In addition to the other information contained in (or incorporated
−Removed: by reference into) this proxy statement/prospectus, including the matters addressed under the heading “Cautionary Note Regarding Forward-Looking Statements,”
−Removed: you should carefully consider the following risk factors in deciding how to vote on the proposals presented in this proxy statement/prospectus.
−Removed: Following the Business Combination the Company will operate in a market environment that is difficult to predict and that involves significant
−Removed: risks, many of which will be beyond its control.
+Added: by reference into) this Form 10-K Report including the matters addressed under the heading “Cautionary Note Regarding Forward-Looking Statements,”
+Added: you should carefully consider the following risk factors.
+Added: The Company operates in a market environment that is difficult to predict and
+Added: that involves significant risks, many of which will be beyond control.
You should carefully consider the risks described below.
−Removed: The occurrence of one or more
−Removed: of the events or circumstances described in these risk factors, alone or in combination with other events or circumstances, may have a
−Removed: material adverse effect on the Company’ business, reputation, revenue, financial condition, results of operations and future prospects,
−Removed: in which event the market price of the Company securities could decline, and you could lose part or all of your investment.
−Removed: Unless otherwise
−Removed: indicated, reference in this section and elsewhere in this Form 10-K Report to the Company’s and/or OSR’s business being adversely
+Added: The occurrence
+Added: of one or more of the events or circumstances described in these risk factors, alone or in combination with other events or circumstances,
+Added: may have a material adverse effect on the Company’s business, reputation, revenue, financial condition, results of operations and
+Added: future prospects, in which event the market price of the Company securities could decline, and you could lose part or all of your investment.
+Added: Unless otherwise indicated, references in this section and elsewhere in this Form 10-K Report to the Company’s business being adversely
affected, negatively impacted or harmed will include an adverse effect on, or a negative impact or harm to, the business, reputation,
financial condition, results of operations, revenue and future prospects of the Company.
−Removed: Risks Related to the Business Combination and Business Combination
−Removed: The Company’s Chief Executive Officer and one of our directors
−Removed: was previously the Chief Executive Officer and is currently the Chairman of the Board of OSR.
−Removed: These dual positions (i) create conflicts
−Removed: of interest in the performance of his duties;
−Removed: and (ii) may provide for him to receive compensation following the Business Combination
−Removed: that amplified his conflicts of interest in determining whether the transaction was the most advantageous.
−Removed: The Company’s Chief Executive Officer and one of its directors,
−Removed: Kuk Hyoun Hwang, was previously the Chief Executive Officer and is currently the Chairman of the Board of OSR.
−Removed: Such dual positions may
−Removed: cause him to have conflicts of interest in performing his duties to both companies.
−Removed: Hwang is expected to remain with the Company
−Removed: following the completion of the Business Combination and receive future compensation in the form of cash payments and/or the Company securities
−Removed: for services he would render to the Company going forward.
−Removed: The personal and financial interests of Mr.
−Removed: Hwang may have influenced
−Removed: his motivation in negotiating the Business Combination and in managing the combined Company going forward.
−Removed: Despite the approval of the
−Removed: terms of the Business Combination Agreement by a majority of our independent directors ( i.e.
−Removed: , the Company M&A Committee), potential
−Removed: conflicts of interest still may exist and, as a result, the terms of the Business Combination may not be as advantageous to our public
−Removed: stockholders as they would have been absent any conflicts of interest.
−Removed: Hwang beneficially owns 13,069,104 shares of the
−Removed: post-combination company and controls 67.8%
−Removed: The PIPE Investment did not close at the closing of the Business
−Removed: Combination and is not expected to be consummated with the original PIPE investor.
−Removed: As a result of the PIPE Investment not closing, BLAC did not receive
−Removed: $20 million in cash at the closing of the Business Combination.
−Removed: The Company was insolvent at the closing of the Business Combination and
−Removed: will not have enough cash to fund its operations or pay its outstanding expenses and debts.
−Removed: Toonon, PIPE Investor, exercised its right
−Removed: to cancel the PIPE investment based upon its assessment of macroeconomic factors specific to Korean markets.
−Removed: If the Company fails to secure
−Removed: other funding in the next few months, the Company could enter bankruptcy proceedings and the value of the stock and warrants of the Company
−Removed: would likely become worthless.
−Removed: The Sponsor and the Company’s directors and officers have
−Removed: interests that are different from or that conflict with the interests of the Company’s stockholders and that may
−Removed: have influenced their analysis of whether the Business Combination with the Company is appropriate as BLAC’s initial business
−Removed: Such interests include that the Sponsor will lose its entire investment in BLAC if the Business Combination is not completed.
−Removed: The personal and financial interests of the Sponsor as well as the
−Removed: Company’s directors and officers may have influenced their motivation in identifying and selecting OSR as an initial business combination
−Removed: target, completing an initial business combination with OSR and may influence the operation of the business following consummation of
−Removed: the initial business combination.
−Removed: Following the consummation of the Business Combination, the Company’s
−Removed: only significant asset will be its ownership of OSR and such ownership may not be sufficient to pay its expenses or satisfy other financial
−Removed: Following the consummation of the Business Combination, the Company
−Removed: will be a holding company and will not directly own any operating assets other than its ownership of interests in OSR.
−Removed: will depend on OSR for distributions, loans and other payments to generate the funds necessary to meet its financial obligations, including
−Removed: its expenses as a publicly traded company.
−Removed: The earnings from, or other available assets of, the Company may not be sufficient to pay expenses
−Removed: or satisfy the Company’s other financial obligations.
+Added: Conflicts of interest arising from related-party relationships could
+Added: adversely affect the terms and economic outcomes of our licensing arrangements.
+Added: The Chief Executive Officer of OSR Holdings, Inc.
+Added: or the “Company”) serves in senior leadership roles across affiliated entities, including as Chief Executive Officer of BCM
+Added: Europe AG (“BCME”) and as a board member of Vaximm AG, creating overlapping fiduciary obligations and potential conflicts
+Added: In addition, Vaximm AG, our wholly owned subsidiary, has entered into a binding term sheet with BCME, our largest shareholder,
+Added: for a proposed exclusive global license of the VXM01 oral cancer immunotherapy platform.
+Added: Because Vaximm AG and BCM Europe AG are affiliated
+Added: through common ownership and management, the negotiation and approval of this arrangement constitute a related-party transaction.
+Added: The structure of the transaction includes non-standard economic features,
+Added: including a royalty pass-through mechanism under which BCME, acting as a financial intermediary, is entitled to use 100% of downstream
+Added: royalty payments from any ultimate commercial partner to recover milestone payments made to Vaximm AG and a preferred return to its investment
+Added: fund investors before any royalties are distributed to Vaximm AG.
+Added: This recovery mechanism could significantly delay or reduce the timing
+Added: of royalty revenues ultimately received by Vaximm AG and, indirectly, the Company.
+Added: Although the transaction is subject to an independent third-party fairness
+Added: opinion, such safeguards may not eliminate all potential conflicts of interest.
+Added: These relationships and structural features could influence
+Added: the negotiation, approval, and ongoing operation of the arrangement in a manner that is not as favorable to the Company or its stockholders
+Added: as terms that might have been obtained in an arm’s-length transaction with an unaffiliated third party.
+Added: The Company’s only significant asset is its ownership
+Added: of OSR and such ownership may not be sufficient to pay its expenses or satisfy other financial obligations.
+Added: The Company is a holding company and will not directly own any operating
+Added: assets other than its ownership of interests in OSR.
+Added: The Company depends on OSR for distributions, loans and other payments to generate
+Added: the funds necessary to meet its financial obligations, including its expenses as a publicly traded company.
+Added: The earnings from, or other
+Added: available assets of, the Company may not be sufficient to pay expenses or satisfy the Company’s other financial obligations.
The Company’s principal stockholders and management own
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Our executive officers, directors and their affiliates and our principal
−Removed: stockholders beneficially hold, in the aggregate, approximately 92.9% of the outstanding shares of Company Common Stock.
−Removed: These stockholders,
−Removed: acting together, would be able to significantly influence all matters requiring stockholder approval, including the proposals presented
−Removed: at the Company Stockholders’ Meeting.
−Removed: For example, these stockholders would be able to significantly influence elections of directors,
−Removed: amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction.
−Removed: prevent or discourage unsolicited acquisition proposals or offers for our common stock that stockholders may feel are in their best interests.
+Added: stockholders beneficially held, in the aggregate, approximately 48.5% of the outstanding shares of Company Common Stock as of December
+Added: As a result, these stockholders are able to exert significant influence over matters requiring stockholder approval, including
+Added: the election of directors, amendments to our organizational documents and approval of mergers or other major corporate transactions.
+Added: concentration of ownership may discourage or delay a change in control that other stockholders may consider favorable.
Lack of Business Diversification
−Removed: For an indefinite period of time after the completion of our initial
−Removed: business combination, the prospects for our success may depend entirely on the future performance of a single business and a single industry—the
−Removed: health care sector.
−Removed: Unlike other entities that have the resources to complete business combinations with multiple entities in one or several
−Removed: industries, it is probable that we will not have the resources to diversify our operations and mitigate the risks of being in a single
−Removed: line of business.
−Removed: By completing our initial business combination with only a single entity, our lack of diversification may:
−Removed: ● subject us to negative economic, competitive and regulatory developments,
−Removed: any or all of which may have a substantial adverse impact on the particular industry in which we operate after our initial business combination,
−Removed: ● cause us to depend on the marketing and sale of a single product
−Removed: or limited number of products or services.
−Removed: Limited Ability to Evaluate OSR’s Management Team
−Removed: Although we attempted to closely scrutinize the management of OSR as
−Removed: a target business when evaluating the desirability of effecting our initial business combination with OSR, our assessment of OSR’s
−Removed: business’ management may not prove to be correct.
−Removed: In addition, the future management may not have the necessary skills, qualifications
−Removed: or abilities to manage a public company.
−Removed: Furthermore, the future role of members of our management team, if any, in the target business
−Removed: cannot presently be stated with any certainty.
−Removed: The determination as to whether any of the members of our management team will remain with
−Removed: the combined company will be made at the time of our initial business combination.
−Removed: While it is possible that one or more of our directors
−Removed: will remain associated in some capacity with us following our initial business combination, it is unlikely that any of them will devote
−Removed: their full efforts to our affairs or that our future management team will have significant experience or knowledge relating to the operations
−Removed: of the particular target business.
−Removed: We cannot assure you that any of our key personnel will remain in senior management or advisory positions
−Removed: going forward.
−Removed: Having completed our initial business combination, we will seek to recruit additional managers to supplement the incumbent
−Removed: management of OSR.
−Removed: We cannot assure you that we will have the ability to recruit additional managers, or that additional managers will
−Removed: have the requisite skills, knowledge or experience necessary to enhance the incumbent management.
+Added: Our prospects for success depend largely on the future performance
+Added: of a single business and a single industry—the health care sector.
+Added: Unlike other entities that have the resources to operate multiple
+Added: businesses across several industries, we may not have sufficient resources to significantly diversify our operations and mitigate the
+Added: risks associated with operating in a single line of business.
+Added: As a result, our lack of diversification may:
+Added: subject us to negative economic, competitive and regulatory developments, any or all of which may have a substantial adverse impact on the particular industry in which we operate, and
+Added: cause us to depend on the marketing and sale of a single product or limited number of products or services.
+Added: Ability of the Company’s Management Team to Execute Its
+Added: Business Strategy
+Added: The Company’s future performance depends on the continued services
+Added: and effectiveness of its management team.
+Added: If members of management are unable to successfully execute the Company’s business strategy,
+Added: including advancing its clinical development programs and managing its operations as a public company, the Company’s business, financial
+Added: condition, and results of operations could be adversely affected.
+Added: In addition, the Company may need to recruit and retain additional
+Added: qualified personnel to support its growth and operations.
+Added: Competition for experienced executives, scientific personnel, and other key
+Added: employees in the biotechnology industry is intense, and the Company may not be successful in attracting or retaining such individuals
+Added: on acceptable terms, or at all.
+Added: Any failure to build and maintain an effective management team could adversely affect the Company’s
+Added: ability to execute its strategic objectives.
The Company may be subject to tax liability if OSR fails to pay
12 unchanged sentences
events occur in the future which will reverse or eliminate such basis difference (i.e., sales of subsidiaries).
−Removed: Risks Related to the Company Securities
−Removed: The price of the Company’ Common Stock and warrants may
−Removed: The price of the Company’ Common Stock and warrants may fluctuate
+Added: Risks Related to Our Securities and Being a Public Company
+Added: The price of the Company’s Common Stock and warrants may
+Added: The price of the Company’s Common Stock and warrants may fluctuate
due to a variety of factors, including:
−Removed: ● actual or anticipated fluctuations in its quarterly and annual
−Removed: results and those of other public companies in the same or similar industry;
−Removed: ● mergers and strategic alliances in the industry in which it
+Added: actual or anticipated fluctuations in its quarterly and annual results and those of other public companies in the same or similar industry;
+Added: mergers and strategic alliances in the industry in which it operates;
market prices and conditions in the industry in which it operates;
1 unchanged sentence
potential or actual military conflicts or acts of terrorism;
−Removed: ● the failure of securities analysts to publish research about
−Removed: the Company, or shortfalls in its operating results compared to levels forecasts by securities analysts;
+Added: the failure of securities analysts to publish research about the Company, or shortfalls in its operating results compared to levels forecasts by securities analysts;
announcements concerning the Company or its competitors;
1 unchanged sentence
These market and industry factors may materially reduce the market
−Removed: price of the Company’ Common Stock and warrants, regardless of its operating performance.
−Removed: Following the Business Combination, the Company is a controlled
−Removed: company within the meaning of the Nasdaq Listing Rules and, as a result, will qualify for, and may rely on, exemptions
−Removed: from certain corporate governance requirements.
−Removed: Stockholders of the Company may not have the same protection afforded to stockholders
−Removed: of companies that are subject to such governance requirements.
−Removed: After the Business Combination, Kuk Hyoun Hwang, the Company’s
−Removed: Chief Executive Officer will control a majority of the voting power of the outstanding shares of the Company Common Stock.
−Removed: the Company will be a “controlled company” within the meaning of the corporate governance standards of Nasdaq.
−Removed: these corporate governance standards, a company of which more than 50% of the voting power for the election of directors is held by an
−Removed: individual, group or another company is a “controlled company” and may elect not to comply with certain corporate governance
−Removed: requirements.
−Removed: For example, controlled companies:
−Removed: ● are not required to have a board that is composed of a majority
−Removed: of “independent directors” as defined under the Nasdaq listing rules;
−Removed: ● are not required to have a compensation committee that is composed
−Removed: entirely of independent directors or have a written charter addressing the committee’s purpose and responsibilities;
−Removed: ● are not required to have director nominations be made, or recommended
−Removed: to the full board of directors, by its independent directors or by a nominating and corporate governance committee that is composed entirely
−Removed: of independent directors, and to adopt a written charter or a board resolution addressing the nominations process.
−Removed: While the Company does not initially intend to rely on these exemptions,
−Removed: the Company may opt to utilize these exemptions in the future as long as it remains a controlled company.
−Removed: Accordingly, the Company
−Removed: stockholders may not have the same protections afforded to stockholders of companies that are subject to all of the corporate governance
−Removed: requirements of Nasdaq.
−Removed: If the Company ceases to be a “controlled company” in the
−Removed: future, it will be required to fully comply with the Nasdaq Listing Rules, which may require replacing a number of its directors and may
−Removed: require development of certain other governance-related policies and practices.
−Removed: These and any other actions necessary to achieve
−Removed: compliance with such rules may increase the Company’ legal and administrative costs, will make some activities more difficult, time-consuming,
−Removed: and costly and may also place additional strain on the Company’ personnel, systems and resources.
+Added: price of the Company’s Common Stock, regardless of its operating performance.
+Added: The market price of the Company’s Common Stock
+Added: has declined significantly in recent months, making the financing of continuing business operations more difficult and dilutive and increasing
+Added: the risk of the Common Stock being delisted.
+Added: These and other factors, including a potential loss of liquidity in the market for the Common
+Added: Stock may limit the ability to sell the Company Common Stock.
+Added: We are no longer a “controlled company” under Nasdaq
+Added: rules and we cannot rely on certain Nasdaq corporate governance requirement exemptions
+Added: The “controlled company” exception to the Nasdaq rules
+Added: provides that a company of which more than 50% of the voting power for the election of directors is held by an individual, a group or
+Added: another company, a “controlled company,” need not comply with certain requirements of the Nasdaq corporate governance rules.
+Added: Until December 31, 2025, Kuk Hyoun Hwang, directly and indirectly, owned a majority of the voting power of our outstanding common stock
+Added: and was able to determine all matters requiring approval by our stockholders.
+Added: As a “controlled company” within the meaning
+Added: of the corporate governance rules of Nasdaq, during 2025, we were exempt from the Nasdaq’s corporate governance rules requiring
+Added: that listed companies have (i) a majority of the Board consist of “independent” directors under the listing standards of the
+Added: Nasdaq rules, (ii) selection or recommendation for the Board’s selection of director nominees made by (a) independent directors
+Added: constituting a majority of the Board’s independent directors in a vote in which only the independent directors participate or (b)
+Added: a nominating and corporate governance committee composed entirely of independent directors (subject to exceptions under limited and exceptional
+Added: circumstances) and a written nominating and corporate governance committee charter meeting the requirements of the Nasdaq rules and (iii)
+Added: a compensation committee composed entirely of independent directors (subject to exceptions under limited and exceptional circumstances)
+Added: and a written compensation committee charter meeting the requirements of the Nasdaq rules.
+Added: As of the date of this Annual Report, Kuk Hyoun
+Added: Hwang no longer owns a majority of the voting power of our outstanding common stock.
+Added: As a result, we no longer qualify as a “controlled
+Added: company” and have entered the applicable phase-in period for compliance with corporate governance requirements.
+Added: We have also ceased
+Added: relying on the exemption available to newly public companies regarding a majority independent board.
An active, liquid trading market for the Company Common Stock
and warrants may not develop or persist, which may limit your ability to sell such common stock and warrants.
−Removed: Although Company stock and warrants were listed on Nasdaq under the
−Removed: ticker symbols “OSRH” and “OSRHW,” respectively, upon Closing of the Business Combination, a sufficiently liquid
−Removed: or active trading market for the Company Common Stock and warrants may never develop or be sustained going forward.
−Removed: A public trading market
−Removed: having the desirable characteristics of depth, liquidity and orderliness depends upon the existence of willing buyers and sellers at any
−Removed: given time, such existence being dependent upon the individual decisions of buyers and sellers over which neither we nor any market maker
−Removed: The failure of an active and liquid trading market to develop and continue would likely have a material adverse effect on
−Removed: the value of the Company Common Stock and warrants.
−Removed: An inactive market may also impair our ability to raise capital to continue to fund
−Removed: operations by issuing the Company Common Stock and warrants.
+Added: The Company’s common stock and warrants are listed on the Nasdaq
+Added: Stock Market under the ticker symbols “OSRH” and “OSRHW,” respectively.
+Added: However, a sufficiently liquid or active
+Added: trading market for the Company Common Stock and warrants may not develop or may not be sustained.
+Added: A public trading market having the desirable
+Added: characteristics of depth, liquidity and orderliness depends upon the existence of willing buyers and sellers at any given time, such existence
+Added: being dependent upon the individual decisions of buyers and sellers over which neither we nor any market maker has control.
+Added: of an active and liquid trading market to develop and continue would likely have a material adverse effect on the value of the Company
+Added: Common Stock and warrants.
+Added: An inactive market may also impair our ability to raise capital to continue to fund operations by issuing the
+Added: Company’s Common Stock and warrants.
In addition, the price of the Company securities can vary due to general
9 unchanged sentences
The Company currently anticipates that it will retain future earnings
−Removed: for the development, operation and expansion of the Company’ business and does not anticipate declaring or paying any cash dividends
+Added: for the development, operation and expansion of the Company’s business and does not anticipate declaring or paying any cash dividends
for the foreseeable future.
Furthermore, future debt or other financing arrangements may contain terms prohibiting or limiting the amount
−Removed: of dividends that may be declared or paid on the Company’ Common Stock.
+Added: of dividends that may be declared or paid on the Company’s Common Stock.
Any return to stockholders will therefore be limited to
4 unchanged sentences
or the perception that such sales could occur, by the Company or its stockholders or warrant holders, could harm the prevailing market
−Removed: price of shares of New Holdings Common Stock.
+Added: price of shares of OSR Holdings Common Stock.
These sales, or the possibility that these sales may occur, also might make it more difficult
3 unchanged sentences
Common Stock and may be dilutive to existing stockholders.
−Removed: In the future, the Company is likely to issue additional shares of
−Removed: common stock or issue preferred stock or incur debt.
+Added: In the future, the Company may issue additional shares of common stock
+Added: or issue preferred stock or incur debt.
Debt and preferred stock will generally have priority upon liquidation.
−Removed: Such securities
−Removed: also may be governed by an indenture or other instrument containing covenants restricting our operating flexibility.
−Removed: Additionally, any
−Removed: convertible or exchangeable securities that the Company issues in the future may have rights, preferences and privileges more favorable
−Removed: than those of the Company Common Stock.
−Removed: Because the decision to issue debt or equity in the future will depend on market conditions and
−Removed: other factors beyond the Company’ control, we cannot predict or estimate the amount, timing, nature or success of our future capital
−Removed: raising efforts.
+Added: Such securities also may
+Added: be governed by an indenture or other instrument containing covenants restricting our operating flexibility.
+Added: Additionally, any convertible
+Added: or exchangeable securities that the Company issues in the future may have rights, preferences and privileges more favorable than those
+Added: of the Company Common Stock.
+Added: Because the decision to issue debt or equity in the future will depend on market conditions and other factors
+Added: beyond the Company’s control, we cannot predict or estimate the amount, timing, nature or success of our future capital raising
As a result, future capital raising efforts may reduce the market price of the Company Common Stock and warrants to purchase
11 unchanged sentences
The registration and availability of such a significant number of securities for trading in the public market may have an adverse effect
−Removed: on the market price of the Company Common Stock.
−Removed: The abovementioned risks are specifically relevant to Company’s
−Removed: recent Equity Line of Credit (“ELOC”) Agreement
−Removed: In on February 25, 2025 we entered into an equity purchase agreement
−Removed: and registration rights agreement (taken together, the “ ELOC Agreement ”) with White Lion GBM Innovation Fund, providing
+Added: on the market price of the Company’s Common Stock.
+Added: The abovementioned risks are specifically relevant to the Company’s
+Added: Equity Line of Credit (“ELOC”) Agreement
+Added: On February 25, 2025 we entered into an equity purchase agreement and
+Added: registration rights agreement (taken together, the “ ELOC Agreement ”) with White Lion GBM Innovation Fund, providing
that the Company has the right, but not the obligation, to require White Lion to purchase, from time to time, up to the lesser of (i)
62 unchanged sentences
Some of these provisions include:
−Removed: ● a requirement that special meetings of stockholders be called
−Removed: only by the chairperson of the board of directors, the chief executive officer, or by the directors entitled to cast a majority of the
−Removed: votes of the whole board of directors;
−Removed: ● advance notice requirements for stockholder proposals and nominations
−Removed: for election to our board of directors;
−Removed: ● the authority of the board of directors to issue preferred stock
−Removed: on terms determined by the board of directors without stockholder approval and which preferred stock may include rights superior to the
−Removed: rights of the holders of common stock.
+Added: a requirement that special meetings of stockholders be called only by the chairperson of the board of directors, the chief executive officer, or by the directors entitled to cast a majority of the votes of the whole board of directors;
+Added: advance notice requirements for stockholder proposals and nominations for election to our board of directors;
+Added: the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approval and which preferred stock may include rights superior to the rights of the holders of common stock.
These anti-takeover provisions and other provisions in the Company
4 unchanged sentences
corporate actions you desire.
−Removed: Any delay or prevention of a change of control transaction or changes in the Company’ board of directors
+Added: Any delay or prevention of a change of control transaction or changes in the Company’s board of directors
could cause the market price of our common stock to decline.
12 unchanged sentences
is prohibited unless it satisfies one of the following conditions:
−Removed: ● before the stockholder became an interested stockholder, the
−Removed: board of directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming
−Removed: an interested stockholder;
−Removed: ● upon the consummation of the transaction which resulted in the
−Removed: stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation
−Removed: outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding those shares owned
−Removed: by persons who are directors and also officers, and employee stock plans, in some instances;
−Removed: ● at or after the time the stockholder became an interested stockholder,
−Removed: the business combination was approved by the board of directors of the corporation and authorized at an annual or special meeting of
−Removed: the stockholders by the affirmative vote of at least 66 ⅔ % of the outstanding voting stock which is not owned by the
−Removed: interested stockholder.
+Added: before the stockholder became an interested stockholder, the board of directors of the corporation approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;
+Added: upon the consummation of the transaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding those shares owned by persons who are directors and also officers, and employee stock plans, in some instances;
+Added: at or after the time the stockholder became an interested stockholder, the business combination was approved by the board of directors of the corporation and authorized at an annual or special meeting of the stockholders by the affirmative vote of at least 66 ⅔
+Added: % of the outstanding voting stock which is not owned by the interested stockholder.
Under certain circumstances, Section 203 of the DGCL will make
3 unchanged sentences
board of directors of the Company.
−Removed: Section 203 of the DGCL also may have the effect of preventing changes in the Company board of
−Removed: directors and may make it more difficult to accomplish transactions which stockholders may otherwise deem to be in their best interests.
−Removed: If, following the Business Combination, securities or industry
−Removed: analysts do not publish or cease publishing research or reports about the Company, its business, or its market, or if they change their
−Removed: recommendations regarding the Company securities adversely, then the price and trading volume of the Company securities could decline.
+Added: Section 203 of the DGCL also may have the effect of preventing changes in the Company’s board
+Added: of directors and may make it more difficult to accomplish transactions which stockholders may otherwise deem to be in their best interests.
+Added: If securities or industry analysts do not publish or cease publishing
+Added: research or reports about the Company, its business, or its market, or if they change their recommendations regarding the Company securities
+Added: adversely, then the price and trading volume of the Company securities could decline.
The trading market for the Company securities will be influenced by
4 unchanged sentences
If any of the analysts who may cover the Company
−Removed: change their recommendation regarding the Company securities adversely, or provide more favorable relative recommendations about the Company’
−Removed: competitors, the price of the Company’ securities would likely decline.
−Removed: If any analyst who may cover the Company were to cease coverage
−Removed: of the Company or fail to regularly publish reports on it, the Company could lose visibility in the financial markets, which could cause
−Removed: the Company’ securities price or trading volume to decline.
+Added: change their recommendation regarding the Company’s securities adversely, or provide more favorable relative recommendations about
+Added: the Company’s competitors, the price of the Company’s securities would likely decline.
+Added: If any analyst who may cover the Company
+Added: were to cease coverage of the Company or fail to regularly publish reports on it, the Company could lose visibility in the financial markets,
+Added: which could cause the Company’s securities price or trading volume to decline.
There can be no assurance that the Company will be able to comply
with the continued listing standards of Nasdaq.
−Removed: The Company failure to meet the continued listing requirements of Nasdaq could result
−Removed: in a delisting of the Company Common Stock and warrants.
−Removed: Effective at the time of the Business Combination the Company Common
−Removed: Stock and warrants were listed on Nasdaq under the symbols “OSRH” and “OSRHW,” respectively.
−Removed: eligibility for listing on Nasdaq depends on its ability to comply with Nasdaq’s continued listing standards, including requirements
−Removed: relating to the trading price and trading volume of its securities, and other corporate governance requirements.
−Removed: If the Company is not
−Removed: able to comply with the continued listing standards of Nasdaq, the Company and its stockholders could face significant material adverse
−Removed: consequences including, but not limited to:
+Added: The Company’s failure to meet the continued listing requirements of Nasdaq could result
+Added: in a delisting of the Company’s Common Stock and warrants.
+Added: The Company Common Stock and warrants were listed on Nasdaq under the
+Added: symbols “OSRH” and “OSRHW,” respectively.
+Added: The Company’s eligibility for listing on Nasdaq depends on its
+Added: ability to comply with Nasdaq’s continued listing standards, including requirements relating to the trading price and trading volume
+Added: of its securities, and other corporate governance requirements.
+Added: If the Company is not able to comply with the continued listing standards
+Added: of Nasdaq, the Company and its stockholders could face significant material adverse consequences including, but not limited to:
a limited availability of market quotations for its securities;
−Removed: ● reduced liquidity for the Company securities;
−Removed: ● a determination that the Company Common Stock is a “penny
−Removed: stock,” which will require brokers trading in the Company Common Stock to adhere to more stringent rules and possibly result in
−Removed: a reduced level of trading activity in the secondary trading market for the Company Common Stock;
+Added: reduced liquidity for the Company’s securities;
+Added: a determination that the Company Common Stock is a “penny stock,” which will require brokers trading in the Company Common Stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for the Company Common Stock;
a limited amount of or no analyst coverage;
−Removed: ● a decreased ability to issue additional securities or obtain
−Removed: additional financing in the future.
+Added: a decreased ability to issue additional securities or obtain additional financing in the future.
The National Securities Markets Improvement Act of 1996,
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securities.” As long as the Company’s Common Stock and warrants are listed on Nasdaq, they will be considered covered securities.
−Removed: If the Company’ securities were no longer listed on Nasdaq, the securities would not be covered securities and would therefore be
−Removed: subject to regulation in each state in which the Company offers its securities.
−Removed: If, after listing, the Company fails to satisfy the continued listing
−Removed: requirements of Nasdaq such as the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps
−Removed: to delist the Company’ securities.
−Removed: Such a delisting would likely have a negative effect on the price of the securities and would
−Removed: impair your ability to sell or purchase the securities when you wish to do so.
−Removed: In the event of a delisting, and no assurance can be provided
−Removed: that any action taken to restore compliance with listing requirements would allow the securities to become listed again, stabilize the
−Removed: market price or improve the liquidity of its securities, prevent its securities from dropping below the Nasdaq minimum bid price requirement
+Added: If the Company’s securities were no longer listed on Nasdaq, the securities would not be covered securities and would therefore
+Added: be subject to regulation in each state in which the Company offers its securities.
+Added: If the Company fails to satisfy the continued listing requirements
+Added: of Nasdaq such as the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps to delist
+Added: the Company’s securities.
+Added: Such a delisting would likely have a negative effect on the price of the securities and would impair your
+Added: ability to sell or purchase the securities when you wish to do so.
+Added: In the event of a delisting, and no assurance can be provided that
+Added: any action taken to restore compliance with listing requirements would allow the securities to become listed again, stabilize the market
+Added: price or improve the liquidity of its securities, prevent its securities from dropping below the Nasdaq minimum bid price requirement
or prevent future non-compliance with Nasdaq’s listing requirements.
−Removed: Additionally, if the Company’ securities are not
+Added: Additionally, if the Company’s securities are not
listed on, or become delisted from, Nasdaq for any reason, and are quoted on any of the markets offered by OTC Markets Group Inc., the
liquidity and price of these securities may be more limited than if they were quoted or listed on Nasdaq or another national securities
−Removed: the Company securityholders may be unable to sell their securities unless a market can be established or sustained.
+Added: In such circumstances, Company securityholders may be unable to sell their securities unless a market can be established or
On February 15, 2024, the Company received a written notice (the
20 unchanged sentences
for initial listing under Listing Rule 5505 and the securities of OSRH began trading on the Nasdaq Capital Market February 18, 2025.
−Removed: [a]ccordingly, the Panel has determined to continue the listing of the Company’s securities on The Nasdaq Stock Market LLC and is closing
−Removed: this matter.” However, this is no guaranty that the Company will be able to maintain compliance with Nasdaq continued listing standards
−Removed: going forward.
+Added: [a]ccordingly, the Panel has determined to continue the listing of the Company’s securities on The Nasdaq Stock Market LLC and is
+Added: closing this matter.” However, this is no guaranty that the Company will be able to maintain compliance with Nasdaq continued listing
+Added: standards going forward.
+Added: On September 5, 2025, the Company received a written notice from the
+Added: Nasdaq Listing Qualifications Department indicating that the Company was not in compliance with the minimum bid price requirement set
+Added: forth in Nasdaq Listing Rule 5550(a)(2) because the closing bid price of the Company’s common stock had been below $1.00 per share
+Added: for 30 consecutive business days.
+Added: The notice had no immediate effect on the listing or trading of the Company’s securities on the
+Added: Nasdaq Capital Market.
+Added: Nasdaq provided the Company with an initial compliance period of 180 calendar days, or until March 4, 2026, to
+Added: regain compliance with the minimum bid price requirement.
+Added: The Company did not regain compliance within that period and Nasdaq subsequently
+Added: granted the Company an additional 180-day compliance period, extending the deadline to August 31, 2026, to regain compliance.
+Added: If the Company
+Added: does not regain compliance by that date, the Company’s securities may become subject to delisting from Nasdaq.
+Added: The Company intends
+Added: to monitor the closing bid price of its common stock and may pursue available options to regain compliance, including a reverse stock
+Added: split, although there can be no assurance that such actions would be successful or that the Company will be able to maintain compliance
+Added: with Nasdaq’s continued listing standards in the future.
We anticipate that the Company will qualify as an “emerging
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first sale of the Company Common Stock, as defined by the JOBS Act.
−Removed: Investors may find the Company’ securities less attractive because
−Removed: it may rely on these exemptions.
−Removed: If some investors find the Company’ securities less attractive as a result of its reliance on these
−Removed: exemptions, the trading prices of its securities may be lower than they otherwise would be, there may be a less active trading market
−Removed: for its securities and the trading prices of its securities may be more volatile.
+Added: Investors may find the Company’s securities less attractive
+Added: because it may rely on these exemptions.
+Added: If some investors find the Company’s securities less attractive as a result of its reliance
+Added: on these exemptions, the trading prices of its securities may be lower than they otherwise would be, there may be a less active trading
+Added: market for its securities and the trading prices of its securities may be more volatile.
Additionally, we anticipate the Company will qualify as a “smaller
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Smaller reporting
−Removed: companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years
−Removed: of audited financial statements.
+Added: companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of
+Added: audited financial statements.
the Company will remain a smaller reporting company for so long as the market value of its common stock
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exercise of the public warrants (1) may be less than the value the holders would have received if they had exercised their public
−Removed: warrants at a later time where the underlying share price is higher and (2) may not compensate the holders for the value of the public
−Removed: The fair value of 6,900,000 public warrants as of April 11, 2025 is $243,922.
+Added: warrants at a later time, where the underlying share price is higher and (2) may not compensate the holders for the value of the
+Added: public warrants.
The private placement warrants are identical to the public warrants,
except that the private placement warrants and the shares of common stock issuable upon the exercise of the private placement warrants
−Removed: are not transferable, assignable or salable until after the completion of a Business Combination, subject to certain limited exceptions,
−Removed: and none of the private placement warrants will be redeemable by the Company so long as they are held by their initial purchasers or their
+Added: were not transferable, assignable or salable prior to the completion of a Business Combination, subject to certain limited exceptions,
+Added: and none of the private placement warrants are redeemable by the Company so long as they are held by their initial purchasers or their
permitted transferees.
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Notice of redemption will be mailed by first class mail, postage prepaid, by the Company not less than 30 days prior
−Removed: to the Redemption Date to the registered holders of the redeemable warrants to be redeemed at their last addresses as they appear on
−Removed: the registration books.
−Removed: Any notice mailed in the manner provided in the Warrant Agreement will be conclusively presumed to have been
−Removed: duly given whether or not the registered holder received such notice.
−Removed: Accordingly, if a holder fails to actually receive the notice of
−Removed: or otherwise fails to respond on a timely basis, it could lose the benefit of being a holder of a Company public warrant.
+Added: to the Redemption Date to the registered holders of the redeemable warrants to be redeemed at their last addresses as they appear on the
+Added: registration books.
+Added: Any notice mailed in the manner provided in the Warrant Agreement will be conclusively presumed to have been duly
+Added: given whether or not the registered holder received such notice.
+Added: Accordingly, if a holder fails to actually receive the notice of or otherwise
+Added: fails to respond on a timely basis, it could lose the benefit of being a holder of a Company public warrant.
The closing price of the Company’s common stock has not exceeded
−Removed: $16.50 per share for any of the 30 trading days prior to the date of this proxy statement/prospectus.
+Added: $16.50 per share for any of the 30 trading days prior to the date of this Annual Report on Form 10-K.
Risks Related to the Company Business and Operations
The following risk factors reference the risks and uncertainties
−Removed: relating to the business and operations of OSR, which, following the closing of the Business Combination, are the business and operations
−Removed: of the Company.
−Removed: References in this section to “we,” “us,” and “our” refer to OSR prior to the closing
−Removed: of the Business Combination and to the Company after closing.
+Added: relating to the business and operations of the Company.
+Added: References in this section to “we,” “us,” and “our”
+Added: refer to OSR Holdings, Inc.
The Company’s limited operating history, the early stage
18 unchanged sentences
We have never generated any operating profits and incurred operating
−Removed: losses of KRW 784.7 million and KRW 14.8 billion for years ending 2022 and 2023, respectively, and operating
−Removed: loss of KRW 15.9 billion for the year ending December 31, 2024.
−Removed: We have an accumulated deficit of KRW 28.18 billion as
−Removed: of December 31, 2024.
+Added: losses of USD 11.7 million and USD 18.3 million for years ending 2024 and 2025, respectively.
+Added: We have an accumulated deficit
+Added: of USD 37.17 million as of December 31, 2025.
We are likely to continue to incur operating losses in the future.
−Removed: While our RMC subsidiary generated revenues of
−Removed: KRW 4.38 billion and KRW 4.81 billion in the years ending December 31, 2023 and 2024, respectively, none of our other subsidiaries
−Removed: have generated any revenues from product sales because none of their current product candidates have received marketing or other required
−Removed: regulatory approvals anywhere in the world.
−Removed: We may never generate product revenue from the commercial sales of our pharmaceutical product
−Removed: candidates or achieve profitability.
+Added: While our RMC subsidiary
+Added: generated revenues of USD 2.9 million for the year ended December 31, 2025, none of our other subsidiaries have generated any revenues
+Added: from product sales because none of their current product candidates have received marketing or other required regulatory approvals anywhere
+Added: in the world.
+Added: We may never generate product revenue from the commercial sales of our pharmaceutical product candidates or achieve profitability.
Our business is dependent on the success of our product candidates
3 unchanged sentences
depends on a number of factors including our ability to:
−Removed: ● successfully develop new product candidates through our drug
−Removed: development strategy and advance those product candidates into pre-clinical studies and clinical trials;
−Removed: ● successfully complete ongoing pre-clinical studies
−Removed: and clinical trials and obtain regulatory approvals for our current and future product candidates;
+Added: successfully develop new product candidates through our drug development strategy and advance those product candidates into pre-clinical studies and clinical trials;
+Added: successfully complete ongoing pre-clinical studies and clinical trials and obtain regulatory approvals for our current and future product candidates;
attract and retain experienced management and advisory teams;
−Removed: ● add operational, financial and management information systems
−Removed: and personnel, including personnel to support clinical, pre-clinical manufacturing and planned future commercialization efforts
−Removed: and operations;
−Removed: ● achieve market acceptance of product candidates in the medical
−Removed: community and with third-party payors and consumers;
+Added: add operational, financial and management information systems and personnel, including personnel to support clinical, pre-clinical manufacturing and planned future commercialization efforts and operations;
+Added: achieve market acceptance of product candidates in the medical community and with third-party payors and consumers;
maintain, expand and protect our intellectual property portfolio.
46 unchanged sentences
for commercial sale, will depend on a number of factors, including:
−Removed: ● the efficacy and potential advantages compared to alternative
−Removed: ● the ability to offer our products, if approved, for sale at
−Removed: competitive prices;
−Removed: ● the convenience and ease of administration compared to alternative
−Removed: ● the willingness of the target patient population to try new
−Removed: therapies and of physicians to prescribe these therapies;
−Removed: ● the price we pay or any of our future collaborators charge for
−Removed: our products;
−Removed: ● the recommendations with respect to our product candidates in
−Removed: guidelines published by various scientific organizations applicable to us and our product candidates;
+Added: the efficacy and potential advantages compared to alternative treatments;
+Added: the ability to offer our products, if approved, for sale at competitive prices;
+Added: the convenience and ease of administration compared to alternative treatments;
+Added: the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
+Added: the price we pay or any of our future collaborators charge for our products;
+Added: the recommendations with respect to our product candidates in guidelines published by various scientific organizations applicable to us and our product candidates;
the strength of marketing and distribution support;
−Removed: ● the ability to obtain sufficient third-party coverage and
−Removed: adequate reimbursement;
+Added: the ability to obtain sufficient third-party coverage and adequate reimbursement;
the prevalence and severity of any side effects;
−Removed: ● the size and effectiveness of our sales, marketing and distribution
+Added: the size and effectiveness of our sales, marketing and distribution support.
If government and other third-party payors do not provide coverage
62 unchanged sentences
potential compared to those we actually fund.
+Added: On July 24, 2025, the Company, together with OSR Holdings Co., Ltd.,
+Added: entered into a non-binding term sheet with Woori IO Co., Ltd.
+Added: (“WORIO”), outlining the principal terms of a proposed share
+Added: exchange transaction pursuant to which WORIO would become a wholly owned subsidiary of OSRK.
+Added: Pursuant to the term sheet, WORIO shareholders would receive newly
+Added: issued shares of OSRK, which may be convertible into Company common stock within three years, subject to certain conditions.
+Added: also agreed to a six-month exclusivity period and to conduct mutual due diligence.
+Added: The transaction is subject to the negotiation and execution
+Added: of definitive agreements.
+Added: On January 26, 2026, the Company completed the acquisition of WORIO
+Added: pursuant to definitive agreements entered into by the parties, and WORIO became a wholly owned subsidiary of OSRK.
+Added: A copy of the term sheet is filed as Exhibit 10.1 to the Company’s
+Added: Current Report on Form 8-K filed with the SEC on October 16, 2025.
Our investments in ongoing and upcoming research and development programs
101 unchanged sentences
Our Korean subsidiary, RMC, is a distributor of medical products currently
−Removed: serving only the Korea market.
−Removed: Three customers of RMC have in recent years represented approximately 95% of RMC’s total sales.
+Added: serving only the Korean market.
+Added: Three main customers of RMC have in recent years represented approximately 95% of RMC’s total
This customer concentration creates risks for RMC (and OSR) in the event that one or more of those customers terminates its distribution
2 unchanged sentences
extended) distribution agreement.
−Removed: Sales of Penumbra’s reperfusion catheter, neuron delivery catheter and related tubing and canister
−Removed: represented between 27% and 47% of RMC’s quarterly revenues in 2023 and 2024, and 40% and 36% of revenues for the years ending December 31,
−Removed: 2023 and 2024, respectively.
−Removed: While RMC may continue to sell its existing inventory of Penumbra products (Penumbra will not repurchase
−Removed: RMC’s inventory), RMC may be unable to sell its inventory or to sell it without discounting the prices.
−Removed: If RMC is unable to sell
−Removed: its inventory and is required by accounting rules to write off the inventory, RMC may incur losses.
−Removed: Since RMC is OSR’s only revenue
−Removed: producing subsidiary, with the termination of RMC’s distribution agreement with Penumbra, OSR expects its revenue to decrease substantially
−Removed: in 2025 and possibly longer, until RMC can replace sales of Penumbra’s products by increasing sales of products from other manufacturers.
−Removed: While RMC intends to replace sales of Penumbra products by becoming the sales representative of other neuro-intervention medical
−Removed: device equipment manufacturers, as well as expanding sales of products offered by companies it currently represents, such efforts may
−Removed: take a substantial time period (which RMC cannot predict) for revenues to return to their current levels.
RMC is required under some of its sales agency agreements to make annual
15 unchanged sentences
financial condition could be adversely affected.
−Removed: The Company has identified material weaknesses in its internal
−Removed: control over financial reporting, which could adversely affect its ability to report its financial condition and results of operations
−Removed: accurately and on a timely basis.
−Removed: Management has concluded that the Company’s internal control over financial reporting
−Removed: was not effective as of December 31, 2024, due to the identification of material weaknesses.
−Removed: These include (i) improper use of Trust
−Removed: Account funds for general operating expenses in violation of the Trust Agreement, (ii) failure to obtain timely Audit Committee approval
−Removed: for related party transactions, (iii) inadequate documentation of related party financing transactions, and (iv) insufficient personnel
−Removed: in the accounting and financial reporting functions.
−Removed: These weaknesses could result in material misstatements not being prevented or detected
−Removed: in a timely manner.
−Removed: Although the Company has taken certain remedial actions, there can be no assurance that the material weaknesses will
−Removed: be fully remediated or that additional material weaknesses will not be identified in the future.
+Added: The Company has previously identified material weaknesses in
+Added: its internal control over financial reporting, which could adversely affect its ability to report its financial condition and results
+Added: of operations accurately and on a timely basis.
+Added: The Company has identified material weaknesses in its internal control
+Added: over financial reporting, which could adversely affect its ability to report its financial condition and results of operations accurately
+Added: and on a timely basis.
+Added: Management previously concluded that its internal control over financial
+Added: reporting was not effective as of December 31, 2024.
+Added: Although management implemented remediation measures during 2025 and concluded that
+Added: such material weaknesses had been remediated as of June 30, 2025, additional deficiencies were identified in connection with the year-end
+Added: evaluation as of December 31, 2025, including deficiencies related to the completeness and accuracy of liabilities and the sufficiency
+Added: of personnel within the accounting and financial reporting function.
+Added: As a result, management concluded that material weaknesses existed
+Added: as of December 31, 2025.
+Added: These material weaknesses could result in material misstatements not
+Added: being prevented or detected on a timely basis.
+Added: For additional information, see “Item 9A.
+Added: Controls and Procedures.”
Risks Related to the Company’s Strategy to Grow the Business
The following risk factors reference the risks and uncertainties
−Removed: relating to the growth strategy of OSR, which, following the closing of the Business Combination, relate to the growth strategy of the
−Removed: Company going forward.
−Removed: References in this section to “we,” “us,” and “our” refer to OSR prior to the
−Removed: closing of the Business Combination and to the Company after closing.
+Added: relating to the business and operations of the Company.
+Added: References in this section to “we,” “us,” and “our”
+Added: refer to OSR Holdings, Inc.
We may not be successful in our efforts to acquire, in-license or
44 unchanged sentences
additional losses.
−Removed: Our investment strategy and future growth relies on a number
−Removed: of assumptions, some or all which may not be realized.
+Added: Our investment strategy and future growth rely on a number of
+Added: assumptions, some or all of which may not be realized.
Our strategy for investment and plans for future expansion are founded
22 unchanged sentences
challenges that may adversely affect our business.
−Removed: As of December 31, 2024, we had 19 full-time employees and
−Removed: two part-time employees whom we rely on for drug development planning, employee relations, financing accounting matters and other
−Removed: support services for our company and all of its subsidiaries.
−Removed: These individuals may not have sufficient time and bandwidth to perform
−Removed: effectively their respective responsibilities, potentially hindering the achievement of our goals and jeopardizing the execution of our
−Removed: business strategy.
−Removed: While our current structure helps us minimize certain overhead expenses, the relatively small size of our central team
−Removed: limits our ability to allocate enough personnel, time, and resources to effectively manage our subsidiaries and investments creation of
−Removed: effective drug development plans, employee recruitment and retention, and overseeing financial and accounting matters.
−Removed: Members of our
−Removed: central team may lack sufficient information about various aspects of our subsidiaries’ business and operations to adequately address
−Removed: these responsibilities.
+Added: As of December 31, 2025, we had 22 full-time employees whom
+Added: we rely on for drug development planning, employee relations, financing, accounting matters and other support services for our company
+Added: and all of its subsidiaries.
+Added: These individuals may not have sufficient time and bandwidth to perform their responsibilities effectively,
+Added: potentially hindering the achievement of our goals and jeopardizing the execution of our business strategy.
+Added: While our current structure
+Added: helps us minimize certain overhead expenses, the relatively small size of our central team limits our ability to allocate enough personnel,
+Added: time, and resources to effectively manage our subsidiaries and investments creation of effective drug development plans, employee recruitment
+Added: and retention, and overseeing financial and accounting matters.
+Added: Members of our central team may lack sufficient information about various
+Added: aspects of our subsidiaries’ business and operations to adequately address these responsibilities.
We will need to expand our organization, and we may experience
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The following risk factors reference the risks and uncertainties
−Removed: relating to additional capital requirements of OSR, which, following the closing of the Business Combination, will be the additional capital
−Removed: requirements of the Company.
−Removed: References in this section to “we,” “us,” and “our” refer to OSR prior
−Removed: to the closing of the Business Combination and to the Company after closing.
+Added: relating to additional capital requirements of the Company.
+Added: References in this section to “we,” “us,” and “our”
+Added: refer to OSR Holdings, Inc.
We will require substantial additional capital to finance our
3 unchanged sentences
studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years.
−Removed: OSR’s operations,
+Added: The Company’s operations,
through its subsidiaries, have consumed substantial amounts of cash since inception.
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long-term, will depend on many factors, including, but not limited to:
−Removed: ● the initiation, progress, timing, costs and results of preclinical
−Removed: studies and clinical trials for our product candidates, including whether and when to advance our diverse portfolio of product candidates;
−Removed: ● the clinical development plans we establish for these product
−Removed: ● the timelines of our clinical trials and the overall costs to
−Removed: finish the clinical trials;
−Removed: ● the number and characteristics of product candidates that we
−Removed: ● the outcome, timing and cost of meeting regulatory requirements
−Removed: established by the FDA, European Medicines Agency and other comparable foreign regulatory authorities;
−Removed: ● the cost of filing, prosecuting, defending and enforcing our
−Removed: patent claims and other intellectual property rights;
−Removed: ● the cost of defending intellectual property disputes, including
−Removed: patent infringement actions brought by third parties against us or our product candidates;
−Removed: ● the extent to which we enter into additional collaboration agreements
−Removed: with regard to product discovery or acquire or in-license products or technologies;
+Added: the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our product candidates, including whether and when to advance our diverse portfolio of product candidates;
+Added: the clinical development plans we establish for these product candidates;
+Added: the timelines of our clinical trials and the overall costs to finish the clinical trials;
+Added: the number and characteristics of product candidates that we develop;
+Added: the outcome, timing and cost of meeting regulatory requirements established by the FDA, European Medicines Agency and other comparable foreign regulatory authorities;
+Added: the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
+Added: the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates;
+Added: the extent to which we enter into additional collaboration agreements with regard to product discovery or acquire or in-license products or technologies;
the effect of competing technological and market developments;
−Removed: ● the cost and timing of completion of commercial-scale outsourced
−Removed: manufacturing activities;
−Removed: ● the cost of establishing sales, marketing and distribution capabilities
−Removed: for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our
+Added: the cost and timing of completion of commercial-scale outsourced manufacturing activities;
+Added: the cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own.
Until we can generate sufficient revenue to finance our cash requirements,
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We may be unable to obtain additional financing to adequately
−Removed: capitalize the Company following the Business Combination or to fund the operations and growth of OSR and its subsidiaries, which could
−Removed: adversely affect the future prospects of the Company.
−Removed: We do not expect to have substantial proceeds from the Company’s
−Removed: IPO in which to provide capital to the Company and fund its growth following the Business Combination.
−Removed: In part because the PIPE Investment
−Removed: was not consummated (a more detailed discussion of this agreement is included in Part II, Item 7, “ Management’s Discussion
−Removed: and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources ”) we will be required
−Removed: to seek additional financing to provide such operating capital.
−Removed: We cannot assure you that such financing will be available on acceptable
−Removed: terms, if at all.
+Added: capitalize the Company or to fund the operations and growth of the Company and its subsidiaries, which could adversely affect the future
+Added: prospects of the Company.
+Added: We did not receive substantial proceeds from the Company’s IPO
+Added: to provide capital to the Company and fund its growth following the completion of the Business Combination.
+Added: We will be required to seek
+Added: additional financing to provide such operating capital.
+Added: We cannot assure you that such financing will be available on acceptable terms,
We may require such financing to fund the operations or growth of the Company.
−Removed: The failure to secure additional financing
−Removed: could have a material adverse effect on the continued development or growth of the Company.
−Removed: None of the Company’s Sponsor, officers,
−Removed: directors or their affiliates is required to provide any financing to us in connection with or after the Business Combination.
−Removed: elect to do so, their additional contributions of capital to the Company may require them to first sell a portion of their founders shares
−Removed: or other Company common stock holdings in qualified insider transactions, which may impact the market price levels of Company common stock.
+Added: The failure to secure additional financing could
+Added: have a material adverse effect on the continued development or growth of the Company.
+Added: None of the Company’s Sponsor, officers, directors
+Added: or their affiliates are obligated to provide any financing to the Company in connection with or following the Business Combination.
+Added: they elect to do so, their additional contributions of capital to the Company may require them to first sell a portion of their founders
+Added: shares or other Company common stock holdings in qualified insider transactions, which may impact the market price levels of Company common
We will require additional capital to fund our operations, and
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Our future cash flows from operations are unlikely to satisfy
−Removed: our capital needs so that we will continue to need to obtain financing through other means that may involve dilution of our stockholders,
+Added: our capital needs, so we will continue to need to obtain financing through other means that may involve dilution of our stockholders,
limits on our financing activities or reductions of our interest in our subsidiaries and investments.
23 unchanged sentences
the assumption of indebtedness or contingent liabilities;
−Removed: ● the issuance of our or our subsidiaries’ equity securities
−Removed: which would result in dilution to our stockholders;
−Removed: ● assimilation of operations, intellectual property, products
−Removed: and product candidates of an acquired company, including difficulties associated with integrating new personnel;
−Removed: ● the diversion of our management’s attention from our existing
−Removed: product programs and initiatives in pursuing such an acquisition or strategic partnership;
−Removed: ● retention of key employees, the loss of key personnel and uncertainties
−Removed: in our ability to maintain key business relationships;
−Removed: ● risks and uncertainties associated with the other party to such
−Removed: a transaction, including the prospects of that party and their existing products or product candidates, intellectual property, and regulatory
−Removed: ● our inability to generate revenue from acquired intellectual
−Removed: property, technology and/or products sufficient to meet our objectives or even to offset the associated transaction and maintenance costs.
+Added: the issuance of our or our subsidiaries’ equity securities which would result in dilution to our stockholders;
+Added: assimilation of operations, intellectual property, products and product candidates of an acquired company, including difficulties associated with integrating new personnel;
+Added: the diversion of our management’s attention from our existing product programs and initiatives in pursuing such an acquisition or strategic partnership;
+Added: retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships;
+Added: risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates, intellectual property, and regulatory approvals;
+Added: our inability to generate revenue from acquired intellectual property, technology and/or products sufficient to meet our objectives or even to offset the associated transaction and maintenance costs.
There is substantial doubt about the Company’s ability
12 unchanged sentences
The following risk factors reference the risks and uncertainties
−Removed: relating to the management of the business and operations of OSR, which, following the closing of the Business Combination, will be the
−Removed: management of the business and operations of the Company.
−Removed: References in this section to “we,” “us,” and “our”
−Removed: refer to OSR prior to the closing of the Business Combination and to the Company after closing.
−Removed: We will incur increased costs as a result of operating as a public
+Added: relating to the management of the business and operations of the Company.
+Added: References in this section to “we,” “us,”
+Added: and “our” refer to OSR Holdings, Inc.
+Added: We incur increased costs as a result of operating as a public
company, and our management will devote substantial time to compliance with its public company responsibilities and corporate governance
−Removed: As a public company, we will incur significant legal, accounting and
−Removed: other expenses that OSR did not incur as a private company, and these expenses may increase even more after we are no longer an emerging
−Removed: growth company, as defined in Section 2(a) of the Securities Act.
+Added: As a public company, we incur significant legal, accounting and other
+Added: expenses that OSR did not incur as a private company, and these expenses may increase even more after we are no longer an emerging growth
+Added: company, as defined in Section 2(a) of the Securities Act.
We are subject to the reporting requirements of the Exchange Act
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public companies.
−Removed: public company, the Company will be subject to significant
+Added: public company, the Company is subject to significant
regulatory oversight and reporting obligations under the U.S.
1 unchanged sentence
and investors.
−Removed: These new obligations and constituents will require significant attention from its senior management and could divert their
−Removed: attention away from the day-to-day management of its business.
−Removed: the Company may not have adequate personnel with the appropriate
−Removed: level of knowledge, experience, and training in the accounting policies, practices or internal controls over financial reporting required
+Added: These obligations and constituents require significant attention from its senior management and could divert their attention
+Added: away from the day-to-day management of its business.
+Added: The Company may not have adequate personnel with the appropriate level
+Added: of knowledge, experience, and training in the accounting policies, practices or internal controls over financial reporting required of
public companies.
2 unchanged sentences
To support its operations as a U.S.
−Removed: company, the Company plans to recruit additional qualified employees or external consultants with relevant experience, which will increase
+Added: company, the Company may recruit additional qualified employees or external consultants with relevant experience, which will increase
its operating costs in future periods.
−Removed: Our ability to successfully operate the business following the
−Removed: Business Combination will depend largely upon the efforts of certain key personnel, including the key personnel of OSR and its subsidiaries,
−Removed: all of whom we expect to remain employed (or retained as consultants) with the Company or its subsidiaries following the Business Combination.
−Removed: The loss of such key personnel could adversely affect the operations and profitability of the Company’ business.
+Added: Our ability to successfully operate the business depends largely
+Added: upon the efforts of certain key personnel, including the key personnel of the Company and its subsidiaries.
+Added: The loss of such key personnel
+Added: could adversely affect the operations and profitability of the Company’s business.
Our ability to recognize certain benefits of the Business Combination
−Removed: and successfully operate the Company’s business following the Business Combination will depend upon the efforts of its key personnel.
−Removed: Although we expect all of such key personnel to remain with the Company following the Business Combination, the unexpected loss of key
−Removed: personnel may adversely affect its operations and profitability.
−Removed: In addition, the Company’s future success depends in part on its
−Removed: ability to identify and retain key personnel to succeed senior management.
−Removed: Furthermore, while we have closely scrutinized the skills,
−Removed: abilities and qualifications of the key OSR’ or its subsidiaries’ personnel that will be employed by the Company, our assessment
−Removed: may not prove to be correct.
−Removed: If such personnel do not possess the skills, qualifications or abilities we expect or those necessary to
−Removed: manage a public company, the operations and profitability of the Company’s business may be negatively impacted.
+Added: and successfully operate the Company’s business following the Business Combination depends upon the efforts of its key personnel.
+Added: Although many of such key personnel have continued with the Company following the Business Combination, the unexpected loss of key personnel
+Added: may adversely affect its operations and profitability.
+Added: In addition, the Company’s future success depends in part on its ability
+Added: to identify and retain key personnel to succeed senior management.
+Added: Furthermore, while we have closely scrutinized the skills, abilities
+Added: and qualifications of the key Company or its subsidiaries’ personnel employed by the Company, our assessment may not prove to be
+Added: If such personnel do not possess the skills, qualifications or abilities expected or those necessary to manage a public company,
+Added: the operations and profitability of the Company’s business may be negatively impacted.
Claims for indemnification by our directors and officers may
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Amended Bylaws and the indemnification agreements that we will enter into with our directors and officers provide that:
−Removed: ● we will indemnify our directors and officers for serving us
−Removed: in those capacities or for serving other business enterprises at its request, to the fullest extent permitted by Delaware law.
−Removed: law generally provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably
−Removed: believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable
−Removed: cause to believe such person’s conduct was unlawful;
−Removed: ● we may, in our discretion, indemnify employees and agents in
−Removed: those circumstances where indemnification is permitted by applicable law;
−Removed: ● we are required to advance expenses, as incurred, to our directors
−Removed: and officers in connection with defending a proceeding, except that, if required by the DGCL, such directors or officers shall undertake
−Removed: to repay such advances if it is ultimately determined that such person is not entitled to indemnification;
−Removed: ● we are not obligated pursuant to the Amended Bylaws to indemnify
−Removed: a person with respect to proceedings initiated by that person against us or our other indemnitees, except with respect to proceedings
−Removed: authorized by our board of directors or brought to enforce a right to indemnification;
−Removed: ● the rights conferred in the Amended Bylaws are not exclusive,
−Removed: and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance
−Removed: to indemnify such persons.
+Added: we will indemnify our directors and officers for serving us in those capacities or for serving other business enterprises at its request, to the fullest extent permitted by Delaware law.
+Added: Delaware law generally provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful;
+Added: we may, in our discretion, indemnify employees and agents in those circumstances where indemnification is permitted by applicable law;
+Added: we are required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that, if required by the DGCL, such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification;
+Added: we are not obligated pursuant to the Amended Bylaws to indemnify a person with respect to proceedings initiated by that person against us or our other indemnitees, except with respect to proceedings authorized by our board of directors or brought to enforce a right to indemnification;
+Added: the rights conferred in the Amended Bylaws are not exclusive, and we are authorized to enter into indemnification agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons.
The outbreak of new, novel diseases, similar to the world’s
9 unchanged sentences
impact our business, including:
−Removed: ● interruptions in preclinical studies due to restricted or limited
−Removed: operations at our laboratory facilities or at facilities of our collaborators;
−Removed: ● interruption of, or delays in receiving, supplies for preclinical
−Removed: studies and/or clinical trials from our Contract Research Organizations (“CROs”), Contract Manufacturing Organizations (“ CMOs ”)
−Removed: or other collaborators due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;
−Removed: ● limitations on employee resources that would otherwise be focused
−Removed: on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families or the desire
−Removed: of employees to avoid contact with large groups of people;
−Removed: ● interruption or delays to outsourced research and discovery
−Removed: and clinical activities;
−Removed: ● delays in receiving authorizations from regulatory authorities
−Removed: to initiate our planned clinical trials;
−Removed: ● delays or difficulties in commencing enrollment of patients
−Removed: in our clinical trials, enrolling and retaining patients in our clinical trials in adequate numbers and difficulties in clinical site
−Removed: initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
−Removed: ● diversion of healthcare resources away from the conduct of clinical
−Removed: trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical
−Removed: ● interruption of key clinical trial activities, such as clinical
−Removed: trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others
−Removed: or interruption of clinical trial participant visits and study procedures that are deemed nonessential, which may impact the integrity
−Removed: of participant data and clinical trial endpoints;
−Removed: ● interruption or delays in the operations of the FDA, European
−Removed: Medicines Agency or other regulatory authorities, which may impact review and approval timelines.
+Added: interruptions in preclinical studies due to restricted or limited operations at our laboratory facilities or at facilities of our collaborators;
+Added: interruption of, or delays in receiving, supplies for preclinical studies and/or clinical trials from our Contract Research Organizations (“CROs”), Contract Manufacturing Organizations (“ CMOs ”) or other collaborators due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;
+Added: limitations on employee resources that would otherwise be focused on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;
+Added: interruption or delays to outsourced research and discovery and clinical activities;
+Added: delays in receiving authorizations from regulatory authorities to initiate our planned clinical trials;
+Added: delays or difficulties in commencing enrollment of patients in our clinical trials, enrolling and retaining patients in our clinical trials in adequate numbers and difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
+Added: diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;
+Added: interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial participant visits and study procedures that are deemed nonessential, which may impact the integrity of participant data and clinical trial endpoints;
+Added: interruption or delays in the operations of the FDA, European Medicines Agency or other regulatory authorities, which may impact review and approval timelines.
The extent to which an outbreak impacts our business will depend on
5 unchanged sentences
Since securities class action litigation and/or stockholder derivative
−Removed: litigation and inquiries or investigations by regulatory authorities often follows significant business transactions, such as the sale
−Removed: of a company or announcement of any other strategic transaction, such as the Business Combination, we may become subject to those types
−Removed: of lawsuits or investigations.
−Removed: Shareholder activism, which could take many forms or arise in a variety of situations, has been increasing
−Removed: Any stockholder litigation, stockholder activism, including potential proxy contests, and/or regulatory investigations against
−Removed: the Company, whether or not resolved in the Company’s favor, could result in substantial costs and divert the Company’s management’s
−Removed: attention from other business concerns, which could adversely affect the Company’s business and cash resources and the ultimate
−Removed: value the Company’s shareholders receive as a result of the Business Combination.
+Added: litigation and inquiries or investigations by regulatory authorities often follow significant business transactions, such as the sale
+Added: of a company or announcement of any other strategic transaction, we may become subject to those types of lawsuits or investigations.
+Added: activism, which could take many forms or arise in a variety of situations, has been increasing recently.
+Added: Any stockholder litigation, stockholder
+Added: activism, including potential proxy contests, and/or regulatory investigations against the Company, whether or not resolved in the Company’s
+Added: favor, could result in substantial costs and divert the Company’s management’s attention from other business concerns, which
+Added: could adversely affect the Company’s business and cash resources and the ultimate value the Company’s shareholders receive
+Added: from their investment in the Company.
We may be the target of securities class action and derivative
22 unchanged sentences
and results of operations.
−Removed: In March of 2025 Company Management became aware of a civil action filed against the Company by Benjamin Securities,
−Removed: in Supreme Court, New York County, seeking $500,000.00 in brokerage fees and costs the plaintiff alleges are due and owing.
+Added: In March and May of 2025, Company Management became aware of a civil action filed against the Company by Benjamin
+Added: Securities, Inc.
+Added: in Supreme Court, New York County, seeking $500,000.00 in brokerage fees and costs the plaintiff alleges are due and
+Added: On September 2, 2025, Chardan Capital Markets, LLC commenced an action in federal court in the United States District Court for
+Added: the Southern District of New York seeking $2,070,000 in damages.
Our internal computer systems, or those used by our third-party research
10 unchanged sentences
or reproduce the lost data.
−Removed: We could be held liable for monetary damages resulting from
−Removed: security breaches of our internal computer systems, and our insurance policies may be insufficient to cover potential losses.
+Added: We could be held liable for monetary damages resulting from security
+Added: breaches of our internal computer systems, and our insurance policies may be insufficient to cover potential losses.
We may also incur liability for unauthorized disclosure of sensitive
54 unchanged sentences
would lose your entire investment in the Company.
−Removed: Our pharmaceutical products may expose us to product liability or
−Removed: other product claim risks.
−Removed: We currently do not have product liability or other insurance for such claims and may not be able to obtain
−Removed: such insurance on acceptable terms or that any insurance we do obtain will be sufficient to protect us against potential claims or that
−Removed: insurance will be available in the future in amounts sufficient to protect us.
−Removed: A product liability claim or other claim, as well as any
−Removed: claims for uninsured liabilities or in excess of insured liabilities, could have a material adverse effect on our business, financial
−Removed: condition, results of operations and prospects.
+Added: Our pharmaceutical products may expose us to product liability or other
+Added: product claim risks.
+Added: We currently do not have product liability or other insurance for such claims and may not be able to obtain such
+Added: insurance on acceptable terms or that any insurance we do obtain will be sufficient to protect us against potential claims or that insurance
+Added: will be available in the future in amounts sufficient to protect us.
+Added: A product liability claim or other claim, as well as any claims for
+Added: uninsured liabilities or in excess of insured liabilities, could have a material adverse effect on our business, financial condition,
+Added: results of operations and prospects.
Our relationships with healthcare providers and physicians and third-party payors
43 unchanged sentences
among other things:
−Removed: ● restrictions on the marketing or manufacturing of our products,
−Removed: withdrawal of the product from the market or voluntary or mandatory product recalls;
−Removed: ● manufacturing delays and supply disruptions where regulatory
−Removed: inspections identify observations of noncompliance requiring remediation;
−Removed: ● revisions to the labeling, including limitation on approved
−Removed: uses or the requirement of additional warnings, contraindications or other safety information, including boxed warnings;
−Removed: ● imposition of a Risk Evaluation and Mitigation Strategy (“ REMS ”),
−Removed: which may include distribution or use restrictions;
−Removed: ● requirements to conduct additional post-market clinical
−Removed: trials to assess the safety of the product;
+Added: restrictions on the marketing or manufacturing of our products, withdrawal of the product from the market or voluntary or mandatory product recalls;
+Added: manufacturing delays and supply disruptions where regulatory inspections identify observations of noncompliance requiring remediation;
+Added: revisions to the labeling, including limitation on approved uses or the requirement of additional warnings, contraindications or other safety information, including boxed warnings;
+Added: imposition of a Risk Evaluation and Mitigation Strategy (“ REMS ”), which may include distribution or use restrictions;
+Added: requirements to conduct additional post-market clinical trials to assess the safety of the product;
fines, warning letters or holds on clinical trials;
−Removed: ● refusal by the FDA to approve pending applications or supplements
−Removed: to approved applications filed by us or suspension or revocation of license approvals;
−Removed: ● product seizure or detention or refusal to permit the import
−Removed: or export of our product candidates;
+Added: refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;
+Added: product seizure or detention or refusal to permit the import or export of our product candidates;
injunctions or the imposition of civil or criminal penalties.
69 unchanged sentences
Certain of our directors or officers, including Mr.
−Removed: also directors and/or officers of one or more of our subsidiaries and, if those subsidiaries were to become majority-owned subsidiaries
−Removed: (as a result of third-party financing or investments), our officers would have fiduciary or other duties both to us and any majority-owned subsidiaries
+Added: also directors and/or officers of one or more of our subsidiaries and, if those subsidiaries become majority-owned subsidiaries (as
+Added: a result of third-party financing or investments), our officers would have fiduciary or other duties both to us and any majority-owned subsidiaries
(including future subsidiaries).
31 unchanged sentences
The following risk factors reference the risks and uncertainties
−Removed: relating to the international operations of OSR, which, following the closing of the Business Combination, will be the international operations
−Removed: of the Company.
−Removed: References in this section to “we,” “us,” and “our” refer to OSR prior to the closing
−Removed: of the Business Combination and to the Company after closing.
+Added: relating to the international operations of the Company.
+Added: References in this section to “we,” “us,” and “our”
+Added: refer to OSR Holdings, Inc.
If political and economic conditions in South Korea deteriorate,
our current business and future growth could be materially and adversely affected.
−Removed: OSR is headquartered in the Republic of Korea (“ Korea ”)
−Removed: and significant operations and assets are located in Korea.
+Added: The Company’s significant operations and assets are located in
There is currently a high level of political unrest occurring in Korea.
−Removed: a result, we are subject to political, economic, legal and regulatory risks specific to Korea, and our performance and successful fulfilment
−Removed: of our operational strategies are dependent in part on the overall Korean economy.
−Removed: The economic indicators in Korea in recent years
−Removed: have shown mixed signs of growth and uncertainty, and the current political environment in Korea is expected to continue to result in
−Removed: an erosion of the currency exchange rate between the Korean Won and the U.S.
−Removed: As a result, future growth of the Korean economy
−Removed: is subject to many factors beyond our control, including developments in the global economy.
+Added: As a result, we are subject to political, economic, legal
+Added: and regulatory risks specific to Korea, and our performance and successful fulfilment of our operational strategies are dependent in part
+Added: on the overall Korean economy.
+Added: The economic indicators in Korea in recent years have shown mixed signs of growth and uncertainty,
+Added: and the current political environment in Korea is expected to continue to result in an erosion of the currency exchange rate between the
+Added: Korean Won and the U.S.
+Added: As a result, future growth of the Korean economy is subject to many factors beyond our control, including
+Added: developments in the global economy.
The Korean economy is closely tied to, and is affected by developments
71 unchanged sentences
and its executives and employees.
−Removed: For example, complaints alleging infringement of intellectual property rights, breaches of certain
−Removed: Korean laws ( e.g.
−Removed: , labor standards laws and fair trade laws), and product-related claims may be investigated and prosecuted
−Removed: as criminal offenses with both the company and the company’s executive officers being named as defendants in such proceedings.
−Removed: As a result of these current and changing risks, OSR’ executive
+Added: For example, complaints alleging infringement of intellectual property rights, breaches of certain Korean
+Added: , labor standards laws and fair trade laws), and product-related claims may be investigated and prosecuted as criminal
+Added: offenses with both the company and the company’s executive officers being named as defendants in such proceedings.
+Added: As a result of these current and changing risks, OSR’s executive
officers may be named in the future in criminal investigations or proceedings stemming from its operations.
2 unchanged sentences
no liability to the individual.
−Removed: If OSR’ executive officers were to be named in such criminal proceedings or held either directly
+Added: If OSR’s executive officers were to be named in such criminal proceedings or held either directly
or vicariously criminally liable for the actions of OSR and its executives and employees, the Company’s business, financial condition,
11 unchanged sentences
As a result, if circumstances arise in which the best
−Removed: interests of OSR conflicts with the best interests of the Company or its stockholders, OSR may not be permitted under applicable Korean
+Added: interests of OSR conflict with the best interests of the Company or its stockholders, OSR may not be permitted under applicable Korean
law to act in a manner that is in the best interest of the Company or its stockholders.
7 unchanged sentences
financial condition, and results of operations.
−Removed: OSR’ transactions with related parties are subject to close
−Removed: scrutiny by the Korean tax authorities, which may result in adverse tax consequences.
−Removed: Under Korean tax law, there is an inherent risk that OSR’ transactions
+Added: OSR’s transactions with related parties are subject to
+Added: close scrutiny by the Korean tax authorities, which may result in adverse tax consequences.
+Added: Under Korean tax law, there is an inherent risk that OSR’s transactions
with its subsidiaries, affiliates or any other person or company that is related to us may be challenged by the Korean tax authorities
22 unchanged sentences
have a “place of effective management” in Korea include that (i) Mr.
−Removed: Kuk Hyoun Hwang, OSR’ Chairman of the
+Added: Kuk Hyoun Hwang, OSR’s Chairman of the
Board of Directors, is a Korean national, and Mr.
1 unchanged sentence
(ii) most of the members of the board of directors of our largest subsidiary, OSR, are Korean;
−Removed: and (iii) after
−Removed: the Closing, important documents, including the accounting documents of our domestic business, may be maintained and controlled in Korea.
−Removed: If we are deemed to have a “place of effective management” in Korea, we will be required to file annual corporate income tax
−Removed: returns with the Korean tax authorities and be subject to Korean corporate income tax.
−Removed: Currently, the applicable rates are 11% (inclusive
−Removed: of local corporate taxes) for taxable income up to 200 million Korean Won, 22% (inclusive of local corporate taxes) for taxable income
−Removed: exceeding 200 million Korean Won and less than 20 billion Korean Won, 24.2% (inclusive of local corporate taxes) for taxable
−Removed: income greater than 20 billion won and less than 300 billion Korean Won, and 27.5% (inclusive of local corporate tax) for taxable
−Removed: income greater than 300 billion Korean Won.
−Removed: Taxable income would include any worldwide income, such as dividends we receive from
−Removed: our Korean operating company and any interest income earned outside of Korea.
−Removed: If we are required to pay Korean corporate income tax, it
−Removed: may reduce our cash flow and negatively impact the returns to investors.
+Added: and (iii) important documents,
+Added: including the accounting documents of our domestic business, may be maintained and controlled in Korea.
+Added: If we are deemed to have a “place
+Added: of effective management” in Korea, we will be required to file annual corporate income tax returns with the Korean tax authorities
+Added: and be subject to Korean corporate income tax.
+Added: Currently, the applicable rates are 11% (inclusive of local corporate taxes) for taxable
+Added: income up to 200 million Korean Won, 22% (inclusive of local corporate taxes) for taxable income exceeding 200 million Korean
+Added: Won and less than 20 billion Korean Won, 24.2% (inclusive of local corporate taxes) for taxable income greater than 20 billion
+Added: won and less than 300 billion Korean Won, and 27.5% (inclusive of local corporate tax) for taxable income greater than 300 billion
+Added: Taxable income would include any worldwide income, such as dividends we receive from our Korean operating company and any
+Added: interest income earned outside of Korea.
+Added: If we are required to pay Korean corporate income tax, it may reduce our cash flow and negatively
+Added: impact the returns to investors.
If we are deemed to have a “permanent establishment” in
27 unchanged sentences
are 11% (inclusive of local corporate taxes) for taxable income up to 200 million Korean Won, 22% (inclusive of local corporate taxes)
−Removed: for taxable income exceeding 200 million Korean Won and less than 20 billion Korean Won, 21% (inclusive of local corporate taxes)
−Removed: for taxable income greater than 20 billion won and less than 300 billion Korean Won, and 24% (inclusive of local corporate tax)
−Removed: for taxable income greater than 300 billion Korean Won.
−Removed: Taxable income includes any Korean source income attributable to or effectively
−Removed: connected with such permanent establishment, such as dividends we receive from our Korean operating company.
−Removed: If we are required to pay
−Removed: Korean corporate income tax, it may reduce our cash flow and negatively impact the returns to investors.
+Added: for taxable income exceeding 200 million Korean Won and less than 20 billion Korean Won, 24.2% (inclusive of local corporate
+Added: taxes) for taxable income greater than 20 billion won and less than 300 billion Korean Won, and 27.5% (inclusive of local corporate
+Added: tax) for taxable income greater than 300 billion Korean Won.
+Added: Taxable income includes any Korean source income attributable to or
+Added: effectively connected with such permanent establishment, such as dividends we receive from our Korean operating company.
+Added: If we are required
+Added: to pay Korean corporate income tax, it may reduce our cash flow and negatively impact the returns to investors.
New or higher taxes resulting from changes in tax regulations
21 unchanged sentences
the United States and in an international setting, including any of the following:
−Removed: ● higher costs and difficulties inherent in managing cross-border business
−Removed: operations and complying with different commercial and legal requirements of overseas markets;
+Added: higher costs and difficulties inherent in managing cross-border business operations and complying with different commercial and legal requirements of overseas markets;
rules and regulations regarding currency exchange;
complex corporate withholding taxes on individuals;
−Removed: ● laws governing the manner in which future business combinations
−Removed: may be effected;
+Added: laws governing the manner in which future business combinations may be effected;
tariffs and trade barriers;
regulations related to customs and import/export matters;
−Removed: ● longer payment cycles and challenges in collecting accounts
−Removed: ● tax issues, including but not limited to tax law changes and
−Removed: variations in tax;
+Added: longer payment cycles and challenges in collecting accounts receivable;
+Added: tax issues, including but not limited to tax law changes and variations in tax;
currency fluctuations and exchange controls;
2 unchanged sentences
employment regulations;
−Removed: ● trade restrictions including limitations on imports or exports
−Removed: of components or assembled products, unilaterally or bilaterally;
−Removed: ● trade sanctions and related regulatory enforcement actions and
−Removed: other proceedings;
+Added: trade restrictions including limitations on imports or exports of components or assembled products, unilaterally or bilaterally;
+Added: trade sanctions and related regulatory enforcement actions and other proceedings;
potential trade wars;
−Removed: ● increased scrutiny by the media and other third parties of labor
−Removed: practices within our industry (including but not limited to working conditions) which may result in allegations of violations, more stringent
−Removed: and burdensome labor laws and regulations and inconsistency in the enforcement and interpretation of such laws and regulations, higher
−Removed: labor costs, and/or loss of revenues if our customers become dissatisfied with our labor practices and diminish or terminate their relationship
−Removed: ● imposition of restrictions on currency conversion or the transfer
+Added: increased scrutiny by the media and other third parties of labor practices within our industry (including but not limited to working conditions) which may result in allegations of violations, more stringent and burdensome labor laws and regulations and inconsistency in the enforcement and interpretation of such laws and regulations, higher labor costs, and/or loss of revenues if our customers become dissatisfied with our labor practices and diminish or terminate their relationship with us;
+Added: imposition of restrictions on currency conversion or the transfer of funds;
expropriation of private entities;
−Removed: ● ineffective legal protection of our intellectual property rights
−Removed: in certain countries;
−Removed: ● crime, strikes, riots, civil disturbances, terrorist attacks,
−Removed: natural disasters and wars;
+Added: ineffective legal protection of our intellectual property rights in certain countries;
+Added: crime, strikes, riots, civil disturbances, terrorist attacks, natural disasters and wars;
deterioration of political relations with the United States;
2 unchanged sentences
we were unable to do so, our operations might suffer, which may adversely impact our results of operations and financial condition.
−Removed: of the foregoing risks have already manifested, and are likely to increase in scope and impact in light of the recent public posture
−Removed: and executive action of the new presidential administration in the United States .
+Added: of the foregoing risks have already manifested, and are likely to increase in scope and impact in light of the recent public posture and
+Added: executive action of the new presidential administration in the United States .
Even if we obtain FDA approval of any of our product candidates,
106 unchanged sentences
The following risk factors reference the risks and uncertainties
−Removed: relating to the development of product candidates by OSR, which, following the closing of the Business Combination, will be the development of
−Removed: product candidates by the Company.
−Removed: References in this section to “we,” “us,” and “our” refer to OSR
−Removed: prior to the closing of the Business Combination and to the Company after closing.
+Added: relating to the development of product candidates by the Company.
+Added: References in this section to “we,” “us,” and
+Added: “our” refer to OSR Holdings, Inc.
Our business includes subsidiaries that are developing oral immunotherapies
3 unchanged sentences
This may make it difficult to evaluate our prospects and likelihood of success.
−Removed: Our business includes subsidiaries that are (i) developing oral
−Removed: immunotherapies for the treatment of cancer, and (ii) developing design-augmented biologics for age-related and other degenerative
−Removed: Each of these subsidiaries is an early-stage company with a limited operating history, has no pharmaceutical products approved
−Removed: for commercial sale and has not generated any revenue from sales of its products.
−Removed: Our approach to the discovery and development of any
−Removed: therapeutic product candidates is unproven, and we do not know whether we will be able to develop any products of commercial value.
−Removed: product candidates will require substantial additional development and clinical research time and resources before we would be able to
−Removed: apply for or receive regulatory approvals and begin generating revenue from product sales.
−Removed: We do not yet have substantial experience progressing
−Removed: therapeutic product candidates through clinical trials.
−Removed: We may be unable to demonstrate safety and efficacy in clinical trials, obtain
−Removed: regulatory approval, manufacture at a commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing
−Removed: activities necessary for successful product commercialization of any of our product candidates.
+Added: Our business includes subsidiaries that are developing oral immunotherapies
+Added: for the treatment of cancer, design-augmented biologics for age-related and other degenerative diseases, and, following the
+Added: recent acquisition of Woori IO Co., Ltd., non-invasive biosensing technologies for glucose monitoring and related health parameters.
+Added: of these subsidiaries is an early-stage company with a limited operating history, has no pharmaceutical products approved for commercial
+Added: sale and has not generated any revenue from sales of its products.
+Added: Our approach to the discovery and development of any therapeutic product
+Added: candidates is unproven, and we do not know whether we will be able to develop any products of commercial value.
+Added: These product candidates
+Added: will require substantial additional development and clinical research time and resources before we would be able to apply for or receive
+Added: regulatory approvals and begin generating revenue from product sales.
+Added: We do not yet have substantial experience progressing therapeutic
+Added: product candidates through clinical trials.
+Added: We may be unable to demonstrate safety and efficacy in clinical trials, obtain regulatory
+Added: approval, manufacture at a commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities
+Added: necessary for successful product commercialization of any of our product candidates.
We have not yet demonstrated the ability to progress any therapeutic
23 unchanged sentences
timely completion of our preclinical studies and clinical trials;
−Removed: ● negative or inconclusive results from our preclinical studies
−Removed: or clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct
−Removed: additional preclinical testing or clinical trials or abandon a program;
−Removed: ● the prevalence, duration and severity of potential product-related side
−Removed: effects experienced by participants receiving our product candidates in our clinical trials or by individuals using drugs or therapeutics
−Removed: similar to our product candidates;
−Removed: ● delays in submitting Investigational New Drug (“IND”)
−Removed: or comparable foreign applications or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial,
−Removed: or a suspension or termination of a clinical trial once commenced;
−Removed: ● conditions imposed by the FDA or comparable foreign authorities
−Removed: regarding the scope or design of our clinical trials;
+Added: negative or inconclusive results from our preclinical studies or clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional preclinical testing or clinical trials or abandon a program;
+Added: the prevalence, duration and severity of potential product-related side effects experienced by participants receiving our product candidates in our clinical trials or by individuals using drugs or therapeutics similar to our product candidates;
+Added: delays in submitting Investigational New Drug (“IND”) or comparable foreign applications or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced;
+Added: conditions imposed by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;
delays in enrolling participants in clinical trials;
high drop-out rates of participants from clinical trials;
−Removed: ● inadequate supply or quality of product candidates or other
−Removed: materials necessary for the conduct of our clinical trials;
+Added: inadequate supply or quality of product candidates or other materials necessary for the conduct of our clinical trials;
greater than anticipated clinical trial costs;
1 unchanged sentence
poor efficacy of our product candidates during clinical trials;
−Removed: ● unfavorable FDA or other regulatory agency inspection and review
−Removed: of a clinical trial site;
−Removed: ● failure of our third-party contractors or investigators
−Removed: to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all;
−Removed: ● delays related to the impact of recessions, man-made and/or
−Removed: natural disasters, pandemics, and/or any other such events;
−Removed: ● delays and changes in regulatory requirements, policy and guidelines,
−Removed: including the imposition of additional regulatory oversight around clinical testing generally or with respect to our technology in particular;
−Removed: ● varying interpretations of data by the FDA and similar foreign
−Removed: regulatory agencies.
+Added: unfavorable FDA or other regulatory agency inspection and review of a clinical trial site;
+Added: failure of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all;
+Added: delays related to the impact of recessions, man-made and/or natural disasters, pandemics, and/or any other such events;
+Added: delays and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our technology in particular;
+Added: varying interpretations of data by the FDA and similar foreign regulatory agencies.
We do not have complete control over many of these factors, including
6 unchanged sentences
Clinical trials can be delayed or terminated for a variety of reasons, including:
−Removed: ● regulators or institutional review boards (“ IRB ”)
−Removed: or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective
−Removed: ● the FDA or other comparable regulatory authorities may disagree
−Removed: with our clinical trial design, including with respect to dosing levels administered in our planned clinical trials, which may delay
−Removed: or prevent us from initiating our clinical trials with our originally intended trial design;
−Removed: ● we may experience delays in reaching, or fail to reach, agreement
−Removed: on acceptable terms with prospective trial sites and prospective contract research organizations, or CROs, which can be subject to extensive
−Removed: negotiation and may vary significantly among different CROs and trial sites;
−Removed: ● The number of participants required for clinical trials of any
−Removed: product candidates may be larger than we anticipate or participants may drop out of these clinical trials or fail to return for post-treatment follow-up at
−Removed: a higher rate than we anticipate;
−Removed: ● our third-party contractors may fail to comply with regulatory
−Removed: requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from a clinical trial protocol
−Removed: or drop out of a trial, which may require that we add new clinical trial sites or investigators;
−Removed: ● we may need to address any safety concerns that arise during
−Removed: the course of a clinical trial;
−Removed: ● we may experience delays and interruptions to our manufacturing
−Removed: supply chain, or we could suffer delays in reaching, or we may fail to reach, agreement on acceptable terms with third-party service
−Removed: providers on whom we rely;
−Removed: ● the cost of clinical trials of our product candidates may be
−Removed: greater than we anticipate;
−Removed: ● logistical issues relating to any future clinical trials we
−Removed: ● we may elect to, or regulators, IRBs, Data and Safety Monitoring
−Removed: Boards, or ethics committees may require that we or our investigators, suspend or terminate clinical research or trials for various reasons,
−Removed: including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
−Removed: ● we may not have the financial resources available to begin and
−Removed: complete the planned trials, or the cost of clinical trials of any product candidates may be greater than we anticipate;
−Removed: ● the supply or quality of our product candidates or other
−Removed: materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate to initiate or complete a
−Removed: given clinical trial;
−Removed: ● the FDA or other comparable foreign regulatory authorities
−Removed: may require us to submit additional data such as long-term toxicology studies, or impose other requirements before permitting us
−Removed: to initiate a clinical trial.
+Added: regulators or institutional review boards (“ IRB ”) or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
+Added: the FDA or other comparable regulatory authorities may disagree with our clinical trial design, including with respect to dosing levels administered in our planned clinical trials, which may delay or prevent us from initiating our clinical trials with our originally intended trial design;
+Added: we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective contract research organizations, or CROs, which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
+Added: The number of participants required for clinical trials of any product candidates may be larger than we anticipate or participants may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate;
+Added: our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from a clinical trial protocol or drop out of a trial, which may require that we add new clinical trial sites or investigators;
+Added: we may need to address any safety concerns that arise during the course of a clinical trial;
+Added: we may experience delays and interruptions to our manufacturing supply chain, or we could suffer delays in reaching, or we may fail to reach, agreement on acceptable terms with third-party service providers on whom we rely;
+Added: the cost of clinical trials of our product candidates may be greater than we anticipate;
+Added: logistical issues relating to any future clinical trials we may conduct;
+Added: we may elect to, or regulators, IRBs, Data and Safety Monitoring Boards, or ethics committees may require that we or our investigators, suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;
+Added: we may not have the financial resources available to begin and complete the planned trials, or the cost of clinical trials of any product candidates may be greater than we anticipate;
+Added: the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate to initiate or complete a given clinical trial;
+Added: the FDA or other comparable foreign regulatory authorities may require us to submit additional data such as long-term toxicology studies, or impose other requirements before permitting us to initiate a clinical trial.
We could also encounter delays if a clinical trial is suspended or
10 unchanged sentences
circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities.
−Removed: FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has
−Removed: created a conflict of interest or otherwise affected interpretation of the study.
−Removed: The FDA or comparable foreign regulatory authority
−Removed: may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial
−Removed: itself may be jeopardized.
−Removed: This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable
−Removed: foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product
+Added: or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has created
+Added: a conflict of interest or otherwise affected interpretation of the study.
+Added: The FDA or comparable foreign regulatory authority may therefore
+Added: question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be
+Added: This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory
+Added: authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product candidates.
Our product development costs will increase if we experience additional
58 unchanged sentences
initial clinical trials.
−Removed: In addition, results from clinical trials or pre-clinical studies may require further evaluation,
−Removed: delaying the next stage of development or submission of an NDA/BLA or similar application.
−Removed: A future failure of a clinical trial to meet
−Removed: its pre-specified endpoints would likely cause us to abandon our product candidates.
−Removed: Any delay in, or termination of, our clinical
−Removed: trials will delay the submission of an NDA/BLA or other similar applications to the FDA or other relevant comparable non-U.S.
−Removed: authorities and, ultimately, our ability to commercialize our product candidates, if approved, and generate product revenues.
−Removed: our clinical trials are completed as planned, we cannot be certain that their results will support our claims for differentiation or
−Removed: the effectiveness or safety of our product candidates.
−Removed: The FDA has substantial discretion in the review and approval process and may
−Removed: disagree that our data support the differentiated claims we propose.
−Removed: In addition, only a small percentage of product candidates under
−Removed: development result in the submission of an NDA/BLA or other similar application to the FDA and other comparable non-U.S.
−Removed: authorities and even fewer are approved for commercialization.
+Added: In addition, results from clinical trials or pre-clinical studies may require further evaluation, delaying
+Added: the next stage of development or submission of an NDA/BLA or similar application.
+Added: A future failure of a clinical trial to meet its pre-specified endpoints
+Added: would likely cause us to abandon our product candidates.
+Added: Any delay in, or termination of, our clinical trials will delay the submission
+Added: of an NDA/BLA or other similar applications to the FDA or other relevant comparable non-U.S.
+Added: regulatory authorities and, ultimately,
+Added: our ability to commercialize our product candidates, if approved, and generate product revenues.
+Added: Even if our clinical trials are completed
+Added: as planned, we cannot be certain that their results will support our claims for differentiation or the effectiveness or safety of our
+Added: product candidates.
+Added: The FDA has substantial discretion in the review and approval process and may disagree that our data support the differentiated
+Added: claims we propose.
+Added: In addition, only a small percentage of product candidates under development result in the submission of an NDA/BLA
+Added: or other similar application to the FDA and other comparable non-U.S.
+Added: regulatory authorities and even fewer are approved for
+Added: commercialization.
Interim, top-line or preliminary data from our clinical
54 unchanged sentences
Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
−Removed: Generally, if a product candidate with an orphan drug designation
−Removed: receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing
−Removed: exclusivity, which precludes the FDA or foreign regulatory authorities from approving another marketing application for a product that
−Removed: constitutes the same drug treating the same indication for a period of seven (7) years, except in limited circumstances, such as
−Removed: a showing of clinical superiority to the product with orphan drug exclusivity or where the manufacturer is unable to assure sufficient
−Removed: product quantity.
−Removed: Orphan drug exclusivity may be revoked if any regulatory agency determines that the request for designation was materially
−Removed: defective or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease
−Removed: or condition.
+Added: Generally, if a product candidate with an orphan drug designation receives
+Added: the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity,
+Added: which precludes the FDA or foreign regulatory authorities from approving another marketing application for a product that constitutes
+Added: the same drug treating the same indication for a period of seven (7) years, except in limited circumstances, such as a showing of
+Added: clinical superiority to the product with orphan drug exclusivity or where the manufacturer is unable to assure sufficient product quantity.
+Added: Orphan drug exclusivity may be revoked if any regulatory agency determines that the request for designation was materially defective or
+Added: if the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease or condition.
We may seek orphan drug designation for some of our future product
49 unchanged sentences
Regardless of merit or eventual outcome, liability claims may result
−Removed: ● decreased demand for any product candidates or medicines
−Removed: that we may develop;
+Added: decreased demand for any product candidates or medicines that we may develop;
injury to our reputation and significant negative media attention;
14 unchanged sentences
The following risk factors reference the risks and uncertainties
−Removed: relating to the reliance on third parties by OSR, which, following the closing of the Business Combination, will be the reliance on third
−Removed: parties by the Company.
−Removed: References in this section to “we,” “us,” and “our” refer to OSR prior to
−Removed: the closing of the Business Combination and to the Company after closing.
+Added: relating to the reliance on third parties by the Company.
+Added: References in this section to “we,” “us,” and “our”
+Added: refer to OSR Holdings, Inc.
We currently outsource, and intend to continue to outsource,
100 unchanged sentences
affect our business in a number of ways, including:
−Removed: ● an inability to initiate or continue clinical trials of product
−Removed: candidates under development;
−Removed: ● delay in submitting regulatory applications, or receiving
−Removed: regulatory approvals, for product candidates;
+Added: an inability to initiate or continue clinical trials of product candidates under development;
+Added: delay in submitting regulatory applications, or receiving regulatory approvals, for product candidates;
loss of the cooperation of an existing or future collaborator;
−Removed: ● subjecting third-party manufacturing facilities or our
−Removed: manufacturing facilities to additional inspections by regulatory authorities;
−Removed: ● requirements to cease distribution or to recall batches of
−Removed: our product candidates;
−Removed: ● in the event of approval to market and commercialize a product
−Removed: candidate, an inability to meet commercial demands for our products.
+Added: subjecting third-party manufacturing facilities or our manufacturing facilities to additional inspections by regulatory authorities;
+Added: requirements to cease distribution or to recall batches of our product candidates;
+Added: in the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products.
Changes in methods of product candidate manufacturing or formulation
28 unchanged sentences
trials or our products for patients, if approved, could be delayed or prevented.
−Removed: Manufacturing drugs, particularly biologics, especially in large
−Removed: quantities, is often complex and may require the use of innovative technologies to handle living cells.
−Removed: Each lot of an approved
−Removed: biologic must undergo thorough testing for identity, strength, quality, purity and potency.
−Removed: Manufacturing biologics requires
−Removed: facilities specifically designed for and validated for this purpose, and sophisticated quality assurance and quality control
−Removed: procedures are necessary.
−Removed: Slight deviations anywhere in the manufacturing process, including filling, labeling, packaging, storage
−Removed: and shipping and quality control and testing, may result in lot failures, product recalls or spoilage.
−Removed: When changes are made to the
−Removed: manufacturing process, we may be required to provide preclinical and clinical data showing the comparable identity, strength,
−Removed: quality, purity or potency of the products before and after such changes.
−Removed: If microbial, viral or other contaminations are discovered
−Removed: at the facilities of our manufacturers, such facilities may need to be closed for an extended period of time to investigate and
−Removed: remedy the contamination, which could delay clinical trials and adversely harm our business.
+Added: Manufacturing drugs, particularly biologics, especially in large quantities,
+Added: is often complex and may require the use of innovative technologies to handle living cells.
+Added: Each lot of an approved biologic must undergo
+Added: thorough testing for identity, strength, quality, purity and potency.
+Added: Manufacturing biologics requires facilities specifically designed
+Added: for and validated for this purpose, and sophisticated quality assurance and quality control procedures are necessary.
+Added: Slight deviations
+Added: anywhere in the manufacturing process, including filling, labeling, packaging, storage and shipping and quality control and testing, may
+Added: result in lot failures, product recalls or spoilage.
+Added: When changes are made to the manufacturing process, we may be required to provide
+Added: preclinical and clinical data showing the comparable identity, strength, quality, purity or potency of the products before and after such
+Added: If microbial, viral or other contaminations are discovered at the facilities of our manufacturers, such facilities may need to
+Added: be closed for an extended period of time to investigate and remedy the contamination, which could delay clinical trials and adversely
+Added: harm our business.
In addition, there are risks associated with large scale manufacturing
11 unchanged sentences
The following risk factors reference the risks and uncertainties
−Removed: relating to the intellectual property of OSR, which, following the closing of the Business Combination, will be the intellectual property
−Removed: of the Company.
−Removed: References in this section to “we,” “us,” and “our” refer to OSR prior to the closing
−Removed: of the Business Combination and to the Company after closing.
+Added: relating to the intellectual property of the Company.
+Added: References in this section to “we,” “us,” and “our”
+Added: refer to OSR Holdings, Inc.
If we are unable to obtain and maintain patent and other intellectual
43 unchanged sentences
in other countries.
−Removed: Our pending PCT patent applications are not eligible to become issued patents until, among other things, we file
−Removed: a national stage patent application within 30 months in the countries in which we seek patent protection.
+Added: Our pending PCT patent applications are not eligible to become issued patents until, among other things, we file a
+Added: national stage patent application within 30 months in the countries in which we seek patent protection.
If we do not timely file
3 unchanged sentences
meaningful protection or competitive advantage.
−Removed: There is no assurance that all of the potentially relevant prior art relating to our
−Removed: patents and patent applications have been found, which can prevent a patent from issuing from a pending patent application or be used
−Removed: to invalidate an issued patent.
−Removed: The examination process may require us to narrow our claims, which may limit the scope of patent protection
−Removed: that we may ultimately obtain.
−Removed: Even if patents do successfully issue and even if such patents cover our product candidates or any future
−Removed: product candidate, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowly
−Removed: construed, invalidated, or held unenforceable, any of which could limit our ability to prevent competitors and other third parties from
−Removed: developing and marketing similar product candidates or limit the length of terms of patent protection we may have for our product candidates
−Removed: and technologies.
+Added: There is no assurance that all of the potentially relevant prior art relating to our patents
+Added: and patent applications have been found, which can prevent a patent from issuing from a pending patent application or be used to invalidate
+Added: an issued patent.
+Added: The examination process may require us to narrow our claims, which may limit the scope of patent protection that we
+Added: may ultimately obtain.
+Added: Even if patents do successfully issue and even if such patents cover our product candidates or any future product
+Added: candidate, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowly construed,
+Added: invalidated, or held unenforceable, any of which could limit our ability to prevent competitors and other third parties from developing
+Added: and marketing similar product candidates or limit the length of terms of patent protection we may have for our product candidates and
+Added: technologies.
Other companies may also design around technologies we have patented, licensed or developed.
−Removed: In addition, the issuance
−Removed: of a patent does not give us the right to practice the patented invention.
−Removed: Third parties may have blocking patents that could prevent
−Removed: us from marketing product candidates or practicing our own patented technology or impose a substantial royalty burden to do so.
+Added: In addition, the issuance of
+Added: a patent does not give us the right to practice the patented invention.
+Added: Third parties may have blocking patents that could prevent us
+Added: from marketing product candidates or practicing our own patented technology or impose a substantial royalty burden to do so.
Any successful
68 unchanged sentences
with us to license, develop or commercialize current or future product candidates.
−Removed: Such challenges may result in loss of exclusivity
−Removed: or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others
−Removed: from using or commercializing similar or identical technology and product candidates, or limit the duration of the patent protection
−Removed: of our technology and product candidates.
+Added: Such challenges may result in loss of exclusivity or
+Added: in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others
+Added: from using or commercializing similar or identical technology and product candidates, or limit the duration of the patent protection of
+Added: our technology and product candidates.
Such challenges also may result in substantial cost and require significant time from our scientists
119 unchanged sentences
misappropriation and other violations of the patents and proprietary rights of third parties.
−Removed: However, our research, development and
−Removed: commercialization activities may be subject to claims that we infringe, misappropriate or otherwise violate patents or other intellectual
−Removed: property rights owned or controlled by third parties.
−Removed: Our competitors or other third parties may assert infringement claims against us,
−Removed: alleging that our product candidates are covered by their patents.
−Removed: We cannot be certain that we do not infringe existing patents or that
−Removed: we will not infringe patents that may be granted in the future.
−Removed: There is a substantial amount of litigation, both within and outside
−Removed: the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including
−Removed: patent infringement lawsuits, interferences, derivation and administrative law proceedings, inter partes review, and
−Removed: post-grant review before the USPTO, as well as oppositions and similar processes in other jurisdictions.
+Added: However, our research, development and commercialization
+Added: activities may be subject to claims that we infringe, misappropriate or otherwise violate patents or other intellectual property rights
+Added: owned or controlled by third parties.
+Added: Our competitors or other third parties may assert infringement claims against us, alleging that
+Added: our product candidates are covered by their patents.
+Added: We cannot be certain that we do not infringe existing patents or that we will not
+Added: infringe patents that may be granted in the future.
+Added: There is a substantial amount of litigation, both within and outside the United States,
+Added: involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement
+Added: lawsuits, interferences, derivation and administrative law proceedings, inter partes review, and post-grant review
+Added: before the USPTO, as well as oppositions and similar processes in other jurisdictions.
Numerous U.S.
−Removed: patents and pending patent applications, which are owned by third parties, exist in the fields in which we and our collaborators are
−Removed: developing product candidates.
−Removed: As the biotechnology and pharmaceutical industries expand and more patents are issued, and as we gain
−Removed: greater visibility, the risk increases that our product candidates or other business activities may be subject to claims of infringement
−Removed: of the patent and other proprietary rights of third parties.
−Removed: Third parties may assert that we are infringing their patents or employing
−Removed: their proprietary technology without authorization.
−Removed: There may be third-party patents or patent applications with claims to materials,
−Removed: formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates.
+Added: patents and pending patent applications, which are owned by third parties, exist in the fields in which we and our collaborators are developing
+Added: product candidates.
+Added: As the biotechnology and pharmaceutical industries expand and more patents are issued, and as we gain greater visibility,
+Added: the risk increases that our product candidates or other business activities may be subject to claims of infringement of the patent and
+Added: other proprietary rights of third parties.
+Added: Third parties may assert that we are infringing their patents or employing their proprietary
+Added: technology without authorization.
+Added: There may be third-party patents or patent applications with claims to materials, formulations,
+Added: methods of manufacture or methods for treatment related to the use or manufacture of our product candidates.
Additionally, because patent applications can take many years
456 unchanged sentences
examples are illustrative:
−Removed: ● others may be able to make formulations or compositions that
−Removed: are the same as or similar to product candidates, but that are not covered by the claims of the patents that we own;
−Removed: ● others may be able to make product candidates that are similar
−Removed: to product candidates that we intend to commercialize that are not covered by the patents that we exclusively licensed and have the right
−Removed: ● we, our licensor or any collaborators might not have been
−Removed: the first to make or reduce to practice the inventions covered by the issued patents or pending patent applications that we own or have
−Removed: exclusively licensed;
−Removed: ● we or our licensor or any collaborators might not have been
−Removed: the first to file patent applications covering certain of our inventions;
−Removed: ● others may independently develop similar or alternative technologies
−Removed: or duplicate any of our technologies without infringing our intellectual property rights;
−Removed: ● issued patents that we own or have exclusively licensed may
−Removed: not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges;
−Removed: ● our competitors might conduct research and development activities
−Removed: in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development
−Removed: activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to
−Removed: develop competitive product candidates for sale in our major commercial markets;
−Removed: and we may not develop additional proprietary technologies
−Removed: that are patentable;
−Removed: ● third parties performing manufacturing or testing for us
−Removed: using our product candidates or technologies could use the intellectual property of others without obtaining a proper license;
−Removed: ● parties may assert an ownership interest in our intellectual
−Removed: property and, if successful, such disputes may preclude us from exercising exclusive rights over that intellectual property;
−Removed: ● we may not develop or in-license additional proprietary
−Removed: technologies that are patentable;
−Removed: ● we may not be able to obtain and maintain necessary licenses
−Removed: on commercially reasonable terms, or at all;
+Added: others may be able to make formulations or compositions that are the same as or similar to product candidates, but that are not covered by the claims of the patents that we own;
+Added: others may be able to make product candidates that are similar to product candidates that we intend to commercialize that are not covered by the patents that we exclusively licensed and have the right to enforce;
+Added: we, our licensor or any collaborators might not have been the first to make or reduce to practice the inventions covered by the issued patents or pending patent applications that we own or have exclusively licensed;
+Added: we or our licensor or any collaborators might not have been the first to file patent applications covering certain of our inventions;
+Added: others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;
+Added: issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges;
+Added: our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive product candidates for sale in our major commercial markets;
+Added: and we may not develop additional proprietary technologies that are patentable;
+Added: third parties performing manufacturing or testing for us using our product candidates or technologies could use the intellectual property of others without obtaining a proper license;
+Added: parties may assert an ownership interest in our intellectual property and, if successful, such disputes may preclude us from exercising exclusive rights over that intellectual property;
+Added: we may not develop or in-license additional proprietary technologies that are patentable;
+Added: we may not be able to obtain and maintain necessary licenses on commercially reasonable terms, or at all;
the patents of others may harm our business;
−Removed: ● we may choose not to file a patent application in order to
−Removed: maintain certain trade secrets or know-how, and a third party may subsequently file a patent application covering such intellectual
+Added: we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent application covering such intellectual property.
Should any of these events occur, they could significantly harm our
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.