PALATIN TECHNOLOGIES INC
For the period ended Jun 30, 2025. Filed Sep 23, 2025.
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FY2025 · Filed Sep 23, 2025
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
For the fiscal year endedJune 30, 2025
or
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|---|
For the transition period from ___________ to __________
Commission file number:001-15543
PALATIN TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 95-4078884 |
|---|---|
| (State or other jurisdiction ofincorporation or organization) | (I.R.S. Employer Identification No.) |
| 103 Carnegie Center Drive, Suite 300Princeton, New Jersey | 08852 |
| (Address of principal executive offices) | (Zip Code) |
(609)495‑2200
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol | Name of Each Exchange on Which Registered |
|---|---|---|
| Common Stock, par value $.01 per share | PTN1 | NYSE American |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
|---|---|---|---|
| Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| Emerging growth company | ☐ | ||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐ No ☒
State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter (December 31, 2024): $25,548,549
Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date (September 19, 2025):973,291
1 Palatin Technologies, Inc. (the “Company”) has received a notice from the NYSE American LLC (“NYSE American”) stating that the NYSE Regulation has determined 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. NYSE American commenced delisting proceedings in connection with the foregoing determination, and trading the Company’s common stock was suspended on May 7, 2025. The Company’s common stock is currently traded on the OTCQB® Venture Market under the symbol “PTNT”
PALATIN TECHNOLOGIES, INC.
Table of Contents
| Page | ||
|---|---|---|
| PART I | ||
| Item 1. | Business | 1 |
| Item 1A. | Risk Factors | 13 |
| Item 1B. | Unresolved Staff Comments | 36 |
| Item 1C. | Cybersecurity | 36 |
| Item 2. | Properties | 36 |
| Item 3. | Legal Proceedings | 37 |
| Item 4. | Mine Safety Disclosures | 37 |
| PART II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 38 |
| Item 6. | [Reserved] | 38 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 38 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 42 |
| Item 8. | Financial Statements and Supplementary Data | 43 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 66 |
| Item 9A. | Controls and Procedures | 66 |
| Item 9B. | Other Information | 66 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 66 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance | 67 |
| Item 11. | Executive Compensation | 71 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 79 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 82 |
| Item 14. | Principal Accountant Fees and Services | 82 |
| PART IV | ||
| Item 15. | Exhibits and Financial Statement Schedules | 84 |
Special Note Regarding Forward-Looking Statements
In this Annual Report on Form 10-K (this “Annual Report”) references to “we,” “our,” “us,” the “Company” or “Palatin” means Palatin Technologies, Inc. and its subsidiary.
Statements in this Annual Report, as well as oral statements that may be made by us or by our officers, directors, or employees acting on our behalf, that are not historical facts constitute “forward-looking statements,” which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). The forward-looking statements in this Annual Report do not constitute guarantees of future performance. Investors are cautioned that statements that are not strictly historical facts contained in this Annual Report, including, without limitation, the following are forward-looking statements:
| · | our significant operating losses since our inception and our need to obtain additional financing has caused management to determine there is substantial doubt regarding our ability to continue as a going concern; |
| · | our ability to obtain additional financing on terms acceptable to us, or at all, including unavailability of funds or delays in receiving funds as a result of economic disruptions; |
| · | our expectation that we will incur losses for the foreseeable future and may never achieve or maintain profitability; |
| · | our business, financial condition, and results of operations may be adversely affected by increases in costs of and delays in conducting human clinical trials and the performance of our contractors and suppliers, reduction in our productivity or the productivity of our contractors and suppliers, supply chain constraints, and labor shortages; |
| · | whether Boehringer Ingelheim International GmbH (“Boehringer Ingelheim”), which in August 2025 acquired certain Palatin patent applications to first-in-class melanocortin receptor-targeted peptides developed by Palatin, will be able to successfully develop a product for the treatment of retinal diseases, including diabetic retinopathy; |
| · | whether Cosette Pharmaceuticals, Inc. (“Cosette”), which acquired our Vyleesi® (the trade name for bremelanotide for treatment of hyperactive sexual desire disorder in premenopausal women) product in December 2023, will have sufficient sales to generate significant milestone payments under our purchase agreement with Cosette; |
| · | the results of clinical trials and the timing of regulatory submissions with our late-stage products, including co-administration of bremelanotide with tirzepatide, a GLP-1 agonist for treatment of obesity, which entered Phase 2 in the second quarter of calendar year 2024 and reported positive topline date in the first quarter of calendar year 2025; a novel once-weekly melanocortin receptor-4 (“MC4R”) peptide agonist for obesity indications, with an Investigational New Drug (“IND”) filing projected in the first quarter of calendar year 2026; PL7737, an oral small molecule MC4R agonist, with an IND filing projected in the first quarter of calendar year 2026; PL9643, an MCR agonist for dry eye disease, which successfully completed a Phase 3 clinical trial with a second Phase 3 clinical trial targeted for the first half of calendar year 2026; PL8177, an oral peptide formulation for treatment of ulcerative colitis, which reported positive topline data in a Phase 2 clinical trial proof-of-concept trial in the first quarter of 2025; and an MC4R agonist for diabetic nephropathy, which reported positive topline date in the fourth quarter of 2024; |
| · | estimates of our expenses, future revenue and capital requirements; |
| · | our ability to achieve profitability; |
| · | our ability to advance product candidates into, and successfully complete, clinical trials; |
| · | the initiation, timing, progress and results of future preclinical studies and clinical trials, and our research and development programs; |
| · | the timing or likelihood of regulatory filings and approvals; |
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| · | our expectations regarding the clinical efficacy and utility of our melanocortin agonist product candidates for treatment of inflammatory and autoimmune related diseases and disorders, including ocular indications; |
| · | our ability to compete with other products and technologies treating the same or similar indications as our product candidates; |
| · | the ability of our contract manufacturers to perform their manufacturing activities for us in compliance with applicable regulations; |
| · | our ability to recognize the potential value of our licensing arrangements with third parties; |
| · | the potential to achieve revenues from the sale of our product candidates; |
| · | our ability to obtain adequate reimbursement from private insurers and other healthcare payers; |
| · | our ability to maintain product liability insurance at a reasonable cost or in sufficient amounts, if at all; |
| · | the performance and retention of our management team, senior staff professionals, other employees, and third-party contractors and consultants; |
| · | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology in the United States and throughout the world; |
| · | our compliance with federal and state laws and regulations; |
| · | the timing and costs associated with obtaining regulatory approval for our product candidates; |
| · | the impact of fluctuations in foreign exchange rates; |
| · | the impact of any geopolitical instability, economic uncertainty, financial markets volatility, or capital markets disruption resulting from the ongoing military conflict between Russia and Ukraine, and any resulting effects on our revenue, financial condition, or results of operations; |
| · | the impact of legislative or regulatory healthcare reforms in the United States; |
| · | our ability to adapt to changes in global economic conditions as well as competing products and technologies; and |
| · | our ability to remain listed on the NYSE American stock exchange and to have trading on the NYSE American stock exchange reinstated. |
Such forward-looking statements involve risks, uncertainties and other factors that could cause our actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Our future operating results are subject to risks and uncertainties and are dependent upon many factors, including, without limitation, the risks identified under the caption “Risk Factors” and elsewhere in this Annual Report, and any of those made in our other reports filed with the U.S. Securities and Exchange Commission (the “SEC”). Except as required by law, we do not intend, and undertake no obligation, to publicly update forward-looking statements to reflect events or circumstances after the date of this document or to reflect the occurrence of unanticipated events.
Trademarks and Trade Names
Palatin Technologies® is a registered trademark of Palatin Technologies, Inc., and Palatin™ and the Palatin logo are trademarks of Palatin Technologies, Inc. Other trademarks referred to in this report are the property of their respective owners.
Risk Factors Summary
The following is a summary of the principal risks that could adversely affect our business, financial condition, operating results, cash flows or stock price. Discussion of the risks listed below, and other risks that we face, are discussed in the section titled “Risk Factors” in Part I, Item 1A of this Annual Report.
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Risks Related to Our Financial Results and Need for Financing
| · | Our management has determined that there is substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing. |
| · | We have a history of substantial net losses, including a net loss of $17.3 million for the year ended June 30, 2025, and expect to incur substantial net losses over the next few years, and we may never achieve or maintain profitability. |
| · | We will need additional funding, including funding to complete clinical trials for our product candidates, which additional funding may not be available on acceptable terms, if at all. |
| · | We have a limited operating history upon which to base an investment decision. |
| · | Raising additional capital may cause dilution to existing stockholders, restrict our operations or require us to relinquish rights. |
Risks Related to Our Business, Strategy, and Industry
| · | Our product candidates, including a novel once-weekly peptide agonist, PL7737 oral small molecule MCR agonist, PL9643 for dry eye disease and PL8177 for the treatment of ulcerative colitis, are still in the early stages of development and remain subject to clinical testing and regulatory approval. If we are unable to successfully develop and test our product candidates, we will not be successful. |
| · | If clinical trials for our product candidates are prolonged or delayed, we may be unable to commercialize our product candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any revenue from potential product sales. |
| · | Even if our product candidates receive regulatory approval in the United States, they may never achieve market acceptance in the United States or approval outside the United States, in which case our business, financial condition and results of operations will be materially adversely affected. |
| · | If side effects emerge that can be linked to any of our product candidates (either while they are in development or after they are approved and on the market), we may be required to perform lengthy additional clinical trials, change the labeling of any such products, or withdraw such products from the market, any of which would hinder or preclude our ability to generate revenues. |
Risks Related to Government Regulation
| · | Both before and after marketing approval, our product candidates are subject to ongoing regulatory requirements and, if we fail to comply with these continuing requirements, we could be subject to a variety of sanctions and the sale of any approved commercial products could be suspended. |
Risks Related to the Ownership of Our Common Stock
| · | Our stock price is volatile and may fluctuate in a way that is disproportionate to our operating performance and we expect it to remain volatile, which could limit investors’ ability to sell stock at a profit. |
| · | Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be our stockholders’ sole source of gains. |
| · | As of September 19, 2025, there were 838,142 shares of common stock underlying outstanding convertible preferred stock, options, restricted stock units and warrants. Stockholders may experience dilution from the conversion of preferred stock, exercise of outstanding options and warrants and vesting and delivery of restricted stock units. |
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