Palatin Reports Fiscal Year 2026 Financial Results and Provides Business Update

• Programs are focused on rare obesity disorders associated with the melanocortin 4 receptor (MC4R) pathway, including hypothalamic obesity, Prader-Willi syndrome and Bardet-Biedl syndrome
  • Once-weekly injectable MC4R selective peptide agonist Phase 1 SAD/MAD study targeted to initiate in the first half of calendar 2027, with initial data targeted in the second half of 2027
  • Oral MC4R selective agonist Phase 1 SAD/MAD study targeted to initiate in the second half of calendar 2027, with initial data targeted in the first half of 2028
  • Multiple lipidated and non-lipidated peptide compounds demonstrated potent MC4R agonist activity but are not agonists at melanocortin 1 receptor (MC1R), supporting the potential to minimize or eliminate MC1R-mediated hyperpigmentation
• Fiscal 2026 collaboration and license revenue totaled $13.2 million, with approximately $9.4 million related to Boehringer Ingelheim and $3.8 million of non-cash license revenue under the Altanispac Labs agreement
• Cash and cash equivalents were $7.5 million as of June 30, 2026; additional funding will be required to continue advancing development programs and fund operations
• Conference call and webcast scheduled for September 28, 2026, at 11:00 a.m. ET

PRINCETON, N.J., Sept. 28, 2026 /PRNewswire/ -- Palatin Technologies, Inc. (Nasdaq: PTN), a biopharmaceutical company developing medicines that target the melanocortin receptor ("MCR") system, today reported financial results for the fiscal year ended June 30, 2026 and provided an update on its MC4R-focused obesity development programs and partnering activities.

"MC4R agonism is now clinically and commercially validated in multiple rare and syndromic obesity disorders, establishing a strong foundation for the development of next-generation therapies," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin Technologies. "While currently available and emerging therapies have demonstrated meaningful efficacy, gastrointestinal adverse events and hyperpigmentation remain important challenges for patients requiring long-term treatment. Our objective is to develop MC4R therapies that deliver comparable or greater efficacy with improved tolerability, little to no hyperpigmentation, and product profiles suitable for lifelong use."

"We are advancing two complementary peptide series, non-lipidated PL1000 and lipidated PL2000, with tested compounds from both demonstrating potent MC4R agonist activity and not acting as agonists at MC1R. These findings support our strategy to minimize or potentially eliminate MC1R-mediated hyperpigmentation. Combined with our work to improve gastrointestinal tolerability, develop a long-acting injectable therapy and advance our oral small-molecule program, we believe we are building a differentiated portfolio for patients with rare and syndromic obesity disorders," continued Dr. Spana.

Obesity Program Update
Palatin is advancing three distinct and complementary treatment approaches to developing selective MC4R agonists for rare and syndromic obesity disorders: a lipidated peptide program, a non-lipidated peptide program, and an oral small-molecule program. The programs are being designed around a common target product profile of meaningful efficacy, improved tolerability, little to no hyperpigmentation and dosing profiles suitable for long-term treatment. Initial clinical development is planned in hypothalamic obesity ("HO"), Prader-Willi syndrome ("PWS") and Bardet-Biedl syndrome ("BBS"), with potential application to other rare MC4R pathway disorders.

The Company is progressing these programs toward clinical development, with IND-enabling and CMC activities ongoing for the lead lipidated peptide candidate, controlled-release formulation optimization for the non-lipidated candidate, and continued preclinical optimization of the oral small-molecule program. Planned development activities, clinical studies and associated milestones remain subject to the availability of appropriate funding.

Next-Generation Peptide MC4R Selective Agonists

• Palatin is advancing two complementary selective MC4R peptide series: non-lipidated PL1000 and lipidated PL2000, with the objective of developing long-acting subcutaneous therapies suitable for chronic treatment.
• Palatin's lead lipidated MC4R peptide development candidate has demonstrated significant reductions in food intake and body weight with once-weekly subcutaneous dosing in a diet-induced obese mouse model. Preclinical pharmacokinetic data support the potential for once-weekly or less frequent dosing in humans.
• IND-enabling and CMC activities are ongoing for the lead lipidated peptide candidate in preparation for planned first-in-human clinical development.
• For its lead PL1000 non-lipidated peptide candidate, Palatin has established the feasibility of once-weekly subcutaneous dosing and is working to optimize a controlled-release formulation.
• Tested compounds from both peptide series have demonstrated potent MC4R agonist activity and are not agonists at MC1R, supporting Palatin's objective to minimize or potentially eliminate MC1R-mediated hyperpigmentation.
• A Phase 1 SAD/MAD study of the lead lipidated peptide candidate is targeted to initiate in the first half of calendar 2027, with initial data targeted in the second half of calendar 2027.

Oral MC4R Selective Agonists

• Palatin is developing oral small-molecule MC4R selective agonists as a third and complementary treatment approach, building on learnings from its earlier drug candidate, PL7737, and utilizing multiple drug-design approaches, including AI and ML tools.
• Preclinical work has identified candidates with improved potency and MC4R selectivity relative to earlier compounds, along with favorable oral bioavailability. Palatin's objective is to develop an oral MC4R agonist capable of delivering comparable or greater efficacy with improved tolerability compared with emerging oral MC4R therapies, while limiting or avoiding MC1R agonism to minimize or eliminate hyperpigmentation.
• A Phase 1 SAD/MAD study is targeted to initiate in the second half of calendar 2027, with initial Phase 1 data targeted in the first half of calendar 2028.

Partnering and Out-Licensing Update

Retinal Diseases – Boehringer Ingelheim

• Palatin and Boehringer Ingelheim have a research collaboration and license agreement covering proprietary MCR-targeted compounds for retinal diseases.
• Palatin recognized approximately $9.4 million in collaboration and license revenue related to the agreement during fiscal 2026.
• Palatin remains eligible for success-based development, regulatory and commercial milestone payments and tiered royalties on net sales of licensed products.
• Palatin conducts collaborative research and development activities, with approved costs reimbursed by Boehringer Ingelheim.

PL9643 – Dry Eye Disease

• Palatin has an exclusive sublicense agreement with Altanispac Labs for PL9643 in dry eye disease.
• Palatin recognized approximately $3.8 million in fiscal 2026 license revenue under the agreement in the form of non-cash debt cancellation.
• Palatin remains eligible for future payments and tiered royalties under the agreement.

PL8177 – Ulcerative Colitis

• Palatin has reported positive Phase 2 proof-of-concept results for PL8177 in ulcerative colitis.
• PL8177 is available for partnering or out-licensing, and strategic discussions are ongoing.

Diabetic Nephropathy – MCR Agonist

• Palatin has reported positive Phase 2 open-label results with an MCR agonist in diabetic nephropathy.
• The program is available for partnering or out-licensing, and strategic discussions are ongoing.

Fiscal Fourth Quarter and Year Ended June 30, 2026 Financial Results

Revenue
For the fiscal fourth quarter ended June 30, 2026, Palatin recognized approximately $0.3 million in collaboration and license revenue, compared with no revenue for the comparable prior-year period. For the fiscal year 2026, Palatin recognized $13.2 million in collaboration and license revenue, compared with no revenue for fiscal year 2025. The collaboration and license revenue recognized was related to the Boehringer Ingelheim and Altanispac agreements.

Operating Expenses
Total operating expenses were approximately $4.7 million for the fiscal fourth quarter ended June 30, 2026, compared with approximately $2.3 million for the comparable prior-year period, which included gains related to Vyleesi and purchase commitments.

For fiscal year 2026, total operating expenses were $21.9 million compared with $17.5 million for fiscal year 2025, which included a $3.1 million gain on the sale of Vyleesi and a $2.1 million gain on purchase commitments.

Research and development expenses were approximately $2.0 million for both the fiscal fourth quarter ended June 30, 2026 and the comparable prior-year period. For fiscal year 2026, research and development expenses were $12.4 million compared with $14.9 million for fiscal year 2025. The year-over-year decrease was primarily attributable to lower expenses related to the timing of certain activities on the Company's MC4R programs.

General and administrative expenses were approximately $2.7 million for the fiscal fourth quarter ended June 30, 2026, compared with approximately $2.6 million for the comparable prior-year period. For fiscal year 2026, general and administrative expenses were $9.5 million compared with $7.8 million for fiscal year 2025. The year-over-year increase was primarily attributable to higher professional fees.

Net Loss
For the fiscal fourth quarter ended June 30, 2026, Palatin reported a net loss of $4.4 million, or $(1.11) per basic and diluted common share, compared with a net loss of $2.2 million, or $(2.73) per basic and diluted common share for the comparable prior-year period. The increase in net loss was primarily attributable to gains related to Vyleesi and purchase commitments that reduced operating expenses for the fourth quarter ended June 30, 2025.

For fiscal year 2026, Palatin reported a net loss of $8.4 million, or $(2.96) per basic and diluted common share, compared with a net loss of $17.3 million, or $(32.15) per basic and diluted common share for fiscal year 2025. The reduced fiscal-year net loss was primarily attributable to collaboration and license revenue recognized during fiscal year 2026, offset by gains related to Vyleesi and purchase commitments that reduced operating expenses for fiscal year 2025.

Cash Flows
Net cash used in operating activities was $13.5 million for fiscal year 2026 compared with $21.3 million for fiscal year 2025. The decrease was primarily attributable to the lower net loss resulting from collaboration and license revenue under the Boehringer Ingelheim and Altanispac agreements.

Net cash provided by financing activities was $18.5 million during fiscal year 2026, consisting primarily of approximately $16.9 million in net proceeds from sales of common stock and warrants and $1.6 million from warrant exercises. Net cash provided by financing activities during fiscal year 2025 was $11.2 million, consisting primarily of approximately $8.0 million in net proceeds from sales of common stock and warrants and $3.4 million from warrant exercises offset by approximately $0.2 million of cash payments for lease and tax obligations.

Cash Position
As of June 30, 2026, Palatin had $7.5 million in cash and cash equivalents, compared with $2.6 million as of June 30, 2025. Current liabilities were approximately $1.8 million as of June 30, 2026.

Based on our cash and cash equivalents as of June 30, 2026, and our current operating and development plans, including our ability to reduce or delay certain expenditures within management's control, we do not expect our existing cash and cash equivalents to be sufficient to fund our operations for at least twelve months following the issuance of these financial statements.

We will require additional financing to continue advancing our development programs and fund our operations. Although we intend to pursue additional capital through equity financings, collaboration arrangements and other potential sources, there can be no assurance that financing will be available when needed or on acceptable terms. Accordingly, substantial doubt exists about our ability to continue as a going concern.

Conference Call / Webcast
Palatin will host a conference call and audio webcast on September 28, 2026, at 11:00 a.m. ET to discuss fiscal 2026 financial results and provide an update on corporate and development activities. To listen to the live conference call, dial 1-888-506-0062 (US) or 1-973-528-0011 (International), Participant Access Code: 115353. 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 54564. The webcast and telephone replay will be available through October 12, 2026.

Role of MC4R Agonists in Obesity
Hypothalamic neurons expressing the melanocortin-4 receptor ("MC4R") play a central role in regulating stored energy, food intake and body weight. When MC4R pathway signaling is impaired, patients can experience severe hunger, reduced energy expenditure and early-onset or severe obesity. MC4R agonism represents a clinically validated therapeutic approach for obesity 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 is involved in the regulation of metabolism, food intake, inflammation, immune responses and sexual function. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors through receptor-specific agonists or antagonists can produce medically significant pharmacological effects.

About Palatin
Palatin is a biopharmaceutical company developing first-in-class medicines based on peptide and small-molecule compounds that modulate the activity of the melanocortin receptor system. Palatin's principal strategic development focus is advancing selective MC4R agonists for rare obesity disorders, while utilizing collaborations, licensing arrangements and strategic partnerships to advance other MCR-based programs and generate potential milestone and royalty economics.

For more information, visit the Company's website at www.palatin.com.

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 timing and results, potential actions by regulatory agencies, regulatory plans, development programs, proposed indications for product candidates, financing and cash runway, 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 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 preclinical studies and clinical trials, regulatory actions by the FDA and other regulatory authorities, 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 undertakes no obligation to update forward-looking statements except as required by law.

SOURCE Palatin Technologies, Inc.