• Phase 2 obesity co-administration study with MC4R agonist bremelanotide plus GLP-1/GIP dual agonist tirzepatide
  • Database lock completed
  • Topline data readout expected later this month
• Novel 'next generation' selective MC4R long-acting peptide and an oral small molecule
  • Multiple clinical trials targeted in calendar year 2025
  • For the treatment of general obesity, weight loss management, and rare MC4R pathway diseases, including hypothalamic obesity
• Phase 2 clinical study of PL8177 oral formulation for the treatment of ulcerative colitis
  • Topline data readout expected later this quarter
• Teleconference and Webcast to be held on February 13, 2025, at 11:00 AM ET

CRANBURY, N.J., Feb. 13, 2025 /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, 2024 and the completion of database lock for its Phase 2 obesity co-administration study with melanocortin 4 receptor (MC4R) agonist bremelanotide plus glucagon like peptide-1/gastric inhibitory polypeptide (GLP-1/GIP) dual agonist tirzepatide.

"Reaching database lock for our Phase 2 obesity study is a step forward in our mission to bring an alternative treatment to the millions of patients battling obesity," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "Statistical analysis is underway, and we look forward to reporting topline results later this month."

"GLP-1 receptor agonists are popular for treating obesity, but other options are needed for several reasons: they can cause unwanted side effects, be expensive, lead to long-term dependency, and often result in weight gain after stopping them," continued Dr. Spana. "The MC4R pathway helps control eating and how our bodies use energy. We believe that MC4R agonists, especially the long-acting peptides and oral small molecules we are developing, could be an important way to treat obesity, manage weight loss, and help with rare conditions like hypothalamic obesity. These treatments could work alone or in combination with other therapies."

Business Update

Obesity Programs

• Phase 2 BMT-801 'signal detection' clinical study with MC4R agonist bremelanotide plus a GLP-1/GIP dual agonist tirzepatide:
  • Database lock completed.
  • Topline results expected by the end of February 2025.
  • Primary objective: Demonstrate that co-administration of bremelanotide with tirzepatide is safe and has a significant effect on reducing body weight.
• Novel 'next generation' selective MC4R agonists:
  • Once weekly peptide and oral small molecule ready to advance.
  • Potential for monotherapy or combination (with a GLP-1/GIP agonist) therapy.
  • Treating general obesity, weight loss management, rare/orphan genetically caused MC4R pathway diseases, including hypothalamic obesity.
  • Investigational new drug (IND) enabling activities expected to commence 1Q calendar year 2025.
  • Filing of INDs anticipated 2H of calendar year 2025.
  • Commencement of Phase 1 clinical studies targeted for 4Q calendar year 2025.

Non-Obesity Programs: dry eye disease (DED) and other ocular programs, ulcerative colitis (UC), and diabetic nephropathy programs

• Program specific licensing/collaboration and spinout activities ongoing with multiple deals targeted for calendar year 2025.
• DED
  • FDA agreement on sign and symptom endpoints for remaining two Phase 3 pivotal trial protocols, with patient enrollment prepared to commence 1H calendar year 2025.
• UC
  • Topline results from our Phase 2 clinical study of PL8177 oral formulation for the treatment of UC expected later this quarter.
• Diabetic nephropathy
  • Phase 2B study in patients with Type 2 diabetic nephropathy / reported positive and beneficial results for the majority of patients related to worsening kidney function and disease progression.

Fiscal Second Quarter Ended December 31, 2024 Financial Results

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 second quarter ended December 31, 2024. For the second quarter ended December 31, 2023, gross product sales were $4.3 million and net product revenue was $2.0 million.

Operating Expenses

Total operating expenses were $2.6 million, net of a $2.5 million gain on the sale of Vyleesi for the second quarter ended December 31, 2024, compared to $0.9 million, net of a $7.8 million gain on the sale of Vyleesi for the comparable quarter last year. The increase was mainly the result of the decrease in gain on the sale of Vyleesi to Cosette Pharmaceuticals for the second quarter ended December 31, 2024.

Other (Expense) / Income

Total other income / (expense), net, consists mainly of foreign currency transaction gains and (loss) and the change in fair value of warrant liabilities, which Palatin had recorded as a liability on the consolidated financial statements. For the quarter ended December 31, 2023, Palatin recorded a fair value adjustment loss of $8.1 million and offering expenses of $0.7 million.

Cash Flows

Palatin's net cash used in operations for the quarter ended December 31, 2024, was $4.8 million, compared to net cash used in operations of $10.5 million for the same period in 2023. The decrease in net cash used in operations is mainly due to the decrease on the gain on the sale of Vyleesi during the period and secondarily to working capital changes.

Net Loss

Palatin's net loss for the quarter ended December 31, 2024, was $2.4 million, or $(0.12) per basic and diluted common share, compared to a net loss of $7.8 million, or $(0.56) per basic and diluted common share, for the same period in 2023.

The decrease in net loss for the quarter ended December 31, 2024, over the quarter ended December 31, 2023, was driven primarily by the change in fair values of the warrant liability and the elimination of Vyleesi net product revenue and selling expenses, offset by the decrease on gain on the sale of Vyleesi.

Cash Position

As of December 31, 2024, Palatin's cash and cash equivalents were $3.4 million, compared to cash and cash equivalents of $2.4 million at September 30, 2024, and $9.5 million as of June 30, 2024.

The $3.4 million of cash and cash equivalents as of December 31, 2024, does not include $4.3 million of net proceeds from the equity offering, which closed in February 2025.

The Company is actively engaged with multiple potential funding sources for future operating cash requirements.

Conference Call / Webcast

Palatin will host a conference call and audio webcast on February 13, 2025, 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 882092. The audio webcast and replay can be accessed by logging on to the "Investor-Webcasts" section of Palatin's website at http://www.palatin.com. A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone reply, dial 1-877-481-4010 (US) or 1-919-882-2331 (International), passcode 52016. The webcast and telephone replay will be available through February 27, 2025.

About Melanocortin 4 Receptor Agonists Effect on Obesity

Genetic analysis has identified the melanocortin 4 receptor (MC4R) of the paraventricular nucleus of the hypothalamus as playing a central role in appetite regulation. Genetic mutations that inhibit signaling in the MC4R pathway lead to hyperphagia, decreased energy expenditure and early-onset obesity; such mutations have been identified as the cause of several rare genetic obesity disorders. Agouti-related peptide is an endogenous antagonist of the MC4R that works with neuropeptide Y to stimulate appetite, whereas MC4R agonists such as α- and β-melanocyte-stimulating hormone promote satiety. Agonism of the MC4R therefore represents an attractive target for potential obesity treatments.

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 www.Palatin.com 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.