SecProbe.io

United States securities and exchange commission logo
May 23, 2024
Erik Emerson
Chief Executive Officer
Apimeds Pharmaceuticals US, Inc.
2 East Broad Street 2nd Floor
Hopewell, NJ 08425
Re:Apimeds Pharmaceuticals US, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted May 13, 2024
CIK No. 0001894525
Dear Erik Emerson:
            We have reviewed your amended 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. Unless we note otherwise, any references to prior comments are to comments in our
February 26, 2024 letter.
Amendment No. 1 to Draft Registration Statement on Form S-1
Cover Page
1.Please revise the cover page to disclose whether your offering is contingent upon final
approval of your NYSE listing, as you have done on page 113, and ensure the disclosure
is consistent with your underwriting agreement.
Prospectus Summary
Overview, page 1
2.Please remove the statement on pages 1 and 62 that you believe the additional Phase III
trial, supplemented by the data accumulated during the development and
commercialization of Apitoxin in Korea and the Apimeds Korea Phase III OA

 FirstName LastNameErik Emerson
 Comapany NameApimeds Pharmaceuticals US, Inc.
 May 23, 2024 Page 2
 FirstName LastName
Erik Emerson
Apimeds Pharmaceuticals US, Inc.
May 23, 2024
Page 2
Trial, "positions [you] for FDA approval for the use of Apitoxin in the treatment of pain
and lack of mobility in knee OA patients."
Risk Factors
We or the third parties upon whom we depend on may be adversely affected by natural
disasters..., page 24
3.We note your response to prior comment 15 and the newly included disclosure on page
25. Please further revise this disclosure to clarify whether any of the company's CMOs or
third-party vendors have experienced or continue to experience manufacturing difficulties
or delays as a result of the military conflicts in Ukraine and Israel.
We are controlled by our principal stockholders and management, page 40
4.We note your response to prior comment 16. However, your disclosure on the cover page
and page 4 states that Inscobee Inc. holds approximately 86.1% of the company's common
stock, while pages 40 and 103 state that Inscobee holds approximately 88.8% of the
common stock. Please reconcile.
Use of Proceeds, page 49
5.We note your newly included disclosure on page 49 that the company intends to use
proceeds from the offering to initiate at least one non-registered company sponsored
"trial" in MS. Please reconcile this with your disclosure on page 2 and in your response
letter that the company "will not be pursuing a Phase III trial for MS at this time".
Capitalization, page 51
6.We note your response to prior comment 18. However, we do not see a revision to double
underline the cash amount in your revised total capitalization table on page 51. Please
revise your filing accordingly.
7.We note your response to prior comment 19. However, we do not see where you have
revised your disclosures to explain the event(s) that trigger conversion of your convertible
notes. Therefore, we reissue prior comment 19.
Clinical Development History, page 66
8.Please remove the following statement from page 67, as it implies the efficacy of Apitox,
which determination is within the sole purview of the FDA in the context of the trial
discussed: "In conclusion, the statistical and clinically significant improvements in all
outcome measures of pain, physical function, and disease assessment suggest Apitox
injections may offer a potential treatment for patients with knee pain from OA who failed
to respond adequately to conservative non-pharmacologic therapy and simple analgesics,
e.g., acetaminophen."

 FirstName LastNameErik Emerson
 Comapany NameApimeds Pharmaceuticals US, Inc.
 May 23, 2024 Page 3
 FirstName LastName
Erik Emerson
Apimeds Pharmaceuticals US, Inc.
May 23, 2024
Page 3
            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,
Division of Corporation Finance
Office of Life Sciences
cc:       David Mannheim