Bremelanotide Acetate

Advancing differentiated MC4R-based obesity programs into clinical development Melanocortin-based obesity therapies targeting rare MC4R pathway disorders with a primary focus on hypothalamic obesity and Prader-Willi syndrome Oral small-molecule MC4R agonist PL7737 progressing through IND-enabling toxicology studies, with IND submission and clinical trial initiation planned for the first half of 2026 Next-generation selective peptide MC4R agonists d esigned for once-weekly subcutaneous dosing, with IND submission and clinical trial initiation planned for the second half of 2026 Executed sublicensing of MC1R agonist PL9643 in January 2026, sharpening focus on core obesity portfolio while preserving upside Received $3.8 million in upfront consideration Eligible for future milestone payments and royalties Strengthened balance sheet through successful public financing Completed an $18.2 million public offering, including the full exercise of the over-allotment option, on November 12, 2025 Restored NYSE American listing compliance and trading, re-establishing market visibility and liquidity Teleconference and webcast to be held on February 17, 2026 at 11:00 AM ET PRINCETON, N.J. , Feb. 17, 2026 /PRNewswire/ -- 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 (MCR) system, today announced financial results for its fiscal second quarter ended December 31, 2025, and provided a corporate update. "Palatin continues to advance its MC4R-based obesity pipeline, with our oral small-molecule MC4R agonist, PL7737, on track to enter clinical evaluation in the first half of this year, and a long-acting peptide MC4R agonist expected to initiate clinical development in the second half of the year," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin Technologies. "As we progress these programs, we remain focused on delivering differentiated product profiles designed to enhance patient tolerability, including the potential for reduced gastrointestinal side effects, while minimizing off-target effects such as hyperpigmentation. Our preclinical data support the potential applicability of this approach across both rare and select broader obesity indications, with a particular emphasis on neuroendocrine disorders, including hypothalamic obesity and Prader-Willi syndrome. This focus underscores the differentiated nature of our melanocortin platform and our commitment to addressing areas of significant unmet medical need." "We delivered meaningful execution across our core strategic priorities, highlighted by the successful completion of our $18.2 million public offering, the resumption of trading of our common stock on the NYSE American, and the sublicensing of PL9643, an MC1R agonist Phase 3 asset for dry eye disease," continued Dr. Spana. "Entering 2026, Palatin is positioned with a strengthened balance sheet, multiple partnerships supported by defined near-term milestones, and a focused and differentiated obesity pipeline that provides a clear path toward sustainable, long-term value creation." Obesity Program Update The obesity program is focused on developing differentiated MC4R agonists designed to enhance patient tolerability, including the potential for reduced gastrointestinal side effects, while minimizing off-target effects such as hyperpigmentation. Planned clinical studies are expected to enroll and evaluate patients with hypothalamic obesity and Prader-Willi syndrome, addressing populations with significant unmet medical need. PL7737 (oral MC4R agonist): Demonstrated meaningful weight loss, oral bioavailability across relevant preclinical models. IND-enabling toxicology studies are progressing as planned, with an IND submission and initiation of a Phase 1 single- and multiple-ascending dose (SAD/MAD) trial anticipated in the first half of 2026. Next-generation selective peptide MC4R agonists: Designed for once-weekly subcutaneous dosing, with an IND submission and initiation of a Phase 1 SAD/MAD trial targeted for the second half of 2026. Out-Licensing Programs Update Retinal diseases (MCR agonists) – Collaboration with Boehringer Ingelheim, providing near-term non-dilutive capital and substantial downstream value potential. Received an upfront payment of €2.0 million ($2.3 million) in August 2025. Achieved €5.5 million ($6.5 million) research milestone in September 2025, reflecting continued program progress. Eligible to receive up to €12.5 million ($14.5 million) in additional near-term research milestones and up to €260 million ($307.0 million) in 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 near-term value, while preserving long-term participation. 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 and commercialization milestones, as well as royalties on net sales. PL8177 (MCR agonist) - Ulcerative Colitis, advancing toward strategic partnering following clinical validation. Delivered positive Phase 2 proof-of-concept results, supporting the therapeutic potential of the program. Active out-licensing discussions are underway, reflecting interest from potential partners in the asset's clinical pro commercial potential. Diabetic nephropathy (MCR agonists) - Building on encouraging clinical data to advance partnering opportunities. 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. Corporate Update Public Offering On November 12, 2025, Palatin announced the closing of its upsized $18.2 million underwritten public offering ("Offering"), including the full exercise of the over-allotment option, consisting of 2,795,384 shares of common stock (or pre-funded warrants in lieu thereof) of the Company, together with Series J warrants to purchase up to 2,795,384 shares of common stock (or pre-funded warrants in lieu thereof), (the "Series J Warrants"), and Series K warrants to purchase up to 2,795,384 shares of common stock (or pre-funded warrants in lieu thereof), (the "Series K Warrants"), at a combined public offering price of $6.50 per share of common stock and accompanying Series J and Series K warrants (the "Offering"). Each Series J Warrant has an exercise price of $6.50 per share and will expire on the earlier of (i) the eighteen-month anniversary of the original issuance date or (ii) on the 31st calendar day following the date that the Company receives the U.S. Food and Drug Administration ("FDA") acceptance of the Company's Investigational New Drug for an in-house obesity treatment compound (oral small molecule or long-acting peptide) (the "FDA Exercise Period"). Each Series K Warrant has an exercise price of $8.125 per share and will expire on the five-year anniversary of the original issuance date, however, if a holder's Series J Warrants have not been terminated in accordance with their terms prior to the expiration of the FDA Exercise Period, such holder's Series K Warrants will automatically terminate. The gross proceeds from the Offering, before deducting the underwriting discounts and commissions and offering expenses, were approximately $18.2 million, with net proceeds amounting to $16.9 million. The Company may receive additional proceeds of up to $18.2 million upon the cash exercise of the milestone related Series J Warrants, however, there is no guarantee that such warrants will be exercised and accordingly that the Company will receive any proceeds from the exercise thereof. The Company intends to use the net proceeds from the Offering to support the development of its obesity program and for working capital and general corporate purposes. NYSE American As a result of the closing of the Offering, the Company regained compliance with NYSE American continued listing standard of the NYSE American Company Guide and all applicable requirements for continued listing on NYSE American. Effective November 12, 2025, the Company's common stock resumed trading on the NYSE American under the symbol "PTN." Fiscal Second Quarter Ended December 31, 2025, Financial Results Revenue For the second quarter ended December 31, 2025, Palatin recognized $116,036 in collaboration and license revenue compared to $0 for the comparable quarter last year. The increase in collaboration and license revenue is related to the Boehringer Ingelheim agreement which consisted of certain cost related reimbursements. Operating Expenses Total operating expenses were $7.4 million for the second quarter ended December 31, 2025, compared to $2.6 million for the comparable quarter last year. The increase in operating expenses was mainly due to the gain on the sale of Vyleesi recorded in the quarter ended December 31, 2024, which resulted in a decrease in net operating expenses, and an increase in operating expenses for the quarter ended December 31, 2025, consisting of an increase in costs on our MCR obesity development programs and higher compensation costs and professional fees. Other Income / (Expense) Total other income (expense), net was $64,687 for the second quarter ended December 31, 2025, compared to $168,841 for the comparable quarter last year. The decrease was a result of a decrease in investment income and foreign currency translation gain, offset by a decrease in interest expense incurred during the second quarter ended December 31, 2025. Cash Flows Palatin's net cash used in operations was $4.8 million for the second quarter ended December 31, 2025, and for comparable quarter last year. Net Loss Palatin reported a net loss for the second quarter ended December 31, 2025, of $7.3 million, or $(2.86) per basic and diluted common share, compared to a net loss of $2.4 million, or $(5.92) per basic and diluted common share, for the comparable quarter last year. Cash Position As of December 31, 2025, Palatin's cash and cash equivalents were $14.5 million, compared to cash and cash equivalents of $1.3 million at September 30, 2025, and $2.6 million as of June 30, 2025. Palatin currently expects a cash runway beyond the quarter ending March 31, 2027. In January 2026, as partial consideration for the rights to PL9643, the sublicensing agreement provided for upfront consideration in the form of non-cash debt cancellation of approximately $3,800,000, which is reflected in the Company's current liabilities as of December 31, 2025. The $3,800,000 million will be recognized as license revenue in the Consolidated Statements of Operations for the quarter ending March 31, 2026. Conference Call / Webcast Palatin will host a conference call and audio webcast on February 17, 2026, at 11:00 a.m. ET 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 1-888-506-0062 (US) or 1-973-528-0011 (International), Participant Access Code: 967781. The audio webcast and replay can be accessed by logging on to the "Investor-Webcasts" section of Palatin's website at 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 83633. The webcast and telephone replay will be available through March 3, 2026. Melanocortin-4 Receptor Agonists Effect on Obesity Hypothalamic neurons expressing the melanocortin-4 receptor (MC4R) play a central role in regulating stored energy, food intake, and body weight. Genetic mutations that inhibit signaling through 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. MC4R agonism represents an attractive target for potential obesity treatments. About Hypothalamic Obesity Hypothalamic obesity 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. Hypothalamic obesity 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 hypothalamic obesity typically experience rapid, excessive weight gain, uncontrollable hunger, and profound metabolic disturbances that are resistant to conventional diet, exercise, and behavioral interventions. There are currently no approved pharmacologic treatments specifically indicated for hypothalamic obesity, representing a significant unmet medical need. 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, but there are no approved pharmacologic therapies that directly address hyperphagia or the underlying hypothalamic dysfunction associated with PWS. As a result, PWS represents a significant unmet medical need. 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 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 more information, visit the company's website at and follow us on X (formally 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. PALATIN TECHNOLOGIES, INC. and Subsidiary Consolidated Statements of Operations (unaudited) Three Months Ended December 31, Six Months Ended December 31, 2025 2024 2025 2024 REVENUES Collaboration and license $ 116,036 $ - $ 8,963,586 $ - OPERATING EXPENSES Research and development 4,319,767 3,429,479 6,845,533 9,173,233 General and administrative 3,124,817 1,681,844 4,785,548 3,702,775 Gain on sale of Vyleesi - (2,500,000) - (2,500,000) Total operating expenses 7,444,584 2,611,323 11,631,081 10,376,008 Loss from operations (7,328,548) (2,611,323) (2,667,495) (10,376,008) OTHER INCOME (EXPENSE) Investment income 65,185 29,044 83,668 107,620 Foreign currency transaction gain - 143,600 - 12,000 Interest expense (498) (3,803) (2,500) (9,743) Total other income (expense), net 64,687 168,841 81,168 109,877 NET LOSS $ (7,263,861) $ (2,442,482) $ (2,586,327) $ (10,266,131) Basic and diluted net loss per common share $ (2.86) $ (5.92) $ (1.47) $ (25.36) Weighted average number of common shares outstanding used in computing basic and diluted net loss per common share 2,539,632 412,697 1,755,641 404,799 PALATIN TECHNOLOGIES, INC . and Subsidiary Consolidated Balance Sheets (unaudited) December 31, 2025 June 30, 2025 ASSETS Current assets: Cash and cash equivalents $ 14,476,162 $ 2,564,265 Accounts Receivable 1,636,325 - Other receivables - 29,468 Prepaid expenses and other current assets 1,354,992 325,695 Total current assets 17,467,479 2,919,428 Property and equipment, net 113,485 129,444 Right-of-use assets - operating leases 346,764 161,166 Other assets - 56,916 Total assets $ 17,927,728 $ 3,266,954 LIABILITIES AND STOCKHOLDERS' DEFICIENCY Current liabilities: Accounts payable $ 5,453,080 $ 6,998,806 Accrued expenses 659,841 881,412 Short-term operating lease liabilities 219,727 129,812 Total current liabilities 6,332,648 8,010,030 Long-term operating lease liabilities 129,061 33,969 Total liabilities 6,461,709 8,043,999 Stockholders' equity (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 December 31, 2025: issued and outstanding 4,030 shares as of December 31, 2025 and June 30, 2025 40 40 Series D Convertible: authorized 3,400 shares as of December 31, 2025: issued and outstanding 3,400 shares as of December 31, 2025 and June 30, 2025 34 34 Common stock of $0.01 par value – authorized 300,000,000 shares: issued and outstanding 1,757,199 shares as of December 31, 2025 and 929,597 shares as of June 30, 2025 17,572 9,296 Additional paid-in capital 473,108,599 454,287,484 Accumulated deficit (461,660,226) (459,073,899) Total stockholders' equity (deficiency) 11,466,019 (4,777,045) Total liabilities and stockholders' equity (deficiency) $ 17,927,728 $ 3,266,954 View original content to download multimedia: SOURCE Palatin Technologies, Inc.