I’m simply going to copy/paste the official PR here and bold certain areas that I felt were interesting.
To our Shareholders,
The last period has been an important time for re-assessing our corporate strategy, consolidating our company and strengthening our abilities to execute our strategy. We believe that the strategic re-assessment that we have carried out over the last few months will be critical to our success.
The field in which we operate is increasingly crowded with unproven products. We believe that the companies that will succeed in such a market, will be the ones which have invested their resources in providing validated proof of efficacy and safety for their products. In the past, we have spoken of “market ready” products. This definition related to formulated products which were potentially marketable without the validation that I have eluded to above. We have made the decision that we do not want to compete in this undifferentiated market. Whilst in the short term, this will delay our commercial development, in the long term, this should be strongly value generating for our company and our shareholders.
In order to undertake this positioning, it was important to strengthen our company financially. In May, we announced the closing of the largest funding in the history of our company – a convertible preferred stock offering for US $5 million to an institutional investor. This funding will provide us with the runway to carry out our planned clinical programs. With respect to strengthening our team, we announced the recruitment of Dr. Oron Yacoby Zeevi, formerly CSO at Neuroderm, as our Chief Scientific Officer in February and we are currently planning additional senior personnel additions to increase our capabilities in clinical development and testing.
In December 2017, we announced that we had received a new permit from the Israeli Medical Cannabis Agency (IMCA) to proceed with safety studies for our cannabis soluble tablet delivery system. We subsequently received Institutional Review Board (IRB) approval from the Sourasky Medical Center in Tel Aviv and from the central Israeli Review Board to conduct these studies. In parallel, we announced the completion of the pre-clinical development of our next generation, orally-disintegrating tablet, the subject of the safety studies described above, and the initiation of these studies is now imminent. This tablet is intended to be a replacement for smoking cannabis in chronic pain syndromes. We also announced late in June that we had completed the first stage of the safety study of our cannabis cream. This initial stage comprised the single dosing of healthy volunteers. We are now waiting final volunteer license approval to initiate the second part of this trial, which comprises the twice daily dosing of healthy volunteers for 6 weeks.
With respect to our timeline going forward, key events till the end of this year include the following:
- Completion of the cannabis cream safety study – Q4 2018
- Initiation of the Oral Disintegrating Tablet safety study – Q4 2018
- Completion of the Nasal Spray animal safety, pharmaco-kinetics and pharmaco-dynamics studies – Q4 2018
Whilst we understand that investors are keen to receive news flow, our clinical programs are complex to initiate in that they require multiple levels of approval from different authorities and the studies themselves are time consuming. These clinical programs are however key to our strategy and our positioning as a company dedicated to the pharmaceutical development of cannabis-based products to meet patients’ needs.
On the commercial front, we have continued our business development activities in key future markets for our products. We will announce more specific developments in this area as soon as definitive agreements have been finalized.
The funding that we have obtained provides us with the resources to carry out our research and development programs and to continue our corporate and commercial development. We look forward to updating you on our progress in the coming months.
Dr. Stanley Hirsch,
Chairman of the Board
So, all in all, it was a recap with some additional bonus wording. Is this great news for somebody hoping OWCP would run back to $0.50 by the end of July? Of course not. But, thankfully 99% of the 20+ shareholders I talk to on a monthly basis have all told me they intend to hold long term. They’ve all told me there’s no reason to sell at these levels.
The thing I can’t wait to hear more about is the underlined part of having more specific developments relating to commercial product development agreements. That tells me it’s NOT impossible to expect a Licensing deal in the somewhat shorter term. We’ll see.
Good luck to all. Decide for yourself if you’re going to buy more, hold what you have, or sell some/all. In my opinion, nothing has really changed. This remains an “investment” that requires patience. All investments come with risk.