling author on sexual health and pleasure. Dr. Berman also acts as assistant clinical professor of OBGYN and psychiatry at the Feinberg School of Medicine at Northwestern University in Chicago. Dr. Berman is assisting us with the promotion ToConceive and providing insight and consultation on the development of other products.
- In the summer, we added Dr. Gregory Smith as our Chief Cannabis Advisor. Dr. Smith earned his medical degree from Rush Medical School in Chicago, and a Masters of Public Health from Harvard University. He completed residency training in Preventive Medicine at Walter Reed Army Medical Center. Since getting out of the US Army as a Major, Dr. Smith has been in primary care practice in California, Georgia and Florida for the past 30 years. He first trained on use of medical cannabis in California in 2000. He has had extensive experience and education in the field of cannabinoid medications. Dr. Smith is an avid writer, having published over a dozen peer reviewed medical publications, two medical textbooks, and a novel called “Malpractice.” His most recent textbook, is entitled Medical Cannabis: Basic Science and Clinical Applications (Aylesbury Press, 2016 – www.AylesburyPress.com). It is a scientifically-based textbook directed at educating medical students and medical professionals on the science and applications of cannabinoid medications. His recently released book for patients and caregivers is called CBD: What You Need to Know (Kindle Press, 2017). Dr. Smith has been working with medical cannabis-related issues full-time for the past 4 years. He is a prolific writer on the topic of clinical applications of medical cannabis with many publications and video training courses. He is editor-in-chief of www.Cannabis-MD.com, and Director of Medical Affairs for First Harvest Financial, Inc. (a cannabis investment firm.)
Increasing our Profile with the Investor Community
Throughout 2018, we continued our efforts to increase the Company’s visibility with the investor community. We engaged in numerous meetings with members of the financial community and our management team attended, participated and presented at several key scientific and investor events.
Going Forward
We expect 2019 to be a breakout year. Management will focus on creating shareholder value through progress on our clinical and pre-clinical milestones, executing on partnership opportunities, expanding our OTC presence, and quickly capitalizing on the Cannabis opportunities in the U.S. and abroad, in both CBD and THC legal markets. We will continue to make our shareholders our top priority as we achieve a series of key milestones in 2019. Callitas Health is well positioned for growth and the Management team plans to fully execute our focus business strategy in the New Year.
Sincerely,
James Thompson
President and Chief Executive Officer
About Callitas Health
Formed in early 2015, Callitas Health Inc. is an integrated clinical-stage pharmaceutical development and OTC consumer goods marketing company, focused on developing innovative technologies for weight management, female sexual health and wellness, cannabis delivery technologies and other proprietary drugs. In addition to its recent acquisitions of C-103, a reformulation of Orlistat, Extrinsa and assets from 40J’s LLC, the Company successfully launched ToConceive in North America as a clinically proven option for couples struggling with the inability to conceive (www.toconceive.com), and is in the research and development and business development process for its other OTC products, cannabis dosing technologies and orphan drug technologies. For more information visit www.callitas.com.
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 “T3F3.”
For more information contact:
Callitas Investor Relations
Phone: +1 (859) 868-3131
www.callitas.com
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 and the commercialization of the rights to the Company’s biomedical & drug technologies. 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.
