Developing an actual medicine that medical doctors prescribe is an extremely expensive exercise as you know. If successful, however, medicines are amongst the most valuable assets anyone can own, which is why pharmaceutical companies are amongst the most valuable companies in the world.
In our case, we are most fortunate to have Dr. Shackelford’s real-world experience. A significant portion of the expense in drug development is found in the discovery process, which generally happens in a chemistry lab. As you know, we are unique. Thanks to Dr. Shackelford’s work, our discoveries come from actual patient interactions from his medical practice. However, the next stage, which is the regulatory pathway, is expensive, and this path is determined by the FDA.
Our Phase 2 trial will cost approximately $30 million. This covers the manufacture of clinical trial supplies, which is significant. It also encompasses all the necessary work establishing trial sites and enrolling participants into the trial based upon the criteria accepted by the FDA and Institutional Review Boards. Our trial is expected to run approximately 24 months, with interim results announced halfway through the trial.
Our plan is to tackle this funding requirement in two steps, starting with a Regulation A crowdfunding round, just like our initial financing. We expect this new round will launch in the coming days. As investors in Shackelford, we will open this new offering to our existing shareholders first, so please keep your eyes open for our next email, where we expect to share more details along with an invitation to participate if you wish1.
In anticipation of this financing, we engaged a respected international firm that focuses specifically on pharmaceutical company valuations. This independent, 3rd-party opinion valued our company between USD $70-million and USD $187 million. Recognizing the soft macro market conditions that have affected the capital markets over the last year, we chose to value our company at the lower end of this valuation, and set the price at USD $1.50 per share, which correlates to a pre-raise market cap of about USD $70-million.
Our Regulation A funding round will be open for up to a total of USD $12 million.
We are working on the balance of the funding by targeted institutional investors and funds, and we are in discussions with several parties who are interested in our target indication, our team and our approach, and have started due diligence to learn more about Shackelford and the opportunity. While we are committed to helping as many people as we can who suffer from epilepsy, we are also committed to making sure that our shareholders have an opportunity to benefit from the increase in value of our Company as we progress as well. This may be as a private, or public entity, depending upon how we can best raise capital and maximize shareholder value.
As mentioned above, we will be hosting an investor webinar early this year, where I will invite key members of our team to attend. This will allow anyone who attends the opportunity to hear directly from the Shackelford team, and more importantly, provide a venue to ask questions and learn more about what I have described above. I hope you are all able to join us. We’ll be sure to record it and share it as well if you cannot.
THANK YOU again, to each of you reading this and for your support, without which we would not be here. We are on the precipice of an exciting new chapter in our Company’s development, and we owe much of this progress to you.
On behalf of YOUR team, I wish everyone an incredible 2023!!
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