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Curanex Pharmaceuticals Inc
CIK: 0002025942  ·  File(s): 333-282686, 377-07290  ·  Started: 2024-10-28  ·  Last active: 2025-08-08
Response Received 7 company response(s) High - file number match
UL SEC wrote to company 2024-10-28
Curanex Pharmaceuticals Inc
Offering / Registration Process Regulatory Compliance Financial Reporting
File Nos in letter: 333-282686
CR Company responded 2024-11-01
Curanex Pharmaceuticals Inc
Offering / Registration Process Financial Reporting Regulatory Compliance
References: October 28, 2024
CR Company responded 2025-03-17
Curanex Pharmaceuticals Inc
File Nos in letter: 333-282686
References: February 14, 2025
CR Company responded 2025-04-08
Curanex Pharmaceuticals Inc
File Nos in letter: 333-282686
CR Company responded 2025-04-08
Curanex Pharmaceuticals Inc
File Nos in letter: 333-282686
CR Company responded 2025-04-09
Curanex Pharmaceuticals Inc
File Nos in letter: 333-282686
CR Company responded 2025-08-08
Curanex Pharmaceuticals Inc
Offering / Registration Process
File Nos in letter: 333-282686
CR Company responded 2025-08-08
Curanex Pharmaceuticals Inc
Offering / Registration Process
File Nos in letter: 333-282686
Curanex Pharmaceuticals Inc
CIK: 0002025942  ·  File(s): 333-282686, 377-07290  ·  Started: 2025-02-21  ·  Last active: 2025-02-21
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2025-02-21
Curanex Pharmaceuticals Inc
Financial Reporting Related Party / Governance Regulatory Compliance
File Nos in letter: 333-282686
Curanex Pharmaceuticals Inc
CIK: 0002025942  ·  File(s): 377-07290  ·  Started: 2024-09-23  ·  Last active: 2024-10-16
Response Received 1 company response(s) Medium - date proximity
UL SEC wrote to company 2024-09-23
Curanex Pharmaceuticals Inc
Offering / Registration Process Financial Reporting Business Model Clarity
CR Company responded 2024-10-16
Curanex Pharmaceuticals Inc
Business Model Clarity Financial Reporting Offering / Registration Process
References: September 23, 2024
Curanex Pharmaceuticals Inc
CIK: 0002025942  ·  File(s): 377-07290  ·  Started: 2024-08-28  ·  Last active: 2024-08-28
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2024-08-28
Curanex Pharmaceuticals Inc
Regulatory Compliance Risk Disclosure Business Model Clarity
Curanex Pharmaceuticals Inc
CIK: 0002025942  ·  File(s): 377-07290  ·  Started: 2024-07-17  ·  Last active: 2024-07-17
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2024-07-17
Curanex Pharmaceuticals Inc
DateTypeCompanyLocationFile NoLink
2025-08-08 Company Response Curanex Pharmaceuticals Inc NV N/A
Offering / Registration Process
Read Filing View
2025-08-08 Company Response Curanex Pharmaceuticals Inc NV N/A
Offering / Registration Process
Read Filing View
2025-04-09 Company Response Curanex Pharmaceuticals Inc NV N/A Read Filing View
2025-04-08 Company Response Curanex Pharmaceuticals Inc NV N/A Read Filing View
2025-04-08 Company Response Curanex Pharmaceuticals Inc NV N/A Read Filing View
2025-03-17 Company Response Curanex Pharmaceuticals Inc NV N/A Read Filing View
2025-02-21 SEC Comment Letter Curanex Pharmaceuticals Inc NV 377-07290
Financial Reporting Related Party / Governance Regulatory Compliance
Read Filing View
2024-11-01 Company Response Curanex Pharmaceuticals Inc NV N/A
Offering / Registration Process Financial Reporting Regulatory Compliance
Read Filing View
2024-10-28 SEC Comment Letter Curanex Pharmaceuticals Inc NV 377-07290
Offering / Registration Process Regulatory Compliance Financial Reporting
Read Filing View
2024-10-16 Company Response Curanex Pharmaceuticals Inc NV N/A
Business Model Clarity Financial Reporting Offering / Registration Process
Read Filing View
2024-09-23 SEC Comment Letter Curanex Pharmaceuticals Inc NV 377-07290
Offering / Registration Process Financial Reporting Business Model Clarity
Read Filing View
2024-08-28 SEC Comment Letter Curanex Pharmaceuticals Inc NV 377-07290
Regulatory Compliance Risk Disclosure Business Model Clarity
Read Filing View
2024-07-17 SEC Comment Letter Curanex Pharmaceuticals Inc NV 377-07290 Read Filing View
DateTypeCompanyLocationFile NoLink
2025-02-21 SEC Comment Letter Curanex Pharmaceuticals Inc NV 377-07290
Financial Reporting Related Party / Governance Regulatory Compliance
Read Filing View
2024-10-28 SEC Comment Letter Curanex Pharmaceuticals Inc NV 377-07290
Offering / Registration Process Regulatory Compliance Financial Reporting
Read Filing View
2024-09-23 SEC Comment Letter Curanex Pharmaceuticals Inc NV 377-07290
Offering / Registration Process Financial Reporting Business Model Clarity
Read Filing View
2024-08-28 SEC Comment Letter Curanex Pharmaceuticals Inc NV 377-07290
Regulatory Compliance Risk Disclosure Business Model Clarity
Read Filing View
2024-07-17 SEC Comment Letter Curanex Pharmaceuticals Inc NV 377-07290 Read Filing View
DateTypeCompanyLocationFile NoLink
2025-08-08 Company Response Curanex Pharmaceuticals Inc NV N/A
Offering / Registration Process
Read Filing View
2025-08-08 Company Response Curanex Pharmaceuticals Inc NV N/A
Offering / Registration Process
Read Filing View
2025-04-09 Company Response Curanex Pharmaceuticals Inc NV N/A Read Filing View
2025-04-08 Company Response Curanex Pharmaceuticals Inc NV N/A Read Filing View
2025-04-08 Company Response Curanex Pharmaceuticals Inc NV N/A Read Filing View
2025-03-17 Company Response Curanex Pharmaceuticals Inc NV N/A Read Filing View
2024-11-01 Company Response Curanex Pharmaceuticals Inc NV N/A
Offering / Registration Process Financial Reporting Regulatory Compliance
Read Filing View
2024-10-16 Company Response Curanex Pharmaceuticals Inc NV N/A
Business Model Clarity Financial Reporting Offering / Registration Process
Read Filing View
2025-08-08 - CORRESP - Curanex Pharmaceuticals Inc
CORRESP
 1
 filename1.htm

 Curanex
Pharmaceuticals Inc

 2
Jericho Plaza, Suite 101B

 Jericho,
NY 11753

 August
8, 2025

 VIA
EDGAR

 U.S.
Securities and Exchange Commission

 Division
of Corporation Finance

 Office
of Technology

 100
F Street N.E.

 Washington,
D.C. 20549

 Attn:
Doris Stacey Gama and Chris Edward

 Re:

 Curanex
 Pharmaceuticals Inc
 Registration
 Statement on Form S-1, as amended (the "Registration Statement")
 File
 No. 333-282686
 Request
 for Acceleration of Effectiveness

 Ladies
and Gentlemen:

 Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended (the "Act"), Curanex Pharmaceuticals Inc (the "Company")
hereby requests acceleration of the effectiveness of the above-referenced Registration Statement so that such Registration Statement
will become effective at 5:00 p.m. on August 12, 2025, or as soon thereafter as is practicable. In connection with such request, the
undersigned hereby acknowledges the following:

 1.
Should the Securities and Exchange Commission (the "Commission") or the staff, acting pursuant to delegated authority, declare
the filing effective, it does not foreclose the Commission from taking any action with respect to the filing.

 2.
The action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve
the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing.

 3.
The Company may not assert staff comments or the declaration of effectiveness as a defense in any proceeding initiated by the Commission
or any person under the federal securities laws of the United States.

 Sincerely,

 Curanex
 Pharmaceuticals Inc

 By:

 /s/
 Jun Liu

 Jun
 Liu

 Chief
 Executive Officer
2025-08-08 - CORRESP - Curanex Pharmaceuticals Inc
CORRESP
 1
 filename1.htm

 Dominari
Securities LLC

 725
Fifth Avenue

 New
York NY 10022

 VIA
EDGAR

 August
8, 2025

 United
States Securities and Exchange Commission

 Division
of Corporation Finance

 100
F Street, N.E.

 Washington,
D.C. 20549

 Re:
 Curanex
 Pharmaceuticals Inc. ("Company")

 Registration
Statement on Form S-1, as amended

 File
No. 333-282686

 Ladies
and Gentlemen:

 Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the "Securities Act"), we, as
the representative of the several underwriters of the Company's public offering, hereby join the Company's request that the
effective date of the above-referenced Registration Statement be accelerated so that the above-referenced Registration Statement will
be declared effective at 5:00 p.m., Eastern Time, on Tuesday, August 12, 2025, or as soon as practicable thereafter.

 Pursuant
to Rule 460 under the Securities Act, we, as the representative of the several underwriters, wish to advise you that there will be distributed
to each Underwriter or dealer, who is reasonably anticipated to participate in the distribution of the securities, as many copies of
the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus.

 We,
the undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating
underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934,
as amended.

 Very
 truly yours,

 DOMINARI
 SECURITIES LLC

 /s/
 Eric Newman

 Name:

 Eric
 Newman

 Title:

 Executive
 Vice President, Head of Investment Banking
2025-04-09 - CORRESP - Curanex Pharmaceuticals Inc
CORRESP
 1
 filename1.htm

 Curanex
Pharmaceuticals Inc

 2
Jericho Plaza, Suite 101B

 Jericho,
NY 11753

 April
9, 2025

 VIA
EDGAR

 U.S.
Securities and Exchange Commission

 Division
of Corporation Finance

 Office
of Technology

 100
F Street N.E.

 Washington,
D.C. 20549

 Attn:
Doris Stacey Gama and Chris Edward

 Re:

 Curanex
 Pharmaceuticals Inc - Withdrawal of Acceleration Request
 Registration
 Statement on Form S-1, as amended (the "Registration Statement")
 File
 No. 333-282686

 Ladies
and Gentlemen:

 Reference
is made to our letter, filed as correspondence via EDGAR on April 8, 2025, in which the undersigned registrant, Curanex Pharmaceuticals
Inc, a Nevada corporation (the "Company"), requested acceleration of the effectiveness of the above-referenced Registration
Statement on Form S-1 (the "Registration Statement") to 5:00 p.m. Eastern Daylight Time on April 9, 2025, or as
soon thereafter as practicable (the "Effective Time"), in accordance with Rule 461 under the Securities Act of 1933, as amended.

 The
Company is no longer requesting that the Registration Statement be declared effective at the Effective Time and we hereby formally withdraw
our request for acceleration of the effective date until further notice from the Company.

 Sincerely,

 Curanex Pharmaceuticals
 Inc

 By:
 /s/ Jun Liu

 Jun Liu

 Chief Executive Officer
2025-04-08 - CORRESP - Curanex Pharmaceuticals Inc
CORRESP
 1
 filename1.htm

 Curanex
Pharmaceuticals Inc

 2
Jericho Plaza, Suite 101B

 Jericho,
NY 11753

 April
8, 2025

 VIA
EDGAR

 U.S.
Securities and Exchange Commission

 Division
of Corporation Finance

 Office
of Technology

 100
F Street N.E.

 Washington,
D.C. 20549

 Attn:
Doris Stacey Gama and Chris Edward

 Re:

 Curanex
 Pharmaceuticals Inc
 Registration
 Statement on Form S-1, as amended (the "Registration Statement")
 File
 No. 333-282686
 Request
 for Acceleration of Effectiveness

 Ladies
and Gentlemen:

 Pursuant
to Rule 461 promulgated under the Securities Act of 1933, as amended (the "Act"), Curanex Pharmaceuticals Inc (the "Company")
hereby requests acceleration of the effectiveness of the above-referenced Registration Statement so that such Registration Statement
will become effective at 5:00 p.m. on April 9, 2025, or as soon thereafter as is practicable. In connection with such request, the undersigned
hereby acknowledges the following:

 1.
Should the Securities and Exchange Commission (the "Commission") or the staff, acting pursuant to delegated authority, declare
the filing effective, it does not foreclose the Commission from taking any action with respect to the filing.

 2.
The action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve
the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing.

 3.
The Company may not assert staff comments or the declaration of effectiveness as a defense in any proceeding initiated by the Commission
or any person under the federal securities laws of the United States.

 Sincerely,

 Curanex
 Pharmaceuticals Inc

 By:

 /s/
 Jun Liu

 Jun
 Liu

 Chief
 Executive Officer
2025-04-08 - CORRESP - Curanex Pharmaceuticals Inc
CORRESP
 1
 filename1.htm

 Dominari
Securities LLC

 725
Fifth Avenue

 New
York NY 10022

 VIA
EDGAR

 April
8, 2025

 United
States Securities and Exchange Commission

 Division
of Corporation Finance

 100
F Street, N.E.

 Washington,
D.C. 20549

 Re: Curanex
 Pharmaceuticals Inc. ("Company")

 Registration
Statement on Form S-1, as amended

 File
No. 333-282686

 Ladies
and Gentlemen:

 Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the "Securities Act"), we, as
the representative of the several underwriters of the Company's public offering, hereby join the Company's request that the
effective date of the above-referenced Registration Statement be accelerated so that the above-referenced Registration Statement will
be declared effective at 5:00 p.m., Eastern Time, on Wednesday, April 9, 2025, or as soon as practicable thereafter.

 Pursuant
to Rule 460 under the Securities Act, we, as the representative of the several underwriters, wish to advise you that there will be distributed
to each Underwriter or dealer, who is reasonably anticipated to participate in the distribution of the securities, as many copies of
the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus.

 We,
the undersigned, as representatives of the several underwriters, have complied and will comply, and we have been informed by the participating
underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934,
as amended.

 Very
 truly yours,

 DOMINARI
 SECURITIES LLC

 /s/
 Eric Newman

 Name:

 Eric
 Newman

 Title:

 Executive
 Vice President, Global Head of Investment Banking
2025-03-17 - CORRESP - Curanex Pharmaceuticals Inc
Read Filing Source Filing Referenced dates: February 14, 2025
CORRESP
 1
 filename1.htm

 Eleanor
 Osmanoff
 Partner
 eosmanoff@cronelawgroup.com

 VIA
EDGAR

 March
17, 2025

 THE
UNITED STATES SECURITIES

 AND
EXCHANGE COMMISSION

 Division
of Corporation Finance

 Office
of Life Sciences

 Washington,
D.C. 20549

 Attn:
 Doris
 Stacey Gama, Chris Edwards, Christine Torney and Daniel Gordon

 Re:
 Re:
 Curanex Pharmaceuticals Inc
 Amendment
 No. 3 to Registration Statement on Form S-1
 Filed
 February 14, 2025
 File
 No. 333-282686

 Ladies
and Gentlemen:

 On
behalf of our client, Curanex Pharmaceuticals Inc (the "Company"), we are responding to the comments of the staff (the "Staff")
of the Securities and Exchange Commission (the "Commission") contained in the letter dated February 14, 2025 (the "Comment
Letter"), relating to the above-referenced Amendment No. 3 to Registration Statement on Form S-1 (the "Registration Statement").
Concurrently with the submission of this letter, the Company is hereby filing with the Commission Amendment No. 4 to the Registration
Statement ("Amendment #4"). Set forth below are the Company's responses to the
Comment Letter. All references in this response letter include the references to Amendment No. 4. Page
references in the text of this response letter correspond to the page numbers stated in the Comment Letter.

 Notes
to the Financial Statements

 Note
1. Description of Business and Summary of Significant Accounting Policies

 Intangible
Assets, page F-11

 1.
Please revise disclosures to explain why the legal expenses related to filing the provisional patent applications would be
classified as an impairment expense as opposed to being recorded as a research and development expense. Please reference the
accounting literature you relied upon in your response.

 Response :
Please see below the Company's response to this Staff's comment. The Company also amended its disclosures in Amendment #4.

 The
Company has revised its disclosure to clearly state that the legal fees were initially capitalized as an intangible asset on the balance
sheet but were subsequently impaired as an impairment expense in the fourth quarter of 2024. Management originally applied ASC 805-50-30-5
when recognizing the intangible asset as part of the transfer from a related party. This guidance requires that assets transferred between
entities under common control be recorded at their historical carrying amounts.

 However,
management later determined that the intangible asset did not qualify for capitalization, and the immaterial misstatement was corrected
in the fourth quarter of 2024. In addressing the impairment, management referred to ASC 350-30-50-3, which outlines the disclosure requirements
for impairment losses on intangible assets. The following information must be included in the financial statement notes for the period
in which the impairment loss is recognized:

 a.

 A
 description of the impaired intangible asset and the circumstances leading to the impairment

 b.

 The
 impairment loss amount and the method used to determine fair value

 c.

 The
 income statement caption in which the impairment loss is reported

 d.

 If
 applicable, the segment in which the impaired intangible asset is reported under Topic 280.

 Note
5. Related Party Transaction, page F-17

 2.
Please describe the contents of the $100,000 non-cash consideration received in the Duraviva asset purchase agreement and how they were
accounted for the financial statements.

 Response :
The $100,000 in non-cash consideration received in the Duraviva asset purchase agreement consisted of a total of $100,000 paid to the
Company's legal counsel, The Crone Law Group, P.C. ("Crone") in satisfaction of a $100,000 invoice due and payable
by the Company. Of the total $100,000 amount, $75,000 was paid directly to Crone by Duraviva. The remaining $25,000 consisted of
funds held at Crone as a credit balance in favor of the Company's advisor and consultant ("Independent Consultant").
At that time, Independent Consultant was indebted to Duraviva in the amount of $25,000. Duraviva and Independent Consultant mutually
agreed to apply Independent Consultant's $25,000 credit balance at Crone toward the $100,000 invoice owed by the Company,
thereby satisfying Independent Consultant's liability to Duraviva and completing payment of the Company's $100,000
total balance owed to Crone. The total $100,000, consisting of the $75,000 paid directly to Crone on behalf of the Company and
the application of Independent Consultant's credit balance at Crone to the Company's balance due, was recognized in the financial
statements as consideration from Duraviva in the Company's asset acquisition from Duraviva.

 Please
feel free to contact me should you require additional information at (917) 679-5931 or eosmanoff@cronelawgroup.com.

 THE
CRONE LAW GROUP, P.C.

 By:

 /s/
 Eleanor Osmanoff

 Eleanor
 Osmanoff
2025-02-21 - UPLOAD - Curanex Pharmaceuticals Inc File: 377-07290
February 21, 2025
Jun Liu
Chief Executive Officer
Curanex Pharmaceuticals Inc
2 Jericho Plaza, Suite 101B
Jericho, NY 11753
Re:Curanex Pharmaceuticals Inc
Amendment No. 3 to Registration Statement on Form S-1
Filed February 14, 2025
File No. 333-282686
Dear Jun Liu:
            We have reviewed your amended registration statement and have the following
comments.
            Please respond to this letter by amending your registration statement and providing
the requested information. 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 any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments.
Notes to the Financial Statements
Note 1. Description of Business and Summary of Significant Accounting Policies
Intangible Assets, page F-11
1.Please revise disclosures to explain why the legal expenses related to filing the
provisional patent applications would be classified as an impairment expense as
opposed to being recorded as a research and development expense. Please reference
the accounting literature you relied upon in your response.
Note 5. Related Party Transaction, page F-17
2.Please describe the contents of the $100,000 non-cash consideration received in the
Duraviva asset purchase agreement and how they were accounted for the financial
statements.

February 21, 2025
Page 2
            Please contact Christine Torney at 202-551-3652 or Daniel Gordon at 202-551-3486
if you have questions regarding comments on the financial statements and related matters.
Please contact Doris Stacey Gama at 202-551-3188 or Chris Edwards at 202-551-6761 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Joe Laxague, Esq.
2024-11-01 - CORRESP - Curanex Pharmaceuticals Inc
Read Filing Source Filing Referenced dates: October 28, 2024
CORRESP
1
filename1.htm

    Mark
    Crone

    Managing
    Partner

    mcrone@cronelawgroup.com

    Eleanor
    Osmanoff

    Partner

    eosmanoff@cronelawgroup.com

VIA
EDGAR

November
1, 2024

THE
UNITED STATES SECURITIES

AND
EXCHANGE COMMISSION

Division
of Corporation Finance

Office
of Life Sciences

Washington,
D.C. 20549

    Attn:
    Doris
    Stacey Gama, Chris Edwards, Christine Torney and Daniel Gordon

    Re:
    Re:
    Curanex Pharmaceuticals Inc

    Registration
    Statement on Form S-1

    Filed
    October 16, 2024

    CIK
    No. 0002025942

Ladies
and Gentlemen:

On
behalf of our client, Curanex Pharmaceuticals Inc (the “Company”), we are responding to the comments of the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) contained in the letter dated October 28, 2024 (the “Comment
Letter”), relating to the above-referenced Registration Statement on Form S-1 (the “Registration Statement”). Concurrently
with the submission of this letter, the Company is hereby filing with Commission Amendment No. 1 to the Registration Statement (“Amendment
#1”). Set forth below are the Company’s responses to the Comment Letter. All references in this response letter include the
references to Amendment No. 1. Page references in the text of this response letter correspond to the page numbers stated in the Comment
Letter.

Registration
Statement on Form S-1

The
Offering, page 4

1.
We note your response to prior comment 1. Please also clarify in The Offering, Lock-Ups section that your directors, officers and
holders that will beneficially own more than 5% of the Company’s outstanding shares of common stock agreed to enter into and
execute their lock-up agreements on the date this registration statement on Form S-1 is declared effective by the Commission. Also,
please clarify that the lock-up period under these lock-up agreements will be 180 days or 6 months starting on the effective date of
this registration statement on Form S-1 rather than up to 6 months.

Response:
In response to this Staff’s comment, the Company amended the disclosures in Amendment #1, clarifying and confirming that the lock-up
period under these lock-up agreements will be 180 days starting on the effective date of this registration statement on Form S-1.

2.
You state that the resale offering is conditioned upon the successful completion of the sale of shares by the company in the
underwritten primary offering, which is conditioned on the Nasdaq Capital Market listing. You also state that sales by selling
stockholder prior to listing of your shares of common stock on Nasdaq, if any, will be at a fixed price of $5.00 per share. Please
reconcile these statements and revise your disclosure accordingly.

Response:
In response to this Staff’s comment, the Company revised the statements throughout Amendment #1, deleting the statements that prior
to listing of the Company’s shares of common stock on Nasdaq, the Selling Stockholder Shares may be sold at a fixed price of $5.00
per share.

3.
We refer to your explanatory note regarding the two alternate prospectuses for the primary and secondary offering. Please provide us
an analysis explaining your basis for determining that the secondary offering is eligible to be made under Rule 415(a)(1)(i). In
responding, please consider the guidance provided in Compliance Disclosure Interpretations, Securities Act Rules, Question 612.09.
In your response, please tell us whether the selling stockholder has business or familial relationships with employees or affiliates
of your company.

Response:
Using the guidance provided in Compliance Disclosure Interpretations, Securities Act Rules, Question 612.09 and applying the factors
referenced therein, the Company determined that the secondary offering is eligible to be made under Rule 415(a)(1)(i) because:

 (a) the
                                            Selling Stockholder does not any business or familial relationships with the Company, its
                                            employees or affiliates. The only relationship between the Selling Stockholder and the Company
                                            is the relationship between an issuer and its stockholder.

 (b) the
                                            Selling Stockholder is a not an affiliate; its beneficial ownership of the Company’s
                                            equity securities is currently less than 5%, and is anticipated that after the completion
                                            of the underwritten primary offering and the secondary offering, the Selling Stockholder
                                            will beneficially own less than 1% of the Company’s equity securities;

 (c) the
                                            Selling Stockholder acquired all of its 1,946,100 shares of the Company’s common stock
                                            on June 17, 2024, upon the closing of the Asset Purchase Agreement among the Company, Duraviva
                                            Pharma Inc.  (“Duraviva”) and all stockholders of Duraviva, pro rata to its
                                            beneficial ownership in Duraviva;

 (d) the
                                            Selling Stockholder became the stockholder of Duraviva on December 1, 2023, and received
                                            the shares of Duraviva in consideration for the payment of costs for Duraviva’s animals
                                            studies. The Selling Stockholder held the shares issued by Duraviva until June 17, 2024,
                                            at which time it ceased to be a stockholder of Duraviva and became a stockholder of the Company;

 (e) the
                                            Selling Stockholder is not in the business of underwriting securities, and

 (f) under
                                            all the circumstances the Selling Stockholder is not acting as a conduit for the Company.

4.
We note your disclosure on your resale prospectus cover page and ALT-3 that your selling stockholders may sell their securities through
one or more broker-dealers or agents. Please confirm your understanding that the retention by a selling stockholder of a dealer or underwriter
would constitute a material change to your plan of distribution requiring a post-effective amendment.

Response:
In response to this Staff’s comment, the Company confirms that the retention by a selling stockholder of a dealer or underwriter
would constitute a material change to the plan of distribution requiring a post-effective amendment. The Company disclosed in Item 17
– Undertakings (a)(1)(iii) that it undertakes to file a post-effective amendment to this registration statement to include any
material information with respect to the plan of distribution not previously disclosed in the registration statement or any material
change to such information in the registration statement.

Please
feel free to contact me should you require additional information at (917) 679-5931 or eosmanoff@cronelawgroup.com.

THE
CRONE LAW GROUP, P.C.

  By:
  /s/ Eleanor Osmanoff

  Eleanor
    Osmanoff
2024-10-28 - UPLOAD - Curanex Pharmaceuticals Inc File: 377-07290
October 28, 2024
Jun Liu
Chief Executive Officer
Curanex Pharmaceuticals Inc
2 Jericho Plaza, Suite 101B
Jericho, NY 11753
Re:Curanex Pharmaceuticals Inc
Registration Statement on Form S-1
Filed October 16, 2024
File No. 333-282686
Dear Jun Liu:
            We have reviewed your registration statement and have the following comments.
            Please respond to this letter by amending your registration statement and providing
the requested information. 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 any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments.
Registration Statement on Form S-1
The Offering, page 4
1.We note your response to prior comment 1. Please also clarify in The Offering, Lock-
Ups section that your directors, officers and holders that will beneficially own more
than 5% of the Company’s outstanding shares of common stock agreed to enter into
and execute their lock-up agreements on the date this registration statement on Form
S-1 is declared effective by the Commission. Also, please clarify that the lock-up
period under these lock-up agreements will be 180 days or 6 months starting on the
effective date of this registration statement on Form S-1 rather than up to 6 months.
General
You state that the resale offering is conditioned upon the successful completion of the
sale of shares by the company in the underwritten primary offering, which is
conditioned on the Nasdaq Capital Market listing. You also state that sales by selling 2.

October 28, 2024
Page 2
stockholder prior to listing of your shares of common stock on Nasdaq, if any, will be
at a fixed price of $5.00 per share. Please reconcile these statements and revise your
disclosure accordingly.
3.We refer to your explanatory note regarding the two alternate prospectuses for the
primary and secondary offering. Please provide us an analysis explaining your basis
for determining that the secondary offering is eligible to be made under Rule
415(a)(1)(i). In responding, please consider the guidance provided in Compliance
Disclosure Interpretations, Securities Act Rules, Question 612.09. In your response,
please tell us whether the selling stockholder has business or familial relationships
with employees or affiliates of your company.
4.We note your disclosure on your resale prospectus cover page and ALT-3 that your
selling stockholders may sell their securities through one or more broker-dealers or
agents. Please confirm your understanding that the retention by a selling stockholder
of a dealer or underwriter would constitute a material change to your plan of
distribution requiring a post-effective amendment.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence
of action by the staff.
            Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
            Please contact Christine Torney at 202-551-3652 or Daniel Gordon at 202-551-3486
if you have questions regarding comments on the financial statements and related
matters. Please contact Doris Stacey Gama at 202-551-3188 or Chris Edwards at 202-551-
6761 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Joe Laxague, Esq.
2024-10-16 - CORRESP - Curanex Pharmaceuticals Inc
Read Filing Source Filing Referenced dates: September 23, 2024
CORRESP
1
filename1.htm

    Mark
                                            Crone

    Managing
    Partner

    mcrone@cronelawgroup.com

    Eleanor
    Osmanoff

    Partner

    eosmanoff@cronelawgroup.com

VIA
EDGAR

October
16, 2024

THE
UNITED STATES SECURITIES

AND
EXCHANGE COMMISSION

Division
of Corporation Finance

Office
of Life Sciences

Washington,
D.C. 20549

    Attn:
    Doris
    Stacey Gama, Chris Edwards, Christine Torney and Daniel Gordon

    Re:
    Re:
                                            Curanex Pharmaceuticals Inc

    Amendment
    No. 2 to Draft Registration Statement on Form S-1

    Submitted
    September 16, 2024

    CIK
    No. 0002025942

Ladies
and Gentlemen:

On
behalf of our client, Curanex Pharmaceuticals Inc (the “Company”), we are responding to the comments of the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) contained in the letter dated September 23, 2024 (the “Comment
Letter”), relating to the above-referenced Amendment No. 2 to the Draft Registration Statement on Form S-1 (“DRS”).
Concurrently with the submission of this letter, the Company is hereby filing with the Commission a Registration Statement on
Form S-1 (the “Form S-1”). In this Form S-1, the Company revised and updated its statements and, among other things,
added the resale prospectus, to register the shares of common stock of the Company held by the selling stockholder identified in the
resale prospectus.

Set
forth below are the Company’s responses to the Staff’s comments related to the prospectus for the underwritten primary offering
in this Form S-1. The Staff’s comments are repeated below in bold and are followed by the Company’s responses. All
references in this response letter include the references to Form S-1. Page references in the text
of this response letter correspond to the page numbers stated in the Comment Letter.

Amendment
No. 2 to Draft Registration Statement on Form S-1

The
Offering, page 4

1.
We note that your directors, officers, and holders of more than 5% of your company’s outstanding ordinary shares are expected to
enter into lock-up agreements with the underwriter for a period of up to six months from the closing of this offering. Please amend to
clarify if those identified have entered into the lock-up agreement or will enter prior to the closing of this offering and clarify the
lock-up period. Further, if these will be stand-alone agreements, separate from your underwriting agreement, please revise your exhibit
index and file these as exhibits.

Response:
In response to this Staff’s comment, the Company reiterated in its statements on Form S-1 that its directors, officers and holders
that will beneficially own more than 5% of the Company’s outstanding shares of common stock as of the effective date of this registration
statement on Form S-1 agreed to enter into and execute their lock-up agreements on the date this registration statement on Form S-1 is
declared effective by the Commission. The lock-up period under these lock-up agreements will be 180 days starting on the effective date
of this registration statement on Form S-1. A form of a lock-up agreement will be included as an exhibit to the underwriting agreement.
The underwriting agreement will be filed as an exhibit to Form S-1 by an amendment.

Use
of Proceeds, page 21

2.
We note your response to prior comment 3. Please also disclose what your full business plan is, quantify the amount of funding you require
to execute your full business plan, and how you plan to fund the remaining stages of your full business plan here as you do on page 5.

Response:
In response to this Staff’s comment, the Company revised the statements throughout Form S-1, disclosing its full business plan
and clearly identifying the stages of its full business plan, the approximate period and the amount of funds needed to implement each
stage of the Company’s full business plan.

3.
Please reconcile the disclosure that you will prioritize your use of proceeds if you receive less than $8 million from this offering,
with your disclosure elsewhere in the prospectus that this is a firm-commitment offering. Please ensure that your disclosure throughout
the prospectus is consistent with the type of offering that you disclose on the cover page of the prospectus and in the Underwriting
section.

Response:
The Company revised and updated its statements throughout Form S-1, among other things, estimating that the price per share in this firm
commitment primary offering will be between $4.00 and $6.00 per share and estimating the amount of the underwriting discounts and commissions
and offering expenses payable by the Company based on the assumed price of $5.00 per share, the midpoint of this range. In response to
this Staff’s comment, the Company reconciled its disclosure in the Net of Proceeds section with disclosures contained in other
sections of Form S-1.

Please
feel free to contact me should you require additional information at (917) 679-5931 or eosmanoff@cronelawgroup.com.

THE
CRONE LAW GROUP, P.C.

    By:

    /s/
    Eleanor Osmanoff

    Eleanor
    Osmanoff
2024-09-23 - UPLOAD - Curanex Pharmaceuticals Inc File: 377-07290
September 23, 2024
Jun Liu
Chief Executive Officer
Curanex Pharmaceuticals Inc
2 Jericho Plaza, Suite 101B
Jericho, NY 11753
Re:Curanex Pharmaceuticals Inc
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted September 16, 2023
CIK No. 0002025942
Dear Jun Liu:
            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 August 28,
2024 letter.
Amendment No. 2 to Draft Registration Statement on Form S-1
The Offering, page 4
1.We note that your directors, officers, and holders of more than 5% of your company's
outstanding ordinary shares are expected to enter into lock-up agreements with the
underwriter for a period of up to six months from the closing of this offering. Please
amend to clarify if those identified have entered into the lock-up agreement or will enter
prior to the closing of this offering and clarify the lock-up period. Further, if these will be
stand-alone agreements, separate from your underwriting agreement, please revise your
exhibit index and file these as exhibits.

September 23, 2024
Page 2
Use of Proceeds, page 21
2.We note your response to prior comment 3. Please also disclose what your full business
plan is, quantify the amount of funding you require to execute your full business plan, and
how you plan to fund the remaining stages of your full business plan here as you do on
page 5.
3.Please reconcile the disclosure that you will prioritize your use of proceeds if you receive
less than $8 million from this offering, with your disclosure elsewhere in the prospectus
that this is a firm-commitment offering. Please ensure that your disclosure throughout the
prospectus is consistent with the type of offering that you disclose on the cover page of
the prospectus and in the Underwriting section.
            Please contact Christine Torney at 202-551-3652 or Daniel Gordon at 202-551-3486 if
you have questions regarding comments on the financial statements and related matters. Please
contact Doris Stacey Gama at 202-551-3188 or Chris Edwards at 202-551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Joe Laxague, Esq.
2024-08-28 - UPLOAD - Curanex Pharmaceuticals Inc File: 377-07290
August 28, 2024
Jun Liu
Chief Executive Officer
Curanex Pharmaceuticals Inc
2 Jericho Plaza, Suite 101B
Jericho, NY 11753
Re:Curanex Pharmaceuticals Inc
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted August 15, 2024
CIK No. 0002025942
Dear Jun Liu:
            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
July 17, 2024 letter.
Amendment No. to Draft Registration Statement on Form S-1
Prospectus Summary
Business Overview, page 1
1.You state that you plan to submit an IND for the treatment of ulcerative colitis in 2025
and if the FDA allows you to proceed, a Phase I trial will be initiated 30 days post-IND
submission. In parallel, you also intend to initiate additional Phase II trials in the other
indications listed. Please clarify what is meant by "in parallel." If you intend to conduct
multiple Phase II trials for different indications after or pending Phase I results, please
state so.
In response to prior comment 3 we note that you have removed some statements or
inferences of safety or efficacy throughout the document. Nonetheless, we note that there 2.

August 28, 2024
Page 2
are still many inferences regarding efficacy throughout the document. We remind you
that safety and efficacy determinations are solely within the authority of the FDA or
comparable foreign regulator. Please revise or remove statements/inferences throughout
your prospectus that your product candidate is safe and/or effective. You may present
clinical trial end points and objective data without concluding efficacy and you may state
that your product is well tolerated, if accurate. As examples and not limited to, we note
that following:
•"This platform enables us to create a pipeline... superior efficacy compared to existing
treatments." (pg. 2)
•"We are excited about the potential...with enhanced efficacy..." (pg. 42)
•"The Disease Activity Index...demonstrating rapid and sustained efficacy." (pg. 46)
•"Phyto-N's superior efficacy compared to existing therapies..." (pg. 47)
•"suggesting its efficacy in modulating immune responses and alleviating
inflammation." (pg. 49)
•"The preclinical data demonstrating Phyto-N's efficacy..." (pg. 49)
•"The efficacy of Phyto-N as a prophylactic treatment was evaluated in..." (pg. 50)
•"indicating its rapid onset of action and efficacy in controlling local inflammation."
(pg. 62)
Risk Factors
If we fail to raise capital when needed it will have a material adverse effect on our business...,
page 5
3.We note the disclosure that indicates the proceeds of the Offering will allow you to
execute your full business plan. Please disclose what your full business plan is and
quantify the amount of funding you require to execute your full business plan. Please also
revise the Use of Proceeds section as appropriate.
Use of Proceeds, page 21
4.In response to prior comment 10 we note you now include a percentage of the proceeds
for each purpose. Please also provide the approximate dollar amount intended to be used
for each purpose listed and disclose how far in the Phase I or proof-of-concept and Phase
II trial clinical trial you expect to reach with the proceeds of the offering.
Business
Market Opportunity for Phyto-N, page 28
5.We note that the FDA identifies approving two botanical products, Veregen®
(sinecatechins) and Fulyzaq®/Mytesi® (crofelemer). Please discuss your basis for
concluding that NEXOBRID® was approved by the FDA as a botanical drug.
            Please contact Christine Torney at 202-551-3652 or Daniel Gordon at 202-551-3486 if
you have questions regarding comments on the financial statements and related matters. Please
contact Doris Stacey Gama at 202-551-3188 or Chris Edwards at 202-551-6761 with any other
questions.

August 28, 2024
Page 3
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Joe Laxague, Esq.
2024-07-17 - UPLOAD - Curanex Pharmaceuticals Inc File: 377-07290
July 17, 2024
Jun Liu
Chief Executive Officer
Curanex Pharmaceuticals Inc
2 Jericho Plaza, Suite 101B
Jericho, NY 11753
Re:Curanex Pharmaceuticals Inc
Draft Registration Statement on Form S-1
Submitted June 20, 2024
CIK No. 0002025942
Dear Jun Liu:
            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
Cover Page
1.Please clarify on the cover page whether you intend to take advantage of the controlled
company exemptions under the Nasdaq rules.
Prospectus Summary
Corporate History and Recent Development, page 1
2.You state that you entered into a Subscription Agreement on April 15, 2024 with an
investor. Please identify the investor and disclose the expected price per share to be paid.
Business Overview, page 2
You state that your lead product candidate, Phyto-N, has demonstrated promising efficacy
in animal models and has a long history of safe use in traditional medicine. Safety and
efficacy determinations are solely within the authority of the FDA or comparable foreign 3.

July 17, 2024
Page 2
regulator. Please revise or remove statements/inferences throughout your prospectus that
your product candidate is safe and/or effective. You may present clinical trial end points
and objective data without concluding efficacy and you may state that your product is
well tolerated, if accurate.
4.You state that your lead product candidate, Phyto-N, is an extract from a single plant.
Please identify the plant or otherwise advise.
5.Please balance your disclosure to discuss that although your drug development pipeline
encompasses seven core indications you have only conducted preclinical studies for each.
Further, please also discuss that you have not submitted an IND and that you plan to
submit an IND in 2025 and begin Phase I clinical trials in 2025 for the treatment of
ulcerative colitis only as you do on page 44.
Risk Factors
If we fail to raise capital when needed..., page 5
6.You state that you have very limited revenue-producing operations. We note that your
single product candidate Phyto-N is in very early stages. Please discuss, here and
wherever else applicable, the revenue-producing operations your business conducts.
A majority of our directors are officers and/or directors of Duraviva..., page 7
7.You state that your Chief Executive Officer, director, and President, Jun Liu, is also the
President of Duraviva. Please state whether Jun Liu will be working as CEO on a non-full
time basis. If so, please revise your disclosure to clearly state Jun Liu's time commitment
to the company and include an appropriate risk factor.
We are dependent on our collaborative agreements..., page 7
8.You state that you currently rely, and will in the future rely, on collaborative agreements
with third parties. Please identify your current collaborative agreements and disclose the
material terms of those agreements and attach them as exhibits or otherwise advise. Refer
to Item 601(b)(10) of Regulation S-K for guidance.
Risk Related to Ownership of Our Securities, page 13
9.We note that you anticipate that the Offering will be approximately in the range of $5
million to $30 million. Given the relatively small size of your offering, please include a
separate risk factor addressing the potential for rapid and substantial price volatility and
any known factors particular to your offering that may add to this risk and discuss the
risks to investors when investing in stock where the price is changing rapidly. Clearly
state that such volatility, including any stock-run up, may be unrelated to your actual or
expected operating performance and financial condition or prospects, making it difficult
for prospective investors to assess the rapidly changing value of your stock.
Use of Proceeds, page 20
10.Please revise your use of proceeds section to provide the approximate dollar amount
intended to be used for each purpose listed.
You state that you plan to use the net proceeds from this offering to initiate Phase I or
proof-of-concept Phase II trials in inflammatory diseases, among other things. Please 11.

July 17, 2024
Page 3
specify if this relates to your product candidate Phyto-N, how far in the development
process you expect to reach with the proceeds of the offering, and the specific
inflammatory diseases you plan to pursue.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 25
12.You state that during fiscal year ended December 31, 2022 you generated $26,000 from
related party transactions including $21,571 for costs of goods sold and sales of
supplement products. Please identify the supplemental products and discuss if you plan to
continue the sale of such products.
Business
Market Opportunities for Phyto-N, page 28
13.You state that in clinical practice, Phyto-N has shown the ability to cure certain diseases,
such as ulcerative colitis, and maintain long-term remission, offering a significant
advantage over existing therapies that often require continuous treatment. Please discuss
your basis in claiming that Phyto-N has the ability to cure certain diseases. We also note
your reference to the robust clinical experience of Phyto-N in China, if Phyto-N has been
approved in other jurisdictions please state so, if not please remove such statements.
14.You state that you are actively identifying and isolating the active chemical compounds
responsible for the therapeutic effects. Please identify these compounds.
15.You state that a key competitive advantage is that Phyto-N is well-positioned for an
accelerated development and regulatory pathway in the US. Please expand your
discussion to explain how clinical experience in China and FDA approval of other
botanical drugs will accelerate your development process. Further, with a view to
disclosure, please tell us how many botanical drug products to date have received FDA
approval. To the extent that only a limited number of botanical drug products are FDA
approved, please revise this section to disclose this information and similarly highlight
this information in the Summary to convey the novelty and/or challenges of receiving
approval for a botanical drug.
Product Pipelines, page 29
16.You state that Phyto-N is an alternative for patients with moderate to severe ulcerative
colitis as it addresses limitations of current treatments. Please identify the limitations of
the current treatments.
Market analysis of inflammatory bowel disease (IBD) treatment..., page 30
17.We note your market projections here and for each indication you intend to pursue. Given
the lengthy timeline and uncertainty with regard to clinical development, please remove
these estimated and projected market values as they appear to be premature and
speculative given your stage of development.
Market Potential of Phyto-N IBD and Target Market, page 31
You state that your initial target market for Phyto-N for IBD could be Asia where clinical
observations and animal studies were conducted and expansion into other major IBD 18.

July 17, 2024
Page 4
markets would require additional clinical trials and regulatory approvals. Please clarify if
you have performed clinical trials in Asia, if so, specify the country, and discuss if you
received regulatory approval of your product.
19.You state that your results highlight the promising therapeutic effects of Phyto-N on
various autoimmune diseases. Please discuss the results referenced.
20.You state that the actual market value may vary depending on factors such as the
company's profitability, growth prospects, competition, and investor sentiment. Please
balance your disclosure and include a discussion that there is no guarantee that your
product candidate will be approved.
Market Analysis of Nonalcoholic Fatty Liver Disease (NAFLD) Treatments..., page 37
21.You state that there are over 40 drugs in development for NASH, that there are currently
two late-stage drugs, and that the FDA recently approved the first drug for NASH,
Madrigal, on March 14, 2024. Please include a discussion that although a drug has been
approved and there are other late-stage drugs, this is not an indication that your product
will receive regulatory approval and that your product candidate is a botanical drug and as
such may face different challenges as it goes through the regulatory process.
22.You state that Phyto-N boasts superior anti-inflammatory properties and unlike recently
FDA approved Rezdiffra, Phyto-N mitigates inflammation occurrence without causing
adverse reaction, such as diarrhea, nausea, and potential liver enzyme elevations. Please
discuss your basis for such claims.
23.You state that Phyto-N has dual preventive and therapeutic benefits and potentially better
safety profile when compared to the newly approved drug Rezdiffra. Please discuss if you
have conducted head-to-head studies. If not, please remove such comparisons as you do
not have the basis to compare your candidate to other products.
Our Growth Strategy, page 42
24.You state that the successful completion of clinical trials would position Phyto-N as a
potential first-in-class botanical drug. Please remove references throughout your
prospectus to potential "first-in-class" when describing your product candidate as these
descriptions imply an expectation of regulatory approval and are inappropriate given the
length of time and uncertainty with respect to securing marketing approval.
Intellectual Property, page 43
25.Please revise here and elsewhere in the prospectus, where appropriate, to explain what
a provisional patent application is and how it differs from a nonprovisional patent
application. Revise the table and your risk factor disclosure to disclose the expiration
dates of the provisional patents and the risks associated with not having patent coverage
for the work you are conducting.
26.We note your table on page 43 listing your provisional patent applications. Please
identify the applicable jurisdiction for the Plant Extract Compositions and Uses Thereof
For Treating Acne.

July 17, 2024
Page 5
Our Business Plan, page 44
27.You state that you have conducted animal pharmacology studies to demonstrate efficacy
in relevant disease models. Please identify the disease models.
Our Revenue Model, page 45
28.You state that you anticipate that Curanex's revenue streams will primarily derive from
commercialization of your botanical drug products through product sales and
collaboration and licensing agreements. Please balance your disclosure by including a
discussion that your product candidate, Phyto-N, is in pre-clinical studies and that
although you plan to file an IND in 2025 there is no guarantee that you will receive
regulatory approval and reach commercialization. Please also identify and quantify the
research grants and contracts you have received to date.
Research and Development (FDA Related Application)
Moderate to Severe Ulcerative Colitis
Human Application Case, page 45
29.We note your discussion of a patient with ulcerative colitis who took Phyto-N
orally. Please discuss where this case took place and if Phyto-N has been clinically
approved in any jurisdiction. Please also balance the case study to indicate that Phyto-N
is in the early stages of pre-clinical development, that it will take many years to
commercialize this product candidate and that there can be no guarantee that Phyto-N will
achieve similar results in clinical testing.
Animal Experiment Research, page 46
30.You state that the Disease Activity Index (DAI) was significantly lower in the Phyto-N
group by day 14 of the treatment and continued to improve until the end of the study.
Please identify the scores referenced and discuss the significance of such results.
31.We note Figure 1 includes a reference to p-values in Note D. Please define the term at
first use and discuss the significance of the p-value results shown.
32.With respect to the figures, tables, and graphics included throughout this section, please
revise your tables or graphics to ensure that the text in each, including subscript or other
notations, are large enough and clearly legible and that each includes a discussion of the
significance of each result presented.
33.We note your discussion of the results from previously conducted animal studies for
ulcerative colitis and the other seven indications you plan to pursue. Please discuss here,
and for each indication, where each study was conducted and if there were any adverse or
severe adverse events observed.
Regulation, page 64
34.Please revise your discussion of FDA regulation and product approval to address
regulatory issues and technical challenges that are unique to botanical drug products as
compared to nonbotanical drugs and include any appropriate risk factors. In this regard,
we refer to the information contained in FDA’s “Botanical Drug Development: Guidance
for Industry” available at: https://www.fda.gov/files/drugs/published/Botanical-Drug-
Development--Guidance-for-Industry.pdf

July 17, 2024
Page 6
35.You state that the FDA has established special provisions for botanical drugs that have a
long history of safe human use. Please discuss the special provisions referenced or
otherwise remove such statement.
Executive Compensation, page 74
36.You state that for fiscal years ended December 31, 2023 and 2022, the Company did not
make any compensation to Dian Ying Jin. Please clarify if there were any other executive
officers during fiscal years ended December 31, 2023 and 2022 that received
compensation.
Certain Relationship and Related Party Transactions, page 77
37.You state that Duraviva transferred and assigned to you all of its IP assets together with
$730,000 consideration. Please identify all assets that were transferred to you as part of
the asset purchase agreement as you do on page 25.
General
38.Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain, copies of those
communications.
            Please contact Christine Torney at 202-551-3652 or Daniel Gordon at 202-551-3486 if
you have questions regarding comments on the financial statements and related matters. Please
contact Doris Stacey Gama at 202-551-3188 or Chris Edwards at 202-551-6761 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Joe Laxague, Esq.