As filed with the Securities and Exchange Commission on February 14, 2025.

Registration No. 333-282686

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

Amendment No. 3

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

CURANEX PHARMACEUTICALS INC

(Exact name of registrant as specified in its charter)

2 Jericho Plaza, Suite 101B

Jericho, NY 11753

(718) 673-6078

(Address, including zip code, and telephone number, including area code,

of registrant’s principal executive offices)

Jun Liu

Chief Executive Officer

Curanex Pharmaceuticals Inc

2 Jericho Plaza, Suite 101B

Jericho, NY 11753

(718) 673-6078

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box. ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act. ☐

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission acting pursuant to said Section 8(a), may determine.

EXPLANATORY NOTE

This Registration Statement contains two prospectuses, as set forth below.

The Resale Prospectus is substantively identical to the Public Offering Prospectus, except for the following principal points:

The Registrant has included in this Registration Statement a set of alternate pages after the back-cover page of the Public Offering Prospectus (the “Alternate Pages”) to reflect the foregoing differences in the Resale Prospectus as compared to the Public Offering Prospectus. The Public Offering Prospectus will exclude the Alternate Pages and will be used for the public offering by the Registrant. The Resale Prospectus will be substantively identical to the Public Offering Prospectus except for the addition or substitution of the Alternate Pages and will be used for the resale offering by the Selling Stockholder.

Unless noted otherwise, all share and the price per share numbers for all periods presented in these prospectuses have been retroactively adjusted for the reverse stock split of our outstanding Common Stock at a ratio of 3-for-5, which became effective as of November 19, 2024.

The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and we are not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

2,000,000 Shares of Common Stock

CURANEX PHARMACEUTICALS INC

This is an initial public offering (the “Offering” or the “IPO”) of 3,750,000 shares (the “Shares”) of common stock, $0.0001 par value per share (the “Common Stock”) of Curanex Pharmaceuticals Inc, a Nevada corporation (the “Company,” “Curanex,” “we,” “us” or “our”). The Company is registering in this Offering 2,000,000 shares of Common Stock on a firm commitment underwritten basis. We are also registering up to 1,750,000 shares of Common Stock (the “Selling Stockholder Shares”) for resale by the stockholders named in the separate Resale Prospectus (the “Selling Stockholders”). We will not receive any proceeds from the sales of outstanding common shares by the Selling Stockholders.

The sale of the Selling Stockholder Shares in the resale offering is conditioned upon the successful completion of the sale of Shares by the Company in the underwritten primary offering. Following listing of our shares on the Nasdaq Capital Market (“Nasdaq”), the per share public offering price of the Selling Stockholder Shares to be sold by the Selling Stockholders will be at market prices prevailing at the time of sale, at prices related to prevailing market prices, or at negotiated prices. The Selling Stockholders may sell shares to or through underwriters, broker-dealers or agents, who may receive compensation in the form of discounts, concessions or commissions from the selling shareholders, the purchasers of the shares, or both. Any participating broker-dealers and who are affiliates of broker-dealers may be deemed to be “underwriters” within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), and any commissions or discounts given to any such broker-dealer or affiliates of a broker-dealer may be regarded as underwriting commissions or discounts under the Securities Act. The registration of the resale of the Selling Stockholder Shares does not mean that any of the Selling Stockholders will offer or sell any of the Selling Stockholder Shares. The successful listing of the Company’s Shares on the Nasdaq Capital Market is a condition to the closing of our underwritten primary offering and the secondary offering by the Selling Stockholders.

We will pay all fees and expenses incident to the registration of the resale of the Selling Stockholder Shares. However, the Selling Stockholders will not sell any Selling Stockholder Shares until after the closing of the underwritten primary offering. For additional information on the possible methods of sale that may be used by the Selling Stockholders, you should refer to the section of this prospectus entitled “Selling Stockholders—Plan of Distribution”.

Prior to this Offering, there has been no public market for the Shares of the Company. The Company expects that the initial public offering price will be between US$4.00 and US$6.00 per share. We have applied to have our Common Stock listed on The Nasdaq Capital Market under the symbol “CURX”. There is no assurance that this Offering will be closed and that we will be successful in listing our Common Stock on Nasdaq.

Upon the completion of this Offering, the Company will have 26,000,000 shares of Common Stock issued and outstanding if the Over-allotment Option is not exercised. Our founders, Dian Ying Jing and Chang Liu, together with our Chief Executive Officer and President, Jun Liu, all of whom are members of the same family, beneficially own approximately 80.0% of the outstanding shares of Common Stock as of the date of this prospectus and will own approximately 73.9% of our outstanding voting stock after the completion of this Offering. They also beneficially own 100% of Series A Preferred Stock (“Series A Preferred Stock”) as of the date of this prospectus that provide them with 40% of the voting power of our equity voting stock. To the extent that these individuals agree to vote their shares together with regard to the election of directors, we will be deemed a “controlled company” under the corporate governance standards for Nasdaq listed companies, and for so long as we remain a controlled company under this definition, we are eligible to utilize certain exemptions from the corporate governance requirements under Nasdaq Listing Rules. We do not plan to rely on these exemptions, but we may elect to do so in the future. Please read “Prospectus Summary – Implications of Being a Controlled Company” beginning on page 3 of this prospectus for more information.

We are an emerging growth company and a smaller reporting company under the federal securities laws, and, as such, have elected to comply with certain reduced public company reporting requirements. Investing in our Common Stock involves a high degree of risk.

Investing in our Common Stock involves a high degree of risk. See “Risk Factors” beginning on page 5 of this prospectus for a discussion of information that should be considered in connection with an investment in our Common Stock.

Neither the Securities and Exchange Commission (“SEC”) nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The underwriters are selling 2,000,000 Shares (or 2,300,000 Shares if the underwriters exercise their over-allotment option in full) in this Offering on a firm commitment basis. We have granted to the underwriters an option, exercisable within 45-days after the closing of the Offering, to purchase an additional 15% of the total number of shares of our Common Stock sold in the Offering at the initial public offering price solely for the purpose of covering over-allotments, if any (the “Over-allotment Option”).

The underwriters expect to deliver our shares to purchasers in the Offering on or about ______________, 2025.

Prospectus dated ______________, 2025

TABLE OF CONTENTS

Through and including ______________ 2025 (the 25th day after the date of this prospectus), all dealers that effect transactions in these securities, whether or not participating in the Offering, may be required to deliver a prospectus. This is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriter and with respect to their unsold allotments or subscriptions.

You should rely only on the information contained in this prospectus or any prospectus supplement or amendment. Neither we, nor the underwriters, have authorized any other person to provide you with information that is different from, or adds to, that contained in this prospectus. If anyone provides you with different or inconsistent information, you should not rely on it. Neither we nor the underwriters take responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. You should assume that the information contained in this prospectus or any free writing prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of our Common Stock. Our business, financial condition, results of operations and prospects may have changed since that date. We are not making an offer of any securities in any jurisdiction in which such offer is unlawful.

No action is being taken in any jurisdiction outside the United States to permit a public offering of our Common Stock or possession or distribution of this prospectus in that jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this public offering and the distribution of this prospectus applicable to that jurisdiction.

For investors outside the United States: Neither we nor the underwriters have taken any action that would permit the Offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the Offering of the securities covered hereby and the distribution of this prospectus outside of the United States.

The information in this prospectus is accurate only as of the date on the front cover of this prospectus. Our business, financial condition, results of operations and prospects may have changed since those dates.

No person is authorized in connection with this prospectus to give any information or to make any representations about us, the securities offered hereby or any matter discussed in this prospectus, other than the information and representations contained in this prospectus. If any other information or representation is given or made, such information or representation may not be relied upon as having been authorized by us.

Neither we nor the underwriters have done anything that would permit the Offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than the United States. You are required to inform yourself about, and to observe any restrictions relating to, the Offering and the distribution of this prospectus.

PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our Common Stock. Before investing in our securities, you should carefully read this entire prospectus, including our financial statements and the related notes thereto and the information set forth under the sections “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes thereto, in each case included in this prospectus. Some of the statements in this prospectus constitute forward-looking statements. See “Cautionary Note Regarding Forward-Looking Statements.” Except as otherwise indicated, references to “we,” “us,” “our” and the “Company” refer to Curanex Pharmaceuticals Inc., New York corporation, prior to the reincorporation from New York to Nevada, and to Curanex Pharmaceuticals Inc, a Nevada corporation, following that reincorporation.

Corporate History and Recent Development

Curanex was originally incorporated under the laws of the State of New York on June 1, 2018 under the name “Durand Damiel Health Inc,” focusing on research and development (R&D) of health products and botanical medicines. On October 24, 2023, the Company changed its name to “Fordman Pharma Inc.,” and on November 9, 2023, the Company changed its name to Curanex Pharmaceuticals Inc and changed its focus on discovering, developing and commercializing innovative botanical drugs for major unmet needs to treat patients suffering from inflammatory diseases.

On April 15, 2024, the Company entered into an initial subscription agreement with an individual, Xiaohong Song (the “Investor”), which was superseded by the amended and restated subscription agreement entered between the parties on November 27, 2024 (the Subscription Agreement”) pursuant to which the Investor agreed to purchase a number of shares of our Common Stock representing 0.1% of the total outstanding number of our Common Stock following the completion of the Offering for the purchase price of $200,000. Upon the successful completion of the sale of Shares by the Company in the underwritten primary offering, the Company will have 26,000,000 shares of Common Stock issued and outstanding if the over-allotment option is not exercised or 26,300,000 shares of Common Stock if the underwriters exercise in full the over-allotment option. Accordingly, the Company anticipates that it will issue to the Investor 26,000 or 26,300 shares of Common Stock, as applicable.

On June 10, 2024, Curanex Pharmaceuticals Inc., a New York corporation (“Curanex NY”), entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Curanex Pharmaceuticals Inc, a newly formed Nevada corporation and a wholly owned subsidiary of Curanex NY (the “Surviving Corporation”), pursuant to which, on the same date, Curanex NY, as parent in this transaction, merged with and into the Surviving Corporation (the “Reincorporation”). Upon the consummation of the Reincorporation, Curanex NY ceased its legal existence as a New York corporation, and the Surviving Corporation continued business of Curanex NY as the surviving corporation in the Reincorporation under the name “Curanex Pharmaceuticals Inc” succeeding all our rights, assets, liabilities and obligations, except that our affairs ceased to be governed by the New York Business Corporation Law and became subject to the Nevada Revised Statutes.

On June 17, 2024, we entered into an Asset Purchase Agreement and Plan of Reorganization (the “Asset Purchase Agreement”) with Duraviva Pharma Inc (“Duraviva”), a New York corporation, and an entity in which our majority shareholders, including its President and members of the President’s immediate family, also majority shareholders and officers and directors, and on the same date, closed the transactions contemplated by the Asset Purchase Agreement (the “Closing”). Upon the Closing, Duraviva transferred and assigned to the Company four (4) provisional patent applications and its 8 research and development animal studies and reports and the rights to use the studies for further R&D, clinical and commercial purposes (the “IP Assets”). In consideration for $730,000 and the transfer and assignment of the IP Assets by Duraviva, constituting all or substantially all the assets of Duraviva, the Company issued an aggregate of 23,400,000 shares of Common Stock to Duraviva’s shareholders, pro-rata to their beneficial ownership in Duraviva. Pursuant to the terms of the Asset Purchase Agreement, Duraviva intends to liquidate, distribute out its remaining assets, as promptly as reasonably possible after the Closing, and to dissolve its charter under the laws of its incorporation. As of the date of this prospectus, Duraviva is implementing its plan toward liquidating its remaining assets, anticipated to be completed by the end of 2024.

On November 19, 2024, our Board of Directors (the “Board”) and our stockholders approved an amendment to our amended and restated articles of incorporation (the “Amendment”) to effect a reverse stock split of the outstanding shares of the Common Stock, at a ratio of three-for-five (3-for-5) (the “Reverse Stock Split”). The Amendment became effective on the same date, upon filing of the Amendment with the Secretary of State of the State of Nevada. As a result of the Reverse Stock Split, every five (5) shares of our issued and outstanding Common Stock, automatically and without any action of the Company or any holder thereof, were combined into three (3) validly issued and non-assessable shares of Common Stock, resulting in 24,000,000 post Reverse Stock Split shares of Common Stock. No fractional shares were issued to any stockholder of the Company, and in lieu of issuing any such fractional shares, any fractional shares resulting from the Reverse Stock Split, if applicable, will be rounded up to the nearest whole share of Common Stock. Proportionate adjustments will be made to the exercise prices and the number of shares underlying the Company’s outstanding equity awards, convertible notes, and warrants, as applicable. The shares of Common Stock as adjusted to the Reverse Stock Split will remain fully paid and non-assessable. The Reverse Stock Split will not affect the number of authorized shares of Common Stock or the par value of the Common Stock nor will it change the authorized shares of preferred stock or the relative voting power of holders of the outstanding Common Stock.

Business Overview

Curanex is a developmental stage pharmaceutical company dedicated to discovering, developing and commercializing innovative botanical drugs to treat patients suffering from inflammatory diseases. Our mission is to address significant unmet medical needs and improve patients’ lives by harnessing the power of natural substances. We are dedicated to discovering, developing and commercializing botanical medicines for treating patients with immune and inflammatory diseases and to develop therapies that may offer potential benefits to patients with unmet clinical needs in various fields, such as autoimmune diseases, metabolic diseases and viral infections.

Our founders and related research personnel have been devoted to natural substances (“phytomedicine”) since 1996. Based on their knowledge and experience of natural substances and relevant technologies, they developed a proprietary platform for identifying, extracting and optimizing novel anti-inflammatory compounds from medicinal plants. We believe that this platform will allow us to create a pipeline of botanical drug candidates with potentially unique mechanisms of action to address unmet medical needs.

Our lead drug candidate, Phyto-N, is a proprietary botanical extract with chemical components and pharmacological activities that harnesses potential anti-inflammatory properties of a medicinal plant with a long history of human use. Phyto-N has a long history of use in Chinese traditional medicine, which focuses on an alternative herbal medical practice, and has shown positive results in animal models of multiple inflammatory diseases.

Our objective is to prioritize the development of Phyto-N and its active compounds, to conduct further preclinical and clinical studies to evaluate its therapeutic potential and safety profile, and if warranted, to seek the necessary regulatory approval in order to commercialize Phyto-N. Specifically, we aim to establish proof-of-concept for our botanical drug development platform to bring therapies that will improve life of patients who currently have limited or no effective treatment options and to generate value for our stockholders. Our current drug development pipeline encompasses seven core indications: ulcerative colitis, atopic dermatitis, COVID-19, diabetes, nonalcoholic fatty liver disease (“NAFLD”), gout and acne. If successfully developed and approved, Phyto-N may improve the lives of many patients worldwide. However, our research to date has been limited to preclinical studies for each of these indications.

Our initial business plan is to submit an Investigational New Drug application (“IND”) for the treatment of ulcerative colitis in the fourth quarter of 2025. If allowed to proceed by the U.S. Food and Drug Administration (“FDA”), a Phase I trial will be initiated 30 days post-IND submission. If the Phase I trial is completed with positive results, we intend to proceed with a Phase II trial for ulcerative colitis as our lead indication. Contingent upon the success of our ulcerative colitis trials, available funding, and other strategic considerations, Curanex may subsequently initiate additional Phase II trials in other high-value indications such as atopic dermatitis, coronavirus (COVID-19), gout, diabetes, NAFLD, and acne. This multiple indication strategy represents our long-term vision to explore and maximize the value of Phyto-N and build a robust pipeline of botanical drug candidates targeting inflammatory diseases. The successful completion of these clinical trials could position Phyto-N as a potential botanical drug candidate for multiple inflammatory indications, addressing specific unmet medical needs. If approved, Phyto-N could provide patients with new treatment options for various inflammatory conditions.

As we progress towards clinical development, we will continue to invest in translational research to further elucidate the mechanisms of action, biomarkers, and patient stratification strategies for Phyto-N. These efforts will support our precision medicine approach and help us optimize the design and execution of our clinical trials to improve the chances of success. However, the process for conducting clinical trials is uncertain and there is no assurance that our clinical development activities will meet our planned timelines. There is also no assurance that we will be successful in obtaining FDA regulatory approval, in obtaining sufficient funds to pursue our growth strategy, and in commercialization of our lead or other product candidates. 

As a company that is developing botanical drugs, we may face challenges that similar companies experienced in the past with obtaining regulatory approval, as the development and approval process for botanical drugs involves additional challenges, including, but not limited to the complex nature of botanical extracts, which may contain multiple active compounds, making it difficult to identify and characterize all active ingredients, challenges in standardization and quality control due to natural variations in plant materials, difficulties in predicting pharmacokinetics and potential drug interactions due to the complex composition of botanical extracts, and manufacturing complexities in scaling up production while maintaining consistency and quality. Currently only two (2) botanical drugs have received FDA approval, such as Veregen® (sinecatechins), a green tea extract for the treatment of genital and perianal warts, and Fulyzaq®/Mytesi® (crofelemer), derived from the Croton lechleri tree, for managing diarrhea in HIV/AIDS patients on antiretroviral therapy. This limited number of approvals highlights both the innovative nature of our approach and the potential challenges in obtaining regulatory approval. These challenges involve additional costs and may result in delays, or failure to obtain the required FDA regulatory approval.

Implications of Being an Emerging Growth Company

As a company with less than $1.235 billion in revenue during our last completed fiscal year, we qualify as an “emerging growth company” as defined in the federal securities laws. An emerging growth company may take advantage of specified reduced reporting requirements that are otherwise applicable generally to public companies. These reduced reporting requirements include:

We will remain an emerging growth company until the earliest to occur of: (i) the end of the first fiscal year in which our annual gross revenue is $1.235 billion or more; (ii) the date on which we are deemed to be a “large accelerated filer,” as defined in the Securities Exchange Act of 1934, as amended, (the “Exchange Act”); (iii) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt securities; and (iv) the end of the fiscal year during which the fifth anniversary of the Offering occurs. We may choose to take advantage of some, but not all, exemptions afforded to emerging growth companies. We currently intend to take advantage of the exemptions discussed above. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock. We will take advantage of the extended transition period for complying with any new or revised financial account standards provided pursuant to Section 7(a)(2)(B).

Implications of Being a Smaller Reporting Company

We are also a “smaller reporting company,” as defined under SEC Regulation S-K. As such, we also are exempt from the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley”) and also are subject to less extensive disclosure requirements regarding executive compensation in our periodic reports and proxy statements. We will continue to be deemed a smaller reporting company until the end of the fiscal year in which (i) we have a public common equity float of more than $250 million or (ii) we have annual revenues for the most recently completed fiscal year of more than $100 million and a public common equity float or public float of more than $700 million. We also would not be eligible for status as a smaller reporting company if we become an investment company, an asset-backed issuer or a majority-owned subsidiary of a parent company that is not a smaller reporting company.

We have elected to take advantage of certain of the reduced disclosure obligations in the registration statement of which this prospectus is a part and may elect to take advantage of other reduced reporting requirements in future filings. As a result, the information that we provide to our stockholders may be different from what you might receive from other public reporting companies in which you hold equity interests.

Implications of Being a Controlled Company

Our founders, Dian Ying Jing and Chang Liu, together with our Chief Executive Officer and President, Jun Liu, all of whom are members of the same family, beneficially own approximately 80% of the outstanding shares of Common Stock as of the date of this prospectus and will own approximately 73.9% of our outstanding voting stock after this offering. They also beneficially own 100% of Series A Preferred Stock as of the date of this prospectus that provide them with 40% of the voting power of our equity voting stock. To the extent that these individuals agree to vote their shares together with regard to the election of directors, we will be deemed a “controlled company” under the corporate governance standards for Nasdaq listed companies and for so long as we remain a controlled company under this definition, we are eligible to utilize certain exemptions from the corporate governance requirements of Nasdaq.

For so long as we are a controlled company under that definition, we are permitted to rely on certain exemptions from corporate governance rules, including:

Although we do not intend to rely on the “controlled company” exemption under Nasdaq listing rules, we could elect to rely on this exemption in the future. If we elect to rely on the “controlled company” exemption, a majority of the members of our Board might not be independent directors and our nominating and corporate governance and compensation committees might not consist entirely of independent directors.

As a result, you will not have the same protection afforded to shareholders of companies that are subject to these corporate governance requirements.

Corporate Information

Our principal executive offices are located at 2 Jericho Plaza, Suite 101B, Jericho, NY 11753. Our telephone number is (718) 673-6078. Our website address is www.curanexpharma.com. Information contained in, or that can be accessed through, our website is not incorporated by reference into this prospectus, and you should not consider information on our website to be part of this Prospectus.

THE OFFERING

The following summary of the Offering contains basic information about the offering and Common Stock and is not intended to be complete. It does not contain all the information that is important to you. For a more complete understanding of the Common Stock, please refer to the section of this Public Offering Prospectus entitled “Description of Securities”.

Except as otherwise indicated, all information in this prospectus assumes that:

RISK FACTORS

Our business is subject to many risks and uncertainties, which may affect our future financial performance. If any of the events or circumstances described below occur, our business and financial performance could be adversely affected, our actual results could differ materially from our expectations, and the price of our stock could decline. The risks and uncertainties discussed below are not the only ones we face. There may be additional risks and uncertainties not currently known to us or that we currently do not believe are material that may adversely affect our business and financial performance. You should carefully consider the risks described below, together with all other information included in this prospectus including our financial statements and related notes, before making an investment decision. The statements contained in this prospectus that are not historic facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in or implied by forward-looking statements. If any of the following risks actually occurs, our business, financial condition or results of operations could be harmed. In that case, the trading price of our Common Stock could decline, and investors in our securities may lose all or part of their investment.

Risks Related to Our Business

We have a limited operating history in an evolving industry, which makes it difficult to evaluate our future prospects and may increase the risk that we will not be successful.

We have a limited operating history on which to base an evaluation of its business and prospects. We are subject to all the risks inherent in a small company seeking to develop, market and distribute new services, particularly companies in evolving markets such as the pharmaceutical industry. The likelihood of our success must be considered, in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection with the development, introduction, marketing and distribution of new products and services in a competitive environment. We are therefore subject to many of the risks common to early-stage enterprises, including under-capitalization, cash shortages, limitations with respect to personnel, financial and other resources and lack of revenues.

If we fail to raise capital when needed it will have a material adverse effect on our business, financial condition and results of operations.

We have a very limited revenue-producing operation and will require the proceeds from this Offering to execute our full business plan. Beginning in 2023, when the Company discontinued its sale of health and dietary supplemental products and changed its focus on developing and marketing Phyto-N as a botanical drug, the Company did not generate any revenue. Our lead product candidate, Phyto-N, is still in early preclinical development stage, and we do not generate any revenue from product sales or other commercial activities.

The Company’s full business plan includes conducting FDA-required GLP toxicology and pharmacokinetic studies, manufacturing clinical trial material, initiating and conducting Phase I clinical trials, advancing to Phase II trials for our lead indication (ulcerative colitis), potentially conducting additional Phase II trials in other high-value indications, proceeding to Phase III trials, and ultimately launching, manufacturing, and marketing the product. We estimate that it will require over $150 million to execute our full business plan through FDA approval and product launch. We believe that we will be able to raise net proceeds from this Offering that will enable us to implement our initial business plan, specifically to complete an IND and initiate Phase I clinical trial for Phyto-N in ulcerative colitis. However, there is no assurance that we will be able to sell all or a significant portion of the shares in this Offering and to implement our initial business plan. Further, even if we receive proceeds from this Offering sufficient to implement our initial plan, significant additional funding will be required for completion of Phase II and subsequent development stages of our full business plan. We expect to finance these stages of our business plan through a combination of additional public or private equity offerings, debt financings, strategic partnerships, and grants. No assurance can be given as to how much additional capital will be required or that additional financing can be obtained, or if obtainable, that the terms will be satisfactory to us, or that such financing would not result in a substantial dilution of shareholder’s interest. A failure to raise capital when needed would have a material adverse effect on our business, financial condition and results of operations. In addition, debt financing may involve a pledge of assets and may be senior to interests of equity holders. Any debt financing secured in the future could involve restrictive covenants relating to capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital or to pursue business opportunities, including potential acquisitions. If we are unable to obtain adequate funds to pursue our growth strategy and to implement our business plan, as necessary, we may be required to reduce, curtail or discontinue operations.

Risks Related to Our Financial Conditions

We are a developmental stage pharmaceutical company with no commercial products. Our lead product candidate, Phyto-N, requires significant clinical development and investment before it can potentially be commercialized and before we can generate any revenue from product sales or other commercial activities. The Company expects to incur further losses in the development of its business, has negative cash flows from operating activities, and is dependent upon future issuances of equity or other financing to fund ongoing operations.

Furthermore, upon becoming an SEC reporting company, we will be required to comply with numerous financial reporting and legal requirements, including those pertaining to audits and internal control. The costs of maintaining a public company reporting requirements could be significant and may preclude us from seeking financing or equity investment on terms acceptable to us and our shareholders. We estimate these costs to be more than $100,000 per year and may be higher if our business volume or business activity increases significantly.

Until we can generate significant revenues, we expect to satisfy our future cash needs through equity and debt financing, including loans from our founders, and proceeds from this Offering. There can be no assurance that the Company will be able to achieve its business plan, raise additional capital, or secure the additional financing necessary to implement its operating plan. If our revenues are insufficient or non-existent, and we are unable to obtain adequate funds to implement our business plan, as necessary, we may be required to reduce, curtail or discontinue operations, and investors could lose part or all of their investment in our Company.

Risks Related to Protection of Intellectual Property Rights

If we are unable to obtain patent protection for our lead product candidate, to successfully develop and commercialize Phyto-N, our ability to sustain future operations will be significantly diminished.

We are currently developing only one drug, Phyto-N, a botanical extract with distinct chemical components and pharmacological activities. Although we obtained several applications for provisional patents related to Phyto-N, we cannot guarantee that we will be successful in converting these provisional patent applications into utility patents upon expirations of provisional patents, that our patents will be registered in the United States, and that our effort to successfully develop and obtain commercialization of Phyto-N will be successful. If we are unable to obtain FDA regulatory approval, to obtain patent protections related to Phyto-N, to develop successfully and commercialize Phyto-N, we may be required to cease or reduce our operations.

Any failure in our clinical trials could impair the commercial prospects for our development of Phyto-N.

Clinical trials have a high risk of failure. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in advanced clinical trials, even after achieving promising results in earlier trials. If we experience delays in the testing or approval process or need to perform more or larger clinical trials than originally planned, our commercial prospects for Phyto-N may be impaired and we may be required to cease or reduce our operations.

Our success is largely dependent on our ability to obtain and maintain patent protection and preserve trade secrets, which cannot be guaranteed.

The future success of our business is dependent upon the intellectual property rights surrounding the technology, including registration of patents, trade secrets, know-how and continuing technological innovation. Although we will seek to protect our proprietary rights, our actions may be inadequate to protect any proprietary rights or to prevent others from claiming violations of their proprietary rights. Litigation or other legal proceedings may be necessary to defend against claims of infringement. Such litigation could result in substantial costs and diversion of our management’s attention.

The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions. On June 17, 2024, we acquired the IP Assets from Duraviva, including the exclusive license to use certain rights of Duraviva. This includes assignment of the four provisional patent applications to us.

A provisional patent application in the United States lasts only 12 months and essentially acts as a placeholder. It does not automatically turn into a non-provisional (utility) patent. Instead, it requires filing a utility patent application within a year of the filing date of the provisional patent application to claim the earlier priority date and to receive the full protection that a utility patent provides.

Effective patent protection is expensive to develop and maintain, both in terms of initial and ongoing registration requirements and expenses and the costs of defending our rights. Any litigation of this nature, regardless of outcome or merit, could result in substantial costs and diversion of management and technical resources, any of which could adversely affect our business and operating results.

If we fail to maintain, protect and enhance our intellectual property rights, our business and operating results may be harmed. There can be no assurance that other companies are not investigating or developing other technologies that are similar to our technology. If the protection of proprietary rights is inadequate to prevent unauthorized use or appropriation by third parties, the value of our brand and other intangible assets may be diminished. Any of these events could have an adverse effect on our business and financial results.

Failure to file non-provisional patent applications timely or to obtain and maintain effective registration of non-provisional patents in the United States will have a significant adverse effect on our business.

While provisional patent applications have certain benefits, including that it is an informal application and therefore can be filed quickly to establish an earlier filing date (this can be crucial in the event of potential disputes or challenges regarding patent right), and having lower filing fees compared to non-provisional applications, making them a cost-effective initial step in the patent process, provisional patent applications lasts only 12 months, which subject their owners to risks of losing patent protections unless the non-provisional patent applications are filed during that 12-month window before expiration of provisional patent applications.

If we do not file non-provisional patent applications prior to the expiration dates of the 4 provisional patents assigned to us by Duraviva, we will lose the priority dates with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional patent applications and we could lose patent protections with respect to these provisional patents.

There is also no assurance that we will be successful in obtaining registrations of non-provisional patent applications we submit for review to the United States Patent and Trademark Office and obtaining the patent protection we need.

Compared to provisional patent applications, non-provisional applications require to undergo a thorough examination process by patent examiners to determine patentability, patentability of the invention, including its novelty and non-obviousness. Non-provisional applications also require providing formal claims, detailed drawings, and a written description that fully discloses the invention’s subject matter and scope.

Moreover, patent applications and patents may be opposed or challenged by third parties. As patent applications in the United States are maintained in secrecy until published or issued and as publication of discoveries in the scientific or patent literature often lag behind the actual discoveries, we cannot be certain that there are no other pending patent applications or issued patents from other parties. Additionally, the breadth of claims allowed in biotechnology and pharmaceutical patents, or their enforceability cannot be predicted. We cannot be sure that we will be successive in obtaining and maintaining effective patent protection for the technologies underlying Phyto-N and successfully defending patent rights in those technologies against third-party challenges.

Claims by other companies that we infringe on their proprietary technology may result in liability for damages or stop our development and commercialization efforts.

The pharmaceutical industry is highly competitive, and patents have been applied for by, and issued to, other parties relating to products competitive with Phyto-N. This may give rise to claims that they infringe the patents or proprietary rights of other parties existing now and in the future. Furthermore, to the extent that we or our respective consultants or research collaborators use intellectual property owned by others in work performed for us, disputes may also arise as to the rights in such intellectual property or in resulting know-how and inventions. An adverse claim could subject us to significant liabilities to such other parties and/or require disputed rights to be licensed from such other parties.

We cannot be sure that any license required under any such patents or proprietary rights would be made available on terms acceptable to us, if at all. If we do not obtain such licenses, we may encounter delays in product market introductions, or may find that the development, manufacture or sale of products requiring such licenses may be precluded. We have not conducted any searches or made any independent investigations of the existence of any patents or proprietary rights of other parties.

We may be subject to substantial costs stemming from our defense against third-party intellectual property infringement claims.

Third parties may assert that we are using their proprietary information without authorization. Third parties may also have or obtain patents and may claim that technologies licensed to or used by us infringe their patents. If we are required to defend patent infringement actions brought by third parties, or if we sue to protect our own patent rights, we may be required to pay substantial litigation costs and managerial attention may be diverted from business operations even if the outcome is not adverse to us. In addition, any legal action that seeks damages or an injunction to stop us from carrying on our commercial activities relating to the affected technologies could subject us to monetary liability and require us or any third-party licensors to obtain a license to continue to use the affected technologies. We cannot predict whether we would prevail in any of these types of actions or that any required license would be made available on commercially acceptable terms or at all.

We may enter into collaboration agreements for the development of products and business development, which could expose us to the risk of reliance on the viability of third parties.

In conducting our research and development activities, we may in the future rely on collaborative agreements with third parties such as manufacturers, contract research organizations, commercial partners, universities, governmental agencies and not-for-profit organizations for both strategic and financial resources. We do not currently have such agreements with third-party manufacturers, suppliers or other service companies, including commercial partners. In the future, if we are able to establish and maintain arrangements with these third-party manufacturers, suppliers or other service companies, reliance on them may expose us to the risk of reliance on the viability of third parties.

If the third parties that we engage to supply any materials or manufacture product for our nonclinical studies and clinical trials should cease to continue to do so for any reason, we likely would experience delays in advancing these studies and trials while we identify and qualify replacement suppliers or manufacturers and we may be unable to obtain replacement supplies on terms that are favorable to us or at all. In addition, if we are not able to obtain adequate supplies of our drug candidates or the substances used to manufacture them, it will be more difficult for us to develop our drug candidates and compete effectively.

The loss of, or failure to perform by us or our partners under, any applicable agreements or arrangements, or our failure to secure additional agreements for other products in development, would substantially disrupt or delay our research and development and commercialization activities. Any such loss would likely increase our expenses and materially harm our business, financial condition and results of operation.

There is no assurance we will be profitable.

There is no assurance that we will earn profits in the future, or that profitability will be sustained. There is no assurance that future revenues will be sufficient to generate the funds required to continue our business development and marketing activities. If we do not have sufficient capital to fund our operations, we may be required to reduce our drug research and development efforts or forego certain business opportunities.

We may not have the ability to manage its growth.

We anticipate that significant expansion will be required to address potential growth in its customer base and market opportunities. Our anticipated expansion is expected to place a significant strain on our management, operational and financial resources. To manage any material growth of its operations and personnel, we may be required to improve existing operational and financial systems, procedures and controls and to expand, train and manage its employee base. There can be no assurance that our planned personnel, systems, procedures and controls will be adequate to support our future operations, that management will be able to hire, train, retain, motivate and manage required personnel or that our management will be able to successfully identify, manage and exploit existing and potential market opportunities. Failure to manage our growth effectively could cause us to misallocate management or financial resources, and result in additional expenditures and inefficient use of existing human and capital resources or we otherwise may be forced to grow at a slower pace that could impair or eliminate our ability to achieve and sustain profitability. If we are unable to manage growth effectively, our business, prospects, financial condition and results of operations may be materially adversely affected.

We may engage in acquisition activity, which could have adverse effects on its business.

If appropriate opportunities present themselves, we intend to acquire businesses, technologies, platforms, services, or products that we believe are strategic. We currently have no understandings, commitments or agreements with respect to any material acquisition and no material acquisition is currently being pursued. There can be no assurance that we will be able to identify, negotiate or finance future acquisitions successfully, or to integrate such acquisitions with our current business. The process of integrating an acquired business, technology, service or product into the Company may result in unforeseen operating difficulties and expenditures and may absorb significant management attention that would otherwise be available for ongoing development of the Company’s business. Future acquisitions could result in potentially dilutive issuances of equity securities, the incurrence of debt, contingent liabilities and/or amortization expenses related to goodwill and other intangible assets, which could materially adversely affect our business, results of operations and financial condition. Any such future acquisitions of other businesses, technologies, services or products might require us to obtain additional equity or debt financing, which might not be available on terms favorable to us, or at all, and such financing, if available, might be dilutive.

We will rely on third parties for the manufacturing of our clinical drug supplies, and we may face various risks and uncertainties based on our dependence on these manufacturers, which may impair the development of our drug candidates.

We have no ability to internally manufacture the drug candidates that we need to conduct our clinical trials for the products that we acquire. For the foreseeable future, we expect to continue to rely on third-party manufacturers and other third parties to produce, package and store sufficient quantities of our drug candidates and any future drug candidates for use in our clinical trials. We may face various risks and uncertainties in connection with our reliance on third-party manufacturers, including:

Phyto-N may be complicated and expensive to manufacture. If our third-party manufacturers fail to deliver our drug candidates for clinical use on a timely basis, with sufficient quality, and at commercially reasonable prices, we may be required to delay or suspend clinical trials or otherwise discontinue development of our drug candidates. While we may be able to identify replacement third-party manufacturers or develop our own manufacturing capabilities for these drug candidates, this process would likely cause a delay in the availability of our drug candidates and an increase in costs. In addition, third-party manufacturers may have a limited number of facilities in which our drug candidates can be manufactured, and any interruption of the operation of those facilities due to events such as equipment malfunction or failure or damage to the facility by natural disasters could result in the cancellation of shipments, loss of product in the manufacturing process or a shortfall in available drug candidates.

We rely on the performance of highly skilled personnel, and if we are unable to attract, retain and motivate well-qualified employees, our business could be harmed.

We are, and will be, heavily dependent on the skill, acumen and services of our management and other employees. Our future success depends on our continuing ability to attract, develop, motivate and retain highly qualified and skilled employees. Qualified individuals are in high demand, and we may incur significant costs to attract them. In addition, the loss of any of our senior management or key employees could materially adversely affect our ability to execute our business plan, and we may not be able to find adequate replacements. All of our officers and. employees are at-will employees, which means they may terminate their employment relationship with us at any time, and their knowledge of our business and industry would be extremely difficult to replace. We cannot ensure that we will be able to retain the services of any members of our senior management or other key employees. If we do not succeed in attracting well-qualified employees or retaining and motivating existing employees, our business could be harmed.

We may become a party to various legal proceedings, which could have a material adverse effect on our business, financial condition or results of operations.

The Company and/or its directors and officers may be subject to a variety of civil or other legal proceedings, with or without merit. From time to time in the ordinary course of its business, we may become involved in various legal proceedings, including commercial, employment and other litigation and claims, as well as governmental and other regulatory investigations and proceedings. Such matters can be time-consuming, divert management’s attention and resources and cause us to incur significant expenses. Furthermore, because litigation is inherently unpredictable, the results of any such actions may have a material adverse effect on our business, operating results or financial condition.

Even if the claims are without merit, the costs associated with defending these types of claims may be substantial, both in terms of time, money, and management distraction. In particular, patent and other intellectual property litigation may be protracted and expensive, and the results are difficult to predict and may require us to stop offering certain features, purchase licenses or modify our products and features while we develop non-infringing substitutes or may result in significant settlement costs. We do not own any patents, and, therefore, may be unable to deter competitors or others from pursuing patent or other intellectual property infringement claims against us.

The results of litigation and claims to which we may be subject cannot be predicted with certainty. Even if these matters do not result in litigation or are resolved in our favor or without significant cash settlements, these matters, and the time and resources necessary to litigate or resolve them, could harm our business, results or operations and reputation.

Risks Related to the Regulation of Our Business and Products

Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical study process. The results of pre-clinical studies and early clinical studies, if any are commenced, of our product candidates may not be predictive of the results of later-stage clinical studies. Product candidates that have shown promising results in early-stage clinical studies may still suffer significant setbacks in subsequent advanced clinical studies. There is a high failure rate for drugs proceeding through clinical studies, and product candidates in later stages of clinical studies may fail to show the desired safety and efficacy traits despite having progressed satisfactorily through preclinical studies and initial clinical studies. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical studies due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier studies. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses. We do not know whether any Phase I, Phase II, Phase III (if any) or other clinical studies we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain regulatory approval to market our product candidates.

The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.

The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable, typically takes many years following the commencement of clinical studies and depends upon numerous factors. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. We have not obtained regulatory approval for any product candidate, including Phyto-N, and it is possible that our lead candidate, Phyto-N, or any product candidates we may seek to develop in the future will not ever obtain regulatory approval.

Applications for Phyto-N and our additional product candidates could fail to receive regulatory approval for many reasons, including but not limited to the following:

We are heavily dependent on the success of Phyto-N, our lead product candidate, Phyto-N. We cannot give any assurance that Phyto-N will proceed to clinical development or that it will receive regulatory approval, which is necessary before we can commercialize it.

We have not submitted marketing applications to the FDA or comparable foreign regulatory authorities. We cannot be certain that our lead product candidate, Phyto-N or any other of our product candidates will be successful in clinical studies or receive regulatory approval or what regulatory pathway the regulatory authorities shall designate for our product candidates. Further, our product candidates may not receive regulatory approval even if they are successful in clinical studies. If we do not receive regulatory approvals for our product candidates, we may not be able to continue our operations.

We plan to seek regulatory approval to commercialize Phyto-N in the United States and foreign countries. To obtain regulatory approvals we must comply with the numerous and varying regulatory requirements of such countries regarding safety, efficacy, chemistry, manufacturing and controls, clinical studies, commercial sales, pricing and distribution of our product candidates. Even if we are successful in obtaining approval in one jurisdiction, we cannot ensure that we will obtain approval in any other jurisdiction. If we are unable to obtain approval for our product candidates in multiple jurisdictions, our revenue and results of operations would be negatively affected.

The development and approval process for botanical drugs involves unique challenges and regulatory considerations that may result in additional costs, delays, or failure to obtain regulatory approval.

As a company focused on developing botanical drugs, we face specific challenges that are distinct from those encountered in conventional drug development. These include:

These factors may result in a more complex and potentially longer regulatory review process, additional costs, and a higher risk of regulatory delays or rejections compared to conventional drug development. The FDA’s approach to botanical drugs, while acknowledging their unique characteristics, still requires rigorous evidence of safety and efficacy. As of 2024, only two (2) botanical drugs have received FDA approval, such as Veregen® (sinecatechins), a green tea extract for the treatment of genital and perianal warts, and Fulyzaq®/Mytesi® (crofelemer), derived from the Croton lechleri tree, for managing diarrhea in HIV/AIDS patients on antiretroviral therapy. This limited number of approvals highlights both the innovative nature of our approach and the potential challenges in obtaining regulatory approval. If we fail to adequately address these botanical-specific challenges, it could significantly impact our ability to obtain regulatory approval for our product candidates and adversely affect our business, financial condition, and results of operations.

We may encounter substantial delays in our clinical studies, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies to demonstrate the safety and efficacy of the product candidates in humans. Clinical testing is expensive, time consuming and uncertain as to the outcome. We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical studies can occur at any stage of testing, and our future clinical studies may not be successful. Events that may prevent successful or timely completion of clinical development include but are not limited to:

Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue. We may also be required to conduct additional safety, efficacy and comparability studies before we will be allowed to start clinical studies with our repurposed drugs. Clinical study delays could also shorten any periods during which our product candidates have patent protection and may allow our competitors to bring product candidates to market before we do, which could impair our ability to obtain orphan exclusivity and successfully commercialize our product candidates and may harm our business and results of operations.

We face risks related to compliance with corporate governance laws and financial reporting standards.

We also expect that there will continue to be new laws, regulations and industry standards concerning privacy, data protection and information security proposed and enacted in various jurisdictions. Any failure or perceived failure by us to comply with our posted privacy policies, our privacy-related obligations to users or other third parties or any other legal obligations or regulatory requirements relating to privacy, data protection or information security may result in governmental investigations or enforcement actions, litigation, claims or public statements against us by consumer advocacy groups or others and could result in significant liability, cause our users to lose trust in us and otherwise have an adverse effect on our reputation and business. Furthermore, the costs of compliance with, and other burdens imposed by, the laws, regulations and policies that are applicable to the businesses of our users may limit the adoption and use of, and reduce the overall demand for, our platform.

Additionally, if third parties we work with violate applicable laws, regulations or agreements, such violations may put our users’ data at risk, could result in governmental investigations or enforcement actions, fines, litigation, claims or public statements against us by consumer advocacy groups or others and could result in significant liability, cause our users to lose trust in us and otherwise have an adverse effect on our reputation and business. Further, public scrutiny of or complaints about technology companies or their data handling or data protection practices, even if unrelated to our business, industry or operations, may lead to increased scrutiny of technology companies, including us, and may cause government agencies to enact additional regulatory requirements, or to modify their enforcement or investigation activities, which may increase our costs and risks.

We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.

Significant disruptions to our information technology systems or breaches of information security could adversely affect our business. In the ordinary course of business, we may collect, store and transmit large amounts of confidential information, and it is critical that we do so in a secure manner to maintain the confidentiality and integrity of such information. We have also outsourced significant elements of our information technology infrastructure; as a result, we manage independent vendor relationships with third parties who are responsible for maintaining significant elements of our information technology systems and infrastructure and who may or could have access to our confidential information. The size and complexity of our information technology systems, and those of our third-party vendors, make such systems potentially vulnerable to service interruptions and security breaches from inadvertent or intentional actions by our employees, partners or vendors. These systems are also vulnerable to attacks by malicious third parties and may be susceptible to intentional or accidental physical damage to the infrastructure maintained by us or by third parties. Maintaining the secrecy of confidential, proprietary and/or trade secret information is important to our competitive business position. While we have taken steps to protect such information and have invested in systems and infrastructures to do so, there can be no guarantee that our efforts will prevent service interruptions or security breaches in our systems or the unauthorized or inadvertent wrongful use or disclosure of confidential information that could adversely affect our business operations or result in the loss, dissemination or misuse of critical or sensitive information. The increasing sophistication and frequency of cybersecurity threats, including targeted data breaches, ransomware attacks designed to encrypt our data for ransom and other malicious cyber activities, pose a significant risk to the integrity and confidentiality of our data systems. A breach our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse of trade secrets, proprietary information or other confidential information, whether as a result of theft, hacking, fraud, trickery or other forms of deception, or for any other cause, could enable others to produce competing products, use our proprietary technology or information, and/or adversely affect our business position. Further, any such interruption, security breach, loss or disclosure of confidential information could result in financial, legal, business and reputational harm to us and could have a material adverse effect on our business, financial position, results of operations and/or cash flow.

Geopolitical conditions, including trade disputes and direct or indirect acts of war or terrorism, could have an adverse effect on our operations and financial results.

Our operations could be disrupted by geopolitical conditions, political and social instability, acts of war, terrorist activity or other similar events. In February 2022, Russia initiated significant military action against Ukraine. In response, the U.S. and certain other countries imposed significant sanctions and export controls against Russia, Belarus and certain individuals and entities connected to Russian or Belarusian political, business, and financial organizations, and the U.S. and certain other countries could impose further sanctions, trade restrictions, and other retaliatory actions should the conflict continue or worsen. It is not possible to predict the broader consequences of the conflict, including related geopolitical tensions, and the measures and retaliatory actions taken by the U.S. and other countries in respect thereof as well as any counter measures or retaliatory actions by Russia or Belarus in response, including, for example, potential cyberattacks or the disruption of energy exports, is likely to cause regional instability, geopolitical shifts, and could materially adversely affect global trade, currency exchange rates, regional economies and the global economy. In addition, the ongoing conflicts in the Middle East may further impact global economic conditions and market sentiments. This, in turn, could adversely affect the trading price of our shares of Common Stock and investor interest in us. The outcome of the Russia-Ukraine war and conflicts in the Middle East remain uncertain, and while it is difficult to predict the impact of any of the foregoing, the conflict and actions taken in response to the conflict could increase our costs, disrupt our supply chain, reduce our sales and earnings, impair our ability to raise additional capital when needed on acceptable terms, if at all, or otherwise adversely affect our business, financial condition, and results of operations.

Inflation may adversely affect our operations and financial results.

In periods of rising inflation, the cost of raw materials, components and labor essential for manufacturing our products may increase and as a consequence, our overall profit margin may be adversely affected.

Risks Relating to Ownership of Our Securities.

There is no active public trading market for our Common Stock and we cannot assure you that an active trading market will develop in the near future.

Our Common Stock is not quoted in the over-the-counter markets and is not listed on any stock exchange and there is currently no active trading in our securities. We will apply to have our Common Stock listed on The Nasdaq Capital Market under the symbol “CURX” which listing is a condition to this Offering. We cannot assure you that an active trading market for our Common Stock will develop in the future due to a number of factors, including the fact that we are a small company that is relatively unknown to stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable. We cannot give you any assurance that an active public trading market for our Common Stock will develop or be sustained. You may not be able to liquidate your shares quickly or at the market price if trading in our common stock is not active.

The price of our Common Stock may rapidly fluctuate or may decline regardless of our operating performance, resulting in substantial losses for investors.

The initial public offering price for the Shares in this Offering will be determined by negotiations between us and the underwriters and may not be indicative of prices that will prevail in the open market following this Offering. We anticipate that our initial public offering price will be between $4.00 and $6.00 per share. Given the small size of the offering and the anticipated public float, the trading price of our Common stock following this Offering may be subject to instances of extreme stock price run-ups followed by rapid price declines and stock price volatility unrelated to both our actual and expected operating performance and financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our stock. Additional factors that may contribute to high volatility of our Common Stock, many of which are beyond our control, include limited trading volume, actual or anticipated fluctuations in our results of operations; the financial projections we may provide to the public, any changes in these projections or our failure to meet these projections; failure of securities analysts to initiate or maintain coverage of our Company, changes in financial estimates or ratings by any securities analysts who follow our Company or our failure to meet these estimates or the expectations of investors; announcements by us or our competitors of significant innovations, acquisitions, strategic partnerships, joint ventures, operating results or capital commitments; changes in operating performance and stock market valuations of other companies in our industry; price and volume fluctuations in the overall stock market, including as a result of trends in the economy as a whole. As such, it may make it difficult for prospective investors to assess the value of our securities. The market price of our common stock may also decline below the initial offering price, and you may not be able to sell your shares of our Common Stock at or above the price you paid in the offering, or at all.

A possible “short squeeze” due to a sudden increase in demand of our Common Stock that largely exceeds supply may lead to price volatility in our Common Stock.

Following this Offering, investors may purchase our Common Stock to hedge existing exposure in our Common Stock or to speculate on the price of our Common Stock. Speculation on the price of our Common Stock may involve long and short exposures. To the extent aggregate short exposure exceeds the number of shares of our Common Stock available for purchase in the open market, investors with short exposure may have to pay a premium to repurchase our Common Stock for delivery to lenders of our Common Stock. Those repurchases may in turn dramatically increase the price of our Common Stock until investors with short exposure are able to purchase additional shares of Common Stock to cover their short position. This is often referred to as a “short squeeze.” A short squeeze could lead to volatile price movements in our Common Stock that are not directly correlated to the performance or prospects of our Company and once investors purchase the shares of Common Stock necessary to cover their short position the price of our Common Stock may decline.

Future sales of our Common Stock, or the perception that such sales may occur, may depress our share price, and any additional capital through the sale of equity or convertible securities may dilute your ownership in us.

We may in the future issue our previously authorized and unissued securities. We are authorized to issue 475,000,000 shares of Common Stock and 25,000,000 shares of blank check preferred stock with such designations, preferences and rights as determined by our Board. As of the date of this prospectus, we designed and issued 1,000,000 shares of Series A Preferred Stock. The potential issuance of additional shares of Common Stock and other series of preferred stock could result in the dilution of the ownership interests of the holders of our securities and may create downward pressure on the trading price, if any, of our Common Stock. The registration rights of certain of our stockholders and the sales of substantial amounts of our Common Stock following the effectiveness of the registration statement of which this prospectus is a part or other effective registration statements of the Company, or the perception that these sales may occur, could cause the market price of our Common Stock to decline and impair our ability to raise capital. These shares also may be sold pursuant to Rule 144 under the Securities Act, depending on their holding period and subject to restrictions in the case of shares held by persons deemed to be our affiliates. We also may grant additional registration rights in connection with any future issuance of our capital stock.

Our founders will continue to own a significant percentage of our Common Stock and our Series A Preferred Stock and will be able to exert significant control over matters subject to shareholder approval.

Our founders, Dian Ying Jing and Chang Liu, together with our Chief Executive Officer and President, Jun Liu, all of whom are members of the same family, beneficially own approximately 80% of the outstanding shares of Common Stock. They also beneficially own 100% of Series A Preferred Stock that provide them with 40% of the voting power of our equity voting stock. Upon the closing of this Offering, they will beneficially own approximately 73.9% of the voting power of our outstanding voting stock, or approximately 73.0% if the underwriter exercises its option to purchase additional shares of Common Stock from us in full. Therefore, even after this Offering, they will have the ability to substantially influence us through this ownership position. For example, they may be able to significantly influence elections of directors, amendments of our organizational documents or approval of any merger, sale of assets or other major corporate transaction. Their interests may not always coincide with our corporate interests or the interests of other shareholders, and he may act in a manner with which you may not agree or that may not be in the best interests of our other shareholders. So long as they continue to own a significant amount of our equity, they will continue to be able to strongly influence or effectively control our decisions.

The requirements of being a public company.

As a public company, we will be subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, or the “Exchange Act,” the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act and other applicable securities rules and regulations. Compliance with these rules and regulations will increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on our systems and resources. The Exchange Act requires, among other things, that we file annual, quarterly and current reports with respect to our business and operating results. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. In order to maintain and, if required, improve our disclosure controls and procedures and internal control over financial reporting to meet this standard, significant resources and management oversight may be required. As a result, management’s attention may be diverted from other business concerns, which could harm our business and operating results. We may need to hire more employees in the future to comply with these requirements, which will increase our costs and expenses.

In addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time consuming. These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities. If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us and our business may be harmed.

We also expect that being a public company and these new rules and regulations will make it more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult for us to attract and retain qualified members of our board of directors, particularly to serve on our audit committee and compensation committee and qualified executive officers.

As a result of disclosure of information in this prospectus and in filings required of a public company, our business and financial condition will become more visible, which we believe may result in increased threatened or actual litigation, including by competitors and other third parties. If such claims are successful, our business and operating results could be harmed, and even if the claims do not result in litigation or are resolved in our favor, these claims, and the time and resources necessary to resolve them, could divert the resources of our management and harm our business and operating results.

We may not be able to satisfy the listing requirements of Nasdaq to maintain a listing of our Common Stock.

If our Common Stock is listed on Nasdaq, we must meet certain financial and liquidity criteria to maintain such listing. If we violate the maintenance requirements for continued listing of our Common Stock, our Common Stock may be delisted. In addition, our Board may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing. A delisting of our Common Stock from Nasdaq may materially impair our stockholders’ ability to buy and sell our Common Stock and could have an adverse effect on the market price of, and the efficiency of the trading market for, our Common Stock. In addition, the delisting of our Common Stock could significantly impair our ability to raise capital.

There was no public market for our Common Stock prior to this Offering, and an active market in which investors can resell their shares may not develop.

Prior to this Offering, there was no public market for our Common Stock. All investments in securities involve the risk of loss of capital. No guarantee or representation is made that an investor will receive a return of its capital. The value of our Common Stock can be adversely affected by a variety of factors, including development problems, regulatory issues, technical issues, commercial challenges, competition, legislation, government intervention, industry developments and trends, and general business and economic conditions. We cannot predict the extent to which an active market for our Common Stock will develop or be sustained after this Offering, or how the development of such a market might affect the market price of our Common Stock.

Our failure to maintain effective internal controls over financial reporting could have an adverse impact on us.

We are required to establish and maintain appropriate internal controls over financial reporting. Failure to establish those controls, or any failure of those controls once established, could adversely impact our public disclosures regarding our business, financial condition or results of operations. In addition, management’s assessment of internal controls over financial reporting may identify weaknesses and conditions that need to be addressed in our internal controls over financial reporting or other matters that may raise concerns for investors. Any actual or perceived weaknesses and conditions that need to be addressed in our internal control over financial reporting, disclosure of management’s assessment of our internal controls over financial reporting or disclosure of our public accounting firm’s attestation to or report on management’s assessment of our internal controls over financial reporting may have an adverse impact on the price of our Common Stock.

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. In addition, the design of a control system must reflect the fact that there are resource constraints and the benefit of controls must be relative to their costs. Because of the inherent limitations in all control systems, no system of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Further, controls can be circumvented by individual acts of some persons, by collusion of two or more persons, or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, control may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Because of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and may not be detected.

Our financial controls and procedures may not be sufficient to ensure timely and reliable reporting of financial information, which, as a public company, could materially harm our stock price.

We require significant financial resources to maintain our public reporting status. We cannot assure you that we will be able to maintain adequate resources to ensure that we will not have any future material weakness in our system of internal controls. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles in the United States of America. Our internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that could have a material effect on the financial statements.

Despite these controls, because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance of achieving their control objectives. Furthermore, smaller reporting companies like us face additional limitations. Smaller reporting companies employ fewer individuals and can find it difficult to employ resources for complicated transactions and effective risk management. Additionally, smaller reporting companies tend to utilize general accounting software packages that lack a rigorous set of software controls.

If we fail to have effective controls and procedures for financial reporting in place, we could be unable to provide timely and accurate financial information and be subject to investigation by the SEC and civil or criminal sanctions.

We must implement additional and expensive procedures and controls in order to grow our business and organization and to satisfy new reporting requirements, which will increase our costs and require additional management resources.

Upon becoming a fully public reporting company, we will be required to comply with the Sarbanes-Oxley Act and the related rules and regulations of the SEC, including the requirements that we maintain disclosure controls and procedures and adequate internal control over financial reporting. In the future, if our securities are listed on a national exchange, we may also be required to comply with marketplace rules and heightened corporate governance standards. Compliance with the Sarbanes-Oxley Act and other SEC and national exchange requirements will increase our costs and require additional management resources. We recently have begun upgrading our procedures and controls and will need to continue to implement additional procedures and controls as we grow our business and organization and to satisfy new reporting requirements. If we are unable to complete the required assessment as to the adequacy of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act or if we fail to maintain internal control over financial reporting, our ability to produce timely, accurate and reliable periodic financial statements could be impaired.

If we do not maintain adequate internal control over financial reporting, investors could lose confidence in the accuracy of our periodic reports filed under the Exchange Act. Additionally, our ability to obtain additional financing could be impaired or a lack of investor confidence in the reliability and accuracy of our public reporting could cause our stock price to decline.

We are an “emerging growth company” under the JOBS Act of 2012 and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we may take advantage of certain exemptions from various reporting requirements that are not applicable to other public companies that are not “emerging growth companies” including, but not limited to, not being required to comply with the auditor attestation requirements of section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. We cannot predict if investors will find our Common Stock less attractive because we may rely on these exemptions. If some investors find our Common Stock less attractive as a result, there may be a less active trading market for our Common Stock and our stock price may be more volatile.

In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933 (the “Securities Act”) for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We are choosing to take advantage of the extended transition period for complying with new or revised accounting standards. We will remain an “emerging growth company” until the last day of the fiscal year following the fifth anniversary of the date of the first sale of our Common Stock pursuant to an effective registration statement under the Securities Act, although we will lose that status sooner if our revenues exceed $1.235 billion, if we issue more than $1 billion in non-convertible debt in a three year period, or if the market value of our common stock that is held by non-affiliates exceeds $700 million as of the last day of our most recently completed second fiscal quarter.

Investors may be unable to compare our business with other companies in our industry if they believe that our financial accounting is not as transparent as other companies in our industry. If we are unable to raise additional capital as and when we need it, our financial condition and results of operations may be materially and adversely affected.

As a “controlled company” under the rules of Nasdaq, we may choose to exempt our Company from certain corporate governance requirements that could have an adverse effect on our public shareholders.

Upon the completion of this offering, our founders and the management will beneficially own voting stock that provides them with approximately 73.9% of the voting power of our voting stock (approximately 73.0% if the Over-allotment Option is exercised) and we will be a “controlled company” within the meaning of the listing rules of Nasdaq.

As long as our officers and directors, either individually or in the aggregate, own at least 50% of the voting power of our Company, we are a “controlled company” as defined under the listing rules of Nasdaq.

For so as we are a controlled company under that definition, we are permitted to elect to rely, and may rely, on certain exemptions from corporate governance rules, including:

We do not intend to rely on the “controlled company” exemption under the Nasdaq listing rules at this time, but we could elect to rely on this exemption in the future. If we elect to rely on the “controlled company” exemption, a majority of the members of our Board might not be independent directors and our nominating and corporate governance and compensation committees might not consist entirely of independent directors.

As a result, you will not have the same protection afforded to shareholders of companies that are subject to these corporate governance requirements.

We have not paid dividends in the past and do not expect to pay dividends in the future, and any return on investment may be limited to the value of our stock.

We have never paid cash dividends on our Common Stock and do not anticipate paying cash dividends on our Common Stock in the foreseeable future. We currently intend to retain any future earnings to support the development of our business and do not anticipate paying cash dividends in the foreseeable future. Our payment of any future dividends will be at the discretion of our Board after taking into account various factors, including, but not limited to, our financial condition, operating results, cash needs, growth plans and the terms of any credit agreements that we may be a party to at the time. In addition, our ability to pay dividends on our common stock may be limited by Nevada state law. Accordingly, investors must rely on sales of their Common Stock after price appreciation, which may never occur, as the only way to realize a return on their investment. Investors seeking cash dividends should not purchase our Common Stock.

We will indemnify and hold harmless our officers and directors to the maximum extent permitted by Nevada law.

Our bylaws provide that we will indemnify and hold harmless our officers and directors against claims arising from our activities to the fullest extent not prohibited by Nevada law. If we were called upon to perform under our indemnification agreement, then the portion of our assets expended for such purpose would reduce the amount otherwise available for our business.

Risks Related to this Offering

Our management will have broad discretion over the use of any net proceeds from this offering and you may not agree with how we use the proceeds, and the proceeds may not be invested successfully.

Our management will have broad discretion as to the use of any net proceeds from this offering and could use them for purposes other than those contemplated at the time of this offering and in ways that do not necessarily improve our results of operations or enhance the value of our Common Stock. Accordingly, you will be relying on the judgment of our management with regard to the use of any proceeds from this offering and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used appropriately. It is possible that the proceeds will be invested in a way that does not yield a favorable, or any, return for you.

If you purchase shares of Common Stock in this offering, you will incur immediate and substantial dilution in the book value of your common shares of Common Stock.

The initial public offering price is substantially higher than the pro forma as adjusted net tangible book value per share of our Common Stock. Investors purchasing shares of Common Stock, in this Offering will pay a price per share that substantially exceeds the pro forma as adjusted net tangible book value of our Common Stock. As a result, investors purchasing shares of Common Stock in this Offering will incur immediate dilution of $4.79 per share, based on an assumed initial public offering price of $5.00 per share, the midpoint of the estimated price range of $4.00 and $6.00 per share set forth on the cover page of this prospectus (assuming the over-allotment option is not exercised), and our as adjusted pro forma net tangible book value as of December 31, 2024. As a result of this dilution, investors purchasing shares of Common Stock may receive significantly less than the purchase price paid in this offering in the event of liquidation. See “Dilution” for additional information.

Investors in this Offering may experience future dilution as a result of future equity offerings.

In order to raise additional capital, we may in the future offer additional shares of our Common Stock or other securities convertible into or exchangeable for our Common Stock. Investors purchasing our shares or other securities in the future could have rights superior to existing common stockholders, and the price per share at which we sell additional shares of our Common Stock or other securities convertible into or exchangeable for our Common Stock in future transactions may be higher or lower than the price per share in this Offering.

Sales of a significant number of shares of our Common Stock in the public markets, or the perception that such sales could occur, could depress the market price of our Common Stock.

Sales of a substantial number of shares of our Common Stock in the public markets could depress the market price of our Common Stock and impair our ability to raise capital through the sale of additional equity securities. We cannot predict the effect that future sales of our Common Stock would have on the market price of our Common Stock.

Existing Shareholders may sell significant quantities of Common Stock.

Notwithstanding that certain officers and directors who are shareholders will sign lock-up agreements for a period of 180 days following the completion of this offering, they may have acquired their shares at a lower price than that of this Offering. Accordingly, they may be incentivized to sell all or part of their holdings as soon as any applicable transfer restrictions have ended and such sales could have a negative impact on the market price of our Common Stock.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

The trading market for our Common Stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. Several analysts may cover our stock. If one or more of those analysts downgraded our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. If one or more of these analysts cease coverage of our Company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.

IN ADDITION TO THE ABOVE RISKS, BUSINESSES ARE OFTEN SUBJECT TO RISKS NOT FORESEEN OR FULLY APPRECIATED BY MANAGEMENT. IN REVIEWING THIS FILING, POTENTIAL INVESTORS SHOULD KEEP IN MIND THAT OTHER POSSIBLE RISKS MAY ADVERSELY IMPACT THE COMPANY’S BUSINESS OPERATIONS AND THE VALUE OF THE COMPANY’S SECURITIES.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections entitled “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” but are also contained in this prospectus. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “aim,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” “target,” “seek” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained in this prospectus include, but are not limited to, statements about:

We caution you that the foregoing list may not contain all of the forward-looking statements made in this prospectus.

These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this prospectus, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain.

You should refer to the “Risk Factors” section of this prospectus for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this prospectus will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by federal securities law.

You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

Market data and certain industry data and forecasts used throughout this prospectus were obtained from internal company surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. To our knowledge, certain third-party industry data that includes projections for future periods does not take into account the effects of the worldwide coronavirus pandemic. Accordingly, those third-party projections may be overstated and should not be given undue weight. Forecasts are particularly likely to be inaccurate, especially over long periods of time. In addition, we do not necessarily know what assumptions regarding general economic growth were used in preparing the forecasts we cite. Statements as to our market position are based on the most currently available data. While we are not aware of any misstatements regarding the industry data presented in this prospectus, our estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under the heading “Risk Factors” in this prospectus.

USE OF PROCEEDS

We estimate that we will receive net proceeds of approximately $8,000,000 (or approximately $9,344,192 if the underwriters’ option to purchase additional shares is exercised in full) from the sale of the Common Stock offered by us in this offering, based on an assumed public offering price of $5.00 per share, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

Each $1.00 increase or decrease in the assumed initial public offering price of $5.00 per share would increase or decrease, as applicable, the net proceeds that we receive from this offering by approximately $1,840,000, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We will receive no proceeds from the sale of the Selling Stockholder Shares under the separate Resale Prospectus.

The primary purposes of this underwritten Offering are to advance the development of our lead product candidate, Phyto-N, for the treatment of ulcerative colitis and to create a public market for the Company’s shares of Common Stock for the benefit of all stockholders, retain talented employees by providing them with equity incentives and obtain additional capital. Based on our current plans and assumptions, we intend to use such amount of the net proceeds from this Offering as follows:

The foregoing information is an estimate only based on our current business plan. We estimate that it will require over $150 million to execute our full business plan through FDA approval and product launch.

We may find it necessary or advisable to re-allocate portions of the net proceeds reserved for one category to another, and we will have broad discretion in doing so. Pending these uses, we intend to invest the net proceeds of this Offering in a money market or other interest-bearing account. Our management will have broad discretion in the application of the net proceeds from this Offering and investors will be relying on the judgment of our management regarding the application of the proceeds.

MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS

Our Common Stock is not listed on any stock exchange or over-the-counter market or quotation system. There is currently no active trading market in our Common Stock. We submitted a listing application to have our Common Stock listed on The Nasdaq Capital Market under the symbol “CURX,” which listing is a condition to this offering. There can be no assurance that our listing application will be approved. For more information see the section “Risk Factors.”

As of February 14, 2025, 24,000,000 shares of our Common Stock were issued and outstanding and were held by 13 stockholders of record.

We also have outstanding as of the date of this prospectus:

Dividend Policy

We have not declared any cash dividends since inception and we do not anticipate paying any dividends in the foreseeable future. Instead, we anticipate that all of our earnings will be used to provide working capital, to support our operations, and to finance the growth and development of our business, including potentially the acquisition of, or investment in, businesses, technologies or products that complement our existing business. The payment of dividends is within the discretion of the Board and will depend on our earnings, capital requirements, financial condition, prospects, applicable Nevada law, which provides that dividends are only payable out of surplus or current net profits and other factors our board might deem relevant. There are no restrictions that currently limit our ability to pay dividends on our common stock other than those generally imposed by applicable state law.

Securities Authorized for Issuance under Equity Compensation Plan

Currently, we do not have any equity compensation plan. We are planning to adopt an equity compensation plan immediately after the Offering and we will set aside 15% of the outstanding share capital upon the closing of this Offering for employee stock option plan for our key management and staff.

CAPITALIZATION

The following table sets forth our cash and capitalization, as of December 31, 2024, adjusted to reflect the 3-for-5 reverse stock split of our Common Stock, which became effective on November 19, 2024. As of December 31, 2024, we had 24,000,000 shares of Common Stock issued and outstanding (adjusted from, 40,000,000 shares prior to the reverse split), of which our Chief Executive Officer and Chairman, and the members of his immediate family, have beneficial ownership of 80%.

We also had 1,000,000 shares of Series A Preferred Stock, which remains unchanged. The shares of Series A Preferred Stock entitle the holders thereof 40% of the total voting power, but they do not entitle the holders to any dividend, liquidation, conversion or redemption rights. For more information regarding our securities please refer to “Market for Common Equity and Related Stockholder Matters” and “Description of Securities.”

Such information is set forth on the following basis:

You should read the following table in conjunction with “Use of Proceeds,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes included in this prospectus.

The as adjusted information set forth below is illustrative only and will be adjusted based on the reverse split, the actual public offering price and other terms of this offering determined at pricing.

Our capitalization following the completion of this Offering will be adjusted based on the actual initial public offering price and other terms of this offering determined at the pricing of this offering. You should read the information in this table together with our financial statements and the related notes appearing at the end of this prospectus and the sections titled “Use of Proceeds” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

DILUTION

Purchasers of our Common Stock in this offering will experience an immediate and substantial dilution in the as adjusted net tangible book value of their shares of Common Stock, adjusted for the 3-for-5 reverse stock split on November 19, 2024. Dilution in as adjusted net tangible book value represents the difference between the public offering price per share and the as adjusted net tangible book value per share of our Common Stock immediately after the offering.

The historical net tangible book value of our Common Stock as of December 31, 2024 was $565,847, or approximately $0.0236 per share, adjusted for the reverse stock split. Historical net tangible book value per share of our Common Stock represents our total tangible assets (total assets less net intangible assets) less total liabilities divided by the number of shares of Common Stock outstanding as of that date.

Assuming the over-allotment option is not exercised, after giving effect to the issuance of 2,000,000 Shares in this offering at an assumed initial public offering price of $5.00 per share, and adjusting for the reverse stock split, resulting in the net proceeds of approximately $7,964,192, our as adjusted net tangible book value as of December 31, 2024, would have been approximately $8,530,039 or $0.3281 per share of our Common Stock. This represents an immediate increase in historical net tangible book value of $0.3045 per share and an immediate dilution of $4.6719 per share to the new investors purchasing shares in the offering.

Each $1.00 increase or decrease in the assumed initial public offering price of $5.00 per share would increase or decrease, as applicable, the net proceeds that we receive from this offering would increase or decrease by approximately $1,840,000, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The following table illustrates this per share dilution to new investors:

After completion of this offering, and assuming that the underwriters do not exercise their over-allotment option, our existing stockholders would own approximately 92.31% and our new investors would own approximately 7.69% of the total number of shares of our Common Stock outstanding after this Offering.

In addition, we may choose to raise additional capital due to market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities may result in further dilution to our stockholders.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the information presented in our historical financial statements and the related notes included elsewhere in this prospectus. In addition to historical information, the following discussion contains forward-looking statements, such as statements regarding our expectation for future performance, liquidity and capital resources, that involve risks, uncertainties and assumptions that could cause actual results to differ materially from our expectations. Our actual results may differ materially from those contained in or implied by any forward-looking statements. Factors that could cause such differences include those identified below and those described in “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors.” We assume no obligation to update any of these forward-looking statements.

Overview and Recent Development

Curanex was incorporated on June 1, 2018 as a New York corporation under the name “Durand Damiel Health Inc, focusing on research and development (R&D) of health products and botanical medicines. On October 24, 2023, the Company changed its name to “Fordman Pharma Inc.,” and on November 9, 2023, the Company changed its name to Curanex Pharmaceuticals Inc and changed the focus of its business operations on discovering, developing, and commercializing innovative botanical drugs for major unmet needs to treat patients suffering from inflammatory diseases.

Our business strategy is centered on developing innovative botanical drugs, with a focus on Phyto-N as our lead candidate, for the treatment of inflammatory diseases. By leveraging our founders’ expertise in botanical medicine, pursuing strategic partnerships, implementing efficient development processes, building a strong IP portfolio, fostering a culture of innovation, and maintaining focus and adaptability, we aim to establish Curanex as a leader in the field and create significant value for patients as well as our shareholders.

Reincorporation

On June 10, 2024, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Curanex Pharmaceuticals Inc, a newly formed Nevada corporation and our wholly owned subsidiary of the Company (the “Surviving Corporation”), pursuant to which, on the same date, we, as parent in this transaction, merged with and into the Surviving Corporation (the “Reincorporation”). Upon the consummation of the Reincorporation, we ceased our legal existence as a New York corporation, and the Surviving Corporation continued our business as the surviving corporation in the Reincorporation under the name “Curanex Pharmaceuticals Inc” succeeding all our rights, assets, liabilities and obligations, except that our affairs ceased to be governed by the New York Business Corporation Law and became subject to the Nevada Revised Statutes (“NRS”).

Asset Purchase Agreement

On June 17, 2024, we entered into the Asset Purchase Agreement with Duraviva, a related entity in which our Chief Executive Officer and President and members of his immediate family, including our Secretary, are also directors, officers and majority shareholders. At the Closing, occurred on the same date, Duraviva transferred to us all of its IP Assets, which together with $730,000 consideration, constitute all or substantially all of the assets of Duraviva. The IP Assets include four (4) provisional patent applications and 8 research and development animal study reports for:

1. Ulcerative Colitis

2. Atopic Dermatitis

3. Nonalcoholic fatty liver disease prevention

4. Nonalcoholic fatty liver disease treatment

5. Diabetes

6. COVID-19 prevention and treatment

7. Gouty nephritis

8. Gouty arthritis

Reverse Stock Split

On November 19, 2024, our Board and our stockholders approved an amendment to our amended and restated articles of incorporation (the “Amendment”) to effect a reverse stock split of the outstanding shares of the Common Stock, at a ratio of three-for-five (3-for-5) (the “Reverse Stock Split”). The Amendment became effective on the same date, upon filing of the Amendment with the Secretary of State of the State of Nevada. As a result of the Reverse Stock Split, every five (5) shares of our issued and outstanding Common Stock, automatically and without any action of the Company or any holder thereof, were combined into three (3) validly issued and non-assessable shares of Common Stock, resulting in 24,000,000 post Reverse Stock Split shares of Common Stock. No fractional shares were issued to any stockholder of the Company, and in lieu of issuing any such fractional shares, any fractional shares resulting from the Reverse Stock Split, if applicable, will be rounded up to the nearest whole share of Common Stock. Proportionate adjustments will be made to the exercise prices and the number of shares underlying the Company’s outstanding equity awards, convertible notes, and warrants, as applicable. The shares of Common Stock as adjusted to the Reverse Stock Split will remain fully paid and non-assessable. The Reverse Stock Split will not affect the number of authorized shares of Common Stock or the par value of the Common Stock nor will it change the authorized shares of preferred stock or the relative voting power of holders of the outstanding Common Stock.

Promissory Note issued to Dian Ying Jing.

On February 4, 2025, the Company received a loan in the amount of $200,000 from Dian Ying Jing, one of our founders, Secretary and the wife of our Chief Executive Officer, Jun Liu. To evidence this loan, on February 4, 2025, the Company issued Ms. Jing a promissory note in the principal amount of $200,000, with a maturity date of February 4, 2026 (the “Note”). Interest on the Note will accrue on the principal amount at the rate of four and thirty-four percent (4.34%) per annum, and shall be paid on the maturity date. The Company may prepay any amounts due under the Note without penalty or premium.

Results of Operations

Comparison of Results of Operations for the Fiscal Years Ended December 31, 2024, and 2023

Revenue and Cost of Sales

We did not generate any revenue during the fiscal year ended December 31, 2024, or 2023. The absence of revenue is due to our continued focus on our strategic transition towards discovering, developing, and commercializing innovative botanical drugs for treating inflammatory diseases.

If our product candidates successfully progress through development and obtain regulatory approval or if we secure license agreements with third parties, we may generate revenue from product sales or licensing income. However, there is no guarantee as to when, or if, we will achieve these revenue streams.

Operating Expenses

General and Administrative Expenses

General and administrative expenses for the fiscal year ended December 31, 2024, totaled $290,386, a significant increase from $19,298 in the prior year. The increase was primarily driven by legal and accounting costs related to our S-1 registration filing and public company readiness efforts, as well as expenses associated with the Curanex-Duraviva asset acquisition and corporate reorganization.

Impairment Charge

During 2024, we recorded a $74,676 impairment charge related to legal fees incurred for the filing of four provisional patent applications. These applications are set to expire in March 2025, and we intend to pursue a Patent Cooperation Treaty (PCT) application in 2025 to secure broader international protection.

Net Loss

As a result of the above factors, we reported a net loss of $(361,506) for the fiscal year ended December 31, 2024, compared to a net loss of $(19,198) for the fiscal year ended December 31, 2023. The higher net loss was primarily driven by increased G&A, IPO-related costs, and the impairment charge.

Liquidity and Capital Resources

As of December 31, 2024, we had cash and cash equivalents totaling $148,891, compared to $74,336 as of December 31, 2023. The substantial increase was driven by $730,000 we received from Duraviva in connection with the Asset Purchase Agreement which strengthened our balance sheet and positioned us for future R&D investments.

On February 4, 2025, we received a loan in the amount of $200,000 from Dian Ying Jing, our Secretary, and the wife of our Chief Executive Officer. The loan is documented by a promissory note with an annual interest rate of 4.34%, payable on its maturity date of February 4, 2026. The Company may prepay any outstanding amounts under the Note at any time without penalty or premium.

Given our current cash position and anticipated IPO proceeds, we believe we have sufficient capital to fund operations through at least the next twelve months. However, our long-term liquidity will depend on our ability to secure additional financing through the IPO and strategic partnerships.

Going Concern Considerations

We have yet to achieve profitability and anticipate continued operating losses in the near term. The accompanying financial statements include a going concern disclosure due to our historical losses, negative cash flows from operations, and reliance on external financing. However, management believes that substantial doubt regarding our ability to continue as a going concern has been alleviated. This conclusion is based on our strong cash position, recent financing activities, anticipated IPO proceeds, and support from shareholders, which collectively support our ability to continue operations for the foreseeable future.

Cash Flows

Operating Activities

Net cash used in operating activities was $(555,575) for the year ended December 31, 2024, compared to $(120) in 2023. The increase was primarily due to higher R&D spending and IPO-related expenses.

Financing Activities

Net cash provided by financing activities amounted to $630,100 for the year ended December 31, 2024, primarily driven by proceeds from equity issuances and capital contributions.

Contractual Obligations and Contingencies

On October 3, 2024, we entered into an agreement with Revere Securities for underwriting services related to our IPO. Upon completion of the offering, we will be required to pay a success-based fee, consisting of:

As of December 31, 2024, no amounts related to these contingency fees have been recognized in our financial statements.

SEC Compliance Considerations

As a company pursuing an IPO under SEC regulations, we have made adjustments to enhance our disclosures in accordance with SEC guidance. Key highlights include:

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements as of December 31, 2024.

Emerging Growth Company and Smaller Reporting Company Status

We operate as an emerging growth company (EGC) under the JOBS Act, allowing us to delay the adoption of new or revised accounting standards. Additionally, we qualify as a smaller reporting company (SRC) under SEC regulations, enabling us to provide scaled disclosures to streamline our reporting process.

Critical Accounting Policies and Estimates

Our financial statements are prepared in accordance with U.S. GAAP and require management to make significant judgments and estimates. Key areas include:

Conclusion

Our strategic transition towards botanical drug development, combined with our ongoing IPO efforts, marks a significant phase in our corporate growth. We remain focused on advancing our lead drug candidates, securing regulatory approvals, and optimizing capital allocation to drive shareholder value.

BUSINESS

Overview.

We are a developmental stage pharmaceutical company dedicated to discovering, developing and commercializing innovative botanical drugs to treat patients suffering from inflammatory diseases. Our mission is to address significant unmet medical needs and to improve patients’ lives by harnessing the power of natural substances. We are dedicated to discovering, developing and commercializing botanical medicines for treating patients with immune and inflammatory diseases and to develop therapies that may offer potential benefits to patients with unmet clinical needs in various fields, such as autoimmune diseases, metabolic diseases and viral infections. We are committed to “Bringing hope and healing through the wisdom of plants.”

Opportunities and Challenges in the Pharmaceutical Industry for Botanical Drugs

Market Overview

The global market for inflammatory disease treatments is rapidly growing, driven by increasing prevalence, unmet medical needs, and the limitations of current therapies. The botanical and plant-derived drugs market includes pharmaceuticals, nutraceuticals, and herbal remedies derived from botanical sources, plants, and natural compounds for therapeutic purposes. These drugs may include herbal extracts, phytochemicals, traditional medicines, and plant-based supplements used in managing various health conditions and promoting wellness. With over 100 types of inflammatory diseases affecting various organ systems and requiring long-term or lifelong treatment, there is a significant demand for innovative solutions that can provide efficacy, safety, and better quality of life for patients. Traditional anti-inflammatory drugs, primarily chemical compounds, often have limited efficacy and severe side effects. In contrast, botanical drugs with their multi-target mechanisms may represent a promising new frontier in the treatment of inflammatory diseases, with enormous market potential.

According to the “In-depth Market Research Report on the Global Phytomedicine Industry 2022-2026” released by the New Vision Industry Research Center, the market for phytomedicine and its active ingredients has been expanding rapidly, reaching approximately 34 billion USD, as consumer preferences shift towards natural and holistic health solutions. In summary, the botanical and plant-derived drugs market offers substantial growth potential, driven by consumer preferences for natural therapies and increasing research efforts.

Market Opportunities for Phyto-N

Phyto-N, our lead product candidate, is a medicinal botanical plant with distinct chemical components and potentially a wide spectrum of therapeutic effects. We believe that Phyto-N has a potential ability to target multiple disease pathways and regulate various pathological processes, and if these efforts are successful and lead to regulatory approval of Phyto-N determined by clinical trials, will make it a “pipeline in a product” that will address unmet needs in complex and hard-to-treat conditions. Our preclinical research on Phyto-N has shown early positive results, as it indicated its potential anti-inflammatory, immunomodulatory, and tissue-protective properties, which have been observed through animal studies and which may have the potential to be used to treat autoimmune diseases, metabolic disorders, and viral infections, where current treatment options may fall short in terms of efficacy, safety, and durability of response.

Phyto-N has been used as an herbal medicine by traditional Chinese medicine practitioners to treat patients over the last 30 years in China and has been shown promising results in managing symptoms of certain inflammatory diseases, such as ulcerative colitis, with some patients experiencing extended periods of symptom relief. These promising results of Phyto-N, as demonstrated in animal disease models and its use in traditional Chinese medicine, have motivated us to undertake rigorous scientific research and clinical development to further evaluate its therapeutic potential. We are currently preparing for an IND application and planning clinical trials for Phyto-N. If these efforts are successful and lead to regulatory approval, we believe that Phyto-N will address diverse medical needs. However, Phyto-N has not received regulatory approval as a drug in any jurisdiction, including China, and drug development is a complex, lengthy, and uncertain process, and there can be no assurance of clinical or commercial success.

We acquired from Duraviva its research and development animal study reports, including preliminary safety study reports.

Duraviva previously evaluated Phyto-N’s therapeutic potential in animal models of six inflammatory diseases: ulcerative colitis, atopic dermatitis, gout, diabetes, nonalcoholic fatty liver disease (NAFLD), and COVID-19 at multiple institutes, including Rutgers University, which reports the Company acquired from Duraviva pursuant to the Asset Purchase Agreement. The preliminary safety studies, including single-dose and repeated-dose toxicity tests, have shown that Phyto-N does not exhibit any toxicity or side effects in experimental animals at the doses tested.

In addition to our focus on developing Phyto-N as a botanical drug, we are actively identifying and isolating the active chemical compounds responsible for its therapeutic effects. Our research is ongoing, and we anticipate that we will conclude our research prior to the filing of our IND application.

We believe that Phyto-N’s key competitive advantages include:

1. History of use in Chinese Traditional Medicine: Phyto-N’s history of human use in Chinese traditional medicine may provide an encouraging insight for multiple inflammatory diseases that may inform our clinical development process, though further rigorous studies are needed.

2. Potential multi-target mechanism of action: Phyto-N may modulate multiple inflammatory pathways simultaneously, potentially providing a more comprehensive treatment effect compared to single-target agents, with the potential to address complex disease pathologies and overcome treatment resistance.

3. Broad therapeutic potential: Phyto-N has shown effects in animal models across several inflammatory diseases, highlighting its versatility and potential to treat multiple indications with a single drug.

4. Potential for tolerability: Phyto-N’s botanical origin and potential multi-target mechanism may contribute to a favorable tolerability profile, and comprehensive clinical trials are needed to establish Phyto-N’s safety profile as a pharmaceutical product.

Development path of Phyto-N as a botanical drug.

The development of Phyto-N as a botanical drug presents both opportunities and challenges. As of the date of this prospectus, only two (2) botanical drugs have received FDA approval, such as Veregen® (sinecatechins), a green tea extract for the treatment of genital and perianal warts, and Fulyzaq®/Mytesi® (crofelemer), derived from the Croton lechleri tree, for managing diarrhea in HIV/AIDS patients on antiretroviral therapy. This highlights both the innovative nature of our approach and the potential challenges in obtaining regulatory approval.

Challenges:

While the traditional use of Phyto-N in Chinese traditional medicine is encouraging, we recognize that our development process must meet the FDA’s rigorous standards for safety and efficacy. This includes conducting comprehensive preclinical and clinical studies, potentially requiring more time and resources compared to the development of conventional single-molecule drugs. We believe that the potential benefits of Phyto-N as a multi-component botanical drug may justify this investment and could lead to a novel therapeutic option for patients with inflammatory diseases. However, there can be no assurance that our efforts will be successful or that Phyto-N will ultimately receive regulatory approval or be commercially viable.

Product Pipelines

Our drug development pipelines encompass seven various therapeutic areas: ulcerative colitis, atopic dermatitis, COVID-19, diabetes, NAFLD, gout, and acne.

1) Ulcerative colitis, a form of inflammatory bowel disease, is characterized by chronic nonspecific inflammation of the gastrointestinal tract. Standard care involves corticosteroids, immunomodulators, and biologic therapies targeting specific inflammatory pathways. Phyto-N is being developed as an orally administered alternative for patients with moderate to severe ulcerative colitis, aiming to address limitations of current treatments. These limitations include:

Upon the completion of the Offering, we are planning to conduct clinical trials, to explore whether Phyto-N will offer an alternative treatment approach for patients with moderate to severe ulcerative colitis.

2) Atopic Dermatitis is a common chronic inflammatory skin disease that significantly impacts patients’ quality of life. While current treatments include topical steroids, calcineurin inhibitors, and systemic immunosuppressants, many patients with moderate to severe atopic dermatitis experience inadequate disease control or frequent relapses. We are developing Phyto-N as a potential orally administered option for these patients.

3) COVID-19 is an acute respiratory illness caused by the novel coronavirus. Current treatments focus on supportive care and antiviral therapies such as remdesivir and monoclonal antibodies. Phyto-N presents a potential adjunctive therapy for COVID-19 with the convenience of oral administration.

4) Diabetes is a metabolic disorder characterized by impaired insulin secretion or function, leading to dysregulated carbohydrate, protein, and fat metabolism. Current treatments include metformin, insulin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, and other oral medications, but some patients experience inadequate glycemic control or adverse effects. Phyto-N offers an alternative approach to diabetes management, providing an orally administered option.

5) Nonalcoholic fatty liver disease (“NAFLD”) is a common liver condition characterized by hepatic steatosis, inflammation, and fibrosis. Current therapies focus on addressing metabolic comorbidities rather than directly targeting liver fat accumulation and inflammation. Phyto-N presents a potential therapeutic option for NAFLD, addressing its underlying pathophysiology and providing an orally administered alternative.

6) Gout is an inflammatory arthritis caused by the deposition of uric acid crystals in joints and surrounding tissues. Current treatments aim to reduce serum uric acid levels and prevent gout flares and complications. Phyto-N offers a potential alternative or adjunct therapy for gout management, addressing limitations of existing treatments.

7) Acne is a common skin condition that occurs when hair follicles become clogged with oil and dead skin cells with significant unmet medical needs. Current anti-acne treatments have limited efficacy and may cause adverse effects. Phyto-N offers a promising alternative for acne management, potentially addressing inflammation-related mechanisms implicated in its pathogenesis and providing an alternative oral option.

The market analysis and challenges of each core indicator is discussed below.

Market analysis of inflammatory bowel disease (IBD) treatment and the potential of Phyto-N

In general, IBD treatment market is expected to continue its steady growth, driven by the rising prevalence of the disease, the introduction of innovative therapies, and the increasing availability of healthcare services in developing regions (Source: Data Bridge Market Research, 2023). The global IBD treatment market was valued at around $26.7 billion in 2023 and is expected to grow at a CAGR of 6-7% from 2023 to 2034 and reach $50 billion by the end of 2034 (Source: Research and Market, 2024).

The IBD treatment market is segmented by disease type (Crohn’s disease, ulcerative colitis), drug class (biologics, immunomodulators, amino salicylates, corticosteroids), route of administration (oral, parenteral), and geography (Source: Global Market Insights, 2023). Biologics, such as anti-TNF agents (e.g. Remicade, Humira) and anti-integrin agents (e.g. Entyvio), account for the largest and fastest growing market share due to their higher efficacy and rapid uptake (Source: Coherent Market Insights, 2022). The ulcerative colitis segment holds a slightly larger market share (52%) compared to Crohn’s disease (48%), but Crohn’s disease is expected to see faster growth in the coming years (Source: Research and Markets, 2021). Opportunities exist in the development of new drug classes, personalized treatments, and improved diagnosis and monitoring techniques (Source: Emergen Research, 2022).

North America dominates the global IBD treatment market with a 48% share, with the United States being the largest contributor (Source: Mordor Intelligence, 2023). Europe holds 28% of the market share and is the second-largest market. The Asia-Pacific region accounts for 18% share currently but is expected to witness the fastest growth of 9-10% annually due to improving healthcare infrastructure and rising disease awareness (Source: Fortune Business Insights, 2022). The IBD treatment market is highly competitive, with the presence of both large pharmaceutical companies and smaller biotech firms (Source: Precedence Research, 2023). The key players include AbbVie, Janssen Biotech, Takeda Pharmaceutical, Pfizer, Merck, Novartis, and Boehringer Ingelheim (Source: Market Data Forecast, 2023). These companies are focusing on developing novel biologics, expanding their product portfolios, and investing in R&D to maintain their market share (Source: Roots Analysis, 2022).

Market Potential of Phyto-N for IBD

Phyto-N is not a monoclonal antibody drug and does not directly target specific cytokines. Instead, it may indirectly modulate inflammatory pathways, which could provide a wider therapeutic window compared to biologics. Preclinical studies suggest Phyto-N may modulate multiple inflammatory pathways like NF-kB, MAPK, JAK-STAT by acting on key regulators. This multi-target approach may provide a novel strategy for IBD treatments.

Our preclinical studies of Phyto-N in animal models of IBD have yielded promising results that we believe warrant further investigation. Details of these studies are presented in the “Research and Development” section under the Ulcerative Colitis heading. We have not conducted any clinical trials or received regulatory approval for Phyto-N in any country, including in Asia. Our future plan involves conducting clinical trials and seeking regulatory approvals in various markets, potentially including Asia, North America, and Europe, subject to regulatory requirements and strategic considerations.

While we believe there is a substantial opportunity in the IBD treatment market, our ability to capture any portion of this market is subject to numerous risks and uncertainties, including the successful completion of clinical trials, obtaining regulatory approvals, and effectively commercializing our product candidates.

Commercialization Challenges:

The challenges include: the development of biosimilars of the biologics, which may put pressure on pricing (Source: MarketsandMarkets, 2023); securing regulatory approvals for Phyto-N as an IBD treatment, especially in Western markets, requires comprehensive clinical trials to demonstrate safety and efficacy; establishing manufacturing, supply chain, and distribution capabilities on a global scale could be a significant challenge for a herbal product; educating healthcare providers and patients on the benefits of Phyto-N compared to existing IBD therapies would be crucial for market acceptance.

Market analysis of the Atopic Dermatitis (AD) treatment and the potential of Phyto-N

Market Size and Growth:

The global atopic dermatitis treatment market was valued at around $14.2 billion in 2022 and is expected to grow at a CAGR of 8-9% from 2023 to 2030 and reach 27.7 billion by the end of 2030 (Source: Research and Market, 2023). The AD treatment market is moderately competitive, with the presence of both large pharmaceutical companies and smaller biotechnology firms (Source: Precedence Research, 2023). Opportunities exist in the development of targeted therapies, combination treatments, and the expansion of the pipeline for severe AD (Source: Emergen Research, 2022). Overall, the AD treatment market is expected to continue its robust growth, driven by the increasing prevalence of the disease, the introduction of innovative therapies, and the growing emphasis on improving the quality of life for patients with AD (Source: Data Bridge Market Research, 2023).

The key drivers of market growth include the rising prevalence of AD, the launch of novel biologic therapies, increasing awareness and diagnosis rates, and the growing geriatric population (Source: Persistence Market Research, 2022). The AD treatment market is segmented by drug class (topical, oral, and injectable), severity (mild, moderate, and severe), and geography (Source: Global Market Insights, 2023). Topical therapies, such as corticosteroids and calcineurin inhibitors, account for the largest market share, but the injectable biologics segment is expected to grow the fastest (Source: Coherent Market Insights, 2022). The moderate-to-severe AD segment holds a significant market share, as this population requires more advanced and expensive treatments (Source: Research and Markets, 2021).

North America dominates the global AD treatment market, with the United States being the largest contributor (Source: Mordor Intelligence, 2023). Europe is the second-largest market, followed by the Asia-Pacific region, which is expected to witness the fastest growth due to improving healthcare infrastructure and increasing disease awareness (Source: Fortune Business Insights, 2022).

Market Potential of Phyto-N for AD treatment:

Atopic dermatitis is a chronic inflammatory skin condition with a high prevalence globally, representing a significant market opportunity for new treatments. Preliminary data from animal models suggests that Phyto-N may have the potential to improve atopic dermatitis symptoms, skin lesions, inflammation, and overall disease management. Details of these studies are presented in the “Research and Development” section under the AD heading. As a botanical drug candidate, Phyto-N could potentially be positioned as an alternative to current pharmaceutical treatments, which may appeal to patients interested in plant-based therapies.

Unlike targeted biologics like Dupilumab, which focus on specific receptors (e.g., IL-4Rα), Phyto-N appears to have a multi-target approach based on preclinical studies. The potential ability of Phyto-N to simultaneously target multiple inflammatory pathways and achieve anti-inflammatory effects could be advantageous if these effects are confirmed in human clinical trials.

Commercialization Challenges:

The challenges include: conducting comprehensive clinical trials to demonstrate the safety and efficacy of Phyto-N in human patients with atopic dermatitis would be crucial for regulatory approvals and market acceptance; establishing large-scale manufacturing, supply chain, and distribution capabilities for a herbal product may pose challenges compared to conventional pharmaceuticals; educating healthcare providers and patients about the benefits of Phyto-N over existing treatments would be necessary for market adoption.

Market analysis of COVID-19 treatment and the potential of Phyto-N.

Market Size and Growth

The global COVID-19 treatment market was valued at around $31 billion in 2021 and is expected to contract at a CAGR of -8.3% from 2022 to 2031 and reach more than $16 billion by the end of 2031 (Source: Transparency Market Research, 2023).

The key drivers of market growth include the ongoing need for effective COVID-19 treatments, the development of new therapeutic options, increased government funding for research and development, and the rising prevalence of COVID-19 globally (Source: Persistence Market Research, 2022). North America dominates the global COVID-19 treatment market, with the United States being the largest contributor (Source: Mordor Intelligence, 2023). Europe is the second-largest market, followed by the Asia-Pacific region, which is expected to witness the fastest growth due to the high prevalence of COVID-19 and increasing healthcare infrastructure (Source: Fortune Business Insights, 2022).

The COVID-19 treatment market is segmented by drug class (antivirals, monoclonal antibodies, steroids, and others), route of administration (oral, intravenous, and others), and geography (Source: Global Market Insights, 2023). Antiviral drugs, such as Remdesivir and Molnupiravir, currently hold the largest market share, but the monoclonal antibodies segment is expected to grow the fastest (Source: Coherent Market Insights, 2022). The oral route of administration is the most dominant, as it offers convenience and ease of use for patients (Source: Research and Markets, 2021).

Market Potential of Phyto-N for COVID-19 treatment:

The COVID-19 pandemic has created a massive global demand for effective preventive and therapeutic options against SARS-CoV-2 infection. Preliminary preclinical studies suggest Phyto-N may have the potential to reduce viral loads in various organs, inhibit inflammation, and potentially affect transmission, which warrants further investigation as a possible approach to COVID-19 management. Details of these studies are presented in the “Research and Development” section under the COVID-19 heading. As a natural herbal compound, Phyto-N may appeal to patients seeking complementary or alternative therapies, particularly in regions with the Chinese traditional medicine practices. However, it’s important to note that botanical drugs must meet the same rigorous safety and efficacy standards as conventional pharmaceuticals.

Preclinical studies have shown potential anti-inflammatory and immune-modulating effects, but these results need to be replicated in human clinical trials before any conclusions can be drawn about Phyto-N’s efficacy or potential advantages. If proven safe and effective in humans, Phyto-N might initially be considered in regions where botanical medicines are more commonly accepted. However, this would still require thorough clinical testing and regulatory approvals. Expansion into major markets would require extensive clinical trials and regulatory approvals, and there is no guarantee of success given the complex nature of botanical drug development and the evolving landscape of COVID-19 treatments.

Challenges:

The COVID-19 treatment market is highly competitive, with the presence of both large pharmaceutical companies and smaller biotechnology firms (Source: Precedence Research, 2023). It is crucial for regulatory approvals and market acceptance that we conduct comprehensive clinical trials to demonstrate the safety and efficacy of Phyto-N in preventing and treating COVID-19 in human. In addition, the supply chain, and distribution capabilities for an herbal product may pose challenges compared to conventional pharmaceuticals; educating healthcare providers and patients about the benefits of Phyto-N over existing COVID-19 treatments and preventive measures would be necessary for market adoption.

Market analysis for diabetes treatments and the potential of Phyto-N

The market for diabetes treatments is dynamic and robust, driven by the increasing prevalence of diabetes mellitus globally. With diabetes emerging as a significant public health concern due to lifestyle changes, aging populations, and rising obesity rates, the demand for effective treatment options continues to grow. This analysis delves into key market dynamics, trends, challenges, and opportunities shaping the diabetes treatment landscape.

Market Size and Growth

The global diabetes treatment market was valued at around $66 billion in 2023 and is projected to hit around USD 118 billion by 2032, growing at a CAGR of 6.67% during the forecast period 2023 to 2032. Diabetes affects 62 million people in the Americas, with the majority living in low- and middle-income countries. Diabetes is directly responsible for 284,049 deaths each year. (Source: Precedence Research, 2023).

Key growth drivers include the rising prevalence of diabetes globally, increasing obesity/sedentary lifestyles, aging populations, and demand for innovative therapies and disease management products (Source: International Diabetes Federation, 2021).

There are the following key market segments:

- By Diabetes Type: Type 1 Diabetes, Type 2 Diabetes (T2D accounts for over 90% market share, Source: Centers for Disease Control and Prevention, 2022)

- By Product Type: Insulin (human, analogs), Non-Insulin Injectables (GLP-1 agonists, Amylin analogs), Oral Antidiabetics, SGLT-2 Inhibitors, and Devices (insulin pumps, CGM, etc.) (Source: American Diabetes Association, 2023)

- Insulin and Insulin Analogs hold the largest revenue share currently

- Non-Insulin Injectables like GLP-1 agonists are the fastest-growing segment

North America dominates the market led by high treatment rates and adoption of advanced therapies in the US. Europe is the second-largest market driven by rising T2D prevalence with big pharmaceutical companies: Novo Nordisk, Eli Lilly, Sanofi, Merck, AstraZeneca, Boehringer Ingelheim. Asia-Pacific region is expected to be the fastest-growing market fueled by increasing diabetic populations in India and China (Source: World Health Organization, 2022).

The key branded products include Lantus, Toujeo, Tresiba (insulin analogs), Ozempic, Trulicity, Rybelsus (GLP-1 agonists). Strategies involve developing innovative biologics, combination regimens, and investments in next-gen devices and digital solutions. Overall, the diabetes market is characterized by innovation, technological advancement, and a growing emphasis on personalized care. With the rising prevalence of diabetes worldwide, there is a pressing need for comprehensive, patient-centric approaches to diabetes management that address not only glycemic control but also cardiovascular risk factors, comorbidities, and patient preferences.

The potential of Phyto-N for diabetes treatments

The diabetes treatment market is undergoing a transformative phase with the emergence of innovative therapies and the growing demand for effective, safe, and holistic management options. Phyto-N, our botanical drug candidate, has shown potential effects in animal research, suggesting it may have potential in the diabetes treatment landscape. Details of these studies are presented in the “Research and Development” section under the Diabetes heading.

Preclinical studies suggest that Phyto-N may be well-tolerated and may have the potential to reduce blood sugar and lipids, improve insulin resistance, and protect the structure and function of vital organs such as the pancreas, liver, and kidneys. These initial findings are promising and provide a rationale for further investigation.

Phyto-N is in the early stages of development as a potential diabetes treatment, and we are excited about the opportunity to advance it through the clinical research process. Our team is dedicated to conducting the necessary large-scale human trials to rigorously assess its potential benefits for diabetes patients. While we acknowledge the inherent risks and uncertainties in drug development, we remain hopeful about Phyto-N’s prospects and are committed to its careful and thorough evaluation as a potential new option in diabetes care.

Market Analysis of Nonalcoholic Fatty Liver Disease (NAFLD) Treatments and the Potential of Phyto-N

Nonalcoholic Fatty Liver Disease (NAFLD) is a chronic liver condition caused by accumulation of excess fat in the liver. It encompasses a spectrum from simple fatty liver (steatosis) to Nonalcoholic Steatohepatitis (“NASH”) which can progress to fibrosis, cirrhosis and liver failure. NAFLD has become a global health concern due to its rising prevalence, driven primarily by factors such as sedentary lifestyles, unhealthy diets, and increasing rates of obesity and type 2 diabetes. As a result, the market for NAFLD treatment has witnessed significant growth and is expected to continue expanding in the coming years.

Market Size and Growth:

The NAFLD treatment market has experienced steady growth in recent years and is projected to continue expanding at a considerable rate. The global market value is around $4.8 billion in 2022 and is projected to reach $160 billion by the end of 2030. The market is anticipated to grow at a CAGR of approx. 55% during the forecasted period of 2022-2030 (Research and markets, 2024). Factors such as the increasing prevalence of NAFLD, growing awareness among healthcare providers and patients, and advancements in treatment options contribute to market growth. The NASH market in the U.S. is estimated at US$1.6 Billion in the year 2022. China, the world’s second largest economy, is forecast to reach a projected market size of US$24 Billion by the year 2030 trailing a CAGR of 51.9% over the analysis period 2022 to 2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 46.6% and 45.2% respectively over the 2022-2030 period. Within Europe, Germany is forecast to grow at approximately 35.4% CAGR (Source: Global Industry Analysts, Inc., 2022).

The prevalence of NAFLD is increasing globally, with estimates suggesting that it affects approximately 25% of the world’s population. Moreover, the disease is becoming more prevalent among younger populations, including children and adolescents, further driving the demand for effective treatments (Source: Nonalcoholic fatty liver disease in children and adolescents. Clinics in Liver Disease, 2023, 27(1), 127-144).

Currently, the treatment options for NAFLD primarily focus on lifestyle modifications, including diet and exercise, as well as pharmacological interventions to manage associated conditions such as obesity, diabetes, and dyslipidemia. However, there is a growing need for specific pharmacotherapies targeting NAFLD itself, presenting opportunities for drug development and market expansion.

The pharmaceutical industry is actively engaged in developing novel therapies specifically targeting NAFLD and its complications, such as NASH and fibrosis. The NAFLD treatment market is characterized by the presence of both established pharmaceutical companies and emerging biotechnology firms focusing on drug development for metabolic disorders. Multiple big pharma like Gilead, Novo Nordisk, Pfizer as well as biotech companies have therapies in late-stage development for NASH. There are over 40 drugs in development for NASH, representing a very active pipeline across different therapeutic classes. Leading drug candidates target mechanisms like FXR agonism, THR-β agonism, ACC inhibition and ASK1 inhibition. FDA approved Resmetirom (Madrigal), the first drug, for NASH, on March 14, 2024 (Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease). Some other key late-stage drugs are obeticholic acid (Intercept) and semaglutide (Novo Nordisk).

Factors driving market growth include increasing awareness about NAFLD among healthcare professionals and patients, rising healthcare expenditure, and supportive government initiatives aimed at addressing metabolic disorders. However, challenges such as the lack of approved pharmacotherapies for NAFLD/NASH, regulatory hurdles, and the complexity of the disease present barriers to market expansion. North America accounts for the largest market share currently driven by high disease incidence and established healthcare infrastructure, and Europe is the second-largest market. Asia-Pacific region is anticipated to be the fastest growing market due to increasing obesity/diabetes rates and rising healthcare spending.

The potential of Phyto-N for NAFLD treatments

The market for the prevention and treatment of Nonalcoholic Fatty Liver Disease (NAFLD) is poised for substantial growth driven by the increasing global prevalence of the condition and advancements in therapeutic options. With the recent approval of Rezdiffra by the US FDA for treating NASH, the landscape for NAFLD treatment has witnessed a significant milestone.

While the recent approval of Rezdiffra (resmetirom) by the FDA for NASH treatment and the presence of other late-stage drug candidates in development represent significant advancements in the field, this does not imply that Phyto-N will receive regulatory approval. As a botanical drug, Phyto-N may be subject to unique additional challenges in the regulatory process compared to traditional small molecule drugs or biologics. The FDA’s regulatory pathway for botanical drugs can differ from that of conventional pharmaceuticals, potentially requiring additional or different types of evidence to demonstrate safety and efficacy.

Phyto-N, our botanical drug candidate, is being developed as a potential treatment for NAFLD/NASH. Preclinical studies have shown that Phyto-N demonstrates anti-inflammatory properties in animal models of NAFLD. See details of these studies in the “Research and Development” section under the NAFLD heading.

Preclinical studies also suggest that Phyto-N may have both preventive and therapeutic effects in animal models of NAFLD. However, the comparative efficacy and safety profile of Phyto-N relative to approved treatments can only be determined through direct clinical comparisons, which we have not yet conducted. The potential benefits and risks of Phyto-N in humans will need to be carefully evaluated in future clinical trials.

As we advance Phyto-N through clinical development, we aim to generate the necessary data to evaluate its potential as a safe and effective therapy for NAFLD/NASH. Our goal is to improve treatment options for patients suffering from this complex liver disorder.

Market Analysis of Gout Treatments and Potential of Phyto-N.

The global gout treatment market size was valued at around $2.4 billion in 2022. It is projected to grow at a robust CAGR of 8.6% during the forecast period of 2022 to 2032 and reach $5.4 billion by the end of 2032.

Major growth drivers include the rising prevalence of gout, which is linked to aging populations, obesity, dietary factors like high purine intake, as well as increasing healthcare access and awareness about effective gout management (Source: Persistence Market Research, 2022). Development of new targeted therapies and increasing investment in R&D by pharmaceutical companies is also fueling market expansion.

The market is segmented into uric acid lowering therapies (xanthine oxidase inhibitors like allopurinol, febuxostat; uricosurics), anti-inflammatory drugs (NSAIDs, colchicine, corticosteroids), and biologics/newer therapies. Xanthine oxidase inhibitors hold the largest market share as they are recommended as the first-line urate-lowering therapy for most gout patients (Source: Global Market Insights, 2023). The biologics segment, including interlukin-1 inhibitors like Ilaris (canakinumab), is expected to witness the fastest growth in the coming years for treatment of uncontrolled gout. Oral formulations dominate due to higher convenience and patient preference, while parenteral routes are used for severe cases. The market is categorized into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies currently lead the distribution. North America dominates the global gout treatment market, largely due to the high prevalence of the disease and greater access to healthcare services in the region, especially in the United States (Source: Mordor Intelligence, 2023). Europe is the second largest regional market.

The potential of Phyto-N for Gout Treatment

Based on the animal study data provided in the “Research and Development” section under the Gout heading, Phyto-N demonstrated potential therapeutic effects in treating both gouty nephritis and gouty arthritis, which could give it a potential advantage in the gout treatment market. The studies show that Phyto-N can reduce levels of inflammatory mediators such as TNF-α, Caspase-1, IL-6, IL-18, IL-1β, and NLRP3 inflammasome, which play crucial roles in the inflammatory cascade associated with gout. By targeting these inflammatory factors, Phyto-N may offer an approach to treating gout-related inflammation. In the gouty nephritis mouse study, Phyto-N was able to reduce serum levels of uric acid, creatinine, and BUN, as well as improve renal fibrosis and tubular damage. These results suggest that Phyto-N may have the potential to address both hyperuricemia and kidney-related issues in mouse gouty nephritis model. Further research would be needed to confirm these effects and determine their clinical significance.

Challenges:

Key challenges include: conducting comprehensive clinical trials to demonstrate the safety and efficacy of Phyto-N in human patients with gout would be crucial for regulatory approvals and market acceptance; establishing large-scale manufacturing, supply chain, and distribution capabilities for a herbal product may pose challenges compared to conventional pharmaceuticals; and educating healthcare providers and patients about the benefits of Phyto-N over existing treatments would be necessary for market adoption.

Market analysis for acne treatments and the potential of Phyto-N

Acne is a common skin condition that occurs when hair follicles become clogged with oil and dead skin cells. This often results in the formation of whiteheads, blackheads, or pimples. Acne typically appears on areas of the skin that have the most oil glands, such as the face, forehead, chest, upper back, and shoulders. It is most prevalent among teenagers due to hormonal changes that increase oil production but can affect individuals of all ages (Knowledge Sourcing Intelligence LLP).

The primary causes of acne include the overproduction of oil (sebum) by sebaceous glands, the accumulation of dead skin cells in hair follicles, and the presence of the bacterium Propionibacterium acnes. These factors contribute to the blockage and inflammation of hair follicles, leading to the visible symptoms of acne. Hormonal changes, stress, certain medications, and diet can also influence acne severity (Knowledge Sourcing Intelligence LLP). Acne treatment is crucial for several reasons. Firstly, treating acne can prevent scarring. Severe acne, particularly cystic acne, can leave permanent scars if not managed properly. Early and effective treatment reduces this risk. Secondly, acne can cause significant physical discomfort, including pain and itching, especially when the lesions are deep or widespread. Addressing acne effectively can alleviate these symptoms and improve overall skin health. Moreover, acne can have a profound psychological impact. The visible nature of acne can lead to decreased self-esteem and confidence, social withdrawal, and even depression or anxiety. Effective treatment can improve a person’s appearance, which in turn can enhance their emotional well-being and quality of life. Additionally, untreated acne can worsen over time, potentially spreading and becoming more severe. Timely treatment helps control and reduce the severity of acne outbreaks, preventing them from escalating (Knowledge Sourcing Intelligence LLP).

The global acne treatment market is a well-established and growing market, driven by the high prevalence of acne across various age groups, particularly among adolescents and young adults. Acne is a common skin condition that affects millions of people worldwide, leading to a consistent demand for effective treatments. The global acne treatment market is experiencing robust growth, projected to expand from approximately USD 9.7 billion in 2022 to USD 16.2 billion by 2032, with a compound annual growth rate (CAGR) of around 5.4% (Market.US). This expansion is driven by technological advancements, increasing awareness about acne treatment options, and a growing trend towards natural and organic products (Custom Market Insights).

The market is segmented into various product types including retinoids, antibiotics, isotretinoin, and others such as hormonal agents and anti-inflammatory medications. Retinoids are particularly notable for their efficacy in treating acne and are expected to see significant growth due to increasing dermatological endorsements. Antibiotics are often prescribed in combination with other treatments to reduce inflammation and bacterial growth, while isotretinoin remains a powerful option for severe acne cases. The market also includes hormonal agents and anti-inflammatory medications, which contribute to comprehensive acne treatment plans (Knowledge Sourcing Intelligence LLP). The market can also be segmented by acne severity, which includes mild, moderate, and severe acne. Distribution channels for acne treatments include retail pharmacies, online pharmacies, and hospitals & clinics.

Acne treatments are administered in two main ways: topically and orally. Topical treatments (retinoids, antibiotics, benzoyl peroxide, salicylic acid, etc.) include creams, gels, and lotions applied directly to the skin, which are favored for their ease of use and minimal systemic effects. Oral treatments (antibiotics, isotretinoin, hormonal therapies), including pills and capsules, are used when topical treatments are insufficient, often for more severe cases and include antibiotics and hormonal treatments (PBI Insights).

Several factors are driving the growth of the acne treatment market. Technological advancements, such as innovations in laser therapy and light-based treatments, are enhancing the market landscape. Dermatologist recommendations play a significant role in the adoption of treatments. Social media platforms and influencers significantly impact consumer choices by promoting and reviewing various products. Additionally, the trend towards natural and organic products is influencing market offerings (Custom Market Insights).

Regionally, North America holds the largest market share, driven by high product availability and early adoption of new treatments, with the United States being the primary contributor within this region. Europe is the second-largest market, with substantial contributions from countries like Germany, France, and the UK, where increased awareness and promotional efforts are key drivers. The Asia-Pacific region is expected to grow at the highest CAGR, fueled by rising disposable incomes, improved healthcare infrastructure, and greater awareness of skincare. Latin America and the Middle East & Africa regions show moderate growth, with increasing healthcare investments and expanding product availability (Market Data Forecast).

Despite the robust growth, the market faces several challenges. Patient adherence to treatment regimens can be inconsistent, impacting the effectiveness of treatments. Potential adverse effects, especially with oral medications, can deter usage. Moreover, the overuse of antibiotic treatments can lead to resistance, complicating treatment protocols (Market Data Forecast).

The acne treatment market is highly competitive, with major players such as Pfizer, Inc., GlaxoSmithKline plc, Johnson & Johnson, L’Oréal S.A., AbbVie Inc., F. Hoffmann-La Roche Ltd, Bausch Health Companies Inc., Sun Pharmaceutical Industries Ltd., Mylan N.V., and Mayne Pharma Group Limited. These companies are continuously investing in research and development to introduce innovative and effective products, contributing to the market’s dynamic nature (Market Data Forecast).

In conclusion, the acne treatment market is expected to witness steady growth in the coming years, driven by increasing awareness, rising disposable income, and the availability of advanced treatment options. Market players should focus on developing innovative and personalized treatments, expanding their distribution networks, and addressing the challenges associated with side effects and antibiotic resistance to capitalize on the growing market opportunities.

There is no preclinical data available specifically for Phyto-N’s effects on acne currently. However, based on its known properties and mechanisms of action in other conditions, Phyto-N may potentially have applications in acne treatment. This projection is speculative and would require thorough investigation to confirm.

Possible reasons Phyto-N might be considered for acne research:

It’s important to emphasize that at this stage, any market potential for Phyto-N in acne treatment is entirely theoretical. Substantial research and development would be required before its value in this area could be determined.

Our Growth Strategy

Our growth strategy is to leverage our expertise in botanical medicine to identify and develop potential novel drug candidates derived from herbal extracts and their active ingredients. Botanical drugs may offer several potential advantages, including the potential for multi-target mechanisms of action, and a potential source of bioactive compounds. By focusing on botanical drug development, we hope to differentiate ourselves in the pharmaceutical industry and capitalize on the growing demand for natural treatment options. In addition to our focus on developing Phyto-N as a botanical drug, we are actively engaged in identifying and isolating the active chemical compounds responsible for its therapeutic effects. We are investigating the potential of these compounds to serve as the basis for the development of novel small molecule drugs with potentially targeted mechanisms of action; however the process of identifying these compounds is still ongoing, and there is no assurance of success. We anticipate that we will conclude this research prior to the submission of an IND application for ulcerative colitis.

By conducting preclinical studies and clinical trials, we aim to evaluate Phyto-N’s safety and efficacy in various indications and gather the necessary data to support its approval as a botanical drug by the FDA. The Company’s initial focus will be on advancing Phyto-N into clinical trials for this debilitating condition with significant unmet medical needs. We plan to submit an IND application for ulcerative colitis in the fourth quarter of 2025. If the Phase I trial is completed with positive results, we intend to proceed with a Phase II trial for ulcerative colitis as our lead indication. Contingent upon the success of our ulcerative colitis trials, obtaining sufficient funding from a combination of public or private equity offerings and debt financings, and other strategic considerations, Curanex may subsequently initiate additional Phase II trials in other high-value indications such as atopic dermatitis, COVID-19, gout, diabetes, NAFLD, and acne. By pursuing this multiple indication strategy, Curanex aims to explore and maximize the value of Phyto-N and build a robust pipeline of botanical drug candidates targeting inflammatory diseases. The successful completion of these clinical trials could position Phyto-N as a potential botanical drug candidate for multiple inflammatory indications, addressing specific unmet medical needs. If approved, Phyto-N could provide patients with a new treatment option.

As we progress towards clinical trials, we will continue to invest in translational research to further elucidate the mechanisms of action, biomarkers, and patient stratification strategies for Phyto-N. These efforts will support our precision medicine approach and help us optimize the design and execution of our clinical trials to improve the chances of success. However, the process for conducting clinical trials is uncertain and there is no assurance that our clinical development activities will meet our planned timelines. There is also no assurance that we will be successful in obtaining FDA regulatory approval, in obtaining sufficient funds to pursue our growth strategy, and in commercialization of our lead or other product candidates.

Our Competitive Strengths

Our leadership team is comprised of experienced industry professionals with a proven track record of success in bringing innovative therapies to market with deep expertise in drug discovery, development, and commercialization. Our board and advisors include experts in inflammatory diseases, botanical medicine, and US regulatory strategy, ensuring that we have the knowledge and network to successfully navigate the clinical development and approval process. We have also attracted top talent in the areas of botanical medicine, inflammatory diseases, and regulatory affairs, ensuring that we have the knowledge and skills necessary to navigate the complex process of drug development and approval. We believe that our distinctive approach, combining the power of nature with scientific research and development, will set us apart in the pharmaceutical industry and positions us for long-term success.

We hope to collaborate with academic institutions, research organizations, and contract research organizations (CROs) to advance our understanding of the underlying mechanisms of inflammatory diseases and identify potential novel therapeutic targets. We believe that these partnerships could provide access to technologies, expertise, and resources that complement our internal R&D capabilities. For example, Duraviva in the past collaborated with researchers at Rutgers University, which have been instrumental in validating Phyto-N’s therapeutic potential in animal models of inflammatory diseases. These research and development animal studies and reports were assigned and transferred to the Company by Duraviva pursuant to the Asset Purchase Agreement. We are planning to partner with experienced contract manufacturing organizations (CMOs) that have a proven track record of producing high-quality, GMP-compliant botanical drug substances and drug products. We believe that these partnerships will ensure the reliable and efficient production of our therapeutics at various stages of development and commercialization.

We are also looking to establish working strategic relationships with clinical research organizations and clinical trial sites to design, conduct, and monitor our clinical trials. These collaborations may help us efficiently execute our clinical development plans, ensure data quality and integrity, and meet regulatory requirements.

Technological Achievements

During the last five years, our founders worked on combining the potential therapeutic properties of phytomedicines and their potentially active ingredients with unmet needs in the market for various therapeutic areas. They have mastered key technologies for extracting, isolating, chemically synthesizing, and structurally modifying active ingredients in phytomedicines. They are actively working to ensure that our processes for extracting phytomedicine, formulation, and quality control will meet FDA standards for the industrial production of botanical drugs. By leveraging their extensive technical and practical experience in drug development, founders of Curanex, together with our team of executive officers, directors, and consultants, aim to focus on initiating and developing drugs with potential targeted effects and significant market demand. However, there can be no assurance that our technological achievements will result in commercially viable products or that we will be successful in obtaining FDA approval for any products we may develop.

Intellectual Property

Our commercial success depends in part upon our ability to obtain and maintain patent and other proprietary protection for commercially important technologies, inventions and know-how related to our business, defend and enforce our intellectual property rights, particularly our patent rights, preserve the confidentiality of our trade secrets and operate without infringing valid and enforceable intellectual property rights of others. Pursuant to the Asset Purchase Agreement, on June 17, 2024, we acquired the following applications to provisions patents from Duraviva:

Below is a list of patents and patent applications assigned to us and their status:

(1) The Notices of the provisional patent applications were submitted with the United States Patent and Trademark Office (“USPTO”) on June 6, 2024.

While provisional patent applications have certain benefits, including that it is an informal application and therefore can be filed quickly to establish an earlier filing date (this can be crucial in the event of potential disputes or challenges regarding patent right), and having lower filing fees compared to non-provisional applications, making them a cost-effective initial step in the patent process, provisional patent applications lasts only 12 months, which subject their owners to risks of losing patent protections unless the non-provisional patent applications are filed during that 12-month window before expiration of provisional patent applications.

If we do not file non-provisional patent applications prior to the expiration dates of the 4 provisional patents assigned to us by Duraviva, we will lose the priority dates with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional patent applications and we could lose patent protections with respect to these provisional patents.

There is also no assurance that we will be successful in obtaining registrations of non-provisional patent applications we submit for review to the United States Patent and Trademark Office and obtaining the patent protection we need.

Compared to provisional patent applications, non-provisional applications require to undergo a thorough examination process by patent examiners to determine patentability, patentability of the invention, including its novelty and non-obviousness. Non-provisional applications also require providing formal claims, detailed drawings, and a written description that fully discloses the invention’s subject matter and scope. Moreover, patent applications and patents may be opposed or challenged by third parties. As patent applications in the United States are maintained in secrecy until published or issued and as publication of discoveries in the scientific or patent literature often lag behind the actual discoveries, we cannot be certain that there are no other pending patent applications or issued patents from other parties. Additionally, the breadth of claims allowed in biotechnology and pharmaceutical patents, or their enforceability cannot be predicted. We cannot be sure that we will be successive in obtaining and maintaining effective patent protection for the technologies underlying Phyto-N and successfully defending patent rights in those technologies against third-party challenges.

Duraviva also transferred to the Company 8 research and development animal studies and reports, including the right to use the studies for further R&D, clinical & commercial purposes, for:

1. Ulcerative Colitis

2. Atopic Dermatitis

3. Nonalcoholic fatty liver disease prevention

4. Nonalcoholic fatty liver disease treatment

5. Diabetes

6. COVID-19 prevention and treatment

7. Gouty nephritis

8. Gouty arthritis

Our Business Plan

Our business plan and strategy are centered on developing innovative botanical drugs, with a focus on Phyto-N as our lead candidate, for the treatment of inflammatory diseases.

Preclinical Evaluation: Our lead product candidate, Phyto-N, has undergone extensive preclinical testing in animal models of six inflammatory diseases: ulcerative colitis, atopic dermatitis, gout, diabetes, nonalcoholic fatty liver disease (“NAFLD”) and COVID-19. We have conducted the following preclinical studies:

1) Pharmaceutical experiments to characterize the active ingredients of Phyto-N;

2) Animal pharmacology studies to demonstrate potential effects in relevant disease models, including:

3) Preliminary safety pharmacology and toxicology studies, including single-dose and repeated-dose toxicity tests.

Details of these animal pharmacology studies are presented in the “Research and Development” section. These studies, conducted at institutions such as Rutgers University, have consistently shown that Phyto-N exhibits potent therapeutic effects without any significant toxicity or side effects at the intended therapeutic doses. Additionally, Phyto-N has a long history of human use in China, where it has been used as a herbal medicine by traditional Chinese medicine practitioners to treat thousands of patients over the past 30 years.

Regulatory Progress: Curanex is committed to advancing Phyto-N towards clinical development in the United States and has made significant strides in this direction. We are actively preparing to engage with the FDA to discuss our development plans and seek guidance on the regulatory path forward.

Building on this preclinical foundation, we are currently focused on completing the necessary IND-enabling studies to support our planned clinical trials. These include:

By leveraging our in-house expertise and strategic partnerships with leading CROs and CMOs, we are well-positioned to complete these IND-enabling activities in a timely and efficient manner. We have a clear roadmap to IND submission and are on track to initiate Phase I trials for our lead indications, starting with ulcerative colitis in 2025. As we progress towards clinical development, we will continue to invest in translational research to further elucidate the mechanisms of action, biomarkers, and patient stratification strategies for Phyto-N. These efforts will support our precision medicine approach and help us optimize the design and execution of our clinical trials to explore the chances of success.

Our Revenue Model

We anticipate that our future revenue streams will primarily derive from the commercialization of our botanical drug products. Our lead product candidate, Phyto-N, is currently in pre-clinical studies stage. We plan to file an IND application in the fourth quarter of 2025, with ulcerative colitis to be our first application. As we progress towards clinical development, we will continue to invest in translational research to further elucidate the mechanisms of action, biomarkers, and patient stratification strategies for Phyto-N. These efforts will support our precision medicine approach and help us optimize the design and execution of our clinical trials to explore the chances of success. However, there is no guarantee that we will receive regulatory approval or successfully reach commercialization or generate any revenue. The process of obtaining regulatory approval is lengthy, expensive, and uncertain. Assuming we successfully navigate the regulatory process and obtain approval for our products, we anticipate the following potential revenue streams:

Commercialization

Commercialization of a drug requires approval from the regulatory body of each country in which the drug is to be marketed. Successful commercialization requires high quality marketing campaigns and distribution arrangements in order to gain market share as fast as possible. Global pharmaceutical companies have large and professional marketing and distribution functions that regularly introduce new drugs throughout the world. For that reason, we are likely to choose to seek a strategic partnership in any or all territories in which Phyto-N is to be marketed. Decisions on both the appropriate territories in which regulatory approval will be sought and the nature of commercialization in those territories will be made by the board of directors at the appropriate time and with due regard to maximizing the commercial benefit to us.

Research and Development (FDA Related Application)

The objective of our research and development program is the generation of data sufficient to achieve regulatory approval of Phyto-N in one or more dosage forms in major markets such as the United States, and/or to allow us to enter into a commercial relationship with another party.

The animal studies described in this section were conducted in two locations. The COVID-19 study was performed at Rutgers University in the United States, while the studies for ulcerative colitis and our other target indications were conducted in Yunnan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences in China. All studies were carried out in accordance with local regulations and ethical guidelines for animal research. It is important to note that throughout these studies, we did not observe any adverse or severe adverse events in the animals treated with Phyto-N. While these results are encouraging, we emphasize that the safety and efficacy of Phyto-N in humans can only be determined through future clinical trials.

Moderate to Severe Ulcerative Colitis

Ulcerative colitis, a chronic inflammatory bowel disease (IBD) affecting the colon and rectum, is characterized by abdominal pain, diarrhea, rectal bleeding, and urgency. Current treatments, such as aminosalicylates, corticosteroids, immunomodulators, and biologic therapies, often fail to provide adequate symptom control and may cause significant adverse effects, highlighting the need for novel and safe therapeutic options. Phyto-N, an investigational botanical drug candidate, is being studied as a potential alternative for patients with moderate to severe ulcerative colitis.

Human Application Case

An example of Phyto-N’s potential in ulcerative colitis is the case of 69-year-old Ms. Li from Harbin, China, who had suffered from severe ulcerative colitis for over 20 years, experiencing frequent flares and inadequate response to conventional treatments. Her symptoms included debilitating abdominal pain, bloody diarrhea, anemia, and fatigue, significantly impacting her quality of life. In January 2023, Ms. Li began taking Phyto-N orally, and within one week, she noticed improvements in her condition. It’s important to note that Phyto-N is currently used as a Chinese herb medicine and is allowed to be used in patients in China. However, it has not been clinically approved as a pharmaceutical drug in any jurisdiction and is currently in the early stages of pre-clinical development for such approval.

After three months of consistent use, Ms. Li reported complete clinical remission, with resolution of abdominal pain, normalization of bowel movements, and no further rectal bleeding or pus. Additionally, her anemia resolved, she regained lost weight, and her overall strength and vitality improved. Ms. Li remained symptom-free for 12 months after discontinuing Phyto-N, suggesting the potential for long-term remission and a reduced risk of relapse.

While this individual case from Harbin is of interest, and Phyto-N is used as a Chinese herbal medicine in China, it is crucial to understand that as a pharmaceutical drug candidate, Phyto-N is still in the early stages of pre-clinical development. It will likely take several years to complete the necessary clinical trials and regulatory processes required for commercialization as an approved pharmaceutical product. There can be no guarantee that Phyto-N will achieve similar results in larger-scale clinical testing or that it will ultimately be approved for use in treating ulcerative colitis outside of its current use in Chinese medicine. The development of new drugs is a complex and uncertain process, and many promising candidates fail to reach the market as approved pharmaceutical products.

Animal Experiment Research

Preclinical studies in animal models of ulcerative colitis provide initial evidence of Phyto-N’s possible therapeutic potential. In a well-established model using 8-week-old male C57BL/6 mice with dextran sulfate sodium (DSS)-induced colitis, oral administration of Phyto-N (3.3g/kg/d) for 10 days significantly reduced disease severity compared to control groups receiving either mesalazine (100mg/kg/d, positive control) or physiological saline. Phyto-N-treated mice exhibited decreased weight loss, improved colon morphology, and increased colon length, indicating a reduction in inflammation and tissue damage.

In Figure 1, statistical significance is indicated by p-values. The p-value is a statistical measure that indicates the probability of obtaining test results at least as extreme as the observed results, assuming that the null hypothesis (typically that there is no real difference between groups) is true. A smaller p-value suggests stronger evidence against the null hypothesis. In scientific research, p-values less than 0.05 (p < 0.05) are generally considered statistically significant, indicating that the observed difference between groups is unlikely to have occurred by chance.

In our study:

The p-values shown in Figure 1A, which depicts the effect of Phyto-N on DSS-induced colonic length in mice, indicate that the differences in colon length between the Phyto-N treated group and the DSS control group are statistically significant (p < 0.01). This high level of statistical significance suggests that the protective effect of Phyto-N on colon length reduction in DSS-induced colitis is very likely to be a real effect rather than a result of random chance.

Colon length is an important indicator of inflammation in colitis models, with shorter colon length typically indicating more severe inflammation. The statistically significant difference in colon length between the Phyto-N treated group and the DSS control group supports our hypothesis that Phyto-N has a protective effect against colitis-induced inflammation in this model.

The Disease Activity Index (DAI), a composite score encompassing weight loss, stool consistency, and rectal bleeding, was significantly lower in the Phyto-N group by day 14 of treatment and continued to improve until the end of the study (Figure 1C). Specifically, the mean DAI scores at day 14 were 2.75 ± 0.0.85 for the Phyto-N group, compared to 4.10 ± 0.45 for the control group (p < 0.01). By the end of the study at day 20, the mean DAI scores were 7.45 ± 0.76 for the Phyto-N group and 5.15 ± 0.0.75 for the control group (p < 0.001). The lower DAI scores in the Phyto-N group indicate a significant reduction in disease severity on body weight loss (Figure 1D), stool consistency, and rectal bleeding. This improvement is promising as it suggests that Phyto-N may not only alleviate symptoms rapidly but also maintain its potential therapeutic effect over time. The sustained lower DAI scores in the Phyto-N group compared to the control group demonstrate the potential of Phyto-N as a candidate treatment for ulcerative colitis, potentially capable of providing both quick relief and long-term management of the disease. However, further clinical studies are needed to confirm these findings in human patients.

Figure 1. Pharmacological Effects of Phyto-N on Moderate to Severe Ulcerative Colitis

Note: (A) Effect on DSS-induced colonic length in mice; (B) Gross observation of colon morphology in mice; (C) Line graph of DAI scores in mice; (D) Line graph of body weight changes in mice. The result is represented by x̅±S. x̅±S means the average plus or minus the standard deviation, a measure of variability in the data. * indicates P<0.05; ** indicates P<0.01. P-values indicate the statistical significance of the results, with lower values suggesting stronger evidence.

Histopathological analyses of colon tissues revealed that Phyto-N treatment markedly reduced inflammatory cell infiltration, preserved mucosal architecture, and increased goblet cell count compared to control groups (Figure 2). These preliminary findings suggest Phyto-N’s potential ability to alleviate inflammation, promote tissue repair, and maintain intestinal barrier integrity, which are essential for achieving and sustaining remission in ulcerative colitis.

Figure 2. Pharmacological Effects of Phyto-N on Moderate to Severe Ulcerative Colitis

Note: Observations of H&E stained sections of mouse colon tissue (H&E,200×).

To elucidate the molecular mechanisms underlying Phyto-N’s anti-inflammatory effects, further experiments were conducted focusing on key pathways involved in the pathogenesis of ulcerative colitis. The results showed that after administration of Phyto-N, the protein expression of IL-6, TNF-α, IL-1β, IL-18 in the colon tissues of mice with ulcerative colitis decreased, and the levels of IL-6, TNF-α, IL-1β, IL-18 in the serum decreased (Figure 3), as well as the gene expression of NLRP3, NF-κB, Caspase-1, GSDMD in the colon tissues of mice (Figure 4). These preliminary findings suggest that Phyto-N may exert its therapeutic effects by inhibiting the activation of NF-κB and the NLRP3 inflammasome, thereby reducing the production and secretion of pro-inflammatory mediators and preventing pyroptosis, a highly inflammatory form of programmed cell death (Figure 5).

Figure 3. Pharmacological Effects of Phyto-N on Moderate to Severe Ulcerative Colitis

Comparison of serum IL-6, TNF-α, IL-1β and IL-18 levels in mice. The result is represented by x̅±S. * indicates P<0.05; ** indicates P<0.01.

Figure 4. Pharmacological Effects of Phyto-N on Moderate to Severe Ulcerative Colitis

Comparison of NLRP3, NF-κB, Caspase1, GSDMD mRNA expression levels in mice. The result is represented by x̅±S. * indicates P<0.05; ** indicates P<0.01.

The preliminary data from these studies suggest that Phyto-N may have the potential ability to modulate both upstream regulators (e.g., NF-κB) and downstream effectors (e.g., IL-6, TNF-α) of the inflammatory response. This potentially multi-faceted mechanism of action warrants further investigation in clinical studies to determine its potential therapeutic effects. While these early results are encouraging, it’s important to note that animal studies may not always translate directly to human outcomes.

These studies were conducted in Yunnan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences in China. No adverse or severe adverse events were observed in the Phyto-N treated group during this study.

The preclinical studies in animal models of ulcerative colitis suggest potential effects of Phyto-N that warrant further investigation. In the DSS-induced colitis model using 8-week-old male C57BL/6 mice, oral administration of Phyto-N (3.3g/kg/d) for 10 days appeared to reduce some markers of disease severity compared to control groups. However, it’s important to note that animal models may not fully replicate human disease conditions. The molecular studies indicated possible effects of Phyto-N on inflammatory pathways, including reductions in certain pro-inflammatory cytokines and gene expressions related to inflammation. However, these findings are preliminary and their clinical significance remains to be determined through extensive further research.

In conclusion, the preclinical data and limited clinical observations suggest that Phyto-N may have potential in the treatment of ulcerative colitis. However, it is crucial to emphasize that these findings are preliminary and based on early-stage research. Extensive further research, including rigorous clinical trials, would be necessary to establish any potential therapeutic effects or safety profile of Phyto-N in humans. The goal of improving treatment options for patients with ulcerative colitis drives our commitment to rigorous scientific investigation and adherence to regulatory standards. 

Figure 5. Mechanism of Phyto-N Treatment for Severe Ulcerative Colitis

Note: Phyto-N can enter the cells and reduce the transcription of downstream nuclear inflammatory factors (IL-6, TNF-α, etc.) induced by the activation of NF-κB, reduce the formation of NLRP3-ASC-procaspase-1 inflammasomes, thereby inhibiting a series of reactions such as the generation of Caspase-1 leading to the splicing of pro-IL-1β and pro-IL-18 by GSDMD, reducing the levels of extracellular inflammatory factors IL-6, TNF-α, IL-1β, and IL-18, as well as cell pyroptosis, exerting a therapeutic effect on ulcerative colitis.

Atopic Dermatitis

Atopic dermatitis, a chronic inflammatory skin disorder, affects millions of people worldwide, causing significant discomfort and impacting quality of life. Current treatment options, such as topical corticosteroids, calcineurin inhibitors, and systemic immunosuppressants, often provide inadequate disease control and may lead to adverse effects. Dupilumab (Dupixent), the first targeted biologic therapy approved for moderate to severe atopic dermatitis, has shown promise by inhibiting the signaling of IL-4 and IL-13 through blockade of the IL-4 receptor α (IL-4Rα) chain. However, despite its efficacy, Dupilumab is associated with adverse events such as ocular diseases, erythema, and an increased risk of cutaneous T-cell lymphoma, likely due to its single-target approach and the saturation of IL-4Rα.

Phyto-N, a botanical drug candidate, is being investigated as a potential alternative treatment for atopic dermatitis. This report summarizes the preliminary findings from preclinical studies conducted on Phyto-N.

Preclinical studies in animal models of atopic dermatitis have provided evidence of Phyto-N’s therapeutic potential effects. In a study using 6-8-week-old male BALB/c mice, (a specific strain of laboratory mice) with DNCB-induced acute atopic dermatitis (a chemical used to induce a condition similar to atopic dermatitis in mice), oral administration of Phyto-N (3.3g/kg/d) for 21 days significantly improved skin appearance, reduced skin lesion scores, and promoted overall health compared to control groups receiving either dexamethasone (0.585mg/kg/d, a potent anti-inflammatory steroid) or physiological saline. These benefits were evident as early as the 8th day of treatment and continued to improve until the end of the study period.

Histological analyses showed that Phyto-N treatment reduced skin keratinization (excessive production of keratin, a protein in the outer layer of skin), incomplete keratinization, and epidermal thickening in mice with acute atopic dermatitis (Figure 6 A, B). Additionally, Phyto-N decreased the infiltration of inflammatory cells and mast cells (types of immune cells involved in allergic reactions) in the dermis while promoting the growth of adnexal structures such as hair follicles and sebaceous glands, indicating its ability to restore skin structure and function.

Importantly, Phyto-N demonstrated potential anti-inflammatory properties by significantly reducing TNF-α levels (a protein involved in systemic inflammation) in the skin tissue of atopic dermatitis mice (Figure 6C), suggesting its potential effects in modulating immune responses and alleviating inflammation. These findings highlight Phyto-N’s potential approach to treating atopic dermatitis in animal model, targeting not only the visible symptoms but also the underlying immunological mechanisms.

The preclinical data demonstrating Phyto-N’s potential effects on improving skin appearance, reducing dermatitis scores, modulating skin keratinization, and decreasing inflammation provide experimental evidence to support its therapeutic potential in atopic dermatitis.

These studies were conducted in Yunnan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences in China. No adverse or severe adverse events were observed in the Phyto-N treated group during this study.

While the multi-target, anti-inflammatory approach of Phyto-N observed in these preclinical studies appears promising, it is crucial to emphasize that these are early-stage findings. There is no guarantee that these effects will translate effectively to human patients or that Phyto-N will successfully navigate the drug development process. The path from these early results to a clinically approved drug is long, complex, and uncertain, typically involving years of additional research, large-scale clinical trials, and rigorous regulatory reviews.

As we continue to advance Phyto-N through clinical development, we remain cautiously optimistic about its potential while acknowledging the significant challenges ahead. The goal of improving treatment options for patients with atopic dermatitis drives our commitment to rigorous scientific investigation and adherence to regulatory standards.

Figure 6. Pharmacological Effects of Phyto-N on Atopic Dermatitis

Note: (A) H&E staining of mice dorsal skin tissue (H&E, 200×); (B) Epidermal thickness of mice; (C) Determination of TNF-α content in mice skin lesions. The result is represented by x̅±S. * indicates P<0.05; ** indicates P<0.01.

Virus Infection: COVID-19

The emergence of COVID-19 caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has inflicted unprecedented damage on the global healthcare system, with over 770 million reported infections and 6.9 million deaths worldwide. While vaccines have been developed to prevent the disease, there remains a critical need for effective therapeutic agents to treat COVID-19 patients and reduce the risk of severe complications. Current treatment options primarily focus on symptomatic relief using palliative medications, which often come with side effects such as gastrointestinal reactions and leukocyte damage. Given the high infectivity, rapid spread, and diverse sequelae associated with COVID-19, preventive strategies are of paramount importance in controlling the pandemic.

Phyto-N, a botanical drug candidate, is being investigated as a potential prophylaxis and treatment of COVID-19 in animal models. Phyto-N has demonstrated in animal studies the ability to reduce viral loads in various organs and inhibit inflammation, thereby addressing the underlying mechanisms of SARS-CoV-2 infection. We believe that by targeting the virus at its source and modulating the host immune response, Phyto-N has the potential to prevent the development of severe COVID-19 and limit the spread of the virus in animal models.

The potential prophylactic effects of Phyto-N was evaluated in a hamster model of SARS-CoV-2 infection. Hamsters are commonly used in COVID-19 research because they develop symptoms similar to humans when infected with SARS-CoV-2. Animal experiments were conducted at the Biosafety level 3 facilities of Rutgers University in the United States have confirmed the favorable effects of Phyto-N treatment during SARS-CoV2 infection. Hamsters were divided into two groups, no treatment group (n=10) and Phyto-N (260 mg/ animal) pre-treatment group (oral gavage (n=10) for one week before infection). All the 20 hamsters were infected with SARS-CoV-2 (10³ PFU) via intranasal inoculation with 50µL inoculum prepared in sterile 1X PBS. PFU stands for Plaque-Forming Units, which is a measure of the number of infectious virus particles. Intranasal inoculation means the virus was introduced into the hamsters’ nasal passages. Five hamsters from each group were euthanized at 4 and 7-days post-infection (dpi), and tissues (lungs, liver, spleen, kidney, heart, and brain) were collected for analysis. Viral load in tissues was determined by plaque assay. Histopathological analysis was performed on tissue sections stained with hematoxylin and eosin (H&E). H&E staining allows researchers to visualize tissue structures and cellular changes under a microscope. Immunohistochemistry and mRNA-fluorescent in situ hybridization (mRNA-FISH) were used to assess the expression of immune cells and cytokines in the lungs. These techniques help identify specific types of cells and molecules in tissue samples. Gene expression of cytokines and immune markers in various tissues was evaluated using quantitative real-time PCR (qPCR). qPCR measures the amount of specific genes being expressed in a tissue.

Reduced body weight loss: hamsters pre-treated with Phyto-N showed less body weight loss compared to untreated hamsters from day 1 to 7 post-infection. The mean body weight loss was approximately 2% in the Phyto-N pre-treated group, compared to 5% in the untreated group at 2-4 dpi. This suggests that Phyto-N may help maintain overall health during infection.

Lower Viral load in tissues: a significant reduction in viral load was noted in the lungs of hamsters treated with Phyto-N before infection at both 4- and 7-days post-infection (dpi) (Figure 7). This indicates that Phyto-N may help control the amount of virus in the lungs throughout the infection.

Figure 7. Viral load in the lung at 4- and 7-days post-infection (dpi). The result is represented by x̅±SE. * indicates P<0.05; ** indicates P<0.01; *** indicates P<0.005. x̅±SE means the average plus or minus the standard error. P-values indicate the statistical significance of the results, with lower values suggesting stronger evidence.

Viral loads were also significantly lower in the liver, kidney, spleen, heart, and brain at 4 dpi in the Phyto-N pre-treated group (Figures 8). This result suggests that pre-treatment with Phyto-N before infection may have a beneficial role on the host to control the SARS-CoV-2 dissemination and to curb the viral load in the lungs as well as the extra pulmonary organs, particularly during early phase of infection (e.g., 4dpi). This implies that Phyto-N may help prevent the virus from spreading to other organs beyond the lungs.

Figure 8. Viral load in the lung, liver and kidney at 4 dpi. The result is represented by x̅±SE. * indicates P<0.05; ** indicates P<0.01; *** indicates P<0.005.

Reduced histopathological changes (H&E staining): Phyto-N pre-treatment reduced inflammation, inflammatory cell infiltration, and bronchiolar epithelial hyperplasia in hamster lungs at 4 and 7 dpi (Figure 9). This means that Phyto-N appeared to decrease the damage and abnormal changes in lung tissue caused by the virus.

Figure 9. H&E-stained sections of the lungs from untreated and Phyto-N treated hamsters at 4 and 7 dpi.

The severity of pathologic manifestations, such as thrombotic lesions and tissue degeneration, was reduced in the liver and kidney of Phyto-N pre-treated hamsters, while a slight reduction in hemorrhagic response was observed in the brain at 4 dpi. This suggests that Phyto-N may help protect other organs from damage caused by the virus or the body’s response to it.

Modulation of immune cell infiltration (Immunohistochemistry): Increased infiltration of CD3 positive T cells and decreased infiltration of activated macrophages (IBA1 positive cells) were observed in the lungs of Phyto-N pre-treated hamsters compared to untreated infected hamsters (Figures 10 & 11), indicating a potential immunomodulatory effect of Phyto-N. This means Phyto-N may help balance the immune response, potentially reducing harmful inflammation while maintaining protective immunity.

Figure 10. Immunohistochemistry of lung with or without Phyto-N treatment

Figure 11. Immune cells in SARS-CoV-2 infected Hamster Lungs with or without Phyto-N treatment measured by immunofluorescence. The result is represented by x̅±SE. * indicates P<0.05; ** indicates P<0.01; *** indicates P<0.005.

Regulation of cytokine and immune marker gene expression:

Phyto-N pre-treatment upregulated the expression of IFN-γ, IL-1β, TNF-α, CCL2, IL-10, and IL-4 in the lungs, spleen, liver, kidney, brain, and heart of hamsters, while decreasing the expression of IL-6, CRP, and TMPRSS in various organs, further suggesting its immune-modulatory properties. These changes in gene expression suggest that Phyto-N may help regulate the immune response, potentially reducing harmful inflammation while maintaining protective immunity.

Pre-treatment with Phyto-N before SARS-CoV-2 infection was observed to have protective effects in a hamster model. Pre-treatment with Phyto-N was associated with reduced replicative viral burden at the site of infection (lungs) and viral dissemination, as noted by reduction in viral load in extrapulmonary organs, such as liver, kidney, spleen, heart and brain. The improved viral load clearance in Phyto-N pre-treated hamster appeared to be more pronounced during early stages (i.e., 4dpi) of SARS-CoV-2 infection. Therefore, it can be hypothesized that administration of Phyto-N acts as an immune-booster and prepares the host to defend the viral replication in the internal organs. The reduced viral load in organs might also have a positive association with the improvement in body weight loss in the Phyto-N pretreated hamsters, compared to untreated animals. The histopathologic analysis of internal organs of SARS-CoV-2 infected hamsters also suggested signs of immune modulation, marked by a mild to moderate level of reduction in disease severity in the Phyto-N pretreated animals, compared to the untreated animals.

Phyto-N pre-treatment reduced body weight loss, viral loads in the lungs and extrapulmonary organs, and the severity of histopathological changes in the lungs, liver, and kidney. The observed protective effects of Phyto-N might be associated with increased infiltration of T cells, decreased infiltration of activated macrophages in the lungs, and modulation of cytokine and immune marker expression in various organs. No adverse or severe adverse events were observed in the Phyto-N treated group during this study.

In conclusion, the preclinical studies suggest that Phyto-N may be a promising prophylactic agent against SARS-CoV-2 infection in this animal model, with the potential to reduce viral load, mitigate inflammatory responses, and prevent severe COVID-19 complications. While the preclinical data on Phyto-N in the context of COVID-19 prevention presents intriguing possibilities, it is important to note that results from animal studies may not directly translate to human outcomes. The path from these early results to a clinically approved drug is long, complex, and uncertain, typically involving years of additional research, large-scale clinical trials, and rigorous regulatory reviews. As we continue to advance Phyto-N through clinical development, we remain cautiously optimistic about its potential while acknowledging the significant challenges ahead. Extensive clinical research is needed to establish its safety and efficacy in humans. We look forward to conducting these necessary studies and reporting on the results as they become available.

Diabetes

Diabetes, a chronic metabolic disorder characterized by elevated blood glucose levels, affects millions of people worldwide. While current treatments, such as insulin and metformin, have been lifesaving for many patients, there remains a significant unmet need for more effective and comprehensive therapies that can address the complex pathophysiology of diabetes and its associated complications. Phyto-N, a botanical drug candidate, has demonstrated therapeutic potential in animal studies, suggesting potential for further investigation in the management of diabetes.

The high-sugar and high-fat diet combined with low-dose intraperitoneal injection of streptozotocin (STZ), a chemical that damages insulin-producing cells, was used to induce a type 2 diabetes mellitus (T2DM) rat model. According to the groups, gastric lavage was administered continuously for 12 weeks with Phyto-N (1.8g/kg/d), the positive control drug metformin (0.2g/kg/d, a common diabetes medication), or a placebo with equivalent physiological saline.

After administering Phyto-N, the body weight of diabetic rats increased, which can be a positive sign in diabetes management. Fasting blood glucose concentration and glycated hemoglobin (HbA1c) concentration decreased (Figure 12). HbA1c is a measure of average blood sugar levels. Phyto-N also reduced fasting serum insulin concentration, with its effect comparable to the first-line hypoglycemic drug metformin in animal studies. Oral glucose tolerance test (OGTT) analysis measures how well the body processes glucose. Phyto-N decreased the area under the curve (AUC) of OGTT curve, indicating improved glucose processing. The peak blood glucose level was significantly lower than that in the metformin drug group. Insulin tolerance test (ITT) analysis measures how sensitive the body is to insulin. Phyto-N decreased the AUC of ITT curve, and the blood sugar levels at all time points were significantly lower than that in the metformin drug group (Figure 12).

Figure 12. Pharmacological Effects of Phyto-N on Diabetes

Note: (A) Body weight of rats; (B) Fasting blood glucose concentration of rats; (C) HbA1c concentration of rats; (D) Insulin concentration of rats; (E) OGTT AUC of rats; (F) ITT AUC of rats. The result is represented by x̅±S. * indicates P<0.05, ** indicates P<0.01.

Figure 13. Pharmacological Effects of Phyto-N on Diabetes

Note: (A) Homeostatic model assessment for insulin resistance (HOMA-IR) and homeostatic model assessment for insulin sensitivity (HOMA-IS) of rats; (B) TG, TC, HDLC and LDLC concentration of rats. The result is represented by x̅±S. * indicates P<0.05, ** indicates P<0.01.

Figure 14. Pharmacological Effects of Phyto-N on Diabetes

Note: (A) ALT and AST concentration of rats; (B) Blood urea nitrogen (UREA) and creatinine (CREA) concentration of rats. The result is represented by x̅±S. * indicates P<0.05, ** indicates P<0.01.

Additionally, Phyto-N reduced the insulin resistance index HOMA-IR and increased the insulin sensitivity index HOMA-IS in diabetic rats (Figure 13). These are important measures of how well the body responds to insulin. Phyto-N improved lipid profile by reducing levels of triglycerides (TG), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C), while increasing high-density lipoprotein cholesterol (HDL-C).

Beyond its effects on glycemic control, Phyto-N demonstrated benefits in protecting the structure and function of key organs affected by diabetes. Histological analyses revealed that Phyto-N restored pancreatic tissue morphology, improved liver tissue structure, and reduced markers of kidney dysfunction, such as UREA and CREA levels (Figure 14). These findings suggest that Phyto-N may have the potential to prevent or reverse diabetes-related complications, such as pancreatic beta-cell dysfunction, nonalcoholic fatty liver disease, and diabetic nephropathy.

These studies were conducted in Yunnan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences in China. No adverse or severe adverse events were observed in the Phyto-N treated group during this study.

The data from our preclinical studies suggests that Phyto-N may have the potential to influence glycemic control, insulin sensitivity, and organ protection in animal models of diabetes. The observed multifaceted effects of Phyto-N in these preclinical studies present an interesting avenue for future investigation in diabetes treatment. If these effects are confirmed in human studies, Phyto-N could potentially offer a new approach for patients seeking improved long-term outcomes and quality of life. However, it’s important to note that many promising preclinical candidates do not successfully translate to effective human therapies.

We will thoroughly evaluate Phyto-N’s safety and efficacy in humans. Our goal is to explore whether Phyto-N could potentially address some of the unmet needs in diabetes care.

Prevention and Treatment of Nonalcoholic Fatty Liver Disease

Nonalcoholic fatty liver disease (NAFLD) is a chronic liver condition characterized by excessive fat accumulation in the liver, often leading to inflammation, fibrosis, and cirrhosis. Nonalcoholic fatty liver disease (NASH) is an inflammatory subtype of NAFLD, characterized by hepatic steatosis and evidence of hepatocellular injury (ballooning) and inflammation, with or without fibrosis. Despite the recent approval of Rezdiffra (resmetirom) by the US FDA in March 2024 as the first drug for the treatment of NASH, there remains a significant unmet need for safe and effective therapies that can address the underlying pathophysiology of NAFLD and prevent its progression.

Rezdiffra, a thyroid hormone receptor-β (THR-β) agonist, aims to target the impaired THR-β activity in the liver, which contributes to decreased mitochondrial function, reduced β-oxidation of fatty acids, and subsequent inflammation and fibrosis. However, Rezdiffra is associated with common side effects such as diarrhea and nausea, and its label includes a safety warning for physicians to monitor liver enzymes and liver-related adverse events. Moreover, the FDA recommends limiting the use of statins in patients receiving Rezdiffra due to potential drug interactions. Phyto-N, a botanical drug, offers a promising alternative approach to the prevention and treatment of NAFLD.

Preclinical studies in animal models of NAFLD evaluated the therapeutic potential of Phyto-N in preventing and treating this chronic liver condition.

Nonalcoholic Fatty Liver Disease (Prevention)

Nonalcoholic Fatty Liver Disease (NAFLD) is a condition where excess fat accumulates in the liver of people who drink little or no alcohol. To study the potential preventive effects of Phyto-N on NAFLD, 40 male SPF C57BL/6 mice, a specific strain of laboratory mice, were treated with Gubra-Amylin NASH (GAN) feed for 22 consecutive weeks to induce NAFLD. From the 4th week onwards until the end of modeling, the Phyto-N group was administered Phyto-N (3.9g/kg/d) via gastric lavage, the Positive group was administered metformin (0.221g/kg/d), a common diabetes medication, via gastric lavage, and the other groups were administered equivalent physiological saline. Insulin resistance is an important factor in the occurrence and development of NAFLD. After insulin resistance occurs, glucose in the blood is converted into triglycerides stored in the liver, which then leads to liver damage and inflammation. We first observed changes in body weight and blood sugar trends in mice and found that after Phyto-N intervention, both body weight and blood sugar decreased compared to model mice. Results from OGTT and ITT analyses suggested that Phyto-N improved glucose tolerance and insulin sensitivity in mice fed a high-fat diet (Figure 15). After Phyto-N intervention, the liver color of mice returned to a healthy deep red, the greasy feeling disappeared, and the weight and index of the liver decreased.

Figure 15. Preventive Effect of Phyto-N on Nonalcoholic Fatty Liver Disease

Note: (A) Body weight and (B) blood sugar trends in mice; AUC of OGTT (C) and ITT (D) in mice; (E) Liver weight and (F) liver index of mice. The result is represented by x̅±S. * indicates P<0.05, ** indicates P<0.01.

H&E staining of the liver tissue showed a significant reduction in the number of white vacuoles in mice given Phyto-N, indicating inhibition of liver steatosis, and the volume of liver cells decreased, with occasional vesicular fat vacuoles and no inflammatory reaction observed (Figure 16). Oil red O staining of the liver showed that Phyto-N could reduce the number and volume of red lipid droplets accumulated in liver cells. Serum index analysis showed that Phyto-N improved blood lipid levels and liver function in mice. Inflammatory factors IL-1β, IL-6, and TNF-α in the liver were also significantly reduced by Phyto-N, suggesting potential anti-inflammatory effects.

Figure 16. Preventive Effect of Phyto-N on Nonalcoholic Fatty Liver Disease

Note: (A) Liver tissue staining slice observation (H&E, 200x), black arrow indicates fatty vacuoles, blue arrow indicates balloon-like lesions; (B) Liver tissue staining slice observation (oil red O, 200×); (C) Serum AST, ALT, and LDL-C. The result is represented by x̅±S. * indicates P<0.05, ** indicates P<0.01.

These findings suggest that Phyto-N can effectively prevent the development and progression of NAFLD potentially by modulating glucose and lipid metabolism, enhancing insulin sensitivity, reducing hepatic steatosis and inflammation, and improving overall liver function in this animal model.

Nonalcoholic Fatty Liver Disease (Treatment)

Building on the preventive effect of Phyto-N on NAFLD in animal model, we further investigated its therapeutic effect on NAFLD. Forty male SPF C57BL/6 mice were induced with Gubra-Amylin NASH (GAN) feed for 22 consecutive weeks, and drug intervention began in the 22nd week while continuing to feed them with GAN control feed. For 12 weeks continuously, the Phyto-N group was administered Phyto-N (3.9g/kg/d) via gastric lavage, the Positive group was administered metformin (0.221g/kg/d) via gastric lavage, and the other groups were administered equivalent physiological saline. The main research results obtained are as follows: Phyto-N intervention reduced the body weight and blood sugar of NAFLD mice (Figure 17).

Figure 17. Therapeutic Effect of Phyto-N on Nonalcoholic Fatty Liver Disease

Note: Body weight and blood sugar trends in mice. The result is represented by x̅±S. * indicates P<0.05, ** indicates P<0.01.

Phyto-N intervention could significantly reduce AST and ALT enzymes that indicate liver damage when elevated, improving liver damage in mice induced by a high-fat diet (Figure 18).

Figure 18. Therapeutic Effect of Phyto-N on Nonalcoholic Fatty Liver Disease

Note: (A) Liver tissue staining slice observation (H&E, 200x), black arrow indicates fatty vacuoles; blue arrow indicates balloon-like lesions; (B) Serum AST and ALT. The result is represented by x̅±S. * indicates P<0.05, ** indicates P<0.01.

These results demonstrate that Phyto-N, even when the high-fat diet was continued, can effectively treat established NAFLD by reducing hepatic steatosis, improving liver function, and attenuating inflammation, even in the presence of ongoing dietary challenges in animal model.

In conclusion, the preclinical studies suggest potential benefits of Phyto-N for the prevention and treatment of NAFLD. By affecting multiple pathways potentially involved in the pathogenesis of NAFLD, including glucose and lipid metabolism, insulin resistance, and inflammation, Phyto-N may offer an alternative approach to managing this complex liver disorder. However, further research is needed to confirm these initial findings.

These studies were conducted in Yunnan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences in China. While no adverse or severe adverse events were observed in the Phyto-N treated group during this preclinical study, it’s important to note that results in animal studies don’t always translate directly to humans.

As Curanex advances Phyto-N through clinical development, we hope that this botanical drug candidate may provide an alternative approach to current NAFLD therapies, potentially addressing some limitations of single-target approaches. With its observed anti-inflammatory and hepatoprotective properties in preclinical studies and potential for disease modification, Phyto-N could represent a new direction in the management of NAFLD and its associated comorbidities. However, clinical trials are necessary to establish its efficacy and safety in humans.

Gout

Gout, a common form of inflammatory arthritis, is caused by the deposition of monosodium urate crystals in joints and surrounding tissues due to hyperuricemia. Current treatments for gout, such as Febuxostat, aim to reduce serum uric acid levels by inhibiting xanthine oxidase, the enzyme responsible for uric acid synthesis. However, despite its efficacy in lowering uric acid levels, Febuxostat carries a black box warning from the FDA, indicating an increased risk of cardiovascular death in gout patients. The pathogenesis of gout involves the activation of inflammatory pathways, with urate crystals triggering the secretion of key inflammatory mediators such as TNF-α, Caspase-1, IL-6, IL-18, and IL-1β at the site of inflammation. These mediators recruit neutrophils and perpetuate the inflammatory cascade, leading to the clinical manifestations of gouty arthritis and nephropathy. The NLRP3 inflammasome, a critical component of the innate immune system, plays a pivotal role in the progression of gout-related diseases.

Phyto-N, a botanical drug candidate, has shown potential in preclinical studies as an alternative approach to gout treatment. These studies suggest that Phyto-N may reduce the activation of the NLRP3 inflammasome through ubiquitination modification and other pathways, thereby decreasing the secretion of downstream inflammatory factors.

Gouty Nephritis

Gouty nephritis is characterized by hyperuricemia accompanied by renal damage. Due to disturbances in purine metabolism in the body, uric acid is either overproduced or excreted insufficiently, leading to prolonged saturation of uric acid in the body. Subsequently, the deposition of urate crystals in the kidneys causes damage, leading to gouty nephritis.

Uric acid (UA), creatinine (Cr), blood urea nitrogen (BUN) are important indicators for evaluating renal function. Higher levels of these substances in the blood typically indicate impaired kidney function. Xanthine oxidase (XOD) and adenosine deaminase (ADA) are key enzymes in the process of uric acid production, while TNF-α, Caspase-1, IL-6, IL-18, IL-1β, and NLRP3 are important inflammatory factors in the body. These inflammatory factors are proteins that promote inflammation and are often elevated in various diseases.

Animal experiments have suggested the potential good therapeutic effect of Phyto-N on gouty nephritis. 60 SPF-grade (Specific Pathogen Free, meaning the animals are free from certain pathogens) male KM mice were administered an oral suspension of adenine (100mg/kg) and potassium oxonate (500mg/kg) to induce hyperuricemia and renal damage. The animals were then divided into three groups, receiving either Phyto-N (2.6g/kg/d), the positive control drug nifedipine (5.2mg/kg/d), or physiological saline for 3 weeks via gastric lavage.

The results demonstrated that Phyto-N significantly reduced serum levels of uric acid (UA), creatinine (Cr), blood urea nitrogen (BUN), xanthine oxidase (XOD), and adenosine deaminase (ADA), which are key indicators of renal function and uric acid metabolism (Figure 19). Histological analyses revealed that Phyto-N treatment improved renal fibrosis (scarring of kidney tissue), glomerular atrophy (shrinkage of kidney filtering units), and tubular dilatation (widening of kidney tubules) caused by the adenine and potassium oxonate administration.

Figure 19. Pharmacological Effects of Phyto-N on Gouty Nephritis

Note: (A) UA, Cr and BUN in mice serum; (B) XOD, ADA in mouse liver and SOD in mice kidney. The result is represented by x̅±S. x̅±S means the average plus or minus the standard deviation, a measure of variability in the data. * indicates P<0.05; ** indicates P<0.01. P-values indicate the statistical significance of the results, with lower values suggesting stronger evidence.

Furthermore, Phyto-N increased the activity of superoxide dismutase (SOD) in the kidneys, an important antioxidant enzyme which helps protect cells from damage caused by harmful molecules, and significantly decreased the levels of inflammatory factors TNF-α, Caspase-1, IL-6, IL-18, IL-1β, and NLRP3 (Figure 20). These findings suggest that Phyto-N may exert its therapeutic effects by modulating oxidative stress and inflammation in gouty nephritis animal model.

Figure 20. Pharmacological Effects of Phyto-N on Gouty Nephritis

Inflammatory factors in mice kidney. The result is represented by x̅±S. * indicates P<0.05; ** indicates P<0.01.

Notably, during the experiment, Phyto-N also demonstrated a positive impact on the body weight and food intake of the gouty nephritis mice, suggesting its potential to improve overall health and quality of life in the context of this disease. In summary, the preclinical data suggested that Phyto-N can significantly alleviate inflammation in gouty nephritis and effectively reverse the symptoms of this condition by targeting the underlying pathogenic mechanisms in gout animal model.

Gouty Arthritis

Gouty arthritis, another manifestation of gout, occurs when urate crystals deposit in the joints due to prolonged hyperuricemia, leading to intense pain, swelling, and inflammation. This condition can significantly impact patients’ mobility and quality of life. To evaluate the potential positive effects of Phyto-N on treating gouty arthritis, a preclinical study was conducted using SPF-grade male SD rats. The animals were divided into three groups, receiving either Phyto-N (1.8g/kg/d), the positive control drug colchicine (0.3mg/kg/d), or physiological saline via gastric lavage for 7 days. On the seventh day, gouty arthritis was induced by injecting a 0.7% acetic acid solution intraperitoneally, with the dose adjusted according to the rats’ body weight. The analgesic effect of Phyto-N was assessed by measuring the number of twists after the acetic acid injection and the activity time in an open field experiment (Figure 21 A,B). These measurements are used to evaluate pain and discomfort in animal models. The results showed that Phyto-N significantly reduced pain-related behavior, demonstrating its potent analgesic properties. Moreover, following the intra-articular injection of urate crystals injection into the joint, rats in the Phyto-N group experienced a transient decrease in food intake and body weight, followed by a rapid rebound the next day. The rebound rate in the Phyto-N group was superior to that observed in the gouty arthritis model rats, suggesting that Phyto-N may promote recovery and mitigate the systemic effects of acute inflammation.

The anti-inflammatory effects of Phyto-N were further evaluated by measuring joint swelling at various time points (2h, 4h, 6h, 8h, 10h, 12h, and 24h) after urate crystal injection. Phyto-N treatment significantly reduced joint swelling compared to the control group, indicating potential effects on local inflammation in this animal model (Figure 21C). To assess potential effects of Phyto-N on liver and kidney function, serum levels of uric acid, creatinine (CREA), urea, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were measured in the animal model. ALT and AST are enzymes that can indicate liver damage when elevated in the blood. All five indicators decreased following Phyto-N administration, suggesting no observed adverse effects on the liver or kidneys function in this animal model (Figure 22).

Figure 21. Pharmacological Effects of Phyto-N on Gouty Arthritis

Note: (A) rats twist counts; (B) Rats activity time; (C) Swelling index of rats’ ankle joints at various time points; The result is represented by x̅±S. * indicates P<0.05; ** indicates P<0.01.

Figure 22. Pharmacological Effects of Phyto-N on Serum Biochemical Parameters in Rats Gouty Arthritis

Note: The result is represented by x̅±S. * indicates P<0.05; ** indicates P<0.01.

These studies were conducted in Yunnan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences in China. In conclusion, the experimental results suggest analgesic and anti-inflammatory effects of Phyto-N in preclinical models of gouty arthritis, with no observed any apparent side effects on the liver or kidneys in these studies. These findings suggest the promising therapeutic potential of Phyto-N in the management of this debilitating condition. As Curanex advances Phyto-N through clinical development for the treatment of gout, we believe that this botanical drug candidate may offer an alternative to current therapies.

By potentially affecting the underlying inflammatory pathways and reducing the activation of the NLRP3 inflammasome, Phyto-N has the potential to provide relief from both gouty nephritis and arthritis. The preclinical data, showing Phyto-N’s ability in animal models to reduce serum uric acid levels, alleviate inflammation, improve renal function, and mitigate pain and joint swelling, provide a basis for further clinical investigation. As we progress Phyto-N through clinical trials, we aim to develop a potential treatment option for gout patients worldwide, addressing the need for additional therapies in this field. However, it is important to note that results from preclinical studies may not necessarily translate to human patients, and the safety and efficacy of Phyto-N in humans can only be determined through rigorous clinical trials.

Competition

The pharmaceutical industry is characterized by rapidly advancing technologies and intense competition. While we believe that our knowledge, experience, and scientific resources provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies and public and private research institutions. Any product candidates for which we complete clinical development successfully and for which we receive marketing approval may compete with existing therapies and new therapies that may become available in the future.

Many of our competitors have far greater marketing and research capabilities than us, such as Regeneron/Sanofi, Pfizer, LEO Pharma, Eli Lilly, Galderma, AbbVie, and Novartis, among others (Source: Market Data Forecast, 2023). These companies are focused on developing novel biologics, expanding their product portfolios, and investing in R&D to maintain their market position.

We also face potential competition from academic institutions, government agencies and private and public research institutions, among others, which may in the future develop products to treat those diseases that we currently or, in the future, seek to treat. The current market for treatments that assist in novel therapeutics for major unmet medical needs, is highly unknown. Our commercial opportunity would be reduced significantly if our competitors developed and commercialize products that are safer, more effective, more convenient, have fewer side effects or are less expensive than our product candidates.

Regulation

The development, manufacturing, and commercialization of our botanical drug product candidates are subject to extensive regulation by authorities in the United States and other countries. In the United States, the FDA is the primary regulatory agency overseeing the approval and marketing of new drugs. FDA imposes substantial requirements upon the research, development, preclinical and clinical testing, labeling, manufacture, quality control, storage, approval, advertising, promotion, marketing, distribution, and export of pharmaceutical products, including biologics, as well as significant reporting and record-keeping obligations. State governments may also impose obligations in these areas.

In the United States, pharmaceutical products are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act, or FDCA, and other laws, including in the case of biologics, the Public Health Service Act. We believe, but cannot be certain, that our products will be regulated as biologics and drugs by the FDA. The process required by the FDA before biologics or drugs may be marketed in the United States generally involves the following:

The testing and approval process requires substantial time, effort, and financial resources, and we cannot be certain that any approval will be granted on a timely basis, if at all.

The results of the preclinical tests, together with initial specified manufacturing information, the proposed clinical trial protocol, and information about the participating investigators, are submitted to the FDA as part of an IND, which must be approved before we may begin human clinical trials. Additionally, an independent Institutional Review Board at each clinical trial site proposing to conduct the clinical trials must review and approve each study protocol and oversee conduct of the trial. An IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises concerns or questions about the conduct of the trials as outlined in the IND and imposes a clinical hold. If the FDA imposes a clinical hold, the IND sponsor must resolve the FDA’s concerns before clinical trials can begin. Pre-clinical tests and studies can take several years to complete, and there is no guarantee that an IND we submit based on such tests and studies will become effective within any specific time period, if at all.

Human clinical trials are typically conducted in three sequential phases that may overlap:

Results of preclinical studies and trials, as well as detailed information about the manufacturing process, quality control methods, and product composition, among other things, are submitted to the FDA as part of an NDA seeking approval to market and commercially distribute the product on the basis of a determination that the product is safe and effective for its intended use. NDAs are used for products that are regulated as drugs, such as synthetic chemicals. Before approving an NDA, the FDA will inspect the facilities at which the product is manufactured and will not approve the product unless cGMP compliance is satisfactory. If applicable regulatory criteria are not satisfied, the FDA may deny the NDA or require additional testing or information. As a condition of approval, the FDA also may require post-marketing testing or surveillance to monitor the product’s safety or efficacy. Even after an NDA is approved, the FDA may impose additional obligations or restrictions (such as labeling changes), or even suspend or withdraw a product approval on the basis of data that arise after the product reaches the market, or if compliance with regulatory standards is not maintained. We cannot be certain that any NDA we submit will be approved by the FDA on a timely basis, if at all. Also, any such approval may limit the indicated uses for which the product may be marketed. Any refusal to approve, delay in approval, suspension or withdrawal of approval, or restrictions on indicated uses could have a material adverse impact on our business prospects.

Satisfaction of FDA requirements typically takes several years. The actual time required varies substantially, based upon the type, complexity, and novelty of the pharmaceutical product, among other things. Government regulation imposes costly and time-consuming requirements and restrictions throughout the product life cycle and may delay product marketing for a considerable period of time, limit product marketing, or prevent marketing altogether. Success in pre-clinical or early-stage clinical trials does not assure success in later stage clinical trials. Data obtained from preclinical and clinical activities is not always conclusive and may be susceptible to varying interpretations that could delay, limit, or prevent marketing approval. Even if a product receives marketing approval, the approval is limited to specific clinical indications. Further, even after marketing approval is obtained, the discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.

As a company focused on botanical drug development, we are committed to complying with all applicable laws, regulations, and guidance set forth by the FDA and other relevant regulatory bodies, although it is costly and time-consuming. We recognize that the path to approval for botanical drugs may differ from that of traditional small molecules or biologics, and we will work closely with the FDA to ensure that our development programs meet the necessary requirements for safety, efficacy, and quality.

Botanical Drug Development Considerations

The FDA has established a specific framework for the development and review of botanical drugs. Within the FDA, the Center for Drug Evaluation and Research (CDER) is responsible for reviewing botanical drug applications. Specifically, the Office of New Drugs (OND), the Office of Nonprescription Drugs, and the Division of Clinical Evaluation and Pharmacology/Toxicology are involved in this process.

A key component of this framework is the Botanical Review Team (BRT), a specialized group within CDER that provides expertise in evaluating the unique challenges and scientific considerations involved in the development and regulation of botanical drugs. The BRT works to ensure that botanical drugs meet the same standards of quality, safety, and efficacy as other drug products.

The FDA has published a comprehensive guide, “Botanical Drug Development Guidance for Industry,” which outlines the process and requirements for developing botanical drugs. This guidance acknowledges the unique characteristics of botanical drugs, such as their complex nature and potential history of traditional use, while maintaining rigorous standards for safety and efficacy.

While the fundamental requirements for approval remain the same as for conventional drugs, the FDA’s approach recognizes the distinctive aspects of botanical drugs. Each botanical drug candidate is evaluated on a case-by-case basis, considering its specific properties and the totality of evidence supporting its use.

Unique challenges in botanical drug development include:

These unique aspects of botanical drug development may result in a more complex and potentially longer regulatory review process, additional costs, and a higher risk of regulatory delays or rejections compared to conventional drug development.

Our Regulatory Strategy for Phyto-N

Considering these unique challenges for botanical drugs, our regulatory strategy for Phyto-N is tailored to address these specific issues while meeting FDA requirements. Key components of our regulatory approach include:

1. Engaging early and often with the FDA: We will proactively seek guidance from the FDA on the most appropriate development path for Phyto-N, including the design of preclinical studies, clinical trials, and CMC (Chemistry, Manufacturing, and Controls) requirements. By maintaining an open and transparent dialogue with the agency, we aim to minimize regulatory risks and optimize our chances of success.

2. Leveraging existing human experience: Phyto-N has a long history of human use as an herbal medicine, with thousands of patients having used it over the past 30 years. We will work with the FDA to determine how this real-world evidence can be incorporated into our development program to potentially streamline the path to approval.

3. Conducting rigorous preclinical and clinical studies: While Phyto-N has a long history of human use, we recognize the need to generate robust scientific evidence to support its efficacy and safety in the target indications. We will conduct well-designed, adequately powered, and properly controlled studies to meet the evidentiary standards required by the FDA and other regulatory agencies.

4. Implementing cGMP compliance: We will ensure that our manufacturing processes and facilities for Phyto-N adhere to current Good Manufacturing Practices (cGMP) as required by the FDA. This includes implementing strict quality control measures, validating analytical methods, and maintaining comprehensive documentation to ensure the consistency, purity, and potency of our botanical drug product.

5. Navigating accelerated approval pathways: Where appropriate, we will explore accelerated approval pathways available for botanical drugs, such as the Fast Track and Breakthrough Therapy designations, which can expedite the development and review process for promising therapies that address serious or life-threatening conditions with high unmet medical needs.

6. Protecting intellectual property: We will build a strong patent portfolio around Phyto-N and its therapeutic uses, to ensure market exclusivity and protect our investment in research and development. We will also safeguard our proprietary knowledge and trade secrets related to the sourcing, processing, and formulation of our botanical drug product.

7. Maintaining ethical standards: Throughout our development and commercialization activities, we will adhere to the highest ethical standards and ensure the protection of patient rights, data privacy, and scientific integrity. We will conduct our clinical trials in accordance with Good Clinical Practices (GCP) and obtain proper informed consent from all participants.

Our activities also may be subject to state laws and regulations that affect our ability to develop and sell our products. We are also subject to numerous federal, state, and local laws relating to such matters as safe working conditions, clinical, laboratory, and manufacturing practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. We may incur significant costs to comply with such laws and regulations now or in the future, and the failure to comply may have a material adverse impact on our business prospects. In addition to complying with FDA regulations, we may be subject to varied regulations in other countries, governing clinical trials, manufacturing, product registration, approval, and pharmaceutical sales. These regulations may differ from those of the FDA, and we must obtain separate approvals from the regulatory authorities of each country prior to commencing product marketing in those countries.

The approval process and requirements vary from country to country, and the time required for approval may be longer or shorter than that required by the FDA. In some countries, regulatory authorities also establish pricing and reimbursement criteria, which can impact the commercial viability of our products.

As part of our global regulatory strategy, we will:

1. Engage with foreign regulatory agencies early in the development process to understand their specific requirements and expectations for botanical drug approval.

2. Design our clinical trials to meet the standards of both the FDA and foreign regulatory agencies, to minimize duplication of efforts and streamline the global development process.

3. Seek out experienced partners and consultants with expertise in navigating the regulatory landscapes of our target markets, to ensure compliance and maximize our chances of success.

4. Monitor evolving regulations and guidance in key markets, and adapt our strategies as needed to stay compliant and competitive.

In China, where Phyto-N has been studied as an herbal medicine, we have accumulated data from hundreds to thousands of patients over thirty years, under the supervision of licensed traditional Chinese medicine practitioners. According to Chinese law, these practitioners can prescribe herbal medications to treat diseases based on their experience and expertise. The clinical observations suggest that Phyto-N may have potential therapeutic effects in various diseases.

The real-world evidence collected in China may provide valuable insight into the potential of Phyto-N as a therapeutic agent. These reports have inspired us to pursue the rigorous scientific research and clinical development necessary to evaluate Phyto-N’s safety and efficacy and seek FDA approval as a botanical drug. As we move forward with our global development plans, we will conduct preclinical and clinical studies under the regulations of the FDA and other relevant authorities to generate the evidence needed to support the approval of Phyto-N for specific indications. We will also work closely with these regulatory agencies to ensure that our research, manufacturing, and marketing practices comply with all relevant laws and regulations in each country where we seek to commercialize Phyto-N.

MANAGEMENT

The following are our executive officers and directors and their respective ages and positions as of the date of this prospectus.

Jun Liu, 61, became our Chief Executive Officer and President in February 2024, and a member of the Board in June 2024, upon the Reincorporation. Mr. Liu has three decades of real estate development experience, having developed over a million square meters of commercial and residential properties in various cities across China. He also has over twenty years of experience in pharmaceutical investment and research, operating traditional Chinese medicine clinics and private hospitals in Hong Kong and mainland China. In the pharmaceutical sector, Mr. Liu has taken leadership roles in research and development, focusing on both botanical and chemical drugs. Since 2020, he has served as the President of Duraviva Pharma Inc, a company in which he and his immediate family own a majority of the equity and voting power, where he oversees strategic planning, business development, and overall management of the company’s operations. Since 2018, he has also offered consultancy services and served as the Manager of TCM Group Inc., another entity where he and his family hold a majority of the equity ownership and voting power, where he provides guidance on strategic initiatives, manages key client relationships, and ensures the delivery of high-quality consultancy services. Mr. Liu received his BA in 1988 from Northeast Normal University. Mr. Liu is qualified to serve on our Board due to his extensive experience in real estate development, pharmaceutical investment and research, and executive leadership roles in multiple successful ventures.

Dian Ying Jing, 58, has been our Secretary since inception. From inception to January 31, 2025, she also served as our director. From 2018 until February 2024, she also served as our Chief Executive Officer and President and from 2018 until June 2024, she served as our Treasurer, where she oversaw the Company’s financial operations, managed relationships with investors and stakeholders, and provided strategic leadership to drive the Company’s growth and development. She is the wife of the Company’s Chief Executive Officer and President, Jun Liu, and together with him and their son, Chang Liu, owns a majority of the equity ownership and the voting power of the Company. She also serves as the director of Duraviva. She provides R&D services for botanical and chemical drugs. Since 2017, she serves as President of TCM Group Inc, where she provides consultation service for herbal products. Ms. Jing holds a bachelor’s degree from Northeast Normal University in 1989.

Haiyan Yang, 45, joined the Company as the Chief Financial Officer and Treasurer in June 2024, upon the Reincorporation. She is a Certified Public Accountant and possesses over 17 years of experience in finance and business management, including strategy, finance, operations, FP&A, M&A advisory, and investor relations. Since 2018, she serves as the CFO of Apollo Program, a leading data-driven advertising technology SaaS company, where she oversees all operational, financial, and administrative functions. From 2022 to 2024, she served on the board of directors of Troika Media Group, a NASDAQ-traded company, where she provided strategic financial oversight and governance. In 2022, she founded NID Consulting Inc., a firm specializing in CFO/COO advisory services tailored to support various needs including IPO readiness, fundraising, capital structure optimization, restructuring, and strategic consulting, where she continues to offer her expertise in financial and operational management.

Ms. Yang received her BA in English and International Business in 2001; MS in Applied Statistics in 2004 and her master’s degree in accounting in 2024 from Louisiana State University. We believe that Ms. Yang’s diverse and extensive professional experience make her a valuable asset in the field of financial leadership and strategic guidance.

Huijuan Zhong, PhD, 58, joined the Company as Chief Science Officer in June 2024, upon the Reincorporation, and was appointed as a member of the Board on February 1, 2025. She possesses over 23 years of experience in the pharmaceutical industry and has knowledge and expertise in drug substances and drug product development. Since 2021, she serves as associate director of Analytical Development at Karuna Therapeutics – a Bristol Myers Squibb company, providing a wide range of risk-based analytical development, method validation and transfer, and specification setting to support clinical programs from IND Phase I to NDA. Between June 2010 and July 2021, she worked as Principal Scientist at Rhodes Pharmaceuticals, where she took a leadership role and provided her expertise in drug substance and drug product development from preclinical development through clinical studies to NDA505(b)(2) filings and commercialization.

Dr. Zhong is a member of American Association for the Advancement of Science and American Chemical Society, American Association of Pharmaceutical Scientists and Sino-American Pharmaceutical Professionals Association EC member. Dr. Zhong is a co-author of many publications in the field of pharmaceutical industry and chemistry. She possesses a Postdoctoral in Analytical Chemistry from Northeastern University (1999-2001), a PhD in 1999 in Analytical Chemistry from, the University of York, UK, an MS in Environmental Analytical Chemistry from Nanjing University, China, in 1989, and BSc in Organic Chemistry from Nanjing University, China 1986. We believe that Dr. Zhong is qualified to serve on our Board due to her extensive experience in pharmaceutical industry, specifically in drug substance and drug product development.

Liqin Xie, PhD, 53, joined the Company as the Chief Operating Officer in June 2024, upon the Reincorporation. With over 15 years of experience across big pharma (Regeneron) and startup biotech (Surrozen), Dr. Xie possesses deep expertise in drug discovery and development for multiple diseases and program leadership, and he has a strong scientific acumen with over 50 publications and 5 patents. From 2018 to 2023, Dr. Xie held the position of Principal Scientist at Surrozen Inc., where he served as the team leader of Inflammatory Bowel Disease in vivo Pharmacology group, designed and conducted Pharmacokinetic/Pharmacodynamic experiments and toxicology analysis, prepared documents for IND filing, and led a first-in-class Ulcerative Colitis drug from discovery to IND.

Dr. Xie holds an M.D. from Beijing University of Chinese Medicine, an M.S. in Medicine (with a focus on Metabolism) from the Institute of Space Medico-Engineering of China, and a Ph.D. in Biomedical Engineering from the State University of New York at Stony Brook. We believe that his diverse skill set and extensive academic and professional accomplishments will help the Company in bringing innovative technologies and managing our business operations successfully.

Ning Zhang, PhD, 49, joined the Company as the Chief Technology Officer in June 2024, upon the Reincorporation. He has extensive experience in traditional Chinese medicine that drives innovation and advancement in pharmaceutical technologies. Since 2014, Dr. Zhang has served as a Professor of Traditional Chinese Medicine at Heilongjiang University of Chinese Medicine, assuming the role of Doctoral Supervisor in 2018, where he leads research projects, supervises doctoral students, and collaborates with industry partners to translate research findings into practical applications. In his academic capacity, Professor Zhang focuses his research on the extraction and identification of active pharmaceutical ingredients, alongside enhancing pharmaceutical dosage forms and pharmacokinetics.

Dr. Zhang holds a BA degree from Shanghai Medical University in 1993; Master’s and Doctoral degrees in Biomedicine and Chinese Medicine from Heilongjiang University of Chinese Medicine in 2003 and 2006, respectively. With his extensive academic background and dedication to advancing pharmaceutical science, the Board believes that Dr. Zhang plays a crucial role in driving technological innovation and excellence at Curanex.

Yong Yan, PhD, 52, joined the Company as a member of the Board in June 2024, upon the Reincorporation. With nearly 25 years of experience in leading financial firms such as Credit Suisse, Merrill Lynch, PingAn Group, and Fosun Group, he has extensive expertise in securitization, structured products, tokenization, and fintech. Since December 2022, he has served as the CEO and Director of AlphaVest Acquisition Corp, a SPAC listed on NASDAQ, where he oversees the company’s strategic direction, identifies and evaluates potential acquisition targets, and leads the process of bringing the acquired company public. He is also the CFO and Director of BitDATA Exchange in Singapore, a regulated digital asset trading platform based on blockchain technology, since May 2020, where he manages the company’s financial operations, ensures regulatory compliance, and contributes to the development and implementation of strategic initiatives. Previously, he was a Partner at Shanghai V-Stone Capital from January 2018 to January 2023, leading venture capital and private equity investments in fintech and digital assets. His notable achievements include co-founding BitDATA Exchange and leading the first internet-based financial platform using securitization technology for Fosun Group. He holds a Ph.D. in Finance from the University of Alabama and a bachelor’s degree in economics from Fudan University. Mr. Yan is qualified to serve on our Board due to his extensive experience in finance, particularly in the areas of securitization, structured products, and digital assets, as well as his leadership roles in successful ventures and his strong academic background in finance and economics.

Xiaohui Hao, 60, joined the Company as a member of the Board in June 2024, upon the Reincorporation. Since January 2021, he serves as the Executive Director & Co-CEO of Citychamp Watch & Jewellery Group Limited, where he oversees the group’s strategic direction, business operations, and risk management, while ensuring compliance with regulatory requirements and corporate governance standards. Since January 2021, he is serving as a member of the Risk Management Committee of the Board of Directors of Bendera Bank (the wholly owned subsidiary of Citychamp Watch & Jewellery Group Limited) to manage various risks, including management risk, operational risk and liquidity risk. From September 2020 to February 2021, he served as Vice Chairman of the board of directors of China Chunlai Education Group (HK1069), where he provided strategic guidance, supported the development and implementation of the company’s growth plans, and ensured effective corporate governance practices. He also served as a non-executive director and vice chairman of Chunlai Education during the same period. From February 2018 to April 2020, Mr. Hao served as Chairman of the Board of Directors and the CEO of Yuanyin International Limited, where he formulated the overall development strategy of the company and control the development risks of various business of the company. He received a bachelor’s degree from Henan University in Economics and Law in 1988; master’s degree from Xiamen University in 1999; master’s degree from University of Northumbria in 2003. He is a PhD candidate. Mr. Hao is qualified to serve on our Board due to his extensive experience in corporate leadership, strategic planning, and risk management across various industries, including banking, education, and international business, as well as his strong academic background in economics, law, and management.

Helen Hsu, MD, MS, 62, joined the Company as a member of the Board on November 1, 2024, upon resignation of Yanming Du. Dr. Hsu has over 30 years of experience in the pharmaceutical industry, academia, and clinical settings. Since December 2023, Dr. Hsu has served as the VP of Medical Science at Phamaron Clinical Services, where she leverages her deep expertise in oncology research, medical affairs, and clinical operations to drive innovative programs. From March 2021 to July 2023, Dr. Hsu held the role of Senior Medical Director, Global Oncology Clinical Development at IPSEN BioPharma Epizyme Pharmaceutical From 2015 to 2020, she was the Head of Oncology/Hematology Research at an US Cancer Centers and an International Cancer Hospital affiliated with Harvard Medical School. Her clinical research and medical affairs experiences has spanned in GSK, Novartis and BI global pharmaceuticals from 2000 - 2013. She also served as a Medical Consultant, CMO, and Strategy Advisor for Biotech, CRO, Medical Device companies, Cancer Centers, and Healthcare Investment Groups for over 10 years. Dr. Hsu received an MD degree from Southeast University Medical School in China and a Master of Science in Molecular Biology and Clinical Lab Science from Michigan State University. In addition to her clinical practice in China, she has been trained in medical science and genetic search at Albert Einstein College of Medicine and North Shore University Hospital in NY.

We believe that Dr. Hsu’s diverse background, strong track record in leading global clinical research programs, medical strategy, drug discovery, product launches, and her leadership abilities make her an invaluable addition to our Board.

Board Of Directors

Our Board consists of five (5) directors. A director is not required to hold any shares in the Company to qualify to serve as a director. A director who is in any way, whether directly or indirectly, interested in a contract or transaction or proposed contract or transaction with the Company is required to declare the nature of his interest at a meeting of our directors. A director may vote with respect to any contract or transaction or proposed contract or transaction notwithstanding that he may be interested therein, and if he does so his vote shall be counted and he may be counted in the quorum at any meeting of our directors at which any such contract or transaction is considered. Our directors may exercise all the powers of the Company to borrow money, mortgage or charge its undertaking, property and uncalled capital and to issue debentures or other securities whenever money is borrowed or as security for any debt, liability or obligation of the Company or of any third party.

Directors serve until the next annual meeting and until their successors are elected and qualified. Officers are appointed to serve for one year until the meeting of the Board following the annual meeting of shareholders and until their successors have been elected and qualified.

Director Independence

Our Board has reviewed the independence of our directors, applying Nasdaq independence standards. Nasdaq Listing Rule 5605(a)(2) provides that an “independent director” is a person other than an officer or employee of the company or any other individual having a relationship which, in the opinion of the Board, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. The Nasdaq listing rules provide that a director cannot be considered independent if:

Based on this review, the board determined that each of Yong Yan, PhD, Helen Hsu, M.D. and Xiaohui Hao, is “independent” within the meaning of the Nasdaq Listing Rules. In making this determination, our Board considered the relationships that each of these non-employee directors has with us and all other facts and circumstances our Board deemed relevant in determining their independence. As required under applicable Nasdaq rules, we anticipate that upon the effectiveness of the registration statement of which this prospectus forms a part, our independent directors will meet on a regular basis as often as necessary to fulfill their responsibilities, including at least annually in executive session without the presence of non-independent directors and management.

Committees of the Board

We established three Board committees: an audit committee, a compensation committee and a nominating and corporate governance committee and adopted a charter for each of the three committees. Each committee’s members and functions are described below.

Audit Committee. Our audit committee consists of Yong Yan, Helen Hsu, and Xiaohui Hao, and is chaired by Yong Yan. Each member of our audit committee satisfies the “independence” requirements of Rule 5605(c)(2) of the Listing Rules of Nasdaq and meets the independence standards under Rule 10A-3 under the Exchange Act. We have determined that Yong Yan qualifies as an “audit committee financial expert.” The audit committee will oversee our accounting and financial reporting processes and the audits of the financial statements of the Company. The audit committee will be responsible for, among other things:

Compensation Committee. Our compensation committee consists of Yong Yan, Helen Hsu, and Xiaohui Hao, and is chaired by Xiaohui Hao. Each member of our compensation committee satisfies the “independence” requirements of Rule 5605(c)(2) of the Nasdaq Listing Rules. The compensation committee will assist the Board in reviewing and approving the compensation structure, including all forms of compensation, relating to our directors and executive officers. Our Chief Executive Officer may not be present at any committee meeting during which his compensation is deliberated upon. The compensation committee will be responsible for, among other things:

Nominating Committee. Our nominating committee consists of Yong Yan, Helen Hsu, and Xiaohui Hao, and is chaired by Dr. Helen Hsu. Each member of our nominating committee satisfies the “independence” requirements of Rule 5605(c)(2) of the Listing Rules of Nasdaq. The nominating committee will assist the board in selecting individuals qualified to become our directors and in determining the composition of the Board and its committees. The nominating committee will be responsible for, among other things:

Family Relationship

Except for our Chief Executive Officer, director and President, Jun Liu, and our Secretary, Dian Ying Jing, who are husband and wife, and for their son, Chang Liu, a beneficial owner of more than ten percent of the Company’s equity securities, there are no family relationships between the Company’s directors, officers, persons nominated or chosen by the issuer to become directors or officers, or beneficial owners of more than 10% of any class of the issuer’s equity securities.

Code of Ethics

Our Board adopted a written code of business conduct and ethics (“Code”) that applies to our directors, officers and employees, including our principal executive officer, principal financial officer and principal accounting officer or controller or persons performing similar functions. A copy of the Code is being filed as an exhibit to the registration statement of which this prospectus is a part. We are required to disclose any amendment to, or waiver from, a provision of our code of ethics applicable to our principal executive officer, principal financial officer, principal accounting officer, controller, or persons performing similar functions. We intend to use our website as a method of disseminating this disclosure as well as by SEC filings, as permitted or required by applicable SEC rules. Any such disclosure will be posted to our website within four (4) business days following the date of any such amendment to, or waiver from, a provision of our Code.

Board Leadership Structure and Risk Oversight

The Board oversees our business and considers the risks associated with our business strategy and decisions. The Board currently implements its risk oversight function as a whole. Each of the Board committees, as set forth below, will also provide risk oversight in respect of its areas of concentration and report material risks to the Board for further consideration.

Director Compensation

We do not have arrangements for compensation of our directors.

Involvement in Certain Legal Proceedings

To our knowledge, none of our current directors or executive officers has, during the past ten (10) years:

EXECUTIVE COMPENSATION

For the fiscal years ended December 31, 2024 and 2023, the Company did not make any compensation to Dian Ying, Jing, for her services as President, Secretary and Treasurer to the Company. Our current Chief Executive Officer and President, Jun Liu, was appointed to these offices in February 2024. The Company did not make any compensation to Jun Liu for the fiscal year ended December 31, 2024 for his services.

Equity Awards

None.

Employment Agreements

None.

Equity Incentive Plans

None.

Board Compensation

None.

Executive Incentive Compensation Recovery Policy

We have adopted an executive incentive compensation recovery policy (the “Recovery Policy”) pursuant to Section 10D of the Exchange Act, Rule 10D-1 promulgated under the Exchange Act (“Rule 10D-1”), and Listing Rule 5608 adopted by Nasdaq (the “Listing Standards”). The Recovery Policy will become effective upon the date of effectiveness of this registration statement. The purpose of the Executive Incentive Compensation Recovery Policy is to provide for the recovery of certain incentive-based compensation in the event of an accounting restatement. In the event of an accounting restatement, it is the Company’s policy to recover reasonably promptly the amount of any erroneously awarded compensation received during the recovery period. An accounting restatement involves a restatement of the Company’s financial statements due to material noncompliance with any financial reporting requirement under the federal securities laws, including any required accounting restatement to correct an error in previously issued financial statements that is material to the previously issued financial statements, or that would result in a material misstatement if the error were corrected in the current period or left uncorrected in the current period. The amount of “erroneously awarded compensation” generally means the amount of incentive-based compensation (compensation that is granted, earned, or vested based wholly or in part upon the attainment of a financial reporting measure) received by a covered executive that exceeds the amount of incentive-based compensation on that otherwise would have been received had it been determined based on the restated financial statements. The Company need not recover any “erroneously awarded compensation” if and to the extent that the Compensation Committee or a majority of the independent members of the Board determines that such recovery is impracticable and not required under Rule 10D-1 and the Listing Standards, including if the Compensation Committee or a majority of the independent members of the Board determines that: (i) the direct expense paid to a third party to assist in enforcing the policy would exceed the amount to be recovered after making a reasonable attempt to recover, or (ii) recovery would likely cause an otherwise tax-qualified broad-based retirement plan to fail the requirements of Section 401(a)(13) or Section 411(a) of the Internal Revenue Code of 1986, as amended, and regulations thereunder.

Once the Recovery Policy becomes effective, it will be administered by our Compensation Committee, except that the Board may decide to act as the administrator in lieu of the Compensation Committee or designate another committee of the Board (including a special committee) to act as the administrator other than the determination that recovery of “erroneously awarded compensation” is impracticable and not required (as described above).

The foregoing description of the Recovery Policy is qualified in its entirety by the full text of the same, which is attached hereto as Exhibit 10.4 and which is herein incorporated by reference.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

The following table sets forth certain information, as of the date of this prospectus, with respect to the holdings of (1) each person who is the beneficial owner of more than 5% of Company voting stock, (2) each of our directors, (3) each executive officer and (4) all of our current directors and executive officers as a group. Beneficial ownership of the voting stock is determined in accordance with the rules of the SEC. Under these rules, a person is deemed to be a beneficial owner of a security if that person directly or indirectly has or shares voting power, which includes the power to vote or direct the voting of the security, or investment power, which includes the power to dispose or direct the disposition of the security. The person is also deemed to be a beneficial owner of any security of which that person has a right to acquire beneficial ownership within 60 days from the date of this prospectus. Under these rules, more than one person may be deemed to be a beneficial owner of the same securities, and a person may be deemed to be a beneficial owner of securities as to which he or she may not have any pecuniary interest.

Except as otherwise indicated, the persons named in this table have sole voting and investment power with respect to all shares of voting stock held by them. Applicable percentage ownership in the following table is based on 24,000,000 shares of common stock issued and outstanding as of the date of this prospectus (excluding shares which may be sold upon exercise of the underwriters’ Over-allotment Option), 1,000,000 shares of Series A Preferred Stock outstanding as of the date of this prospectus and any securities that individual has the right to acquire within 60 days from the date of this prospectus. The percentage of voting power of Series A Preferred Stock in the table below is calculated based on the voting power of 1,000,0000 shares of Series A Preferred Stock outstanding as of the date of this prospectus; holders of which are entitled to 40% votes on all matters submitted to a vote of stockholders. Unless otherwise indicated, the principal address of the named directors and directors and 5% stockholders of the Company is c/o Curanex Pharmaceuticals Inc, 2 Jericho Plaza, Suite 101B, Jericho, NY 11753.