PALATIN TECHNOLOGIES INC
For the period ended Jun 30, 2025. Filed Sep 23, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Sep 23, 2025
PTN$6.27+9.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-06-30; filed 2024-09-30.
0001654954-24-012498
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-06-30; filed 2025-09-23.
0001654954-25-011030
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 50 previous paragraphs and 53 current paragraphs.
28 unchanged; 20 reworded; 5 added; 2 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 1 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (5)
Current report
Our product development activities focus primarily on use of MC4R agonists for treatment of obesity. The Company is developing MC4R peptides and small molecule agonists with potential utility in obesity and metabolic-related disorders, rare MC4R pathway diseases, such as hypothalamic obesity, and orphan indications.
Current report
We are also developing, dependent on resources for development activities, MC1R agonist products, with potential to treat inflammatory and autoimmune diseases, such as dry eye disease, which is also known as keratoconjunctivitis sicca, uveitis, diabetic retinopathy, and inflammatory bowel disease. The Company believes that the MC1R agonist peptides in development have broad anti-inflammatory effects and appear to utilize mechanisms engaged by the endogenous melanocortin system in regulation of the immune system and resolution of inflammatory responses. The Company is also developing, dependent on resources for development activities, peptides and small molecules that are active at more than one melanocortin receptor, with potential utility in obesity and metabolic-related disorders, rare MC4R pathway diseases, such as hypothalamic obesity, and orphan indications.
Current report
On August 14, 2025, we entered into a Research Collaboration, License and Patent Assignment Boehringer Ingelheim to research, develop and commercialize first-in-class melanocortin receptor-targeted peptides developed by the Company for the treatment of retinal diseases, including diabetic retinopathy.
Current report
Under the terms of the Agreement, we received an upfront payment of $2,300,000 (received September 2025) and may receive up to $21,200,000 in near-term research milestone payments and up to $307,000,000 in success-based development, regulatory, and commercial milestone payments, plus tiered royalties on net commercial sales of Products.
Current report
On September 22, 2025, we announced the achievement of a research milestone under its collaboration with Boehringer Ingelheim. This milestone triggers a payment to us of approximately $6,500,000 (expected to be received in October 2025).
Removed paragraphs (2)
Previous report
Our new product development activities focus primarily on use of bremelanotide, or other MC4r agonists, with tirzepatide, a GLP-1 agonist for treatment of obesity, which entered Phase 2 in the second quarter of calendar year 2024, and a co-formulation of bremelanotide with a PDE5i for treatment of erectile dysfunction in patients that do not respond to PDE5i monotherapy. We are also developing MC1r agonists, with potential to treat inflammatory and autoimmune diseases, such as dry eye disease, uveitis, diabetic retinopathy, and inflammatory bowel disease.
Previous report
Income Tax Benefit* –Income tax benefit for fiscal 2023 was $4,674,999 as a result of the Company selling New Jersey state net operating losses (“NOLs”) and R&D credits.*
Reworded paragraphs (20)
Previous wording
Our prior commercial product, Vyleesi®, was approved by the U.S. Food and Drug Administration (“FDA”) in June 2019 for the treatment of hypoactive sexual desire disorder (“HSDD”) in premenopausal women. This product was acquired by Cosette Pharmaceuticals, Inc. (“Cosette”) on December 19, 2023.
Current wording
Our prior commercial product, Vyleesi®, was approved by the U.S. Food and Drug Administration (“FDA”) in June 2019 for the treatment of hypoactive sexual desire disorder (“HSDD”) in premenopausal women. This product was acquired by Cosette Pharmaceuticals, Inc. (“Cosette”) on December 19, 2023, and is still marketed by Cosette, with a release and settlement agreement on June 5, 2025
Previous wording
We recorded product revenues net of allowances for direct and indirect fees, discounts, co-pay assistance programs, estimated chargebacks, and rebates. Certain of these allowances represent estimates of the related obligations and, as such, knowledge and judgement are required when estimating the impact of these allowances on gross product sales for a reporting period. If any of our judgments made during a reporting period are not indicative or accurate estimates of our future experience, our results could be materially affected. Product sales are also subject to return rights, which have not been significant to date.
Current wording
We recorded product revenues net of allowances for direct and indirect fees, discounts, co-pay assistance programs, estimated chargebacks, and rebates. Certain of these allowances represent estimates of the related obligations and, as such, knowledge and judgment are required when estimating the impact of these allowances on gross product sales for a reporting period. If any of our judgments made during a reporting period are not indicative or accurate estimates of our future experience, our results could be materially affected. Product sales are also subject to return rights, which have not been significant to date.
Previous wording
Revenue – For the fiscal year ended June 30, 2024 (“fiscal 2024”) we recognized $4,490,090 of product revenue, net of allowances. For the fiscal year ended June 30, 2023 (“fiscal 2023”) we recognized $4,850,678 of product revenue, net of allowances, and $3,000 in license and contract revenue pursuant to our license agreement with Fosun. The decrease in net revenue is a result of the sale of Vyleesi’s worldwide rights to Cosette during fiscal 2024.
Current wording
Revenue – We did not recognize product revenue for the fiscal year ended June 30, 2025 (“fiscal 2025”). For the fiscal year ended June 30, 2024 (“fiscal 2024”) we recognized $4,490,090 of product revenue, net of allowances. The decrease in net revenue is a result of the sale of Vyleesi’s worldwide rights to Cosette during fiscal 2024.
Previous wording
*Cost of Products Sold –*Cost of products sold was $97,637 for fiscal 2024 compared to $418,470 for fiscal 2023. The decrease in cost of products sold is a result of the sale of Vyleesi’s worldwide rights to Cosette during fiscal 2024.
Current wording
*Cost of Products Sold –*We did not recognize cost of products sold for fiscal 2025. Cost of products sold was $97,637 for fiscal 2024. The decrease in cost of products sold is a result of the sale of Vyleesi’s worldwide rights to Cosette during fiscal 2024.
Previous wording
Research and Development – Total research and development expenses, including general research and development spending, were $22,400,372 for fiscal 2024 compared to $22,630,577 for fiscal 2023. The decrease is a result of lower spending on our MCr programs.
Current wording
Research and Development – Total research and development expenses, including general research and development spending, were $14,898,494 for fiscal 2025 compared to $22,400,372 for fiscal 2024. The decrease is a result of lower spending on our MCR programs.
Previous wording
Research and development expenses related to our Vyleesi, MCr programs, and other preclinical programs were $15,512,149 for fiscal 2024 compared to $16,202,432 for fiscal 2023. The decrease is primarily related to a decrease in spending on our MCr programs.
Current wording
Research and development expenses related to our MCR programs and other preclinical programs were $8,548,616 for fiscal 2025, compared to $15,512,149 for fiscal 2024. The decrease is primarily related to a decrease in spending on our MCR programs.
Previous wording
The amounts of program spending above exclude general research and development spending, which were $6,888,233 for fiscal 2024 compared to $6,428,145 for fiscal 2023. The increase in general research and development spending is primarily attributable to increased compensation costs.
Current wording
The amounts of program spending above exclude general research and development spending, which were $6,349,878 for fiscal 2025, compared to $6,888,233 for fiscal 2024. The decrease in general research and development spending is primarily attributable to decreased compensation costs.
Previous wording
Cumulative spending from inception to June 30, 2024 was approximately $311,900,000 on our Vyleesi program and approximately $234,000,000 on all our other programs (which include PL8177, PL9643, other melanocortin receptor agonists and terminated programs). Due to various risk factors described herein under “Risk Factors,” including the difficulty in currently estimating the costs and timing of future Phase 1 clinical trials and larger-scale Phase 2 and Phase 3 clinical trials for any product under development, we cannot predict with reasonable certainty when, if ever, a program will advance to the next stage of development or be successfully completed, or when, if ever, related net cash inflows will be generated.
Current wording
Cumulative spending from inception to June 30, 2024 was approximately $311,900,000 on our Vyleesi program and approximately $250,700,000 on all our other programs (which include PL8177, PL9643, other melanocortin receptor agonists and terminated programs). Due to various risk factors described herein under “Risk Factors,” including the difficulty in currently estimating the costs and timing of future Phase 1 clinical trials and larger-scale Phase 2 and Phase 3 clinical trials for any product under development, we cannot predict with reasonable certainty when, if ever, a program will advance to the next stage of development or be successfully completed, or when, if ever, related net cash inflows will be generated.
Previous wording
Selling, General and Administrative – Selling, general and administrative expenses, which consist of costs related to Vyleesi in addition to compensation and related costs, were $12,270,046 for fiscal 2024, compared to $15,290,836 for fiscal 2023. The decrease is primarily attributable to $1,912,243 of selling expenses related to Vyleesi in fiscal 2024 compared to $4,621,001 of selling expenses related to Vyleesi in fiscal 2023.
Current wording
Selling, General and Administrative – Selling, general and administrative expenses, which consist of costs related to Vyleesi in addition to compensation and related costs, were $7,809,345 for fiscal 2025, compared to $12,270,046 for fiscal 2024. The decrease is primarily attributable to $1,912,243 of selling expenses related to Vyleesi in fiscal 2024 and decreased compensation costs.
Previous wording
Gain on Purchase Commitment - Gain on purchase commitments was $1,027,322 for fiscal 2023 as a result of the Company amending the minimum purchase commitment that was previously reserved under the Lonza Agreement.
Current wording
Gain on Purchase Commitment - Gain on purchase commitments was $2,117,900 for fiscal 2025 as a result of the Company amending the minimum purchase commitment that was previously reserved under the Catalent and Ypsomed agreements.
Previous wording
Gain on Sale of Vyleesi – On December 19, 2023, the Company entered into an asset purchase agreement (the “Cosette Purchase Agreement”) with Cosette pursuant to which Cosette acquired from the Company worldwide rights to Vyleesi. As a result of the transaction, the Company recorded a gain of $7,781,844 on the sale of Vyleesi for the year ended June 30, 2024. The gain represents the upfront purchase price of $9,500,000 less the cost of net assets transferred to the purchaser.
Current wording
Gain on Sale of Vyleesi – For fiscal 2025, we recorded a gain of $3,130,000 on the sale of Vyleesi as a result of the settlement of sales-based milestone payments and certain purchase commitments. For fiscal 2024, we recorded a gain of $7,781,844 on the sale of Vyleesi. The gain represents the upfront purchase price of $9,500,000 less the cost of net assets transferred to the purchaser.
Previous wording
Other Income (Expense)– Total other income (expense), net was ($7,239,992) for fiscal 2024 compared to $3,747,143 for fiscal 2023. For fiscal 2024, we recognized an increase in the fair value of warrant liabilities of $6,962,562, offering expense of $696,912 and interest expense of $17,114 offset by investment income of $376,843 and unrealized foreign currency gain of $59,753. For fiscal 2023, we recognized a decrease in the fair value of warrant liabilities of $4,620,911 and investment income of $691,981 offset by $1,115,765 of offering expenses, $429,971 of unrealized foreign currency loss and $20,013 of interest expense.
Current wording
Other Income (Expense)– Total other income (expense), net was $152,590 for fiscal 2025 compared to ($7,239,992) for fiscal 2024. For fiscal 2025, we recognized investment income of $167,665 offset by foreign currency transaction losses of $50 and interest expense of $15,025. For fiscal 2024, we recognized an increase in the fair value of warrant liabilities of $6,962,562, offering expense of $696,912 and interest expense of $17,114 offset by investment income of $376,843 and unrealized foreign currency gain of $59,753.
Previous wording
During fiscal 2024, net cash used in operating activities was $31,461,441 compared to net cash used in operating activities of $29,271,346 in fiscal 2023. The increase in cash used in operations in fiscal 2024 compared with fiscal 2023 was a result of a higher net loss in fiscal 2023 due to a change in fair value off warrant liabilities, offset by the gain on the sale of Vyleesi and working capital changes.
Current wording
During fiscal 2025, net cash used in operating activities was $21,306,637 compared to net cash used in operating activities of $31,461,441 in fiscal 2024. The decrease in cash used in operations in fiscal 2025 compared with fiscal 2024 was a result of a lower net loss in fiscal 2024 due to reduced program expenses and a gain on the sale of Vyleesi and a gain on purchase commitments.
Previous wording
During fiscal 2024, net cash provided by investing activities was $12,450,364 which consisted of $9,500,000 related to proceeds from the sale of Vyleesi and $2,992,890 for the maturity of marketable securities offset by $42,526 used for the purchases of property and equipment. During fiscal 2023, net cash used in investing activities was $3,426,757 which consisted of $2,992,830 used for the purchase of marketable securities and $433,927 of leasehold improvements.
Current wording
During fiscal 2025, net cash provided by investing activities was $3,130,000 related to proceeds from the sale of Vyleesi. During fiscal 2024, net cash provided by investing activities was $12,450,364 which consisted of $9,500,000 related to proceeds from the sale of Vyleesi and $2,992,890 for the maturity of marketable securities offset by $42,526 used for the purchases of property and equipment.
Previous wording
During fiscal 2024, net cash provided by financing activities was $20,548,891 which consisted of proceeds from the sale of common stock and warrants, net of issuance costs of $14,693,779 and the exercise of outstanding warrants of $6,045,642 offset by payment of withholding taxes related to restricted stock units of $56,401, and payment of finance lease obligations of $106,392. During fiscal 2023, net cash provided by financing activities was $10,748,591 which consisted of proceeds from the sale of common stock and warrants, net of issuance costs of $10,995,497 and the exercise of outstanding warrants of $78 offset by payment of withholding taxes related to restricted stock units of $146,062, and payment of finance lease obligations of $100,922.
Current wording
During fiscal 2025, net cash provided by financing activities was $11,213,506 which consisted of proceeds from the sale of common stock and warrants, net of issuance costs, of $7,960,765 and the exercise of outstanding warrants of $3,398,237 offset by payment of withholding taxes related to restricted stock units of $99,482, and payment of finance lease obligations of $46,014. During fiscal 2024, net cash provided by financing activities was $20,548,891 which consisted of proceeds from the sale of common stock and warrants, net of issuance costs, of $14,666,042 and the exercise of outstanding warrants of $6,045,642 offset by payment of withholding taxes related to restricted stock units of $56,401, and payment of finance lease obligations of $106,392.
Previous wording
We had a net loss for fiscal 2024 of $29,736,113. We may not attain profitability in future years, which is dependent on numerous factors, including, but not limited to whether and when development and sales milestones are met, regulatory actions by the FDA and other regulatory bodies, the performance of our licensees, and market acceptance of our products.
Current wording
We had a net loss for fiscal 2025 of $17,307,349. We may not attain profitability in future years, which is dependent on numerous factors, including, but not limited to whether and when development and sales milestones are met, regulatory actions by the FDA and other regulatory bodies, the performance of our licensees, and market acceptance of our products.
Previous wording
We have incurred cumulative negative cash flows from operations since our inception, and have expended, and expect to continue to expend in the future, substantial funds to complete our planned product development efforts. Continued operations are dependent upon existing licenses, including royalties and milestones, to complete equity or debt financing activities and enter into additional licensing or collaboration arrangements. As of June 30, 2024, our cash, cash equivalents and marketable securities were $9,527,396 with current liabilities of $9,657,681.
Current wording
We have incurred cumulative negative cash flows from operations since our inception, and have expended, and expect to continue to expend in the future, substantial funds to complete our planned product development efforts. Continued operations are dependent upon existing licenses, including royalties and milestones, to complete equity or debt financing activities and enter into additional licensing or collaboration arrangements. As of June 30, 2025, our cash, cash equivalents and marketable securities were $2,564,265 with current liabilities of $8,010,030.
Previous wording
Our obligations include aggregate lease obligations of $426,556 for the year ending June 30, 2025 and $163,782 for the years ending June 30, 2026 and 2027, and aggregate inventory purchase commitments of $1,976,450 which include $944,150 in current liabilities as of June 30, 2024 and $1,032,300 included in other long-term liabilities.
Current wording
Our obligations include aggregate lease obligations of $129,812 for the year ending June 30, 2026 and $33,969 for the year ending June 30, 2027.
Previous wording
Based on our June 30, 2024, cash and cash equivalents, we have concluded that substantial doubt exists about our ability to continue as a going concern for one year from the date our consolidated financial statements are issued. We are evaluating strategies to obtain additional funding for future operations which include but are not limited to obtaining equity financing, issuing debt, or reducing planned expenses. A failure to raise additional funding or to effectively implement cost reductions could harm our business, results of operations, and future prospects. If we are not able to secure adequate additional funding in future periods, we would be forced to make additional reductions in certain expenditures. This may include liquidating assets and suspending or curtailing planned programs. We may also have to delay, reduce the scope of, suspend, or eliminate one or more research and development programs or its commercialization efforts or pursue a strategic transaction. If we are unable to raise capital when needed or enter into a strategic transaction, then we may be required to cease operations, which could cause our stockholders to lose all or part of their investment. Based on our current existing cash and cash equivalents as of the date of this filing will be sufficient to fund currently anticipated operating expenses through the second half of calendar year 2024.
Current wording
Based on our June 30, 2025, cash and cash equivalents and approximately $2,000,000 we received in September 2025 as a result of the Research Collaboration agreement with Boehringer Ingleheim, we have concluded that substantial doubt exists about our ability to continue as a going concern for one year from the date our consolidated financial statements are issued. We are evaluating strategies to obtain additional funding for future operations which include but are not limited to obtaining equity financing, issuing debt, or reducing planned expenses. A failure to raise additional funding or to effectively implement cost reductions could harm our business, results of operations, and future prospects. If we are not able to secure adequate additional funding in future periods, we would be forced to make additional reductions in certain expenditures. This may include liquidating assets and suspending or curtailing planned programs. We may also have to delay, reduce the scope of, suspend, or eliminate one or more research and development programs or its commercialization efforts or pursue a strategic transaction. If we are unable to raise capital when needed or enter into a strategic transaction, then we may be required to cease operations, which could cause our stockholders to lose all or part of their investment. Based on our current operating and development plans, we expect that our existing cash and cash equivalents as of the date of this filing will be sufficient to fund currently anticipated operating expenses through the second half of calendar year 2025.
Previous wording
We will need additional funding to complete required clinical trials for our product candidates and development programs and, if those clinical trials are successful (which we cannot predict), to complete submission of required regulatory applications to the FDA. However, the COVID-19 pandemic and its resulting impact to economic conditions may negatively impact our operations, including possible effects on our financial condition, ability to access the capital markets on attractive terms or at all, liquidity, operations, suppliers, industry, and workforce. We will continue to evaluate the impact that these events could have on the operations, financial position, and the results of operations and cash flows during fiscal year 2025 and beyond.
Current wording
We will need additional funding to complete required clinical trials for our product candidates and development programs and, if those clinical trials are successful (which we cannot predict), to complete submission of required regulatory applications to the FDA. However, uncertain economic conditions may negatively impact our operations, including possible effects on our financial condition, ability to access the capital markets on attractive terms or at all, liquidity, operations, suppliers, industry, and workforce. We will continue to evaluate the impact that these events could have on the operations, financial position, and the results of operations and cash flows during fiscal year 2025 and beyond.