ADDED
NYSE American commenced delisting proceedings in connection with the foregoing determination, and trading the Company s common stock was suspended on May 7, 2025.
The Company s common stock is currently traded on the OTCQB Venture Market under the symbol PTNT PALATIN TECHNOLOGIES, INC .
Risks Related to Our Business, Strategy, and Industry Our product candidates, including a novel once-weekly peptide agonist, PL7737 oral small molecule MCR agonist, PL9643 for dry eye disease and PL8177 for the treatment of ulcerative colitis, are still in the early stages of development and remain subject to clinical testing and regulatory approval.
As of September 19, 2025, there were 838,142 shares of common stock underlying outstanding convertible preferred stock, options, restricted stock units and warrants.
Our product development activities focus primarily on use of MC4R agonists for treatment of obesity.
The Company is developing MC4R peptides and small molecule agonists with potential utility in obesity and metabolic-related disorders, rare MC4R pathway diseases, such as hypothalamic obesity, and orphan indications.
We are also developing, dependent on resources for development activities, MC1R agonist products, with potential to treat inflammatory and autoimmune diseases, such as dry eye disease, which is also known as keratoconjunctivitis sicca, uveitis, diabetic retinopathy, and inflammatory bowel disease.
The Company believes that the MC1R agonist peptides in development have broad anti-inflammatory effects and appear to utilize mechanisms engaged by the endogenous melanocortin system in regulation of the immune system and resolution of inflammatory responses.
The Company is also developing, dependent on resources for development activities, peptides and small molecules that are active at more than one melanocortin receptor, with potential utility in obesity and metabolic-related disorders, rare MC4R pathway diseases, such as hypothalamic obesity, and orphan indications.
In the first quarter of calendar year 2025, we reported positive topline data in a Phase 2 clinical study for the treatment of obesity with co-administration of the melanocortin agonist bremelanotide with tirzepatide, a GLP-1 (glucagon-like peptide-1) agonist.
REMOVED
Risks Related to Our Business, Strategy, and Industry Our product candidates, including PL9643 for dry eye disease and PL8177 for the treatment of ulcerative colitis, are still in the early stages of development and remain subject to clinical testing and regulatory approval.
As of September 27, 2024, there were 11,385,637 shares of common stock underlying outstanding convertible preferred stock, options, restricted stock units and warrants.
Our primary focus is on the development of melanocortin receptor system treatments for obesity and for male sexual dysfunction.
In the second quarter of calendar year 2024 we initiated a Phase 2 clinical study for the treatment of obesity with co-administration of the melanocortin agonist bremelanotide with tirzepatide, a GLP-1 (glucagon-like peptide-1) agonist, and plan to enroll up to 60 patients who are actively on tirzepatide with the primary endpoint of the trial to demonstrate safety and increased efficacy of co-administration of bremelanotide with tirzepatide in reducing body weight.
We have initiated a clinical program for the evaluation of bremelanotide co-formulated with a phosphodiesterase type 5 inhibitor (PDE5i) for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy.
A pharmacokinetics study is targeted for the first half of calendar year 2025, with a Phase 3 clinical trial in PDE5i non-responder ED patients expected to commence in the second half of calendar year 2025.
Our new product development activities in inflammation disease indications focus primarily on development of MCr peptides for ocular conditions, but also include conditions in the gut and kidney.
We are developing products which incorporate a melanocortin agonist with another pharmaceutical agent, with an initial focus on an MC4r agonist plus a GLP-1 drug for use in obese patients, and on an MC4r agonist plus a PDE5i for use in treatment of erectile dysfunction in patients who do not respond to PDE5i monotherapy.
We believe that use of two active agents may result in increased efficacy and decreased side effects.
We are designing and developing potent and highly selective MC1r agonist peptides and agonist peptides specific for more than one melanocortin receptor for treatment of a variety of inflammatory and autoimmune indications.