MC5R x MC1R

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.

Palatin's Focus is Solely on the Development of its Melanocortin Receptor (MCR) System Pipeline PL9643 MELODY-1 Pivotal Phase 3 Study in Dry Eye Disease (DED) – Topline Data Expected in February Oral PL8177 Phase 2 Clinical Study in Patients with Ulcerative Colitis – Interim Analysis Expected in 2Q Calendar Year 2024 – Topline Results Expected in 2H Calendar Year 2024 BMT 701 Phase 2 BREAKOUT study in patients with diabetic kidney disease – Topline results expected in the second quarter of calendar year 2024 Obesity: Combination of an MCR4 Agonist + glucagon like peptide-1 (GLP-1) – Phase 2 Clinical Study Targeted to Start 1Q Calendar Year 2024 Male Sexual Dysfunction: Bremelanotide Co-Formulated with a PDE5i for the Treatment of ED in Patients that do not Respond to PDE5i Monotherapy – Phase 2 Clinical Study Targeted to Start 1Q Calendar Year 2024 Vyleesi® Completed Asset Sale to Cosette Pharmaceuticals for up to $171 Million – $12 Million Upfront / Up to $159 Million in Sales-Based Milestones Closed on Gross Proceeds of $15 Million in Equity Teleconference and Webcast to be held on February 15, 2024, at 11:00 AM ET CRANBURY, N.J., Feb. 15, 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 financial results for its fiscal second quarter ended December 31, 2023. "With the planned divestiture of Vyleesi completed, our focus is solely on advancing our robust melanocortin-based development and clinical pipeline," said Carl Spana, Ph.D., President and CEO of Palatin. "We have multiple topline data result readouts in the near future, notably our MELODY-1 pivotal Phase 3 dry eye disease trial, our Phase 2 ulcerative colitis trial and our Phase 2 diabetic kidney disease study. Dr. Spana further commented, "We are also excited to commence two new clinical trials in the first half of calendar year 2024, with topline data readouts in the second half of calendar year 2024. The first is a Phase 2 clinical study of a MCR4 agonist plus a GLP-1 in obese patients. The second is a Phase 2 clinical study evaluating bremelanotide co-formulated with a PDE5i, for the treatment of erectile dysfunction in patients that do not respond to PDE5i monotherapy." Fiscal Second Quarter Ended December 31, 2023 Business Highlights and Recent Updates Anti-Inflammatory / Autoimmune Programs (melanocortin agonists) PL9643 MELODY-1 pivotal Phase 3 study for the treatment of dry eye disease (DED) Database lock completed (575 patients enrolled) Topline data readout expected in February Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT04268069 PL8177 Phase 2 oral formulation for the treatment of ulcerative colitis (UC): Interim assessment expected in the second quarter of calendar year 2024 Topline data readout expected in the second half of calendar year 2024 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT05466890 Bremelanotide Phase 2 BREAKOUT study (BMT 701) in patients with diabetic kidney disease: Topline results expected in the second quarter of calendar year 2024 Additional trial information, including inclusion and exclusion criteria, can be found at via the identifier NCT05709444 Metabolic Program (Obesity): Presented positive data with bremelanotide, a melanocortin receptor 4 (MCR4) agonist plus glucagon like peptide-1 (GLP-1) showing increased weight loss and greater glucose control above monotherapy: Phase 2 clinical study targeted to start in the first half of calendar year 2024 Topline data readout expected in the second half calendar year 2024 Initiation of investigational new drug (IND) enabling activities for a novel MCR4 selective long-acting agonist expected in the second half of calendar 2024. Sexual Health Program (Male Sexual Dysfunction) Initiation of clinical program framework 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: Phase 2 clinical study in PDE5i non-responder ED patients expected to commence in the first half of calendar year 2024 Topline data readout expected in the second half of calendar year 2024 Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD) Completed asset sale to Cosette Pharmaceuticals for up to $171 million in December 2023 for female HSDD: $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 Other: Registered Direct Offering: On January 30, 2024, Palatin entered into a securities purchase agreement with healthcare-focused institutional investors, selling and issuing an aggregate of 1,831,503 shares of Palatin common stock, $0.01 par value per share, at a purchase price of $5.46 per share of common stock. Palatin also agreed to issue in a private placement warrants to purchase up to an aggregate of 1,831,503 shares of Palatin common stock at an exercise price of $5.46 per share. The Offering was completed on February 1, 2024, with the Company receiving gross proceeds of $10 million. The Common Warrants are exercisable beginning six months after the date of issuance and will expire on the date that is four years after the closing date. Registered Direct Offering: On October 23, 2023, Palatin entered into a securities purchase agreement with an institutional investor, selling and issuing an aggregate of 2,358,491 shares of Palatin common stock, $0.01 par value per share, at a purchase price of $2.12 per share of common stock. Palatin also agreed to issue in a private placement warrants to purchase up to an aggregate of 2,358,491 shares of Palatin common stock at an exercise price of $2.12 per share. The Offering was completed on October 24, 2023, with the Company receiving gross proceeds of $5 million. The Common Warrants are exercisable beginning six months after the date of issuance and will expire on the date that is five and a half years after the closing date. Fiscal Second Quarter Ended December 31, 2023 Financial Results Revenue Total revenue consists of gross product sales of Vyleesi, net of allowances and accruals. Vyleesi gross product sales to pharmacy distributors for the quarter ended December 31, 2023 were $4.3 million, with net product revenue of $2.0 million, compared to gross product sales of $2.6 million and net product revenue of $1.0 million for the comparable quarter last year. Gross product sales increased 64% and net product revenue increased 98% over the comparable quarter last year. Operating Expenses Total operating expenses were $0.9 million, net of a $7.8 million gain on the sale of Vyleesi, compared to $6.6 million, net of a $1.0 million gain on Vyleesi purchase commitments, for the comparable quarter last year. The decrease in operating expenses was mainly the result of the gain recognized on the sale of Vyleesi to Cosette Pharmaceuticals. Other Income / (Expense) Total other income / (expense), net, consists mainly of the change in fair value of warrant liabilities, which Palatin has 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 is adjusted each quarter to reflect changes in the fair value of these warrants. For the quarters ended December 31, 2023, and 2022, Palatin recorded a fair value adjustment loss of $8.1 million and a gain of $5.2 million, respectively. Warrant Liabilities Palatin has assessed the impact of improperly classifying the warrants related to the October 2022 financing within equity, rather than as a warrant liability that is adjusted through charges or credits to the statement of operations to reflect changes in the fair value of the warrants, and determined the impact is not material, quantitatively or qualitatively, to any prior period impacted. Accordingly, the Company will adjust prior periods as those financial statements are presented for comparative purposes in future filings. On January 24, 2024, the Company and warrant holders amended the terms of the warrants related to the October 2022 and October 2023 financings. As a result, the $11.9 million of warrant liabilities as of December 31, 2023, are expected to be reclassified to additional paid-in capital upon amendment. Cash Flows Palatin's net cash used in operations was $10.5 million, compared to net cash used in operations of $9.7 million for the same period last year. The increase in net cash used in operations is mainly due to the gain on the sale of Vyleesi of $7.8 million and working capital changes, offset by a loss as the result of the change in fair value of liability classified warrants of $8.1 million for the quarter ended December 31, 2023. Net Loss Palatin's net loss was $7.8 million, or $(0.56) per basic and diluted common share, compared to net income of $2.7 million, or $0.25 per basic and diluted common share for the comparable period last year. The change to net loss over the comparable quarter last year was due to several factors, including an increase in net product revenue of Vyleesi of $1.0 million, a gain on the sale of Vyleesi of $7.8 million and the change in fair value of warrant liabilities of $8.1 million of expense, in 2023, and $5.2 million of income in the change in fair value of warrant liabilities and the recognition of an income tax benefit of $4.7 million, in 2022. Cash Position As of December 31, 2023, Palatin's cash, cash equivalents and marketable securities were $9.5 million plus $2.3 million of accounts receivable, compared to cash, cash equivalents and marketable securities of $5.5 million plus $1.3 million of accounts receivable, as of September 30, 2023, and cash, cash equivalents and marketable securities of $11.0 million plus $2.9 million of accounts receivable, as of June 30, 2023. The $9.5 million of cash, cash equivalents and marketable securities as of December 31, 2023, does not include $9.2 million of net proceeds from the Registered Direct Offering, which closed in February 2024. The Company believes that existing cash, cash equivalents, marketable securities and accounts receivable, will be sufficient to fund currently anticipated operating expenses and disbursements into the second half of calendar year 2024. Conference Call / Webcast Palatin will host a conference call and audio webcast on February 15, 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 397299. The audio webcast and replay can be accessed by logging on to the "Investor-Webcasts" section of Palatin's website at or by clicking here. A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone replay, dial 1-877-481-4010 (US) or 1-919-882-2331 (International), passcode 49945. The webcast and telephone replay will be available through February 29, 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 market potential of Vyleesi and other 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 trademarks of Palatin Technologies, Inc. View original content to download multimedia: SOURCE Palatin Technologies, Inc. Company Codes: AMEX:PTN

Dry Eye Disease (DED): PL9643 MELODY-1 Phase 3 Study Data Base Lock 2H January 2024 Topline Data Readout Expected Early 1Q Calendar Year 2024 Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study in Active UC Patients Interim Analysis Data Readout on Track for 1Q Calendar Year 2024 Topline Results Expected in 2Q Calendar Year 2024 Obesity: Melanocortin Receptor 4 (MCR4) Agonist + Glucagon Like Peptide-1 (GLP-1) Phase 2 Clinical Study Targeted to Start 1Q Calendar Year 2024 Topline Results Expected in 2H Calendar Year 2024 Male Sexual Dysfunction: Bremelanotide Co-Formulated with a PDE5i for the Treatment of Erectile Dysfunction (ED) in Patients that do not Respond to PDE5i Monotherapy Phase 2 Clinical Study Targeted to Start 1Q Calendar Year 2024 Topline Results Expected in 2H Calendar Year 2024 Vyleesi® Completed Asset Sale to Cosette Pharmaceuticals for up to $171 Million $12 Million Upfront Plus Sales-Based Milestones of up to $159 Million CRANBURY, N.J., Jan. 8, 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 a corporate update, highlighted the Company's key calendar year 2023 accomplishments and outlined its anticipated calendar year 2024 clinical development milestones. "We made significant operational progress during calendar year 2023 and we believe we are well-positioned for making calendar year 2024 a pivotal and transformative year for Palatin," said Carl Spana, Ph.D., President and CEO of Palatin. "Our internal research and development efforts are focused in areas where we believe we have a high probability of success, product differentiation and the opportunity for a substantial return on our investment. Topline data readout for our Phase 3 PL9643 clinical study for DED is expected early in the first quarter of calendar year 2024. Our Phase 2 study of oral PL8177 in patients with UC is expected to have an interim analysis data readout in the first quarter and topline trial results in the second quarter of calendar year 2024." Dr. Spana further commented, "We are excited by the significant opportunity of melanocortin-based therapeutics for obesity treatment and believe we are well positioned to deliver selective and efficacious MCR4 long-acting peptides and orally active small molecules. We expect to commence a Phase 2 clinical study of a MCR4 agonist plus a GLP-1 in obese patients in the first quarter of calendar year 2024. In addition, following on our significant expertise in product development to treat sexual dysfunction, we expect to commence a Phase 2 clinical study evaluating bremelanotide co-formulated with a PDE5i for the treatment of ED in patients that do not respond to PDE5i monotherapy in the first quarter of calendar year 2024." The recently announced divestiture of Vyleesi is consistent with Palatin's strategic decision to concentrate on its robust development and clinical pipeline. Palatin is now focused on developing novel therapeutics that modulate the melanocortin receptor system. Program Updates and Expected Milestones for 2024 Anti-Inflammatory / Autoimmune Programs PL9643 melanocortin agonist Phase 3 study for the treatment of DED: Patient enrollment completed (n=570) in Phase 3 MELODY-1 study Data base lock second half of January 2024 Topline data readout expected early first quarter of calendar year 2024 Phase 3 safety and efficacy study MELODY-2 and the open label MELODY-3 study are anticipated to commence patient enrollment in the second half of calendar year 2024 PL8177 oral melanocortin agonist Phase 2 study for the treatment of UC: Interim assessment targeted for the first quarter of calendar year 2024 Topline data readout is expected in the second quarter of calendar year 2024 Bremelanotide BREAKOUT Phase 2 study in patients with diabetic kidney disease: Topline data readout is expected in the second quarter of calendar year 2024 Metabolic Program (Obesity) Presented positive data with bremelanotide, a melanocortin receptor 4 (MCR4) agonist, plus glucagon like peptide-1 (GLP-1) showing increased weight loss and greater glucose control above monotherapy: Phase 2 clinical study targeted to start in the first quarter of calendar year 2024 Topline data readout is expected in the second half of calendar year 2024 Initiation of investigational new drug (IND) enabling activities for a novel MCR4 selective long-acting agonist expected in the second half of calendar year 2024 Sexual Health Program (Male Sexual Dysfunction) Initiated a clinical development program evaluating bremelanotide co-formulated with a PDE5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy: Phase 2 clinical study in PDE5i non-responder ED patients is expected to commence in the first quarter of calendar year 2024 Topline data readout is expected in the second half of calendar year 2024 Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD) Completed asset sale to Cosette Pharmaceuticals for up to $171 million in December 2023 for female HSDD: $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 Eligible to receive regulatory approval milestones of $10.5 million related to Fosun ($7.5M China) and Kwangdong ($3.0M S. Korea) licenses – Kwangdong completed a required Phase 3 study in HSDD patients and is preparing a regulatory approval submission Palatin retained rights and use of bremelanotide for obesity and male erectile dysfunction indications About Melanocortin Receptor Agonists and Inflammation 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. To learn more about Palatin, please visit us on and follow us 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 agencies 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.