Quoin Pharmaceuticals, Ltd.

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 this event is being recorded. I would now like to turn the conference over to Gordon Dunn, CFO. Please go ahead.

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 second quarter of 2023, as well as discussing our Q2 2023 financial results. Please note that our operational and financial results press release is now available on COIN's website. In keeping with our normal procedure, to begin, Michael will begin a corporate, clinical, and operational update, following which I will review our financial results. I will then hand the call back to Michael for closing comments. We will also 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 meeting 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 describe any obligation to update these forward-looking statements other than is 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. Michael.

Thank you, Gordon, and good morning, everyone. On our last call, I reported on the very strong start Coin has had to 2023. Today, I'm very pleased to announce that this momentum carried into and through the second quarter. On May 24th, we announced that our open-labeled Nethicine Syndrome clinical trial had achieved 50% recruitment, and additional subjects have been enrolled since then. You may recall that we only dosed the first subject in this study in March of this year, so we are very pleased with the pace of recruitment overall. Our other Nefferson Syndrome clinical study is on track to have recruited the majority of subjects this month, and it is extremely encouraging how high the interest level continues to be for participation in both studies. We announced today the availability of data from the first patient to complete our open-label clinical study, and I will provide more commentary on this later in the call. Also, during the quarter, we made substantial progress on our plans to initiate additional Nessensen syndrome clinical studies, including one in a pre-identified cohort of approximately 20 Nessensen patients in the Middle East, as well as an ex-US study in pediatric subjects. We believe these additional clinical trials will supplement and enhance the data package that is currently being generated by our ongoing studies here in the US. As a leading company in this space, we are fully committed to generating a compelling body of clinical evidence to support global regulatory approval for QRX003 as a safe and effective treatment for Nettleton syndrome. During the quarter, we also continued to engage actively with Queensland University of Technology, or QUT, in Australia. COIN has two ongoing research programs with QUT, one for scleroderma and the other for Nettleton syndrome. The active ingredient in the LASA program has a different mechanism of action to our own QRx003, and we believe this product potentially has complementary features to QRx003. As previously outlined, while both of these programs are still at an early stage of development, we continue to believe that they are important components of our product portfolio and we look forward to their advancement into clinical testing. Both research programs are being conducted in Australia, where COIN is able to take advantage of a 43.5% tax rebate from the Australian government, as well as a more rapid advancement into human clinical testing than is possible here in the US or in Europe. During the quarter, we made tangible progress on our plans to initiate clinical testing of QRX003 in additional indications beyond Nephitan syndrome. These indications include peeling skin syndrome, sham syndrome, and palmoplantar keratoderma, none of which there are any approved treatments for. We hope to provide further updates on our progress in the near future including timing of initiation of proof of concept clinical testing in patients. During our last call, I also updated everyone on our M&A strategy. As discussed, given our strong balance sheet and the potential access to additional capital, we are acutely focused on expanding our product portfolio via acquisition, licensing, or other means. We are primarily interested in late stage assets in the rare and often disease space that are underpinned by strong clinical data and highly favorable commercial opportunities based on readily identifiable competitive strengths. While there can be no guarantees that a transaction will be consummated, I can tell you that a number of discussions continued to advance significantly throughout the quarter and we are optimistic that COIN will enter into at least one such transaction by the end of the year. We look forward to keeping you updated on our progress during this very exciting time for COIN. Also on our last call, I noted that 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 this morning, following a review of the clinicaltrials.gov website, it appears that this study has not yet been initiated and COIN remains the only pharmaceutical company to be actively conducting clinical studies in Nessuson syndrome under an open investigational new drug application, or IND. We and our eight global commercial partners continue to be excited by the extent of the commercial opportunity that obtaining the first regulatory approval for a treatment for this disease represents. Turning now to our ongoing clinical studies in netizens syndrome patients. Today, we had the privilege of announcing the availability of clinical data from the first subject to complete testing in our open-label study. I'm very pleased to be able to tell you that this data is positive across all measured endpoints. You may recall that in this open-label study, subjects are currently receiving off-label systemic treatment and will continue to do so in conjunction with QRx003 for the duration of the study. It is worth noting that all subjects in the study have been treated with off-label systemic therapy for at least one year, and in a number of cases, for multiple years. Notwithstanding this ongoing and long-term systemic therapy treatment, all patients recruited into the study demonstrated clear symptoms of Nessuson syndrome, including compromised skin and poor rhesus or itch. As a result of this long-term systemic therapy, subjects recruited into the study provided a natural baseline for us to assess if treatments with QRX003 over a duration of 12 weeks would lead to any therapeutic improvement across a number of assessed clinical endpoints. And so it was for the first subject who completed testing in the study. Despite the long-term systemic therapy, the subject exhibited classic symptoms of Nathanson syndrome on entry into the study. However, I'm very pleased to say on completion of the study for this subject, the QRX003 treatment area was deemed to be fully clear both by the clinical investigator as well as by a well-recognized visual scoring system. Furthermore, the subject also expressed a very favorable impression of QRX003 across a number of important metrics. Importantly also, on completion of the study, this subject's pruritus, RH, at the QRX003 treatment area was deemed to be negligible. Bear in mind that one of the primary reasons for people with Nessuson syndrome to go on systemic therapy is for symptomatic relief from their pruritus. For this particular subject, despite having been on systemic therapy for well over a year, it was only after 12 weeks of treatment with QRX003 that their pruritus had decreased to a negligible level. Although this data represents an important milestone for COIN as it is the first clinical evidence of the potential efficacy of QRX003 in Nessuson syndrome, I do want to strongly caution that it is from a single patient only and care should be taken not to read too much into this data. As other patients in the study reach the same point, we plan to provide additional updates in due course. As mentioned earlier, our ongoing double-blindness study is now on track to have a majority of subjects recruited this month. We are frequently asked if the open-label study is cannibalizing subjects from the double-blindness study, and I can tell you this is not the case at all. Both studies are recruiting independently of each other, and feedback from the Nessington community is that the availability of two such distinct clinical trial options allows patients the flexibility to enroll in a study that is best suited to their own ongoing treatment regimen. I also want to highlight that in both studies to date and across all subjects tested, QRX003 is demonstrating an exemplary safety profile. Given the highly compromised skin that Nethicin patients have, this is very encouraging news and further bolsters our confidence in the potential for QRX003 to become the first product to safely and effectively treat this disease. With that on our operational progress, let me turn it over to Gordon now to discuss our second quarter financial results.