Quoin Pharmaceuticals, Ltd.

Good morning and welcome to the Coin Pharmaceuticals first quarter financial results and business update conference call. All participants will be in a listen-only mode for the duration of the call. And should you need any assistance at that time, 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. And to withdraw a question, please press star, then two. Please also note that this event is being recorded today. I would now like to turn the conference over to Gordon Dunn, the 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 of our progress in the first quarter of 2023, as well as discussing our Q1 2023 financial results. Please note that our operational and financial results press release is now available on CORN's website. In keeping with our normal procedure, to begin, Michael will provide a corporate, clinical, and operational update, following which I will review our Q1 financial results. I will then hand the call back to Michael for closing comments. We'll be pleased to answer any questions at the end of the call. Before we begin, 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 that 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. Any forward-looking statements are made only as of today and we disclaim any obligation to update these forward-looking statements other than as required by law. Please see the forward-looking statement 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 Morrison.

Michael Morrison Thank you, Gordon, and good morning, everyone. I'm very pleased to report that COIN has had a very strong start to 2023. Both of our Netherson Syndrome clinical trials, which are being conducted under an open IND, are fully up and running, actively recruiting and dosing patients. We look forward to providing clinical data later this year. Our commercial partners in 60 countries outside of the US and Europe continue to make progress in their respective territories as they engage with regulatory authorities, key opinion leaders, and advocacy foundations to deepen their understanding of the requirements both for entry into early access programs as well as for full regulatory approval. Our partners are also working with insurance providers and reimbursement experts to ensure that once our product is approved, a smooth and efficient commercial rollout will occur with established pricing and reimbursement criteria. As you know, there are currently no approved treatments for Nesitin syndrome anywhere in the world, so these interactions by our commercial partners with various regulatory agencies and insurance providers are the first of a kind, which is why the work has been performed in advance of approval. Our earlier stage programs with Queensland University of Technology, or QRUT, in Australia continued to advance during the quarter. While these programs are at an earlier stage of development than QRX003 for Nessus and Syndrome, we continue to believe that they are important components of our development portfolio and have the potential to generate significant downstream shareholder value. During the quarter also, we successfully completed a capital raise of $7 million prior to fees and expenses. I think it is worth noting that the terms of this raise were more favorable than those obtained by a majority of companies in our peer group that also completed a capital raise this past quarter. As we have previously discussed, a primary reason for conducting this raise was to strengthen our balance sheet and provide the company with additional firepower as we actively pursue M&A opportunities to broaden our product portfolio beyond rare skin diseases. We are particularly interested in late-stage assets in the rare and orphan disease space that are underpinned by strong clinical data and highly favorable commercial opportunities based on readily identifiable competitive strengths. We are actively considering a range of therapeutic areas beyond our current rare skin focus, with the primary evaluation criteria being the path to commercialization and the scale of the commercial opportunity thereafter. This current market environment has proven to be highly challenging for many companies, and as a result, we have had an opportunity to assess quite a large number of potential M&A opportunities throughout the past quarter, and that momentum has been maintained into this quarter. Our team has deep experience in M&A, and we employ a systematic and thorough approach to due diligence across a number of important metrics. While there can be no guarantees that a transaction will be consummated, I can tell you that we are in advanced discussions with a number of companies regarding several very exciting opportunities, including some that could potentially be fundamentally transformational for coin. We look forward to updating everyone if and when we have an announcement to make, but I do want to reiterate that broadening our product portfolio through M&A is a key priority for coin this year. On a different note, we are frequently asked questions about the competitive landscape for QRX003 in neticin syndrome. We are aware that another company has filed an IND with the FDA and received a study may proceed notification to initiate the clinical development of their product as a potential treatment for neticin syndrome. I do want to take a moment now and highlight a number of key differences between their clinical program and ours. Principally, their study is at a much earlier stage than ours as it has been labeled by the company itself as a phase 1B study. Please recall that we are currently testing our product in what is potentially the first part of a registration of study. In addition, their study differs from ours in terms of dosing duration, two weeks for them versus 12 weeks for us. And according to publicly available information, their clinical endpoints appear to be somewhat different than the true efficacy endpoints being assessed in both of our ongoing clinical studies. Finally, again based on publicly available information, we believe our well-defined, cost-effective, and reproducible manufacturing process may configure significant advantages over that of the other company. As of now, it does not appear that the company has initiated their clinical study, and to the best of our knowledge, Coyne remains the only company conducting clinical trials in nascent syndrome under an open IND. Whilst acknowledging the presence of a potential competitor in this space, we believe the advanced stage of our clinical program coupled with a well-established, cost-effective manufacturing process, provides us with substantial first-mover advantage, and we believe we are on track to obtain the very first regulatory approval for a product to treat Nesitin syndrome. As outlined previously, the combination of our planned commercial infrastructure in the U.S. and Europe, coupled with The commercial partnership network we have established in 60 countries outside of those territories will enable COIN to affect what is essentially a global launch of QRX003 once approved. We know of no other company in our peer group that could make a similar claim. With that update on our operational progress, let me turn it over to Gordon to discuss our first quarter financial results.