SecProbe.io

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
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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.