APUS 10-K & 10-Q changes, risk factors and insider trading
Apimeds Pharmaceuticals US, Inc. · NYSE · Pharmaceutical Preparations · CIK 1894525 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
As a smaller reporting company, as defined in Rule 12b-2 of the Exchange Act, we are not required to provide the information required by this Item.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Key Developments in Fiscal Year 2025”
New heading “Initial Public Offering”
New heading “Business Combination with MindWave Innovations Inc.”
New heading “PIPE Convertible Note Financing”
New heading “Biopharmaceutical Development Activity”
New heading “Results of Operations”
New heading “Year Ended December 31, 2025 Compared to Year Ended December 31, 2024”
New heading “(e) Other Income (Expense)”
New heading “(c) Financing Activities”
New heading “Future Capital Requirements and Going Concern”
New heading “Segment Information”
New heading “Recently Issued Accounting Pronouncements”
New heading “Recent Developments”
Removed heading “Our Product Candidate”
Removed heading “Financial Results”
Removed heading “Results of operations for the years ended December 31, 2024 and 2023”
Removed heading “Operating Expense”
Removed heading “Off-Balance Sheet Arrangements”
Removed heading “Convertible Instruments”
Largest changes
“Future Capital Requirements and Going Concern”see in full comparison
“We have not yet generated revenue from our biopharmaceutical operations and MindWave operations and do not expect to do so until we have successfully advanced Apitox through clinical development and commercialization. Our ability to continue as a going concern depends on our ability to raise additional capital and execute our operational plans, as discussed further under “Liquidity and Capital Resources” below.”see in full comparison
“The Company has evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year beyond the issuance date of these financial statements. As of December 31, 2024, the Company had accumulated deficit amount to $4,391,924. The Company incurred net losses of $1,389,990 for the year ended December 31, 2024, and expects to continue to incur substantial losses in the future. …”see in full comparison
“The accompanying financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern.”see in full comparison
“Pursuant to the Forbearance Agreement, the Investor has agreed to forbear from exercising any of its rights or remedies under the Existing Note with respect to certain existing events of default (collectively, the “Existing Defaults”) during the period commencing on the date of the Forbearance Agreement through and including June 30, 2026 (or such later date as the Investor may elect in its sole discretion) (the “Forbearance Period”).”see in full comparison
“Going Concern Assessment. Management’s assessment of the Company’s ability to continue as a going concern requires significant judgment regarding future capital raises, the availability of remaining PIPE tranches, and the expected pace of operating expenditures. Changes in these assumptions could affect the going concern conclusion and related disclosures.”see in full comparison
Full comparison: every changed paragraph (95)
You should read the following discussion and
analysis of our financial condition and results of operations in conjunction with our financial statements and related notes and other
financial information included elsewhere in this Annual Report. This discussion and analysis and other parts of this prospectus contain
forward-looking statements based upon our current plans and expectations that involve risks, uncertainties and assumptions, such as statements
regarding our plans, objectives, expectations, intentions and beliefs. Our actual results and the timing of events could differ materially
from those anticipated in these forward-looking statements as a result of various factors, including those set forth under the section
entitled “Risk Factors” and elsewhere in this Annual Report. Please also see the section entitled “Special Note Regarding
Forward-Looking Statements.”
Apimeds Pharmaceuticals US, Inc. (“APUS,” the “Company,” “we,” “us,” or “our”) is a development-stage biopharmaceutical company incorporated in the State of Delaware. Our primary focus is the clinical development of Apitox, a purified honeybee venom-based drug candidate being evaluated for the treatment of acute pain and inflammation associated with knee osteoarthritis. We operate our biopharmaceutical business through our wholly owned subsidiary, Lokahi Therapeutics Inc. (“Lokahi”).
Fiscal year 2025 was a transformative year for the Company. In addition to advancing our biopharmaceutical pipeline and completing our initial public offering on the New York Stock Exchange on May 12, 2025, we completed a merger with MindWave Innovations Inc. (“MindWave”) on December 1, 2025. As a result of the Merger, the Company became a dual-segment operating company, adding a digital asset operations segment alongside our core biopharmaceutical business. MindWave, now a wholly owned subsidiary, operates the MindWaveDAO blockchain ecosystem and holds digital assets consisting of Bitcoin (“BTC”), Tether (“USDT”), and the MindWaveDAO native utility token (“NILA Tokens”). The Merger fundamentally changed the scale and composition of our balance sheet, adding approximately $145.3 million in identifiable net assets, primarily digital assets, and was effected through the issuance of 7,477,017 shares of Series A Convertible Preferred Stock.
We have not yet generated revenue from our biopharmaceutical operations and MindWave operations and do not expect to do so until we have successfully advanced Apitox through clinical development and commercialization. Our ability to continue as a going concern depends on our ability to raise additional capital and execute our operational plans, as discussed further under “Liquidity and Capital Resources” below.
Key Developments in Fiscal Year 2025
Initial Public Offering
On May 12, 2025, we completed our IPO on the New York Stock Exchange, issuing 3,375,000 shares of common stock and generating net proceeds of approximately $11.6 million after deducting underwriting discounts, commissions, and offering costs.
Business Combination with MindWave Innovations Inc.
On December 1, 2025, we completed the Merger with MindWave, which became a wholly owned subsidiary of the Company. The transaction was effected as a non-cash business combination, with consideration consisting solely of 7,477,017 shares of Series A Convertible Preferred Stock with an aggregate fair value of approximately $145.4 million, equivalent to the fair value of the net identifiable assets acquired. No goodwill was recorded. Through the Merger, we acquired digital assets with an aggregate fair value of approximately $146.3 million at the acquisition date, consisting of BTC ($90.8 million), USDT ($4.7 million), and NILA Tokens ($50.8 million), as well as the operations of the MindWaveDAO blockchain.
PIPE Convertible Note Financing
In connection with the Merger, on December 1, 2025, we entered into a Securities Purchase Agreement providing for the issuance of senior secured convertible notes in an aggregate maximum principal amount of $129 million, to be drawn in tranches at our election. On December 8, 2025, we executed the first tranche, issuing a senior secured convertible note with a principal amount of $10.9 million and gross proceeds of $10 million. Of the proceeds, $8 million is currently held in a Deposit Account Control Agreement (“DACA”) account, and $1.1 million was disbursed to MindWave to fund its operations.
Biopharmaceutical Development Activity
During 2025, we significantly increased development activity related to Apitox, incurring research and development expenses of $1.6 million. We also entered into an agreement with Prevail InfoWorks Inc., our Clinical Research Organization (“CRO”), establishing a prepaid balance of approximately $2 million to be applied against future clinical trial execution.
Results of Operations
Year Ended December 31, 2025 Compared to Year Ended December 31, 2024
Apimeds Pharmaceuticals US, Inc. is a clinical
stage biopharmaceutical company that is in the process of developing Apitox, a proprietary intradermally administered bee venom-based
toxin. Our primary focus is to advance Apitox in the treatment of inflammatory conditions in the United States, specifically osteoarthritis
(“OA”) and, eventually, multiple sclerosis (“MS”).
Apitox, is currently marketed and sold by Apimeds,
Inc. in South Korea (“Apimeds Korea”) as “Apitoxin” for the treatment of inflammation and pain management symptoms
associated with OA. There is an extensive history of use of bee venom, both in the United States and around the world, to assist with
pain management. We believe that, in addition to knee OA and MS, Apitox has the potential to help manage difficult to control pain and
inflammation issues, which we will explore in the future.
Our Product Candidate
Our product candidate Apitox is a purified, pharmaceutical
grade venom of the Apis mellifera, or honeybee, which is classified by the U.S Food and Drug Administration (“FDA”) as an
active pharmaceutical ingredient (“API”). Apimeds Korea has developed a proprietary method and process of turning extracted
bee venom into a lyophilized powder for reconstitution prior to intradermal dose injections, which they sell in Korea as South Apitoxin.
Apimeds Korea has exclusively licensed to us all rights to develop, commercialize, market and sell Apitoxin as “Apitox” in
the United States in exchange for a sales royalty. See “Item 13. Certain Relationships and Related Transactions, and Director
Independence — Certain Relationships and Related Transactions — Business Agreement.”
The success of the Company is dependent on obtaining
the necessary regulatory approvals of its product candidates, marketing its products and achieving profitable operations. The continuation
of the research and development activities and the commercialization of its products, if approved, are dependent on the Company’s
ability to successfully complete these activities and to obtain additional financing through a combination of financing activities and
operations. It is not possible to predict either the outcome of future research and development or commercialization programs, or the
Company’s ability to fund these programs.
Financial Results
Since inception, Apimeds has incurred significant
operating losses. For the years ended December 31, 2024 and 2023, Apimeds Pharmaceuticals US, Inc. net loss was $1,389,990 and $777,694,
respectively. As of December 31, 2024, Apimeds Pharmaceuticals US, Inc. had an accumulated deficit of $4,391,924, a stockholders’
deficit of $1,358,121 and a working capital deficit of $1,011,277.
Going Concern
The Company has evaluated whether there are any conditions and events,
considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year beyond the
issuance date of these financial statements. As of December 31, 2024, the Company had accumulated deficit amount to $4,391,924. The Company
incurred net losses of $1,389,990 for the year ended December 31, 2024, and expects to continue to incur substantial losses in the future.
Based on such conditions and the Company’s current plans, which are subject to change, management believes that the Company’s
existing cash as of December 31, 2024, is not sufficient to satisfy its operating cash needs for 12 months from the issuance date of the
report.
The accompanying financial statements have been
prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement
of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability
and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability
to continue as a going concern.
The success of the Company is dependent on obtaining
the necessary regulatory approvals of its product candidates, marketing its products and achieving profitable operations. The continuation
of the research and development activities and the commercialization of its products, if approved, are dependent on the Company’s
ability to successfully complete these activities and to obtain additional financing through a combination of financing activities and
operations. If the Company is unable to maintain sufficient financial resources, its business, financial condition and results of operations
will be materially and adversely affected. This could affect future development and business activities and potential future clinical
studies and/or other future ventures. There can be no assurance that the Company will be able to obtain the needed financing on acceptable
terms or at all.
Results of operations for the years ended December 31, 2024 and
2023
Operating Expense
The following table sets forth the Company’s selected statements
of operations data for the following periods:
Revenues(a) Revenue
We generated no revenue from biopharmaceutical operations during the years ended December 31, 2025 or 2024. Proceeds from the sale of NILA Tokens are recognized as realized gains on digital assets and are not classified as revenue under ASC 606.
For the years ended December 31, 2024 and 2023, the Company had
no revenue.
(b) Research and Development Expenses
Research and development expenses were $1.6 million for the year ended December 31, 2025, compared to zero for the year ended December 31, 2024. The increase reflects the commencement of meaningful development activity related to Apitox during 2025, including consulting fees, manufacturing costs, and CRO expenses incurred in connection with our clinical development program.
The following table summarizes the year-over-year
changes in research and development expenses for the periods presented:
Research and development expenses were $0 for
the year ended December 31, 2024, compared to $98,544 for the same period in 2023, representing a decrease of $98,544. The decrease in
research and development expenses was primarily attributed to a decrease as the Company was not performing any R&D activities currently
in 2024.
(c) General and administrativeAdministrative expensesExpenses
General and administrative expenses increased to $10.2 million for the year ended December 31, 2025, from $1.3 million for the year ended December 31, 2024, an increase of approximately $8.9 million. The increase was driven by a significant expansion of corporate activity and headcount in connection with becoming a public company and completing the Merger. Key drivers included increased consulting and professional fees, payroll and benefits, stock-based compensation of approximately $2.0 million (consisting of option grants, common stock grants, and advisory warrants), merger and acquisition related fees, office rent and supplies, and travel expenses.
The following table summarizes the year-over-year
changes in general and administrative expenses for the years presented:
General and administrative expenses were $1,2750,95
for the year ended December 31, 2024, compared to $648,892 for the same period in 2023, representing an increase of $626,203. The
increase was mostly attributable to an increase in professional expenses for a total of approximately $329,000 and an increase in payroll
expenses for the officers of the Company for a total of approximately $299,000.
Other(d) ExpenseTotal Operating Expenses
Total operating expenses were $11.9 million for the year ended December 31, 2025, compared to $1.3 million for the year ended December 31, 2024, reflecting the significant increase in both R&D and G&A activity described above.
(e) Other Income (Expense)
Total other income was $5.9 million for the year ended December 31, 2025, compared to other expense of approximately $0.1 million for the year ended December 31, 2024. The improvement was driven mostly by the digital asset activities acquired through the MindWave Merger, which closed on December 1, 2025, and was reflected in our consolidated results for the period December 1 through December 31, 2025 only. Key components of other income (expense) are as follows:
The following table summarizes the year-over-year
changes in general and administrative expenses for the years presented:
Other expense was $114,895 for the year ended
December 31, 2024, compared to $30,258 for the same period in 2023. Representing an increase of $84,637. The increase was mainly due to
an increase in interest expense for a total of approximately $80,000.
(f) Net Loss
Net loss was $6.0 million for the year ended December 31, 2025, compared to a net loss of $1.4 million for the year ended December 31, 2024. The increase reflects the scale-up of operations in connection with the IPO, Merger, and advancement of the Apitox development program, partially offset by digital asset gains recognized following the MindWave acquisition.
Net loss per common share, basic and diluted, was $(0.55) for the year ended December 31, 2025, based on weighted-average shares outstanding of 10,881,907. All potentially dilutive securities, including 149.5 million common share equivalents underlying the Series A Convertible Preferred Stock, 8.3 million shares underlying the PIPE convertible note, 1.1 million warrant shares, and 0.5 million stock option shares, were excluded from the diluted calculation as their inclusion would have been anti-dilutive.
Net loss was $1,389,990 for the year ended December 31, 2024, compared
to $777,694 in the same period of 2023, representing an increase of $612,296. The increase was mainly due to the increase in general and
administrative expenses, specifically professional fees associated with the filing of the registration statement on Form S-1 with the
U.S. Securities and Exchange Commission (the “SEC”) and pre-IPO expenses as well as an increase in payroll expenses.
Overview
As of December 31, 2025, we had cash and cash equivalents of $1.6 million and restricted cash of $8.0 million, for total cash, cash equivalents, and restricted cash of $9.6 million. We also held short-term investments of $2.0 million, representing a certificate of deposit established by Lokahi to earn interest on funds not deployed in operations. Working capital, excluding the fair value of digital assets (which are subject to price volatility and liquidity risk and therefore excluded from management’s assessment of near-term operational liquidity), was approximately $3.2 million as of December 31, 2025.
The $8.0 million of restricted cash represents PIPE convertible note proceeds currently held in a DACA account, pending release upon conversion of the Series A Convertible Preferred Stock in accordance with the terms of the note agreement. These funds are not available for general operating purposes until released from the DACA.
The Company has generated no revenue, has incurred
operating losses since inception, expects to continue to incur significant operating losses for the foreseeable future and may never become
profitable. Until such time as the Company is able to establish a revenue stream, it is dependent upon obtaining necessary equity and/or
debt financing to continue operations. The Company cannot make any assurances that sales will commence in the near term or that additional
financing will be available to it on acceptable terms or at all. This could negatively impact our business and operations and could also
lead to the reduction of our operations.
The following table presents selected financial information and statistics
for each of the periods shown below:
During the year ended December 31, 2024, operating activities used
approximately $734,000 of cash, primarily resulting from a net loss of $1,389,990, partially offset by non-cash interest expense-related
parties of $37,766, accretion expense of $79,953, and changes in operating assets and liabilities of $538,745.
During the year ended December 31, 2023, operating activities used
approximately $628,000 of cash, primarily resulting from a net loss of $777,694, partially offset by stock compensation expense of
$69,993, non-cash interest expense-related parties of $33,000, accretion expense of $5,069, and changes in operating assets and liabilities
of $41,842.
Investing
activities(a) Operating Activities
Net cash used in operating activities was $8.9 million for the year ended December 31, 2025, compared to $0.7 million for the year ended December 31, 2024. The increase reflects the significant expansion of operating activity in connection with the IPO, Merger, and clinical development programs. Non-cash charges included in operating activities consisted primarily of stock-based compensation of $3.2 million (inclusive of option grants, common stock grants, and advisory warrants), accretion of debt discount of $0.3 million, and non-cash digital asset operating expenses of $2.4 million, partially offset by unrealized and realized gains on digital assets.
During the years ended December 31, 2024 and 2023 investing activities
used $0.
What changed in the latest 10-Q
Risk Factors
There have been no material changes to the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, other than as follows. Our digital-asset holdings represented 89% of our total assets as of June 30, 2026 and are measured at fair value with changes recognized in earnings; declines in the price of Bitcoin, Tether or the NILA token would have an immediate and material adverse effect on our results of operations and financial condition, and the NILA token trades in markets that are not active, which may limit our ability to monetize that position at its carrying value. Substantial doubt exists about our ability to continue as a going concern. Notes payable with an aggregate principal amount of $5,000,000 matured on July 1, 2026, and the forbearance arrangement with the holder of our senior secured convertible note expired on June 30, 2026; if we are unable to repay, extend or restructure these obligations, the holders may exercise remedies against substantially all of our assets. We are not in compliance with Section 1007 of the NYSE American Company Guide and our common stock could be delisted if we do not regain compliance within the cure period. We effected a 1-for-10 reverse stock split on July 24, 2026, which may adversely affect the liquidity and market price of our common stock.
Largest changes
“There have been no material changes to the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, other than as follows. …”see in full comparison
“As a smaller reporting company under Rule 12b-2 of the Exchange Act, we are not required to include risk factors in this Quarterly Report. However, as of the date of this Quarterly Report, there have been no material changes with respect to those risk factors previously disclosed in the “Risk Factors” section of the Annual Report. Any of these factors could result in a significant or material adverse effect on our results of operations or financial condition. …”see in full comparison
Full comparison: every changed paragraph (2)
There have been no material changes to the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, other than as follows. Our digital-asset holdings represented 89% of our total assets as of June 30, 2026 and are measured at fair value with changes recognized in earnings; declines in the price of Bitcoin, Tether or the NILA token would have an immediate and material adverse effect on our results of operations and financial condition, and the NILA token trades in markets that are not active, which may limit our ability to monetize that position at its carrying value. Substantial doubt exists about our ability to continue as a going concern. Notes payable with an aggregate principal amount of $5,000,000 matured on July 1, 2026, and the forbearance arrangement with the holder of our senior secured convertible note expired on June 30, 2026; if we are unable to repay, extend or restructure these obligations, the holders may exercise remedies against substantially all of our assets. We are not in compliance with Section 1007 of the NYSE American Company Guide and our common stock could be delisted if we do not regain compliance within the cure period. We effected a 1-for-10 reverse stock split on July 24, 2026, which may adversely affect the liquidity and market price of our common stock.
As a smaller reporting company under Rule 12b-2
of the Exchange Act, we are not required to include risk factors in this Quarterly Report. However, as of the date of this Quarterly Report,
there have been no material changes with respect to those risk factors previously disclosed in the “Risk Factors” section
of the Annual Report. Any of these factors could result in a significant or material adverse effect on our results of operations or financial
condition. Additional risk factors not presently known to us or that we currently deem immaterial may also impair our business or results
of operations. We may disclose changes to such risk factors or disclose additional risk factors from time to time in our future filings
with the SEC.
Management's Discussion & Analysis (MD&A)
Removed heading “Special Note Regarding Forward-Looking Statements”
Removed heading “Our Product Candidate”
Removed heading “Results of operations for the three months ended March 31, 2026, and 2025”
Removed heading “Operating Expense”
Removed heading “General and Administrative Expenses”
Removed heading “Other income expense”
Removed heading “Investing activities”
Removed heading “Financing activities”
Removed heading “Contractual Obligations and Commitments”
Removed heading “Off-Balance Sheet Arrangements”
Removed heading “Convertible Instruments”
Largest changes
“We have incurred recurring losses and negative operating cash flows. We incurred a net loss of $55,232,982 for the six months ended June 30, 2026, used $7,734,893 of cash in operating activities, and had an accumulated deficit of $65,626,043 and cash and cash equivalents of $278,371 as of June 30, 2026. In addition, notes payable with an aggregate principal amount of $5,000,000 and a senior secured convertible note with an aggregate principal amount of $10,900,000 were current obligations as of June 30, 2026. …”see in full comparison
“Our ability to fund operations depends on our ability to raise additional capital, to monetize our digital-asset holdings, and to repay, extend or restructure our notes payable and senior secured convertible note. These factors raise substantial doubt about our ability to continue as a going concern.”see in full comparison
“Results of operations for the three months ended March 31, 2026, and 2025”see in full comparison
“As of March 31, 2026, the Company had accumulated deficit amount of $45,452,914. The Company incurred net losses of $35,059,852 for the three months ended March 31, 2026, and expects to continue to incur substantial losses in the future. On December 8, 2025, the Company completed a PIPE financing (the “PIPE”) with an aggregate maximum amount of $120,900,000 drawn in tranches at the Company’s discretion, given the market conditions allow. …”see in full comparison
Full comparison: every changed paragraph (63)
References
in this report (the “Quarterly Report”) to “we,” “us” or the “Company” refer to Apimeds
Pharmaceuticals US, Inc. References to our “management” or our “management team” refer to our officers and directors.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited
condensed financial statements and the notes thereto contained elsewhere in this Quarterly Report. Certain information contained in the
discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties. Our actual results
may differ significantly from the results, expectations and plans discussed in these forward-looking statements.
Special
Note Regarding Forward-Looking Statements
This
Quarterly Report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E
of the Exchange Act that are not historical facts, and involve risks and uncertainties that could cause actual results to differ materially
from those expected and projected. All statements, other than statements of historical fact included in this Form 10-Q including,
without limitation, statements in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
regarding our financial position, business strategy and the plans and objectives of management for future operations, are forward-looking
statements. Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,”
“predict,” “project,” “should,” “would” and variations thereof and similar words and
expressions are intended to identify such forward-looking statements. Such forward-looking statements relate to future events or future
performance, but reflect management’s current beliefs, based on information currently available. A number of factors could cause
actual events, performance or results to differ materially from the events, performance and results discussed in the forward-looking
statements. For information identifying important factors that could cause actual results to differ materially from those anticipated
in the forward-looking statements, please refer to the Risk Factors section of our Annual Report on Form 10-K for the year ended December
31, 2024, filed with the SEC on April 15, 2025 (the “Annual Report”) and the “Risk Factors” section of this report.
Our securities filings can be accessed on the EDGAR section of the SEC’s website at www.sec.gov. Except as expressly required by
applicable securities law, we disclaim any intention or obligation to update or revise any forward-looking statements whether as a result
of new information, future events or otherwise.
The
following discussion and analysis of our financial condition and results of operations should be read in conjunctiontogether with theour unaudited
condensed consolidated financial statements and the related notes thereto contained elsewhereincluded in Item 1 of this Quarterly Report. Certain information contained in the
discussionReport and analysisour setaudited forthconsolidated belowfinancial includesstatements for the year ended December 31, 2025. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed below. All share and per-share amounts have been retroactively adjusted for the 1-for-10 reverse stock split effected July 24, 2026.
We operate through two reportable segments. Our BioBusiness segment, conducted through our subsidiary Lokahi Therapeutics Inc., is a clinical-stage pharmaceutical business developing APITOX for the treatment of pain associated with osteoarthritis and other indications. Our Digital Asset segment, conducted through MindWave Innovations Inc. and its subsidiaries, holds and transacts in digital assets, principally Bitcoin, Tether and NILA tokens. As of June 30, 2026 we held digital assets with a fair value of $116,737,168, representing 89% of our total assets. Because those assets are measured at fair value with changes recognized in earnings, our reported results are subject to substantial period-to-period volatility that is unrelated to our operating performance.
On April 24, 2026 we entered into a Confidential Settlement Agreement and Mutual Release providing, among other things, for a working capital contribution to the BioBusiness, the distribution of 51% of the equity of Lokahi and a contemplated spin-off of the BioBusiness within approximately twelve months. As of June 30, 2026 the distribution had not been effected and Lokahi remained a wholly owned subsidiary.
Going Concern
We have incurred recurring losses and negative operating cash flows. We incurred a net loss of $55,232,982 for the six months ended June 30, 2026, used $7,734,893 of cash in operating activities, and had an accumulated deficit of $65,626,043 and cash and cash equivalents of $278,371 as of June 30, 2026. In addition, notes payable with an aggregate principal amount of $5,000,000 and a senior secured convertible note with an aggregate principal amount of $10,900,000 were current obligations as of June 30, 2026. These conditions raise substantial doubt about our ability to continue as a going concern, as further described in Note 2 to the condensed consolidated financial statements. Our conclusion has changed from the quarter ended March 31, 2026, when we concluded that our cash and expected sources of liquidity were sufficient for twelve months in reliance on the Securities Purchase Agreement providing for the issuance of notes in tranches with an aggregate redemption amount of up to $120,900,000. Additional tranches under that agreement are issuable only on satisfaction of the conditions in the agreement and at the holder’s election, and we have no unilateral right to draw; no further tranche has been drawn and the $10,900,000 drawn to date remains the only amount funded. In addition, since March 31, 2026 the holder of the senior secured convertible note delivered a notice of default, a forbearance agreement entered into on April 30, 2026 expired on June 30, 2026 without extension, our notes payable of $5,000,000 matured on July 1, 2026, $250,000 of the working capital contribution under the Settlement Agreement remained unfunded at June 30, 2026, and release of the $8,000,000 held under the deposit account control arrangement remains contingent on conversion of the Series A Convertible Preferred Stock in accordance with the note agreement and is not available for general corporate purposes. Those developments, taken together, are the basis for the change in conclusion.
Results of Operations — Three Months Ended June 30, 2026 Compared to Three Months Ended June 30, 2025 Research and development expenses were $959,742 for the three months ended June 30, 2026, compared with $651,784 for the same period in 2025, an increase of $307,958, or 47%. The increase was driven by clinical manufacturing costs of $287,623, non-clinical study costs of $187,232 and professional consulting of $240,695, partially offset by lower Phase II clinical trial spend.
General and administrative expenses were $5,319,018 for the three months ended June 30, 2026, compared with $2,012,120 for the same period in 2025, an increase of $3,306,898. The increase was driven principally by $1,281,090 of settlement-related legal and consulting fees, $1,150,000 of transaction and advisory fees, higher investor relations and public-company costs, and the inclusion of $1,153,443 of general and administrative expenses of the Digital Asset segment, which was not part of the Company in the prior-year period.
Total other expense, net, was $13,894,369 for the three months ended June 30, 2026, compared with other income, net, of $1,711 for the same period in 2025. The change reflects an unrealized loss on digital assets of $13,178,928 and interest expense of $3,223,755, partially offset by realized and trading gains on digital assets of $1,987,367, $282,732 of digital asset yield income and a $215,993 gain from the change in fair value of our derivative liability. Interest expense comprises $1,304,011 of contractual and flat interest on our notes payable and related-party notes and $1,859,744 of accretion of debt discounts and the $60,000 cash extension fee paid in June 2026 on Notes 2 and 3.
As a result, net loss was $20,173,129, or $11.77 per basic and diluted share, for the three months ended June 30, 2026, compared with $2,662,193, or $2.57 per basic and diluted share, for the same period in 2025.
Results of Operations — Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025 Research and development expenses were $1,860,886 for the six months ended June 30, 2026, compared with $651,784 for the same period in 2025. The increase reflects a full six months of clinical development activity, including manufacturing costs of $533,159, contract research organization fees of $297,309, professional consulting of $422,705, non-clinical studies of $187,232 and Phase II clinical trial costs of $140,000.
General and administrative expenses were $16,603,568 for the six months ended June 30, 2026, compared with $2,376,488 for the same period in 2025. The increase was driven principally by the $8,113,318 non-cash charge for advisory shares committed for issuance, $1,281,090 of settlement-related legal and consulting fees, $1,210,000 of transaction and advisory fees, and the inclusion of $2,814,364 of general and administrative expenses of the Digital Asset segment.
Total other expense, net, was $36,768,528 for the six months ended June 30, 2026, compared with $36,318 for the same period in 2025, driven principally by an unrealized loss on digital assets of $35,257,529 and interest expense of $4,083,160, partially offset by realized and trading gains on digital assets of $2,004,495, $282,732 of digital asset yield income and a $264,272 gain from the change in fair value of our derivative liability.
Net loss was $55,232,982, or $33.83 per basic and diluted share, for the six months ended June 30, 2026, compared with $3,064,590, or $3.35 per basic and diluted share, for the same period in 2025.
Apimeds
Pharmaceuticals US, Inc. is a development-stage biopharmaceutical company incorporated in the State of Delaware. Our primary focus is
the clinical development of Apitox, a purified honeybee venom-based drug candidate being evaluated for the treatment of acute pain and
inflammation associated with knee osteoarthritis. We operate our biopharmaceutical business through our wholly owned subsidiary, Lokahi
Therapeutics Inc. (“Lokahi”).
Through MindWave Innovations, the Company holds
Bitcoin (“BTC”), Tether (“USDT”), and MindWaveDAO NILA tokens (“NILA”), and participates in the MindWaveDAO
blockchain ecosystem through the continued sale of NILA. The Digital Asset segment’s performance is subject to the volatility inherent
in cryptocurrency markets. A more detailed discussion of the Digital Asset segment, including the MindWave Merger and the Company’s
related accounting policies, is included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
Our
Product Candidate
Our
product candidate Apitox is a purified, pharmaceutical grade venom of the Apis mellifera, or honeybee, which is classified by the U.S
Food and Drug Administration (“FDA”) as an active pharmaceutical ingredient. Apimeds Korea has developed a proprietary method
and process of turning extracted bee venom into a lyophilized powder for reconstitution prior to intradermal dose injections, which they
sell in South Korea as Apitoxin. Apimeds Korea has exclusively licensed to us all rights to develop, commercialize, market and sell Apitoxin
as “Apitox” in the United States in exchange for a sales royalty.
The
success of the Company is dependent on obtaining the necessary regulatory approvals of its product candidates, as well as the continued
advancement of it’s Digital Asset segment, which includes the appreciation of its cryptocurrency holdings consisting of Bitcoin
(“BTC”), Tether (“USDT”), and NILA tokens (“NILA”), and the advancement and continued sale of NILA
on the MindWaveDAO blockchain. The continuation of the research and development activities and the commercialization of its products,
if approved, are dependent on the Company’s ability to successfully complete these activities and to obtain additional financing
through a combination of financing activities and operations. It is not possible to predict either the outcome of future research and
development or cryptocurrency market sentiment or the advancement of the MindWaveDAO blockchain.
Financial
Segment Results
For the three months ended June 30, 2026, the BioBusiness segment reported a net loss of $7,197,738, the Digital Asset segment reported a net loss of $12,061,814 and Corporate reported a net loss of $913,577. For the six months ended June 30, 2026, the BioBusiness segment reported a net loss of $9,479,177, the Digital Asset segment reported a net loss of $35,785,775 and Corporate reported a net loss of $9,968,030. Segment assets as of June 30, 2026 were $2,497,274 for the BioBusiness segment, $117,075,940 for the Digital Asset segment and $9,769,393 for Corporate.
Since
inception, Apimeds has incurred significant operating losses. For the three months ended March 31, 2026 and 2025, Apimeds Pharmaceuticals
US, Inc. net loss was $35,059,852, and $402,397, respectively.
As of June 30, 2026, we had cash and cash equivalents of $278,371 and restricted cash of $8,000,000, compared with $1,636,655 and $8,000,000, respectively, as of December 31, 2025. Our restricted cash consists of $8,000,000 held in a deposit account control arrangement for the benefit of the holder of our senior secured convertible note, pending release upon conversion of the Series A Convertible Preferred Stock in accordance with the terms of the note agreement, and is not available for general corporate purposes.
Net cash used in operating activities was $7,734,893 for the six months ended June 30, 2026, compared with $3,381,409 for the same period in 2025. The 2026 amount reflects our net loss of $55,232,982, adjusted for non-cash items including $35,257,529 of unrealized losses on digital assets, $8,113,318 of advisory shares committed for issuance, $2,710,762 of non-cash accretion of debt discounts, $1,212,398 of accrued but unpaid interest and $219,376 of stock-based compensation, and for a $2,302,994 increase in accounts payable and accrued expenses.
Net cash provided by investing activities was $1,990,606 for the six months ended June 30, 2026, comprising $2,000,000 of redemptions of short-term investments, partially offset by $9,394 of equipment purchases. Net cash used in investing activities was $13,369 for the same period in 2025.
Net cash provided by financing activities was $4,386,002 for the six months ended June 30, 2026, comprising $5,970,000 of proceeds from notes payable net of original issue discount and $1,002 of subscription receivable collected, less $1,000,000 of note repayments and $585,000 of debt issuance costs paid. Net cash provided by financing activities was $12,126,646 for the same period in 2025, principally from our initial public offering and note financings.
Our ability to fund operations depends on our ability to raise additional capital, to monetize our digital-asset holdings, and to repay, extend or restructure our notes payable and senior secured convertible note. These factors raise substantial doubt about our ability to continue as a going concern.
As
of March 31, 2026, the Company had accumulated deficit amount of $45,452,914. The Company incurred net losses of $35,059,852 for the
three months ended March 31, 2026, and expects to continue to incur substantial losses in the future. On December 8, 2025, the Company
completed a PIPE financing (the “PIPE”) with an aggregate maximum amount of $120,900,000 drawn in tranches at the Company’s
discretion, given the market conditions allow. As of March 31, 2026, the Company has drawn a total amount of $10,900,000 from the PIPE
(see note 6) wherein $8,000,000 in proceeds have been recorded as restricted cash. Based on cash that is available and cash that is predicted
to become unrestricted for Company operations, together with continued Tether (“USDT”) proceeds from the digital assets segment,
and projections of future Company operations, the Company believes that its cash will be sufficient to fund the Company’s current
operating plan through at least the next twelve months from the date of issuance of the accompanying condensed financial statements.
Proceeds in the form of USDT have been included in evaluation of liquidity concerns given the fact that the Company uses these proceeds
to satisfy select operating expenses that pertain directly to the maintenance and management of the Digital Asset segment.
Results
of operations for the three months ended March 31, 2026, and 2025
Operating
Expense
The
following table sets forth the Company’s selected statements of operations data for the following periods:
Revenues
For
the three months ended March 31, 2026, and 2025, the Company had no revenue.
General and Administrative Expenses
For the three months ended March 31, 2026, included in General and
administrative expense is $8,113,318 non-cash charge for stock issued to our financial advisor. This charge is not expected to be recur.
Other income expense
The $22,836,129 increase in other expense for the three months ended
March 31, 2026 compared to March 31, 2025 was principally the result of $22,078,601 of unrealized losses on the Company digital asset
holdings. The Company did not hold any digital assets during the three months ended March 31, 2025. Digital asset market volatility can
be expected to be significant in future periods.
Net
Loss
Net
loss was $35,059,852 for the three months ended March 31, 2026, compared to net loss of $402,397 in the same period of 2025, representing
an increase in loss of $34,657,455. The increase was mainly due to the loss on fair value of cryptocurrency holdings and stock compensation
expenses (see Cash Flows).
Cash
Flows
The
following table presents selected financial information and statistics for each of the periods shown below:
During
the three months ended March 31, 2026, operating activities used approximately $2,067,727 of cash, differing drastically from a reported
net loss of $35,059,852 due in large part to noncash additions of $22,061,472 of changes in fair value of cryptocurrency and stock
compensation expenses of $8,113,318, respectively. Other material noncash additions include accretion expense of approximately $851,018,
and changes in operating assets and liabilities of approximate increase of $1,839,261, due to the netting of an increase in prepaid research
costs and increases in accounts payable and accrued expenses.
Comparatively,
during the three months ended March 31, 2025, operating activities used $20,313 of cash, primarily resulting from a net loss of $402,397,
partially offset by non-cash interest expense-related parties of $11,256, accretion expense of $26,776, and changes in operating assets
and liabilities of $344,051.
Investing
activities
During
the three months ended March 31, 2026, and 2025, investing activities used approximately $490,606 and $0, respectively. For the period
ended 2026, this value consists of $500,000 received as a transfer from short term investments and a decrease of $9,394 incurred due
to purchases of furniture and fixtures.
Financing
activities
During
the three months ended March 31, 2026, financing activities provided approximately $920,000 of cash. This was primarily attributable
to net proceeds from the issuance of notes payable, partially offset by issuance costs paid upon closing of the debt offering of $75,000.
Comparatively,
during the three months ended March 31, 2025, financing activities provided $267,200 of cash resulting from $250,000 in proceeds from
notes payable from related parties and cash advances from related parties of $17,200.
Contractual
Obligations and Commitments
See
Note 6 – Debt, and Note 8 – Commitments and Contingencies, of the notes to the Company’s financial statements as of
and for the three months ended March 31, 2026, included elsewhere in this Quarterly Report for further discussion of the Company’s
commitments and contingencies.
Off-Balance
Sheet Arrangements
The
Company is not party to any off-balance sheet transactions. The Company has no guarantees or obligations other than those which arise
out of normal business operations.
Critical
Accounting Policies and Significant Judgments and Estimates
Our critical accounting estimates include the fair value measurement of our digital assets under ASC 350-60 — in particular the NILA token, which is measured using Level 2 inputs and represented $49,983,968, or 43%, of our digital assets as of June 30, 2026 — the fair value of the embedded conversion feature accounted for as a Level 3 derivative liability and measured using a Monte Carlo simulation, and the effective interest rates used to accrete debt discounts. Changes in the assumptions underlying these estimates could have a material effect on our reported results.
Off-Balance-Sheet Arrangements
We do not have any off-balance-sheet arrangements as defined under SEC rules.
The
Company’s management’s discussion and analysis of its financial condition and results of operations is based on its financial
statements, which have been prepared in accordance with U.S. GAAP. The preparation of these unaudited condensed financial statements
requires Apimeds Pharmaceuticals US, Inc. to make estimates, judgments and assumptions that affect the reported amounts of assets and
liabilities, disclosure of contingent assets and liabilities as of the date of the balance sheet and the reported amounts of expenses
during the reporting period. In accordance with U.S. GAAP, Apimeds Pharmaceuticals US, Inc. evaluates its estimates and judgments on
an ongoing basis. The most significant estimates relate to convertible instruments. Apimeds Pharmaceuticals US, Inc. bases its estimates
and assumptions on current facts, historical experiences, and various other factors that Apimeds Pharmaceuticals US, Inc. believes are
reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities
that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
The
Company defines its critical accounting policies as those accounting principles that require it to make subjective estimates and judgments
about matters that are uncertain and are likely to have a material impact on its financial condition and results of operations, as well
as the specific manner in which the Company applies those principles. While its significant accounting policies are more fully described
in Note 2 to its financial statements, the Company believes the following are the critical accounting policies used in the preparation
of its unaudited condensed financial statements that require significant estimates and judgments.
APUS insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding APUS (13F)
None of the 59 investors we track reported a position in their latest 13F.