管理層發言
Greetings. Welcome to Palatin'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. 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.
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. I'll now turn the call over to Steve, and he'll give the financial update.
Thank you, Carl. Good morning, good afternoon, everyone. Before reviewing the financial results, I have a few other corporate items to highlight. Regarding Vyleesi, bremelanotide 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 upfront 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 the fiscal year ended June 30th, 2024, Palatin raised total gross proceeds of $21 million in registered direct and warrant inducement offerings. Regarding Palatin's fourth quarter and fiscal year ended June 30th, 2024 financial results, total revenue consists of gross product sales of Vyleesi, net of expenses, allowances and accruals and license and contract revenue.
Pursuant to the completion of the sale of Vyleesi rights for female sexual dysfunction to Cosette Pharmaceuticals, in December 2023, again, for up to $171 million. Palatin did not record any product sales for the fourth quarter ended June 30th, 2024. For the fourth quarter ended June 30th, '23, gross product sales were $4.1 million and net product revenue was $1.8 million. Vyleesi gross product sales to pharmacy distributors for the fiscal year ended June 30th, 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 30th, 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 Vyleesi.
Total operating expenses for the fiscal year ended June 30th, 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 of Vyleesi and, secondarily, the elimination of related selling expenses. Regarding cash flows, Palatin's net cash used in operations for the quarter ended June 30th, 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. Palatin's net cash used in operations for the fiscal year ended June 30th, 2024, was $31.5 million compared to net cash used in operations of $29.3 million for the same period in 2023. This increase in net cash used in operations was a result of working capital changes and increased payments made related to inventory purchase commitments.
Palatin's net loss for the quarter and fiscal year ended June 30th, 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 periods in 2023. Variances were covered above under the revenue and operating expenses. Regarding our cash position, as of June 30th, 2024, Palatin's cash and cash equivalents were $9.5 million compared to cash and cash equivalents of $10 million as of March 31st, 2024, and $8 million with $3 million in marketable securities as of June 30th, 2023. We, Palatin, are 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 in the same programs that Palatin is advancing. Thank you. And I'll now turn the call back over to Carl.
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 Vyleesi 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 III trial, MELODY-1, and announced 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 trial showed that PL9643 had excellent ocular tolerability, broad efficacy in multiple signs and symptoms, and demonstrated efficacy as early as two weeks. With this emerging product profile, PL9643 has the potential to be the leading treatment for dry eye disease. In summary, the MELODY-1 Phase III trial results compared to view control included the following: PL9643 achieved statistical significance for the co-primary endpoints 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 a 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 achieved statistical significance at the two-week time point in MELODY-1. PL9643's positive effects on the signs and symptoms of dry eye disease were rapid, with efficacy at two weeks after starting treatment and they continue to improve over the 12 weeks of the treatment. PL9643 has excellent ocular tolerability with no subjects discontinuing the study due to an ocular adverse event. Data for approved dry eye disease treatments show that a lack of efficacy and poor tolerability, such as burning, blurry vision, bad taste, and stinging, has led to significant 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 PL9643 as a treatment for the signs and symptoms of dry eye disease.
Specifically, we have FDA agreement on our protocols, a number of subjects, the primary sign and symptom endpoint, and our statistical analysis plan. We are ready to complete the PL9643 Phase III 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 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 treatment 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. PL9654 demonstrated the ability to preserve vision, protect the retina from damage, and a 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 PL9654 is now ready to enter into IND-enabling studies starting in calendar 2025. Now I'll move on to our MCR4 melanocortin-4 receptor obesity program. Drug treatment for obesity is now established and growing rapidly.
We have multiple drugs with different mechanisms of action that affect weight loss and, importantly, weight loss maintenance are needed. Because of the important role of the MCR4 receptor in regulating stored energy and food intake, we strongly believe that MCR4 agonist will be an important part of the future of obesity treatment and weight loss management. Palatin has a long-standing research effort to develop melanocortin therapeutics that selectively activate MCR4 receptor as treatments for obesity and weight loss maintenance. With our extensive experience in the design and development of melanocortin agonist 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 Zepbound and Wegovy, are the primary treatment for obesity and they have demonstrated impressive growth.
However, up to 67% of patients that began 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 agonist with the GLP-1 receptor agonist like tirzepatide 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 the MC4R receptor agonist with a GLP-1 receptor agonist, we initiated a Phase II clinical study in August. In the study, obese subjects will co-administer the MCR4 receptor agonist bremelanotide along with tirzepatide. 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 coadministration of bremelanotide with tirzepatide on reducing body weight over just tirzepatide alone.
Patients will be treated with weekly tirzepatide for four weeks, having eligibility confirmed and then randomized to one to four treatment arms, which consist of weekly and daily study drug, including weekly tirzepatide and daily bremelanotide. Patients will undergo multiple assessments of safety and efficacy to help profile the effectiveness of bremelanotide in treating general obesity as a stand-alone 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 melanocortin-4 receptor peptide agonist as well as small molecules for the treatment of obesity and weight loss maintenance. Our new MCR4 receptor peptide agonists 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 agonist to treat various male and female sexual dysfunctions has led to the development of a novel product that is a co-formulation of bremelanotide and a phosphodiesterase-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 PDE-5 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 bremelanotide coformulated with the PDE-5 inhibitor for the treatment of erectile dysfunction in patients that are nonresponsive to PDE-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 calendar 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 in ulcerative colitis patients. The study is nearly completed enrollment and we expect data from the interim analysis later this quarter. In support of the oral PL8177 program, our preclinical studies demonstrated that treatment with oral PL8177 causes disease 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 differentiated 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, other ocular programs in glaucoma and retinopathies, and our ulcerative colitis program. Upcoming milestones and activities for our novel and differentiated programs include the following: For the MCR4 obesity program, we want to complete the Phase II study evaluating the coadministration of bremelanotide and tirzepatide, and we expect to have the data reported out in the first quarter of calendar 2025. We also are on track to advance our selective MCR4 long-acting peptide agonist through first-in-human studies and positioning the program for a Phase II dose-ranging efficacy during calendar year 2025. For our dry eye disease program, we want to start and complete the Phase III trials MELODY-2 and MELODY-3, with data expected by calendar year-end 2025.
We also 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 pharmacokinetic study started and completed in the first half of calendar year 2025 and begin patient recruitment in a Phase II/III 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 licensing of our major programs as well as our earlier pipeline programs. Steve and I, and the whole Palatin team are extremely excited and enthusiastic about the potential of these programs to bring novel, innovative treatments to improve patient lives and address significant unmet medical needs. I'll now turn the call over to questions.
分析師問答
Certainly. The floor is now open for questions. Your first question is coming from Joe Pantginis with H.C. Wainwright. Please pose your question. Your line is live.
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. I wanted to talk about the benchmarks of success for the study. Are you looking for a minimum or limit of weight loss to see to move to the next stage? What impacts on lean muscle mass? Hopefully, you could share that with us as well as what are you looking to do to eliminate or alleviate or mitigate some of the pigmentation issues?
Sure. There are several points to discuss regarding the expectations for the current Phase II trial where we are utilizing bremelanotide alongside tirzepatide. The key question is whether there is an additive effect, which could mean various outcomes in terms of weight loss benefits. Our primary analysis will compare the results of the combined treatment against tirzepatide used alone, aiming for a measurable or significant difference. It’s important to note that these patients are not undergoing long-term treatment, so anticipated weight losses will range between 2% and 5% over four weeks, rather than the higher percentages like 10% or 15%. We expect to observe an additive effect based on our trial design and our expectations. While this study isn’t designed to produce extraordinary results, we are optimistic about seeing a clear indication that the two treatments work together effectively.
Got it. Got it. And the pigmentation?
Skin darkening associated with the first generation of MCR4 agonists, such as bremelanotide, is primarily caused by activity against the melanocortin-1 receptor. While this may not pose a problem with short-term use, it can become an issue for patients with chronic use, particularly those who are obese, as they typically dislike the skin darkening effect. To address this, next-generation compounds that have minimal MCR1 activity are necessary. Through years of research in this area, we have successfully developed compounds that show significant separation between the two receptors, with many being inactive at MCR1. Therefore, we do not anticipate any skin darkening with these compounds. Regarding peptide development, when we consider small molecules, the pharmacophore is much smaller and is highly selective for MCR4, with no MCR1 activity.
No, that's helpful. Thanks. Yes. 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 looking forward to the start of these programs. So I guess do you think or 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-1? Are they different? And how would they look to in assessing the primary endpoints in the end?
Sure, let’s go through this step by step. The symptom is the same as what was used in MELODY-1. We're transitioning from lissamine green to inferior corneal fluorescein staining since all the fluorescein stains showed significant results at the two-week mark in MELODY-1. Inferior corneal fluorescein staining is a more reliable indicator because it is widely accepted in studies related to dry eye disease. We have alignment with the FDA on using both methods in the study. Regarding our readiness to proceed, we've completed the necessary protocols, and the statistical analysis plan is ready. The contract research organizations are hired and prepared. We are essentially ready to move forward as soon as we secure the necessary funding. As for our progress on that front, we have received strong interest from potential corporate partners. Previously, many of these entities were waiting for the results of the Type C meeting.
Now that those results are available, we are re-engaging in discussions. We are optimistic about reaching a licensing agreement or another type of transaction. Additionally, we have seen encouraging engagement from larger funds interested in possibly financing the Phase III program. We are actively pursuing opportunities from two different angles. I acknowledge I may have taken some of Steve's points, as he is leading these discussions, but overall, we are quite satisfied with the advancements we are making.
Well, it's good to hear about the optionality and thanks for the details, Carl.
Your next question is coming from John Newman with Canaccord Genuity. Please pose your question. Your line is live.
Good morning. Thanks for taking the question. Question here for Carl. The question is, do you see the potential to co-formulate some of your MCR4 agonist with drugs like tirzepatide? 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.
Sure. Yes. 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.
Okay, great. Thank you.
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.
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 this is, 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, quarterly calls, and presentations at various scientific and investor meetings. That being said, hope all of you have a great day and we look forward to keeping you updated. Thank you.
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.