Palatin Reports Fiscal Year 2025 Third Quarter Results and Business Update

Rhea-AI Summary

Palatin Technologies (OTC PINK: PTNT) reported fiscal Q3 2025 results with significant progress in obesity and ocular programs. Their Phase 2 obesity study combining Bremelanotide with Tirzepatide showed 4.4% weight reduction vs 1.6% for placebo, with 19% of patients achieving ≥7% weight loss. The PL9643 Phase 3 MELODY-1 study in Dry Eye Disease demonstrated unprecedented symptom resolution. However, the company faces challenges as it was delisted from NYSE American due to low stock price, now trading on OTC Pink Market. Financially, Palatin reported a net loss of $4.8 million ($0.18 per share) compared to $8.4 million loss year-over-year. Cash position stands at $2.5 million, with additional $3.5 million raised through ATM facility and equity offering. The company recently closed a $1.1 million public offering of shares and warrants at $0.15 per share.

Positive

• Phase 2 obesity study met primary endpoint with high statistical significance (p<0.0001)
• PL9643 achieved unprecedented symptom resolution in dry eye disease Phase 3 trial
• Operating expenses decreased to $4.8M from $9.2M year-over-year
• Net loss reduced to $4.8M from $8.4M compared to previous year

Negative

• Delisted from NYSE American due to low stock price, now trading on OTC Pink Market
• Low cash position of $2.5M as of March 31, 2025
• Dilutive public offering of shares and warrants at $0.15 per share
• No revenue recorded from product sales

Insights

Biotech Financial Analyst

Palatin shows promising clinical results but faces critical financial challenges with NYSE delisting and dwindling cash reserves.

Palatin's Q3 FY2025 results present a stark contrast between clinical progress and financial struggles. The company reported encouraging data from its obesity and dry eye disease (DED) programs but faces serious financial challenges.

Their obesity program showed a synergistic effect when combining bremelanotide with tirzepatide, achieving 4.4% weight reduction versus 1.6% for placebo (p<0.0001) over just 8 weeks. Importantly, 19% of patients achieved ≥7% weight loss, suggesting potentially clinically meaningful outcomes. Their approach of using an MC4R agonist alongside GLP-1 therapy represents an innovative strategy in the competitive obesity market.

The ocular program results are equally promising, with their PL9643 candidate for dry eye disease demonstrating complete symptom resolution in 6 of 13 symptom endpoints compared to placebo. The company claims this level of symptom clearing exceeds what's been achieved by any currently FDA-approved DED treatment.

However, these positive clinical developments are overshadowed by severe financial constraints. Palatin's cash position has deteriorated to just $2.5 million as of March 31, 2025, down from $9.5 million nine months earlier. The company's burn rate of $5.4 million for the quarter, though improved from $8.6 million in the comparable period, remains unsustainable given their cash reserves.

Most concerning is Palatin's delisting from NYSE American on May 7, 2025, due to low stock price, forcing them to trade on the OTC Pink Market. Their recent public offering raised only $1.1 million, substantially below what would be needed to fund operations long-term. With IND filings planned for Q1 2026, Palatin faces a significant funding gap that threatens program advancement.

The net loss of $4.8 million for the quarter ($(0.18) per share) shows improvement from $8.4 million ($(0.53) per share) in the comparable period, but this progress is insufficient given their precarious financial position. The company's statement about being "actively engaged with multiple potential funding sources" signals urgency in securing additional capital to remain operational.

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 /PRNewswire/ -- 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

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/palatin-reports-fiscal-year-2025-third-quarter-results-and-business-update-302454865.html

SOURCE Palatin Technologies, Inc.

FAQ

What were the key results of PTN's Phase 2 obesity study?

The study showed 4.4% weight reduction in patients receiving co-administration vs 1.6% for placebo, with 19% of patients achieving ≥7% weight loss. The combination showed no added tolerability or safety issues.

Why was Palatin Technologies (PTN) delisted from NYSE American?

PTN was delisted due to the low selling price of its common stock, according to Section 1003(f)(v) of the NYSE American Company Guide. Trading was suspended on May 7, 2025, and the stock moved to OTC Pink Market.

What is Palatin's (PTN) current financial position as of Q3 2025?

PTN reported $2.5M in cash and cash equivalents, plus additional $3.5M raised through ATM facility and equity offering. The company posted a net loss of $4.8M ($0.18 per share).

What were the details of PTN's public offering in May 2025?

PTN closed a public offering of 7,324,119 shares with Series F, G, and H warrants at $0.15 per share, raising approximately $1.1M in gross proceeds.

What progress did Palatin (PTN) make in its dry eye disease program?

PTN's PL9643 Phase 3 MELODY-1 study showed significant complete symptom resolution in 6 of 13 symptom endpoints vs placebo, achieving unprecedented levels of symptom clearing compared to FDA-approved treatments.