Quoin Pharmaceuticals, Ltd.

Good day, and welcome to the Coin Pharmaceuticals fourth quarter financial results and business update conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note today's event is being recorded. I would now like to turn the conference over to Gordon Dunn, Chief Financial Officer. Please go ahead, sir.

Thank you and good morning. We appreciate you joining us on today's conference call. With me on the call are Dr. Michael Myers, CEO, and Denise Carter, COO. We're pleased to provide an update on our progress for the fourth quarter of 2023, as well as discussing our Q4 and full year 2023 financial results. Please note that our operations and financial results press release is now available on our website. In keeping with normal procedure, Michael will first provide an operations update following which I will review our financial results. I will then hand the call back to Michael for closing comments before we open the phone lines for questions. I'd like to remind everyone that statements made during this conference call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 which involve risks and uncertainties, which can cause actual results to differ materially from the information expressed or implied by these forward-looking statements. For more information regarding such risks and uncertainties, please see the risk factors outlined in the company's filings with the SEC, and any forward-looking statements are made only as of today. We disclaim any obligation to update these forward-looking statements other than as required by law. Please see the forward-looking statements section in our financial results release issued this morning for more information. It is now my pleasure to turn the call over to our CEO, Michael Myers.

Thank you, Gordon. Good morning, everyone, and welcome to today's call. We are pleased to have the opportunity to report on COIN's progress in the past quarter and throughout the year as a whole. 2023 was quite simply a truly transformational year for COIN. During that year, we released the first ever clinical data generated from a trial in Nettleton Syndrome subjects being conducted under an open investigational new drug application, or IND, with the US FDA. This was a significant and important milestone, not just for COIN, but for the Nettleton community as a whole. I'm pleased to say that this initial data was encouraging and overall positive across a number of clinical endpoints. And crucially, there was also a complete absence of any safety signals whatsoever. On the strength of the combination of both this initial efficacy and safety data that had been generated, we submitted to our open IND a number of proposed protocol amendments to both ongoing clinical trials. These included increasing the size of both studies, changing the dosing frequency from once daily to twice daily, and eliminating the lower 2% dose from our blinded study. Those amendments were cleared by the FDA and have now been fully implemented. Earlier this year, we submitted yet another protocol amendment to the FDA. On this occasion, we proposed lowering the eligibility age for recruitment into our clinical studies to 14 years and older from 18 years and older. This is another extremely important milestone for our company, and once again, for the netizen community, as it marks the very first time that non-adult netizen subjects will be tested in a clinical study that is being conducted under an open IND. As announced on March 4th, this latest protocol amendment was also cleared for implementation by the FDA. It's worth mentioning that each of those protocol amendments I just discussed were made from a position of strength on the basis of positive initial efficacy and safety data. While there is always a temptation to not amend protocols When studies are ongoing, we took the position that while this initial data was indeed positive and encouraging, we should take advantage of the opportunity to generate an even more robust data set with a greater likelihood of approval and with a broad label. We believe these new protocol amendments have the potential to deliver just that. The inclusion of children into our studies is especially noteworthy as it significantly increases the number of eligible subjects and could lead to a faster recruitment race overall. Because children will be eligible to participate in both the blinded and open-label studies, we will be able to accommodate those patients who are currently receiving off-label systemic therapy and those who are not being treated in this manner. This is a very important consideration for parents and caregivers as it eliminates the need for them to have to make the potentially agonizing decision about whether or not to discontinue their loved one's off-label treatment, which may be providing some symptomatic relief, in order to enroll them in a clinical trial where they might end up receiving just a placebo and run the risk of their original symptoms coming roaring back. By concurrently running studies where QRX003 is being tested as a monotherapy and in conjunction with off-label systemic therapy, we believe we are laying the foundation for the generation of a truly broad-based data set that will give physicians the widest possible range of treatment options for people suffering from this terrible disease. With all of these protocol amendments now fully implemented, 2024 is shaping up to be a pivotal year for our company as we move forward with our mission to deliver the first approved treatment for Nethicine Syndrome. We look forward to providing updates on our continued progress with the clinical program throughout the year ahead. On the commercial front, we have continued to lay the groundwork for the establishment of our own infrastructure to support our plans to sell the product ourselves in both the US and Western Europe once approved. As noted previously, we believe that given the relatively small patient population, the limited number of treatment centres and treating physicians, that a small compact commercial infrastructure that is heavily weighted in medical affairs and along with strategically placed regional sales reps could efficiently and effectively detail this product. We also plan to provide updates on these activities on subsequent calls throughout the year. Supporting our own commercial efforts, as you have heard from us in the past, we have now entered into nine commercial partnerships for QRX003 that cover 61 countries, and we will remain in discussions to expand that number to the few remaining unlicensed countries across the world. We continue to believe that this thoughtful, diligent, and systematic approach to entering into commercial partnerships will ensure that QRX003 becomes available to as many Nessus and patients in as many countries as possible once it is approved. As noted previously, these partnerships, along with our own planned commercial infrastructure for the US and Western Europe, will facilitate what will effectively amount to a global launch of the product once approved and also laid a foundation for similar global launches of our pipeline products once they also receive approval. We firmly believe that this global commercial network is unprecedented for a company our size and represents a highly differentiated and perhaps somewhat underappreciated advantage for coin. The potential incremental revenue generating opportunity that this global commercial partnership network represents for coin, all of which will fall directly to the bottom line, could ultimately have a material positive impact on our future profitability. During our previous calls, I have also updated everyone on our M&A strategy. As discussed, Given our strong balance sheet and potential access to additional capital, we have been acutely focused on expanding our product portfolio via acquisition, in-licensing, or other means. We continue to search for M&A opportunities, and it remains a priority for us. But I do want to caution that we will not execute a deal unless it really makes sense for us as a company to do so. Last week, we completed a successful public offering, raising gross proceeds of $6.5 million. In addition, earlier this year, we entered into an $8 million equity line of credit, or ELOC arrangement, with alumni capital, which we will be able to access in the second half of this year. With the proceeds of last week's offering alone, we are now funded into the second half of 2025, and the proceeds from the equity line of credit will extend our cash runway even further. Finally, as we have noted now on our three previous calls, another company has filed an IND with the FDA and received a study may proceed letter to initiate the clinical development of their product as a potential treatment for Nessuson syndrome. As of yesterday, following a review of the clinicaltrials.gov website, it appears that this study has not yet been initiated and Coyne remains the only pharmaceutical company actively conducting clinical studies in Nessuson syndrome under an open IND. Furthermore, as we have previously noted, whilst other companies have also spoken for some time either about filing INDs or initiating Nesitin clinical studies, we continue to see a consistent pattern of those timelines either being pushed further and further out or, in some cases, abandoned completely. As we continue to make significant progress on the clinical front, We and our nine global marketing partners are more excited than ever by the potential commercial opportunity of what could be the first regulatory approved treatment for this horrendous disease. I will now hand the call over to Gordon.