As always, I’ll start with my disclaimer: I own shares of NTVA in which I purchased with my own money. At the time of writing this, I have no plans of selling shares, but that doesn’t mean I won’t sell some at any given point in the future. We invest in order to make money, after all. Furthermore, as always, I have not been compensated in any way, shape, or form by anybody to write this. I’m simply going through the recent 10-K and highlighting things that I personally found interesting and felt I could share. This blog was updated to reflect the new ticker as of 10/19/18.
On September 28th, INTIVA BioPharma released their FORM 10-K / Annual Report for Fiscal Year End June 30th, 2018. To start with, they decided to change their name to Nexien BioPharma, Inc. As of September 28th, 2018, the Outstanding Share count was 44,448,496 and according to OTCmarkets.com, the Float is only 2,710,691. However, on page 39, it states “43,071,470 are restricted” — which technically means the “available Float” is 1,377,026. It is also noted on page 40 that Directors and Executives own approximately 68% of the Common Stock.
On page 5 they start talking about how they will establish a separate subsidiary for each of its drug development projects because they feel it could be beneficial when it comes to raising capital for each individual drug development project. To date, the company has two subsidiaries for its first two drug development projects and will form a subsidiary for each of its four other drug development projects. The company has filed three utility patents in June 2018 as well as provisional patents in June/July 2017.
The Kotzker Development project started with a license agreement with Kotzker Consulting, LLC in March 2017. Dr. Joseph Morgan had developed intellectual property with this entity. Dr. Morgan is talked about on the World Medical Cannabis Conference & Expo website as having a 25 year career in the pharma industry in drug safety and clinical research. They also mention his US Patent pending, which involves cannabinoids and terpenes with data presented at the International Cannabinoid Research Society. The Kotzker project with NEXIEN relates to the use of cannabinoids to treat symptoms caused by organophosphorus nerve agents (highly poisonous chemicals). At the bottom of page 5, they close by saying:
We believe that a cannabinoid-based drug could be beneficial to treat the symptoms caused by organophosphorus nerve agents and we are hopeful that the regulatory pathway to treat the condition will be as expeditious as possible based upon the potential threat posed by the use of organophosphorus nerve agents by terrorists and countries.
The company submitted a pre-IND meeting package to the FDA on July 31, 2017 and received written responses on September 29, 2017. They mention they then will submit to the FDA to seek approvals to conduct clinical studies under an Investigational New Drug exemption. They may also apply for Government grants due to the implications of a nerve agent drug candidate for homeland defense, first responders, and military applications.
The Sharir Development Project — In February 2017, a provisional U.S. patent application was filed relating to the use of cannabinoid receptor modulators and/or terpenes to treat myotonic and muscular diseases such as dystrophia diseases, as there is no standard treatment for the symptoms currently.
In July 2018, NEXIEN retained world-renowned expert, Dr. Benedikt Schoser, who you can even read about on the Myotonic Dystrophy Foundation website. A preliminary proof of concept examination under Dr. Schoser’s guidance is currently being conducted. The FDA pathway for genetic muscular diseases may fall under the Orphan Drug Act of 1983.
On February 28, 2018, the company obtained a worldwide exclusive license from Accu-Break Pharmaceuticals, Inc. with respect to a proprietary delivery system for cannabinoid-based medications. In September 2013, Accu-Break achieved their 50th Patent being granted.
In June 2018, NEXIEN actually filed a couple of U.S. Utility Patent and/or International Patent Treaty applications: one for treating lipidosis and leukodystrophy (which the FDA could grant Orphan Drug designation for), one for treating Lipofuscinosis, one for treating restless leg syndrome, and one for treating sexual dysfunctions. You can read more details about patents on page 12.
Several of the following pages go on to explain details of the industry, the FDA process and the Orphan Drug Act, etc.
There is talk of doing clinical studies in Israel if need be — thanks to their laws being a lot more relaxed as it relates to medical cannabis research.
Conclusion, Opinions, and Perspective: Do I think this company will make shareholders “a lot of money” soon? Not necessarily. The complete pathway to FDA approval and finalized products could take years. However, this is an OTC QB stock and certain assumed upcoming PRs could certainly generate some buzz and hype. It is my opinion that one should be careful investing on ‘speculation and hype’.
For me personally, if the Market Cap runs beyond $100M in 2018 or early 2019 because of Canadian listing, patent updates, FDA approval for clinical studies, etc — I may very well “take some profit” because it’s never guaranteed the Market Cap will remain that high and I made that mistake with $OWCP’s epic (and unrealistic) run in February 2017. Though, it’s worth noting that $AXIM (Axim Biotechnologies) and $CNBX (Cannabics Pharmaceuticals) somehow managed to stay around that $100M+ range.
Hell, $CNBX actually saw $2.66 in January 2018 — a 150+% increase from end of December and a Market Cap of $350M. Why? They filed a patent related to cannabinoids for cancer patients. Hype. It didn’t last as there was already big profit-taking within a day or so that brought the share price down a whole dollar, but then another spike back to $2.47 in a couple days and now has been under $1.25 for the last 6 months.
As of this writing, the Market Cap of $NTVA is only $20M when trading at $0.45/share. So, sure, it’s not unreasonable to think certain news/milestones can create a nice rise in share price/market cap. $NTVA rising to $1/share would still be half of $CNBX’s current Market Cap.
My point is: Please always decide for yourself what your investment/trading strategy and objective is. Either trade the stock based on news, milestones, hype, speculation, whatever… Or, decide if you think it’s “investment worthy” for the coming years, as true FDA Approval could easily bring the market cap over $1 Billion — which based on the current Outstanding Shares would be around $22.50/share.
FDA Approval Perspective: $GWPH currently has a Market Cap of around $4.8 Billion with a single FDA Approved cannabinoid-based/derived drug.
P.S. I remind you about my previous blog about NTVA where I talk about being very impressed by the management line-up.