Significant Progress in Obesity and Ocular Programs
- Teleconference and Webcast to be held today - May 14, 2025, at 11:00 AM EST
CRANBURY, N.J., May 14, 2025 -- Palatin Technologies, Inc. (OTC PINK: PTNT), 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 third quarter ended March 31, 2025.
"We had a strong quarter operationally, with significant progress across both our obesity and ocular pipelines," said Carl Spana, Ph.D., President and CEO of Palatin. "Our obesity program Phase 2 study results demonstrated the synergistic potential of melanocortin receptor modulation with GLP-1-based therapies, and our PL9643 Phase 3 dry eye disease program results showed a level of symptom resolution not previously achieved by any approved treatments."
Obesity Program Highlights
Phase 2 Study Co-administration of Bremelanotide (MC4R agonist) + Tirzepatide (GLP-1/GIP dual agonist):
- Met primary endpoint in the 8-week treatment study with high statistical significance (p<0.0001).
- Patients receiving co-administration showed a 4.4% weight reduction, vs. 1.6% for placebo.
- 19% of patients achieved ≥7% weight loss (p<0.1).
- Low-dose bremelanotide prevented weight regain typically seen following tirzepatide discontinuation.
- No added tolerability or safety issues observed with the combination.
- Next-Generation MC4R Therapeutics:
- Advancing long-acting peptides and oral small molecules targeting MC4R.
- IND filings planned for Q1 2026; initial clinical data expected in 1H 2026.
- Planned Phase 1 SAD/MAD studies will include patients with hypothalamic obesity.
Ocular Program Highlights
PL9643 – Phase 3 MELODY-1 Study in Dry Eye Disease (DED):
- Responder analysis revealed:
- 6 of 13 symptom endpoints showed significantly greater complete symptom resolution with PL9643 vs. placebo (p<0.05).
- These results represent a level of symptom clearing not achieved by any currently FDA-approved DED treatment.
- FDA approval guidance (2020) supports the use of responder analysis to demonstrate symptom improvement.
- PL9643 continues to demonstrate rapid onset, strong efficacy, and excellent tolerability.
Corporate Update
On May 7, 2025, the Company received notice from NYSE Regulation that it had suspended trading of the Company's common stock on the NYSE American LLC stock exchange ("NYSE American") and determined to commence proceedings to delist the Company's common stock from the NYSE American as a result of its determination that the Company is no longer suitable for listing pursuant to Section 1003(f)(v) of the NYSE American Company Guide due to the low selling price of the Company's common stock. Trading of the Company's common stock on the NYSE American was suspended on May 7, 2025 and began trading on the OTC Pink Market on May 8, 2025.
The Company has exercised its right to a review of NYSE Regulation's determination to delist the Company's common stock by the Listings Qualifications Panel of the Committee for Review of the Board of Directors of the Exchange.
"We are disappointed by the NYSE decision and assessing all available options," added Dr. Spana. "We remain confident in the value of our programs and are fully committed to executing our strategic plan and enhancing shareholder value."
Public Offering
On May 8, 2025, Palatin announced the closing of a reduced previously announced public offering consisting of 7,324,119 shares of common stock together with Series F warrants to purchase up to 7,324,119 shares of common stock, Series G warrants to purchase up to 7,324,119 shares of common stock, and Series H warrants to purchase up to 7,324,119 shares of common stock at a combined public offering price of $0.15 per share of common stock and accompanying warrants. Palatin received aggregate gross proceeds of approximately $1.1 million.
Fiscal Third Quarter Ended March 31, 2025 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 third quarter ended March 31, 2025 and March 31, 2024.
Operating Expenses
Total operating expenses were $4.8 million, net of a $0.4 million gain on purchase commitment for the third quarter ended March 31, 2025, compared to $9.2 million, for the comparable quarter last year. The decrease was mainly the result of the decrease in spending related to our MCR programs for the third quarter ended March 31, 2025.
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 March 31, 2024, Palatin recorded a fair value adjustment gain of $0.4 million.
Cash Flows
Palatin's net cash used in operations for the quarter ended March 31, 2025, was $5.4 million, compared to net cash used in operations of $8.6 million for the same period in 2024. The decrease in net cash used in operations is mainly due to the decrease in net loss during the period and secondarily to working capital changes.
Net Loss
Palatin's net loss for the quarter ended March 31, 2025, was $4.8 million, or $(0.18) per basic and diluted common share, compared to a net loss of $8.4 million, or $(0.53) per basic and diluted common share, for the same period in 2024.
The decrease in net loss for the quarter ended March 31, 2025, over the quarter ended March 31, 2024, was driven primarily by the decrease in operating expenses partially offset by the change in fair values of the warrant liability and the foreign currency transaction gain recorded in the quarter ended March 31, 2024.
Cash Position
As of March 31, 2025, Palatin's cash and cash equivalents were $2.5 million, compared to cash and cash equivalents of $9.5 million at June 30, 2024.
The $2.5 million of cash and cash equivalents as of March 31, 2025, does not include approximately $3.5 million of net proceeds in April and May 2025 from our ATM facility and equity offering.
The Company is actively engaged with multiple potential funding sources, including business development initiatives, for future operating cash requirements.
Conference Call / Webcast
Palatin will host a conference call and audio webcast on May 14, 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 1-877-545-0523 (US) or 1-973-528-0016 (International), conference ID 845014. 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 52446. The webcast and telephone replay will be available through May 28, 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 Χ (formally 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.
PALATIN TECHNOLOGIES, INC. | |||||||
and Subsidiary | |||||||
Consolidated Statements of Operations | |||||||
(unaudited) | |||||||
Three Months Ended March 31, | Nine Months Ended March 31, | ||||||
2025 | 2024 | 2025 | 2024 | ||||
REVENUES | |||||||
Product revenue, net | $ - | $ - | $ - | $ 4,140,090 | |||
OPERATING EXPENSES | |||||||
Cost of products sold | - | - | - | 97,637 | |||
Research and development | 3,755,158 | 7,159,686 | 12,928,391 | 17,728,516 | |||
Selling, general and administrative | 1,474,019 | 2,033,410 | 5,176,794 | 8,266,267 | |||
Gain on sale of Vyleesi | - | 25,202 | (2,500,000) | (7,798,280) | |||
Gain on purchase commitment | (416,000) | - | (416,000) | - | |||
Total operating expenses | 4,813,177 | 9,218,298 | 15,189,185 | 18,294,140 | |||
Income (loss) from operations | (4,813,177) | (9,218,298) | (15,189,185) | (14,154,050) | |||
OTHER INCOME (EXPENSE) | |||||||
Investment income | 31,452 | 139,273 | 139,072 | 272,929 | |||
Foreign currency transaction gain (loss) | (27,900) | 215,600 | (15,900) | 68,653 | |||
Interest expense | (1,795) | (1,254) | (11,538) | (13,741) | |||
Offering expenses | - | - | - | (696,912) | |||
Change in fair value of warrant liabilities | - | 429,029 | - | (6,962,562) | |||
Total other income (expense), net | 1,757 | 782,648 | 111,634 | (7,331,633) | |||
NET LOSS | $ (4,811,420) | $ (8,435,650) | $ (15,077,551) | $ (21,485,683) | |||
Basic and diluted net loss per common share | $ (0.18) | $ (0.53) | $ (0.68) | $ (1.53) | |||
Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share | 26,344,584 | 15,792,421 | 22,245,153 | 14,013,848 | |||
PALATIN TECHNOLOGIES, INC. | |||
and Subsidiary | |||
Consolidated Balance Sheets | |||
(unaudited) | |||
March 31, 2025 | June 30, 2024 | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 2,520,062 | $ 9,527,396 | |
Other receivables | 271,037 | - | |
Prepaid expenses and other current assets | 442,178 | 242,272 | |
Total current assets | 3,233,277 | 9,769,668 | |
Property and equipment, net | 182,437 | 388,361 | |
Right-of-use assets - operating leases | 255,863 | 527,321 | |
Other assets | 56,916 | 56,916 | |
Total assets | $ 3,728,493 | $ 10,742,266 | |
LIABILITIES AND STOCKHOLDERS' DEFICIENCY | |||
Current liabilities: | |||
Accounts payable | $ 7,770,567 | $ 4,101,929 | |
Accrued expenses | 506,460 | 4,185,046 | |
Short-term operating lease liabilities | 194,972 | 380,542 | |
Short-term finance lease liabilities | - | 46,014 | |
Other current liabilities | 1,576,350 | 944,150 | |
Total current liabilities | 10,048,349 | 9,657,681 | |
Long-term operating lease liabilities | 67,248 | 163,782 | |
Other long-term liabilities | - | 1,032,300 | |
Total liabilities | 10,115,597 | 10,853,763 | |
Stockholders' deficiency: | |||
Preferred stock of $0.01 par value – authorized 10,000,000 shares: shares issued | |||
and outstanding designated as follows: | |||
Series A Convertible: authorized 4,030 shares as of March 31, 2025: issued and outstanding 4,030 shares | |||
and outstanding 4,030 shares as of March 31, 2025 and June 30, 2024 | 40 | 40 | |
Common stock of $0.01 par value – authorized 300,000,000 shares: | |||
issued and outstanding 28,557,246 shares as of March 31, 2025 and 17,926,640 shares as of June 30, 2024 | 285,572 | 179,266 | |
Additional paid-in capital | 450,171,385 | 441,475,747 | |
Accumulated deficit | (456,844,101) | (441,766,550) | |
Total stockholders' deficiency | (6,387,104) | (111,497) | |
Total liabilities and stockholders' deficiency | $ 3,728,493 | $ 10,742,266 | |
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