Palatin Provides Corporate Update and Highlights Strategic Priorities for Calendar Year 2024

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Jan 08, 2024, 10:33 ET

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 www.Palatin.com 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.