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spk00: 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.
spk05: 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.
spk01: 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.
spk05: Thank you, Michael. As of December 31, our cash and marketable securities was approximately $10.7 million compared to $14 million as of September 30th. As Michael highlighted, last week we strengthened our cash position through the successful completion of a 6.5 million public offering, which we expect will be sufficient to fund our operations into the second half of 2025. And we've also entered into an 8 million equity line of credit transaction, which we'll be able to access and complete in the second half of this year. And the completion of this 8 million transaction will further extend our cash position into the second half of 2026. Our net loss for the year ending December 31, 2023 was $8.7 million compared to $9.4 million in 2022. The decrease in 2023 was primarily due to higher interest income and lower professional fees and other G&A costs, partially offset by higher R&D expenses as we advanced our clinical studies. Our net loss was $2 million in both of the fourth quarter 2023 and the fourth quarter of 2022. I'll now turn the call back to Michael to make some closing remarks and begin our Q&A. Michael.
spk01: Thanks, Gordon. We are very pleased with the positive start the company has made to 2024. With all of the protocol amendments we have submitted to our IND for our ongoing clinical studies, including the reduction in eligibility age to 14, now fully implemented, we believe we have put ourselves in a strong position to build off of the initial positive data that has been generated so far. Our balance sheet has been strengthened as a result of the recent successful capital raise and will be further extended by the ELOC that Gordon just discussed. This strong cash position will enable us to complete the clinical testing of our lead asset for Nessuson syndrome and put the company firmly in position to achieve our mission of delivering the first approved treatment to this long neglected community. With that operator, we are now ready for questions.
spk00: Thank you, sir. We'll now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, we ask that you please pick up your handset before pressing the keys. To withdraw your question, please press star then two. Today's first question comes from Naz Rahman with Maxim Group. Please go ahead.
spk03: Hi, everyone. Congrats on all the progress thus far. I have a few questions, if I may. First, I'm going to just start on the pediatric patients. How many pediatric patients do you plan on enrolling in the randomized portion of the study, and based on your conversations with the FDA, how many pediatric patients do you need for the safety database?
spk01: Thanks, Naz. Good questions. The short answer to the first part is as many as possible. Look, this is a genetic disease, so people are born with it, and what we've seen is that younger people have completed the genetic testing to accurately identify that they have the disease, whereas that's not so common among the older population. So because you have to complete the testing to enroll in our study, we think that now that the eligibility age has been reduced, then it will skew more towards the younger population in the study than the older ones. So I think we may end up with at least 50-50 mix or maybe slightly skewed more in favor of young people. But it's difficult to tell. But as I said, look, we'll recruit as many as are eligible. With regard to the number, that hasn't been discussed with the agency as of yet. As you know from previous discussions, we've had a very positive relationship with the agency around this product as we were the first company to submit an IND to them. So I don't know that they have a hard and fast number in their mind. Bear in mind, the total population that they were guiding us towards for approval was 20 at the commercial dose. And we expect that we'll significantly exceed that and that a good proportion of those will be pediatric patients.
spk03: Got it, that was helpful. So between your two studies, the open label and the randomized portion of the study, when can we see the next data readout and what would be included in that? And ultimately, when do you see or expect the randomized control portion of the trial to read out, the top line results, that is?
spk01: Yeah, so there will be further readouts throughout the year from the open label study. And what we would hope is that we'll see readouts from pediatric patients dosed twice a day, because that is the target now, twice daily dosing, and we think it would be really beneficial if we could see the results on pediatric patients tested at that twice daily rate. So there will be continued readouts. We would expect that this summer there will be a readout. I can't tell you what the mix between pediatric and adult patients will be, but we are targeting a first readout this summer from patients who have received twice daily dosing. With regard to the blinded study readout, as you know, we've increased the number of subjects to 30 in that study. So I certainly don't see an initial readout this year, but my hope is that it would be pretty early in 2025. That's probably as accurate a guidance I can give you at this point, Naz. Look, we'll refine that once the recruitment starts to ramp up and we'll have more visibility.
spk03: Got it. That was helpful. And just on that open-label readout, two quick questions. One, how have you seen, based on what you've seen so far, how have you seen or how have patients tolerated the twice-daily dosing? And two, have you seen any patients choose to discontinue systemic therapy like patexin or steroids because of the potential benefits they're getting from 003?
spk01: So taking them in reverse order, Naz, a condition of the open-label study is that they remain on the systemic therapy throughout the 12-week dosing period. So there's no ability for them to discontinue if they believe that they're getting benefit from 003. So they have to stick with it. And the first part, we have not seen any changes in the safety profile since we made any of the protocol amendments. So, so far so good. There's nothing that's raising any red flags or even amber flags at this point from a safety perspective.
spk03: Got it. That was very helpful. Thanks for taking my questions, and congrats on the progress.
spk01: Thanks, Matt.
spk00: Thank you. And our next question today comes from James Malloy with Alliance Global Partners. Please go ahead.
spk04: Hi, guys. Thanks for taking my question. Just a quick question on, I think you mentioned a little bit about M&A in the, on their prepared remarks. Could you walk through what you guys could be looking at for M&A? I know that You don't have a ton of extra capital lying around, but are there opportunities that fit with what you have currently? Do you need to do additional raise to get that? And what are you seeing out there, please?
spk01: Well, thanks, Jim. Appreciate you hopping on and asking the question. Look, last year, as you've heard, we focused very significantly on M&A activity, and we assessed a lot of opportunities. And let's be fair, there's... There's quite a number of distressed assets out there that are available, but we did not get to a point where we signed any deal. There were some very interesting opportunities that we continue to look at, and we will continue to do so this year. We will remain disciplined within the remit of rare and orphan diseases. Our preference is for later stage orphan assets that have clinical data the closer to approval and commercialization, the better. But we will stay within the rare and orphan disease space and not expand beyond that. So look, we'll continue to look. We will continue to explore what's out there. And I would just say, look, stay tuned in terms of whether we would do an additional raise to support any M&A. That depends on what the deal structure is. So you've heard us before that we don't want to spend from our cash balance on M&A, so more than likely we would seek to do a raise, but it really does depend.
spk04: The question before, you clarified the all-adult trial looking for early 25s on the data, is that correct on that? Do you have an updated timing on the mostly children trial?
spk01: No, so that is the blindest study, Jim. And that now has both adults and children aged 14 and upwards. And as I said, from where we stand today, we think early 2025 is the most likely. timeframe for initial data, whereas from the open label study, which now also does contain adults and children aged 14 and up, we have the opportunity to present data throughout the year as it becomes available.
spk04: Okay, great. Thank you. Then finally, the last question, any updates on when you talk to the FDA about rare pediatric orphan priority?
spk01: Sometime this year. That's about as good as I can give you, but certainly sometime this year.
spk04: Understood. Thank you for taking the questions.
spk01: Thank you, sir.
spk00: And as a reminder, ladies and gentlemen, if you'd like to ask a question, please press star than one. Our next question comes from Dean Finley, a private investor. Please go ahead.
spk02: Good day. Just a quick question from the investment side. I'm just wondering if there's any relevant or valid price targets of
spk01: I don't have anything to add to that. The analysts that cover us, they set their price targets for the share price, so I would point you to their research reports. We don't provide that.
spk02: All right. Thanks.
spk00: Ladies and gentlemen, this concludes our question and answer session. I'd like to turn the conference back over to the management team for any closing remarks.
spk01: Thank you and thanks everybody for participating again. As we always end with, please feel free to reach out to us offline via email or phone if you have any questions or concerns. We are always available to address those. Thank you, and have a great day.
spk00: Thank you, sir. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.
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