The Form 8-K that was released after the market closed on Friday, February 24th, was ohhhhh, so beautiful. It’s really what many of us were waiting for – at least the IRB Approval part. I’ll be honest, I didn’t even know “NIH Registry” was a thing to be excited for.
The 8K is updating us from things that have happened from January 9th through February 22nd, it says. To start with, we learn about over $1.6M in additional funding that was raised by selling Restricted Shares to investors who obviously see the potential here. This is awesome for a couple of reasons off the top of my head — This is non-dilutive financing, as these new investors must wait 6 months to sell a single share, and their 6 month date all comes at different times. (Though, I strongly suspect most won’t sell in 6 months anyway since OWCP is clearly a solid long term play.) Each of these investors has a Warrant that allows them to purchase an equal amount of discounted shares within 18 months. So, on the assumption that it would be idiotic to NOT exercise that warrant — OWCP will have even more cash available anytime between now and 18 months. Once again, I repeat — OWCP has NO TOXIC DEBT whatsoever!
As I went to find a link that deeper explains Non-Dilutive Financing for you all, the first link/source I chose had even more delightful information than I bargained for: “non-dilutive sources of capital can be used to accelerate the commercialization of academic biotech projects.”
Having more money available to fund additional trials for the many products in the pipeline is awesome, but let’s move on to the meat of the 8K.
IRB Approval: In order to do studies and research on human subjects, you must have IRB (Institutional Review Board) approval — which only about 20% get approval from IRB committees. (Learn more about IRB Approval “in general” from the FDA website.) The IRB is a group whose function is to review research to assure the protection of the rights and welfare of the human subjects. So, obviously, getting IRB approval is quite huge. It’s really the requirement to have the ability to complete the final round of testing for any product/medicine used to treat humans. Again, OWCP has it’s final efficacy study underway at the largest hospital in Israel. You can read more about this study and IRB related stuff on a blog I posted on January 13th, 2017. (Note: OWCP’s “IRB Approval” comes from Israel’s Helsinki Committee.)
From the 2nd paragraph of the 8K’s Exhibit 99.1: “The IRB approved study encompasses the cream itself, as a delivery mechanism, as well as the proprietary psoriasis formulation, and is the first to formally make such claims with the NIH Registry. The double-blind study, which will be conducted on healthy volunteers at one of Israel’s leading academic hospitals, is designed to demonstrate the safety of the formulation in treating psoriasis on human skin tissue.”
For those who don’t know, the NIH is the “National Institutes of Health”. Their website says “NIH, part of the U.S. Department of Health and Human Services, is the nation’s medical research agency — making important discoveries that improve health and save lives.”
This approval is a significant milestone for OWC, where our mission is to bring the same rigorous approach common to traditional pharmaceutical development to the medical cannabis field. As we reported earlier this year, the results of our efficacy studies were so encouraging that management decided it was in our interest to extend the size and scope of the study to check the biological markers that had been generated to date, among other things. (Dr. Yehuda Baruch, OWCP Director of Research & Regulatory Affairs)
To a guy who has been investing in BioTech’s for years, the other highlight of Dr. Baruch’s comment was the mention of ‘biological markers’. If you crave information, you can read all about ‘biomarkers’ here, but here’s a summary quote: “In the case of specific biomarkers that have been well characterized and repeatedly shown to correctly predict relevant clinical outcomes across a variety of treatments and populations.” This is very ‘big pharma’ of OWCP. It shows their seriousness and thoroughness of their product, the study, and research as a whole.
As soon as we announced the formulation of our psoriasis treatment we began receiving requests for the product from patients suffering from the condition. After many years of research and development, this is the final study as we prepare to introduce it to the market. We expect to the program will be in full swing by the end of the month and hope to have it completed by during the second quarter of 2017, and in the hands of patients shortly thereafter. (Ziv Turner, OWCP Managing Director and VP of Business Development)
Aside from this glorious Form 8-K, let’s not forget “The Wall Street Conference” in Boca Raton, FL on March 1st, which is “the premiere conference in the venture capital arena and Small Cap marketplace. The most senior and elite Wall Street professionals attend this conference. Industry leaders from the hedge fund, investment banking, and private equity worlds, as well as sophisticated investors, all attend the WALL ST. Conference every year to discuss significant trends in the industry.”
In addition to this bonus, which should bring in more deep pocket investors who know how to identify huge profit potential, OWCP was 1 of 69 stocks included on the first ever Cannabis ETF, Emerging ArgoSphere ETF, which was submitted to the SEC on February 16th, 2017.
OWCP is getting ready for launch, in my opinion. The Friday of the ETF discovery, OWCP closed at $0.915. Then, the following trading day they closed at $2.09. I’m just putting two and two together here and creating my own speculation as to what caused such a surge.
Final Thought: Many of us think next week is going to be big. In fact, the month of March and April should be the start of huge. Why? Aside from everything above, you must remember the final study for our first product will be completed by end of March and they’ve repeatedly said it should be market ready early on in Quarter 2. Remember, there are a couple of other products in the pipeline and a new delivery system that we can hear updates on any time too.
But, as always, YOU must decide when to Buy, Hold, and Sell. I can’t be responsible for you selling too early or too late. Though, seriously, everything appears to be going so damn well, doesn’t it?
If you want some solid Charts & Technical Data, follow @DDRANTE on Twitter.
P.S. I’m going to keep an eye on the ClinicalTrials.gov listing for OWCP’s Phase I trial. It’s been saying the trial should start in February 2017 and finish July 2017.