MATAWAN, N.J.--(BUSINESS WIRE)--Apimeds Pharmaceuticals US, Inc. (NYSE American: APUS) ("Apimeds†) today announced the expansion of its ai² Future Labs program by engaging graduate students from the University of San Diego's Knauss School of Business. The initiative is designed to identify promising pharmaceutical assets critical to improving human health while cultivating the next generation of business leaders for the biopharmaceutical industry. Future Labs is part of Apimeds' ai² innovation. ...

Core Insights - The FDA has released draft guidance on the development of non-opioid pain therapies, which is expected to benefit Apimeds Pharmaceuticals' lead program, Apitox, aimed at treating chronic osteoarthritis pain [1]. Company Summary - Apimeds Pharmaceuticals US, Inc. (NYSE: APUS) is positioned to accelerate its lead program, Apitox, in response to the FDA's new draft guidance [1]. Industry Summary - The draft guidance titled "Development of Non-Opioid Analgesics for Chronic Pain" is a significant regulatory development that may influence the landscape for non-opioid pain management therapies [1].

PART I—FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Apimeds Pharmaceuticals US, Inc.'s unaudited condensed financial statements and notes for June 30, 2025, and December 31, 2024, are presented [Unaudited Condensed Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Balance%20Sheets) The balance sheet shows a significant increase in cash and total assets for Apimeds Pharmaceuticals US, Inc. as of June 30, 2025, primarily driven by the IPO proceeds, while total liabilities decreased and shareholders' equity shifted from a deficit to a positive balance Unaudited Condensed Balance Sheets | Item | June 30, 2025 | December 31, 2024 | | :----------------------------- | :------------ | :------------------ | | Cash | $8,735,323 | $3,455 | | Total Assets | $10,546,681 | $13,057 | | Total Liabilities | $809,002 | $1,371,178 | | Total Shareholders' Equity (Deficit) | $9,737,679 | $(1,358,121) | [Unaudited Condensed Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations) Apimeds Pharmaceuticals US, Inc. reported increased net losses for both the three and six months ended June 30, 2025, compared to the prior year, primarily due to a significant rise in research and development and general and administrative expenses, largely driven by stock-based compensation and expanded operational activities Net Loss (Three Months Ended June 30) | Period | Net Loss | | :----- | :--------- | | 2025 | $(2,662,193) | | 2024 | $(449,363) | Net Loss (Six Months Ended June 30) | Period | Net Loss | | :----- | :--------- | | 2025 | $(3,064,590) | | 2024 | $(745,836) | Total Operating Expenses (Three Months Ended June 30) | Period | Total Operating Expenses | | :----- | :----------------------- | | 2025 | $2,663,904 | | 2024 | $427,757 | Total Operating Expenses (Six Months Ended June 30) | Period | Total Operating Expenses | | :----- | :----------------------- | | 2025 | $3,028,272 | | 2024 | $699,483 | [Unaudited Condensed Statements of Changes in Shareholders' Equity (Deficit)](index=7&type=section&id=Unaudited%20Condensed%20Statements%20of%20Changes%20in%20Shareholders'%20Equity%20(Deficit)) Shareholders' equity significantly increased from a deficit of $(1,358,121) at December 31, 2024, to a positive $9,737,679 by June 30, 2025, primarily due to the net proceeds from the IPO, stock-based compensation, and conversion of convertible debt Total Shareholders' Equity (Deficit) | Date | Amount | | :--- | :------- | | Dec 31, 2024 | $(1,358,121) | | Jun 30, 2025 | $9,737,679 | - Key contributions to equity increase (Dec 31, 2024 to Jun 30, 2025): * Issuance of common stock in IPO (net): **$11,629,727**[17](index=17&type=chunk) * Stock-based compensation (stock options): **$192,053**[17](index=17&type=chunk) * Stock-based compensation (common stock grants): **$1,700,000**[17](index=17&type=chunk) * Conversion of convertible debt: **$499,222**[17](index=17&type=chunk) [Unaudited Condensed Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, the company experienced a significant net increase in cash, primarily driven by substantial cash provided by financing activities, including IPO proceeds, which offset cash used in operating and investing activities Net Cash Used in Operating Activities (Six Months Ended June 30) | Period | Amount | | :----- | :--------- | | 2025 | $(3,381,409) | | 2024 | $(447,155) | Net Cash Provided by Financing Activities (Six Months Ended June 30) | Period | Amount | | :----- | :----------- | | 2025 | $12,126,646 | | 2024 | $100,000 | Net Increase (Decrease) in Cash (Six Months Ended June 30) | Period | Amount | | :----- | :----------- | | 2025 | $8,731,868 | | 2024 | $(347,155) | Cash, End of Period | Period | Amount | | :----- | :--------- | | 2025 | $8,735,323 | | 2024 | $63,326 | [Notes to Unaudited Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) The notes provide detailed information on the company's business, significant accounting policies, financial instruments, debt, equity, and other commitments, highlighting the impact of the recent IPO and related transactions [Note 1. DESCRIPTION OF BUSINESS](index=9&type=section&id=Note%201.%20DESCRIPTION%20OF%20BUSINESS) Apimeds Pharmaceuticals US, Inc. is a clinical-stage biopharmaceutical company focused on obtaining FDA approval for Apitox, an intradermally administered bee venom-based toxin, for osteoarthritis and potentially multiple sclerosis, with Apitox currently marketed in South Korea by a related party - Apimeds is a clinical stage company seeking U.S. Food and Drug Administration ("FDA") approval for Apitox, a proprietary intradermally administered bee venom-based toxin[22](index=22&type=chunk) - Apitox completed a positive Phase 3 trial for the treatment of pain associated with osteoarthritis in 2018[23](index=23&type=chunk) - The Company plans to investigate potential uses for Apitox to treat pain associated with multiple sclerosis ("MS")[23](index=23&type=chunk) - Apitox is currently marketed and sold by Apimeds Korea in South Korea as "Apitoxin" for the treatment of osteoarthritis[23](index=23&type=chunk) [Note 2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=9&type=section&id=Note%202.%20BASIS%20OF%20PRESENTATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Apimeds' U.S. GAAP financial statements detail an accumulated deficit, expected losses, IPO funding for twelve months, and key accounting policies - As of June 30, 2025, the Company had an accumulated deficit of **$7,456,514**[27](index=27&type=chunk) - Net losses of **$2,662,193** (three months) and **$3,064,590** (six months) ended June 30, 2025[27](index=27&type=chunk) - Initial public offering (IPO) on May 12, 2025, generated net cash proceeds of **$11.9 million**, expected to fund operations for at least the next twelve months[27](index=27&type=chunk) Fair Value of Warrant Liability | | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :------------------ | | Warrant Liability | $174,413 | $0 | Reconciliation of Warrant Liability | Item | Amount | | :------------------------------------------ | :------- | | Ending balance, December 31, 2024 | $0 | | Advisor warrant liability incurred in connection with the IPO | $183,931 | | Re-measurement adjustments: Change in fair value of warrant liability | $(9,518) | | Ending balance, June 30, 2025 | $174,413 | - On February 7, 2025, the Company implemented a **1-for-2.6 reverse stock split**[34](index=34&type=chunk) - The Company operates as a single operating and reportable segment, focused on the development of a proprietary intradermally administered bee venom-based therapeutic, and has not generated any revenue[36](index=36&type=chunk) - The Company is an emerging growth company and has elected to use the extended transition period for complying with new or revised accounting standards[62](index=62&type=chunk)[63](index=63&type=chunk) [Note 3. LICENSE AGREEMENTS](index=16&type=section&id=Note%203.%20LICENSE%20AGREEMENTS) Apimeds Pharmaceuticals US, Inc. has exclusive license agreements with Apimeds Korea to develop, commercialize, market, and sell Apitox in the United States, in exchange for a 5% royalty on earnings before interest and taxes from sales or licenses, with a total consideration of $1 for the exclusive patent license - The Company was granted the exclusive right and license under licensed patents to make and sell Apitox in the United States of America by Apimeds Korea[67](index=67&type=chunk) - The Company will pay Apimeds Korea a royalty of **5%** of the earnings before interest and taxes from the sale or license of Apitox[66](index=66&type=chunk) - The total consideration exchanged for the exclusive license agreement was **$1**[68](index=68&type=chunk) [Note 4. PREPAID EXPENSE AND OTHER ASSETS](index=16&type=section&id=Note%204.%20PREPAID%20EXPENSE%20AND%20OTHER%20ASSETS) Prepaid expenses and other current assets significantly increased to $1,614,226 as of June 30, 2025, from $9,602 at December 31, 2024, primarily due to new prepaid insurance and clinical development costs Prepaid Expenses and Other Assets | Item | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :------------------ | | Prepaid Insurance | $399,246 | $0 | | Prepaid clinical development costs | $1,350,230 | $0 | | Other prepaid assets | $48,745 | $9,602 | | Less: long-term portion of prepaid insurance | $(183,995) | $0 | | **Prepaid expenses and other current assets, current** | **$1,614,226** | **$9,602** | [Note 5. ACCOUNTS PAYABLE AND ACCRUED EXPENSE](index=16&type=section&id=Note%205.%20ACCOUNTS%20PAYABLE%20AND%20ACCRUED%20EXPENSE) Accounts payable and accrued expenses decreased significantly to $119,138 as of June 30, 2025, from $591,191 at December 31, 2024, mainly due to reductions in professional fees payable and accrued compensation Accounts Payable and Accrued Expenses | Item | June 30, 2025 | December 31, 2024 | | :---------------------- | :------------ | :------------------ | | Professional fees payable | $43,570 | $410,641 | | Clinical trials payable | $57,412 | $0 | | Other | $9,906 | $0 | | Accrued compensation | $8,250 | $180,550 | | **Total** | **$119,138** | **$591,191** | [Note 6. DEBT](index=18&type=section&id=Note%206.%20DEBT) The company's 2021 and 2022 Convertible Notes, totaling $660,000 principal plus $112,576 accrued interest, converted into 297,133 shares of common stock upon the IPO closing. New 2024 and 2025 Promissory Notes from related parties, totaling $500,000, were issued and their maturity dates extended to May 19, 2026 - The 2022 Convertible Notes and 2021 Convertible Note automatically converted into shares of Common Stock in connection with the IPO closing[74](index=74&type=chunk)[79](index=79&type=chunk) - An aggregate of **$660,000** outstanding principal and **$112,576** accrued interest from the convertible notes converted into **297,133 shares** of Common Stock at a conversion price of **$2.60 per share**[74](index=74&type=chunk) - The 2024 Promissory Notes (**$250,000** total) and 2025 Promissory Note (**$250,000**) were issued to related parties and their maturity dates were extended to May 19, 2026[82](index=82&type=chunk)[84](index=84&type=chunk) [Note 7. ADVANCE PAYABLE — RELATED PARTY](index=20&type=section&id=Note%207.%20ADVANCE%20PAYABLE%20%E2%80%94%20RELATED%20PARTY) Advance payables to related parties significantly decreased from $76,500 at December 31, 2024, to $100 at June 30, 2025, with these advances being non-interest bearing and having no maturity date Advance Payable to Related Party | Date | Amount | | :--- | :------- | | Jun 30, 2025 | $100 | | Dec 31, 2024 | $76,500 | - These advance payables carry **no interest** and do not have a maturity date[86](index=86&type=chunk) [Note 8. COMMITMENTS AND CONTINGENCIES](index=20&type=section&id=Note%208.%20COMMITMENTS%20AND%20CONTINGENCIES) The company is not currently subject to any material legal proceedings. Following the IPO, the CEO was granted 347,279 stock options and 750,000 fully vested common stock shares as per an executive employee agreement - As of June 30, 2025, there are **no pending claims or litigation** that are expected to materially affect the Company's results[87](index=87&type=chunk) - Following the IPO, the CEO was granted **347,279 stock options** (40% vested immediately, remainder in three equal annual installments) and **750,000 fully vested and unrestricted shares** of common stock[89](index=89&type=chunk) [Note 9. SHAREHOLDERS' EQUITY](index=20&type=section&id=Note%209.%20SHAREHOLDERS%27%20EQUITY) Shareholder's equity saw significant changes, including a 1-for-2.6 reverse stock split in February 2025, an IPO in May 2025 generating $11.6 million net proceeds from 3,375,000 shares, and the conversion of convertible notes into 297,133 common shares. Additionally, 168,750 Representative Warrants were issued to underwriters and 202,500 Advisor Warrants were issued to an advisor Common Stock Issued and Outstanding | Date | Shares | | :--- | :----------- | | Jun 30, 2025 | 12,575,983 | | Dec 31, 2024 | 7,903,850 | - On February 7, 2025, the Board approved and implemented a reverse stock split at a ratio of **1-for-2.6**[91](index=91&type=chunk) - The Company consummated its IPO on May 12, 2025, selling **3,375,000 shares** of common stock at **$4.00 per share**, generating net proceeds of **$11.6 million**[92](index=92&type=chunk) - An aggregate of **297,133 shares** of common stock were issued from the conversion of 2021 and 2022 Convertible Notes[93](index=93&type=chunk) - Issued **168,750 Representative Warrants** to underwriters with an exercise price of **$5.00 per share** and a grant date fair value of **$139,388**[95](index=95&type=chunk)[96](index=96&type=chunk) - Issued **202,500 Advisor Warrants** to purchase common stock at **$4.00 per share**[97](index=97&type=chunk) [Note 10. STOCK-BASED COMPENSATION](index=21&type=section&id=Note%2010.%20STOCK-BASED%20COMPENSATION) The company granted 496,179 stock options under the 2024 Equity Incentive Plan during the three and six months ended June 30, 2025, resulting in $192,053 of stock compensation expense for the period - **496,179 stock options** were granted under the 2024 Equity Incentive Plan during the three and six months ended June 30, 2025[101](index=101&type=chunk) - Stock compensation expense related to stock options outstanding was **$192,053** for the three and six months ended June 30, 2025[103](index=103&type=chunk) - As of June 30, 2025, the remaining unamortized expense of **$415,479** will be recognized over the next **2.77 years**[103](index=103&type=chunk) Summary of Stock Options (June 30, 2025) | Item | Value | | :-------------------------- | :------ | | Stock Options Issued and outstanding | 709,871 | | Weighted Average Exercise Price | $3.48 | | Weighted Average Remaining Contractual Term | 8.47 years | [Note 11. INCOME TAXES](index=22&type=section&id=Note%2011.%20INCOME%20TAXES) Apimeds Pharmaceuticals US, Inc. recorded no income tax provision or benefit for the periods presented due to pretax losses and a valuation allowance against deferred tax assets, as the realization of these assets is not considered more likely than not - The Company recorded **no provision or benefit for income tax expense** for the three and six months ended June 30, 2025 and 2024[104](index=104&type=chunk) - A valuation allowance is recorded to reduce deferred tax assets as it is more likely than not that the Company will be unable to realize their value[105](index=105&type=chunk) [Note 12. SUBSEQUENT EVENTS](index=22&type=section&id=Note%2012.%20SUBSEQUENT%20EVENTS) Management has evaluated subsequent events through the financial statement issuance date and found no material events requiring disclosure - Management evaluated subsequent events occurring after June 30, 2025, through the date financial statements were issued[107](index=107&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Apimeds' financial condition and operational results, covering Apitox development, operating losses, IPO liquidity, expense drivers, net losses, cash flows, and critical accounting policies [Special Note Regarding Forward-Looking Statements](index=23&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) This section advises readers that the report contains forward-looking statements subject to risks and uncertainties, which could cause actual results to differ materially from expectations, directing them to the 'Risk Factors' section for cautionary information - The Quarterly Report includes forward-looking statements that involve risks and uncertainties[109](index=109&type=chunk) - Actual results may differ significantly from the results, expectations, and plans discussed in these forward-looking statements[108](index=108&type=chunk)[109](index=109&type=chunk) - Readers are referred to the 'Risk Factors' section of the Annual Report on Form 10-K for factors that could cause actual results to differ materially[109](index=109&type=chunk) [Overview](index=23&type=section&id=Overview) Apimeds Pharmaceuticals US, Inc. is a clinical-stage biopharmaceutical company developing Apitox, a bee venom-based toxin, for inflammatory conditions like osteoarthritis and multiple sclerosis, building on its current marketing in South Korea - Apimeds Pharmaceuticals US, Inc. is a clinical stage biopharmaceutical company developing Apitox, a proprietary intradermally administered bee venom-based toxin[111](index=111&type=chunk) - Primary focus is to advance Apitox for the treatment of inflammatory conditions in the United States, specifically osteoarthritis ("OA") and, eventually, multiple sclerosis ("MS")[111](index=111&type=chunk) - Apitox is currently marketed and sold by Apimeds, Inc. in South Korea as "Apitoxin" for the treatment of inflammation and pain management symptoms associated with OA[112](index=112&type=chunk) [Our Product Candidate](index=24&type=section&id=Our%20Product%20Candidate) Apitox is a purified, pharmaceutical-grade honeybee venom, exclusively licensed from Apimeds Korea for development and commercialization in the U.S., with a sales royalty agreement in place - Apitox is a purified, pharmaceutical grade venom of the Apis mellifera (honeybee), classified by the U.S Food and Drug Administration ("FDA") as an active pharmaceutical ingredient[113](index=113&type=chunk) - Apimeds Korea has exclusively licensed to Apimeds US all rights to develop, commercialize, market and sell Apitoxin as "Apitox" in the United States in exchange for a sales royalty[113](index=113&type=chunk) - The success of the Company is dependent on obtaining necessary regulatory approvals, marketing products, and achieving profitable operations, requiring additional financing[114](index=114&type=chunk) [Financial Results](index=24&type=section&id=Financial%20Results) Apimeds Pharmaceuticals US, Inc. has incurred significant operating losses since inception, with net losses of $2,662,193 and $3,064,590 for the three and six months ended June 30, 2025, respectively, indicating a substantial increase in losses compared to the prior year - Apimeds has incurred significant operating losses since inception[115](index=115&type=chunk) Net Loss | Period | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :----- | :------------------------------- | :----------------------------- | | Amount | $(2,662,193) | $(3,064,590) | [Liquidity](index=24&type=section&id=Liquidity) As of June 30, 2025, the company had an accumulated deficit of $7,456,514 and expects continued losses. However, net proceeds of $11.9 million from its May 2025 IPO are projected to fund operations for at least the next twelve months - As of June 30, 2025, the Company had an accumulated deficit of **$7,456,514**[116](index=116&type=chunk) - The Company expects to continue to incur substantial losses in the future[116](index=116&type=chunk) - The IPO on May 12, 2025, generated net cash proceeds of **$11.9 million**, which, combined with existing cash, is believed to be sufficient to fund operations for at least the next twelve months[116](index=116&type=chunk) [Results of operations for the three months ended June 30, 2025 and 2024](index=24&type=section&id=Results%20of%20operations%20for%20the%20three%20months%20ended%20June%2030,%202025%20and%202024) For the three months ended June 30, 2025, the company reported no revenue and a significantly increased net loss of $2,662,193, up from $449,363 in 2024. This was primarily driven by a substantial increase in operating expenses, particularly research and development (from $0 to $651,784) and general and administrative expenses (from $427,757 to $2,012,120), largely due to higher stock compensation and expanded operational activities [Revenues](index=25&type=section&id=Revenues_3M) The company generated no revenue for the three months ended June 30, 2025 and 2024 - The Company had **no revenue** for the three months ended June 30, 2025 and 2024[118](index=118&type=chunk) [Operating expenses](index=25&type=section&id=Operating%20expenses_3M) Operating expenses for the three months ended June 30, 2025, significantly increased to $2,663,904 from $427,757 in 2024. This was primarily due to the initiation of research and development expenses ($651,784) and a substantial rise in general and administrative expenses ($1,584,363 increase), largely driven by stock-based compensation Operating Expenses (Three Months Ended June 30) | Expense Category | 2025 | 2024 | Change | | :--------------- | :----------- | :--------- | :----------- | | Research and development expenses | $651,784 | $0 | $651,784 | | General and administrative expenses | $2,012,120 | $427,757 | $1,584,363 | | **Total operating expenses** | **$2,663,904** | **$427,757** | **$2,236,147** | - Research and development expenses increased by **$651,784**, primarily due to payroll (**$72,000**), stock-based compensation (**$439,000**), and clinical trial costs (**$118,000**)[119](index=119&type=chunk) - General and administrative expenses increased by **$1,584,363**, mainly driven by stock-based compensation (approximately **$1,453,000**), professional services (approximately **$26,000**), and office expenses (approximately **$66,000**)[120](index=120&type=chunk) [Other Income (expense)](index=26&type=section&id=Other%20Income%20%28expense%29_3M) Other income for the three months ended June 30, 2025, was $1,711, a decrease in expense of $23,317 compared to an other expense of $21,606 in 2024. This improvement was mainly due to increased interest income and a gain from the change in fair value of warrant liability Other Income (Expense) (Three Months Ended June 30) | Item | 2025 | 2024 | Change | | :-------------------------------- | :------- | :---------- | :---------- | | Change in FV of warrant liability | $9,518 | $0 | $9,518 | | Interest income | $15,247 | $517 | $14,730 | | Interest expense | $(23,054) | $(22,123) | $(931) | | **Total Other Income (expense)** | **$1,711** | **$(21,606)** | **$23,317** | [Net Loss](index=26&type=section&id=Net%20Loss_3M) Net loss for the three months ended June 30, 2025, increased to $2,662,193 from $449,363 in the prior year, primarily due to higher general and administrative and research and development expenses driven by increased stock compensation and expanded operational activities Net Loss (Three Months Ended June 30) | Period | Net Loss | | :----- | :--------- | | 2025 | $(2,662,193) | | 2024 | $(449,363) | | Change | $(2,212,830) | - The increase in net loss was mainly due to higher stock compensation costs and expanded operational and research and development activities[122](index=122&type=chunk) [Results of operations for the six months ended June 30, 2025 and 2024](index=26&type=section&id=Results%20of%20operations%20for%20the%20six%20months%20ended%20June%2030,%202025%20and%202024) For the six months ended June 30, 2025, the company reported no revenue and a net loss of $3,064,590, significantly higher than the $745,836 loss in 2024. This increase was primarily due to a substantial rise in research and development expenses (from $0 to $651,784) and general and administrative expenses (from $699,483 to $2,376,488), driven by increased stock compensation and expanded operational activities [Revenues](index=26&type=section&id=Revenues_6M) The company generated no revenue for the six months ended June 30, 2025 and 2024 - The Company had **no revenue** for the six months ended June 30, 2025 and 2024[124](index=124&type=chunk) [Operating expenses](index=27&type=section&id=Operating%20expenses_6M) Operating expenses for the six months ended June 30, 2025, significantly increased to $3,028,272 from $699,483 in 2024. This was primarily due to the initiation of research and development expenses ($651,784) and a substantial rise in general and administrative expenses ($1,677,005 increase), largely driven by stock-based compensation Operating Expenses (Six Months Ended June 30) | Expense Category | 2025 | 2024 | Change | | :--------------- | :----------- | :--------- | :----------- | | Research and development expenses | $651,784 | $0 | $651,784 | | General and administrative expenses | $2,376,488 | $699,483 | $1,677,005 | | **Total operating expenses** | **$3,028,272** | **$699,483** | **$2,328,789** | - Research and development expenses increased by **$651,784**, primarily due to payroll (**$72,000**), stock-based compensation (**$439,000**), and clinical trial costs (**$118,000**)[125](index=125&type=chunk) - General and administrative expenses increased by **$1,677,005**, mainly driven by stock-based compensation (approximately **$1,453,000**), professional services (approximately **$122,000**), and office expenses (approximately **$65,000**)[126](index=126&type=chunk) [Other Expense](index=27&type=section&id=Other%20Expense_6M) Other expense for the six months ended June 30, 2025, was $36,318, a decrease in expense of $10,035 compared to $46,353 in 2024. This improvement was mainly due to increased interest income, decreased interest expense from note conversions, and a gain from the change in fair value of warrant liability Other Expense (Six Months Ended June 30) | Item | 2025 | 2024 | Change | | :-------------------------------- | :---------- | :---------- | :---------- | | Change in FV of warrant liability | $9,518 | $0 | $9,518 | | Interest income | $15,250 | $2,678 | $12,572 | | Interest expense | $(61,086) | $(49,031) | $(12,055) | | **Total Other Expense** | **$(36,318)** | **$(46,353)** | **$10,035** | [Net Loss](index=29&type=section&id=Net%20Loss_6M) Net loss for the six months ended June 30, 2025, increased to $3,064,590 from $745,836 in the prior year, primarily due to higher general and administrative and research and development expenses driven by increased stock compensation and expanded operational activities Net Loss (Six Months Ended June 30) | Period | Net Loss | | :----- | :--------- | | 2025 | $(3,064,590) | | 2024 | $(745,836) | | Change | $(2,318,754) | - The increase in net loss was mainly due to higher stock compensation costs and expanded operational and research and development activities[129](index=129&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) Apimeds Pharmaceuticals US, Inc. has no revenue and continues to incur operating losses, relying on equity and/or debt financing. The company cannot guarantee future sales or financing availability, which could negatively impact operations - The Company has generated **no revenue** and incurred operating losses since inception, expecting to continue to incur significant operating losses[130](index=130&type=chunk) - The Company is dependent upon obtaining necessary equity and/or debt financing to continue operations[130](index=130&type=chunk) - There are no assurances that sales will commence or that additional financing will be available on acceptable terms or at all[130](index=130&type=chunk) [Cash Flows](index=29&type=section&id=Cash%20Flows) For the six months ended June 30, 2025, cash increased significantly by $8,731,868, primarily due to $12,126,646 from financing activities (mainly IPO proceeds), which offset $3,381,409 used in operating activities and $13,369 in investing activities Cash Flow Summary (Six Months Ended June 30) | Activity | 2025 | 2024 | Change | | :------------------------------ | :----------- | :----------- | :----------- | | Net cash used in operating activities | $(3,381,409) | $(447,155) | $(2,934,254) | | Net cash used in investing activities | $(13,368) | $0 | $(13,369) | | Net cash provided by financing activities | $12,126,646 | $100,000 | $12,026,646 | | Net increase (decrease) in cash | $8,731,868 | $(347,155) | $9,079,023 | - Operating activities used approximately **$3,381,000** of cash in 2025, primarily due to net loss and changes in operating assets and liabilities, partially offset by non-cash stock-based compensation[131](index=131&type=chunk) - Financing activities provided approximately **$12,126,600** of cash in 2025, mainly from **$11,953,046** net proceeds from the IPO and **$250,000** from notes payable to related parties[134](index=134&type=chunk) [Contractual Obligations and Commitments](index=30&type=section&id=Contractual%20Obligations%20and%20Commitments) The company refers to Note 6 (Debt) and Note 8 (Commitments and Contingencies) in its financial statements for detailed discussions of its contractual obligations and commitments - Refer to Note 6 – Debt, and Note 8 – Commitments and Contingencies, for further discussion of the Company's commitments and contingencies[136](index=136&type=chunk) [Off-Balance Sheet Arrangements](index=30&type=section&id=Off-Balance%20Sheet%20Arrangements) Apimeds Pharmaceuticals US, Inc. is not party to any off-balance sheet transactions, guarantees, or obligations beyond those arising from normal business operations - The Company is not party to any off-balance sheet transactions[137](index=137&type=chunk) - The Company has no guarantees or obligations other than those which arise out of normal business operations[137](index=137&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=30&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) The company's financial statements rely on management's subjective estimates and judgments, particularly concerning convertible instruments, which are critical due to their material impact on financial condition and results of operations - The preparation of financial statements requires management to make estimates, judgments, and assumptions that affect reported amounts[138](index=138&type=chunk) - The most significant estimates relate to convertible instruments[138](index=138&type=chunk) - The Company evaluates and accounts for conversion options embedded in convertible instruments in accordance with ASC 815 "Derivatives and Hedging Activities"[140](index=140&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Apimeds Pharmaceuticals US, Inc. has elected not to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Apimeds Pharmaceuticals US, Inc. has elected not to provide the disclosure required by this item[142](index=142&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's assessment of the company's disclosure controls and procedures and internal control over financial reporting, concluding that both were not effective as of June 30, 2025, due to identified material weaknesses [Evaluation of Disclosure Controls and Procedures](index=31&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective as of June 30, 2025, due to material weaknesses in internal controls over financial reporting - Management concluded that disclosure controls and procedures were **not effective** as of June 30, 2025[144](index=144&type=chunk) - Ineffectiveness was due to deficiencies in the design and operation of internal controls over financial reporting, considered material weaknesses[144](index=144&type=chunk) [Management's Report on Internal Control over Financial Reporting](index=31&type=section&id=Management's%20Report%20on%20Internal%20Control%20over%20Financial%20Reporting) Management concluded that the company's internal control over financial reporting was not effective as of June 30, 2025, due to material weaknesses, specifically a lack of sufficiently documented procedures and control activities for reliable financial reporting, including deficiencies in journal entry review, segregation of duties, and reconciliations - Management concluded that internal control over financial reporting was **not effective** as of June 30, 2025[148](index=148&type=chunk)[150](index=150&type=chunk) - Material weaknesses identified include an absence of sufficiently documented procedures or control activities to support a reliable financial reporting process[149](index=149&type=chunk) - Specific deficiencies include a lack of controls over the review and approval of journal entries, segregation of duties, and reconciliations[149](index=149&type=chunk) [Changes in Internal Control Over Financial Reporting](index=32&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) There have been no material changes in internal control over financial reporting during the quarter ended June 30, 2025, though the company continues to review and may make changes to enhance effectiveness - There has been **no material change** in internal control over financial reporting during the quarter ended June 30, 2025[151](index=151&type=chunk) - The Company continues to review its disclosure controls and procedures and may make changes to enhance their effectiveness[151](index=151&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) Apimeds Pharmaceuticals US, Inc. is not currently involved in any material legal proceedings, though it may encounter such proceedings in the ordinary course of business - The Company is **not currently subject to any legal proceedings**[154](index=154&type=chunk) - The Company may from time to time become a party to various legal proceedings arising in the ordinary course of business[154](index=154&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, Apimeds Pharmaceuticals US, Inc. is not required to include risk factors in this quarterly report, and there have been no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K - As a smaller reporting company, the Company is **not required to include risk factors** in this Quarterly Report[155](index=155&type=chunk) - There have been **no material changes** with respect to those risk factors previously disclosed in the "Risk Factors" section of the Annual Report on Form 10-K[155](index=155&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In connection with its IPO, Apimeds Pharmaceuticals US, Inc. converted $772,545 of outstanding principal and accrued interest from 2021 and 2022 Convertible Notes into 297,133 shares of common stock at $2.60 per share, relying on Section 4(a)(2) exemption. The IPO itself, which closed on May 12, 2025, generated $11.9 million in net proceeds from the sale of 3,375,000 shares at $4.00 per share, with no material change in the planned use of proceeds - An aggregate of **$772,545** of outstanding principal and accrued interest under the 2021 and 2022 Convertible Notes was converted to **297,133 shares** of common stock[157](index=157&type=chunk) - The conversion was based on a price of **$2.60 per share** and relied on the exemption from registration requirements provided by Section 4(a)(2) of the Securities Act[157](index=157&type=chunk) - The IPO closed on May 12, 2025, with the Company selling **3,375,000 shares** of common stock at **$4.00 per share**, generating approximately **$11.9 million** in net proceeds[158](index=158&type=chunk)[159](index=159&type=chunk) - There has been **no material change** in the planned use of proceeds from the IPO[159](index=159&type=chunk) [Item 3. Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Apimeds Pharmaceuticals US, Inc. reported no defaults upon senior securities - **No defaults** upon senior securities[161](index=161&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Apimeds Pharmaceuticals US, Inc. - Not applicable[162](index=162&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) No other material information to report for the quarter ended June 30, 2025, including no adoption or termination of Rule 10b5-1 trading arrangements by directors or officers - **No other information** to report for the quarter ended June 30, 2025[163](index=163&type=chunk) - **No director or officer adopted or terminated** a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement"[164](index=164&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of, or incorporated by reference into, the Quarterly Report, including corporate governance documents, debt amendments, certifications, and XBRL data files - The section lists exhibits filed as part of, or incorporated by reference into, this Quarterly Report[165](index=165&type=chunk) - Exhibits include corporate governance documents (Certificate of Incorporation, Bylaws), debt amendments, Rule 13a-14(a) Certifications, Section 1350 Certifications, and Inline XBRL documents[166](index=166&type=chunk) SIGNATURES The report is duly signed on behalf of Apimeds Pharmaceuticals US, Inc. by Erick Frim, Chief Financial Officer, on August 19, 2025 - The report is signed by Erick Frim, Chief Financial Officer (Principal Financial and Accounting Officer)[170](index=170&type=chunk) - Date of signature: August 19, 2025[170](index=170&type=chunk)

PART I—FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed financial statements for Apimeds Pharmaceuticals US, Inc. for the three months ended March 31, 2025, and 2024, including balance sheets, statements of operations, changes in shareholders' (deficit) equity, and cash flows, along with comprehensive notes detailing business operations, accounting policies, debt, commitments, and subsequent events [Unaudited Condensed Balance Sheets](index=5&type=section&id=Unaudited%20Condensed%20Balance%20Sheets) | Metric | March 31, 2025 ($) | December 31, 2024 ($) | | :----------------------------------- | :------------- | :---------------- | | Cash | $250,342 | $3,455 | | Total current assets | $259,904 | $13,057 | | Total assets | $259,904 | $13,057 | | Total current liabilities | $1,770,422 | $1,024,334 | | Total liabilities | $2,020,422 | $1,371,178 | | Total shareholders' (deficit) equity | $(1,760,518) | $(1,358,121) | [Unaudited Condensed Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations) | Metric | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | General and administrative expenses | $364,368 | $271,726 | | Loss from operations | $(364,368) | $(271,726) | | Interest income | $3 | $2,161 | | Interest expense | $(38,032) | $(26,908) | | Total other expense, net | $(38,029) | $(24,747) | | Net loss | $(402,397) | $(296,473) | | Basic and diluted loss per share | $(0.05) | $(0.04) | [Unaudited Condensed Statements of Changes in Shareholders'(Deficit) Equity](index=7&type=section&id=Unaudited%20Condensed%20Statements%20of%20Changes%20in%20Shareholders%27(Deficit)%20Equity) | Metric | December 31, 2024 ($) | March 31, 2025 ($) | December 31, 2023 ($) | March 31, 2024 ($) | | :------------------- | :---------------- | :--------------- | :---------------- | :--------------- | | Accumulated Deficit | $(4,391,924) | $(4,794,321) | $(3,001,934) | $(3,298,407) | | Total Equity | $(1,358,121) | $(1,760,518) | $31,869 | $(264,604) | | Net Loss | $(402,397) | $(296,473) | [Unaudited Condensed Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Statements%20of%20Cash%20Flows) | Metric | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(20,313) | $(263,100) | | Net cash provided by investing activities | $0 | $0 | | Net cash provided by financing activities | $267,200 | $0 | | Net increase (decrease) in cash | $246,887 | $(263,100) | | Cash, end of period | $250,342 | $147,381 | [Notes to Unaudited Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) [1. DESCRIPTION OF BUSINESS](index=9&type=section&id=1.%20DESCRIPTION%20OF%20BUSINESS) - Apimeds Pharmaceuticals US, Inc. is a clinical-stage biopharmaceutical company developing **Apitox™**, an intradermally administered bee venom-based toxin. **Apitox™** completed a positive **Phase 3 trial** for Osteoarthritis pain in 2018 and is pursuing **FDA approval**. Future plans include investigating **Apitox™** for multiple sclerosis (MS)[23](index=23&type=chunk)[24](index=24&type=chunk) - The Company's success is contingent on obtaining **regulatory approvals**, marketing products, and securing **additional financing** for research, development, and commercialization[25](index=25&type=chunk) [2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=9&type=section&id=2.%20BASIS%20OF%20PRESENTATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) - The Company has an accumulated deficit of **$4,794,321** as of March 31, 2025, and incurred a net loss of **$402,397** for the three months ended March 31, 2025. Following its IPO on May 12, 2025, which generated **$11.9 million** in net proceeds, the Company believes it has sufficient cash to fund operations for at least the next twelve months[27](index=27&type=chunk) - On February 7, 2025, the Board approved and implemented a **1-for-2.6 reverse stock split**, retrospectively adjusting all share and per share amounts[31](index=31&type=chunk) - The Company operates as a **single operating and reportable segment**, focusing on the development of its bee venom-based therapeutic, with **no revenue generated** and all operations based in the United States[33](index=33&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) Accounts Payable and Accrued Expenses | Category | March 31, 2025 ($) | December 31, 2024 ($) | | :--------------------------------- | :------------- | :---------------- | | Professional fees payable | $648,153 | $410,641 | | Accrued compensation | $287,050 | $180,550 | | Total accounts payable and accrued expenses | $935,203 | $591,191 | Potential Anti-Dilutive Common Shares | Category | Three Months Ended March 31, 2025 (shares) | Three Months Ended March 31, 2024 (shares) | | :----------------------- | :-------------------------------- | :-------------------------------- | | Employee stock options | 213,693 | 213,693 | | Convertible notes and interest | 295,672 | 283,397 | | Total | 509,365 | 497,090 | - The FASB issued **ASU No. 2024-03**, Disaggregation of Income Statement Expenses, effective for annual periods after December 15, 2026, which the Company is currently evaluating for impact[59](index=59&type=chunk) [3. LICENSE AGREEMENTS](index=17&type=section&id=3.%20LICENSE%20AGREEMENTS) - The Company has a business agreement with Apimeds Korea, granting rights to clinical trials and FDA approvals for Apitox™, with a **5% royalty** on earnings before interest and taxes from sales or licenses, excluding merger/acquisition scenarios[60](index=60&type=chunk) - An exclusive patent license agreement with Apimeds Korea grants the Company rights to make and sell licensed products in the U.S. for a total consideration of **$1**[61](index=61&type=chunk)[62](index=62&type=chunk) [4. DEBT](index=17&type=section&id=4.%20DEBT) - The Company has several related-party debt instruments, including **2022 and 2021 Convertible Notes**, and **2024 and 2025 Promissory Notes**, primarily with Inscobee and Apimeds Korea[63](index=63&type=chunk)[67](index=67&type=chunk)[72](index=72&type=chunk)[74](index=74&type=chunk) - The **2022 and 2021 Convertible Notes** were amended in December 2023 to be convertible at **$1 per share** with a maturity date of **December 31, 2026**, or consummation of a qualified offering. These notes automatically converted into common stock upon the IPO[64](index=64&type=chunk)[68](index=68&type=chunk)[71](index=71&type=chunk) Accrued Interest and Outstanding Balances for Convertible Notes | Note Type | Accrued Interest (March 31, 2025) ($) | Accrued Interest (December 31, 2024) ($) | Outstanding Balance (March 31, 2025) ($) | Outstanding Balance (December 31, 2024) ($) | | :------------------------ | :-------------------------------- | :----------------------------------- | :----------------------------------- | :------------------------------------ | | 2022 Convertible Notes | $37,844 | $34,745 | $146,066 | $135,466 | | 2021 Convertible Note | $70,904 | $66,137 | $227,555 | $211,378 | - The **2024 and 2025 Promissory Notes**, bearing **5% interest**, had their maturity dates extended to **May 19, 2026**, via amendments on May 16, 2025[73](index=73&type=chunk)[75](index=75&type=chunk) [5. ADVANCE PAYABLE — RELATED PARTY](index=18&type=section&id=5.%20ADVANCE%20PAYABLE%20%E2%80%94%20RELATED%20PARTY) Advance Payable to Related Party | Metric | March 31, 2025 ($) | December 31, 2024 ($) | | :---------------- | :------------- | :---------------- | | Outstanding balance | $93,700 | $76,500 | | Interest | None | None | | Maturity Date | None | None | [6. COMMITMENTS AND CONTINGENCIES](index=18&type=section&id=6.%20COMMITMENTS%20AND%20CONTINGENCIES) - As of March 31, 2025, and December 31, 2024, there are **no pending legal claims or litigation** expected to materially affect the Company's future results[79](index=79&type=chunk) - The CEO is eligible for an incentive stock option to purchase **3% of post-IPO capitalization**, with **40% vesting immediately** upon grant and the remainder vesting in three equal annual installments. The IPO was consummated on May 12, 2025[80](index=80&type=chunk) [7. SHAREHOLDERS' DEFICIT](index=20&type=section&id=7.%20SHAREHOLDERS'%20DEFICIT) - As of March 31, 2025, and December 31, 2024, the Company had **100,000,000 authorized common shares** (**$0.01 par value**) and **7,903,850 issued and outstanding common shares**[81](index=81&type=chunk) - A **1-for-2.6 reverse stock split** was approved and implemented on February 7, 2025, retrospectively adjusting all share and per share amounts[82](index=82&type=chunk) - The Company authorized **10,000,000 shares of preferred stock** (**$0.01 par value**) on December 5, 2023, but had **no preferred shares issued or outstanding** as of March 31, 2025, and December 31, 2024[83](index=83&type=chunk) [8. STOCK-BASED COMPENSATION](index=20&type=section&id=8.%20STOCK-BASED%20COMPENSATION) - The Company adopted the **2024 Equity Incentive Plan**, reserving **1,000,000 shares of common stock**, but **no stock options were granted or outstanding** under this plan as of the financial statements' issuance date[84](index=84&type=chunk) - An executive officer was granted **213,692 nonqualified stock options** on May 12, 2020, with an exercise price of **$7.33 per share**, fully vested by May 12, 2023, and expiring on May 12, 2030[85](index=85&type=chunk)[86](index=86&type=chunk) - **No stock-based compensation expense** was recognized for the three months ended March 31, 2025, and 2024, and **no unrecognized compensation costs** remain for unvested options[87](index=87&type=chunk)[88](index=88&type=chunk) [9. INCOME TAXES](index=21&type=section&id=9.%20INCOME%20TAXES) - The Company recorded **no income tax provision or benefit** for the three months ended March 31, 2025, and 2024, due to pretax losses and a valuation allowance against deferred tax assets, as realization is not considered more likely than not[89](index=89&type=chunk)[90](index=90&type=chunk) [10. SUBSEQUENT EVENTS](index=21&type=section&id=10.%20SUBSEQUENT%20EVENTS) - On May 12, 2025, the Company completed its IPO, issuing **3,375,000 common shares** at **$4.00 per share**, generating **$13.5 million** in gross proceeds[92](index=92&type=chunk) - In connection with the IPO, **$772,545** of outstanding principal and accrued interest from the **2021 and 2022 Convertible Notes** converted into **297,133 shares of common stock** at **$2.60 per share**[93](index=93&type=chunk) - The Company issued warrants to purchase **168,750 common shares** to underwriters, exercisable at **$5.00 per share** from November 4, 2025, expiring five years from issuance[94](index=94&type=chunk) - On May 16, 2025, the maturity dates for the **2024 and 2025 Promissory Notes** were extended to **May 19, 2026**[95](index=95&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the Company's financial condition and operational results for the three months ended March 31, 2025, and 2024. It highlights the Company's clinical-stage status, product development, significant operating losses, and reliance on financing, particularly the recent IPO, to sustain operations [Overview](index=22&type=section&id=Overview) - Apimeds Pharmaceuticals US, Inc. is a clinical-stage biopharmaceutical company focused on developing **Apitox**, a bee venom-based toxin, for inflammatory conditions like osteoarthritis (OA) and multiple sclerosis (MS) in the United States[99](index=99&type=chunk)[100](index=100&type=chunk) [Our Product Candidate](index=22&type=section&id=Our%20Product%20Candidate) - **Apitox** is a purified, pharmaceutical-grade bee venom, licensed exclusively from Apimeds Korea for development and commercialization in the U.S. The Company's success hinges on regulatory approvals, marketing, and securing additional financing[101](index=101&type=chunk) [Financial Results](index=23&type=section&id=Financial%20Results) - The Company incurred a net loss of **$402,397** for the three months ended March 31, 2025, an increase from **$296,473** in the prior year period. As of March 31, 2025, the accumulated deficit was **$4,794,321**, with a stockholders' deficit of **$1,760,518** and a working capital deficit of **$1,136,898**[102](index=102&type=chunk) [Liquidity](index=23&type=section&id=Liquidity) - With an accumulated deficit of **$4,794,321** and ongoing net losses, the Company's liquidity was significantly bolstered by **$11.9 million** in net proceeds from its IPO on May 12, 2025, which is expected to fund operations for at least the next twelve months[103](index=103&type=chunk) [Results of operations for the three months ended March 31, 2025 and 2024](index=23&type=section&id=Results%20of%20operations%20for%20the%20three%20months%20ended%20March%2031,%202025%20and%202024) Operating Expenses and Net Loss (YoY Change) | Metric | 3 Months Ended March 31, 2025 ($) | 3 Months Ended March 31, 2024 ($) | Change ($) | | :-------------------------------- | :------------------------------ | :------------------------------ | :------- | | General and administrative expenses | $364,368 | $271,726 | $92,642 | | Loss from operations | $(364,368) | $(271,726) | $(92,642) | | Interest income | $3 | $2,161 | $(2,158) | | Interest expense | $(38,032) | $(26,908) | $(11,124) | | Net loss | $(402,397) | $(296,473) | $(105,924) | - The Company generated **no revenue** for the three months ended March 31, 2025, and 2024[105](index=105&type=chunk) - General and administrative expenses increased by **$92,642** to **$364,368**, primarily due to a **$95,454 increase in professional services** and an **$7,500 increase in payroll expenses**[106](index=106&type=chunk) - Other expense increased by **$13,282** to **$38,029**, mainly driven by an **$11,124 increase in interest expense**[107](index=107&type=chunk) - Net loss increased by **$105,924** to **$402,397**, primarily due to higher general and administrative expenses (professional fees for SEC filings and pre-IPO expenses) and increased payroll[108](index=108&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) - The Company has **no revenue** and expects continued operating losses, relying on equity and/or debt financing for operations. There is **no assurance that additional financing will be available** on acceptable terms[109](index=109&type=chunk) Cash Flow Summary (YoY Change) | Cash Flow Activity | 2025 ($) | 2024 ($) | Change ($) | | :-------------------------------- | :--------- | :---------- | :--------- | | Net cash used in operating activities | $(20,313) | $(263,100) | $242,787 | | Net cash used in investing activities | $0 | $0 | $0 | | Net cash provided by financing activities | $267,200 | $0 | $267,200 | | Net increase (decrease) in cash | $246,887 | $(263,100) | $509,987 | - Operating activities used **$20,313** in cash for Q1 2025, a significant improvement from **$263,100** used in Q1 2024, primarily due to changes in operating assets and liabilities offsetting the net loss[110](index=110&type=chunk)[111](index=111&type=chunk) - Financing activities provided **$267,200** in cash for Q1 2025, from **$250,000 in notes payable** and **$17,200 in cash advances from related parties**, compared to **$0** in Q1 2024[113](index=113&type=chunk)[114](index=114&type=chunk) [Contractual Obligations and Commitments](index=25&type=section&id=Contractual%20Obligations%20and%20Commitments) - Refer to Note 4 (Debt) and Note 6 (Commitments and Contingencies) for detailed discussions of the Company's contractual obligations and commitments[115](index=115&type=chunk) [Off-Balance Sheet Arrangements](index=25&type=section&id=Off-Balance%20Sheet%20Arrangements) - The Company is **not party to any off-balance sheet transactions**, guarantees, or obligations beyond normal business operations[116](index=116&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=25&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - The preparation of financial statements requires significant estimates and judgments, particularly concerning convertible instruments, which are evaluated and accounted for in accordance with **ASC 815**[117](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Apimeds Pharmaceuticals US, Inc. has elected not to provide quantitative and qualitative disclosures about market risk - The Company, as a **smaller reporting company**, has elected **not to provide disclosures regarding market risk**[121](index=121&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the Company's disclosure controls and procedures and internal control over financial reporting were not effective as of March 31, 2025, due to material weaknesses, specifically a lack of sufficiently documented procedures and control activities [Evaluation of Disclosure Controls and Procedures](index=26&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - The CEO and CFO concluded that the Company's disclosure controls and procedures were **not effective** as of March 31, 2025, due to **material weaknesses in internal controls over financial reporting**[123](index=123&type=chunk) [Management's Report on Internal Control over Financial Reporting](index=26&type=section&id=Management's%20Report%20on%20Internal%20Control%20over%20Financial%20Reporting) - Management concluded that the Company's internal control over financial reporting was **not effective** as of March 31, 2025, due to **material weaknesses**[126](index=126&type=chunk)[128](index=128&type=chunk) - **Material weaknesses identified** include insufficient documented procedures and control activities to support a reliable financial reporting process, specifically an absence of controls over journal entry review and approval, segregation of duties, reconciliations, and other fundamental accounting processes[127](index=127&type=chunk) [Changes in Internal Control Over Financial Reporting](index=27&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) - There have been **no material changes** in the Company's internal control over financial reporting during the quarter ended March 31, 2025[129](index=129&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The Company is not currently subject to any significant legal proceedings, though it may encounter them in the ordinary course of business - The Company is **not currently subject to any legal proceedings** that are expected to materially affect its business[132](index=132&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, Apimeds Pharmaceuticals US, Inc. is not required to include risk factors in this Quarterly Report, and there have been no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K - As a **smaller reporting company**, the Company is **not required to include risk factors** in this report. **No material changes** to previously disclosed risk factors in the Annual Report on Form 10-K have occurred[133](index=133&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - **No unregistered sales of equity securities or use of proceeds** occurred during the reporting period[134](index=134&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities - There were **no defaults upon senior securities**[137](index=137&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the Company's operations - Mine safety disclosures are **not applicable** to the Company[138](index=138&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) No other material information was reported, including no changes to Rule 10b5-1 trading arrangements by directors or officers during the quarter - **No director or officer adopted or terminated** a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" during the quarter ended March 31, 2025[140](index=140&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of, or incorporated by reference into, this Quarterly Report, including corporate governance documents, debt agreements, and certifications - Exhibits include Amended and Restated Certificate of Incorporation, Bylaws, March 2025 Promissory Note, Rule 13a-14(a) Certifications by Principal Executive and Financial Officers, Section 1350 Certifications, and Inline XBRL documents[143](index=143&type=chunk) SIGNATURES - The report was signed on **May 19, 2025**, by **Erik Emerson**, Chief Executive Officer (Principal Executive Officer) of Apimeds Pharmaceuticals US, Inc[146](index=146&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 ☐ 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: 001-42545 Apimeds Pharmaceuticals US, Inc. (Exact name of registrant as specified in its charter) Delaware 85-1099700 (State or other juris ...