CRANBURY - 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 first quarter ended September 30, 2023, and provided a corporate update.
We continue to expand and execute on business and product development fronts. Our Phase 3 PL9643 clinical study for DED is fully enrolled, with topline data expected late this calendar year. The Phase 2 study of oral PL8177 in patients with ulcerative colitis is expected to have an interim analysis readout in the first quarter and topline trial results in the second quarter of calendar year 2024, said Carl Spana, Ph.D., President and CEO of Palatin. Looking ahead, we are excited to initiate two clinical studies in the first quarter of calendar year 2024 - a Phase 2 study of a melanocortin 4 receptor agonist plus a glucagon like peptide-1 (GLP-1) in obese patients and a Phase 2 clinical study evaluating bremelanotide co-formulated with a PDE5 inhibitor, for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy.
Dr. Spana further commented, On the commercial front, we are pleased with Vyleesi s 7th consecutive quarter of double-digit increases across all value metrics, most notably net product revenue, which increased 20%, and prescriptions dispensed increased 14% over the prior quarter. Importantly, Vyleesi s quarterly net product revenue continues to exceed Vyleesi quarterly operating expenses.
Fiscal First Quarter Ended September 30, 2023 Financial Results
Revenue
Total revenue consists of gross product sales of Vyleesi, net of expenses, allowances and accruals, and license and contract revenue.
Vyleesi gross product sales to pharmacy distributors, for the quarter ended September 30, 2023, were $4.6 million, with net product revenue of $2.1 million, compared to gross product sales of $2.3 million and net product revenue of $0.87 million for the comparable quarter last year. Gross product sales increased 100% and net product revenue increased 142% over the comparable quarter last year.
Operating Expenses
Total operating expenses were $8.2 million for the quarter ended September 30, 2023, compared to $9.6 million for the comparable quarter last year. The decrease in operating expenses was mainly related to the overall decrease in expenses on our MCr programs and secondarily to the overall decrease in selling expenses related to Vyleesi and the reduction in costs of products sold due to the sale of fully reserved Vyleesi inventory.
Cash Flows
Palatin s net cash used in operations for the quarter ended September 30, 2023, was $5.9 million, compared to net cash used in operations of $8.6 million for the same period in 2022. The decrease in net cash used in operations is mainly due to a decrease in net loss offset by working capital changes.
Net Loss
Palatin s net loss for the quarter ended September 30, 2023, was $5.9 million, or $(0.48) per basic and diluted common share, compared to a net loss of $8.3 million, or $(0.86) per basic and diluted common share, respectively, for the same quarter in 2022.
The decrease in net loss for the quarter ended September 30, 2023 over the quarter ended September 30, 2022, was mainly due to the increase of net product revenue of Vyleesi and a decrease in expenses on our MCr programs.
Cash Position
As of September 30, 2023, Palatin s cash, cash equivalents and marketable securities were approximately $5.5 million plus $1.3 million of accounts receivables, compared to $11.0 million plus $2.9 million of accounts receivables as of June 30, 2023.
The $5.5 million of cash, cash equivalents and marketable securities as of September 30, 2023, does not include $4.5 million of net proceeds from the Registered Direct Offering, which closed in October 2023. The Company believes that existing cash, cash equivalents, marketable securities and accounts receivables will be sufficient to fund currently anticipated operating expenses and disbursements into the first half of calendar year 2024.
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.
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 market potential of Vyleesi and other 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, Palatin s ability to establish and maintain the capability for manufacturing, marketing and distribution of Vyleesi, sales of Vyleesi in the United States and elsewhere in the world, 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.
Contact:
Email: info@palatin.com
PALATIN TECHNOLOGIES, INC. 
