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The Company’s product candidates are targeted, receptor-specific therapeutics for the treatment of diseases with significant unmet medical need and commercial potential.
+Added: Our product development activities focus primarily on use of MC4R agonists for treatment of obesity.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
Our prior commercial product, Vyleesi®, was approved by the U.S.
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This product was acquired by Cosette Pharmaceuticals, Inc.
−Removed: (“Cosette”) on December 19, 2023.
−Removed: 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.
−Removed: 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.
+Added: (“Cosette”) on December 19, 2023, and is still marketed by Cosette, with a release and settlement agreement on June 5, 2025
Critical Accounting Policies and Estimates
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We recorded product revenues net of allowances for direct and indirect fees, discounts, co-pay assistance programs, estimated chargebacks, and rebates.
−Removed: 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.
+Added: 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.
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Year Ended June 30, 2025 Compared to the Year Ended June 30, 2024:
−Removed: Revenue – For the fiscal year ended June 30, 2024 (“fiscal 2024”) we recognized $4,490,090 of product revenue, net of allowances.
−Removed: 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.
+Added: Revenue – We did not recognize product revenue for the fiscal year ended June 30, 2025 (“fiscal 2025”).
+Added: 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.
−Removed: Cost of Products Sold – Cost of products sold was $97,637 for fiscal 2024 compared to $418,470 for fiscal 2023.
+Added: Cost of Products Sold – We did not recognize cost of products sold for fiscal 2025.
+Added: 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.
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The decrease is a result of lower spending on our MCR programs.
−Removed: 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.
+Added: 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.
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.
−Removed: The increase in general research and development spending is primarily attributable to increased compensation costs.
+Added: The decrease in general research and development spending is primarily attributable to decreased compensation costs.
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).
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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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: The decrease is primarily attributable to $1,912,243 of selling expenses related to Vyleesi in fiscal 2024 and decreased compensation costs.
+Added: 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.
+Added: 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.
+Added: 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.
Other Income (Expense) – Total other income (expense), net was $152,590 for fiscal 2025 compared to ($7,239,992) for fiscal 2024.
+Added: 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.
−Removed: 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.
−Removed: 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 .
Effects of Inflati on - We do not believe that inflation has had a material impact on our business, revenues or operating results during the periods presented.
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the development and testing of products in animals and humans;
−Removed: dependance on third party contractors and collaborators for part of our research and development;
+Added: dependence on third party contractors and collaborators for part of our research and development;
ability to attract and retain experienced personnel;
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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.
−Removed: 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.
+Added: 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.
+Added: 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.
−Removed: 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.
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.
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As of June 30, 2025, our cash, cash equivalents and marketable securities were $2,564,265 with current liabilities of $8,010,030.
−Removed: 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.
+Added: 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.
We intend to utilize existing capital resources for general corporate purposes and working capital, including preclinical and clinical development of our MC1R and MC4R programs, and development of other portfolio products.
−Removed: 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.
+Added: 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.
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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.
−Removed: 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.
+Added: 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.
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.
−Removed: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: On September 22, 2025, we announced the achievement of a research milestone under its collaboration with Boehringer Ingelheim.
+Added: This milestone triggers a payment to us of approximately $6,500,000 (expected to be received in October 2025).
Quantitative and Qualitative Disclosures About Market Risk.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.