I wanted to take a quick opportunity to break down and highlight, what I felt was, key highlights from the 8K released on September 13th, 2017. I’ve been told by many of you that you appreciate the ability to skim and see the sections I highlighted in bold.
To our Shareholders,
Following my recent appointment as Chairman at OWC Pharma (OTCQB: OWCP), it is my pleasure to introduce myself to you and to initiate a new tradition of biannual shareholder update letters.
On the personal front, I am a biologist by training with a D. Phil. Degree from Oxford University in Cell Biology and Immunology. I have been involved in diagnostics, pharmaceutical and biotechnology (medical and agricultural) companies at CEO level since 1989 and I have run both private and public companies in this sector in Brazil, China, England, Israel and the United States. My roles in these companies have included operational and strategic elements. I currently serve as CEO of FuturaGene Ltd., an agricultural biotech company. I have been the manager of the company since its inception, leading it through a series of private fundings, a reverse merge on the AIM Exchange of the London Stock Market, a successful secondary offering in London and the ultimate sale of the company to Suzano Pulp and Paper in Brazil in a cash transaction which valued the company at US $100 million. As CEO of FuturaGene, I successfully obtained the first ever regulatory approval to commercially deploy a genetically modified commercial tree species. In addition to my role as Chairman at OWC Pharma, I also currently serve as Chairman at Foamix Pharmaceuticals (NASDAQ: FOMX), a specialty dermatology company, inter alia. In my early years as an Executive Director at Foamix, I was responsible for European Business Development, and in this role, I cemented an out-licensing deal with Bayer Pharmaceuticals for the development and commercialization of a topical drug for Rosacea. Marketing of this drug was initiated in late 2015 after FDA approval and today yields multi-million dollar annual royalties to Foamix. In my role as a Director and Chairman at Foamix, I have been actively involved in Foamix’s IPO and two follow-on offerings on NASDAQ, which in aggregate raised approximately $170 million. I believe that the experience I have acquired in these endeavors will be a strong factor in assisting in the development of OWC Pharma.
It has also been my pleasure to work closely in the past with Mr. Mordechai Bignitz, our CEO. I believe that our complementary skills and our proven ability to work successfully together will play a very positive role in helping take our company to new levels of achievement.
Research and Development
Our company is focusing on developing high level cannabis-based products for dealing with unmet medical needs in specific fields. In this respect, we have progressed in a number of areas over the last 8 months:
1) During this period, we completed a pre-clinical efficacy study in psoriasis with unique, and what we believe may be breakthrough results; we previously reported an up to 70% reduction in biological markers directly related to this disease;
2) We have received the first ever Institutional Review Board (IRB) approval to conduct a safety study for a cannabis-based topical cream with more than 3% THC and we are actively conducting a safety study (FDA Phase 1 equivalent) in one of the biggest academic hospitals in Israel . We will update the public with material developments in this area as they occur.
3) We filed for intellectual property (IP) protection for various delivery methods to treat different diseases, a very rare approach in the medical marijuana industry; the attainment of IP protection could represent a significant asset for our company;
4) We have completed the development of an orally disintegrating tablet, an important new delivery form;
5) Our topical cream for Psoriasis is market ready
6) We reported on status in our Multiple Myeloma program and we will continue to report on any material progress in that connection
Our research activities are led by Dr. Yehuda Baruch. Dr. Baruch served as Head of the Israeli Ministry of Health’s Medical Marijuana Program from 2003 through 2013 where he spearheaded the efforts on regulation, chaired the indication committee, secured Helsinki Approvals for medical research, and managed regulation of patient licensing and dosage. He has extensive experience in researching medical cannabis, most notably for its effect on PTSD. Dr. Baruch is a globally acknowledged expert in the field of medical marijuana. His contributions and expertise have been and will continue to be a major factor in our development as one of the leaders in this field and provide strong scientific basis to all our endeavors. As Chairman, it has been my privilege to work with Dr. Baruch in advancing our company.
Note to our Shareholders: Further to the above report, we will, in general, provide broad guidance on our development timetables, but we will do this with due caution as the course of research and development is, by nature, uncertain – it is difficult to put a precise timeline on scientific studies. We will not provide responses to individual approaches between our public communications.
Corporate level & Business Development
Cannabis for medical purposes (also known as “medical Cannabis”) is a new and infant industry with no internationally accepted standards or protocols. Many states that implemented or are about to implement Medical Cannabis bills are still to determine and pass formal sets of regulations, especially when related to products (such as our Topical cream for skin conditions), that include 3% THC or more. We are now in the process of completing a strategic analysis to determine the optimal markets and the best possible way to penetrate these markets. In this context:
1. We have taken proactive steps in various territories including, but not limited to appointing Mediq as our market access consultant for Germany;
2. We are exploring other potential markets and maintaining an ongoing dialogue with various potential business partners including representatives, manufacturers and distributors.
1) Our senior management team has been strengthened by the inclusion of two experienced professionals: Mr. Yossi Dagan, CPA (IL), as our Chief Financial Officer (CFO) and myself, as your Chairman.
2) We have paid down all outstanding debt and the company is now well positioned to deploy capital solely for its development needs;
3) We announced our initiative to cross-list our stock to the TSX and we are evaluating the possibility of cross-listing our stock on additional exchanges to increase trading liquidity as well as to facilitate our ability to raise capital to enhance our development and commercialization efforts.
As a management team, it is our vision to develop OWC Pharma as the leading cannabis-based specialty pharma company. Over the last few months we have executed on a number of important steps in order to fulfill this vision. We appreciate your continued support and interest in OWC Pharma as we move along this pathway to help patients improve their quality of life with validated and tested medication and to create value for our shareholders.
I look forward to updating you in the future,
Dr. Stanley Hirsch,
In my opinion, there are a few good highlights there for shareholders — both current and those still considering buying. I’m actually more confident in this company’s future now than I was back in February when I wrote the blog about holding my shares into the Winter of 2017 at minimum. I’m certainly willing to give them my patience, as I realize this Cannabis industry is one of the craziest right now. Imagine how HELD BACK every other industry would be if each company had to find a manufacturer/distributor in EVERY state and country they wanted to sell in vs. finding a single massive manufacturer/distributor to handle things for an entire country. Some day the Governments of the world will get a clue and work together on a global protocol.
Side note on Foamix’s deal with Bayer: They reported $682,000 in royalty fees in Q1 of 2016 and $927,000 in Q1 of 2017.