Palatin Technologies

Palatin Technologies, Inc. is a biopharmaceutical company, which engages in the development of medicines based on molecules that modulate the activity of the melanocortin receptor system. Its primary product candidate is marketed under the Vyleesi brand, the trade name for bremelanotide, which is used for the treatment of premenopausal women with acquired, generalized, hypoactive sexual desire disorder (HSDD). The company was founded by Carl Spana and John K. A. Prendergast on November 21, 1986 and is headquartered in Cranbury, NJ.

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Palatin Technologies reports revenue challenges but advances pipeline programs

Palatin Technologies faced revenue challenges in Q3 2024 but showcased strengths in pipeline advancements and positive clinical results.
The company's financial performance improved despite increased operating expenses, with a focus on expanding clinical programs and enhancing drug profiles.
While facing cash utilization concerns and upcoming study expenses, Palatin remains optimistic about its progress and future milestones.

Palatin Technologies reports Q4 loss, progresses in ocular treatments

Palatin Technologies navigated Q4 2024 with a focus on cost reduction and asset sales, impacting revenue and expenses.
Despite financial challenges, the company's progress in ocular programs and pipeline development showcases strategic advancements.
Opportunities lie in leveraging asset sale proceeds, advancing clinical programs, and addressing funding needs for future growth.

Palatin Technologies focuses on obesity programs amid financial challenges

Palatin Technologies navigated challenges in Q1 2024 with no product sales and a net loss, while managing operating expenses effectively.
The company's focus on core obesity programs and upcoming study results indicate strategic alignment and progress in key initiatives.
Despite financial constraints and timing risks, Palatin's exploration of strategic options and pipeline advancement offer growth opportunities.

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Open label study designed to evaluate the safety, tolerability, and efficacy of bremelanotide in patients with Type 2 diabetic nephropathy Demonstrated efficacy at 6 months 71% percent of patients achieved a >30% reduction in the urine protein to creatinine ratio (UP/Cr) 71% of patients achieved improved or stabilized estimated glomerular filtration rate (eGFR) Bremelanotide therapy increased urinary VEGF levels in 37.5% of patients and reduced urinary synaptopodin losses in 36% of patients CRANBURY, N.J. , Dec. 19, 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 topline data for the BREAKOUT study.

Palatin Announces Positive Phase IIb BREAKOUT Study Results in Patients with Type 2 Diabetic Nephropathy

CRANBURY, N.J. , Dec. 16, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN) ("Palatin" or the "Company"), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced that it has entered into a warrant exercise inducement agreement (the "inducement agreement") with an institutional investor to exercise certain outstanding warrants that the Company issued in June 2024 and October 2023 totaling 3,907,679 shares of the Company's common stock for gross proceeds of approximately $3.4 million.

Palatin Announces Exercise of Warrants for Approximately $3.4 Million Gross Proceeds

Oral PL8177 may provide a safe, effective, and tolerable treatment option for ulcerative colitis patients prior to immunosuppressive therapies and steroid treatments, which have significant safety and tolerability concerns Preclinical data demonstrated that oral PL8177 caused diseased colons to move towards a healthy state and to resolve damaging inflammation Data expected 1Q calendar year 2025 CRANBURY, N.J. , Nov. 25, 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 the completion of enrollment in its Phase 2 Study of PL8177, a potent melanocortin-1 receptor (MC1R) agonist, in ulcerative colitis (UC).

Palatin Announces Completion of Patient Enrollment in Phase 2 Study of Orally Administered Melanocortin Agonist PL8177 in Ulcerative Colitis

Palatin Technologies, Inc. (NYSE:PTN ) Q1 2025 Earnings Conference Call November 14, 2024 11:00 AM ET Company Participants Carl Spana - CEO and President Stephen Wills - CFO, COO, Treasurer and Secretary Conference Call Participants Joe Pantginis - H. C. Wainwright Operator Greetings.

Palatin Technologies, Inc. (PTN) Q1 2025 Earnings Conference Call Transcript

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.

Palatin Reports First Quarter Fiscal Year 2025 Operating/Financial Results

CRANBURY, N.J. , Nov. 8, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN) will announce its first quarter fiscal year 2025 operating results on Thursday, November 14, 2024, before the open of the U.S. financial markets.

Palatin to Report First Quarter Fiscal Year 2025 Results; Teleconference and Webcast to be held on November 14, 2024

Oral PL7737 significantly decreased food intake and body weight Oral small molecule melanocortin 4 agonist (MC4R) could address unmet needs and challenges of current obesity treatments Multiple clinical trials targeted in calendar year 2025 for the Company's obesity programs CRANBURY, N.J. , Nov. 4, 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 (MCR) system, today announced that preclinical data from the Company's melanocortin 4 receptor (MC4R) selective PL7737 obesity program will be highlighted in a poster presentation at ObesityWeek® 2024, the annual meeting of the Obesity Society held in San Antonio, Texas.

Palatin Presents Data on Novel Melanocortin 4 Receptor Selective Oral Small Molecule PL7737 Obesity Program at ObesityWeek® 2024

Topline results expected in 1Q calendar year 2025 Study is assessing the co-administration of bremelanotide and tirzepatide on reducing body weight Data will inform and support the Company's obesity programs using novel, long-acting and highly selective MC4R peptide and small molecule compounds for treating general obesity, weight loss management, and rare/orphan MC4R pathway diseases, including hypothalamic obesity CRANBURY, N.J. , Oct. 31, 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 (MCR) system, today announced it has completed enrollment in the study entitled "BMT-801, A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity.

Palatin Completes Enrollment in Phase 2 Clinical Study of Bremelanotide (MC4R Agonist) Co-Administered with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity

Data presented from clinical and preclinical studies Melanocortin agonism reduces stress signaling and resolves inflammation Potential to treat inflammatory diseases without immunosuppression CRANBURY, N.J. , Oct. 24, 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, presented a poster titled "Harnessing the Melanocortin System to Heal Inflammatory Diseases" at the 19th Annual Peptide Therapeutics Symposium held October 22-23, 2024 in person and virtually in La Jolla, California.

Inflammatory Disease Healing Data via Palatin's Novel Melanocortin Receptor Agonists Presented at the 19th Annual Peptide Therapeutics Symposium

High selectivity for MC4R significantly reduces potential for skin pigmentation MC4R is a well-validated target for treating obesity Clinical studies with highly selective MC4R agonists targeted to commence in calendar year 2025 CRANBURY, N.J. , Oct. 23, 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, 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 held October 22-23, 2024 in person and virtually in La Jolla, California.

Palatin Presents Foundational Data on Novel and Highly Selective Melanocortin 4 Receptor Agonists at the 19th Annual Peptide Therapeutics Symposium

CRANBURY, N.J. , Oct. 7, 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 it received a notice from the staff of NYSE American LLC (the "Exchange") that Palatin was not in compliance with the Exchange's continued listing standards under Section 1003(a)(iii) of the NYSE American Company Guide.

Palatin Receives Notice of Non-Compliance from NYSE American

Palatin Technologies, Inc. (NYSE:PTN ) Q4 2024 Earnings Conference Call October 1, 2024 11:00 AM ET Company Participants Carl Spana - Chief Executive Officer and President Stephen Wills - Chief Financial Officer, Chief Operating Officer, Treasurer and Secretary Conference Call Participants Joe Pantginis - H.C. Wainwright John Newman - Canaccord Genuity Operator Greetings.

Palatin Technologies, Inc. (PTN) Q4 2024 Earnings Call Transcript

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 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 fourth quarter and fiscal year ended June 30, 2024.

Palatin Reports Fourth Quarter and Fiscal Year Ended 2024 Financial Results, Provides Update on Clinical Programs, Strategic Priorities, and Anticipated Milestones

Teleconference and Webcast to be held on October 1, 2024 CRANBURY, N.J. , Sept. 26, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN) will announce its fourth quarter and fiscal year end 2024 operating results on Tuesday, October 1, 2024, before the open of the U.S. financial markets.

Palatin to Report Fourth Quarter and Fiscal Year End 2024 Results

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.

Palatin Provides Update on Clinical Programs, Strategic Priorities, and Anticipated Milestones

FDA & Palatin agree on clear regulatory path for PL9643 NDA submission in DED FDA confirms acceptability of protocols and endpoints for remaining MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Trials in DED Currently anticipate patient enrollment to start in 4Q calendar year 2024 Topline results currently expected in 4Q calendar year 2025 CRANBURY, N.J. , Aug. 28, 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 receipt of FDA correspondence confirming the acceptability of the protocols and endpoints for signs and symptoms of PL9643 Phase 3 pivotal clinical trials for dry eye disease (DED).

FDA Confirms Acceptability of Palatin's Remaining Phase 3 Pivotal Clinical Trials for PL9643 in Dry Eye Disease (DED)

Complete enrollment currently expected in 3Q 2024 Topline results expected in 1Q calendar year 2025 Additional studies under assessment for multiple metabolic conditions CRANBURY, N.J. , Aug. 22, 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 that patient dosing has started for the clinical study entitled: BMT-801: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity (ClinicalTrials.gov Identifier: NCT06565611).

First Patient Dosed in Phase 2 Clinical Study of Palatin's Bremelanotide Co-Administered with Tirzepatide (GLP-1) for the Treatment of Obesity

CRANBURY, N.J. , June 21, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN) ("Palatin" or the "Company"), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced that it has entered into a warrant inducement agreement with an institutional investor to exercise certain outstanding warrants that the Company issued in November 2022 and October 2023 totaling 3,233,277 shares of the Company's common stock for gross proceeds of approximately $6.1 million.

Palatin Announces Exercise of Warrants for Approximately $6.1 Million Gross Proceeds

In ED patients that do not respond to PDE5i monotherapy ~30-40% of ED patients do not respond to PDE5i treatment Data from this Phase 2 clinical study is expected by end of calendar year 2024 Published clinical data and mechanisms of action support clinical study of bremelanotide in combination with a PDE5i Phase 3 clinical study with new co-formulated bremelanotide plus a PDE5i in ED patients that do not respond to PDE5i monotherapy expected to start in the 1st half of calendar year 2025 CRANBURY, N.J. , June 20, 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, announced the initiation of a Phase 2 clinical study of bremelanotide (BMT), a melanocortin 4 receptor (MC4R), co-administered with a phosphodiesterase 5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy.

Palatin Announces the Initiation of a Phase 2 Clinical Study of Bremelanotide Co-Administered with a PDE5i for the Treatment of Erectile Dysfunction (ED)

Co-Administration Phase 2 study of bremelanotide with tirzepatide (GLP-1) to provide key information for melanocortin treatments of obesity Topline data expected by end of calendar year 2024 Additional studies under assessment for multiple metabolic conditions CRANBURY, N.J. , June 12, 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 the initiation of a Phase 2 clinical study of bremelanotide for the treatment of obesity.

Palatin Initiates Phase 2 Clinical Study of Bremelanotide for the Treatment of Obesity

Palatin Technologies (PTN) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Palatin Technologies (PTN) Upgraded to Buy: What Does It Mean for the Stock?

Positive Phase 3 PL9643 MELODY-1 Pivotal Study Results Co-Primary Symptom Endpoint of Pain Met Statistical Significance (P

Palatin Reports Third Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update

CRANBURY, N.J. , May 9, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN) will announce its third quarter fiscal year 2024 operating results on Wednesday, May 15, 2024, before the open of the U.S. financial markets.

Palatin to Report Third Quarter Fiscal Year 2024 Results; Teleconference and Webcast to be held on May 15, 2024

Phase 2 clinical study expected to begin in mid-calendar year 2024 Topline data expected by calendar year-end 2024 Hosting virtual KOL event "Beyond GLPs" on May 8, 2024 Focus will be on Company's metabolic program and the multiple roles for novel melanocortin receptor 4 agonists in treating obesity and weight loss maintenance CRANBURY, N.J. , May 2, 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 that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the investigational new drug (IND) application for the use of bremelanotide, a melanocortin receptor 4 agonist (MCR4), for the treatment of obesity.

Palatin Announces FDA Clearance of IND Application for the Co-Administration of Bremelanotide with Tirzepatide (GLP-1) for the Treatment of Obesity

CRANBURY, N.J. , April 30, 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 it will host a virtual KOL event on Wednesday, May 8, 2024 at 10:00 AM ET.

Palatin to Host Virtual KOL Event "Beyond GLPs: The Multiple Roles for Novel Melanocortin Receptor 4 Agonists in Treating Obesity and Weight Loss Maintenance" on May 8, 2024

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