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spk00: Welcome to Palatine's fourth quarter and fiscal year end 2024 operating results conference call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. Before we begin our remarks, I would like to remind you that statements made by Palatin are not historical facts and may be forward-looking statements. These statements are based on assumptions that may or may not prove to be accurate, and that the actual results may differ materially from those anticipated due to the variety of risks and uncertainties discussed in the company's most recent filings with the Securities and Exchange Commission. Please consider such risks and uncertainties carefully in evaluating these forward-looking statements by Palatin's prospects. Now I would like to turn the call over to our host, Dr. Carl Spana, President and Chief Executive Officer of Palatin. Please go ahead.
spk03: Thank you. Good morning and welcome to the Palatin year-end fiscal 2024 call. I'm Dr. Carl Spana, CEO and President of Palatin. With me on the call today is Steve Wills, Palatin's Chief Financial Officer and Chief Operating Officer. And I'll turn the call over to Steve, and he'll give the financial update. Thank you, Carl.
spk02: Good morning, good afternoon, everyone. Before reviewing the financial results, I have a few other corporate items to highlight. Regarding Vilisi, remlanotide injection, a commercial product Palatin developed for hypoactive sexual desire disorder, or HSDD, Palatin closed on an asset sale to Cosette Pharmaceuticals for up to $171 million in December 2023. Terms included $12 million up front plus potential milestones of up to $159 million based on annual net sales ranging from $15 million to $200 million. Importantly, Palatin retains rights to and use of bremelanotide for obesity and male treatment indications. Regarding financings, During fiscal year-ended June 30, 2024, Paliton raised total gross proceeds of $21 million in registered direct and warrant inducement offerings. Regarding Paliton's fourth quarter and fiscal year-ended June 30, 2024 financial results, total revenue consists of gross product sales of ILECE, net of expenses, allowances, and accruals, and license and contract revenue. Pursuant to the completion of the sale of bilisi rights for female sexual dysfunction to Cassette Pharmaceuticals in December of 2023, again for up to $171 million, Palatin did not record any product sales for the fourth quarter ended June 30, 2024. For the fourth quarter ended June 30, 2023, gross product sales were $4.1 million, and net product revenue was $1.8 million. YVC gross product sales to pharmacy distributors for the fiscal year ended June 30, 2024 were $8.9 million with net product revenue of $4.5 million compared to gross product sales of $12.5 million with net product revenue of $4.9 million for the prior fiscal year. Total operating expenses were $8.7 million for the fourth quarter ended June 30, 2024 compared to $12.6 million for the comparable quarter last year. The decrease was mainly the result of lesser spending on our MCR, melanocortin receptor programs, and secondarily, the elimination of selling expenses related to Mylesi. Total operating expenses for the fiscal year ended June 30, 2024, were $27 million compared to $37.3 million for the prior fiscal year. This decrease was mainly due to the $7.8 million gain recognized on the sale by leasing, and secondarily, the elimination of related selling expenses. Regarding cash flows, Palatine's net cash used in operations for the quarter ended June 30, 2024, was $6.5 million, compared to net cash used in operations of $9.6 million for the same period in 2023. This decrease in net cash used in operations is mainly due to the decrease in operating expenses and secondarily to working capital changes. Palatine's net cash use and operations for the fiscal year ended June 30, 2024, was $31.5 million compared to net cash use and operations of $29.3 million for the same period in 2023. This increase in net cash use and operations was a result of working capital changes and increased payments made related to inventory purchase commitments. Paddleton's net loss for the quarter and fiscal year end of June 30, 2024, was $8.6 million and $29.7 million, respectively, compared to a net loss of $9.8 million and $24 million, respectively, for the same period in 2023. Variances were covered above under the revenue and operating expenses. Regarding our cash position, as of June 30, 2024, Palatin's cash and cash equivalents were $9.5 million, compared to cash and cash equivalents of $10 million as of March 31, 2024, and $8 million, with $3 million in marketable securities, as of June 30, 2023. We, Palatin, is actively engaged with multiple parties for potential funding sources for future operating cash needs consisting of both business development efforts and other potential collaborators, including entities involved with the same programs that Palatin is advancing. Thank you, and I'll now turn the call back over to Carl.
spk03: Thank you, Steve. Fiscal 2024 was an exciting year for Palatin, with significant growth in all of our pipeline programs. Results confirm that targeting the melanocortin system can result in safe, effective, and differentiated therapeutics that can improve patients' lives and address unmet market needs. Today, I will review some of the significant achievements for each of our therapeutic areas. Since Steve has already covered the sale of Ilesi to Cosette, I'm going to move on and start with some of our ocular programs. We have multiple ocular programs that have made significant progress over the past year. PL9643 is Palatin's topically administered product for treating the signs and symptoms of dry eye disease. We successfully completed the first phase three trial, Melody 1, and announced the positive results earlier in the year. Current FDA-approved treatments for dry eye disease have three significant problems that limit their utility. They have poor ocular tolerability, lack broad efficacy, and they take a long time to have symptom relief. The results of MELODY-1 clearly demonstrated that PL9643 is a truly differentiated treatment for dry eye disease that solves the three main problems of current treatments. The PL9643 MELODY-1 trials show that PL9643 had excellent ocular tolerability, brought efficacy in multiple signs and symptoms, and demonstrated efficacy as early as two weeks. With this emerging product profile, PL9-643 has the potential to be the leading treatment for dry eye disease. In summary, in the MELODY-1 Phase III trial, results compared to view control included the following. PL9-643 achieves statistical significance for the co-primary endpoint of ocular pain in seven of the secondary symptom endpoints, including eye dryness and ocular discomfort. To the best of our knowledge, no FDA-approved treatment for dry eye disease has shown such broad effect on the symptoms of dry eye disease. For inferior corneal fluorescein staining, which is a sign, we have agreement with the FDA that this will be the primary sign endpoint for the next Phase III trial, and PL9643 also achieves statistical significance at the two-week time point in Melody 1. BL9643 positive effects on the signs and symptoms of dry eye disease were rapid, with efficacy at two weeks after starting treatment, and they continued to improve over the 12 weeks of the treatment. BL9643 has excellent ocular tolerability, with no subjects discontinuing the study due to an ocular adverse event. Data for approved dry eye disease treatments shows that a lack of efficacy and poor tolerability, such as burning, blurry vision, bad taste, stinging, has led to a significant amount of patient dissatisfaction and high discontinuation rates. In a recent Type C meeting, the FDA agreed with our plan for the remaining activities required to file a new drug application with the FDA for approval of BL9643 as a treatment for the signs and symptoms of dry eye disease. Specifically, we have the FDA agreement on our protocols, number of subjects, the primary sign and symptom endpoints, and our statistical analysis plans. We are ready to complete the PL9643 phase three program with all remaining clinical studies to be conducted and completed in calendar year 2025 and an anticipated NDA filing in the first half of calendar year 2026. Our two other ocular programs also made substantial progress in fiscal 24. PL9588 is our topically administered treatment in the development to treat glaucoma. In the last year, we completed a comprehensive evaluation of PL9588 in multiple preclinical glaucoma models. Results indicate that PL9588 not only lowers intraocular pressure, but also provides direct neuroprotection. Direct neuroprotection of the optic nerve is a significantly differentiating factor over current treatments for glaucoma, and PL9588 is now ready to begin the IND-enabling studies with clinical trials beginning in calendar year 2025. Retinopathies are a broad category of ocular diseases that cause damage to the retina and can lead to vision loss. The global market for treatments is estimated to be approximately $30 billion by 2030. PL9654 is our novel differentiated treatment for various retinopathies. In fiscal 2024, we completed an extensive evaluation of PL9654 in multiple models of retinal disease. PIL-9654 demonstrated the ability to preserve vision, protect the retina from damage, and in genomic analysis, positively affected multiple pathways that are known to be involved in the progression of retinal diseases. We also made substantial progress in the development of intravitreal injectable formulation, and PIL-9654 is now ready to enter into IND-enabling studies starting in calendar 2025. Now I'll move on to our MCR-4 or melanocortin-4 receptor obesity program. Drug treatment for obesity is now established and growing rapidly. We have multiple drugs with differing mechanisms of action that affect weight loss, and importantly, weight loss maintenance are needed. Because of the important role that the MCR4 receptor plays in regulating stored energy and food intake, we strongly believe that MCR4 agonists will be an important part of the future of obesity treatment and weight loss management. Palatins has a longstanding research effort to develop melanocortin therapeutics that selectively activate the MCR4 receptor, as treatments for obesity and weight loss maintenance. With our extensive experience in the design and development of melanocortin agonists for treating obesity, including two clinical studies previously completed and published, we are well positioned to be a leader in the development of melanocortin-based therapeutics for weight loss and weight loss maintenance. As I'm sure you all know, incretin-based therapeutics such as Zepbounds and Magovi are the primary treatment for obesity, and they have demonstrated expressive growth However, up to 67% of patients that begin treatment discontinue in the first year, mainly due to side effects and a plateau effect, and they often quickly regain the weight that they have lost. Additional approaches are needed to provide patients an opportunity to safely and tolerably reach their weight loss goals. Research by Palatin and academic groups indicate that combining MCR4 receptor agonists with a Glyphorone receptor agonist like Terzepatide may result in synergistic effects on weight loss, allowing for increased or sustained weight loss at lower and better-tolerated doses. To investigate the potential additive effects of combining MC4R receptor agonists with the GLP-1 receptor agonists, we initiated a Phase II clinical study in August. In the study, obese subjects will co-administer the MCR4 receptor agonist premelanotide along with terceptotide. The study is designed to enroll approximately 60 obese subjects at four sites in the U.S., The primary endpoint is to demonstrate the safety and increased efficacy of the co-administration of brimelanotide with terzepatide on reducing body weight over just terzepatide alone. Patients will be treated with weekly terzepatide before weeks, having eligibility confirmed and then randomized to one to four treatment arms, which consist of weekly and daily study drug, including weekly terzepatide and daily brimelanotide. Patients will undergo multiple assessments of safety and efficacy to help profile the effectiveness of remelanotide in treating general obesity as a standalone treatment or in conjunction with GLP-1 therapy. This study will be completely enrolled this quarter, with data in the first quarter of calendar 2025. We've also developed next-generation, highly selective lanocortin-4 receptor peptide agonists, as well as small molecules. for the treatment of obesity and weight loss maintenance. Our new MCR4 receptor peptide agonist are highly selective for the MCR4 receptor versus the MCR1 receptor and are not anticipated to have skin darkening as a side effect. They're designed using a proprietary technology to have once a week dosing. We anticipate final lead selection in the first quarter of calendar 2025 with an IND and first in human clinical studies in the second half of calendar 2025. Now we'll move on to our work in sexual dysfunction. Our research in the use of melanocortin agonists to treat various male and female sexual dysfunctions has led to the development of a novel product that is a co-formulation of remolanotide and a phosphatidase 5 inhibitor. Those are compounds such as Viagra and Cialis. We believe this product could be an ideal treatment for the 35% of men with erectile dysfunction that have an inadequate response to PD5 inhibitor therapy. These patients have limited options and represent a large, underserved market. We have initiated a development and clinical program for the evaluation of remolatatide co-formulated with a PD-5 inhibitor for the treatment of erectile dysfunction in patients that are non-responsive to PD-5 inhibitor monotherapy. A pharmacokinetic study is expected to initiate in the first half of calendar 2025. and patient recruitment in a Phase II clinical study is anticipated in the second half of the calendar of 2025, with top-line results in 2026. The final program I want to cover is our PL8177 for ulcerative colitis, which is in a Phase II study, evaluating oral PL8177, a selective melanocortin-1 receptor agonist, and ulcerative colitis patients. The study has nearly completed enrollment, and we expect data from the interim analysis later this quarter. In support of the oral PL8177 program are preclinical studies demonstrating that treatment with oral PL8177 causes diseased colons to improve toward a healthy state and to resolve inflammation. Resolving inflammation rather than blocking it provides the possibility of efficacy coupled with significantly differentiating safety in treating colitis and inflammatory bowel diseases. As we look forward, we want to continue to build on the successes of the past year by focusing on the continued development of our key programs in obesity and dry eye disease, and importantly, collaborations and partnerships for our dry eye disease program, our other ocular programs in glaucoma and retinopathies, and our ulcerative colitis program. Upcoming milestones and activities for our novel and different programs include the following. For our MCR4 obesity program, we want to complete the Phase II study evaluating the co-administration of remolantotide and drosepatide, We expect to have that data reported out in the first quarter of calendar 2025. We also are on track to advance our selected MCR4 long-acting peptide agonist through first in human studies and the program for a phase two dose ranging efficacy during calendar year 2025. For our dry eye disease program, we want to start and complete the phase three trials, MELODY2 and MELODY3 with beta expected by calendar year end 2025, and also we want to complete all manufacturing activities needed to file a new drug application with the FDA in the first half of calendar 2026. To facilitate moving this program forward, we are in active discussions with potential corporate collaborators and funding partners. For our male sexual dysfunction program, We want to get our public genetic study started and completed in the first half of calendar year 2025 and begin patient recruitment in a phase 2-3 study, which is anticipated to start in the second half of calendar 2025. Importantly, we have also increased our business development activities to support the licenses of our major programs as well as our earlier pipeline programs. Steve and I and the whole Paladin team are extremely excited and enthusiastic by the potential of these programs to bring novel, innovative treatments to improve patient lives and address significant unmet medical needs. We'll now turn the call over to questions.
spk00: Certainly. The floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on a speakerphone to provide optimum sound quality. Please hold just a moment while we poll for questions. Your first question is coming from Joe Pancinus with HC Brain White. Please pose your question. Your line is live.
spk04: Hey, guys. Thanks for the details and thanks for taking the question. So two sets of questions. First on your weight loss program with GLP-1. Wanted to talk about the benchmarks of success for the study. You know, are you looking for a minimum or limit of weight loss to see to move to the next stage? you know, what impacts on lean muscle mass. Hopefully you could share that with us as well as, you know, what are you looking to do to eliminate or alleviate or mitigate some of the pigmentation issues? Sure.
spk03: All right. That's a number of things, Joe. So let me talk about what the expectations are for the current phase two trial where we're using bremelanotide in conjunction with trisepatide. The main primary question there is, is there an additive effect? And that can be one-on-one equals two, one-on-one equals three, et cetera. So the primary analysis will be a comparison of the co-administered versus terzepatide alone. And there's no set, what we're looking for is essentially a measurable or significant separation. Now, these patients are not on long-term treatment, so their weight losses are not gonna be 10, 15% over four weeks. You're gonna be in that two to 3% range, two to 5% range. We wanna see an additive effect which we think based on the design and based on what we expect we're going to see, we should be able to achieve. So, again, it's not, you know, we're not using, you know, again, it's not a long-term study where you're going to expect, you know, explosive numbers, but we should really see a very clear signal from the study that these two are additive or synergistic.
spk04: Got it, got it. And the pigmentation?
spk03: So skin darkening with, you know, the first generation of MCR4 agonists, there are two, there are actually several approved, brinolantazide being one of them, is driven by activity against the melanocortin-1 receptor. And, you know, in the case of, you know, short-term use, you know, it's not an issue. But when we move on to more chronic use in obese patients, you know, it can be an issue for patients. They don't like the skin darkening. So in order to do that, you need next-generation compounds that are really devoid of MCR1 activity. And based on the extensive number of years I've been working in this field, we've been able to achieve that. So compounds that we are in final evaluation have substantial separation between the two receptors. In fact, many of them are non-active at MCR1. So we don't expect any skin darkening with those compounds. And then those are on the peptide front. And when we think about small molecules, That pharmacophore is much smaller, and it's really highly selective MCR4. It doesn't have any MCR1 activity at all.
spk04: No, that's helpful. Oh, sorry. Yep. I just wanted to switch to the dry eye program because I think it's great. You already have the great visibility and discussions from the FDA and, you know, looking forward to the start of these programs. So I guess, you know, do you think or how – how mature are your discussions on business development, but more from a logistical standpoint. The guidance from the FDA, I just wanted to make sure, are these the same signs and symptoms from Melody I? Are they different? And, you know, how would they look to, you know, in assessing the primary endpoints in the end?
spk03: Sure. So I'll kind of work backwards. So the symptom is the exact same one that was used in Melody I. The sign is we're moving from lisamine green to inferior corneal fluorescein staining because all of the fluorescein stains reach significance at the two-week time point in MELODY-1. And inferior corneal fluorescein staining is just a better sign, meaning that it's a generally accepted sign that it's used in dry eye disease studies. So we're going with that. And again, we have concurrence with the FDA on the use of both of those in the study. With regards to being ready to go, assuming appropriate finances and what have you, the protocols are together, SAP is together, the CRO is hired and done, so we're really pretty much ready to go forward as soon as we secure the appropriate funding. And that kind of leads into your first part of your question, which was where are we with that. And we're in, I would say, we're We've had very good interest from a corporate standpoint. There was a lot of pending, a lot of those entities were in ongoing discussions waiting for the results of the Type C meeting. Now that we have those, we've reengaged those entities and we're in the middle of discussions with them and hopefully moving towards what will be a conclusion of a licensing deal or some sort of transaction. In addition to that, we've had some very good uptake more recently with discussions in larger funds that would be also interested in potentially funding the Phase III program and moving it forward as well. So we're really attacking it on two fronts, and obviously I've taken a little of Steve's thunder because Steve actually leads those discussions. But I think we've been pretty pleased with the progress we've been making.
spk04: Well, it's good to hear about the optionality, and thanks for the details, Carl.
spk02: Thanks, Joe.
spk00: Your next question is coming from John Newman with Canaccord Genuity. Please pose your question. Your line is live.
spk01: Good morning. Thanks for taking the question. Question here for Carl. Carl, the question is, do you see the potential to co-formulate some of your MCR-4 agonist with drugs like Terzepatide. The reason I'm asking is because there's obviously been a revolution in weight loss treatment, which has been fantastic with the GLP-1s, but we do know that eventually some of those products at least will be selected for price reductions, but one way to potentially address that is to combine the GLP-1s with novel molecules. And so I'm just curious If maybe over the long term, maybe not immediately, but longer term, that's a potential avenue for your compounds. Thanks.
spk03: Sure. So along those lines, we haven't yet done any of that work. However, I think it's highly feasible. The formulations for these compounds are pretty soluble compounds, both the GLP-1s and stuff that we're working with. So along those lines, it should be relatively easy to come up with formulations in which the two are combined. Now, of course, I say that not being the guy who actually does the lab work, but I think from a theoretical standpoint, it should be relatively easy to do that to get the two together.
spk01: Okay, great. Thank you.
spk00: There are no additional questions in queue at this time. I would now like to turn the floor back over to Dr. Carl Spana for any closing remarks.
spk03: Well, Steve and I and the whole Palatin team would like to thank all of you for listening to the Palatin year-end fiscal 2024 call. I'd like to thank the analysts for their insightful questions as well. We're very excited here. I mean, for a small company, we have a tremendous amount of opportunity, and we're really looking forward to what we can deliver over the next year. and keeping you updated on our progress on press releases and quarterly calls and presentations at various scientific and investor meetings. That being said, I hope all of you have a great day, and we look forward to keeping you updated. Thank you.
spk00: Thank you, everyone. This does conclude today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation.
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