Advancing MC4R-based obesity programs for rare obesity disorders with a focus on improved tolerability and long-term use, and key IND submissions targeted in calendar 2026 and 2027

• Programs target rare obesity disorders linked to the MC4R pathway, including hypothalamic obesity, Prader-Willi syndrome, and Bardet-Biedl syndrome
  • Once-weekly injectable MC4R selective peptide agonist remains on track for an IND submission in the fourth quarter of calendar 2026
  • Oral MC4R selective agonist program is advancing, with a next-generation oral candidate targeted for IND submission in the first half of calendar 2027
• Focus is on developing best-in-class MC4R candidates designed to enhance potency, improve tolerability, reduce off-target effects, including those associated with hyperpigmentation, and support safe and effective long-term use
• Conference call and webcast scheduled for May 13, 2026, at 11:00 a.m. ET

PRINCETON, N.J., May 13, 2026 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing medicines that target the melanocortin receptor (MCR) system, today announced financial results for its fiscal third quarter ended March 31, 2026, and provided a business update.

"Our goal is to develop best-in-class MC4R agonists. To support this, we have made significant advancements in improving MC4R selectivity and reducing MC1R activity, resulting in highly selective MC4R lead candidates," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin Technologies. "Our once-weekly MC4R selective peptide agonist program remains on track for an IND submission in the fourth quarter of calendar 2026. In our oral MC4R selective agonist program, we have used data from PL7737 and broader program insights to develop next-generation highly selective MC4R candidates, targeting an IND submission for the first half of calendar 2027."

Dr. Spana continued, "Available therapies for rare obesity disorders often present challenges for long-term use. We have leveraged our extensive experience in the design of MC4R selective agonists, along with advancements in our understanding of receptor-ligand interactions, to develop optimized candidates. Our once-weekly injectable peptide lead and next-generation oral small molecule candidates are highly selective for MC4R, which we believe could result in a meaningful reduction in off-target effects associated with MC1R activity, with the potential to eliminate hyperpigmentation. Our next-generation oral small molecule candidates, informed by insights from earlier compounds including PL7737, also demonstrate improved potency. These attributes could translate into improved long-term tolerability, usability, and patient adherence."

Obesity Program Update

Palatin's obesity program is focused on MC4R selective agonists designed to enhance efficacy while improving tolerability and long-term usability.

Planned development and clinical studies will focus on advancing both a long-acting peptide and an oral small-molecule MC4R selective agonist for the treatment of hypothalamic obesity, Prader-Willi syndrome, and Bardet-Biedl syndrome, addressing populations with significant unmet medical need.

• Next-generation peptide MC4R selective agonists:
  • Designed as a once-weekly injection.
  • Preclinical data support sustained efficacy with repeat dosing and a tolerability profile designed to minimize and potentially eliminate hyperpigmentation through greater receptor selectivity.
  • Investigational New Drug (IND) submission and initiation of a Phase 1 single- and multiple-ascending dose (SAD/MAD) trial remains on track for the fourth quarter of calendar year 2026.
• Oral MC4R selective agonists:
  • Palatin is advancing next-generation oral small molecule MC4R selective agonist candidates based on data and learnings from earlier compounds, including PL7737, and broader program insights.
  • In internal preclinical models, these candidates demonstrate improved MC4R selectivity relative to earlier compounds, supporting the potential for enhanced potency and tolerability, including a meaningful reduction in MC1R-mediated off-target effects, with the potential to eliminate hyperpigmentation.
  • IND submission and initiation of a Phase 1 SAD/MAD trial for a next-generation oral MC4R selective agonist candidate is targeted for the first half of calendar year 2027.

Partnering and Out-Licensing Update

• Retinal diseases (MCR agonists) – Partnership with Boehringer Ingelheim, providing non-dilutive capital and potential future milestone and royalty payments.
  • Received an upfront payment and research milestone totaling €7.5 million ($8.8 million), in the second half of calendar year 2025.
  • Eligible to receive payments for development, regulatory, and commercial milestones, in addition to tiered royalties on net sales.
• PL9643 (MC1R agonist) - Dry Eye Disease – Sublicensing agreement with Altanispac Labs, providing non-dilutive capital while preserving potential future payments and royalty economics.
  • Received $3.8 million in upfront consideration in January 2026, strengthening the Company's balance sheet.
  • Eligible to receive additional future payments under the sublicensing agreement, including asset disposition, as well as royalties on net sales.
• PL8177 (MCR agonist) - Ulcerative Colitis – Available for potential partnering following positive Phase 2 proof-of-concept results.
  • Delivered positive Phase 2 proof-of-concept results, supporting the therapeutic potential of the program.
  • Active out-licensing discussions are underway, reflecting interest in the asset's clinical data and potential commercial opportunity.
• Diabetic nephropathy (MCR agonists) – Positive Phase 2 open-label data support continued partnering discussions.
  • Reported positive Phase 2 open-label results, supporting the therapeutic potential of the program.
  • Ongoing out-licensing discussions continue to explore strategic pathways to maximize the value of the asset.

Fiscal Third Quarter Ended March 31, 2026, Financial Results

Revenue

For the third quarter ended March 31, 2026, Palatin recognized $3.9 million in collaboration and license revenue compared to no revenue for the comparable prior-year period. The increase was primarily related to the revenue recognition of the upfront consideration under the Altanispac Agreement.

Operating Expenses

Total operating expenses were $5.5 million, compared to $4.8 million in the prior year period, net of a $0.4 million gain on purchase commitment. The increase was mainly due to higher compensation costs and professional fees during the quarter ended March 31, 2026.

Other Income / (Expense)

Total other income, net, was $0.1 million, compared with less than $0.1 million in the prior year period. The increase was mainly due to higher investment income, partially offset by foreign currency transaction losses and reduced interest expense.

Cash Flows

Net cash used in operations was $4.4 million, compared to $5.4 million in the prior year period. The decrease was mainly due to a decrease in net loss relating to the collaboration and license revenue recognized during the quarter offset by working capital changes.

Net Loss

Palatin reported a net loss for the third quarter ended March 31, 2026, of $1.4 million, or $(0.37) per basic and diluted common share, compared to a net loss of $4.8 million, or $(9.13) per basic and diluted common share, for the comparable quarter last year.

The reduced net loss for the quarter ended March 31, 2026, was mainly due to collaboration and license revenue recognized during the quarter.

Cash Position

As of March 31, 2026, cash and cash equivalents were $10.2 million, with $2.2 million of other receivables, which is expected to be received during the quarter ending June 30, 2026.

Based on the Company's current operating and development plans, and the ability to manage the timing of certain operating expenses, the Company believes its existing cash and cash equivalents and expected other receivables will be sufficient to fund operations through June 30, 2027.

Conference Call / Webcast

Palatin will host a conference call and audio webcast on May 13, 2026, at 11:00 a.m. ET to discuss the results of operations in greater detail and provide an update on corporate developments. To listen to the live conference call, dial 1-888-506-0062 (US) or 1-973-528-0011 (International), Participant Access Code: 405313. 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 replay, dial 1-877-481-4010 (US) or 1-919-882-2331 (International), Replay Passcode 54002. The webcast and telephone replay will be available through May 27, 2026.

Role of MC4R Agonists Effect in Obesity

Hypothalamic neurons expressing the melanocortin-4 receptor (MC4R) play a central role in regulating stored energy, food intake, and body weight. When the MC4R pathway signaling is impaired, patients can experience severe hunger, lower energy use, and early onset obesity. MC4R agonism represents a validated and attractive target for the development of therapies to treat obesity, particularly in disorders driven by dysfunction of the melanocortin pathway.

About Hypothalamic Obesity

Hypothalamic obesity (HO) is a rare and severe form of obesity caused by dysfunction or damage to the hypothalamus, the region of the brain that regulates appetite, satiety, and energy balance. HO can occur as an acquired condition, most commonly after surgery or radiation therapy for brain tumors such as craniopharyngioma, or as a congenital disorder associated with genetic syndromes and developmental abnormalities affecting hypothalamic function. Individuals with HO typically experience rapid weight gain, intense hunger, and serious metabolic problems that are resistant to conventional diet, exercise, and behavioral interventions. Although therapeutic options have recently emerged, HO remains a condition with significant unmet medical need, particularly with respect to long-term efficacy, tolerability, and patient management.

About Prader-Willi Syndrome

Prader-Willi syndrome (PWS) is a rare, complex genetic neurodevelopmental disorder caused by the loss of function of specific genes on chromosome 15. The condition is characterized by hyperphagia, impaired satiety, developmental delays, reduced muscle tone, endocrine abnormalities, and behavioral challenges. Individuals with PWS typically develop an intense and persistent drive to eat, beginning in early childhood, which can lead to severe obesity and related metabolic complications if not strictly managed. Current treatment approaches focus primarily on symptom management, including nutritional supervision, behavioral interventions, and growth hormone therapy. While new drug therapies are emerging, there remains significant unmet need, particularly in addressing hyperphagia and improving long-term tolerability and patient adherence.

About Bardet-Biedl Syndrome

Bardet-Biedl syndrome (BBS) is a rare genetic disorder characterized by early-onset obesity, hyperphagia, retinal degeneration, renal abnormalities, and developmental and cognitive impairment. Obesity in BBS is driven, in part, by dysfunction in the melanocortin signaling pathway, leading to impaired satiety and increased food intake. Individuals with BBS often experience significant, early weight gain and associated metabolic complications that are difficult to manage with conventional interventions. While targeted therapies have recently been approved, BBS remains a serious and lifelong condition with ongoing unmet need, particularly with respect to treatment tolerability, durability of treatment benefit, and overall patient quality of life.

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.

About Palatin

Palatin is a biopharmaceutical company developing medicines that target the melanocortin receptor system 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 more information, visit the company's website at www.palatin.com and follow us on X, formerly Twitter, @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, 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.

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SOURCE Palatin Technologies, Inc.