Q4 2024 Palatin Technologies Inc Earnings Call
Speaker Change: Greetings. Welcome to Palatins 4th Quarter at fiscal year end 2024, Operating Results Conference Call. At this time, all participants are in a list and only mode. A question and answer session will follow the formal presentation.
Operator: In 2024, operating results conference call. At this time, all participants are in a listen-only mode.
Operator: 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.
Speaker Change: If anyone should require operator assistance during the conference, please press stars 0 on your telephone keypad.
Operator: Before we begin our remarks, I would like to remind you that statements made by Palatin are not historical facts; they 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.
Speaker Change: As a reminder, this conference call is being recorded. Before we begin our remarks, I would like to remind you that statements made by Paletin are not a historical fact and may be forward looking statements.
Speaker Change: 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.
Speaker Change: Please consider such risk and uncertainty carefully in evaluating these four-word-looking statements by Palatins' prospects.
Operator: 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.
Speaker Change: Now I would like to turn the call over to our host, Dr. Carl Spana, President and Chief Executive Officer of Palatins. Please go ahead.
Carl Spana: Thank you.
Carl Spana: Good morning and welcome to the Palatin Year End Fiscal 2024 call. I'm Dr. Carl Spana, CEO and President of Palatin.
Speaker Change: Thank you. Good morning and welcome to the Paladin year end of the school 2020, four calls. I'm Dr. Carl Spana, CEO and President of Paladin. With me on the call today's D. Wille, Paladin Chief Financial Officer and Chief Operating Officer.
Carl Spana: With me on the call today, Steve Will, Palatin Chief Financial Officer and Chief Operating Officer.
Carl Spana: I'll turn the call over to Steve, and he'll give the financial update.
Stephen Wills: Thank you, Carl. Good morning. Good afternoon, everyone.
Speaker Change: I'll turn the coil over to Steve and he'll give the financial update.
Steve: Thank you, Carl, good morning, good afternoon everyone.
Stephen Wills: Before reviewing the financial results, I have a few other corporate items to highlight. Regarding Vileese, Remelana Tide Injection, a commercial product Palatin developed for hyperactive sexual desire disorder or HDD. Palatin closed on an asset sale to Co-Set Pharmaceuticals for up to 171 million in December 2023. Terms included 12 million out-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 Remelana Tide for obesity and male treatment indications.
Steve Wille: Before reviewing the financial results of a few other corporate items to highlight.
Speaker Change: We're guarding by LEC, we're in the land of tight injection, a commercial product, palletant developed for hyperactive sexual desire disorder or HSDD.
Speaker Change: Paladin closed on an asset sale to co-set pharmaceuticals for up to 171 million in December 2023.
Speaker Change: Terms included 12 million out front, plus potential milestones of up to $159 million based on annual net sales ranging from $15 million to $200 million.
Speaker Change: Importantly, Palatine retains rights to and use a brimalanotide for obesity and male treatment indications.
Stephen Wills: Regarding financing during 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 Vileese, net of expenses, allowances, and accruals, and license and contract revenue. Persuading to the completion of the sale of Vileese rights for female sexual dysfunction to Co-Set 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, 2023, gross product sales were 4.1 million and net product revenue was 1.8 million.
Speaker Change: We're guarding fine-assings during fiscal year-ended June 30, 2024, Palatins raised total gross proceeds of 21 million in registered direct and warrant inducement offerings.
Speaker Change: We're Gardening.
Allison: Allison's fourth quarter and fiscal year ended June 30, 2024 financial results.
Allison: Total revenue consists of gross product sales of LEC, native expenses, allowances and accruals and licensing contracts revenue.
Speaker Change: For so into the completion of the sale by DC rights for female sex with dysfunction to cassette pharmaceuticals in December 2023, again for up to 171 million. Paladin did not record any product sales for the fourth quarter ended June 30, 2024.
Speaker Change: For the fourth quarter ended June 30th, 23 grows products sales for 4.1 million and that product revenue was 1.8 million.
Stephen Wills: Vileese 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.
Speaker Change: By these two gross product sales through Pharmacy Distributors for the fiscal year ended June 30th, 2024, where 8.9 million with net product revenue of 4.5 million.
Speaker Change: Comparative gross product sales of 12.5 million with net product revenue of 4.9 million for the prior fiscal year.
Stephen Wills: here. Total operating expenses were $8.7 million for the fourth quarter and 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, monocortin receptor programs, and, secondarily, the elimination of selling expenses related to Valisi. 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 of Valisi, and secondarily, the elimination of related selling expenses. Regarding cash lows, Palatin'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.
Speaker Change: Total Operating Expenses were 8.7 million for the full quarter and at June 30, 20, 24, compared to 12.6 million for the comparable quarter last year.
Speaker Change: The decrease was mainly the result of less suspending on our MCR, minor court receptor programs, and secondarily the elimination of selling expenses related to my leasy.
Speaker Change: Total operating expenses for the fiscal year ended June 3, 2024, for 27 million, compared to 37.3 million for the prior fiscal year.
Speaker Change: This decrease was mainly due to the 7.8 million gains recognized on the sale by LEC and secondarily the elimination.
Speaker Change: I'm related selling expenses.
Speaker Change: Regarding cash flows, Palatins NetCash used in operations for the quarter-ended June 30, 2024, was $6.5 million, compared to NetCash used in operations of $9.6 million for the same period in 2023.
Stephen Wills: 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 30, 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 the 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 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.
Speaker Change: This decrease in net cash use in operations is mainly due to the decrease in operating expenses and secondarily to working capital changes.
Speaker Change: Calutons NetCash using operations for the fiscal year ended June 30, 2024, was 31.5 million, compared to NetCash using operations of 29.3 million for the same period of 2023.
Speaker Change: This increase in that cash use in operations versus result of working capital changes and increased payments made related to inventory purchase commitments.
Carlton: Carlton's net loss for the quarter, and fiscal year added 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.
Stephen Wills: Variances were covered above under the revenue and operating expenses. Regarding our cash position, as of June 30, 2024, Palatin's cash and cash equivalence were $9.5 million, compared to cash and cash equivalence of $10 million as of March 31, 2024, and $8 million with $3 million in market of securities as of June 30, 2023.
Carlton: Variances were covered above under the revenue and operating expenses.
Speaker Change: We're guarding our cast position as of June 30, 2024, Palatins Cache and Cashew Quilvins were 9.5 million.
Speaker Change: Compared to cash and cash equivalents of 10 million as of March 31, 2020, and 8 million with 3 million in marketable securities as of June 30, 2023.
Stephen Wills: 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 with the same programs that Palatin is advancing.
Palatine: We, Palatine, is actively engaged with multiple parties for potential funding sources, for future operating cash needs.
Palatine: Consisting of both business development, efforts.
Palatine: and other potential collaborators, including entities involved with the same programs that Palatins is advancing.
Stephen Wills: Thank you, and I'll now turn the call back over to Carl. Thank you, Steve.
Palatine: Thank you, and I'll now turn the call back over to Carl.
Carl Spana: Fiscal 2024 was an exciting year for Palatin, with significant growth in all of our pipeline programs. Results confirmed that targeting the Milano-Courtney system can result in safe, effective, and differentiated therapeutics that can improve patient lives and address unmet market needs. Today, I will view some of the significant achievements for each of our therapeutic areas. Since Steve has already covered the sale of Ilysee to CoSET, 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, Palatin's topically administered product with treating the signs and symptoms of dry Ilysee.
Carl Spana: Thank you Steve.
Carl Spana: 224 was an exciting year for Paladin, with significant growth in all of our pipeline programs.
Carl Spana: Results confirmed that targeting the malanocorn system can result in safe, effective, and differentiated therapeutics that can improve patient lives and address unmet market needs. Today I will view some of the significant achievements for each of our therapeutic areas.
Carl Spana: I'm going to move on to start with some of our Oculus programs.
Carl Spana: We have multiple after-the-programs that have made significant progress over the past year. PL-964-3's palsin's topically administered product for treating the science and systems of dry eye disease. We successfully completed the first Phase 3 trial, Melody One, and now surpasses results earlier in the year.
Carl Spana: We successfully completed the first phase 3 trial, Melody 1, and announced about the results earlier in the year. Current FDA-approved treatments for dry eye disease have three significant problems that limit their utility. They have four ocular tolerability, blackboard 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.
Speaker Change: Curn FDA approved treatments for dry agencies have three significant problems that limit their utility. They have four aquatolability, blackboard efficacy, and they take a long time.
Speaker Change: to have symptom relief. The results of Melody One clearly demonstrated that TL9643 is a truly differentiated treatment for dry eye disease that solves the three main problems of current treatments.
Speaker Change: The PL-943 Melody 1 trials showed that PL-9643 had excellent aquatolobility, broad efficacy in multiple signs and symptoms, and demonstrated efficacy as early as two weeks.
Carl Spana: With this emerging product profile, PL9643 has the potential to be the leading treatment for dry eye disease. In summary, in the Melody 1 Phase 3 trial, results compared to view control included the following. PL9643 achieved statistical significance for the co-primary endpoint of ocular pain in seven of the secondary symptoms and endpoints, including eye dryness and ocular discomfort. Through 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 forcing staining, which is a sign, which we have an agreement with the FDA that this will be the primary sign endpoint for the next phase 3 trial, and PL9643 also achieved statistical significance at the two-week time point in Melody 1.
Speaker Change: This is a Mergey Product Profile, the on94-3 has a potential to be the leading treatment for dry identities.
Speaker Change: In summary, in the melody one-faced retrial results compared to the control included the following.
Speaker Change: Bill 964-3E-Cheese, statistical significance for the co-primerary endpoints of ocular pain in seven of the secondary symptoms and points, including eye dryness and ocular discomfort. Through the best of our knowledge, no FDA approved treatment for dry disease as shown as broad effect on the symptoms of dry eye disease.
Speaker Change: For a very colonial forcing staining which is a sign, which we have a agreement with the FDA. This will be the primary sign endpoint for the next phase three trial and TL943 also achieved statistical significance at the two-week time point in that what you want.
Carl Spana: PL9643 positive effects on the signs and symptoms of dry eye disease were rapid, which efficacy had two weeks after starting treatment, and they continued 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 shows that a lack of efficacy in poor tolerability, such as burning, blurry vision, bad taste, stinging, because of a significant amount of patient dissatisfaction and high discontinuation rates. In recent sightseeing meetings, the FDA agreed with our plans 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.
Speaker Change: Bill 94-3 positive effects on the science systems of dry identities were rapid with advocacy at two weeks after the story in treatment and they continue to improve over the 12 weeks of the treatment.
Speaker Change: The online support 3 has excellent oscillatory mobility with no subjects that's continuing the study due to an ocular adverse event.
Speaker Change: Data for Approved 5G Treatment shows that a lack of efficacy in poor tolerability such as burning, burry vision, bad taste, stinging, is literally significant amount of patient dissatisfaction and high discontinuade integration rates.
Speaker Change: The recent sightseeing meeting the FDA agreed with our plans for the remaining activities required to file a new drug application with the FDA for approval of PL-9643 as a treatment for the signs and symptoms of dry disease.
Carl Spana: Specifically, we have FDA agreement on our protocols, a number of subjects, the primary sign and symptom endpoints, and our statistical analysis plan. We are ready to complete the PL9643 Phase 3 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.
Speaker Change: Specifically, we have FDA agreement on our protocols, a number of subjects, the primary sign and system S point and our statistical analysis plan.
Speaker Change: We're ready to complete the PL-943 Phase 3 program with all remaining clinical studies if you can stop getting completed in Calgary Year 2025 and anticipated NDA filing in the first half of Calgary year 2020-26.
Carl Spana: Our two other off of the programs also made substantial progress in fiscal 24. PL9588 is our topically administered treatment and development to treat glaucoma. In the last year, we completed a comprehensive evaluation of PL9588 in multiple preclinical glaucoma models. The results indicate that PL9588 not only lowers interocular pressure but also provides direct neuroprotection. Direct neuroprotection of the optic nerve is a significantly differentiating factor over current treatment 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 close damage to the retina and can lead to vision loss.
Speaker Change: 2 other off-the-programs also made substantial progress in fiscal 24th.
Speaker Change: Peel 9588 is our topically administrative treatment in the development to treat glaucombe.
Speaker Change: The last year we completed a comprehensive evaluation of PL-9588 in multiple preclinical Oklahoma models. Results indicate that PL-9588 not only lowers into awkward pressure but also provide direct neuroprotection.
Speaker Change: Direct neuroprotection of the optic nerve is a significantly differentiating factor over current treatments for glaucoma. And PO9 588 is now ready to begin the I&D enabling studies with clinical trials beginning in calendar year 2025.
Speaker Change: Wettin' off the piece or a broad category of aqua diseases that close damage to the retina and can be division loss.
Carl Spana: The global market for treatments is estimated to be approximately 30 billion by 2030. PO9654 is on novel differentiated treatment for various retinopathies. In fiscal 2024, we completed an extensive evaluation of PO9654 in multiple models of retinal disease. PO9654 demonstrated the ability to preserve vision, protect the retina from damage, and, in economic analysis, positively affected multiple pathways that are known to be involved in the progression of retinal diseases. You also made some sense of progress in the development of an intributual injectual formulation, and PO9654 is now ready to enter into 90 enabling studies starting in calendar 2025.
Speaker Change: The Global Market for Treatments is estimated to be approximately 30 billion by 2030. PO9654 is on novel differentiated treatment for various retinopathy. In fiscal 2024, we completed an extensive evaluation of PO9654 in multiple models of retinal disease.
Speaker Change: The O9654 demonstrated the ability to preserve vision, protect the retina from damage, and an economic analysis positively affected multiple pathways that are known to be involved in progression of retinal diseases.
Speaker Change: You also made substantial progress in the development of an individual injectable formulation in 2006 and 2004 is now ready to enter into IND enabling studies starting in calendar 2025.
Carl Spana: I'll move on to our NCR4, a lot of going to floor receptor of BC programs. Drug treatment for a BC 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. The closer the important role that the NCR4 receptive plays in regulating stored energy and food intake, we strongly believe that NCR4 agonists will be an important part of the future of a BC treatment and weight loss management. Palson says a long-standing research effort to develop NCR4 therapeutics that's electively activate NCR4 receptor as treatments for a BC and weight loss maintenance.
Speaker Change: Now I'll move on to our NCR-4, I'm about to go to the floor receptor obesity program.
Speaker Change: Drunk treatment for obesity is now established and growing rapidly.
Speaker Change: We have legal drugs with differing mechanisms of action that affect weight loss and importantly weight loss maintenance are needed.
Speaker Change: The closing of the important role of the CR-4 receptor plays and regulating stored energy and food intake, we strongly believe that the CR-4 agonists will be an important part of the future of a BC treatment and weight loss management.
Palson: Palson has a long standing research effort to develop a lot of cord and therapeutics that's electively activate MCF4 receptor.
Carl Spana: With our extensive experience in the design and development of NCR4 agonists for treating a BC, including two clinical studies previously completed and published, we are well-positioned to be a leader in the development of the NCR4 and base therapeutic flexible weight loss and weight loss maintenance. As I'm sure you all know, increase in base therapeutic, such as zephounds, emigoby, all the primary treatment for a BC and they have demonstrated expressive growth. However, up to 67% of patients that begin treatment discontinued in the first year, mainly due to side effects and applied to effect, and they often quickly be gained away if they've lost.
Speaker Change: A stream is for a busy and weight loss maintenance, with our extensive experience in the design and development of monochrome magnets for treating a busy, including two clinical studies previously completed and published. We are well positioned to be a leader in the development of a monochrome based therapeutic for weight loss and weight loss maintenance.
Speaker Change: As I'm sure you all know, increase in base therapeutics such as ZEPBounds, Immigobie, all the primary treatment for obesity and they have demonstrated aggressive growth.
Speaker Change: 116% of patients have to get treatment discontinued in the first year, mainly due to side effects and a plateau effect and they often quickly be getting the way they've lost.
Carl Spana: Additional approaches are needed to provide patients in opportunity to safely and tolerably reach their weight loss goals. Research by Palson and academic groups indicate that combining NCR4 receptor agonists with a glypholone receptor agonist like zephetyide 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 MC4 or receptor agonist with a glypholone receptor agonist, we initiated a base two clinical study in August. In this study of diabetes subjects, we'll co-administer the MCF4 receptor agonist pre-malanatide, along with zephetyide.
Speaker Change: Additional approaches are needed to provide patients in opportunity to safely and tolerably reach their weight loss goals.
Speaker Change: Research by Palton and Academic Groups indicate that combining NCO4 receptor agonists with a glypholone receptor agonist like Doseptotide may result in synergistic effects on weight loss, allowing for increased or sustained weight loss at lower and better tolerated doses.
Speaker Change: To investigate the potential added in the effects of combining MC4R receptor agonist with a clip-on receptor agonist, we initiated a Phase II clinical study in August. In this study of these subjects, we'll call it Minister, the MCF4 receptor agonist, pre-malanatized along with receptor type.
Carl Spana: The study is designed to roll approximately 60 of these subjects at four sites in the US. The primary endpoint is to demonstrate the safety and increased efficacy of the co-administration of pre-malanatide with zephetyide on reducing body weight over just zephetyide along. Pays as we'll be treated with weekly zephetyide before weeks, having eligibility confirmed and then randomized to one of four treatment arms, which consists of weekly and daily study drugs, including weekly zephetyide and daily brimline. Pays as we want to go multiple assessments of safety and efficacy to help profile the effectiveness of pre-malanatide in treating general obesity at a standalone treatment or in conjunction with zephetyide.
Settie: Settie's design general Oprochney 60 abuse subjects at four sites in the U.S.
Settie: The primary endpoint is to demonstrate the safety and increased efficacy of the co-ministration of Rimalada Tides with the appetite on reducing body weight or just as appetite a lot.
Speaker Change: Paces will be treated with weekly to step aside before weeks.
Speaker Change: I was having eligibility confirmed and randomized to one of four treatment arms, which consists of weekly and daily study drug, including weekly Thursdays and daily briefings.
Speaker Change: Pages want to go multiple assessments of safety and efficacy to help profile the effectiveness of the free-mallowed side in treating general obesity at a standalone treatment or in conjunction with GLP1 therapy.
Carl Spana: Pantginis. 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 monocortin-4 receptor peptide agonist as well as small molecules. For the treatment of obesity and weight loss maintenance, our new MCF-4 receptor peptide agonist are highly selective for the MCF-4 receptor versus the MCF-1 receptor and are not anticipated to have skin darkening as a side effect. They are designed using a proprietary technology to have once a week no-sing. 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.
Speaker Change: This study will completely enrolled this quarter with data in 1st quarter of Caledor, 2025.
Speaker Change: We have also developed next generation highly selected clinical report receptor peptide agonist as well as small molecules.
Speaker Change: The treatment of obesity and weight loss maintenance are new MCF-4 receptor peptide Agnes are highly selective for MCF-4 receptor versus MCF-1 receptor and are not anticipated to have skin darkening of the side effect. They are designed using a proprietary technology to have one week dosing.
Speaker Change: We anticipate final lead selection in the first quarter of Canada's 2025 with an IND and first human clinical studies in the second half of Canada's 2025.
Carl Spana: Now we move on to homework and sexual dysfunction. Our research in the use of monocortin agonist treat various male to female sexual dysfunction as led to the development of a novel product that is a co-formulation of remalanatide and a phosphorous or a spivin inhibitor; those are compounds such as Viagra and Cialis. We believe this product could be an ideal treatment for the 35 percent of men with a rectile dysfunction that have an analytical response to PD-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 remalanatide co-formulated with the PD-5 inhibitor for the treatment of rectile dysfunction in non-patients that are non-mysmosis to PD-5 inhibitor model therapy.
Speaker Change: Now, we'll move on to our conceptual dysfunction.
Speaker Change: Our research in the use of malnacord and agonist retreat varies male to female sexual dysfunction as led to the development of a novel product that is a co-formulation of remalinated side and a fostered nursery, spine inhibitor, those are compounds such as biagre, and in Seattle.
Speaker Change: We believe this product could be an ideal treatment for a 35% of men as a right-to-all dysfunction that have an inadequate response to PD-5 and Hitted of Therapy.
Speaker Change: We space and have limited options and represent a large, underserved market.
Speaker Change: We have initiated a development and clinical program for the evaluation of the remelatotide co-formulator with the P5 inhibitor for the treatment of rectal dysfunction in non-pacens that are non-missive to P5 inhibitor model therapy.
Carl Spana: If one of the kinetics studies is expected to initiate in the first half of calendar 2025 and patient recruitment in a phase 2 clinical study is anticipated in the second half of calendar 2025 with top-line results in 2026.
Speaker Change: The Department of the United States is expected to initiate in the first half of the calendar 2025 and patient recruit in a phase two clinical study is anticipated in the second half of the calendar 2025 with top line results in 2026.
Carl Spana: The final program we want to cover is a PL-8177 for ulcerative colitis, which is in a phase 2 study, evaluating oral PL-8177, a selective monocortin-1 receptor agonist and ulcerative colitis patients. The study is nearly completed in a moment when we expect data from the intraminalysis later this quarter. In support of the oral PL-8177 program, our clinical pre-clinical studies demonstrating that treatment with oral PL-8177 causes disease colitis 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 and treating colitis in inflammatory bowel diseases.
Speaker Change: and John Wills.
Speaker Change: The final program I want to cover is up TL 8177 for also the Colitis, which is in a Phase 2 study, evaluating oral TL 8177, a selective and inadequate and one receptor of agonists, and also to collect as patients.
Speaker Change: Study is nearly completed enrollment and we expect data from the interminalysis later this quarter.
Speaker Change: and support of the Oral Peel 8177 program.
Speaker Change: from our Clinical Pre-Cledical Studies, demonstrating that treatment with oral PL-8177 causes disease colonists to improve toward a healthy state and to resolve inflammation.
Speaker Change: is all the information rather than blocking it provides the possibility of efficacy coupled with significantly different safety and treating colitis in inflammatory bowel diseases.
Carl Spana: 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 dry eye disease programs or other ocular programs in glaucoma and retinopathy and ulcerative colitis program.
Speaker Change: 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 dry eye disease programs or other roster programs in glaucoma and retinographities and our OASIS clientes program.
Carl Spana: Upcoming milestones and activities for our novel and different project programs include the following. For MCR-4-BC program, we want to complete the phase 2 study evaluating the co-administration of remalanted side interseparatide. And we expect to have that data reported out in the first quarter of calendar 2025. We also want to track the advance of our selective MCR-4 long-acting peptide agonist through first in human studies and focusing in the program for a phase 2 dose-ranging efficacy during calendar year 2020. For our dry eye disease program, we want to start and complete the phase 3 trials Melody 2 and Melody 3 with data expected by calendar year 2025.
Speaker Change: Acoming milestones and activities for our novel and different programs include the following.
Speaker Change: 4th year for B.C. program.
Speaker Change: We want to complete the Phase 2 study evaluating the co-administration of Remalada's side Intercepticide and we expect to have that data reported out in the first quarter of Canada to 2025.
Speaker Change: We also want to track to advance our selected MCF4 long acting peptide agonist who first in human studies and is in the program for a phase two dose ranging efficacy.
Speaker Change: 3, turn Calvary year 2025.
Speaker Change: For our Dryad Disease Program, we want to start and complete the Phase 3 trials, Melody 2 and Melody 3 with beta, expect a bite, count on year and 2025 and also we want to implement all manufacturing activities needed to file a new drug application with the FDA in the first half of Calvit 2026.
Carl Spana: 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 a mail section of the function program, we want to get on, probably the next study started and completed in the first half of calendar year 2025 and begin patient recruitment in a phase two, three study, which is anticipated to start in the second half of calendar 2025.
Speaker Change: To facilitate moving this program forward, we are in active discussions with potential corporate collaborators and funding partners.
Speaker Change: or Mailfax with Function Program.
Speaker Change: We want to get a problem with the next study, starting completed in the first half of the calendar year 2025 and begin patient recruitment in a phase 2-3 study, which is anticipated in the second half of the calendar 2025.
Carl Spana: 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, in 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.
Speaker Change: Importantly, we have also increased our business development activities to support the licenses of our major programs as well as our earlier pipeline programs.
Speaker Change: Stephen 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 addressing living in unmet medical needs.
Operator: We will now turn the program over to questions. Certainly, the floor is now open for questions. If you have any questions or comments, please press star one on your phone at this time. We ask that while posing your question, you please pick up your handset. It's a listening on a speaker phone to provide optimum sound quality. Please hold just a moment while we pull for questions.
Speaker Change: and we'll now turn the quote over to questions.
Speaker Change: Certainly, the floor is no open for questions. If you have any questions or comments, please press star one on your phone at this time. We ask that while posing your question, you please pick up your handset if a listening on a speakerphone to provide up to mom's sound quality. Please hold just a moment while we pull for questions.
Joseph Pantginis: Your first question is coming from Joe Pantginis with Ichi Rainwright. Please pose your question. Your line is live.
Speaker Change: Your first question is coming from Joe Pantina's with Ichi Rainway. Please pose your question. Your line is left.
Carl Spana: Hey guys, thanks for the details, and thanks for taking the question. So two sets of questions. First, on your weight loss program, what GLP1, 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 you are looking to do to eliminate, alleviate, or mitigate some of the pigmentation issues? That's a number of things, Joe. So let me talk about what the expectations are for the current phase to trial or reducing pre-malanetide and conjunction which was appetite.
Speaker Change: Hey guys, thanks for the details and thanks for taking the question. So two sets of questions. First on your weight loss program, which you help you one, wanted to talk about the benchmarks of success for the study. Are you looking for a minimum or limit for a 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 mitigate some of the pigmentation issues.
Speaker Change: Alright, so that's a number of things, Joe. So let me talk about what the expectations are for the current phase to trial, where we're using pre-malanatized incongjunctum, which was epitide. The main primary question there is, is there an antiv effect, and that can be 101 equals 2, 101 equals 3.
Carl Spana: The main primary question there is, is there an additive effect? And that can be 101 equals 2, 101 equals 3, etc. So the primary analysis will be the comparison of the co-administered versus Terseptidal loan. And there's no set; what we're looking for is essentially a measurable or significant separation. Now, these patients are not on one-term treatments, so their weight losses are not going to be 10 to 15 percent over four weeks. You're going to be in that 2 to 3 percent range, 2 to 5 percent range. We want to 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.
Speaker Change: etc. So the primary analysis will be a comparison of the co-administered verses through the epitide alone.
Speaker Change: and there's no set we're looking for is essentially a measurable or significant separation.
Speaker Change: Now, these patients are not on one term treatment, so, you know, their weight losses are not going to be, you know, 10 to 15 percent, you know, over four weeks. You're going to be in that 2 to 3 percent range, 2 to 5 percent range. We want to see an additive effect.
Speaker Change: which we think that's on the design and based on what we expect we're going to see we should be able to achieve.
Carl Spana: So again, it's not, you know, we're not using, you know, again, there's not a long-term study where you're going to expect explosive numbers, but we should really see a very clear signal from the study that these two are additive or synergistic. Got it.
Speaker Change: 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.
Carl Spana: In the pigmentation. So skin darkening with the first generation of MCR4 agonists, there were actually several approved pre-malanetide being one of them, is driven by activity against the Melanocortin 1 receptor. And in the case of short-term use, it's, 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 who don't like to, 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 you'll, based on, you know, the extensive number of years I've been working in this field, we've been able to achieve that.
Scott: Scott got it in the pigmentation. So that's, so, skin darkening with the first generation of MCF4 Agnes, there are two, there are actually several approved, bring a lot of type being one of them, is driven by activity against the Atlantic one receptor.
Speaker Change: and in the case of short-term use, it's not an issue, but when we move on to more chronic use in obese patients.
Speaker Change: It can be an issue for patients that don't like to get, they don't like the skin darkening. So in order to do that, you need next generation compounds that are really devoid of Mcerer One activity.
Speaker Change: and you'll based on the extensive number of years I've even worked in this field, we've been able to achieve that. So you'll compound that we are, you know, in final evaluation, have substantial separation between the two receptors. In fact, many of them are not non-active at MCR1, so we don't expect any skin darkening.
Carl Spana: So, you know, compounds that we are, you know, in final evaluation have substantial, substantial separation between the two receptors. In fact, many of them are not 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 phlomical floor is much smaller and it's really highly selective MCR4; it doesn't have any MCR1 activity at all.
Speaker Change: with those compounds and then those are on the peptide front and when we think about small molecules that flammic floor is much smaller and it's really the highly selective MCR4 doesn't have any MCR4 when I see it all.
Carl Spana: 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? 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 end points in the end? Sure. So I'll go, I'll kind of work backwards.
Speaker Change: I just wanted to switch to the dry eye program because I think it's great to 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 much are your discussions on business development, but more from a logistical standpoint, the guidance from the FDA just wanted to make sure are these same signs and symptoms from Melody One are they different and how would they look to in assessing the primary end points in the end.
Carl Spana: So the symptom is the exact same one that was used in Melody 1. The sign is we're moving from listening to green to an inferior corneal forcing staining because all of the forcing stains reach significance at the two-week time point in Melody 1. And inferior corneal forcing staining is just a better sign than that, meaning that it's generally accepted sign that it's used in dry eye study 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, you know, pending, assuming the appropriate finances would have you, the protocols are together, SAPs together, you know, the TROs hired and done so, and we're really pretty much ready to go forward as soon as we can, 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, you know, we're in, I would say, we've had very good interest from a corporate standpoint. There was a lot of, you know, pending, you know, a lot of those entities were not going to discussions waiting for the results of the type C meeting. Now that we have those, we re-engage those entities and, you know, we're in the middle of discussions with them and we're moving toward, and hopefully moving towards what will be a conclusion of a licensing deal or some sort of transaction.
Speaker Change: John.
Speaker Change: So, I'll kind of work backwards. So, the symptom is the exact same one that was used to melody one.
John: The sign is we're moving from listening green to an inferior point of forcing staining because all of the forcing stains reach significant at the two-week time point in melody 1.
John: and in fear of calling a forcing standing is just a better sign than that, and we're meaning that it's generally except a sign that that is used in drive to these studies.
John: So we're going with that, again we have concurrence with the FDA on the use of both of those in the study.
John: with regards to being ready to go, you know, pending, assuming probably finances and would have you, the protocols are together as they piece together.
Speaker Change: You know, the CRO's hired and done so I knew we were really pretty much this is ready to go forward, as soon as we can secure the appropriate funding and that kind of leads into your first part of your question, which was where are we?
Speaker Change: with that, and you know, we're in, I would say, we're, we've had very good interest from a corporate standpoint.
Speaker Change: There was a lot of pending entities were not going to discuss his waiting for the results of the type C meeting now that we have those, we re-re-engage those entities and...
Speaker Change: 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.
Carl Spana: In addition to that, you know, we've had some very good uptake more recently with discussions in larger funds that would be also interested in, you know, potentially funding the Phase III program and moving us forward as well, so we're really attacking it on two fronts, and obviously I've taken a little bit of a sneeze thunder because you've actually leased those discussions, but I think we've been pretty pleased with the progress we've been making.
Speaker Change: In addition to that, we've had some very good uptake more recently with discussions in larger funds that would be also interested.
Speaker Change: in the potentially funding the Phase 3 program, and moving us forward as well. So we're really attacking it on two fronts, and obviously I've taken a little piece thunder because you actually leave those discussions. But I think we've been pretty pleased with the progress we've been making.
Joseph Pantginis: Well, it's good to hear about the optionality, and thanks for the details, Carl.
Speaker Change: Well, it's good to hear about the optionality and thanks for the details, Carl.
John Newman: Thanks, Joe. Your next question is coming from John Newman with Canaccord Genuity. Please pose your question. Your line is live.
Joe Pantina: Thanks, Joe.
Speaker Change: Your next question is coming from John Newman with Cannecord Genuity. Please push your question, your line is life.
John Newman: Good morning, thanks for taking the question. Question here for Carl. Carl, the question is, do you seek a potential to co-formulate some of your MCR-4 agonists with drugs like Chisepatide?
John Newman: 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...
Carl Spana: The reason I'm asking is because there's obviously been a revolution in weight loss treatment, which has been fantastic with the GOP-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 GOP-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. Yes, sure. Yes, 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 ones and the stuff that we're working with. Along those lines, should be relatively easy to come up with formulations in which the two are combined.
John Newman: MCR4 agonist with drugs like chis-depatide. The reason I'm asking is because there's obviously been a revolution in weight loss treatment, which has been fantastic with the GOP-1s, but we do know that eventually some of those products at least.
John Newman: will be selected for price reductions, but one way to potentially...
Speaker Change: Dress that is to combine the GOP ones 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.
Speaker Change: Yes, so along those lines, we haven't yet done any of that work, however, I think it's highly feasible.
Speaker Change: and the other formulations for these compounds are pretty.
Speaker Change: Oh um
Speaker Change: These are pretty soluble compounds both at GOP ones and what stuff they were working with.
Speaker Change: So, along those lines, you should be relatively easy to come up with the formulations that we should do or combine. Of course, I say that's not being the guy who actually does the lab work, but I think from a regular standpoint, it should be relatively easy to do that together, together.
Carl Spana: 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.
Operator: Thank you. There are no additional questions in queue at this time.
Speaker Change: Okay, great, thank you.
Carl Spana: I would now like to turn the floor back over to Dr. Carl Spana for any closing remarks. Well, Stephen, 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 Alice for their insightful questions as well. We're very excited here.
Speaker Change: There are no additional questions in queue at this time.
Speaker Change: So now I like to turn the floor back over to Dr. Carl Spana for any closing remarks.
Speaker Change: Well, Stephen, I hope you all would like to thank all of you for listening to the Palettes in the year and fiscal 2024 call.
Carl Spana: I mean, for some company, we have a massive 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. Thank you, everyone.
Carl Spana: I'd like to thank the Alice for their insightful questions as well. We're very excited here. I mean, you know, for some of us, we have a managed amount of opportunity and we're really looking forward to where we can deliver over the next year and keeping you updated on our progress on your press releases and quarterly calls and presentations at various scientific and investor meetings.
Speaker Change: I think said, we'll all do have a great day and we look forward to keeping you updated. Thank you.
Operator: 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.