<SEC-DOCUMENT>0000000000-24-002122.txt : 20250312
<SEC-HEADER>0000000000-24-002122.hdr.sgml : 20250312
<ACCEPTANCE-DATETIME>20240226143607
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-24-002122
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20240226

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Apimeds Pharmaceuticals US, Inc.
		CENTRAL INDEX KEY:			0001894525
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				851099700
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD
		SEC FILE NUMBER:	377-07074

	BUSINESS ADDRESS:	
		STREET 1:		2 EAST BROAD STREET
		STREET 2:		2ND FLOOR
		CITY:			HOPEWELL
		STATE:			NJ
		ZIP:			08525
		BUSINESS PHONE:		609-751-4485

	MAIL ADDRESS:	
		STREET 1:		2 EAST BROAD STREET
		STREET 2:		2ND FLOOR
		CITY:			HOPEWELL
		STATE:			NJ
		ZIP:			08525
PUBLIC REFERENCE ACCESSION NUMBER:		0001213900-24-007296
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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United States securities and exchange commission logo





                            February 26, 2024

       Erik Emerson
       Chief Executive Officer
       Apimeds Pharmaceuticals US, Inc.
       2 East Broad Street 2nd Floor
       Hopewell, NJ 08425

                                                        Re: Apimeds
Pharmaceuticals US, Inc.
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted January
29, 2024
                                                            CIK No. 0001894525

       Dear Erik Emerson:

                                                        We have reviewed your
draft registration statement and have the following comments.

              Please respond to this letter by providing the requested
information and either submitting
       an amended draft registration statement or publicly filing your
registration statement on
       EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not
       believe an amendment is appropriate, please tell us why in your
response.

               After reviewing the information you provide in response to this
letter and your amended
       draft registration statement or filed registration statement, we may
have additional comments.

       Draft Registration Statement on Form S-1

       Prospectus Summary
       Overview, page 1

   1.                                                   The disclosure in the
Summary should be a balanced presentation of your business. Please
                                                        revise this section to
balance the description of the company's product candidate and
                                                        related market with
equally prominent disclosure of the company's lack of revenue,
                                                        history of net losses
and accumulated deficit, and the regulatory and competitive
                                                        challenges applicable
to the company's business and operations.
   2.                                                   Please revise your
disclosure both here and throughout the prospectus to clarify, if true,
                                                        that all previously
completed clinical trials referenced and discussed in the prospectus
                                                        were conducted by
Apimeds Korea, which is an entity separate and apart from the
                                                        company, and that
Apimeds Korea transferred sponsorship of IND 122804 to the company
                                                        in October 2020. Please
also clarify that the company has not yet initiated its planned
 Erik Emerson
Apimeds Pharmaceuticals US, Inc.
February 26, 2024
Page 2
         Phase III trials based on IND 122804. We note your disclosure on page
66 in this regard.
         Please also clarify how the agreements in place between the company
and Apimeds Korea
         provide the company with the right to use the clinical data previously
collected by
         Apimeds Korea in support of the company's ongoing clinical efforts.
3.       Please revise to remove the statement on page 1 and elsewhere in your
Prospectus that you
         are    in the process of commercializing Apitox    as you have yet to
obtain FDA approval
         for Apitox and it appears your current commercialization efforts are
limited to preliminary
         discussions with third-parties.
4.       Please revise page 1 where you state Apimeds Korea    completed a
Phase III trial with
         Apitoxin for the treatment of pain associated with osteoarthritis
('OA') in 2018    to
         disclose whether the trial met its primary and secondary endpoints and
why you are
         pursuing additional Phase III clinical trials as opposed to filing a
BLA with the FDA.
         Please also revise to consistently state the indication for clinical
trials throughout your
         Prospectus. For example only, we note on page 1 you disclose Apimeds
Korea   s Phase III
         clinical trial was    for the treatment of pain associated with
osteoarthritis    and also    to
         treat OA in the knee.
5.       Please revise page 1 to identify    the most appropriate population
for which you will
         advance your Phase III trials in OA. To this point, we note your
disclosure on page 63 that
         the purpose of your Phase III trials in OA    will be to evaluate the
effectiveness of Apitox
         in the treatment of grade 3 and 4 OA of the knee.
Our Lead Candidate, page 1

6.       Please revise page 1 where you state    [b]ee venom has traditionally
been used to treat
         painful inflammatory diseases    to state whether the FDA has approved
the use of bee
         venom in any indication and to provide additional support for this
statement.
7.     We note the following statement on page 2: "Apitoxin was approved by the
South Korean
       regulatory authorities for use in the reduction of pain associated with
OA in 2003." Please
FirstName LastNameErik Emerson
       revise your disclosure to clarify that the company does not market and
sell Apitoxin in
Comapany
       SouthNameApimeds
              Korea and thatPharmaceuticals
                              Apitoxin has not US, Inc.approved in the US by
the FDA for use in the
                                                been
       reduction
February         ofPage
          26, 2024  pain 2associated with OA to date, if true.
FirstName LastName
 Erik Emerson
FirstName LastNameErik Emerson
Apimeds Pharmaceuticals US, Inc.
Comapany26,
February  NameApimeds
            2024        Pharmaceuticals US, Inc.
February
Page 3 26, 2024 Page 3
FirstName LastName
Our Market, page 2

8.       Please revise page 2 to disclose the    other future indicia    you
will pursue in the second
         quarter of 2024 or remove the reference.
Our Strategy, page 3

9.       Please revise to remove your statement on page 3 that you will
determine the best path to
         "rapid clinical Phase III success    as the pace of clinical
development and successful
         achievement of designated endpoints is not entirely within the
company's control.
10.      Please remove the reference to a "previously successful" Phase III
trial, as it appears from
         your disclosure elsewhere that additional trials are required.
Controlled Company, page 4

11.      We note your disclosure that the company has applied to list on the
NYSE American.
         Please reconcile this with your reference to the "controlled company"
exemption under the
         Nasdaq listing rules on page 4.
Risk Factors Summary, page 4

12.      We note the two summarized risk factors on page 5 relating to
obtaining and maintaining
         patent protection for the company's technology and products. However,
your disclosure
         elsewhere states that the API relied on for your product candidate is
a natural, non-
         synthetic compound that is not patentable. Please reconcile or remove
these two bullet
         points from page 5.
Risk Factors, page 9

13.      Please revise this section to include a risk factor regarding the fact
that the company's
         chief executive officer, Erik Emerson, also serves as the company's
principal financial
         officer. Please also discuss Mr. Emerson's qualifications to serve as
PFO and whether the
         company's internal controls have been designed with this in mind.
There may be conflicts of interest amongst our directors and officers and
Apimeds Korea., page
11

14.      Please revise this risk factor to clarify which officers and directors
hold positions with
         both the company and Apimeds Korea.
We or the third parties upon whom we depend on may be adversely affected by
natural
disasters..., page 23

15.      We note your mention of the potential impact of the wars in Ukraine
and Israel in the risk
         factor on page 23. Please revise this risk factor to concisely explain
how this risk affects
         the company or the securities being offered, pursuant to Item 105 of
Regulation S-K.
 Erik Emerson
FirstName LastNameErik Emerson
Apimeds Pharmaceuticals US, Inc.
Comapany26,
February  NameApimeds
            2024        Pharmaceuticals US, Inc.
February
Page 4 26, 2024 Page 4
FirstName LastName
We are controlled by our principal stockholders and management..., page 38

16.      We note your statement on page 38 that Inscobee, including through its
wholly-owned
         subsidiary, Apimeds Korea, beneficially owns 91.35% of the company's
common stock.
         Please reconcile this statement with your disclosure on the cover page
and pages 4 and
         100 that Inscobee holds approximately 86.1% of the company's common
stock.

Use of Proceeds, page 47

17.      We note your statement on page 47 that it is difficult to estimate
with certainty the exact
         amount of the net proceeds from the offering that may be used for each
purpose
         mentioned in the third paragraph of this section. However, per Item
504 of Regulation S-
         K, this section should quantify the approximate amount intended to be
used for each listed
         purpose. In addition, if any material amounts of other funds are
necessary to accomplish
         the specified purposes of which the proceeds are to be obtained,
disclosure of the amounts
         of such other funds needed for each such specified purpose and the
sources thereof should
         be included. Please revise your disclosure accordingly.
Capitalization, page 49

18.      Please double underline the cash amount to highlight that cash is not
included in total
         capitalization.
19.      We note that your pro forma capitalization table gives effect to the
conversion of an
         aggregate of $660,000 principal amount of convertible notes. Please
revise to clearly
         disclose the event(s) that trigger conversion of your convertible
notes and explain why
         you believe the current IPO transaction would result in conversion.
Business
Our Product Candidate, page 64

20.      Please revise page 64 to disclose and discuss the data supporting your
statements that
            Apitox has both anti-inflammatory and analgesic effects as well as
hormone-stimulating
         and immune-modulating effects    and that    the components in Apitox
may ameliorate
         immune-inflammatory responses associated with MS.
Clinical Development HIstory, page 64

21.      Please revise your description of the clinical development of Apitoxin
to disclose details
         regarding the trial designs, including the following information:
             the primary and secondary endpoints of each trial;
             whether the designated endpoints were met;
             whether the trials were powered for statistical significance and
if so, whether the
             results were statistically significant;
             the resulting data from each trial.
 Erik Emerson
FirstName LastNameErik Emerson
Apimeds Pharmaceuticals US, Inc.
Comapany26,
February  NameApimeds
            2024        Pharmaceuticals US, Inc.
February
Page 5 26, 2024 Page 5
FirstName LastName

         Additionally, provide the same disclosure for the    formal Phase I
and Phase II
         publications specific to MS    Apimeds Korea relied on in submitting
its 2014 IND, as
         discussed on page 65.
Apitox Preliminary Phase III Trials On MS, page 65

22.      Please revise to disclose the new primary efficacy endpoint you will
implement for your
         Phase III clinical trial in MS in response to the FDA recommendations,
as disclosed on
         page 66.
Competition, page 69

23.      Please revise page 69 to remove the statement that Apitox is a "highly
safe and effective
         option to patients experiencing debilitating pain." You may state that
Apitox was
         determined to be safe and effective for the indications approved by
The Korean Ministry
         of Food and Drug Safety in South Korea, if true, but should make clear
that the FDA has
         not determined Apotix to be safe or effective in the US.
Executive Compensation
Director Compensation Table, page 95

24.      We note your statement that none of your directors received any form
of compensation for
         the years ended December 31, 2022 and 2021. Please revise this
disclosure to also address
         the company's last completed fiscal year. Refer to item 402(r) of
Regulation S-K.
Financial Statements
Unaudited Condensed Balance Sheets, page F-2

25.      We note the significant increase in your prepaid expenses at September
30, 2023. Please
         address the following:

                Disclose the significant terms of the underlying agreements
that comprise your
              prepaid expenses.
                Separately disclose any significant elements of your prepaid
expenses balance.
License Agreement, page F-21

26.      Please revise to disclose all significant terms of the License
Agreement with Apimeds
         Korea, including the estimated term of the agreement and any potential
future payments
         required under the agreement.
Exhibits

27.      Please ensure each exhibit is in the proper text-searchable format.
See Item 301 of
         Regulation S-T.
 Erik Emerson
Apimeds Pharmaceuticals US, Inc.
February 26, 2024
Page 6


28.   Please file the Consulting Agreement with Murdock Capital Partners Corp.
as an exhibit
      to the registration statement. See Item 601(b)(10) of Regulation S-K.
General

29.   Please supplementally provide us with copies of all written
communications, as defined in
      Rule 405 under the Securities Act, that you, or anyone authorized to do
so on your behalf,
      present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
      not they retain copies of the communications.
       Please contact Eric Atallah at 202-551-3663 or Lynn Dicker at
202-551-3616 if you have
questions regarding comments on the financial statements and related matters.
Please contact
Daniel Crawford at 202-551-7767 or Laura Crotty at 202-551-7614 with any other
questions.



                                                            Sincerely,
FirstName LastNameErik Emerson
                                                            Division of
Corporation Finance
Comapany NameApimeds Pharmaceuticals US, Inc.
                                                            Office of Life
Sciences
February 26, 2024 Page 6
cc:       David Mannheim
FirstName LastName
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
