PALATIN TECHNOLOGIES INC
For the period ended Dec 31, 2024. Filed Feb 13, 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.
Dec 31, 2024 · Filed Feb 13, 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 2024-09-30; filed 2024-11-14.
0001654954-24-014335
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-12-31; filed 2025-02-13.
0001654954-25-001431
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 38 previous paragraphs and 41 current paragraphs.
21 unchanged; 15 reworded; 5 added; 2 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 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
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Current report
Three and Six Months Ended December 31, 2024, Compared to the Three and Six Months Ended December 31, 2023:
Current report
*Cost of Products Sold –*Cost of products sold was $0 for the six months ended December 31, 2024 compared to $97,637 for the three and six months ended December 31, 2023. The decrease is a result of the sale to Cosette of worldwide rights to Vyleesi.
Current report
Gain on Sale of Vyleesi – For the three and six months ended December 31, 2024, 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 six months ended December 31, 2024, the Company recorded a gain of $7,823,482 on the sale of worldwide rights to Vyleesi. The gain represents the upfront purchase price of $9,500,000 less the cost of net assets transferred to the purchaser.
Current report
*Other Income (Expense) –*For the three and six months ended, December 31, 2024, total other income (expense), net was $168,841 and $109,877, respectively. For the three and six months ended December 31, 2023, other (expense) income was $(9,017,179) and $(8,114,281), respectively. The increase in other income (expense) for the three and six months ended December 31, 2024 compared to the three and six months ended December 31, 2023 was driven primarily by the change in fair values of the warrant liability, a decrease in offering expenses and foreign currency transaction gains.
Removed paragraphs (2)
Previous report
Three Months Ended September 30, 2024, Compared to the Three Months Ended September 30, 2023:
Previous report
*Other (Expense) Income –*Total other (expense) income, net was ($58,964) and $902,898 for the three months ended September 30, 2024 and 2023, respectively. For the three months ended September 30, 2024, we recognized foreign currency loss of $131,600 and $5,940 of interest expense offset by investment income of $78,576. For the three months ended September 30, 2023, we recognized an increase in the fair value of warrant liabilities of $682,400, foreign currency gain of $159,750 and investment income of $71,630 offset by $10,882 of interest expense.
Reworded paragraphs (15)
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 months ended September 30, 2024. 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, 2024, have not changed during the three and six months ended December 31, 2024. 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
We are a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems. Our product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential.
Current wording
We are a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems. Our product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential.
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 entered Phase 2 in the second quarter of calendar year 2024, and treatment of erectile dysfunction, including a co-formulation of bremelanotide with a phosphodiesterase type 5 inhibitor (“PDE5i”) for treatment of erectile dysfunction in patients that do not respond to PDE5i monotherapy, scheduled to start a pharmacokinetic study in the first quarter of calendar year 2025; 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 a proof-of-concept melanocortin agonist clinical trial for diabetic nephropathy, which entered a Phase 2 clinical in the fourth quarter of calendar year 2022. 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; 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 is expected to report topline results in the first quarter of calendar year 2025. 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.
Previous wording
*Revenues –*For the three months ended September 30, 2024 and 2023, we recognized $0 and $2,105,977 in product revenue, net of allowances, respectively. The decrease in net revenue is a result of the sale of Vyleesi’s worldwide rights to Cosette.
Current wording
Revenues – For the six months ended December 31, 2024, we recognized $0 in product revenue, net of allowances. For the three and six months ended December 31, 2023, we recognized $2,034,113 and $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 wording
Research and Development – Research and development expenses were $5,743,754 and $5,014,630 for the three months ended September 30, 2024 and 2023, respectively. The increase for the three months ended September 30, 2024, as compared to the three months ended September 30, 2023, was related to the overall increase in spending on our MCr programs.
Current wording
Research and Development – Research and development expenses were $3,429,479 and $9,173,233 for the three and six months ended December 31, 2024, respectively, compared to $5,554,200 and $10,568,830 for the three and six months ended December 31, 2023, respectively. The decrease was primarily related to a decrease in spending on our MCr programs.
Previous wording
Research and development expenses related to our MCr programs and other preclinical programs were $4,081,037 and $3,459,587 for the three months ended September 30, 2024 and 2023, respectively. The increase was primarily related to an increase in spending on our MCr programs.
Current wording
Research and development expenses related to our MCr other preclinical programs were $1,888,065 and $5,969,102 for the three and six months ended December 31, 2024, respectively compared to $3,828,383 and $7,287,971 for the three and six months ended December 31, 2023, respectively. 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 $1,662,717 and $1,672,427 for the three months ended September 30, 2024 and 2024, respectively. The decrease is primarily attributable to a decrease in compensation-related expenses.
Current wording
The amounts of project spending above exclude general research and development spending, which was $1,662,717 and $3,204,131 for the three and six months ended December 31, 2024, respectively, compared to $1,725,817 and $3,280,859 for the three and six months ended December 31, 2023, respectively. The decrease is primarily attributable to a decrease in compensation-related expenses.
Previous wording
Cumulative spending from inception to September 30, 2024, was approximately $311,900,000 on our Vyleesi program and approximately $239,700,000 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 December 31, 2024, was approximately $311,900,000 on our Vyleesi program and approximately $243,100,000 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.
Previous wording
Selling, General and Administrative – Selling, general and administrative expenses, which consist mainly of compensation and related costs, were $2,020,931 and $3,200,244 for the three months ended September 30, 2024 and 2023, 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 $1,681,844 and $3,702,775 for the three and six months ended December 31, 2024, respectively, compared to $3,032,613 and $6,232,857 for the three and six months ended December 31, 2023, respectively. The decrease is a result of the elimination of selling expenses relating to Vyleesi.
Previous wording
During the three months ended September 30, 2024, net cash used in operating activities was $7,016,213 compared to $5,906,393 for the three months ended September 30, 2023. The increase in cash used in operations for the three months ended September 30, 2024, compared to the three months ended September 30, 2023, was primarily related to an increase in the net loss during the period and working capital changes.
Current wording
During the six months ended December 31, 2024, net cash used in operating activities was $11,863,319 compared to $16,382,079 for the six months ended December 31, 2023. The decrease was primarily related to a decrease in net loss during the period and working capital changes.
Previous wording
During the three months ended September 30, 2023, net cash provided by investing activities was $2,992,890 related to the maturity of marketable securities.
Current wording
During the six months ended December 31, 2024, net cash provided by investing activities was $2,500,000, which consisted of proceeds from the sale of Vyleesi. During the six months ended December 31, 2023, 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 wording
During the three months ended September 30, 2024, net cash used in financing activities was $126,969, which consisted of $99,482 for payment of withholding taxes related to restricted stock units and $27,487 for payment of finance lease obligations. During the three months ended September 30, 2023, net cash provided by financing activities was $448,894, which consisted of proceeds from the sale of common stock of $531,369, offset by $56,401 for payment of withholding taxes related to restricted stock units and $26,074 for payment of finance lease obligations.
Current wording
During the six months ended December 31, 2024, net cash provided by financing activities was $3,252,527, which consisted of $3,398,023 of proceeds from the exercise of warrants, 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 six months ended December 31, 2023, net cash provided by financing activities was $5,422,474, which consisted of proceeds from the sale of common stock of $5,531,266, proceeds from the exercise of warrants of $103, offset by $56,401 for payment of withholding taxes related to restricted stock units and $52,494 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 September 30, 2024, our cash and cash equivalents were $2,384,214, and our current liabilities were $9,861,717.
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 December 31, 2024, our cash and cash equivalents were $3,416,604, and our current liabilities were $9,558,756.
Previous wording
Our obligations include short-term lease obligations in an aggregate amount of $338,047 in current liabilities as of September 30, 2024, $132,447 in long-term lease liabilities, inventory purchase commitments in an aggregate amount of $2,108,050 which consists of $1,001,350 in current liabilities as of September 30, 2024, and $1,106,700 in other long-term liabilities.
Current wording
Our obligations include short-term lease obligations in an aggregate amount of $257,673 in current liabilities as of December 31, 2024, $100,071 in long-term lease liabilities, inventory purchase commitments in an aggregate amount of $1,964,450 which consists of $932,150 in current liabilities as of December 31, 2024, and $1,032,300 in other long-term liabilities.
Previous wording
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 September 30, 2024, 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 first half of the calendar year 2025.
Current wording
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 December 31, 2024, and $4,309,641 received in February 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.