Quoin Pharmaceuticals, Ltd.

Hello, and welcome to the Coin Pharmaceuticals Limited third 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 or 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 touchtone phone. To withdraw your question, please press star, then two. Please note, today's event is being recorded. I now would like to turn the conference over to your host today, Gordon Dunn. 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 over the quarter and discuss Coin Pharmaceuticals Q3 2022 financial results. Please note that our operational and financial results press release is now available on Coin's website. To begin, Michael will provide a corporate, clinical, and operational update, following which I will review our Q3 2022 financial results. I'll then hand the call back to Michael for further comments. We'll also be pleased to answer any questions that you may have 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 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. Now my pleasure to turn the call over to our CEO, Michael Munters.

Thank you, Gordon, and good morning, everyone. COIN continued to make significant progress in the last quarter as we execute on our plan to build the organization into a global rare disease company, and I am very pleased to provide an update of our most recent achievements on this call today. The key highlight of the quarter was the successful completion of a $16.8 million public offering, which was twice upsized and heavily oversubscribed. As a result of this capital raise, COIN is now funded into 2024, which is well beyond a number of key inflection points for the company. During the quarter, we continue to make significant progress towards our goal of delivering a safe and effective treatment for Nettleton syndrome, a rare and devastating genetic disease for which there is currently no approved treatment or cure. Significantly, during this past quarter, we initiated a clinical trial under an open IMD to evaluate our lead product, QRX003, in Nesodent patients. As discussed previously, this trial is a randomized, double-blinded vehicle control study. It will assess two different doses of QRX003 topical lotion versus the placebo lotion in 18 Nethicin patients. The test materials will be applied once daily over a 12-week period to predesignated areas of the patient's body, and as agreed with the FDA, a number of different clinical endpoints will be evaluated. This study will serve as the first cohort of a pivotal study for US and EU approval. As previously noted, the FDA has indicated that a total of approximately 20 medicine patients tested with QRF003 at the commercial dose may be sufficient for regulatory approval in the US. Based on the positive and constructive feedback we previously received from the EMAEA, we believe a similar number will also enable us to obtain regulatory approval for QRX003 in Europe. I am pleased to inform you that a majority of clinical sites are now fully open with the remaining sites on target to open by year end. In support of the study, this quarter we launched a dedicated website www.Nestatinsyndromeclinicaltrials.com, which provides details of the study design, the location of the clinical site, and a survey link for patients interested in participating in the study. We are also working closely with the First Skins Foundation and our CRO Therapeutics, Inc. to maximize awareness of the study in the Nestatins community and aid in patient recruitment which is now actively underway. Interest in the study remains very high among the Netterson community, and in fact, just yesterday, a patient traveled almost the full length of the country to get to our Boston clinical site, where he will be screened today for participation in the study. We are seeing similar levels of willingness to travel great distances to participate in the study from across the country, and also internationally as we frequently receive requests from overseas patients who are extremely eager to be recruited into this important study. During the quarter, we also announced plans to initiate a second clinical trial to evaluate QRX003 in Nettleton patients who are currently receiving off-label systemic therapy. This trial will also be conducted under COIN's open IND application and will run concurrently with our ongoing clinical trial. The clinical protocol has already been submitted to the FDA and pending no comments from the agency, we will initiate patient recruitment next month. With no approved treatments for Nathanson syndrome, we are increasingly aware that some patients are being treated with investigative systemic therapies including biologics in an effort to provide any level of relief to some, but by no means all, of the symptoms of this disease. To maintain the integrity of our currently ongoing clinical studies, patients must completely wash out of any systemic therapy in order to be eligible to participate. For many patients, this is a very difficult decision. Discontinuing a therapy that is providing even modest relief would result in the return of all of their symptoms just to enroll in a clinical trial where there is a one in three chance that they'll receive a placebo. We fully understand how challenging a decision that must be, so in order to accommodate those patients, we have announced our plans to run this second study. This will be an open-label study in approximately 10 Netterton patients who are currently receiving and will continue to receive off-label systemic therapy throughout the duration of the study. The trial will not be placebo-controlled, and all patients will have a 4% dose of QRS003, which is the highest dose, applied once daily to predesignated sites on the body every day over a 12-week period. As I just mentioned, we anticipate that this study will run concurrently with our ongoing study and we'll use the same clinical sites and the same investigators. By availing of the infrastructure that we have already put in place for our current trial, we will be in a position to maximize the efficiency of this new study whilst minimizing incremental costs to the company. Fundamentally, we believe that assessing the safety and efficacy of QRX003 as adjuvant treatment with systemic therapy could potentially yield valuable clinical data and possibly result in more treatment opportunities for patients and physicians. I would now also like to take a moment and mention that as we continue to deepen our engagement with the Nessington community of patients, family members, treating physicians, and supporting foundations, we find ourselves more and more in awe of the absolute strength and resilience that we see on a daily base from this patient population. We are constantly humbled by the immense courage of this community, something which only serves to increase our determination to provide a safe and effective treatment for this absolutely devastating disease. Turning now to our research projects at Queensland University of Technology, or QUT, we continue to make great progress and are hopeful that one or perhaps both programs will initiate clinical testing next year. While still at a relatively early stage of development, we view these products as important components of our rare disease portfolio. We are very pleased with the strength of this partnership and continue to be impressed with the quality and depth of the science being performed by the QUT researchers. The initial clinical testing will be performed in Australia, where COIN will be able to take advantage of the very generous incentives offered by the Australian government, including but not limited to a rebate of 43.5% of all research dollars spent, rendering these highly cost-effective programs for the company. And finally, during the quarter, we continued to expand our list of international distribution partners for QRX003. On July 15th, we announced that we entered into an exclusive license distribution and supply agreement for the Canadian market with Endo Ventures Limited, a subsidiary of Endo International PLC. Endo's affiliate, Paladin Labs, will be responsible for the commercialization of QRX003 in Canada once approved. This latest agreement marks our eighth such partnership for QRX003 that now covers 60 countries, including Australia, New Zealand, China, Hong Kong, Taiwan, the Middle East, Central and Eastern Europe, Turkey, and parts of Latin America. We continue to work closely with these partners to advance the development of QRX003 in their respective territories as they pursue the entry of the product into early access and compassionate use programs in their local markets. With that update on our operational progress, let me turn it over to our CFO, Gordon Dunn, to discuss the third quarter financial results.