Cosette Pharmaceuticals, Inc.

DUBLIN--( BUSINESS WIRE )--The "Generic Injectables - Global Strategic Business Report" has been added to ResearchAndMarkets.com's offering. The global market for Generic Injectables was estimated at US$95.2 Billion in 2023 and is projected to reach US$206.8 Billion by 2030, growing at a CAGR of 11.7% from 2023 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. One of the primary drivers is the increasing incidence of chronic diseases globally, which has led to a heightened demand for injectable therapies. Conditions such as diabetes, cancer, cardiovascular diseases, and autoimmune disorders often require long-term or rapid-response treatments, and injectables are a preferred delivery method in these cases due to their fast-acting nature. As chronic diseases rise, especially in aging populations, the demand for affordable injectable medications continues to grow. Another significant driver is the advancement in biologics and biosimilars, which has expanded the range of complex injectables available in the market. As more biologic patents expire, opportunities for the introduction of biosimilar injectables increase, providing a lower-cost alternative to expensive branded biologics. Moreover, technological innovations in drug delivery systems, such as the development of prefilled syringes and autoinjectors, have made injectables more accessible to patients. These innovations support the trend towards home-based care and self-administration, reducing the burden on healthcare facilities. The global shift towards cost-effective healthcare solutions, combined with government initiatives to increase the use of generics, has further boosted the demand for generic injectables. Why Are Generic Injectables Gaining Such Immense Popularity Across the Globe? Generic injectables have emerged as a vital component of modern healthcare systems, offering cost-effective alternatives to branded drugs while maintaining the same efficacy and safety standards. With the increasing burden of chronic diseases like cancer, cardiovascular disorders, and diabetes, the demand for injectables has soared, particularly for treatments requiring quick, potent delivery. Generic injectables, being lower-priced versions of branded injectables, allow healthcare systems to treat more patients efficiently without compromising quality. Hospitals, clinics, and emergency care centers have increasingly integrated these generics into their treatment protocols to manage both acute and chronic conditions. The ability to quickly administer life-saving drugs, particularly in critical care settings, has made generic injectables indispensable, with their global demand continuing to grow year on year. Furthermore, advancements in drug delivery systems, including prefilled syringes and ready-to-use vials, have bolstered the adoption of generic injectables across various healthcare settings. Prefilled syringes and other single-use formats provide an extra layer of safety by minimizing contamination risks and ensuring accurate dosing. With their increasing availability in oncology, anesthesia, anti-infective drugs, and immunotherapy, the role of generic injectables in both treatment and prevention is expanding. Their ability to provide cost savings to healthcare providers while ensuring that patient outcomes are not compromised is a major reason for their accelerated adoption. What Role Do Technological Innovations Play in Expanding the Generic Injectables Market? Technological advancements have played a transformative role in driving the growth of the generic injectables market. Improvements in manufacturing technologies, such as continuous production and advanced sterilization processes, have increased the efficiency and scalability of generic injectables production. These innovations have reduced manufacturing costs while ensuring that production meets stringent regulatory standards. Additionally, advancements in biotechnology have enabled the development of complex generic injectables, including biosimilars, which are increasingly used to treat autoimmune diseases and various cancers. The growing use of biologics in modern medicine has opened up new opportunities for generic injectables manufacturers to provide lower-cost alternatives in this high-demand segment. The rise of automation and robotics in injectable production is also a critical factor. Automated systems improve precision in production, reduce human errors, and streamline the manufacturing process, making it easier for pharmaceutical companies to meet global demand. Furthermore, advances in packaging technologies, such as prefilled syringes and autoinjectors, make injectables more user-friendly, facilitating home care administration and reducing hospital visits. As healthcare shifts towards more patient-centered models, the development of self-administrable injectables is gaining traction, contributing to the expansion of the market. Report Features: Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2023 to 2030. In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa. Company Profiles: Coverage of major players in the Global Generic Injectables Market such as American Regent, Inc., Ascendia Pharmaceuticals, Aurobindo Pharma Ltd., Baxter International, Inc., Biocon Ltd. and more. Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments. Key Insights: Market Growth: Understand the significant growth trajectory of the Vials segment, which is expected to reach US$109.9 Billion by 2030 with a CAGR of a 12.7%. The Ampoules segment is also set to grow at 11.2% CAGR over the analysis period. Regional Analysis: Gain insights into the U.S. market, estimated at $20.0 Billion in 2023, and China, forecasted to grow at an impressive 15.0% CAGR to reach $43.7 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific. Key Attributes: Report Attribute Details No. of Pages 602 Forecast Period 2023 - 2030 Estimated Market Value (USD) in 2023 $95.2 Billion Forecasted Market Value (USD) by 2030 $206.8 Billion Compound Annual Growth Rate 11.7% Regions Covered Global Key Topics Covered: MARKET OVERVIEW Efficacy and Cost Benefits Continue to Drive Growth in Global Generic Injectables Market Global Economic Outlook Generic Injectables - Global Key Competitors Percentage Market Share in 2024 (E) Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2024 (E) Generic Injectables: Product Overview Recent Market Activity Influencer/Product/Technology Insights MARKET TRENDS & DRIVERS A Look into Growing Shift Towards Injectables Complex Injectables and Small-Volume Parenterals: A Challenging but High-Value Market Upcoming Patent Expirations of Key Branded Injectable Drugs Throw the Spotlight on Generics as a Cost-Effective Alternative, Opening Up New Market Opportunities Increasing Demand for Cost-Effective Healthcare Solutions Propels Significant Growth in the Generic Injectables Market Regulatory Incentives and Fast-Track Approvals for Biosimilars Strengthen the Business Case for Expanding Generic Injectable Offerings Expanding Geriatric Population and Rising Incidence of Age-Related Diseases Drive Strong Adoption of Generic Injectable Medications Technological Advancements in Injectable Drug Delivery Systems, Including Prefilled Syringes and Auto-Injectors, Sustain Long-Term Growth of Generic Injectables Surge in the Prevalence of Chronic Diseases, Such as Diabetes and Cardiovascular Disorders, Spurs Increased Demand for Generic Injectable Treatment Options Rise in Incidence of Cancer and Associated High Treatment Costs Drives Demand for Generic Injectable Treatments Growing Availability of Complex Biologics and Biosimilars Expands the Addressable Market Opportunity for Generic Injectables, Increasing Market Penetration Growing Preference for Home-Based Healthcare Services and Self-Administration Drives Demand for Generic Injectable Auto-Injectors and Other Patient-Friendly Solutions Rise of Infectious Diseases Drive Demand for Injectables Long-Term Mental Health Management Drives Growth Prospects Rising Demand for Affordable Alternatives to Branded Injectable Drugs Growth in Healthcare Expenditure Driving Demand for Cost-Effective Treatments Increasing Adoption of Generic Injectables in Hospitals and Ambulatory Settings Expansion of Generic Injectable Offerings in Oncology and Chronic Disease Management Surge in Demand for Injectable Antibiotics and Critical Care Medications Technological Advancements in Injectable Formulations for Improved Efficacy Growth in Outsourcing Injectable Manufacturing to Reduce Production Costs Expansion of Generic Injectables in Emerging Markets with Expanding Healthcare Access Increased Focus on Biologics and Biosimilar Injectable Products Rising Adoption of Pre-Filled Syringes and Auto-Injectors in Drug Delivery Development of Generic Injectables to Address Supply Shortages of Critical Medications Growth in Research and Development of Complex Injectables FOCUS ON SELECT PLAYERS: Some of the 43 companies featured in this Global Generic Injectables market report include American Regent, Inc. Ascendia Pharmaceuticals Aurobindo Pharma Ltd. Baxter International, Inc. Biocon Ltd. Biological E. Ltd. Bristol-Myers Squibb Company Cipla Ltd. Cosette Pharmaceuticals, Inc. Dr. Reddy's Laboratories Ltd. For more information about this report visit https://www.researchandmarkets.com/r/h7y985 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Obesity programs: Core focus on obesity includes exploratory co-administration BMT-801 study and two novel development drug candidates Phase 2 BMT-801 clinical study with MC4R agonist bremelanotide plus GLP-1/GIP dual agonist tirzepatide Patient enrollment completed October 2024 Topline results expected 1Q calendar year 2025 Multiple clinical trials targeted in calendar year 2025 with long-acting MC4R peptide and oral small molecule compounds General obesity, weight loss management, and rare MC4R pathway diseases like hypothalamic obesity Dry eye disease (DED) and other ocular programs, ulcerative colitis (UC), male sexual dysfunction, and diabetic nephropathy programs: Investment bank engaged as a financial advisor to explore strategic options for non-obesity programs Teleconference and Webcast to be held on November 14, 2024, at 11:00 AM ET CRANBURY, N.J., Nov. 14, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced operating and financial results for its fiscal first quarter ended September 30, 2024. "With the establishment of pharmacotherapy as the primary treatment for the millions of obese patients and the high discontinuation rate (67%) of obese patients on current therapies resulting from side effects and a weight-loss plateau effect in the first year, we believe our MC4R long-acting peptide and oral small molecule compounds could address the unmet needs and challenges of these treatments," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "We look forward to releasing topline data results from our Phase 2 BMT-801 clinical study of our melanocortin-4 receptor (MC4R) agonist, bremelanotide, plus a glucagon like peptide-1/gastric inhibitory polypeptide (GLP-1/GIP) dual agonist, tirzepatide, in the first quarter of calendar year 2025. Furthermore, we are excited to advance our obesity programs and start multiple clinical trials in 2025 aimed at treating general obesity, weight loss management, and rare MC4R pathway diseases like hypothalamic obesity." Dr. Spana noted, "We believe focusing on our core and most valuable programs in obesity is the right course of action for the long-term success of Palatin. We have retained an investment bank to conduct, explore, and evaluate strategic options for our non-obesity programs. At this stage, there has been significant interest in and ongoing discussions for our Phase 3 DED program, early-stage glaucoma and retina development programs, and our Phase 2 UC program from multiple parties." The MC4R pathway plays a key role in the regulation of energy storage and food intake. The novel MC4R selective agonists being developed by Palatin could potentially play a vital role in treating obesity as monotherapy and/or combination therapy. Program Updates and Anticipated Milestones Obesity Programs: Phase 2 BMT-801 clinical study for the co-administration of melanocortin agonist bremelanotide (MC4R) with tirzepatide (GLP-1/GIP dual agonist) in obese patients: Patient enrollment completed October 2024 The study enrolled approximately twice the target of 60 patients at four sites in the U.S, primarily due to strong patient demand and efficiency of the clinical trial sites Primary endpoint: Demonstrate the safety and increased efficacy of co-administration of bremelanotide with tirzepatide on reducing body weight Patients will be treated with tirzepatide-only for four weeks, have eligibility confirmed, then randomized to one of four treatment arms 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 Topline results expected in 1Q calendar year 2025 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT06565611 Presented a poster titled "Structural Modification Allows the Removal of Melanocortin Receptor 1 Agonism From Melanocortin Receptor 4 Agonists," at the 19th Annual Peptide Therapeutics Symposium in October 2024: MC4R selectivity significantly reduces potential for skin pigmentation Presented data on novel melanocortin-4 receptor selective oral small molecule PL7737 obesity program at ObesityWeek® 2024 in November 2024: Oral PL7737 significantly decreased food intake and body weight Novel MC4R selective long-acting peptide and oral small molecule agonists: Potential for monotherapy or combination (with a GLP-1 agonist) therapy Initiation of investigational new drug (IND) enabling activities expected to commence 1Q calendar year 2025 Filing of INDs anticipated 2H of calendar year 2025 Commencement of Phase 1 clinical studies targeted for 4Q of calendar year 2025 Ocular Programs (melanocortin receptor agonists): Phase 3 PL9643 clinical program for the treatment of dry eye disease (DED): MELODY-1 pivotal study successfully completed Statistical significance (p<0.025) met for co-primary symptom endpoint of pain Statistical significance (p<0.05) met for 7 of 11 secondary symptom endpoints at the 12-week treatment period Rapid onset of efficacy in multiple symptom endpoints at 2 weeks and continued improvement to 12 weeks with statistical significance (p<0.05) met Statistical significance (p<0.05) met for multiple sign endpoints, including 4 fluorescein staining endpoints at the 2-week treatment period Corneal fluorescein staining is used to measure corneal epithelial damage and reductions in corneal fluorescein staining with treatments like PL9643, indicating improvement in corneal health Excellent safety and tolerability profile MELODY-2 & MELODY-3 clinical studies Concluded positive Type C meeting with the FDA and reached agreement on sign and symptom endpoints for remaining two Phase 3 pivotal trial protocols Subject to funding, patient enrollment ready to begin 1Q calendar year 2025 Potential collaboration and funding discussions ongoing Glaucoma (PL9588) and retina (PL9654) development programs Development candidates ready for IND-enabling toxicology studies Glaucoma drug candidate shows lack of adverse events and potential for neuroprotection as differentiating factors Retina drug candidate provides potential differentiating factors Male Sexual Dysfunction Program: Historical data show that approximately 35% of men with ED have an inadequate response to PDE5i treatments, which represents a large underserved market Palatin previously conducted clinical trials showing the synergistic effects of combining bremelanotide with a PDE5i as a treatment for ED Palatin initiated a clinical development program for the evaluation of bremelanotide co-formulated with a PDE5 inhibitor (PDE5i) for the treatment of ED in patients that do not respond to PDE5i monotherapy: Subject to funding, pharmacokinetics (PK) study ready to start 1Q of calendar year 2025 Patient recruitment in Phase 2/3 clinical study could start 2H calendar year 2025 Ulcerative Colitis Program (melanocortin receptor agonist): Phase 2 PL8177 oral formulation for the treatment of ulcerative colitis (UC): Enrollment near complete / interim analysis expected 1Q calendar year 2025 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT05466890 Potential collaboration and funding discussions ongoing Diabetic Nephropathy Program – The BREAKOUT Study (melanocortin receptor agonist): Phase 2 BREAKOUT study of bremelanotide (BMT 701) study in patients with diabetic kidney disease: Topline results expected 4Q calendar year 2024 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT05709444 Vyleesi® (bremelanotide injection) for Hypoactive Sexual Desire Disorder: Asset sale to Cosette Pharmaceuticals for up to $171 million closed in December 2023: Potential milestones of up to $159 million based on annual net sales ranging from $15 million to $200 million Palatin retains rights to and use of bremelanotide for obesity and male ED Received $2.5 million deferred upfront payment in November 2024 Fiscal First Quarter Ended September 30, 2024 Financial Results Revenue 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's worldwide rights for female sexual dysfunction to Cosette Pharmaceuticals for up to $171 million in December 2023, Palatin did not record any product sales to pharmacy distributors, for the first quarter ended September 30, 2024. For the first quarter ended September 30, 2023, gross product sales were $4.6 million and net product revenue was $2.1 million. Operating Expenses Total operating expenses were $7.8 million for the first quarter ended September 30, 2024, compared to $8.2 million for the comparable quarter last year. The decrease was mainly the result of the elimination of selling expenses related to Vyleesi offset by greater spending on our MCR programs. Other (Expense) / Income Total other (expense) / income, net, consists mainly of foreign currency transaction (loss) and gains and the change in fair value of warrant liabilities, which Palatin had recorded as a liability on the consolidated financial statements, including the revisions of certain prior period amounts to correct a misstatement with respect to classifying warrants as equity instead of a liability. The statement of operations was adjusted each quarter through fiscal year ended June 30, 2024 to reflect changes in the fair value of these warrants. For the quarter ended September 30, 2023, Palatin recorded a fair value adjustment gain of $0.7 million. Cash Flows Palatin's net cash used in operations for the quarter ended September 30, 2024, was $7.0 million, compared to net cash used in operations of $5.9 million for the same period in 2023. The increase in net cash used in operations is mainly due to the increase in the net loss during the period and secondarily to working capital changes. Net Loss Palatin's net loss for the quarter ended September 30, 2024, was $7.8 million, or $(0.39) per basic and diluted common share, compared to a net loss of $5.2 million, or $(0.43) per basic and diluted common share, for the same period in 2023. The increase in net loss for the quarter ended September 30, 2024, over the quarter ended September 30, 2023, was mainly due to the elimination of Vyleesi net product revenue, offset by the elimination of Vyleesi selling expenses and the recognition of the change in fair value of warrant liabilities for the quarter ended September 30, 2023. Cash Position As of September 30, 2024, Palatin's cash and cash equivalents were $2.4 million, compared to cash and cash equivalents of $9.5 million as of June 30, 2024. Palatin received a scheduled $2.5 million deferred upfront payment in November 2024 related to the sale of Vyleesi to Cosette Pharmaceuticals. The Company is actively engaged with multiple potential funding sources for future operating cash needs. Conference Call / Webcast Palatin will host a conference call and audio webcast on November 14, 2024, at 11:00 a.m. Eastern Time to discuss the results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-888-506-0062 (US) or 1-973-528-0011 (International), conference ID 176159. The audio webcast and replay can be accessed by logging on to the "Investor-Webcasts" section of Palatin's website at . A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone reply, dial 1-877-481-4010 (US) or 1-919-882-2331 (International), passcode 51641. The webcast and telephone replay will be available through November 28, 2024. About Melanocortin Receptor Agonists The melanocortin receptor ("MCR") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at and follow Palatin on Twitter at @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. (Financial Statement Data Follows) SOURCE Palatin Technologies, Inc. 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Dry Eye Disease (DED): PL9643 MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Studies FDA Confirms Protocols and Endpoints Targeting Enrollment Start in 4Q Calendar Year 2024 Topline Results Anticipated 4Q Calendar Year 2025 Potential Collaboration/Funding Discussions Ongoing Obesity: Phase 2 Clinical Study with Melanocortin-4 Receptor (MC4R) Agonist + Glucagon Like Peptide-1 (GLP-1) Patient Dosing Commenced 3Q Calendar Year 2024 Topline Results Expected 1Q Calendar Year 2025 Male Sexual Dysfunction: Development and Clinical Program with Bremelanotide Co-Formulated with a PDE5i for the Treatment of Erectile Dysfunction (ED) in Patients That Do Not Respond to PDE5i Monotherapy Pharmacokinetics Study Expected to Start 1Q Calendar Year 2025 Patient Recruitment in Phase 3 Study Anticipated in 2H Calendar Year 2025 Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study in Active UC Patients Interim Analysis Readout Expected in 4Q Calendar Year 2024 Topline Results Anticipated 1Q Calendar Year 2025 Potential Collaboration Discussions Ongoing CRANBURY, N.J. , Sept. 9, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today provided an update on its clinical programs, strategic priorities, and anticipated milestones. "We continue to execute on the clinical development front and expect several key milestones from multiple programs over the next twelve months," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "Patient dosing has commenced in our Phase 2 clinical study of an MC4R agonist plus a GLP-1 in obese patients. Our clinical program evaluating bremelanotide co-formulated with a PDE5i for the treatment of ED in patients who do not respond to PDE5i monotherapy is expected to begin in the first half of calendar year 2025. An interim analysis readout on our Phase 2 clinical trial of PL8177 in patients with UC is expected later this calendar year. Additionally, as a result of a positive Type C meeting with the FDA and agreement on PL9643 for DED Phase 3 trial protocols and endpoints, we anticipate the initiation of pivotal clinical studies MELODY-2 and MELODY-3 in the fourth quarter of this calendar year." Dr. Spana further commented, "We are focused on the continued development of melanocortin receptor system treatments for obesity and male sexual dysfunction. We are actively engaging in discussions with potential partners and companies that have the financial and operational resources to progress PL9643 for DED, our other ocular programs, and our ulcerative colitis program, through development, approval, and into commercialization. Program Updates and Anticipated Milestones Ocular Programs (melanocortin receptor agonists): Phase 3 PL9643 clinical program for the treatment of dry eye disease (DED): Potential collaboration/funding discussions ongoing MELODY-2 & MELODY-3 Phase 3 pivotal clinical studies Concluded a positive Type C meeting with the FDA and reached an agreement on sign and symptom endpoints on the remaining two Phase 3 pivotal trial protocols Targeting 4Q calendar year 2024 to begin patient enrollment Topline results anticipated 4Q calendar year 2025 Potential NDA submission 1H calendar year 2026 Successful Phase 3 MELODY-1 pivotal study successfully completed Statistical significance (p<0.025) met for co-primary symptom endpoint of pain Statistical significance (p,0.05) met for 7 of 11 secondary symptom endpoints at the 12-week treatment period Statistical significance (p<0.05) met for rapid onset of efficacy and multiple symptom endpoints, including the co-primary pain endpoint at the 2-week treatment period and continued to improve over the 12-week treatment period Statistical significance (p<0.05) met for multiple sign endpoints, including 4 fluorescein staining endpoints at the 2-week treatment period Corneal fluorescein staining is used to measure corneal epithelial damage and reductions in corneal fluorescein staining with treatments like PL9643 indicate improvement in corneal health Excellent safety and tolerability profile Obesity Program: Phase 2 clinical study for the co-administration of melanocortin agonist bremelanotide (MC4R) with tirzepatide (GLP-1) in obese patients for the treatment of obesity: Initiated 2Q of calendar year 2024 Patient dosing commenced 3Q calendar year 2024 Topline results expected 1H calendar year 2025 The study is designed to enroll up to 60 patients at four trial sites in the United States with the Primary endpoint of the trial to demonstrate the safety and increased efficacy of co-administration of bremelanotide with tirzepatide on reducing body weight Patients will be treated with tirzepatide-only for four weeks, have eligibility confirmed, then randomized to one of four treatment regimens 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/GIP therapy Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT06565611 Novel MC4R selective long-acting agonist: Initiation of investigational new drug (IND) enabling activities expected 4Q of calendar year 2024 Filing of IND anticipated 2H of calendar year 2025 Male Sexual Dysfunction Program: Initiated a development and clinical program for the evaluation of bremelanotide co-formulated with PDE5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy: Pharmacokinetics study initiation expected to start 1Q of calendar year 2025 Patient recruitment in Phase 3 clinical study anticipated 2H calendar year 2025 Topline results targeted for 1H calendar year 2026 Approximately 35% of men with ED have an inadequate response to PDE5i treatments and represent a large underserved market Palatin previously conducted clinical trials showing the synergistic effects of combining bremelanotide with a PDE5i as a treatment for ED Ulcerative Colitis Program (melanocortin receptor agonist): Phase 2 PL8177 oral formulation for the treatment of ulcerative colitis (UC): Potential collaboration discussions ongoing Interim analysis expected in 4Q calendar year 2024 Topline results anticipated 1Q calendar year 2025 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT05466890 Diabetic Nephropathy Program (melanocortin receptor agonist): Phase 2 bremelanotide BREAKOUT study (BMT 701) in patients with diabetic kidney disease: Topline results expected in the fourth quarter of calendar year 2024 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT05709444 Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder: Asset sale to Cosette Pharmaceuticals for up to $171 million closed in December 2023: $12 million upfront, plus potential sales-based milestones of up to $159 million based on annual net sales ranging from $15 million to $200 million Palatin retained rights and use of bremelanotide for obesity and male erectile dysfunction indications About Melanocortin Receptor Agonists The melanocortin receptor ("MCR") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects. Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at and follow Palatin on Twitter at @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. SOURCE Palatin Technologies, Inc.