UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the
quarterly period ended March 31, 2025
or
☐
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 jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
2 East Broad Street 2nd Floor
Hopewell , New Jersey
08425
(Address of principal executive offices) (Zip Code)
(808) 209-7887
(Registrant’s telephone number, including
area code)
Securities registered pursuant to section 12(b) of the Act:
Title of each class Trading symbol(s) Name of each exchange on which registered
Common stock, par value $0.01 per share APUS NYSE American LLC
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☐ No ☒
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☒
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
No ☒
As
of May 19, 2025, there were 11,575,983 shares
of common stock, par value $0.01 per share, of the registrant issued and outstanding.
TABLE OF CONTENTS
Page
PART
I—FINANCIAL INFORMATION
1
Item
1. Financial Statements
1
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
15
Item
3. Quantitative and Qualitative Disclosures About Market Risk
19
Item
4. Controls and Procedures
19
PART
II—OTHER INFORMATION
21
Item
1. Legal Proceedings
21
Item
1A. Risk Factors
21
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
21
Item
3. Defaults Upon Senior Securities
21
Item
4. Mine Safety Disclosures
21
Item
5. Other Information
21
Item
6. Exhibits
22
SIGNATURES
23
i
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
INDEX TO FINANCIAL STATEMENTS
Contents
Page
Unaudited Condensed Balance Sheets as of March 31, 2025 and December 31, 2024
2
Unaudited Condensed Statements of Operations for the Three Months Ended March 31, 2025 and 2024
3
Unaudited Condensed Statements of Changes in Shareholders’(Deficit) Equity for the Three Months Ended March 31, 2025 and 2024
4
Unaudited Condensed Statements of Cash Flows for the Three Months Ended March 31, 2025 and 2024
5
Notes to Unaudited Condensed Financial Statements
6
1
Apimeds Pharmaceuticals US, Inc.
Unaudited Condensed Balance Sheets
March 31,
2025
December 31,
2024
Assets
Current assets:
Cash
$ 250,342
$ 3,455
Prepaid expenses and other current assets
9,562
9,602
Total current assets
259,904
13,057
Total assets
$ 259,904
$ 13,057
Liabilities and shareholders’ (deficit) equity
Current liabilities:
Accounts payable and accrued expenses
$ 935,203
$ 591,191
Accrued interest – related party
117,899
106,643
Advance payable to related party
93,700
76,500
Notes payable – related party
250,000
250,000
Convertible note – related party
373,620
—
Total current liabilities
1,770,422
1,024,334
Long term portion of notes payable – related party
250,000
—
Long term portion of convertible notes payable – related party
—
346,844
Total liabilities
2,020,422
1,371,178
Commitments and contingencies (Note 6)
Shareholders’ (deficit) equity:
Preferred stock, par value $ 0.01 , 10,000,000 shares authorized; none issued and outstanding as of March 31, 2025 and December 31, 2024
—
—
Common stock, par value $ 0.01 , 100,000,000 shares authorized; 7,903,850 issued and outstanding as of March 31, 2025 and December 31, 2024
79,039
79,039
Additional paid-in capital
2,954,764
2,954,764
Accumulated deficit
( 4,794,321 )
( 4,391,924 )
Total shareholders’ (deficit) equity
( 1,760,518 )
( 1,358,121 )
Total liabilities and shareholders’ (deficit) equity
$ 259,904
$ 13,057
The accompanying notes are an integral part
of these unaudited condensed financial statements.
2
Apimeds Pharmaceuticals US, Inc.
Unaudited Condensed Statements of Operations
For the three months ended
March 31,
2025
2024
Operating expenses:
Research and development expenses
$ —
$ —
General and administrative expenses
364,368
271,726
Loss from operations
( 364,368 )
( 271,726 )
Other (expenses) income
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 )
Weighted average shares outstanding
7,903,850
7,903,850
Basic and diluted loss per share
$ ( 0.05 )
$ ( 0.04 )
The accompanying notes are an integral part
of these unaudited condensed financial statements.
3
Apimeds Pharmaceuticals US, Inc.
Unaudited Condensed Statement of Changes in Shareholders’ (Deficit) Equity
Preferred Stock
Common Stock
Additional
Number of Shares
Amount
Number of Shares
Amount
Paid-In Capital
Accumulated Deficit
Total
Balance at December 31, 2024
—
$ —
7,903,850
$ 79,039
$ 2,954,764
$ ( 4,391,924 )
$ ( 1,358,121 )
Net loss
—
—
—
—
—
( 402,397 )
( 402,397 )
Balance at March 31, 2025
—
$ —
7,903,850
$ 79,039
$ 2,954,764
$ ( 4,794,321 )
$ ( 1,760,518 )
Balance at December 31, 2023
—
$ —
7,903,850
$ 79,039
$ 2,954,764
$ ( 3,001,934 )
$ 31,869
Net loss
—
—
—
—
—
( 296,473 )
( 296,473 )
Balance at March 31, 2024
—
$ —
7,903,850
$ 79,039
$ 2,954,764
$ ( 3,298,407 )
$ ( 264,604 )
The accompanying notes are an integral part
of these unaudited condensed financial statements.
4
Apimeds Pharmaceuticals US, Inc.
Unaudited Condensed Statements of Cash Flows
For the Three Months Ended
March 31,
2025
2024
Cash flows from operating activities:
Net loss
$ ( 402,397 )
$ ( 296,473 )
Adjustments to reconcile net loss to net cash used in operating activities:
Accrued interest expense – related parties
11,256
7,956
Accretion expense
26,776
18,952
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
40
1,258
Accounts payable and accrued expenses
344,012
5,207
Net cash used in operating activities
( 20,313 )
( 263,100 )
Cash flows from investing activities:
Net cash provided by investing activities
—
—
Cash flows from financing activities:
Proceeds from notes payable – related parties
250,000
—
Cash advances from related parties
17,200
—
Net cash provided by financing activities
267,200
—
Net increase (decrease) in cash
246,887
( 263,100 )
Cash, beginning of period
3,455
410,481
Cash, end of period
$ 250,342
$ 147,381
The accompanying notes are an integral part
of these unaudited condensed financial statements.
5
Apimeds Pharmaceuticals US, Inc.
Notes to the Unaudited Condensed Financial Statements
1. DESCRIPTION OF BUSINESS
Business Description
Apimeds Pharmaceuticals US, Inc. (the “Company” or “Apimeds”)
was formed as a corporation in May 2020 and was incorporated in the State of Delaware. On August 21, 2021, Apimeds Inc., the
shareholder of the Company (“Apimeds Korea”), and Apimeds Pharmaceuticals US Inc. entered into the business agreement, under
which the Company was designated to operate a pharmaceutical business which provides the biological drug named Apitox™ to clients
in the biological drug commercial transaction area.
Apimeds is a clinical stage company that is in the process of developing
Apitox™, a proprietary intradermally administered bee venom-based toxin which completed a positive Phase 3 trial for the treatment
of pain associated with Osteoarthritis in 2018 and is now proceeding with FDA discussions on next steps in approval. In the future, the
Company plans to investigate potential uses for Apitox™ for in treating multiple sclerosis (“MS”), and intends to conduct
non-registered corporate sponsorship studies to identify appropriate MS patient populations. Apitox™ is currently marketed and sold
by Apimeds Korea in South Korea (Republic of Korea) as “Apitoxin” for the treatment of osteoarthritis. Apimeds Inc. holds
the majority of the Company’s outstanding common stock and is a subsidiary of Inscobee Inc. (“Inscobee”).
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.
2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The Company has prepared these unaudited condensed financial statements
in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) as found in the
Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) promulgated by the Financial
Accounting Standards Board. Except (“FASB”) as disclosed herein, there have been no material changes in the information disclosed
in the Notes to the Financial Statements included in the Annual Report for the years ended December 31, 2024 and 2023. Accordingly,
the unaudited condensed financial statements and related disclosures herein should be read in conjunction with our 2024 Annual Report
on Form 10-K.
6
Liquidity
As of March 31, 2025, the Company had accumulated
deficit amount to $ 4,794,321 . The Company incurred net losses of $ 402,397 for the three months ended March 31, 2025, and expects to continue
to incur substantial losses in the future. On May 12, 2025, the Company consummated its initial public offering (the “IPO”)
of 3,375,000 shares of its common stock at a price of $ 4.00 per share, generating net proceeds to the Company of $ 11.9 million. Based
on cash that is available for Company operations, together with the proceeds from the IPO, 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.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP
requires management to make certain estimates, judgements and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the
reporting period. Significant estimates and assumptions made in the accompanying unaudited condensed financial statements include, but
are not limited to, stock-based compensation and estimates that are related to convertible instruments. Actual results could differ from
those estimates, and such differences could be material to the financial statements.
Fair Value Measurement
The fair value of the Company’s financial assets and liabilities
reflects management’s estimate of amounts that the Company would have received in connection with the sale of the assets or paid
in connection with the transfer of the liabilities in an orderly transaction between market participants at the measurement date. In connection
with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of observable inputs (market data obtained
from independent sources) and to minimize the use of unobservable inputs (internal assumptions about how market participants would price
assets and liabilities). The following fair value hierarchy is used to classify assets and liabilities based on the observable inputs
and unobservable inputs used in order to value the assets and liabilities:
Level 1 —
Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis.
Level 2 —
Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active.
Level 3 —
Unobservable inputs based on the Company’s assessment of the assumptions that market participants would use in pricing the asset or liability.
In some circumstances, the inputs used to measure fair value might
be categorized within different levels of the fair value hierarchy. In those instances, the fair value measurement is categorized in its
entirety in the fair value hierarchy based on the lowest level input that is significant to the fair value measurement.
Common Stock Reverse Stock Split
On February 7,2025 , the
Board approved and implemented a reverse stock split ratio of 1-for-2.6, which provided that every 2.6 shares of its
issued and outstanding Common Stock was automatically combined into one issued and outstanding share of Common Stock,
without any change in the par value per share. All share and per share amounts in the accompanying unaudited condensed financial statements
and footnotes have been retrospectively adjusted for the reverse split.
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to concentration
of credit risk consist of cash accounts in financial institutions which, at times, may exceed the federal depository insurance corporation
limit of $ 250,000 . As of March 31, 2025, the Company has not experienced losses on these accounts and management believes the Company
is not exposed to significant risks on such accounts.
Segment Information
The Company operates as a single operating and reportable segment,
which aligns with the way the Chief Executive Officer, designated as the Chief Operating Decision Maker (CODM), evaluates performance
and allocates resources. The Company is a clinical-stage entity focused on the development of a proprietary intradermally administered
bee venom-based therapeutic. As of March 31, 2025, the Company has not generated any revenue and does not have any long-lived assets.
The CODM assesses the Company’s performance primarily through the analysis of operating expenses, specifically within key categories
such as research and development and general and administrative expenses. Given the Company is in a pre-revenue stage, these expense categories
serve as the primary financial drivers.
7
Financial information provided to and utilized by the CODM is consistent
with the Company’s GAAP financial statements, including the Statements of Operations, which reflect the loss. A single management
team reports directly to the CODM and oversees the entire business comprehensively. Resource allocation, performance evaluation, incentive
setting, and forecasting activities are conducted at the corporate level using the financial statements and a unified budget. Accordingly,
the Company does not evaluate performance by geographic area or product line, as it has not yet commenced commercial operations and has
limited activity due to current liquidity and funding constraints. All operations are based in the United States of America, and all assets
and operating expenses — including those related to research and development and general and administrative functions — are
attributed to the Company’s single reportable segment.
Cash
The Company considers all highly liquid investments with an original
maturity of three months or less at the date of purchase to be cash equivalents. As of March 31, 2025 and December 31, 2024,
the Company had no cash equivalents.
Accrued Expenses
Accrued expenses consist of accrued interest for the convertible and
promissory notes held with related parties, monies owed to vendors, as well as others, such as the taxing authority and employees.
As March 31, 2025, and December 31, 2024, the accounts payable
and accrued expenses balance consists of the following:
March 31,
December 31,
2025
2024
Professional fees payable
$ 648,153
$ 410,641
Accrued compensation
287,050
180,550
Total accounts payable and accrued expenses
$ 935,203
$ 591,191
Convertible Instruments
The Company evaluates and accounts for conversion options embedded
in convertible instruments in accordance with ASC 815 “Derivatives and Hedging Activities”.
Applicable U.S. GAAP requires companies to bifurcate conversion
options from their host instruments and account for them as free-standing derivative financial instruments according to certain criteria.
The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are
not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies
both the embedded derivative instrument and the host contract is not re-measured at fair value under other U.S. GAAP with changes
in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument
would be considered a derivative instrument.
The Company accounts for convertible instruments (when we have determined
that the embedded conversion options should not be bifurcated from their host instruments) as follows: The Company records when necessary,
discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between
the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded
in the note. Debt discounts under these arrangements are accreted over the term of the related debt to their stated date of redemption.
If a security or instrument becomes convertible only upon the occurrence
of a future event outside the control of the Company, or, is convertible from inception, but contains conversion terms that change upon
the occurrence of a future event, then any contingent beneficial conversion feature is measured and recognized when the triggering event
occurs and contingency has been resolved.
Patent Costs
All patent-related costs incurred in connection with filing and prosecuting
patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified
as general and administrative expenses in the accompanying statements of operations.
8
Leases
The Company accounts for a contract as a lease when it has the right
to direct the use of the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company
determines the initial classification and measurement of its right-of-use assets (“ROU”) and lease liabilities at the lease
commencement date and thereafter if modified. ROU assets and liabilities are to be represented on the balance sheet at the present value
of future minimum lease payments to be made over the lease term. The Company has elected as an accounting policy not to apply the recognition
requirements in ASC 2016-02, Leases (“ASC 842”) to short-term leases. Short-term leases are leases that have
a term of 12 months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain
to exercise. The Company recognizes the lease payments for short-term leases on a straight-line basis over the lease term. As of March 31,
2025 and December 31, 2024, the Company did not have leases that qualified as ROU assets.
Related Parties
The Company follows ASC 850, “ Related Party Disclosures” for
the identification of related parties and disclosure of related party transactions.
General and Administrative
General and administrative expenses consist primarily of management
personnel costs, professional service fees, and other general overhead and facility costs, including rent and insurance, which relate
to the Company’s general and administrative functions.
Research and Development
Research and development expenses consist primarily of consulting,
regulatory and manufacturing related costs, third-party license fees and external costs of vendors engaged to conduct preclinical development
activities. These costs are expensed as incurred and non-refundable prepayments for goods or services that will be used or rendered for
future research and development activities are deferred and capitalized in prepaid expenses and other current assets.
The Company enters into arrangements with contract research organizations
in connection with pre-clinical and clinical trials. Such arrangements often provide for payment prior to commencing the project or based
upon predetermined milestones throughout the period during which services are expected to be performed. As part of the process of preparing
the Company’s financial statements, management is required to estimate prepaid and accrued clinical trial expenses. The date on
which services commence, the level of services performed on or before a given date, and the cost of such services are often determined
based on subjective judgments informed by the facts and circumstances known to management from the terms of the contract and the Company’s
ongoing monitoring of service performance. The Company makes these judgments based upon the facts and circumstances known to management
based on the terms of the contract and the Company’s ongoing monitoring of service performance.
In line with the guidance suggested under ASC 450, Contingencies
and ASC 730, Research and Development, all research and development costs will be expensed as incurred. Development and regulatory
milestone payments are accounted for by estimating the probability of milestone achievement.
Stock Based Compensation
The Company accounts for share-based compensation in accordance with
the fair value recognition provision of FASB ASC 718, Compensation — Stock Compensation (“ASC 718”),
which prescribes accounting and reporting standards for all share-based payment transactions in which employee services are acquired.
Transactions include incurring liabilities, or issuing or offering to issue shares, options, and other equity instruments such as employee
stock ownership plans and stock appreciation rights. Share-based payments to employees, including grants of employee stock options, are
recognized as compensation expense in the unaudited condensed financial statements based on the estimated grant date fair values. That
expense is recognized over the period during which an employee is required to provide services in exchange for the award, known as the
requisite service period (usually the vesting period). The Company accounts for forfeitures as they occur. The Company classifies share-based
compensation expense in its statements of operations in the same manner in which the award recipient’s cash compensation costs are
classified.
Given the absence of an active market for the Company’s equity,
the Company and the board of directors were required to estimate the fair value of the Company’s common stock and equity awards
at the time of each grant. The Company and the board of directors determined the estimated fair value of the Company’s equity instruments
based on a number of factors, including external market conditions affecting the pharmaceutical industry sector. The Company and the board
of directors utilized various valuation methodologies in accordance with the framework of the American Institute of Certified Public Accountants’
Technical Practice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation, to estimate the fair value of its
equity instrument. Each valuation methodology includes estimates and assumptions that require the Company’s judgment.
9
Income Taxes
The Company accounts for income taxes using the asset and liability
method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences attributable to
differences between carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax reporting
purposes and for operating loss and tax credit carryforwards. Changes in deferred tax assets and liabilities are recorded in the provision
for income taxes.
The Company’s deferred tax assets and liabilities are measured
using enacted tax rates expected to apply in the years in which these temporary differences are expected to be recovered or settled.
A valuation allowance is recorded to reduce deferred tax assets if it is determined that it is more likely than not that all or a portion
of the deferred tax asset will not be realized. The Company considers many factors when assessing the likelihood of future realization
of deferred tax assets, including recent earnings results, expectations of future taxable income, carryforward periods available and other
relevant factors. The Company records changes in the required valuation allowance in the period that the determination is made.
The Company assesses its income tax position and records tax benefits
for all years subject to examination based upon management’s evaluation of the facts, circumstances and information available
as of the reporting date. For those tax positions where it is more likely than not that a tax benefit will be sustained, the Company records
the largest amount of tax benefit with a greater than 50 % likelihood of being realized upon ultimate settlement with a taxing authority
having full knowledge of all relevant information. For those income tax positions where it is not more likely than not that a tax benefit
will be sustained, the Company does not recognize a tax benefit in the financial statements. The Company records interest and penalties
related to uncertain tax positions, if applicable, as a component of income tax expense.
Basic and Diluted Loss per share
Basic loss per share data for each period presented is computed using
the weighted average number of shares of common stock outstanding during each such period. Diluted net loss per share is computed by giving
effect to all potential shares of common stock to the extent they are dilutive.
The following table sets forth the number of potential shares of common
stock that have been excluded from basic net loss per share because their effect was anti-dilutive:
For the three months ended March 31,
2025
2024
Employee stock options
213,693
213,693
Convertible notes and interest
295,672
283,397
509,365
497,090
Emerging Growth Company
The Company intends to elect as an Emerging Growth Company, as defined
in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (“JOBS
Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to
the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has elected to use this extended
transition period for complying with new or revised accounting standards that have different effective dates for public and private companies
until the earlier of the date that it (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts
out of the extended transition period provided in the JOBS Act. As a result, these unaudited condensed financial statements may not be
comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.
Recently Issued Accounting Pronouncements
The Company considers the applicability and impact
of all Accounting Standard Updates. ASUs not discussed in these unaudited condensed financial statements were assessed and determined
to be either not applicable or are expected to have minimal impact on the financial statements.
In November 2024, the FASB issued Accounting
Standards Update No. 2024-03, Disaggregation of Income Statement Expenses . This guidance will require additional disclosures
and disaggregation of certain costs and expenses presented on the face of the income statement. The amendments are effective for annual
reporting periods beginning after December 15, 2026 and interim reporting period beginning after December 15, 2027 with early adoption
permitted. The Company is currently evaluating the impact of this new guidance to our financial statements.
10
3. LICENSE AGREEMENTS
On August 2, 2021, the Company entered into a business agreement
with Apimeds Korea. Under the agreement, the Company received the right to continue any clinical trial and acquire the permits and approval
necessary from the U.S. Food and Drug Administration. The Company will pay Apimeds Korea a royalty of 5 % of the earnings before interest
and taxes, delivered from the sale or license of Apitox less any credits and charges, however, the royalty terms shall not apply when
shares of the Company are transferred or sold through merger, acquisition, or share transfer agreement to a third party.
On October 12, 2021, the Company entered into an exclusive patent
license agreement with Apimeds Korea, a shareholder of the Company. Under the agreement, the Company was granted the exclusive right and
license under the licensed patents to make and sell the licensed products in the United States of America.
The agreement shall commence on the effective date and shall remain
in force for each licensed product on a licensed-product-by-licensed-product basis for rights and obligations concerning the licensed
patent, until the expiration of the last to expire valid claim of a licensed patent. The total consideration exchanged for the exclusive
license agreement was $ 1 .
4. DEBT
2022 Convertible notes (amended from notes payable) — related
parties
On March 21, 2022, the Company entered into a promissory note
agreement in the amount of $ 160,000 with Inscobee, one of its shareholders. On June 3, 2022, the Company received an additional $ 100,000
from Inscobee, as part of another promissory note agreement (together as “2022 Convertible Notes ”). The 2022 Convertible
Notes bear interest at 5 % per annum and mature on the earlier of (a) the closing of an equity financing with proceeds to the
Company of at least $ 3 million, or (b) July 15, 2022.
On December 5, 2023, the Company amended their promissory notes
to be convertible and extended the maturity date of the convertible notes with the related parties to be the earlier of (i) December 31,
2026 or (ii) consummation of a qualified offering. The notes are convertible at a price of $ 1 per share. The purchase of convertible
notes and cancellation of the old promissory notes was accounted for as a debt extinguishment that did not result in a gain/loss on extinguishment
due to related party treatment. The conversion option was valued utilizing the Black-Scholes model, with the following inputs: volatility
of 92.22 %, current stock price of $ 1.96 , expected dividend yield of 0 % and a risk-free rate of return of 4.33 %. The resulting value of
the convertible option of $ 158,099 based on the allocation of relative fair value to cash proceeds, was applied towards additional paid-in
capital and added as a discount on the convertible note. The note will be accreted over the remaining period through maturity at the calculated
effective interest rate of approximately 41.4 %.
As of March 31, 2025 and December 31, 2024,
there was accrued interest in connection to the 2022 Convertible Notes of $ 37,844 and $ 34,745 , respectively. Interest expenses were $ 3,099
and $ 3,134 for the three months ended March 31, 2025 and 2024, respectively, and are included within accrued interest — related
party on the accompanying balance sheet. There was accretion on the note’s debt discount of $ 10,599 and $ 7,471 for the three
months ended March 31, 2025 and 2024, respectively.
As of March 31, 2025 and December 31, 2024, the outstanding balance
on the 2022 Convertible notes agreement, net of the unamortized debt discounts of $ 113,934 and $ 124,534 , was $ 146,066 and $ 135,466 ,
respectively.
2021 Convertible note — related party
On August 30, 2021, the Company received $ 400,000 in a convertible
note agreement (“2021 Convertible Note”) with Apimeds Korea, one of its shareholders. The 2021 Convertible Note bears interest
at 5 % per annum and matures on the earlier of (a) the sale of the Company or (b) August 30, 2026. The 2021 Convertible
Note is convertible at any time up through the maturity date. The number of shares of common stock shall be determined by dividing (x) the
outstanding principal balance hereof plus accrued but unpaid interest by the first closing price on the first day of trading following
a Qualified Direct Listing.
On December 5, 2023, the Company amended their convertible note
to be convertible at $ 1 per share and extended the maturity date to be the earlier of (i) December 31, 2026 or (ii) consummation
of a qualified offering. The repurchase and cancellation of the old note was accounted for as a debt extinguishment that did not result
in any gain/loss on extinguishment due to related party treatment. The conversion option was valued utilizing the Black-Scholes model,
with the following inputs: volatility of 92.22 %, the fair value of the stock of $ 1.96 , expected dividend yield of 0 %, and a risk-free
rate of return of 4.33 %. The resulting value of the convertible option of $ 240,079 , based on the allocation of relative fair value to
cash proceeds, was applied towards additional paid-in capital and added as a discount on the convertible note. The note will be accreted
over the remaining period through maturity at the calculated effective interest rate of approximately 40.6 %.
11
As March 31, 2025 and December 31, 2024, there was accrued interest
in connection with the 2021 Convertible Note of $ 70,904 and $ 66,137 , respectively, and is included within accrued interest — related
party on the accompanying unaudited condensed balance sheets. Interest expense was $ 4,767 and $ 4,822 for the three months ended March 31,
2025 and 2024, respectively. Accretion on the 2021 Convertible Note discount is included within interest expense on the unaudited condensed
statement of operations. There was accretion on the 2021 Convertible Note debt discount of $ 16,177 and $ 11,481 for the three months
ended March 31, 2025 and 2024.
As of March 31, 2025 and December 31, 2024, the outstanding balance
on the 2021 Convertible Note, net of the unamortized debt discounts of $ 172,445 and $ 188,622 , was $ 227,555 and $ 211,378 , respectively.
In connection with the closing of its initial
public offering (the” IPO’), 2022 Convertible Notes and 2021 Convertible Note automatically converted into shares of common
stock. Pursuant to the terms of the 2021 and 2022 Convertible Notes agreements (as emended), all outstanding accrued and unpaid interest
owed under the 2021 and 2022 Convertible Notes was to convert into Common Stock simultaneously with the consummation of an offering of
Common Stock resulting in the listing of the common stock on the NYSE American, or other national securities exchange. An aggregate of
$ 772,545 of outstanding principal and accrued interest under the Notes was converted to common stock, resulting in the issuance of an
aggregate of 297,133 shares of Company’s common stock, based on a conversion price of $ 2.60 per share, as set forth in the 2021
and 2022 Convertible Notes.
2024 Promissory Notes — Related Parties
On May 20, 2024, the Company received $ 100,000
in a promissory note agreement with Inscobee Inc., one of its shareholders. On August 19, 2024, the Company received an additional $ 150,000
from Inscobee, as part of another promissory note agreement (together as “2024 Promissory Notes ”). The 2024 Promissory
Notes bear interest at 5 % per annum and mature on the earlier of (a) the closing of an equity financing by the Company with gross
proceeds of at least $ 3,000,000 ; or (b) May 19, 2025.
As of March 31, 2025 and December 31, 2024, there was accrued
interest in connection with the 2024 Promissory Notes of $ 8,842 and $ 5,760 . Interest expense was $ 3,082 for the three months ended March 31,
2025, and is included within accrued interest — related party on the accompanying unaudited condensed balance sheet.
On May 16, 2025, the 2024 Promissory Notes were
further amended extending the maturity date of for the outstanding principal and accrued interest payment date to May 19, 2026.
2025 Promissory Note — Related
Parties
On March 21, 2025, the Company received $ 250,000 in a promissory note
agreement with Apimeds, Korea, one of its shareholders (“ 2025 Promissory Note ”). The 2025 Promissory Note bears interest
at 5 % per annum and matures on the earlier of (a) December 31, 2026 or (b) consummation of a Qualified Offering.
As of March 31, 2025, there was accrued interest in connection with
the 2025 Promissory Note of $ 308 . Interest expense was $ 308 for the three months ended March 31, 2025, and is included within accrued
interest — related party on the accompanying unaudited condensed balance sheet.
On May 16, 2025, the 2025 Promissory Note was
further amended extending the maturity date of for the outstanding principal and accrued interest payment date to May 19, 2026.
2024 Short Term Borrowing
On July 19, 2024, the Company entered into a non-interest-bearing
loan agreement with a private lender for $ 20,000 . The note matured on August 31, 2024 , or may be extended upon mutual agreement.
This loan was paid off in full on August 27, 2024.
5. ADVANCE PAYABLE — RELATED PARTY
As of March 31, 2025, and December 31, 2024 the Company had an
outstanding balance of $ 93,700 and $ 76,500 , respectively, due to funds received from an officer of the Company.
These advance payables carry no interest and do not have a maturity
date. The cash proceeds from these advance payables were used for operating purposes.
6. COMMITMENTS AND CONTINGENCIES
Legal
Periodically, the Company reviews the status of any significant matters
that exist and assesses its potential financial exposure. If the potential loss from any claim or legal claim is considered probable and
the amount can be estimated, the Company accrues a liability for the estimated loss. Legal proceedings are subject to uncertainties, and
the outcomes are difficult to predict. Because of such uncertainties, accruals are based on the best information available at the time.
As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation.
As of March 31, 2025 and December 31, 2024, there are no pending claims or litigation that are expected to materially affect the
Company’s results going forward.
12
Executive employee agreement
On September 21, 2023, the Company signed
an executive employee agreement with the CEO of the Company. Under the executive employee agreement terms, if the Company closes on a
public offering, the CEO will be eligible to receive an incentive stock option to purchase a number of shares of the Company’s common
stock equal to 3 % of the post-Public Offering capitalization of the Company. 40 % of the options shall vest immediately upon grant and
the remainder will vest in three equal installments on the annual anniversary of the date of grant. On May 12, 2025, the Company consummated
its initial public offering (the “IPO”) of 3,375,000 shares of its common stock at a price of $ 4.00 per share, generating
gross proceeds to the Company of $ 13.5 million before deducting underwriting discounts and offering expenses. The Company is currently
in a process of evaluating of post-IPO capitalization with the grants to be approved by the board of directors.
7. SHAREHOLDERS’ DEFICIT
Common Stock
As of March 31, 2025 and December 31, 2024, the Company had 100,000,000
authorized shares of common stock, respectively, at a par value of $ 0.01 . The Company had 7,903,850 common shares issued and outstanding,
as of March 31, 2025 and December 31, 2024, respectively. Each Common share is entitled to one vote.
On February 7, 2025, the Board approved and implemented
a reverse stock split ratio of 1-for-2.6 , which provided that every 2.6 shares of its issued and outstanding Common
Stock were automatically combined into one issued and outstanding share of Common Stock, without any change in the
par value per share. All share and per share amounts in the accompanying unaudited condensed financial statements and footnotes have been
retrospectively adjusted for the reverse split
Preferred Stock
On December 5, 2023, the Company authorized 10,000,000 shares
of preferred stock with a par value of $ 0.01 . The rights and preferences of preferred shareholders have not been determined as of the
date of filing. The Company had no preferred shares issued or outstanding as of March 31, 2025 and December 31, 2024, respectively.
8. STOCK-BASED COMPENSATION
Stock Options
On September 18, 2024, the Company adopted an equity incentive plan
for its employees, the Apimeds Pharmaceuticals US, Inc. 2024 Equity Incentive Plan (the “2024 Equity Incentive Plan”). 1,000,000
shares of common stock have initially been reserved for the issuance of awards under the 2024 Equity Incentive Plan with no stock options
granted or outstanding as of the issuance date of the financial statements.
On May 12, 2020, the Company granted one of its executive officers
a total of 213,692 nonqualified stock option awards issued outside of the 2024 Equity Incentive Plan. The stock options vested
in three equal tranches of 71,231 on the grant anniversary date through May 12, 2023. The shares have an exercise price of $ 7.33
per share and expire in 10 years on May 12, 2030.
There were no stock option awards issued, canceled or forfeited during the three months ended March 31, 2025 and 2024.
As of March 31,
2025, there were 213,692 stock option awards outstanding and exercisable, with $ 7.33 weighted average exercised price and 5.12 years in
weighted average remaining life, and no aggregated intrinsic value.
13
During the three months ended March 31, 2025 and 2024, there
was $ 0 of stock-based compensation recognized.
The options were valued utilizing the Black-Scholes options pricing
model with the following inputs: 0.20 % risk-free rate, 66.8 % volatility, 0 % dividend rate, vesting term of 3 years , and the expected
term of 6.5 years.
As of March 31, 2025, there were no remaining unrecognized compensation
costs related to unvested options.
9. INCOME TAXES
The Company recorded no provision or benefit for income tax
expense for the three months ended March 31, 2025 and 2024, respectively.
For all periods presented, the pretax losses incurred by the Company
received no corresponding tax benefit because the Company concluded that it is more likely than not that the Company
will be unable to realize the value of any resulting deferred tax assets. The Company will continue to assess its position in future periods
to determine if it is appropriate to reduce a portion of its valuation allowance in the future.
The Company has no open tax audits with any taxing authority
as of March 31, 2025.
10. SUBSEQUENT EVENTS
Initial public offering
On May 12, 2025, the Company consummated its initial
public offering (the “IPO”) of 3,375,000 shares of its common stock at a price of $ 4.00 per share, generating gross proceeds
to the Company of $ 13.5 million before deducting underwriting discounts and offering expenses.
Conversion of Related Parties 2022 Convertible
Notes and 2021 Convertible Note
In connection with the closing of its initial
public offering (the” IPO’), the Related Parties 2022 Convertible Notes and 2021 Convertible Note automatically converted
into shares of common stock. Pursuant to the terms of the 2021 and 2022 Convertible Notes agreements (as emended), all outstanding accrued
and unpaid interest owed under the 2021 and 2022 Convertible Notes was to convert into Common Stock simultaneously with the consummation
of an offering of Common Stock resulting in the listing of the common stock on the NYSE American, or other national securities exchange.
An aggregate of $ 772,545 of outstanding principal and accrued interest under the Notes was converted to common stock, resulting in the
issuance of an aggregate of 297,133 shares of Company’s common stock, based on a conversion price of $ 2.60 per share, as set forth
in the 2021 and 2022 Convertible Notes.
Underwriting Agreement and Representative’s
Warrants
In connection with the IPO, the Company entered
into an underwriting agreement, dated May 8, 2025, between the Company and D. Boral Capital LLC, as representative of the underwriters.
In connection with the agreement, the company issued warrants to purchase an aggregate of 168,750 shares of common stock (the “Representative’s
Warrants”. The Representative’s Warrants have an exercise price of $ 5.00 per share, are exercisable on or after November
4, 2025, and will expire five years from the date of issuance.
Amendments of Related Parties 2024 Promissory
Notes and 2025 Promissory Note
On May 16, 2025, the Related Parties 2024
Promissory Notes and 2025 Promissory Note were further amended extending the maturity date of for the outstanding principal and accrued
interest payment dates for all notes to May 19, 2026.
14
Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
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 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.
Overview
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.
15
Financial Results
Since inception, Apimeds has incurred significant
operating losses. For the three months ended March 31, 2025 and 2024, Apimeds Pharmaceuticals US, Inc. net loss was $402,397 and $296,473,
respectively. As of March 31, 2025, Apimeds Pharmaceuticals US, Inc. had an accumulated deficit of $4,794,321, a stockholders’ deficit
of $1,760,518 and a working capital deficit of $1,136,898.
Liquidity
As of March 31, 2025, the Company had accumulated
deficit amount to $4,794,321. The Company incurred net losses of $402,397 for the three months ended March 31, 2025, and expects to continue
to incur substantial losses in the future. On May 12, 2025, the Company consummated its initial public offering (the “IPO”)
of 3,375,000 shares of its common stock at a price of $4.00 per share, generating net proceeds to the Company of $11.9 million. Based
on cash that is available for Company operations, together with the proceeds from the IPO, 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.
Results of operations for the three months ended March 31, 2025
and 2024
Operating Expense
The following table sets forth the Company’s selected statements
of operations data for the following periods:
Three Months Ended
March 31,
2025
2024
Change
Operating expenses
Research and development expenses
$ —
$ —
$ —
General and administrative expenses
364,368
271,726
92,642
Loss from operations
(364,368 )
(271,726 )
(92,642 )
Other expenses
Interest income
3
2,161
(2,158 )
Interest expense
(38,032 )
(26,908 )
(11,124 )
Net loss
$ (402,397 )
$ (296,473 )
$ (105,924 )
Revenues
For the three months ended March 31, 2025 and 2024, the Company
had no revenue.
General and administrative expenses
The following table summarizes the year-over-year
changes in general and administrative expenses for the years presented:
Three Months Ended
March 31,
2025
2024
Change
Payroll expenses
$ 106,500
$ 99,000
$ 7,500
Professional services
249,512
154,058
95,454
Office expenses
512
6,853
(6,341 )
General administrative
7,844
11,815
(3,971 )
$ 364,368
$ 271,726
$ 92,642
General and administrative expenses were $364,368
for the three months ended March 31, 2025, compared to $271,726 for the same period in 2024, representing an increase of $92,642.
The increase was mainly attributable to an increase in professional expenses for a total of approximately $95,000 and an increase in payroll
expenses for the officers of the Company for a total of approximately $8,000.
16
Other Expense
The following table summarizes the year-over-year
changes in general and administrative expenses for the years presented:
Three Months Ended
March 31,
2025
2024
Change
Interest income
$ 3
$ 2,161
$ (2,158 )
Interest expense
(38,032 )
(26,908 )
(11,124 )
$ (38,029 )
$ (24,747 )
$ (13,282 )
Other expense was $38,029 for the three months
ended March 31, 2025, compared to $24,747 for the same period in 2024, representing an increase in expense of $13,282. The increase was
mainly due to an increase in interest expense for a total of approximately $11,000.
Net Loss
Net loss was $402,397 for the three months ended
March 31, 2025, compared to $296,473 in the same period of 2024, representing an increase in loss of $105,924. The increase was mainly
due to the increase in general and administrative expenses, specifically professional fees associated with the filing of the registration
statements with the U.S. Securities and Exchange Commission (the “SEC”) and pre-IPO expenses as well as an increase in payroll
expenses.
Liquidity and Capital Resources
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.
Cash Flows
The following table presents selected financial information and statistics
for each of the periods shown below:
2025
2024
Change
Net cash used in operating activities
$ (20,313 )
$ (263,100 )
$ 242,787
Net cash used in investing activities
—
—
—
Net cash provided by financing activities
267,200
—
267,200
Net increase (decrease) in cash
$ 246,887
$ (263,100 )
$ 509,987
During the three months ended March 31, 2025,
operating activities used approximately $20,000 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.
During the three months ended March 31, 2024,
operating activities used approximately $263,000 of cash, primarily resulting from a net loss of $296,473, partially offset by non-cash
interest expense-related parties of $7,956, accretion expense of $18,952, and changes in operating assets and liabilities of $6,464.
Investing activities
During the three months ended March 31, 2025 and 2024 investing activities
used $0.
17
Financing activities
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.
During the three months ended March 31, 2024,
financing activities used $0.
Contractual Obligations and Commitments
See Note 4 – Debt, and Note 6 – Commitments
and Contingencies, of the notes to the Company’s financial statements as of and for the three months ended March 31, 2025 included
elsewhere in this Annual 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
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 generally accepted accounting principles in the United States of America (“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 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.
Convertible
Instruments
The Company evaluates and accounts for conversion
options embedded in convertible instruments in accordance with ASC 815 “Derivatives and Hedging Activities”.
The Company accounts for convertible instruments
(when we have determined that the embedded conversion options should not be bifurcated from their host instruments) as follows: The Company
records when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based
upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective
conversion price embedded in the note. Debt discounts under these arrangements are amortized over the term of the related debt to their
stated date of redemption.
18
Item 3. Quantitative and Qualitative Disclosures
About Market Risk
As a smaller reporting company, we have elected
not to provide the disclosure required by this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Management, under the supervision and with the
participation of the Chief Executive Officer and Chief Financial Officer, have conducted an evaluation of the effectiveness of the design
and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Disclosure
controls and procedures are designed to ensure that information required to be disclosed by a company in the reports that it files or
submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules
and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information
required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to
our management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding
required disclosure.
Based on that evaluation, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of the end of the period
covered by this Quarterly Report in providing reasonable assurance of achieving the desired control objectives. This was due to deficiencies
that existed in the design and operation of our internal controls over financial reporting, involving internal controls and procedures,
that were considered to be material weaknesses, as described below.
Management ’ s Report
on Internal Control over Financial Reporting
Our management is responsible for establishing
and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f).
Internal control over financial reporting refers to the process designed by, or under the supervision of, our principal executive officer
and principal financial officer, and effected by our Board, management and other personnel, to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
accepted accounting principles, and includes those policies and procedures that:
(1)
pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets
(2) provide reasonable assurance
that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that our receipts
and expenditures are being made only in accordance with authorization of our management and directors; and
(3) provide reasonable assurance
regarding prevention or timely detection of unauthorized acquisitions, use or disposition of our assets that could have a material effect
on the financial statements.
19
Internal control over financial reporting
has inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject
to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented
by collusion or improper management override. Because of such limitations, there is a risk that material misstatements may not be prevented
or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of
the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this
risk.
We have conducted an assessment of the effectiveness
of our internal control over financial reporting as of the end of the period covered by this Quarterly Report, based on the framework
established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (the COSO Framework). This assessment included an evaluation of the design of our internal control over financial reporting
and testing of the operational effectiveness of those controls. Based on that evaluation, as a result of the material weaknesses
described below, management has concluded that our internal control over financial reporting was not effective as of the end of the period
covered by this Quarterly Report.
A material weakness in internal controls is a deficiency in internal
control, or combination of control deficiencies, that adversely affects our ability to initiate, authorize, record, process, or report
external financial data reliably in accordance with GAAP such that there is more than a remote likelihood that a material misstatement
of our annual or interim financial statements that is more than inconsequential will not be prevented or detected. In the course of making
our assessment of the effectiveness of internal controls over financial reporting, we identified material weaknesses in our internal control
over financial reporting. Specifically, we do not have sufficiently documented procedures or control activities in place to support
a reliable financial reporting process. This includes an absence of controls over the review and approval of journal entries, segregation
of duties, reconciliations, and other fundamental accounting processes.
Based on our assessment under the criteria described above, we
have concluded that our internal control over financial reporting was not effective as of the end of the period covered by this Quarterly
Report.
Changes in Internal Control Over Financial
Reporting
There has been no change in our internal control
over financial reporting, as defined in Rules 13a-15(f) of the Exchange Act, during the quarter ended March 31, 2025, that has materially
affected, or is reasonably likely to materially affect, our internal control over financial reporting. The Company continues to review
its disclosure controls and procedures, including its internal control over financial reporting, and may from time to time make changes
aimed at enhancing their effectiveness and to ensure that the Company’s systems evolve with its business.
20
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
We are not currently subject to any legal proceedings.
However, we may from time to time become a party to various legal proceedings arising in the ordinary course of our business.
Item 1A. Risk Factors.
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.
Item 2. Unregistered Sales of Equity Securities
and Use of Proceeds
(a) None.
(b) Not applicable.
(c) None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
(a) None.
(b) None.
(c) During the quarter ended March 31, 2025, no
director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading
arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
21
Item 6. Exhibits
The following exhibits are filed as part of, or
incorporated by reference into, this Quarterly Report.
No.
Description of Exhibit
3.1
Amended and Restated Certificate of Incorporation of Apimeds Pharmaceuticals US, Inc. (incorporated herein by reference to Exhibit 3.1 to our Registration Statement on Form S-1 filed on September 25, 2024)
3.2
Certificate of Amendment to the Amended and Restated Certificate of Incorporation (incorporated herein by reference to Exhibit 3.2 to our Annual Report on Form 10-K filed on April 15, 2025)
3.3
Amended and Restated Bylaws of Apimeds Pharmaceuticals US, Inc. (incorporated by reference to Exhibit 3.3 to our Annual Report on Form 10-K filed on April 15, 2025 )
10.1
March 2025 Promissory Note by and between Apimeds Pharmaceuticals US, Inc. and Apimeds, Inc., dated March 21, 2025 (incorporated by reference to Exhibit 10.26 to our Annual Report on Form 10-K filed on April 15, 2025 )
31.1*
Rule 13a-14(a) Certification by Principal Executive Officer
31.2*
Rule 13a-14(a) Certification by Principal Financial and Accounting Officer
32.1*
Section 1350 Certification of Principal Executive Officer
32.2*
Section 1350 Certification of Principal Financial and Accounting Officer
101.INS*
Inline XBRL Instance Document
101.SCH*
Inline XBRL Taxonomy Extension Schema Document
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104*
Cover Page Interactive Data File (formatted in iXBRL, and included in exhibit 101)
*
Filed or furnished with this Report.
22
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
APIMEDS PHARMACEUTICALS US, INC.
Date: May 19, 2025
By:
/s/ Erik Emerson
Name:
Erik Emerson
Title:
Chief Executive Officer
(Principal Executive Officer)
23
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.