AN OFFERING STATEMENT PURSUANT TO REGULATION A RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. INFORMATION CONTAINED IN THIS PRELIMINARY OFFERING CIRCULAR IS SUBJECT TO COMPLETION OR AMENDMENT. THESE SECURITIES MAY NOT BE SOLD NOR MAY OFFERS TO BUY BE ACCEPTED BEFORE THE OFFERING STATEMENT FILED WITH THE COMMISSION IS QUALIFIED. THIS PRELIMINARY OFFERING CIRCULAR SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY NOR MAY THERE BE ANY SALES OF THESE SECURITIES IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL BEFORE REGISTRATION OR QUALIFICATION UNDER THE LAWS OF SUCH STATE. THE COMPANY MAY ELECT TO SATISFY ITS OBLIGATION TO DELIVER A FINAL OFFERING CIRCULAR BY SENDING YOU A NOTICE WITHIN TWO BUSINESS DAYS AFTER THE COMPLETION OF THE COMPANY’S SALE TO YOU THAT CONTAINS THE URL WHERE THE FINAL OFFERING CIRCULAR OR THE OFFERING STATEMENT IN WHICH SUCH FINAL OFFERING CIRCULAR WAS FILED MAY BE OBTAINED.

Offering Circular Dated: 01/01/2026

Offering Termination Date: 12/31/2025

Niihara International, Inc.

Maximum Total Offering $20,000,000

Up to $20,000,000 of Offering Amount Available in Original Issuance Common Shares

(10,000,000 Common Shares)

This Offering has been prepared in compliance with the Offering Circular Format contained in Part II of Form 1-A, as called for under Regulation A of the Securities Act of 1933, as amended.

Niihara International, Inc. (the “Company”) is offering the following securities on a “best efforts” basis:

• 10,000,000 shares of common stock originally issued by the Company

All of the securities made available in this Offering shall be called the "Offering Securities.” Since there is no minimum amount of securities that must be purchased, all investor funds will be available to the Company upon commencement of this Offering and no investor funds will be returned if an insufficient number of securities are sold to cover the expenses of this Offering and provide net proceeds to the Company. Investor funds received in this Offering will not be held in escrow.

The minimum purchase requirement per investor is $1,000; however, the Company can waive the minimum requirement on a case-by-case basis in its sole discretion. The Company expects to commence the sale of the Offered Securities as of the date

on which the Offering Statement (“Offering Statement”) of which this Offering Circular is a part, is qualified by the United States Securities and Exchange Commission (the “SEC”).

Prior to this Offering, there has been no trading market for our common stock.

A maximum of $20,000,000 of Offered Securities will be offered worldwide. No sales of Offered Securities will be made anywhere in the world prior to the qualification of the Offering Statement by the SEC in the United States. All Offered Securities will be initially offered in the jurisdiction at the same U.S. dollar price that is set forth in this Offering Circular.

(1) We are not currently using commissioned sales agents or underwriters. 

These are speculative securities. Investing in our securities involves significant risks. You should purchase these securities only if you can afford a complete loss of your investment. See “Risk Factors” beginning on page 5.

The SEC does not pass upon the merits of or give its approval to any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering circular or other solicitation materials. These securities are offered pursuant to an exemption from registration with the SEC; however, the SEC has not made an independent determination that the securities offered are exempt from registration.

TABLE OF CONTENTS

THIS OFFERING CIRCULAR MAY CONTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO, AMONG OTHER THINGS, THE COMPANY, ITS BUSINESS PLAN AND STRATEGY, AND ITS INDUSTRY. THESE FORWARD-LOOKANG STATEMENTS ARE BASED ON THE BELIEFS OF, ASSUMPTIONS MADE BY, AND INFORMATION CURRENTLY AVAILABLE TO THE COMPANY’S MANAGEMENT. WHEN USED IN THE OFFERING MATERIALS, THE WORDS “ESTIMATE,” “PROJECT,” “BELIEVE,” “ANTICIPATE,” “INTEND,” “EXPECT” AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. THESE STATEMENTS REFLECT MANAGEMENT’S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS. INVESTORS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE ON WHICH THEY ARE MADE.

OFFERING CIRCULAR SUMMARY

The following summary highlights selected information contained in this Offering Circular. This summary does not contain all the information that may be important to you. You should read this entire Offering Circular carefully, including the sections titled “Risk Factors”, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statement and the related notes included elsewhere in this Offering Circular, before making an investment decision. Unless the context otherwise requires, the terms “Niihara International, Inc.”, “the Company,” “Se,” “us” and “our” in this Offering Circular refer to Niihara International, Inc.

OUR COMPANY

Niihara International, Inc. is a United States company.

THE OFFERING

RISK FACTORS

An investment in our securities involves a high degree of risk and many uncertainties. You should carefully consider the specific factors listed below, together with the cautionary statement that follows this section and the other information included in this Offering Circular, before purchasing securities in this offering. The risks and uncertainties described below are not the only ones that we face. Additional risks and uncertainties that we are unaware of may also become important factors that adversely affect our business. If one or more of the possibilities described as risks below actually occur, our operating results and financial condition would likely suffer and the trading price, if any, of our shares could fall, causing you to lose some or all of your investment. The following is a description of what we consider the key challenges and material risks to our business and an investment in our securities.

We may not successfully execute our business plan to generate revenue and create a sustainable growth trajectory

Niihara is an early-stage pharmaceutical startup that has not yet generated any commercial revenue. Our ability to succeed depends on our capacity to manufacture and sell a generic L-glutamine product named Entabor2 for the treatment of sickle cell disease. If we are unable to complete facility upgrades, meet regulatory standards, or establish a market presence, our ability to generate revenue and become self-sustaining could be compromised.

We may encounter unanticipated obstacles in executing our business plan

Niihara’s business plan requires regulatory approvals, significant capital investments, international distribution partnerships, and the establishment of a manufacturing infrastructure. Unexpected regulatory delays, quality assurance issues, or inability to convert our existing letters of interest into purchase agreements may impair our ability to carry out our business objectives. Furthermore, changes in market conditions or pharmaceutical pricing policies may also negatively impact our strategic execution.

We may experience fluctuations in operating results and our financial performance is difficult to predict

Due to our early stage of operations, lack of sales history, and dependence on international markets, our quarterly and annual results may be highly volatile. Variables such as production delays, regulatory reviews, international logistics, and timing of funding will all affect results. These factors make it difficult to forecast revenue, cash flow, and costs, and our operating results may fall significantly short of expectations.

We rely solely on one individual, and the loss of this person could cause our business to cease operations

As of the time of this Offering, Niihara’s only officer, director, and employee is Dr. Yutaka Niihara. Dr. Niihara plays a critical role in all aspects of the business, including product development, strategic planning, operations, and fundraising. If Dr. Niihara were to become unavailable for any reason, the Company’s operations would be severely disrupted, and the business could cease to function. Additionally, we currently do not maintain any Director & Officer insurance, which increases our exposure to potential liabilities in his absence.

We may not retain ownership of our manufacturing facility in Japan

Niihara acquired its factory in Ube, Japan using a promissory note that requires a single large balloon payment in the future. If we are unable to generate sufficient revenue or raise additional capital before the payment is due, we may default and lose the facility. Loss of the factory would significantly impair our ability to produce L-glutamine and delay or derail our commercialization plans.

Our factory requires significant capital investment before production can commence

Although we own the manufacturing facility in Ube, Japan, it is not currently operational for pharmaceutical manufacturing. We estimate that at least $1,000,000 in capital improvements will be required to make the facility suitable for GMP-compliant pharmaceutical production. If we do not raise sufficient funds from this Offering, we may not be able to complete these improvements, in which case we will not be able to initiate manufacturing.

We face strong competition from larger and more established companies

L-glutamine for sickle cell treatment is no longer protected by patent. Multiple pharmaceutical companies—including Dr. Niihara’s former company, Emmaus Life Sciences, Inc.—already have the capability and experience to manufacture and distribute this compound. Many of these companies have significantly greater financial resources, well-established production lines, and international distribution networks. Competing with these firms will be challenging, especially as a startup with limited personnel and funding.

Our initial expressions of interest are not binding and may not result in actual revenue

We have received letters of interest and non-binding purchase orders from parties located in India, Africa, Oman, and the broader Middle East. However, to date, no payments have been received, and none of these parties have completed a transaction. Due to the complexity of international trade and regulatory environments in these regions, there is significant uncertainty regarding the legitimacy and enforceability of these purchase orders.

We have no research and development capabilities beyond our founder

While Niihara plans to develop future pharmaceutical treatments, we do not currently have a research team or the necessary capital to begin development activities. Dr. Niihara is the only individual working on R&D at this time. Our ability to innovate and diversify our product offerings is therefore highly constrained until we secure further funding or add qualified personnel.

We may not raise sufficient funds through this Offering

We are seeking to raise up to $20,000,000 in gross proceeds from this Offering. If we raise significantly less than this amount, we may not have adequate resources to complete the necessary improvements to our factory, hire additional staff, fund operational costs, or bring our product to market. In that case, we may be required to seek additional capital or restructure our business plan, potentially to the detriment of early investors.

We are exposed to international manufacturing and regulatory risks

Our manufacturing operations will be based in Japan, and our sales efforts are initially focused on emerging markets in Africa, the Middle East, and Asia. Operating across these jurisdictions introduces risks related to logistics, currency exchange, foreign regulations, political instability, and legal enforcement. Any delays or complications in cross-border operations could have material adverse effects on our business.

We do not yet have product sales or regulatory approval for our pharmaceutical

Although L-glutamine is no longer under patent protection, regulatory approval is still required in each jurisdiction where we plan to sell. These processes vary significantly and can be costly and time-consuming. Until these approvals are secured, we cannot sell our product or generate revenue.

We lack financial diversification and operational depth

As a single-product, single-employee company, Niihara’s business model is highly concentrated and vulnerable to operational disruption, regulatory delay, or competitive pressures. The absence of operational redundancy, experienced staff, and a pipeline of diversified products leaves the company at heightened risk.

We Rely on a Single Supplier for Prescription-Grade L-Glutamine and a Single Packager for Our Finished Goods, Which Exposes Us to Supply Chain Disruptions That Could Delay Development and Commercialization Efforts

Our ability to develop and potentially commercialize our product candidates depends on a continuous supply of prescription-grade L-glutamine and timely packaging of our finished goods. We currently rely on a single supplier for prescription-grade L-glutamine and a single-source packager for the preparation of our finished products. This reliance on sole-source facilities exposes us to significant risks, including the possibility of interruptions due to manufacturing defects, contamination, labor shortages, equipment failure, regulatory non-compliance, natural disasters, or geopolitical events. Any disruption at the manufacturing facility or the packaging site could result in delays in clinical development, regulatory submissions, or potential product launch timelines. Furthermore, identifying and qualifying alternative sources could take significant time and resources and may not be successful, which could further delay our programs and adversely affect our business, financial condition, and results of operations.

As we do not have an escrow or trust account with this subscription, if we file for or are forced into bankruptcy protection, investors will lose their entire investment.

Invested funds for this offering will not be placed in an escrow or trust account and if we file for bankruptcy protection or a petition for involuntary bankruptcy is filed by creditors against us, your funds will become part of the bankruptcy estate and administered according to the bankruptcy laws. As such, you will lose your investment and your funds will be used to pay creditors.

There is no current market for the company’s securities

There is no formal marketplace for the resale of Niihara International, Inc.’s securities. The securities may or may not be traded on the over-the-counter market to the extent any demand exists. However, we do have plans to apply for or otherwise seek trading or quotation of the company’s securities in a later stage. Investors should assume that there will not be able to liquidate their investment for some time, or be able to pledge their shares as collateral.

We have established no minimum offering of our securities

Because there is no minimum offering of our securities, purchasers in this offering may be one of a few to purchase our securities and management’s plans for the offering proceeds may not be met, in which case the purchasers may lose their entire investment.

We do not anticipate paying dividends in the foreseeable future, so there will be less ways in which you can make a gain on any investment in the Company

We do not intend to pay any dividends for the foreseeable future. Further, to the extent that we may require additional funding currently not provided for in our financing plan, our funding sources may prohibit the declaration of dividends. Because we do not intend to pay dividends, any gain on your investment will need to result from an appreciation in the price of our Common Stock.

DILUTION

The price of the current offering is set as follows:

• $2 per Share of common stock for common stock to be originally issued by the Company

If you invest in our securities, your interest will be diluted.

Dilution represents the difference between the offering price and the net tangible book value per Common Shares immediately after completion of this offering. Net tangible book value is the amount that results from subtracting total liabilities and intangible assets from total assets. Dilution arises mainly as a result of the Company’s arbitrary determination of the offering

price of the Common Shares being offered. Dilution of the value of the securities you purchase is also a result of the lower book value of the Common Shares held by our existing securities holders.

Niihara International, Inc. has 145,167,494 Common Shares outstanding as of 03/02/2025. The following table demonstrates the dilution that new investors will experience relative to the Company’s net tangible book value of $-707,077 based on 145,167,494 Common Shares as of 06/01/2025.

The table represents three scenarios: $5,000,000 raised from this offering, $10,000,000 raised from this offering and a fully subscribed $20,000,000 raised from this offering. This table assumes that in each scenario the same percentage of securities being made available directly from the issuer as those securities being offered by existing securities holders are sold relative to the overall number of securities being made available in each of these respective groups.

Dilution Per Share 

The following table summarizes the difference between the existing securities holders and the new investors with respect to the number of Common Shares of common stock purchased, the total consideration paid, and the average price per share paid, if maximum offering price of reached.

Average Price Per Common Shares

PLAN DISTRIBUTION AND SELLING SECURITY HOLDERS

We are offering the following securities:

• 10,000,000 shares of common stock originally issued by the Company

All of the above securities are being offered on a “best efforts” basis.

Further, the collective securities mentioned are being offered directly by the Company to investors who meet the suitability standards set forth herein and on the terms and conditions set forth in this Offering Circular. All subscribers will be instructed by the company or its agents to transfer funds by wire or ACH transfer directly to the company account established for this Offering or deliver checks made payable to Niihara International, Inc.

The offering will terminate at the earlier of: (1) the date at which the maximum offering amount has been sold, (2) the date at which the offering is terminated by us in our sole discretion, but in no event for more than one year from the date that the Offering is qualified with SEC. We may undertake one of more closings on a “rolling” basis. After each closing, funds tendered by investors will be available to the Company. Upon closing, funds tendered by investors will be made available to us for our use.

We will use our existing website, www.niiharainternational.com, to provide notification of the Offering. Persons who desire

information may be directed to a website owned and operated by an unaffiliated third party (www.glassboxlaw.com) that provides technology support to issuers engaging in Regulation A offerings.

No dividends to purchasers of our offered securities are assured, nor are any returns on, or of, a purchaser’s investment guaranteed. Dividends are subject to our ability to generate positive cash flow from operations. All dividends are further subject to the discretion of our board of directors. It is possible that we may have cash available for dividends, but our board of directors could determine that the reservation, and not distribution, of such cash by our Company would be in our best interest.

You will be required to complete a subscription agreement in order to invest. We may be required to rely on pursuing private financing options in order to continue operations if it takes some time for us to raise funds in this offering.

SELLING SECURITY HOLDERS

The table below represents all of the Officers, Directors and 5%+ Owners of the Company that have included Common Shares for sale in this Offering.

Total Securities Being Offered by the Selling Security Holders designated above in This Offering: 0 Common Shares

Percentage of Pre-Offering Securities Being Offered by Selling Securities Holders in This Offering: NA

USE OF PROCEEDS TO ISSUER

The Company estimates that the net proceeds after all offering expenses will be approximately $20,000,000.00 if:

• We can sell 10,000,000 shares of common stock originally issued by the Company

A further sensitivity analysis is provided below assuming we raise 25%, 50% and 75% of the offering amount.

General Proposed Use of Funds:

We aim to retrofit our existing L-glutamine manufacturing facility in Japan (the "Manufacturing Facility") to begin production of our own generic L-glutamine, Entabor2. We expect to spend between $1,500,000 to $10,000,000 for both materials and contracting labor to upgrade the Manufacturing Facility. None of these funds will be paid to officers, directors or shareholders of the Company. Contemplated upgrades to the Manufacturing Facility are noted in the Capital Expenditures section of the Use of Proceeds table below.

The Company plans to upgrade its Manufacturing Facility so that the Company can control its supply chain and place the Company in a strategically competitive position with respect to the fulfilment of orders for sickle cell pharmaceuticals from India, Africa and the Middel East.

The active pharmaceutical Ingredient (API) in Entabor2 is from the same source with the same quality as the USFDA approved L-glutamine.

Objectives Targeted:

The primary objective of the funds raised through this offering is to enable the Company to begin commercialization of its primary product L-glutamine under the name Entabor2. The Company seeks to build a strong infrastructure that will enable Niihara International, Inc. to serve a large population of sickle cell patients across India, Africa, and the Middle East. By leveraging these resources, we aim to expand access to essential treatments in regions with significant unmet medical needs.

A substantial portion of the proceeds will be allocated to key operational initiatives, including:

* Procurement of Active Pharmaceutical Ingredients (API): Securing a reliable supply of API is essential for the production and distribution of our medications. This investment will ensure the steady availability of high-quality pharmaceutical materials necessary for our formulations.

* Hiring of Key Personnel: We plan to recruit experienced professionals, including executive officers and pharmaceutical specialists, who will play a pivotal role in executing our business strategy and driving operational efficiency.

* Establishment of Satellite Offices: To strengthen our presence in key international markets, we will establish satellite offices in India, the Middle East, and various African countries. These offices will facilitate local operations, regulatory compliance, and distribution efforts, ensuring efficient market entry and sustained growth.

Through these strategic investments, Niihara International, Inc. is committed to building a robust foundation for long-term success, enabling us to expand our reach and improve the quality of life for sickle cell patients in underserved regions.

Targeted Impact on Profitability and/or Enterprise Value:

The funds raised through this offering will provide Niihara International, Inc. with the necessary resources to transition into the revenue-generating phase of its operations. By strategically deploying these funds, we will be able to establish our supply chain, gain market presence, and initiate product distribution in key regions.

Based on our financial projections, once revenue generation begins, which is targeted within 2 years of the close of this offering, we anticipate achieving a profit margin of approximately 30%. Achieving this profit margin will not be dependent on the retrofit of our manufacturing facility, as we expect to be able to outsource manufacturing until our facility is complete. However, achieving our profit margin forecast will depend on our company receiving regulatory approval in at least one of the countries in which we aim to sell our products.

Our profit margin forecast reflects our efficient cost structure, strategic sourcing of Active Pharmaceutical Ingredients (API), and targeted market expansion efforts. Our ability to reach profitability will further support reinvestment into operations, enabling sustained growth and long-term value creation for our stakeholders.

Our profit margin projection considers our API costs, manufacturing labor and facilities costs, distribution costs, administrative costs, and tariffs. We have also assumed a customer base of 5,000 patients. We believe this customer base to be a conservative estimate, given that there are over 20 million potential patients in India alone.

Through this offering, Niihara International, Inc. is positioning itself for financial strength and scalability, ensuring that we can effectively meet the growing demand for our products while delivering strong returns.

The distribution of our use of net proceeds is listed as follows if 20%, 50%, 75% or 100% of the offering amount is raised.

1 See the accompanying notes to the Use of Proceeds Table.

Notes to the Use of Proceeds Table

1. The foregoing information is an estimate based on our current business plan. We may find it necessary or advisable to reallocate portions of the net proceeds reserved for one category to another category, and we will have broad discretion in doing so. Pending these uses, we may invest the net proceeds of this offering in short-term, interest-bearing securities.

2. The Company, without limitation, may hold cash or invest in cash equivalents for short-term investments. Among the cash equivalents in which the Company may invest are: (i) obligations of the U.S. Government, its agencies or instrumentalities or governmental agencies of other developed nations; (ii) commercial paper; and (iii) repurchase agreements, money market mutual funds, any certificates of deposit and bankers’ acceptances issued by domestic branches of U.S. banks that are members of the Federal Deposit Insurance Corporation or other similar banks.

3. While not presently contemplated, the Company may also enter into repurchase and reverse repurchase agreements involving any preceding instruments, as well as invest in money market mutual funds.

4. The Company’s use of net proceeds from this Offering for working capital, shall include capital allocations to cover marketing and sales, as well as ongoing administrative costs.

5. No amount of the proceeds are currently assigned to acquire assets outside of the ordinary course of business; however, asset acquisition is planned as part of our growth strategy. If we acquire assets in the future, we may use a material amount of the proceeds for the acquisition.

DESCRIPTION OF BUSINESS

Overview

Niihara International, Inc. was incorporated in the State of California on 08/24/2023 as a c-corporation. 

Business Lines

The Company is a development-stage biopharmaceutical company primarily focused on the development, commercialization, and distribution of innovative therapies for rare and orphan diseases. The company’s initial product is a generic prescription-grade L-glutamine oral powder designed to reduce acute complications associated with sickle cell disease (SCD) in patients aged five years and older.

The Company markets and plans to distribute its initial product in the United States and select international markets, including the Middle East and North Africa (MENA) region. Additionally, the company has pursued regulatory approvals in India and Oman..

The Company’s generic L-glutamine product under the name Entabor2 is essentially identical to USFDA approved L-glutamine from other current producers. Further, the Company’s factory used to produce USFDA approved L-glutamine for another competitor. Once factory retrofits are complete, the Company plans to pursue new USFDA approval for Entabor2. Prior to obtaining USFDA approval, the Company plans to sell its product in India and the Middle East, but will need regulatory approvals prior to selling in those locations as well.

Since L-glutamine has previously received USFDA approval under the tradename Endari prior to its patent expiration, we expect USFDA approval should be achievable for our generic brand of L-glutamine under our Entabor2 tradename, so long as Entabor2 is manufactured to the same standards as Endari has been manufactured.

Development History & Primary Products/Services

The Company’s initial product is a generic FDA approved prescription-grade L-glutamine oral powder under the name Entabor2 designed to reduce acute complications associated with sickle cell disease (SCD) in patients aged five and older.

Prior Financial Impairment

NA

Prior Restructuring and/or Major Asset Sales

NA

Potential Changes to Special Characteristics

Below are of the Company's distinctive characteristics that could impact future performance.

* Dependence on a Single Product: The Company heavily relies on the commercial success of its initial product, making it vulnerable to market fluctuations and competition.

* Regulatory Challenges: The pharmaceutical industry is subject to stringent government regulations, including pricing and reimbursement policies that could impact profitability.

* Competitive Market: The company faces competition from gene therapies such as Casgevy from Vertex Pharmaceuticals. Casgevy offers gene editing and therapy for cure. While this is a remarkable achievement, the cost is prohibitive for the patients in developing countries. It costs millions per patient per treatment. Also, it requires advanced medical facilities which are not available to most of the patients in the countries that we plan to supply. There will be plenty of patients who will not be able to receive Casgevy treatment in the foreseeable future. We are to cover those patients with more affordable therapy.

* Manufacturing and Supply Chain Risks: The Company has faced challenges in securing reliable packaging sources, leading to delays in its production and distribution.

Marketing and Sales Strategies

In the United States, the Company works within a network of relationships to market and sell its product. It also collaborates with Community-Based Organizations (CBOs) to raise awareness among sickle cell patients. Internationally, the Company has distribution agreements in the MENA region and India to drive sales.

Industry Analysis and Trends

The global sickle cell disease treatment market is expanding due to increased awareness, improved diagnostics, and emerging new therapies.

The Company seeks to leverage its market relationships and distribution network to expand into underserved markets like Africa and India. However, at this time, it should be noted that the Company does not generate any revenue and has no operating facilities to produce and distribute its product.

The Competition

The Company competes with well funded bio-pharmaceutical companies such as Vertex Pharmaceuticals that provide gene therapies and medical supplement companies that offer non-prescription grade L-glutamine supplements which may be sold at lower price but not covered by insurances in most of the regions.

Company Management and Employees

Senior Management

At the present time, the individuals below are actively involved in the management of the Company.

(i) Yutaka Niihara, CEO whose key responsibilities are making major corporate decisions, managing the overall operations of our company, creating and implementing strategies to grow the business and communicating between the corporate operations.

(ii) Yutaka Niihara, CFO whose key responsibilities are overseeing our company’s financial condition and capital structure, and presenting and reporting financial information, and implementing the company’s financial forecasting.

(iii) Yutaka Niihara, COO whose key responsibilities are managing operational issues within the organization to make sure that our company as well as our employees are complying with regulatory requirements and internal policies and procedures.

Employees

As of the date of publication of this offering Circular, our company had 1 full time employees and 1 part time employees. From time to time we have other part time employees. Our company believes that its relationship with its employees is good. Over the next couple years, we are planning to recruit more high-qualified candidates to meet the needs to our business expansion, and we have access to a large pool of qualified candidates.

Government Regulation

Our initial product, L-glutamine under the name Entabor2, is a generic pharmaceutical, which will require approval under the USFDA. Previously, when L-glutamine was patent protected and sold under the brand name Endari, it was approved by the USFDA.

The documents that led to USFDA approval are available to our Company, as this medication was developed by Yutaka Niihara, MD MPH who is our Company’s CEO.

It should be noted that we e will also have to obtain regulatory approvals in other countries wherewe sell this product. Specifically, we will have to obtain approvals in India and Oman where our first purchase orders are likely to be coming from. We may also have to obtain regulatory approvals in Africa, Europe, and other parts of the Middle East.

Background on L-glutamine and Endari

L-glutamine oral powder is already an FDA-approved treatment for reducing acute complications of sickle cell disease in patients 5 years and older under the proprietary name Endari. Entabor2 is intended to be a generic version of the previously approved Endari product and will require its own FDA authorization, which is expected to follow the abbreviated new drug application (“ANDA”) pathway or a comparable generic approval framework.

Dependence on generic FDA approval

Although L-glutamine has been approved previously in branded form, there is no assurance that the FDA will approve Entabor2 as a generic product on a timely basis or at all, or that the approved indication, labeling, or conditions of use will match those of Endari. The FDA may require additional data, impose new conditions specific to Entabor2, or decline or delay approval of the generic application, which could prevent or materially impair the company’s ability to market Entabor2 and realize anticipated revenues.

Reference product status and regulatory changes

Entabor2’s regulatory pathway depends on the status of Endari and the applicable generic drug regulations, including requirements for demonstrating pharmaceutical equivalence and bioequivalence to the reference listed drug. Any changes to Endari’s label, market status, exclusivity, or safety profile, or changes in FDA regulations, guidance, or interpretation for generic L-glutamine products, could increase development costs, delay approval, limit the scope of approval, or require reformulation or additional studies for Entabor2.

Manufacturing, cGMP and inspection risks

Even if Entabor2 is approved as a generic equivalent to Endari, the company’s ability to manufacture and sell the product will depend on ongoing compliance by the company and any contract manufacturers with current Good Manufacturing Practice (“cGMP”) and other FDA quality requirements, which are enforced in part through routine and for-cause inspections. Failure to maintain cGMP compliance, to satisfactorily address inspectional findings, or to ensure consistent product quality comparable to Endari and other approved generics may result in FDA enforcement actions, supply disruptions, recalls, or other measures that could materially adversely affect the company’s operations and financial condition.

Post-approval oversight, competition and investor impact

Following any approval of Entabor2, the company will remain subject to ongoing FDA oversight, including pharmacovigilance, adverse event reporting, complaint handling, stability monitoring, promotional review, and potential post-marketing requirements or labeling changes triggered by new information about Endari, other L-glutamine products, or Entabor2 itself. In addition, approved generic competitors to Endari already exist or may enter the market, and any delay, limitation, or interruption in Entabor2’s approval or manufacturing could severely limit market penetration in a competitive generic L-glutamine space, which could result in the loss of some or all of an investment in the company’s securities.

Regulatory approval process outside the United States

For Entabor2 to be commercialized outside the United States, the company will generally need separate local or regional regulatory approvals (or registrations) for manufacturing, importation, and marketing in each country or territory, and there is no assurance that any such approvals will be obtained or maintained.

India

In India, the Central Drugs Standard Control Organization (“CDSCO”) is responsible for granting marketing approval for generic drug formulations, while State Licensing Authorities issue manufacturing and distribution licenses. Entabor2 (L-glutamine) would generally require approval of a product dossier by CDSCO (including quality, safety, and, where applicable, bioequivalence data), followed by issuance of manufacturing and/or import and sale licenses, and delays, deficiencies, or changes in CDSCO requirements could prevent or materially delay launch or continuation of sales in India.

Oman

In Oman, the Ministry of Health (“MOH”), through its Directorate General for Pharmaceutical Affairs and Drug Control, determines whether a pharmaceutical product may be distributed by deciding whether to register the product in its official list of pharmaceutical registrations. Entabor2 would generally need to be registered by a locally licensed agent or distributor, supported by a product dossier that may include certificates of Good Manufacturing Practice, certificates of pharmaceutical product, quality/clinical data and pricing information, and any refusal, delay, or withdrawal of such registration would prevent marketing of Entabor2 in Oman.

Europe

In Europe, generic medicines are subject to the European Union (“EU”) medicines legislation, and may be authorized either centrally via the European Medicines Agency (“EMA”) or through national, mutual-recognition, or decentralized procedures, depending on the reference product and strategy. Entabor2 would require a marketing authorisation (for example as a generic application under Article 10 of Directive 2001/83/EC) supported by a complete dossier including quality data and evidence of equivalence to the reference product, and any failure to obtain or maintain such authorisation—centrally or at Member State level—would bar or disrupt access to part or all of the EU market.

Africa and other Middle East markets

Across African countries and the wider Middle East, including Gulf Cooperation Council (“GCC”) members other than Oman, pharmaceutical registration and marketing are generally conditioned on prior product approval or registration by national health authorities or, where applicable, regional regulatory bodies. Requirements commonly include submission of a technical dossier, proof of Good Manufacturing Practice, local representation or sponsorship, and post-marketing pharmacovigilance obligations, and variations among jurisdictions, evolving local standards, and potential reliance on reference approvals may result in staggered, delayed, or denied approvals for Entabor2 in one or more countries in Africa and the Middle East.

General non-US regulatory risk

Outside the United States, regulatory authorities may interpret data, impose conditions, or apply pharmacovigilance and manufacturing standards differently than the FDA, which can result in inconsistent labeling, additional studies, pricing controls, or restrictions or suspensions of marketing for Entabor2. Any failure or delay in obtaining or maintaining regulatory approvals or registrations in India, Oman, Africa, Europe, or other Middle Eastern markets could materially and adversely affect the company’s ability to commercialize Entabor2 globally, limit revenue diversification, and increase reliance on a smaller number of markets, which could in turn adversely affect the company’s business, financial condition, and results of operations.

Intellectual Property

The only product that we plan to manufacture at this time is generic form of L-glutamine under the name Entabor2.

We do not currently hold rights to any intellectual property and have not filed for copyright or trademark protection for our name, products, services or website. We do intend to trademark any of our future product or service names, our company logo and any other logo we create.

We do not have to acquire intellectual property rights to be able to manufacture Entabor2. Entabor2 is a generic form of L-glutamine. L-glutamine was been previously sold under the brand name Endari by a competitor. However, the patent for Endari expired in 2024. Further our competitor’s prior exclusivity rights for Endari as an orphan drug has also expired.

Description of Real Property

The Company currently owns 100% of one of only two factories in the world that can manufacture pharmaceutical grade L-glutamine. 

This factory is located in Ube, Yamaguchi Japan. It is facing Seto Inland Sea with a dock. The size of the land on which it sits is approximately 90 acres. The estimated cost to fully retrofit the facility is approximately $10,000,000. The factory was purchased with a promissory note, a copy of which is included as an exhibit to this offering. 

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

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and the related notes and other financial information included elsewhere in this Offering Circular (“prospectus”). Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that reflect our current views with respect to future events and financial performance, which involve risks and uncertainties. Forward-looking statements are often identified by words like: “believe”, “expect”, “estimate”, “anticipate”, “intend”, “project” and similar expressions, or words that, by their nature, refer to future events. You should not place undue certainty on these forward-looking statements, which apply only as of the date of this prospectus. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or our predictions. You should review the “Risk Factors” section of this prospectus for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Description of Financial Condition

The Company is a commercial-stage biopharmaceutical company focusing on the discovery, development, marketing, and sale of treatments for rare and orphan diseases. The company's financial condition reflects its ongoing commercialization efforts for its lead product, a prescription-grade L-glutamine oral powder under the name Entabor2 designed to reduce the acute complications of sickle cell disease (SCD) in both adult and pediatric patients aged five and older.


The Company has been working towards increasing its revenues by expanding commercialization efforts in both the United States and internationally. However, the Company continues to face financial uncertainty and is financing its operations through related-party loans, third-party loans, equity or debt financings, and possible corporate collaborations and licensing arrangements.

The Company acknowledges that it cannot predict if or when it will become profitable, given the costs associated with product commercialization and regulatory approvals. Over the past two years, the Company has sought to optimize revenue

generation through distribution partnerships, physician group purchasing organizations, and pharmacy benefits managers, to try to ensure that it’s product is accessible through selected retail and specialty pharmacies.

Results of Operations

The Company has not yet generated revenue.

Factors Affecting Income

The Company has not yet begun to generate revenue.

Material Changes in Sales or Revenues

There have not been changes in revenue because the Company has not yet begun to generate revenue.

Liquidity and Company Resources

Current Liquidity

The Company faces short-term liquidity challenges and long-term funding uncertainties, with a heavy reliance on external financing sources to sustain operations. Below is an overview of the company’s liquidity position, funding sources, and strategic measures taken to address deficiencies.

1. Short-Term Liquidity Position
As of December 31, 2024, the Company reported a cash balance of $76,101 and $2,172,643 in current liabilities.

Due to these short-term liabilities and uncertainties regarding its ability to generate sufficient cash flow, there is substantial doubt about the Company's’ ability to continue as a going concern for the next 12 months.

2. Internal and External Sources of Liquidity
The Company relies on a combination of internal cash reserves and external funding mechanisms to meet its liquidity needs.

Internal Sources of Liquidity
Accounts Receivable Factoring: The Company may need to sell eligible accounts receivable to sustain operations. 

Operational Revenue
The company has not yet begun to generate revenue. 

External Sources of Liquidity
Debt Financing: The Company has raised capital through convertible notes and promissory notes, which are a major component of its outstanding liabilities.

Related-Party Loans: The company continues to receive funding support from affiliated parties.
Equity and Private Placements: The Company is currently pursuing a Reg A application to raise additional capital.

Material Unused Sources of Liquidity
There are no significant unused credit facilities or major untapped funding sources identified in the report.

3. Liquidity Deficiency and Remedies
The Company has acknowledged a material liquidity deficiency and is actively taking measures to secure additional financing and reduce cash outflows.

The Company is pursuing financing through new loans, equity sales, or strategic partnerships.

Despite these efforts, uncertainty remains about the Company's ability to generate sufficient cash flow to meet obligations, and additional equity or debt financing is critical for long-term stability.

Capital Commitments

The Company has not yet made any material capital commitments for the current or future years.  

Plan of Operations for Non-Revenue-Generating Divisions

Overview:

The Company as a whole is currently a development-stage biopharmaceutical company, which has yet to generate revenue.

Impact of Trends on Capital Requirements
Significant Recent Trends in Production, Sales, Inventory, Orders, Costs, and Selling Prices

1. Production and Inventory: The Company relies on a single supplier for prescription-grade L-glutamine and a single packager for finished goods. Inventory levels may fluctuate due to forecasting challenges, leading to occasional excess stock or shortages that impact financial performance. Further, we have yet to enter a formal written agreement with our single supplier.

2. Sales and Orders: Net revenues may fluctuate as more generic drug competitors enter the marketplace.

3. Costs and Selling Prices: Selling expenses may rise to address competition in the market. Trends, Uncertainties, and Material Events Affecting Capital Resources

4. Liquidity and Profitability Challenges: There is no assurance of achieving sustainable profitability, and the Company anticipates continued net losses until it can further increase sales.

5. Debt and Financing Requirements: The Company will need to raise additional capital through debt or equity financing in the next six months to meet ongoing operational expenses and debt obligations.

6. Regulatory and Market Risks: Economic and geopolitical factors, including inflation, supply chain disruptions, and currency fluctuations, may impact production costs and profitability.

Plan of Operations

We anticipate that the capital we intend to raise in this offering will be sufficient to enable us to execute our business plan, including, but not limited to hiring a strong management team and key personnel; executing on the milestones described in this Offering Circular; and achieving growth by way of strategic partnerships.

It is the opinion of Company management that the proceeds from this proposed offering will satisfy the Company’s need for liquidity and cash requirements and put the Company in a position to grow its business in accordance with its business plan. Please refer to Use of Proceeds, Part II for the Company’s planned use of proceeds to be generated from this proposed offering.

Milestone 1: Month 1

Within one month of the offering’s closing, the Company plans to take key operational steps to position the company for growth and execution of its strategic initiatives. First, we intend to finalize the hiring of all C-level officers, with candidates already identified and selected. This leadership team will be critical in driving our mission forward and ensuring the successful implementation of our business objectives. Additionally, we plan to place orders for the Active Pharmaceutical Ingredient (API) necessary for the final formulation and packaging of our product, marking a significant milestone in our product commercialization efforts.

Milestone 2: Month 2 to Month 6

Within two to six months following the closing of this offering, the Company anticipates achieving several key milestones to advance our growth strategy and global market expansion. First, we expect to commence the distribution of our packaged medications in India, the Middle East, and Africa. These products will be introduced both as pharmaceutical materials and as dietary supplements, allowing us to establish a strong foothold in these high-demand markets. Simultaneously, we will initiate the planning phase for the retrofitting project of our Japanese purification plant in Ube, Japan. This facility will play a crucial role in supplementing our current supply of Active Pharmaceutical Ingredients (API), which we currently source from Ajinomoto Co. Given our projected growth, we anticipate that demand for our products will exceed current supply within one to two years. As part of our long-term strategy, we will continue evaluating opportunities for the development of additional production facilities to meet future demand. Additionally, we plan to begin exploring opportunities in the European Union market, identifying regulatory pathways and potential distribution partners to expand our international presence further. Through these strategic initiatives, Niihara International, Inc. is committed to scaling its operations, securing a reliable supply chain, and broadening its global market reach.

Milestone 3: Month 7 to Month 12

Niihara International, Inc. projects that cash flow from operations will commence approximately seven to eight months following the closing of this offering. Based on market potential, if we are able to reach just 0.1% of patients in India, we anticipate generating approximately $60 million in revenue. Expanding our coverage to 1% of the patient population in India alone could result in revenue of approximately $600 million. These projections underscore the significant market opportunity and the scalability of our business model. Additionally, we plan to initiate the construction phase of the retrofitting project for our Japanese purification plant. This facility will serve as a critical component of our long-term supply chain strategy, supplementing our existing API source from Ajinomoto Co. and positioning us for increased production capacity as demand grows.

The patient population is estimated to exceed 20 million in India. Our goal is to reach just a small fraction of these patients in the beginning. We have a network of physicians who have agreed to utilize our product once approved. We expect that this will help us reach about 5,000 patients immediately. We have a packager and distributor that will be able to achieve distribution to these patients immediately. Once 5,000 patients are reached, we plan to expand based on supply availability to other regions.

DIRECTORS, EXECUTIVE OFFICERS AND SIGNIFICANT EMPLOYEES

The following tables list the current Directors, Officers and Significant Employees of the Company. Significant Employees that are not Officers or Directors are those employees whose decisions and activities are expected to have a material impact on the Company’s performance.

Executive Officers and Significant Employees

Directors

Yutaka Niihara: CEO

Family Relationship to Company: Founding Shareholder

Background:

Yutaka Niihara is a seasoned pharmaceutical executive and entrepreneur with a proven track record in leadership, fundraising, and global healthcare expansion. From 2020 to 2023, Yutaka served as the Chairman and CEO of Emmaus Life Sciences, Inc., where he successfully navigated the company through the challenges of the COVID-19 pandemic. During this period, he secured critical funding, optimized operational efficiency, and strategically relocated assets to sustain business continuity. Post-pandemic, he led Emmaus to profitability within a year. After departing Emmaus, Yutaka shifted his focus to expanding the distribution of sickle cell treatment to underserved regions, including the Middle East, India, and Africa. To support this mission, he acquired a pharmaceutical manufacturing plant from Emmaus, ensuring a steady supply to meet the growing demand in these markets. From 2023 through fall 2024, Yutaka spearheaded the preparation of a regulatory dossier for submission to the Indian government, which is currently under review. Since 2023, he has personally raised over $2 million to fund these initiatives. In addition to founding Niihara Pharma PVT. Ltd. in India, Yutaka also leads EJH of Japan as its

Executive Chairman. He is actively involved in the regulatory approval process, currently managing a Reg A application to further expand operations. Operating with an unparalleled level of commitment, Yutaka currently serves as CEO, CFO, COO, and CSO, overseeing strategic growth while working with new assets to drive innovation in global healthcare.

Legal Proceedings:

None

COMPENSATION OF DIRECTORS AND EXECUTIVE OFFICERS

Compensation of Executive Officers
For the Last Fiscal Year Prior to This Offering

The Company may choose to establish an equity compensation plan for its management and other employees in the future.

Total Compensation of Officers For the Last Fiscal Year Prior to This Offering : $0
Total Annual Compensation to Directors: $0
Total Number of Directors: 1

Future Compensation Plans for Officers and Directors

The Company anticipates that Mr. Niihara will be paid a salary in the future, the amount of which has not yet been determined.

SECURITY OWNERSHIP OF MANAGEMENT AND CERNTAIN SECURITY HOLDERS

The following table sets forth information regarding beneficial ownership of our Common Stock as of the date of this Offering and as adjusted to reflect the sale of shares of our Common Stock offered by this Offering Circular, by:

• Each of our Directors and named Executive Officers;
• All of our Directors and Executive Officers as a group;
• Each person or group of affiliated persons known by us to be the beneficial owner of more than 5% of our outstanding shares of Common Stock, and
• All other shareholders as a group.

Beneficial ownership and percentage ownership are determined in accordance with the rules of the Securities and Exchange Commission and includes voting or investment power with respect to shares of stock. This information does not necessarily indicate beneficial ownership for any other purpose.

Unless otherwise indicated and subject to applicable community property laws, to our knowledge, each stockholder named in the following table possesses sole voting and investment power over their shares of common stock, except for those jointly owned with that person s spouse. Percentage of beneficial ownership before the offering is based on 145,167,494 Common Shares outstanding on 03/02/2025.

(1) The address of those listed is Niihara International, Inc., 24 Covered Wagon Ln., Rolling Hills Estates, California, 90274

(2) Unless otherwise indicated, all shares are owned directly by the beneficial owner.

INTEREST OF MANAGEMENT AND OTHERS IN CERTAIN TRANSACTIONS

Yutaka Niihara, his son Albert Niihara and Hope International Hospice, which is owned by Yutaka Niihara, previously entered promissory notes with the Company in December 2023. These notes all carry an interest rate of 5% and are due on December 31, 2028. Payment for all principal and interest is due upon maturity.

Related Party Transactions

A relatively small group of executives and directors own a large portion of the issued and outstanding shares of Niihara International, Inc.. These parties are Yutaka Niihara, Loma Linda University and the Japanese Foundation, as stated above. Consequently, these shareholders can control the operations of the Company and will have the ability to control all matters submitted to stockholders for approval, including, but not limited to:

• Election of the Board of Directors,
• Removal of any Director(s),
• Removal of any Director(s),
• Adoption of measures that could delay or prevent a change in control or impede a merger, takeover or other business combination.

Thus, a small group of executives and directors will have complete control over the Company’s management and affairs. Accordingly, their ownership may have the effect of impeding a merger, consolidation, takeover or other business combination, or discouraging a potential acquirer from making a tender offer for the Common Stock.

SECURITIES BEING OFFERED

The Company is offering the following securities:

• 10,000,000 shares of common stock originally issued by the Company

The following is a summary of the rights of our capital stock in our certificate of incorporation, as amended, and bylaws. For more detailed information, please see our articles of incorporation and bylaws, which have been filed as exhibits to the Offering Statement of which this Offering Circular is a part.

Description of Securities

The following table summarizes the rights and restrictions applicable to participants in this offering.

Potential liabilities imposed on Security holders

Security holders shall not have any direct liabilities associated with their investment, other than the risk of loss of their investment. Please see Risk Factors within this Offering Memorandum for a discussion of specific investment risks.

Part F/S

We recognize that, until the Financial Statements are prepared by a CPA experienced in GAAP and SEC accounting, adjustments may be necessary; however, it is the opinion of the management of the Company that any adjustments will be non-material.

NIIHARA INTERNATIONAL, INC.

Unaudited Interim Financial Statements

FOR  THE PERIOD FROM JANUARY 1, 2025 TO SEPTEMBER 30, 2025

INTERIM FINANCIAL STATEMENT

See accompanying notes to financial statements.

INTERIM FINANCIAL STATEMENT
 

 See accompanying notes to financial statements.

INTERIM FINANCIAL STATEMENT

See accompanying notes to financial statements.

INTERIM FINANCIAL STATEMENT

 See accompanying notes to financial statements.

INTERIM FINANCIAL STATEMENT

Niihara International Inc.

(Unaudited)

INTERIM FINANCIAL STATEMENT

Niihara International Inc.

(Unaudited)

NOTE 1 - NATURE OF OPERATIONS AND GOING CONCERN

Description of Business:

Historical Information:         

• Yutaka Niihara MD MPH developed treatment for sickle cell disease using L-glutamine while on faculty at UCLA
• The treatment was approved by the US FDA in 2017 July.
• At the time of approval, Nihara was the CEO of Emmaus Life Sciences, Inc.
• Niihara Left Emmaus in 2023 August to pursue distribution of L-glutamine therapy to India, Africa and the Middle East
• September 2023, Niihara International, Inc. was formed to accomplish Niihara goal of distributing the medication to where prevalence of sickle cell disease is high.
• Initial funding for Niihara International was from the assets of Niihara Family.

Current Information:

• As soon as the company was formed, preparation of dossier for India and Oman was started.
• India application was accepted in October 11, 2024. We are currently waiting for the review.
• Oman application is now ready and it was sent over to our partner the Seas Corporation.

Nature of Operation:

• We are manufacturer and distributor of pharmaceutical agent as well as nutritional supplements of highest quality
• We have a contract packager in India. Mg biological Pvt. Ltd
• Yutaka Niihara also owns a manufacturing plant that is currently in process for retrofitting. It was purchased from Emmaus Life Sciences and Japan Industrial partners in January 2024.
• Ajinomot Company with whom there is 30 year relationship.
• Niihara’s goal is to bring safe, effective and practical treatments to developing countries at affordable cost.
• Niihara International, Inc. plans to dominate the supply chain and prevent competition from entering the market by utilizing limited amount of pharmaceutical L-glutamine in the newly developed demand in sickle cell patients.

Going Concern:
• Limitation of supply.
• Limited funding at this moment. We have limited cash on hand. The Company expects that as it expands its planned scope of business and works to increase revenues, it will continue to incur operating losses. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The Company’s operations have been funded to date by management and shareholders. The Company expects this funding to continue until such time as it can acquire a profitable operating business or undertake a financing. There can be no assurance that the Company will continue to receive this funding from management or shareholders will be able to generate sufficient revenue from sales of products or that the funding received or generated will be sufficient to pay for its ongoing operations. Management’s plans for the continuation of the Company as a going concern includes successful operation of its recently acquired assets in order to attain profitable operations, the development of a commercially viable business, and financing of the Company’s operations through sale of its common stock, as well as shareholder and management advances until such time as it has established profitable operations.
• Potential competitor with rich financial resources trying to build manufacturing facility

Anticipated Business:
• Currently, there is no safe, effective and practical affordable treatment for sickle cell disease, especially for children except for L-glutamine therapy. Large pharmaceutical companies have pulled back or approval withdrawn due to ineffectiveness of their treatments
• In India alone, the new estimate of sickle cell patients exceeds 20 million. If 1% of patients get treated with our medication, it will reduce their cost of medical care by 50%. In the meantime, the revenue to Niihara International will be $600mm.
• We also expand the business to the Middle East starting with the Sultanate of Oman.

NOTE 2 - USE OF ESTIMATES IN THE PREPARATION OF FINANCIAL STATEMENTS

The preparation of financial statements in conformity with Generally Accepted Accounting Principles (GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, at the date of these financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

NOTE 3 – SUMMARY OF ACCOUNTING POLICIES

Basis of Presentation

The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles (US GAAP).  In the opinion of management, all adjustments considered necessary for a fair presentation have been included.  All such adjustments are of a normal recurring nature. The accompanying interim financial statements have been prepared in accordance with U.S. GAAP and Article 8 of Regulation S-X and include statements of operations, cash flows, and changes in shareholders’ equity.

Fiscal Year-End

The Company has selected December 31 as its fiscal year-end.

Cash and Cash Equivalents


The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents.

Fair Value of Financial Instruments


The Company follows the fair value measurement rules, which provide guidance on the use of fair value in accounting and disclosure for assets and liabilities when such accounting and disclosure is called for by other accounting literature. These rules establish a fair value hierarchy for inputs to be used to measure fair value of financial assets and liabilities. This hierarchy prioritizes the inputs to valuation techniques used to measure fair value into three levels: Level 1 (highest priority), Level 2, and Level 3 (lowest priority).

Level 1—Unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the balance sheet date.

Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.), and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).

Level 3—Inputs are unobservable and reflect the Company’s assumptions as to what market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available.

Investments are reflected in the accompanying financial statements at fair value. The carrying amount of receivables and accounts payable and accrued expenses approximates fair value due to the short-term nature of those instruments. The estimated fair values for financial instruments are determined at discrete points in time based on relevant market information.  These estimates involve uncertainties and cannot be determined with precision.  The carrying amounts of lease receivables, accounts payable, and accrued liabilities approximate fair value given their short-term nature or effective interest rates, which constitutes level three inputs.

Basic and Diluted Loss per Share


In accordance with ASC Topic 260 – "Earnings per Share," the basic loss per common share is computed by dividing the net loss available to common stockholders by the weighted average number of common stock outstanding. Diluted loss per common share is computed similar to basic loss per common share except that the denominator is increased to include the number of additional shares of common stock that would have been outstanding if the potential common stock had been issued and if the additional shares of common stock were dilutive.

Potential common stock consists of the incremental common stock issuable upon the exercise of common stock warrants (using the if-converted method), convertible notes, and classes of shares with conversion features, stock awards and stock options. The computation of loss per share for the comparative periods excludes potentially dilutive securities of underlying preferred shares if their inclusion would be antidilutive. During the year ended December 31, 2023 and 2024 the Company recorded net losses and therefore, inclusion of potentially dilutive securities would be antidilutive and are excluded from the statement of profit and loss. The table below reflects the potentially dilutive securities at year ended December 31, 2023 and 2024.

Revenue Recognition


The Company recognizes revenue when the earnings process is complete and persuasive evidence of an arrangement exists. This generally occurs when a purchased product has been shipped to a customer from our fulfillment center at which time both title and the risks and rewards of ownership are transferred to and accepted by the customer, and the selling price has been collected.  However, the company did not earn any revenue till the date of reporting.

Recent Accounting Pronouncements


The Company has implemented all new accounting pronouncements that are in effect and that may impact its financial statements and does not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.

NOTE 4 – CONVERTIBLE NOTE


The Company executed a Convertible Promissory Note (the “CPN”) with the third parties as follows:

Particulars		Debit		Credit
CONVERTIBLE NOTE ANDREW PRIDE				25,000.00
CONVERTIBLE NOTE APRIL WILLIAMS				1,000.00
CONVERTIBLE NOTE BERNARD JACKSON				5,000.00
CONVERTIBLE NOTE BOGUE				1,000.00
CONVERTIBLE NOTE DOMINION CHURCH				1,000.00
CONVERTIBLE NOTE ELITE RESOURCES				15,000.00
CONVERTIBLE NOTE ERNE WILLIAMS				20,000.00
Convertible Note Glen Reynolds				10,000.00
CONVERTIBLE NOTE GREGORY CASON				10,000.00
CONVERTIBLE NOTE JABARI A PRIDE				50,000.00
Convertible Note Kena M				15,000.00
CONVERTIBLE NOTE LYNN REYNOLDS				10,000.00
Convertible Note Mr Williams				20,000.00
Convertible Note Nicola Cooper				10,000.00
CONVERTIBLE NOTE ORRICK CURRY				10,000.00
CONVERTIBLE NOTE QUIN				1,000.00
CONVERTIBLE NOTE RENEE WELLS				1,000.00
CONVERTIBLE NOTE RICHARD WILSON				10,000.00
CONVERTIBLE NOTE TASHA BUTLER				10,000.00
CONVERTIBLE NOTE TYDUS				10,000.00

INTERIM FINANCIAL STATEMENT Niihara International Inc. Notes to Financial Statements for the year ended September 30, 2025 (Unaudited)

In accordance with ASC 470-20, Debt with Conversion and Other Options, we evaluated the embedded conversion feature and determined that it contained a material beneficial conversion feature, as the fair value of our common stock on the issuance date was $2.00 per share, compared to a conversion price of $0.75 per share. We recorded the beneficial conversion feature as a discount to the debt with a corresponding credit to additional paid-in capital. Due to the magnitude of the beneficial conversion feature, we classified the entire balance as equity at issuance, and no portion of the notes remains recorded as a liability as of year-end. We continue to evaluate our convertible instruments for modification, extinguishment, or reclassification in accordance with applicable U.S. GAAP.

The CPN was for a 2 year term, bearing interest at 1% per annum and was convertible into shares of common stock of the Company based on the following: Upon Maturity, the Company shall pay the entire principal, plus any accrued and unpaid interest, back to the Lender, or at any time from the original date of the CPN the Lender may choose to convert the unpaid balance of the CPN, and any accrued interest thereon, into shares of the Company’s Common Stock at a conversion price of $0.75/ share.

Formerly, US GAAP used to bifurcate convertible debt into debt and equity components but had several, more complicated approaches depending on the structure of the convertible. However, US GAAP no longer uses the bifurcation model and instead assumes the convertible debt is straight debt.

NOTE 5 - RELATED PARTY TRANSACTIONS

The company has entered into loan agreements with the above parties without an agreement and hence, we are unable to do a fair value assessment of these loans in the absence of information like maturity date, ROI, etc.

NOTE 6 – COMMON AND PREFERRED STOCK

The Company has authorized 145,167,494 shares of Common Stock, $0.00001 par value.

NOTE 7 – OTHER EVENTS         

• As soon as the company was formed, preparation of dossier for India and Oman was started.
• India application was accepted in October 11, 2024. We are currently waiting for the review.
• Oman application is now ready and it was sent over to our partner the Seas Corporation.

NOTE 8 – SUBSEQUENT EVENTS

The Company has evaluated subsequent events from the balance sheet date through the date that the financial statements were issued and determined that there are no additional subsequent events to disclose. 

INTERIM FINANCIAL STATEMENT

NIIHARA INTERNATIONAL INC
Notes to Financial Statements for the year ended March 31, 2024 (Unaudited)
Note 4 Reserves and Surplus			As at September 30, 2025				As at December 31, 2024				As at December 31, 2023
Surplus in Statement of Profit and Loss:
Balance as at the beginning of the year			(664,072	)			(81,988	)			—
Profit / (Loss) for the period			(355,897	)			(582,085	)			(81,988	)
Balance at the end of the year			(1,019,969	)			(664,072	)			(81,988	)

NIIHARA INTERNATIONAL, INC.

Audited Financial Statements

AS OF DECEMBER 31, 2024 AND 2023, AND FOR THE YEAR ENDED DECEMBER 31, 2024 AND THE PERIOD FROM INCEPTION (AUGUST 24, 2023) TO DECEMBER 31, 2023

Index to Financial Statements

INDEPENDENT AUDITORS’ REPORT

To the Stockholders

NIIHARA INTERNATIONAL, INC.

Austin, California

Opinion

We have audited the financial statements of NIIHARA INTERNATIONAL, INC., which comprise the balance sheets as of December 31, 2024, and 2023, and the related statements of operations, changes in stockholders’ deficit, and cash flows for the year ended December 31, 2024, and for the period from inception (August 24, 2023) through December 31, 2023 and the related notes to the financial statements (collectively, the “financial statements”).

In our opinion, the accompanying financial statements present fairly, in all material respects, the financial position of NIIHARA INTERNATIONAL INC. as of December 31, 2024, and 2023, and the results of its operations and its cash flows for the year ended December 31, 2024, and for the period from inception (August 24, 2023) through December 31, 2023, in accordance with accounting principles generally accepted in the United States of America.

Basis for Opinion

We conducted our audits in accordance with auditing standards generally accepted in the United States of America (GAAS). Our responsibilities under those standards are further described in the Auditor’s Responsibilities for the Audit of the Financial Statements section of our report. We are required to be independent of NIIHARA INTERNATIONAL, INC. and to meet our other ethical responsibilities in accordance with the relevant ethical requirements relating to our audits. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.

Responsibilities of Management for the Financial Statements

Management is responsible for the preparation and fair presentation of the financial statements in accordance with accounting principles generally accepted in the United States of America and for the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of financial statements that are free from material misstatement, whether due to fraud or error.

In preparing the financial statements, management is required to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about NIIHARA INTERNATIONAL, INC.’s ability to continue as a going concern for a period of twelve months from the date of issuance of these financial statements.

Auditor’s Responsibilities for the Audit of the Financial Statements

Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance but is not absolute assurance and therefore is not a guarantee that an audit conducted in accordance with GAAS will always detect a material misstatement when it exists. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control. Misstatements are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users made on the basis of these financial statements.

In performing an audit in accordance with GAAS, we:

We are required to communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit, significant audit findings, and certain internal control–related matters that we identified during the audit. 

Going Concern

As discussed in Note 9, certain conditions indicate that the Company may be unable to continue as a going concern. The accompanying financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern.

August 26, 2025

Los Angeles, California

NIIHARA INTERNATIONAL, INC.

Balance Sheets 

See accompanying notes to financial statements.

NIIHARA INTERNATIONAL INC.

Statements of Operations 

See accompanying notes to financial statements.

NIIHARA INTERNATIONAL, INC.

Statements of Changes in Stockholders’ Deficit