It was ‘discovered’ that OWCP had updated their Investor Presentation and published it on their website in the past few days — and it had some nice, juicy updates that are creating some joy for many shareholders. Allow me to break down what I gathered. If I missed anything or if you interpreted it a different way — comment below or shoot me an e-mail.
Mission: Notice they’ve now included the word “devices” in their statements? For starters, on Page 19 (Development Program Overview) it actually mentions a Nasal Spray in relation to Fibromyalgia and PTSD. But, my guess is we’ll see (some day) see an announcement about the “Novel Condom”, which you can read more about on the World Intellectual Property Organization (WIPO) website. (By the way, there are some new search results on the WIPO website when you search “One World Cannabis” now. Some submitted in July & August 2017.)
Roadmap: It’s my understanding that they show the Roadmap going in two different directions, “Medical Cannabis Product Development” and “Pharmaceutical Development”, because they intend on starting the sale of ‘Medical Cannabis Products’ through dispensaries soon but will continue through more and more studies so they can eventually earn FDA (and FDA equivalent) Approval in order to have their products prescribed by a Doctor and covered by Insurance.
Those who have the patience to hold their shares into 2019 (and beyond) will be far wealthier than those who were only patient enough to hold into early 2018. Don’t get me wrong, “taking profits” is a must when you need money for ‘general life expenses’ — but I’m going to try and keep as many shares as I can until the ‘end result’ is achieved. That’s when I feel share prices in excess of $20 become possible. (Keep in mind, with the current share structure — $24 per share is a $3.5 Billion Market Value. That’s not much higher than $GWPH is currently sitting at — without FDA approval.)
Developed Cannabis-Based Products: It’s always nice to see the Tablet being discussed as ‘Developed’ because, in my opinion, the Tablet will be worth much more than the Cream. Then again, I’m not sure which skin conditions the cream will be useful for yet — aside from Psoriasis.
The most exciting aspect of this page, however, is the mention of $2 – $4 million per month in potential income in a 3 year timeframe. It’s my understanding, based on conversations long ago, that they’re wanting to be very conservative on these numbers too because of this being a new, emerging market. The one thing we’ll need clarification on is what 3 years is based on. The starting sales of the products (possibly in 2017 still?) or after a hopeful FDA approval? My guess is we’ll see an 8K and/or PR soon with some more details.
Psoriasis (Skin Disease): This page dives into the specifics on the next phases of studies. They have 26 patients doing a study at Sheba Hospital (the largest academic hospital in Israel) and they expect it to complete in Q1 of 2018. Then, the next steps will take place later in 2018 and early 2019.
It’s noted once again that the Topical Cream is “Product fully developed without indication label”.
Cannabis Cream (CanaPsor014) Development Plan Timeline: This page is the first to lay out a timeline. It starts with the IRB approval of a 6-week efficacy study (Phase 2), but the best part is the “Pre-IND Meeting Request”.
According to the FDA website, “The IND (investigational new drug application) is the vehicle through which a sponsor advances to the next stage of drug development known as clinical trials (human trials)”. That will certainly be a big step towards FDA approval.
Oral Disintegrating Tablet: I talked about in previous blogs that it was my assumption, based on the most recent (at the time) 10-Q, that Fibromyalgia would be the first use OWCP goes after for their Tablet. Sure enough, that’s what this slide tells me as well.
The first generation of this tablet is “fully developed” and a second generation formulation is “in development”.
Phase I safety study to start in Q1 of 2018. This product will be great for the many, many patients who can’t or don’t want to “smoke marijuana”.
The next slide shows the timeline, which, for the first time (to my knowledge) talks about “IRB Human Safety and PK/PD Study” as being in Q4 of 2017. The “Pre-IND Meeting” isn’t until end of Q1 2019, but they will have completed the Phase 1 and Phase 2A studies during 2018.
Multiple Myeloma (Cancer): The most recent update here states “On-going testing” in their Pre-clinical study, which was previously thought to be completed by this point. But, as Dr. Hirsch pointed out in his update letter in September — “the course of research and development is, by nature, uncertain – it is difficult to put a precise timeline on scientific studies.” OWCP is, after all, trying to find “the most effective combination” with “new cannabis extracts”.
Development Program Overview: This slide shows all of the projected Research & Development budgets between now and end of 2019. Based on the projected costs, we can use the information a few pages down to see that OWCP still has enough cash on-hand to fund everything through the end of Q2 2018, start of Q3 2018. Considering the progress made, the past success of Dr. Hirsch raising money for FOMX, and seeing OWCP on the website for “The Wall Street Conference” again — I’m going out on a limb and saying there won’t be an issue raising the money to cover all R&D through the end of 2019.
MICHEPRO: Scrolling down a few more slides, they talk again about the Michepro Joint Venture, where OWCP will get 75% of revenue. It states Michepro will establish “a European entity to promote, manufacture and sell OWCP products in Europe.”
Furthermore, they mention “Additional MOUs in Canada” are “in negotiation”. For those not familiar, an MOU is a “memorandum of understanding” — which is a non-binding agreement between two (or more) parties outlining the terms and details of an understanding, including each parties’ requirements and responsibilities. An MOU is often the first stage in the formation of a formal contract.
Corporate & Financial Details: Debt free, fully funded for 2017 operations and development plan, same number of Shares Outstanding (146,416,300), they raised $1.74 million in 2017, projected end balance at 2017 year end is $750,000.
So, there you have it. That’s the break down. Obviously most of what I wrote was easy enough to read for yourself, but based on some of the questions and comments I received before writing this blog — some folks skim these things too quickly. Perhaps they’re too excited.