PALATIN TECHNOLOGIES INC
For the period ended Sep 30, 2025. Filed Nov 14, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 14, 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-Q
Period ended 2025-03-31; filed 2025-05-14.
0001654954-25-005610
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0001654954-25-013091
Item 2. 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 43 previous paragraphs and 40 current paragraphs.
23 unchanged; 13 reworded; 4 added; 7 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 3 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 (4)
Current report
In August 2025, as disclosed in Note 5 to the Consolidated Financial Statements, we entered into a Research Collaboration, License and Patent Assignment Agreement with Boehringer-Ingelheim International GmbH (“Boehringer Ingelheim”) to research, develop and commercialize first-in-class melanocortin receptor-targeted peptides we developed for the treatment of retinal diseases, including diabetic retinopathy.
Current report
Revenues – For the three months ended September 30, 2025, we recognized $8,847,550 in collaboration and license revenue compared to $0 for the three months ended September 30, 2024. The increase in collaboration and license revenue is related to the BI Agreement which consisted of an upfront payment, the achievement of a research milestone, and FTE related reimbursements.
Current report
*Other Income (Expense) –*Total other income (expense), net was $16,481 for the three months ended September 30, 2025, compared to $(58,964) for the three months ended September 30, 2024. The increase was a result of foreign currency transaction losses incurred during the three months ended September 30, 2024 and a decrease interest expense offset by a decrease in investment income.
Current report
Based on the Company’s available cash and cash equivalents as of September 30, 2025, of $1,273,083 approximately $5,400,000 in cash received during October 2025 in conjunction with the agreement with Boehringer Ingelheim, and approximately $16,900,000 in net proceeds from a public offering in November, 2025, we have concluded that the prior conditions and events raising substantial doubt about our ability to continue as a going concern no longer exist as of the date our consolidated financial statements are issued. 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 enable us to fund operations through the next twelve months following the issuance of the financial statements.
Removed paragraphs (7)
Previous report
Revenues – For the nine months ended March 31, 2025, we recognized $0 in product revenue, net of allowances. For the nine months ended March 31, 2024, we recognized $4,140,090 in product revenue, net of allowances, respectively. The decrease in product revenue, net of allowances is a result of the sale to Cosette of worldwide rights to Vyleesi.
Previous report
*Cost of Products Sold –*Cost of products sold was $0 for the nine months ended March 31, 2025 compared to $97,637 for the nine months ended March 31, 2024. The decrease is a result of the sale to Cosette of worldwide rights to Vyleesi.
Previous report
Gain on Sale of Vyleesi – For the nine months ended March 31, 2025, the Company recorded a gain of $2,500,000 on the sale of Vyleesi as a result of the settlement of certain purchase commitments. For the three and nine months ended March 31, 2024, the Company recorded a loss of $25,202 and a gain of $7,798,280 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 report
Gain on Purchase Commitment - Gain on purchase commitments were $416,000 for the three and nine months ended March 31, 2025 as a result of the completion of certain inventory production runs by Cosette.
Previous report
*Other Income (Expense) –*For the three and nine months ended, March 31, 2025, total other income (expense), net was $1,757 and $111,634, respectively. For the three and nine months ended March 31, 2024, other income (expense) income was $782,648 and $(7,331,633), respectively. The decrease in other income (expense) for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was driven primarily by the change in fair values of the warrant liability and foreign currency transaction gains. The increase in other income (expense), net for the nine months ended March 31, 2025 compared to the nine months ended March 31, 2024 was primarily driven by the an increase in the change in fair value of warrant liabilities and offering expenses.
Previous report
During the nine months ended March 31, 2025, net cash provided by investing activities was $2,500,000, which consisted of proceeds from the sale of Vyleesi. During the nine months ended March 31, 2024, net cash provided by investing activities was $12,455,275, which consisted of $9,500,000 of proceeds from the sale of Vyleesi and $2,992,890 proceeds from the maturity of marketable securities, offset by $37,615 used for the purchase of property and equipment.
Previous report
As a result of our sale of worldwide rights to Vyleesi pursuant to the Purchase Agreement, we currently do not have a recurring source of revenue. Based on our available cash and cash equivalents as of March 31, 2025, the Company has 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 enable the Company to fund its operations into the second half of the calendar year 2025.
Reworded paragraphs (13)
Previous wording
Our significant accounting policies, which are described in the notes to our consolidated financial statements included in this report and in our Annual Report on Form 10-K for the year ended June 30, 2024, have not changed during the three and nine months ended March 31, 2025. We believe that our accounting policies and estimates relating to the carrying value of inventory, revenue recognition, accrued expenses, purchase commitment liabilities, warrants and stock-based compensation are the most critical.
Current wording
Our significant accounting policies, which are described in the notes to our consolidated financial statements included in this report and in our Annual Report on Form 10-K for the year ended June 30, 2025, have not changed during the three months ended September 30, 2025. We believe that our accounting policies and estimates relating to the carrying value of inventory, revenue recognition, accrued expenses, purchase commitment liabilities, warrants and stock-based compensation are the most critical.
Previous wording
Our new product development activities focus on obesity, including co-administration of bremelanotide with tirzepatide, a GLP-1 agonist for treatment of obesity, which has completed Phase 2 in the fourth quarter of calendar year 2024, with topline results expected in the first quarter of calendar year 2025 announced in March 2025, in which co-administration demonstrated an increased weight loss over tirzepatide alone; and secondarily on ocular indications, including PL9643, an ophthalmic peptide solution for dry eye disease (“DED”), which completed Phase 3 clinical trials and announced top line results from the first Phase 3 clinical trial in the first quarter of calendar year 2024; ulcerative colitis, including PL8177, an oral peptide formulation, which entered Phase 2 ulcerative colitis clinical trials in the third quarter of calendar year 2022 and announced topline results in March 2025, with one-third of patients dosed with PL8177 achieving clinical remission while the placebo group saw no clinical remission is expected to report topline results later this quarter. We are actively engaged in discussions with potential partners and licensees that have the financial and operational resources to progress our products for ocular conditions through development, approval and commercialization.
Current wording
Our new product development activities focus on obesity, including co-administration of bremelanotide with tirzepatide, a GLP-1 agonist for treatment of obesity, which has completed Phase 2 in the fourth quarter of calendar year 2024, with topline results expected in the first quarter of calendar year 2025 announced in March 2025, in which co-administration demonstrated an increased weight loss over tirzepatide alone; and secondarily on ocular indications, including PL9643, an ophthalmic peptide solution for dry eye disease (“DED”), which completed Phase 3 clinical trials and announced top line results from the first Phase 3 clinical trial in the first quarter of calendar year 2024; ulcerative colitis, including PL8177, an oral peptide formulation, which entered Phase 2 ulcerative colitis clinical trials in the third quarter of calendar year 2022 and announced topline results in March 2025, with one-third of patients dosed with PL8177 achieving clinical remission while the placebo group saw no clinical remission is expected to report topline results later this quarter. We are actively engaged in discussions with potential partners and licensees that have the financial and operational resources to progress our products for ocular conditions, including PL9643, through development, approval and commercialization.
Previous wording
We were incorporated under the laws of the State of Delaware on November 21, 1986 and commenced operations in the biopharmaceutical area in 1996. Our corporate offices are located at 4B Cedar Brook Drive, Cedar Brook Corporate Center, Cranbury, New Jersey 08512, and our telephone number is (609) 495-2200. We maintain an Internet site, where among other things, we make available free of charge on and through this website our Forms 3, 4 and 5, annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) and Section 16 of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Our website and the information contained in it or connected to it are not incorporated into this Quarterly Report on Form 10-Q. The reference to our website is an inactive textual reference only.
Current wording
We were incorporated under the laws of the State of Delaware on November 21, 1986 and commenced operations in the biopharmaceutical area in 1996. Our corporate offices are located at 103 Carnegie Center Drive, Suite 300 Princeton, New Jersey 08852, and our telephone number is (609) 495-2200. We maintain an Internet site, where among other things, we make available free of charge on and through this website our Forms 3, 4 and 5, annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) and Section 16 of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Our website and the information contained in it or connected to it are not incorporated into this Quarterly Report on Form 10-Q. The reference to our website is an inactive textual reference only.
Previous wording
Three and Nine Months Ended March 31, 2025, Compared to the Three and Nine Months Ended March 31, 2024:
Current wording
Three Months Ended September 30, 2025, Compared to the Three Months Ended September 30, 2024:
Previous wording
Research and Development – Research and development expenses were $3,755,158 and $12,928,391 for the three and nine months ended March 31, 2025, respectively, compared to $7,159,686 and $17,728,516 for the three and nine months ended March 31, 2024, respectively. The decrease was primarily related to a decrease in spending on our MCr programs.
Current wording
Research and Development – Research and development expenses were $2,525,766 for the three months ended September 30, 2025, compared to $5,743,754 for the three months ended September 30, 2024. The decrease was primarily related to a decrease in spending on our MCR programs.
Previous wording
Research and development expenses related to our MCr other preclinical programs were $1,853,851 and $7,822,953 for the three and nine months ended March 31, 2025, respectively compared to $5,487,259 and $12,775,229 for the three and nine months ended March 31, 2024, respectively. The decrease was primarily related to a decrease in spending on our MCr programs.
Current wording
Research and development expenses related to our MCR programs were $970,629 for the three months ended September 30, 2025, compared to $4,081,037 for the three months ended September 30, 2024. The decrease was primarily related to a decrease in spending on our MCR programs.
Previous wording
The amounts of project spending above exclude general research and development spending, which was $1,901,307 and $5,105,438 for the three and nine months ended March 31, 2025, respectively, compared to $1,672,427 and $4,953,286 for the three and nine months ended March 31, 2024, respectively. The decrease is primarily attributable to an decrease in compensation-related expenses.
Current wording
The amounts of project spending above exclude general research and development spending which was $1,554,137 for the three months ended September 30, 2025 compared to $1,662,718 for the three months ended September 30, 2024. The decrease is primarily attributable to a decrease in compensation-related expenses.
Previous wording
Cumulative spending from inception to March 31, 2025, was approximately $311,900,000 on our Vyleesi program and approximately $246,800,000 on all our other programs (which include PL3994, melanocortin receptor agonists, other discovery programs and terminated programs). Due to various risk factors described in our Annual Report on Form 10-K for the year ended June 30, 2024, 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 September 30, 2025, was approximately $311,900,000 on our Vyleesi program and approximately $251,400,000 on all our other programs (which include PL3994, melanocortin receptor agonists, other discovery programs and terminated programs). Due to various risk factors described in our Annual Report on Form 10-K for the year ended June 30, 2025, 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 mainly of compensation and related costs, were $1,474,019 and $5,176,794 for the three and nine months ended March 31, 2025, respectively, compared to $2,033,410 and $8,266,267 for the three and nine months ended March 31, 2024, respectively. The decrease is a result of the elimination of selling expenses relating to Vyleesi.
Current wording
Selling, General and Administrative – Selling, general and administrative expenses, which consist mainly of compensation and related costs, were $1,660,731 for the three months ended September 30, 2025, compared to $2,020,931 for the three months ended September 30, 2024. The decrease is a result of decreased compensation costs.
Previous wording
During the nine months ended March 31, 2025, net cash used in operating activities was $17,217,595 compared to $24,988,985 for the nine months ended March 31, 2024. The decrease was primarily related to a decrease in net loss during the period and working capital changes.
Current wording
During the three months ended September 30, 2025, net cash used in operating activities was $1,619,382 compared to $7,016,213 for the three months ended September 30, 2024. The decrease was primarily related to license and produce revenue recognized during the three months ended September 30, 2025.
Previous wording
During the nine months ended March 31, 2025, net cash provided by financing activities was $7,710,261, which consisted of $3,398,237 of proceeds from the exercise of warrants and 4,457,520 from the sale of common stock, offset by $99,482 for payment of withholding taxes related to restricted stock units and $46,014 for payment of finance lease obligations. During the nine months ended March 31, 2024, net cash provided by financing activities was $14,558,216, which consisted of proceeds from the sale of common stock of $14,693,779, proceeds from the exercise of warrants of $103, offset by $56,401 for payment of withholding taxes related to restricted stock units and $79,265 for payment of finance lease obligations.
Current wording
During the three months ended September 30, 2025, net cash provided by financing activities was $328,200 which consisted of proceeds from the exercise of warrants. During the three months ended September 30, 2024, net cash used in financing activities was $126,969, which consisted $99,482 for payment of withholding taxes related to restricted stock units and $27,487 for payment of finance lease obligations.
Previous wording
We have incurred cumulative negative cash flows from operations since our inception, and have expended substantial funds to advance our planned product development efforts. Continued operations are dependent upon our ability to complete equity or debt financing activities and to enter into additional licensing or collaboration arrangements. As of March 31, 2025, our cash and cash equivalents were $2,520,062, and our current liabilities were $10,048,349.
Current wording
We have incurred cumulative negative cash flows from operations since our inception, and have expended substantial funds to advance our planned product development efforts. Continued operations are dependent upon our ability to complete equity or debt financing activities and to enter into additional licensing or collaboration arrangements. As of September 30, 2025, our cash and cash equivalents were $1,273,083, and our current liabilities were $8,218,261.
Previous wording
Current liabilities include short-term lease obligations in an aggregate amount of $194,972 and inventory purchase commitments in an aggregate amount of $1,576,350. Our long-term obligations consist of $67,248 in long-term lease liabilities.
Current wording
Current liabilities include short-term lease obligations in an aggregate amount of $132,446.