Obesity: Phase 2 Clinical Study with Melanocortin-4 Receptor (MC4R) Agonist plus Glucagon Like Peptide-1 (GLP-1)
Patient Dosing Commenced 3Q Calendar Year 2024
Patient Enrollment Expected to be Completed Early 4Q Calendar Year 2024
Topline Results Expected 1Q Calendar Year 2025
Dry Eye Disease (DED): PL9643
MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Studies
FDA Confirms Protocols and Endpoints
Patient Enrollment Start Expected 1Q Calendar Year 2025
Topline Results Anticipated 4Q Calendar Year 2025
Potential Partner Collaboration and Funding Discussions Ongoing
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
Pharmacokinetics Study Expected to Start 1Q Calendar Year 2025
Patient Recruitment in Phase 2/3 Study Anticipated in 2H Calendar Year 2025
Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study in Active UC Patients
Interim Analysis Readout Expected 4Q Calendar Year 2024
Topline Results Anticipated 1Q Calendar Year 2025
Potential Partner Collaboration and Funding Discussions Ongoing
Diabetic Nephropathy: Phase 2 BMT 701 Study in Patients with Diabetic Kidney Disease
Topline Results Expected 4Q Calendar Year 2024
Teleconference and Webcast to be held on October 1, 2024, at 11:00 AM ET
CRANBURY, N.J., Oct. 1, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE: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 fourth quarter and fiscal year ended June 30, 2024.
"This is a very exciting time for Palatin. We executed on multiple operational and clinical development fronts on all of our programs and are anticipating several key milestones over the coming quarters," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "We are on track to complete enrollment this month in our Phase 2 clinical study of our MC4R agonist plus a GLP-1 agonist in obese patients, with topline data expected early in the first quarter of calendar year 2025. Data to date of GLP-1 agonist monotherapy to treat obesity has shown incredible results, however data also shows that more than two-thirds of patients discontinue use due to side effects and a plateau effect in the first year, and often quickly regain the loss weight. This clearly suggests that a longer-term approach is needed. Our internal research and research by academic groups indicate that combining an MC4R agonist with a GLP-1, like tirzepatide, may result in synergistic effects on weight loss, allowing for increased and/or sustained weight loss at lower and more tolerated doses."
Dr. Spana, commenting on Palatin's other clinical development programs, noted, "We have agreement with the FDA on the remaining PL9643 Phase 3 DED trial protocols and endpoints. The MELODY-2 and MELODY-3 studies of PL9643 are expected to begin patient enrollment in the first quarter of calendar year 2025. Lastly, we are actively engaging in collaboration and funding discussions with potential partners that have the financial and operational resources to advance PL9643 for DED through development, approval, and into commercialization."
Program Updates and Anticipated Milestones
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:
The study is designed to enroll approximately 60 patients at four sites in the U.S.
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
Patient enrollment expected to be completed early 4Q calendar year 2024
Topline results expected in 1Q calendar year 2025
Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov via the identifier NCT06565611
Novel MC4R selective long-acting agonist:
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 IND anticipated 2H of calendar year 2025
Ocular Programs (melanocortin receptor agonists):
Phase 3 PL9643 clinical program for the treatment of dry eye disease (DED):
Positive 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
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 Phase 3 pivotal 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
Patient enrollment anticipated to begin 1Q calendar year 2025
Topline results anticipated 4Q calendar year 2025
Potential NDA submission 1H calendar year 2026
Potential collaboration and funding discussions ongoing
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:
Pharmacokinetics (PK) study expected to start 1Q of calendar year 2025
Patient recruitment in Phase 2/3 clinical study anticipated 2H calendar year 2025
Topline results targeted for 1H calendar year 2026
Ulcerative Colitis Program (melanocortin receptor agonist):
Phase 2 PL8177 oral formulation for the treatment of ulcerative colitis (UC):
Interim analysis expected 4Q calendar year 2024
Topline results anticipated 1Q calendar year 2025
Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov via the identifier NCT05466890
Potential collaboration 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 https://clinicaltrials.gov 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:
Received $12 million upfront, plus 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
Other Corporate
Financings:
During fiscal year ended June 30, 2024, Palatin raised total gross proceeds of $21 million in registered direct and warrant inducement offerings
Fourth Quarter and Fiscal Year Ended June 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 fourth quarter ended June 30, 2024. For the fourth quarter ended June 30, 2023, gross product sales were $4.1 million and net product revenue was $1.8 million.
Vyleesi gross product sales to pharmacy distributors for the fiscal year ended June 30, 2024, were $8.9 million, with net product revenue of $4.5 million, compared to gross product sales of $12.5 million, with net product revenue of $4.9 million, for the prior fiscal year.
Operating Expenses
Total operating expenses were $8.7 million for the fourth quarter ended June 30, 2024, compared to $12.6 million for the comparable quarter last year. The decrease was mainly the result of lesser spending on our MCR programs and secondarily the elimination of selling expenses related to Vyleesi.
Total operating expenses for the fiscal year ended June 30, 2024, were $27.0 million, compared to $37.3 million for the prior fiscal year. The decrease was mainly due to the $7.8 million gain recognized on the sale of Vyleesi and secondarily the elimination of related selling expenses.
Other Income / (Expense)
Total other income / (expense), net, consists mainly of offering expenses 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 to reflect changes in the fair value of these warrants. For the quarter ended June 30, 2023, Palatin recorded a fair value adjustment gain of $0.9 million.
Warrant Liabilities
Palatin 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 was not material to any prior period impacted. Accordingly, the Company adjusted 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 $1.9 million of warrant liabilities as of June 30, 2023, was reclassified to additional paid-in capital upon amendment.
Cash Flows
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. The 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. The increase in net cash used in operations was ...
