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Item 1A. Risk Factors

2025-04-22 compared with 2024-04-17 · 3182 added, 284 removed, 0 unchanged (100% of the section changed)

An investment in our securities involves a high degree of risk.

You should carefully consider all of the risks described below, together with the other information contained in this Annual Report on Form 10-K.

If any of the following events occur, our business, financial condition and operating results may be materially adversely affected.

In that event, the trading price of our securities could decline, and you could lose all or part of your investment.

Risks Relating to Our Search for, Consummation of, or Inability to Consummate, a Business Combination and Post-Business Combination Risks

Our independent registered public accounting firm’s report contains an explanatory paragraph that expresses substantial doubt about our ability to continue as a “going concern.”

As of December 31, 2023, we had $15,419 in cash held out of the trust and $2,015,645 of working capital deficiency.

Further, we have incurred and expect to continue to incur significant costs in pursuit of our finance and

acquisition plans.

Additionally, if we do not complete our initial business combination by May 14, 2024 (subject to extension by approval of the Company’s stockholders), the Company will cease operations and liquidate.

Management’s plans to address these risks are discussed under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” While Management cannot guarantee that the Company will complete an initial business combination prior to May 14, 2024 (subject to extension by approval of the Company’s stockholders), this date for mandatory liquidation and subsequent dissolution raises substantial doubt about the Company’s ability to continue as a going concern.

The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

If we are unable to consummate our initial business combination, our public stockholders may be forced to wait more than 15 months before receiving distributions from the Trust Account.

We may not be able to consummate an initial business combination within 15 months after the closing of our IPO or such later time as may be approved by our stockholders voting on such extension.

We have no obligation to return funds to investors prior to such date unless we consummate our initial business combination prior thereto and only then in cases where investors have sought to convert their shares.

Only after the expiration of this full time period will holders of our common stock be entitled to distributions from the Trust Account if we are unable to complete our initial business combination.

Accordingly, investors’ funds may be unavailable to them until after such date and to liquidate your investment, public security holders may be forced to sell their public shares, potentially at a loss.

We may not be able to consummate an initial business combination within 15 months after the closing of our IPO or such later time as may be approved by our stockholders voting on such extension, in which case we would cease all operations except for the purpose of winding up and we would redeem our public shares and liquidate, in which case our public stockholders may only receive $10.175 per share, or less than such amount in certain circumstances, and our warrants and rights will expire worthless.

Our Charter provides that we must complete our initial business combination within 15 months from the closing of our IPO or such later time as may be approved by our stockholders voting on such extension.

We may not be able to find a suitable target business and complete our initial business combination within such time period.

If we have not completed our initial business combination within such time period or otherwise extend, we will:

(i) cease all operations except for the purpose of winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem the public shares, at a per share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account including interest earned on the funds held in the Trust Account and not previously released to us to pay our taxes (less up to $100,000 of interest to pay dissolution expenses), divided by the number of then outstanding public shares, which redemption will completely extinguish public stockholders’ rights as stockholders (including the right to receive further liquidating distributions, if any), subject to applicable law, and (iii) as promptly as reasonably possible following such redemption, subject to the approval of our remaining stockholders and our board of directors, dissolve and liquidate, subject in each case to our obligations under Delaware law to provide for claims of creditors and the requirements of other applicable law.

In such case, our public stockholders may only receive $10.175 per share, and our warrants and rights will expire worthless.

In certain circumstances, our public stockholders may receive less than $10.175 per share on the redemption of their shares.

The requirement that we complete our initial business combination within the prescribed time frame may give potential target businesses leverage over us in negotiating a business combination and may decrease our ability to conduct due diligence on potential business combination targets as we approach our dissolution deadline, which could undermine our ability to complete our business combination on terms that would produce value for our stockholders.

Any potential target business with which we enter into negotiations concerning a business combination will be aware that we must complete our initial business combination by May 14, 2024 (subject to extension by approval of the Company’s stockholders).

Consequently, such target business may obtain leverage over us in negotiating a business combination, knowing that if we do not complete our initial business combination

with that particular target business, we may be unable to complete our initial business combination with any target business.

This risk will increase as we get closer to the timeframe described above.

In addition, we may have limited time to conduct due diligence and may enter into our initial business combination on terms that we would have rejected upon a more comprehensive investigation.

We have identified material weaknesses in our internal control over financial reporting as of December 31, 2023.

If we are unable to develop and maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results in a timely manner, which may adversely affect investor confidence in us and materially and adversely affect our business, operating results, and ability to consummate an initial business combination.

After consultation with our management, we have identified material weaknesses in our internal controls over financial reporting related to the review and approval of certain financial transactions, including use of restricted funds for general corporate purposes and related party transactions.

In November 2023, the Company withdrew approximately $562,000 of interest income earned in the Trust Account for payment of the Company’s franchise tax and income tax liabilities as permitted by the terms of the Trust Agreement governing the Trust Account.

The Company did not immediately pay its tax obligations (which were not yet due and payable) and instead the funds were deposited in the Company’s general account and used for the payment of general operating expenses.

In consultation with counsel and the Company’s Audit Committee, management determined that this use of funds was not in accordance with the Trust Agreement.

As of April 16, 2024, the funds have been replaced in full by funds loaned to the Company from the Company’s Sponsor and the Company has paid its federal tax obligations on time.

Although the funds have been replaced and the Company has paid its federal tax obligations on time, management failed in its requirement to detect and prevent this use of funds that was not in accordance with the Trust Agreement.

Additionally, the Company has failed to timely receive Audit Committee approval for related party transactions, as required by the Audit Committee’s charter, including financing transactions pursuant to promissory notes between the Company and related parties, and the Company has failed to timely and properly document certain related party financing transactions.

As a result of these events, we have identified material weaknesses in our internal control over financial reporting.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented, or detected and corrected, on a timely basis.

Effective internal controls are necessary for us to provide reliable financial reports and prevent fraud.

Measures to remediate material weaknesses may be time-consuming and costly and there is no assurance that such initiatives will ultimately have the intended effects.

We continue to evaluate steps to remediate the material weaknesses.

If we identify any new material weaknesses in the future, any such newly identified material weaknesses could limit our ability to prevent or detect a misstatement of our accounts or disclosures that could result in a material misstatement of our annual or interim financial statements.

In such case, we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports in addition to applicable stock exchange listing requirements, investors may lose confidence in our financial reporting and our share price may decline.

We cannot assure you that the measures we have taken to date, or any measures we may take in the future, will be sufficient to avoid potential future material weaknesses.

As a result of the material weaknesses in our internal controls over financial reporting described above, we may face the prospect of litigation or other disputes which may include, among others, claims invoking the federal and state securities laws, contractual claims or other claims arising from the material weaknesses in our internal control over financial reporting and the preparation of our financial statements, any of which claims could result in adverse effects to our business.

As of the date of the filing of this Annual Report on Form 10-K, we have no knowledge of any such litigation or dispute.

We cannot predict the impact of the ongoing military conflicts and the related humanitarian crises on the global economy, geopolitical stability and our search for a business combination, and any target business with which we may ultimately consummate a business combination.

United States and global markets are experiencing volatility and disruption following the geopolitical instability resulting from the ongoing Russia-Ukraine conflict and the recent escalation of the Israel-Hamas conflict.

In response to the ongoing Russia-Ukraine conflict, the North Atlantic Treaty Organization (“NATO”) deployed additional military forces to eastern Europe, and the United States, the United Kingdom, the European Union and other countries have announced various sanctions and restrictive actions against Russia, Belarus and related individuals and entities, including the removal of certain financial institutions from the Society for Worldwide Interbank Financial Telecommunication (SWIFT) payment system.

Certain countries, including the United States, have also provided and may continue to provide military aid or other assistance to Ukraine and to Israel, increasing geopolitical tensions among a number of nations.

The invasion of Ukraine by Russia and the escalation of the Israel-Hamas conflict and the resulting measures that have been taken, and could be taken in the future, by NATO, the United States, the United Kingdom, the European Union, Israel and its neighboring states and other countries have created global security concerns that could have a lasting impact on regional and global economies.

Although the length and impact of the ongoing conflicts are highly unpredictable, they could lead to market disruptions, including significant volatility in commodity prices, credit and capital markets, as well as supply chain interruptions and increased cyber-attacks against U.S.

Additionally, any resulting sanctions could adversely affect the global economy and financial markets and lead to instability and lack of liquidity in capital markets.

Management is currently evaluating the full impact and the possible negative effect these conflicts could have on the Company’s financial position, results of its operations and/or search for a target company.

The specific impact is not readily determinable as of the date of these audited financial statements and the audited financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Any negative impact on the global economy, capital markets or other geopolitical conditions resulting from the Russian invasion of Ukraine, the war in the Middle East and subsequent sanctions could adversely affect our search for an initial business combination and any target business with which we may ultimately consummate an initial business combination.

The extent and duration of the Russian invasion of Ukraine and the war in the Middle East, resulting sanctions and any related market disruptions are impossible to predict, but could be substantial, particularly if current or new sanctions continue for an extended period of time or if geopolitical tensions result in expanded military operations on a global scale.

Any such disruptions may also have the effect of heightening many of the other risks described elsewhere in this Annual Report on Form 10-K.

The extent and duration of the military action, sanctions and resulting market disruptions are impossible to predict, but could be substantial.

Any such disruptions may also magnify the impact of other risks described in this Annual Report on Form 10-K.

As the net proceeds of our IPO and the sale of the Private Placement Units not being held in the Trust Account were insufficient to allow us to operate for the 15 months or such other time period as our stockholders may approve following the closing of our IPO, and we’ve had to seek other sources of funding to pay for our operations, we are limited in the amount available to fund our search for a target business or businesses and our ability to complete our initial business combination, and we have an may continue to depend on loans from our Sponsor, officers and directors or their affiliates or members of our management team to fund our search and to complete our initial business combination.

If we are unable to obtain these loans, we may be unable to complete our initial business combination.

We have spent the net proceeds of our IPO and the sale of the Private Placement Units from our IPO to pay offering expenses and to fund our working capital requirements.

We were required to seek additional capital, we have and may in the future continue to need to borrow funds from our Sponsor, management team or other third parties to operate or may be forced to liquidate.

None of our Sponsor, members of our management team nor any of their affiliates is under any obligation to advance funds to us in such circumstances.

These advances and any future advances will be repaid only from funds held outside the Trust Account or from funds released to us upon completion of our initial business combination.

Up to $1,000,000 of any such loans may be convertible into additional placement units, at a price of $10.00 per unit at the option of the lender, upon consummation of our initial business combination.

These units would be identical to the Private Placement Units.

Prior to the completion of our initial business combination, we do not expect to seek loans from parties other than our initial stockholders, officers and directors or their affiliates, as we do not believe third parties will be willing to loan such funds and provide a waiver against any and all rights to seek access to funds in our Trust Account.

If we are unable to obtain these loans, we may be unable to complete our initial business combination.

If we are unable to complete our initial business combination because we do not have sufficient funds available to us, we will be forced to cease operations and

liquidate the Trust Account.

Loans made by Chardan or any of its related persons, if any, will not be convertible into any of our securities and Chardan and its related persons will have no recourse with respect to their ability to convert their loans into any of our securities.

Consequently, our public stockholders may only receive approximately $10.175 per share on our redemption of our public shares, and our warrants and rights will expire worthless.

In certain circumstances, our public stockholders may receive less than $10.175 per share on the redemption of their shares.

We have incurred and expect to incur significant costs associated with an initial business combination.

Whether or not an initial business combination is completed, the incurrence of these costs will reduce the amount of cash available to be used for other corporate purposes by us if an initial business combination is not completed.

We expect to incur significant transaction and transition costs associated with an initial business combination and operating as a public company following the closing of any business combination.

We may also incur additional costs to retain key employees.

Certain transaction expenses incurred in connection with an initial business combination, including all legal, accounting, consulting, investment banking and other fees, expenses and costs, will be paid by the combined company following the closing of an initial business combination.

Even if an initial business combination is not completed, we expect to incur a large number of expenses in the aggregate.

These expenses will reduce the amount of cash available to be used for other corporate purposes by us if an initial business combination is not completed.

Since the Sponsor will lose its entire investment in us if an initial business combination is not completed, and since the Sponsor is an affiliate of the target in the acquisition, it may have a conflict of interest to the interest of other stockholders.

There will be no distribution from the Trust Account with respect to the Company’s warrants and rights, which will expire worthless in the event of our winding up.

In the event of a liquidation, our Sponsor will not receive any monies held in the Trust Account as a result of its ownership of 2,000,500 shares of common stock.

As a consequence, a liquidating distribution will be made only with respect to the public shares.

We are not prohibited from pursuing an initial business combination with a business that is our Sponsor, or affiliated with our Sponsor, officers or directors.

The Sponsor, however, may have an interest in completing an initial business combination as its stockholders stand to benefit from the merger consideration as well seeing that the equity it owns in our company, and the deposits made to the Trust Account are put to use in the business combination, and not liquidated in a winding up of our company.

Due to personal and financial interests of our Sponsor, it may have interests different from, or in addition to, your interests as a stockholder.

We are a newly formed company with no operating history and no revenues, and you have no basis on which to evaluate our ability to achieve our business objective.

We are a newly formed company with no operating results.

Because we lack an operating history, you have no basis upon which to evaluate our ability to achieve our business objective of completing our initial business combination with one or more target businesses.

We may be unable to complete our initial business combination.

If we fail to complete our initial business combination, we will never generate any operating revenues.

Our public stockholders may not be afforded an opportunity to vote on our proposed initial business combination, which means we may complete our initial business combination even though a majority of our public stockholders do not support such a combination.

We may choose not to hold a stockholder vote to approve our initial business combination unless the initial business combination would require stockholder approval under applicable law or stock exchange listing requirements or if we decide to hold a stockholder vote for business or other legal reasons.

Except as required by law, the decision as to whether we will seek stockholder approval of a proposed initial business combination or will

allow stockholders to sell their shares to us in a tender offer will be made by us, solely in our discretion, and will be based on a variety of factors, such as the timing of the transaction and whether the terms of the transaction would otherwise require us to seek stockholder approval.

Accordingly, we may complete our initial business combination even if holders of a majority of our public shares do not approve of the initial business combination we complete.

If we seek stockholder approval of our initial business combination, our Sponsor, officers and directors and Chardan have agreed to vote in favor of such initial business combination, regardless of how our other public stockholders vote.

Pursuant to the letter agreement, our sponsor, officers and directors have agreed to vote their founder shares and placement shares, as well as any public shares purchased during or after our IPO (including in open market and privately negotiated transactions), in favor of our initial business combination.

In addition, Chardan has agreed to vote all equity participation shares as well as any public shares purchased during or after our IPO (including in open market and privately negotiated transactions) in favor of our initial business combination.

As a result, in addition to our founder shares, placement shares and equity participation shares held by Chardan, we would need only 676,478, or approximately 19.5%, of the 3,467,954 remaining shares sold in in our IPO to be voted in favor of an initial business combination (assuming all outstanding shares are voted) in order to have our initial business combination approved.

Our initial stockholders, officers, directors and Chardan own shares representing approximately 38.0% of our outstanding shares of common stock.

Accordingly, if we seek stockholder approval of our initial business combination, the agreement by our initial stockholders, officers, directors and Chardan to vote in favor of our initial business combination will increase the likelihood that we will receive the requisite stockholder approval for such initial business combination.

The only opportunity to affect the investment decision regarding a potential business combination will be limited to the exercise of the right to redeem shares from us for cash, unless we seek stockholder approval of the initial business combination.

At the time of your investment in us, you will not be provided with an opportunity to evaluate the specific merits or risks of our initial business combination.

Since our board of directors may complete an initial business combination without seeking stockholder approval, public stockholders may not have the right or opportunity to vote on the initial business combination, unless we seek such stockholder vote.

Accordingly, if we do not seek stockholder approval, your only opportunity to affect the investment decision regarding a potential business combination may be limited to exercising your redemption rights within the period of time (which will be at least 20 business days) set forth in our tender offer documents mailed to our public stockholders in which we describe our initial business combination.

The ability of our public stockholders to redeem their shares for cash may make our financial condition less attractive to potential business combination targets, which may make it difficult for us to enter into an initial business combination with a target.

We may seek to enter into an initial business combination agreement with a prospective target that requires as a closing condition that we have a minimum net worth or a certain amount of cash.

If too many public stockholders exercise their redemption rights, we might not be able to meet such closing condition and, as a result, would not be able to proceed with the initial business combination.

Furthermore, we will only redeem our public shares so long as (after such redemption) our net tangible assets will be at least $5,000,001 either immediately prior to or upon consummation of our initial business combination and after payment of underwriters’ fees and commissions (so that we are not subject to the SEC’s “penny stock” rules) or any greater net tangible asset or cash requirement which may be contained in the agreement relating to our initial business combination.

Consequently, if accepting all properly submitted redemption requests would cause our net tangible assets to be less than $5,000,001 or such greater amount necessary to satisfy a closing condition, each as described above, we would not proceed with such redemption and the related business combination and may instead search for an alternate business combination.

Prospective targets will be aware of these risks and, thus, may be reluctant to enter into an initial business combination with us.

The ability of our public stockholders to exercise redemption rights with respect to a large number of our shares may not allow us to complete the most desirable business combination or optimize our capital structure.

At the time we enter into an agreement for our initial business combination, we will not know how many stockholders may exercise their redemption rights, and therefore will need to structure the transaction based on our expectations as to the number of shares that will be submitted for redemption.

If our initial business combination agreement requires us to use a portion of the cash in the Trust Account to pay the purchase price, or requires us to have a minimum amount of cash at closing, we will need to reserve a portion of the cash in the Trust Account to meet such requirements, or arrange for third party financing.

In addition, if a larger number of shares are submitted for redemption than we initially expected, we may need to restructure the transaction to reserve a greater portion of the cash in the Trust Account or arrange for third party financing.

Raising additional third-party financing may involve dilutive equity issuances or the incurrence of indebtedness at higher than desirable levels.

The above considerations may limit our ability to complete the most desirable business combination available to us or optimize our capital structure.

The amount of the deferred underwriting commissions payable to Chardan will not be adjusted for any shares that are redeemed in connection with an initial business combination.

The per share amount we will distribute to stockholders who properly exercise their redemption rights will not be reduced by the deferred underwriting commission and after such redemptions, the per share value of shares held by non-redeeming stockholders will reflect our obligation to pay the deferred underwriting commissions.

The ability of our public stockholders to exercise redemption rights with respect to a large number of our shares could increase the probability that our initial business combination would be unsuccessful and that you would have to wait for liquidation in order to redeem your stock.

If our initial business combination requires us to use a portion of the cash in the Trust Account to pay the purchase price, or requires us to have a minimum amount of cash at closing, the probability that our initial business combination would be unsuccessful is increased.

If our initial business combination is unsuccessful, you would not receive your pro rata portion of the Trust Account until we liquidate the Trust Account.

If you are in need of immediate liquidity, you could attempt to sell your stock in the open market;

however, at such time our stock may trade at a discount to the pro rata amount per share in the Trust Account.

In either situation, you may suffer a material loss on your investment or lose the benefit of funds expected in connection with our redemption until we liquidate or you are able to sell your stock in the open market.

If we seek stockholder approval of our initial business combination, our Sponsor, directors, officers, advisors and their affiliates may elect to purchase shares, warrants or rights from public stockholders, which may increase the likelihood of closing our initial business combination and reduce the public “float” of our common stock, warrants and rights.

If we seek stockholder approval of our initial business combination and we do not conduct redemptions in connection with our initial business combination pursuant to the tender offer rules, our Sponsor, directors, officers, advisors or their affiliates may purchase shares, warrants or rights or a combination thereof in privately negotiated transactions or in the open market either prior to or following the completion of our initial business combination, although they are under no obligation to do so.

However, they have no current commitments, plans or intentions to engage in such transactions and have not formulated any terms or conditions for any such transactions.

None of the funds in the Trust Account will be used to purchase shares, warrants or rights in such transactions.

Such a purchase may include a contractual acknowledgement that such stockholder, although still the record holder of our shares is no longer the beneficial owner thereof and therefore agrees not to exercise its redemption rights.

In the event that our Sponsor, directors, officers, advisors or their affiliates purchase shares in privately negotiated transactions from public stockholders who have already elected to exercise their redemption rights or submitted a proxy to vote against our initial business combination, such selling stockholders would be required to revoke their prior elections to redeem their shares and any proxy to vote against our initial business combination.

The price per share paid in any such transaction may be different than the amount per share a public stockholder would receive if it elected to redeem its shares in connection with our initial business combination.

The purpose of such purchases could be to increase the likelihood of closing the initial business combination, or to satisfy a closing condition in an agreement with a target that requires us to have a minimum net worth or a certain amount of cash at the closing of our initial business combination, where it appears that such requirement would otherwise not be met.

The purpose of any such purchases of warrants or rights could be to reduce the number of warrants or rights outstanding.

Any such purchases of our securities may result in the completion of our initial business combination that may not otherwise have been possible.

Any such purchases will be reported pursuant to Section 13 and Section 16 of the Exchange Act to the extent such purchasers are subject to such reporting requirements.

To the extent that any such securities are purchased, such public securities will not be voted as required by Tender Offers and Schedules Compliance and Disclosure Interpretations Question 166.01 promulgated by the SEC.

In addition, if such purchases are made, the public “float” common stock or warrants and the number of beneficial holders of our securities may be reduced, possibly making it difficult to obtain or maintain the quotation, listing or trading of our securities on a national securities exchange.

The SEC has recently adopted new rules relating to certain activities of Special Purpose Acquisition Companies (“SPACs”).

Certain of the procedures that we, a potential business combination target, or others may determine to undertake in connection with such rules may increase our costs and the time needed to complete a business combination and may make it more difficult to complete a business combination.

The need for compliance with the 2024 SPAC Rules may cause us to liquidate the funds in the Trust Account or liquidate the Company at an earlier time than we might otherwise choose.

On January 24, 2024, the SEC adopted final rules (the “2024 SPAC Rules”) that, together with the additional guidance provided in the SEC’s adopting release, impose additional disclosure requirements in business combination transactions involving SPACs and private operating companies;

amend the financial statement requirements applicable to business combination transactions involving such companies;

enhance disclosure requirements and provide additional guidance regarding the general use of projections in SEC filings, as well as when and how projections are disclosed in connection with proposed business combination transactions;

increase the potential liability of certain participants in proposed business combination transactions;

and impact the extent to which SPACs could become subject to regulation under the Investment Company Act of 1940, as amended (the “Investment Company Act”).

Certain of the procedures that we, a potential business combination target, or others may determine to undertake in connection with the 2024 SPAC Rules, or pursuant to the SEC’s views expressed in the adopting release, may increase the costs and time of negotiating and completing a business combination, and may make it more difficult to complete a business combination.

The need for compliance with the 2024 SPAC Rules may cause us to liquidate the funds in the Trust Account or liquidate the Company at an earlier time than we might otherwise choose.

If we are deemed to be an investment company for purposes of the Investment Company Act, we would be required to institute burdensome compliance requirements and our activities would be severely restricted and, as a result, we may abandon our efforts to consummate a business combination and liquidate the Company.

As described further above, the 2024 SPAC Rules relate, among other matters, to the circumstances in which SPACs such as the Company could potentially be subject to the Investment Company Act and the regulations thereunder.

There is currently uncertainty concerning the applicability of the Investment Company Act to a SPAC.

As a result, it is possible that a claim could be made that we have been operating as an unregistered investment company.

If we are deemed to be an investment company and subject to compliance with and regulation under the Investment Company Act, our activities would be severely restricted.

In addition, we would be subject to additional burdensome regulatory requirements and expenses for which we have not allotted funds.

As a result, if we are deemed an investment company under the Investment Company Act, we may abandon our efforts to consummate a business combination and instead liquidate the Company.

If we were deemed to be an investment company for purposes of the Investment Company Act, we may be forced to abandon our efforts to complete an initial business combination and instead be required to liquidate the Company.

To avoid that result, on or shortly prior to the 24-month anniversary of the effective date of the registration statement relating to our IPO, we may liquidate the securities held in the Trust Account and instead hold all funds in the Trust Account in an interest bearing bank demand deposit account, which may earn less interest than we otherwise would have if the Trust Account had remained invested in U.S.

government securities or money market funds.

There is currently uncertainty concerning the applicability of the Investment Company Act to a SPAC, including companies that do not enter into a definitive agreement within 18 months after the effective date of the registration statement relating to their initial public offerings or that do not complete an initial business combination within 24 months after such date.

We may not be able to complete our initial business combination within 24 months of such date and, as a result, we may in the future be subject to a claim that we have been operating as an unregistered investment company.

If we were deemed to be an investment company for purposes of the Investment Company Act, we might be forced to abandon our efforts to complete an initial business combination and instead be required to liquidate.

If we are required to liquidate, our investors would not be able to realize the benefits of owning stock in a successor operating business, including the potential appreciation in the value of our stock and rights following such a transaction, and our rights would expire worthless.

Changes in laws or regulations, or a failure to comply with any laws and regulations, may adversely affect our business, including our ability to negotiate and complete our initial business combination and results of operations.

We are subject to laws and regulations enacted by national, regional and local governments.

In particular, we will be required to comply with certain SEC and other legal requirements.

Compliance with, and monitoring of, applicable laws and regulations may be difficult, time consuming and costly.

Those laws and regulations and their interpretation and application may also change from time to time and those changes could have a material adverse effect on our business, investments and results of operations.

In addition, a failure to comply with applicable laws or regulations, as interpreted and applied, could have a material adverse effect on our business, including our ability to negotiate and complete our initial business combination and results of operations.

A decline in interest rates could limit the amount available to fund our search for a target business or businesses and complete a business combination since we will depend on interest earned on the Trust Account to pay our tax obligations and to complete a business combination.

We depend on sufficient interest being earned on the proceeds held in the Trust Account to pay any tax obligations that we may owe.

The funds held in trust will be invested in United States “government securities” within the meaning of Section 2(a)(16) of the Investment Company Act having a maturity of 185 days or less, or in money market funds meeting certain conditions under Rule 2a-7 promulgated under the Investment Company Act.

While we are entitled to have released to us for such purpose certain interest earned on the funds in the Trust Account, a substantial decline in interest rates may result in our having insufficient funds available with which to pay our taxes which would reduce the amount of funds available to structure, negotiate or close a business combination.

In such event, we would need to obtain additional funds from our existing stockholder or another source or be forced to liquidate.

Our existing stockholder is under no obligation to advance such funds in such circumstances.

Because of our limited resources and the significant competition for business combination opportunities, it may be more difficult for us to research a large number of potential target businesses or to complete our initial business combination.

If we are unable to complete our initial business combination, our public stockholders may receive only approximately $10.175 per share on our redemption of our public shares, or less than such amount in certain circumstances, and our warrants and rights will expire worthless.

If a proposed business combination does not progress, and we have to search for another business to acquire, we expect to encounter intense competition from other entities having a business objective similar to ours, including private investors (which may be individuals or investment partnerships), other blank check companies and other entities competing for the types of businesses we intend to acquire.

Many of these individuals and entities are well-established and have extensive experience in identifying and effecting, directly or indirectly, acquisitions of companies operating in or providing services to various industries.

Many of these competitors possess greater technical, human and other resources or more industry knowledge than we do, and our financial resources will be relatively limited when contrasted with those of many of these competitors.

While we believe there are numerous target businesses we could potentially acquire, our ability to compete with respect to the acquisition of certain target businesses that are sizable will be limited by our available financial resources.

This inherent competitive limitation gives others an advantage in pursuing the acquisition of certain target businesses.

Our limited resources may also limit the number of potential targeted businesses we are able to research and we may depend on third-party information, such as reports from academic conferences and industry seminars, as well as leverage our relationships venture capital firms globally, in order to selectively identify target businesses to contact directly and research further.

Furthermore, because we are obligated to pay cash for the shares of common stock which our public stockholders redeem in connection with our initial business combination, target companies will be aware that this may reduce the resources available to us for our initial business combination.

This may place us at a competitive disadvantage in successfully negotiating an initial business combination.

If we are unable to complete our initial business combination, our public stockholders may receive only approximately $10.175 per share on the liquidation of our Trust Account and our warrants and rights will expire worthless.

In certain circumstances, our public stockholders may receive less than $10.175 per share upon our liquidation.

federal excise tax may be imposed on us in connection with our redemptions of shares in connection with an initial business combination or other stockholder vote pursuant to which stockholders would have a right to submit their shares for redemption (a “Redemption Event”).

Pursuant to the Inflation Reduction Act of 2022 (the “IR Act”), which commenced in 2023, a 1% U.S.

federal excise tax is imposed on certain repurchases (including redemptions) of stock by publicly traded domestic (i.e., U.S.) corporations and certain domestic subsidiaries of publicly traded foreign corporations.

The excise tax is imposed on the repurchasing corporation and not on its stockholders.

The amount of the excise tax is equal to 1% of the fair market value of the shares repurchased at the time of the repurchase.

However, for purposes of calculating the excise tax, repurchasing corporations are permitted to net the fair market value of certain new stock issuances against the fair market value of stock repurchases during the same taxable year.

Department of the Treasury (the “Treasury Department”) has authority to promulgate regulations and provide other guidance regarding the excise tax.

Internal Revenue Service guidance, liquidating distributions made by publicly traded domestic corporations are exempt from the excise tax.

In addition, any redemptions that occur in the same taxable year as a liquidation is completed will also be exempt from such tax.

Accordingly, redemptions of our public shares may subject us to the excise tax, unless one of the two exceptions above apply.

If the outside deadline for us to complete an initial business combination (currently May 14, 2024) is extended, our public stockholders will have the right to require us to redeem their public shares.

Any redemption or other repurchase may be subject to the excise tax.

The extent to which we would be subject to the excise tax in connection with a Redemption Event would depend on a number of factors, including:

(i) the fair market value of the redemptions and repurchases in connection with the Redemption Event, (ii) the nature and amount of any “PIPE” or other equity issuances in connection with an initial business combination (or otherwise issued not in connection with the Redemption Event but issued within the same taxable year of an initial business combination), (iii) if we fail to timely consummate an initial business combination and liquidate in a taxable year following a Redemption Event and (iv) the content of any proposed or final regulations and other guidance from the Treasury Department.

In addition, because the excise tax would be payable by us and not by the redeeming holders, the

mechanics of any required payment of the excise tax remains to be determined.

Any excise tax payable by us in connection with a Redemption Event may cause a reduction in the cash available to us to complete an initial business combination and could affect our ability to complete an initial business combination;

however, we will not use the funds held in the Trust Account and any additional amounts deposited into the Trust Account, as well as interest earned thereon, to pay the excise tax.

We may not be able to complete an initial business combination with a U.S.

target company since such initial business combination may be subject to U.S.

foreign investment regulations and review by a U.S.

government entity such as the Committee on Foreign Investment in the United States (CFIUS), and ultimately prohibited.

Our Sponsor is controlled by and has substantial ties with non-U.S.

persons who are nationals of South Korea.

CFIUS is an interagency committee chaired by the U.S.

Department of the Treasury that is authorized to review certain “covered transactions,” which include direct and indirect control acquisitions of and certain non-control investments in U.S.

businesses by foreign persons, in order to determine whether such covered transactions threaten to impair the national security of the United States.

If CFIUS determines that a covered transaction threatens to impair U.S.

national security, it has the authority to undertake mitigation measures including recommending that the President prohibit the transaction or require divestment by the foreign person if the transaction has been completed.

The potential for CFIUS review of a covered transaction depends on a number of factors including the nature and structure of the transaction, the operations of the U.S.

business including whether the business is a “TID U.S.

business” as defined in 31 C.F.R.

§ 800.248, and the foreign persons involved in the transaction including their nationality, intermediate and ultimate shareholders, and operations elsewhere globally.

CFIUS has the discretion to initiate review of a covered transaction.

Parties to a covered transaction may submit a notice voluntarily to CFIUS to request clearance, which is a safe harbor against future review.

Certain covered transactions involving a TID U.S.

business, however, are subject to a mandatory notice requirement.

Because we may be considered a foreign person, under CFIUS regulations, an initial proposed business combination may fall within the scope of a covered transaction and be subject to CFIUS review jurisdiction.

If so, we may be required to make a mandatory filing or, if no mandatory filing is required, we may decide to submit a voluntary notice to CFIUS or proceed with the initial business combination without notifying CFIUS and risk CFIUS intervention before or after closing the initial business combination.

CFIUS may decide to block or delay our initial business combination, impose conditions to mitigate national security concerns with respect to such initial business combination, or order us to divest all or a portion of a U.S.

business of the combined company if we had proceeded without first obtaining CFIUS clearance.

The potential impact of CFIUS may limit the attractiveness of a transaction with us or prevent us from pursuing certain initial business combination opportunities that we believe would otherwise be beneficial to us and our shareholders.

As a result, the pool of potential targets with which we could complete an initial business combination may be limited and we may be adversely affected in terms of competing with other special purpose acquisition companies that do not have similar foreign ownership issues.

Moreover, the process of review by CFIUS may be lengthy.

Because we have only a limited time to complete our initial business combination, our failure to obtain required approvals within the requisite time period may require us to liquidate.

If we liquidate, our warrants and rights would expire worthless.

This will also cause you to lose any potential investment opportunity in a target company and the chance of realizing future gains on your investment through any price appreciation in the combined company.

Risks Relating to Our Securities

If a stockholder fails to receive notice of our offer to redeem our public shares in connection with our initial business combination, or fails to comply with the procedures for tendering its shares, such shares may not be redeemed.

At the time of your investment in us, you will not be provided with an opportunity to evaluate the specific merits or risks of our initial business combination.

You will not have any rights or interests in funds from the Trust Account, except under certain limited circumstances.

Therefore, to liquidate your investment, you may be forced to sell your public shares, warrants or rights, potentially at a loss.

If our initial business combination agreement requires us to use a portion of the cash in the Trust Account to pay the purchase price, or requires us to have a minimum amount of cash at closing, the probability that our initial business combination would be unsuccessful is increased.

If our initial business combination is unsuccessful, you would not receive your pro rata portion of the Trust Account until we liquidate the Trust Account.

If you are in need of immediate liquidity, you could attempt to sell your stock in the open market;

however, at such time our stock may trade at a discount to the pro rata amount per share in the Trust Account.

We are currently not in compliance with the Nasdaq continued listing requirements.

If we are unable to regain compliance with Nasdaq’s listing requirements, our securities could be delisted, which could affect our securities’ market price and liquidity.

On June 27, 2023, the Company notified Nasdaq that it is not currently in compliance with Nasdaq Listing Rule 5605(c)(2)(A) (the “Listing Rule”), but that it intends to regain compliance within the cure period provided by section (c)(4)(B) of the Listing Rule.

The Listing Rule requires the Audit Committee of the Board to be composed of at least three members, each of whom must meet independence requirements under the Nasdaq Listing Rules and the Securities Exchange Act of 1934, as amended.

the Audit Committee is comprised of two independent directors and one vacancy and, therefore, does not currently comply with Nasdaq’s audit committee requirements as set forth in the Listing Rule.

Pursuant to the Listing Rule’s section (c)(4)(B), the Company is entitled to a cure period to regain compliance with the Listing Rule.

The Company has until the earlier of its next annual stockholders’ meeting or June 21, 2024 to regain compliance.

The Company is evaluating the appropriate membership and composition of its Board and Board committees and intends to regain compliance with Listing Rule prior to the expiration of the applicable cure period.

On February 15, 2024, we received a written notice (the “Notice”) from the Nasdaq Listing Qualifications Department indicating that we were not in compliance with Nasdaq Listing Rule 5550(a)(3), which requires us to have at least 300 public holders for continued listing on the Nasdaq Capital Market (the “Minimum Public Holders Rule”).

The Notice is only a notification of deficiency, not of imminent delisting, and has no current effect on the listing or trading of our securities on the Nasdaq Capital Market.

The Company submitted a plan to regain compliance with the Minimum Public Holders Rule to Nasdaq on April 1, 2024.

If Nasdaq accepts our plan, Nasdaq may grant us an extension of up to 180 calendar days from the date of the Notice to evidence compliance with the Minimum Public Holders Rule.

If Nasdaq does not accept our plan, we will have the opportunity to appeal the decision in front of a Nasdaq Hearings Panel.

There can be no assurance that Nasdaq will accept the proposed plan or that we will not receive additional notices of our failure to maintain the requirements for continued listing on Nasdaq.

Our stockholders may be held liable for claims by third parties against us to the extent of distributions received by them upon redemption of their shares.

Under the DGCL, stockholders may be held liable for claims by third parties against a corporation to the extent of distributions received by them in a dissolution.

The pro rata portion of our Trust Account distributed to our public stockholders upon the redemption of our public shares in the event we do not complete our initial business combination within the completion window may be considered a liquidating distribution under Delaware law.

If a corporation complies with certain procedures set forth in Section 280 of the DGCL intended to ensure that it makes reasonable provision for all claims against it, including a 60-day notice period during which any third-party claims can be brought against the corporation, a 90-day period during which the corporation may reject any claims brought, and an additional 150-day waiting period before any liquidating distributions are made to stockholders, any liability of stockholders with respect to a liquidating distribution is limited to the lesser of such stockholder’s pro rata share

of the claim or the amount distributed to the stockholder, and any liability of the stockholder would be barred after the third anniversary of the dissolution.

However, it is our intention to redeem our public shares as soon as reasonably possible following the 15 month (or such other time period as our stockholders may approve).following the closing of our IPO in the event we do not complete our initial business combination and, therefore, we do not intend to comply with the foregoing procedures.

Because we do not intend to comply with Section 280, Section 281(b) of the DGCL requires us to adopt a plan, based on facts known to us at such time that will provide for our payment of all existing and pending claims or claims that may be potentially brought against us within the 10 years following our dissolution.

However, because we are a blank check company, rather than an operating company, and our operations will be limited to searching for prospective target businesses to acquire, the only likely claims to arise would be from our vendors (such as lawyers, investment bankers, consultants, etc.) or prospective target businesses.

Pursuant to the obligation contained in our underwriting agreement, we will seek to have all vendors, service providers, prospective target businesses or other entities with which we do business execute agreements with us waiving any right, title, interest or claim of any kind in or to any monies held in the Trust Account.

As a result of this obligation, the claims that could be made against us are significantly limited and the likelihood that any claim that would result in any liability extending to the Trust Account is remote.

If our plan of distribution complies with Section 281(b) of the DGCL, any liability of stockholders with respect to a liquidating distribution is limited to the lesser of such stockholder’s pro rata share of the claim or the amount distributed to the stockholder, and any liability of the stockholder would likely be barred after the third anniversary of the dissolution.

We cannot assure you that we will properly assess all claims that may be potentially brought against us.

As such, our stockholders could potentially be liable for any claims to the extent of distributions received by them (but no more) and any liability of our stockholders may extend beyond the third anniversary of such date.

Furthermore, if the pro rata portion of our Trust Account distributed to our public stockholders upon the redemption of our public shares in the event we do not complete our initial business combination within the completion window is not considered a liquidating distribution under Delaware law and such redemption distribution is deemed to be unlawful, then pursuant to Section 174 of the DGCL, the statute of limitations for claims of creditors could then be six years after the unlawful redemption distribution, instead of three years, as in the case of a liquidating distribution.

We may not hold an annual meeting of stockholders until after we consummate our initial business combination and you will not be entitled to any of the corporate protections provided by such a meeting.

We may not hold an annual meeting of stockholders until after we consummate our initial business combination (unless required by Nasdaq) and thus may not be in compliance with Section 211(b) of the DGCL, which requires an annual meeting of stockholders be held for the purposes of electing directors in accordance with a company’s bylaws unless such election is made by written consent in lieu of such a meeting.

Therefore, if our stockholders want us to hold an annual meeting prior to our consummation of our initial business combination, they may attempt to force us to hold one by submitting an application to the Delaware Court of Chancery in accordance with Section 211(c) of the DGCL.

In addition to the other information contained in (or incorporated

by reference into) this proxy statement/prospectus, including the matters addressed under the heading “Cautionary Note Regarding Forward-Looking Statements,”

you should carefully consider the following risk factors in deciding how to vote on the proposals presented in this proxy statement/prospectus.

Following the Business Combination the Company will operate in a market environment that is difficult to predict and that involves significant

risks, many of which will be beyond its control.

You should carefully consider the risks described below.

The occurrence of one or more

of the events or circumstances described in these risk factors, alone or in combination with other events or circumstances, may have a

material adverse effect on the Company’ business, reputation, revenue, financial condition, results of operations and future prospects,

in which event the market price of the Company securities could decline, and you could lose part or all of your investment.

Unless otherwise

indicated, reference in this section and elsewhere in this Form 10-K Report to the Company’s and/or OSR’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.

Risks Related to the Business Combination and Business Combination

The Company’s Chief Executive Officer and one of our directors

was previously the Chief Executive Officer and is currently the Chairman of the Board of OSR.

These dual positions (i) create conflicts

of interest in the performance of his duties;

and (ii) may provide for him to receive compensation following the Business Combination

that amplified his conflicts of interest in determining whether the transaction was the most advantageous.

The Company’s Chief Executive Officer and one of its directors,

Kuk Hyoun Hwang, was previously the Chief Executive Officer and is currently the Chairman of the Board of OSR.

Such dual positions may

cause him to have conflicts of interest in performing his duties to both companies.

Hwang is expected to remain with the Company

following the completion of the Business Combination and receive future compensation in the form of cash payments and/or the Company securities

for services he would render to the Company going forward.

The personal and financial interests of Mr.

Hwang may have influenced

his motivation in negotiating the Business Combination and in managing the combined Company going forward.

Despite the approval of the

terms of the Business Combination Agreement by a majority of our independent directors ( i.e.

, the Company M&A Committee), potential

conflicts of interest still may exist and, as a result, the terms of the Business Combination may not be as advantageous to our public

stockholders as they would have been absent any conflicts of interest.

Hwang beneficially owns 13,069,104 shares of the

post-combination company and controls 67.8%

The PIPE Investment did not close at the closing of the Business

Combination and is not expected to be consummated with the original PIPE investor.

As a result of the PIPE Investment not closing, BLAC did not receive

$20 million in cash at the closing of the Business Combination.

The Company was insolvent at the closing of the Business Combination and

will not have enough cash to fund its operations or pay its outstanding expenses and debts.

Toonon, PIPE Investor, exercised its right

to cancel the PIPE investment based upon its assessment of macroeconomic factors specific to Korean markets.

If the Company fails to secure

other funding in the next few months, the Company could enter bankruptcy proceedings and the value of the stock and warrants of the Company

would likely become worthless.

The Sponsor and the Company’s directors and officers have

interests that are different from or that conflict with the interests of the Company’s stockholders and that may

have influenced their analysis of whether the Business Combination with the Company is appropriate as BLAC’s initial business

Such interests include that the Sponsor will lose its entire investment in BLAC if the Business Combination is not completed.

The personal and financial interests of the Sponsor as well as the

Company’s directors and officers may have influenced their motivation in identifying and selecting OSR as an initial business combination

target, completing an initial business combination with OSR and may influence the operation of the business following consummation of

the initial business combination.

Following the consummation of the Business Combination, the Company’s

only significant asset will be its ownership of OSR and such ownership may not be sufficient to pay its expenses or satisfy other financial

Following the consummation of the Business Combination, the Company

will be a holding company and will not directly own any operating assets other than its ownership of interests in OSR.

will depend on OSR for distributions, loans and other payments to generate the funds necessary to meet its financial obligations, including

its expenses as a publicly traded company.

The earnings from, or other 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

a significant percentage of Company Common Stock and are able to exert significant control over matters subject to stockholder approval.

Our executive officers, directors and their affiliates and our principal

stockholders beneficially hold, in the aggregate, approximately 92.9% of the outstanding shares of Company Common Stock.

These stockholders,

acting together, would be able to significantly influence all matters requiring stockholder approval, including the proposals presented

at the Company Stockholders’ Meeting.

For example, these stockholders would be able to significantly influence elections of directors,

amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction.

prevent or discourage unsolicited acquisition proposals or offers for our common stock that stockholders may feel are in their best interests.

Lack of Business Diversification

For an indefinite period of time after the completion of our initial

business combination, the prospects for our success may depend entirely on the future performance of a single business and a single industry—the

health care sector.

Unlike other entities that have the resources to complete business combinations with multiple entities in one or several

industries, it is probable that we will not have the resources to diversify our operations and mitigate the risks of being in a single

line of business.

By completing our initial business combination with only a single entity, our lack of diversification may:

● 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 after our initial business combination,

● cause us to depend on the marketing and sale of a single product

or limited number of products or services.

Limited Ability to Evaluate OSR’s Management Team

Although we attempted to closely scrutinize the management of OSR as

a target business when evaluating the desirability of effecting our initial business combination with OSR, our assessment of OSR’s

business’ management may not prove to be correct.

In addition, the future management may not have the necessary skills, qualifications

or abilities to manage a public company.

Furthermore, the future role of members of our management team, if any, in the target business

cannot presently be stated with any certainty.

The determination as to whether any of the members of our management team will remain with

the combined company will be made at the time of our initial business combination.

While it is possible that one or more of our directors

will remain associated in some capacity with us following our initial business combination, it is unlikely that any of them will devote

their full efforts to our affairs or that our future management team will have significant experience or knowledge relating to the operations

of the particular target business.

We cannot assure you that any of our key personnel will remain in senior management or advisory positions

going forward.

Having completed our initial business combination, we will seek to recruit additional managers to supplement the incumbent

management of OSR.

We cannot assure you that we will have the ability to recruit additional managers, or that additional managers will

have the requisite skills, knowledge or experience necessary to enhance the incumbent management.

The Company may be subject to tax liability if OSR fails to pay

its local taxes.

Under the Framework Act on National Taxes, if OSR is unable to meet

its national tax obligations with its assets, we will be subject to the secondary tax liability for any taxes accrued during the period

we hold our shares in OSR.

Under the Local Tax Act (of Korea), we may also be subject to the secondary tax liability if OSR fails to pay

its local taxes.

The secondary tax liability is equal to the amount of unpaid taxes multiplied by our shareholding ratio of OSR.

is no assurance that we will not be subject to such tax liabilities or that the Company will have sufficient cash flow to cover such potential

tax liabilities.

In addition, as of December 31, 2024, OSR had deferred tax liabilities

of approximately $28,035,508, resulting from the differences between book and tax basis for assets acquired or created during previous

business combinations as a result of purchase price allocation for accounting purposes, which will be due if and only when certain taxable

events occur in the future which will reverse or eliminate such basis difference (i.e., sales of subsidiaries).

Risks Related to the Company Securities

The price of the Company’ Common Stock and warrants may

The price of the Company’ Common Stock and warrants may fluctuate

due to a variety of factors, including:

● actual or anticipated fluctuations in its quarterly and annual

results and those of other public companies in the same or similar industry;

● mergers and strategic alliances in the industry in which it

● market prices and conditions in the industry in which it operates;

● changes in government regulation;

● potential or actual military conflicts or acts of terrorism;

● 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;

● the general state of the securities markets.

These market and industry factors may materially reduce the market

price of the Company’ Common Stock and warrants, regardless of its operating performance.

Following the Business Combination, the Company is a controlled

company within the meaning of the Nasdaq Listing Rules and, as a result, will qualify for, and may rely on, exemptions

from certain corporate governance requirements.

Stockholders of the Company may not have the same protection afforded to stockholders

of companies that are subject to such governance requirements.

After the Business Combination, Kuk Hyoun Hwang, the Company’s

Chief Executive Officer will control a majority of the voting power of the outstanding shares of the Company Common Stock.

the Company will be a “controlled company” within the meaning of the corporate governance standards of Nasdaq.

these corporate governance standards, a company of which more than 50% of the voting power for the election of directors is held by an

individual, group or another company is a “controlled company” and may elect not to comply with certain corporate governance

requirements.

For example, controlled companies:

● are not required to have a board that is composed of a majority

of “independent directors” as defined under the Nasdaq listing rules;

● are not required to have a compensation committee that is composed

entirely of independent directors or have a written charter addressing the committee’s purpose and responsibilities;

● are not required to have director nominations be made, or recommended

to the full board of directors, by its independent directors or by a nominating and corporate governance committee that is composed entirely

of independent directors, and to adopt a written charter or a board resolution addressing the nominations process.

While the Company does not initially intend to rely on these exemptions,

the Company may opt to utilize these exemptions in the future as long as it remains a controlled company.

Accordingly, the Company

stockholders may not have the same protections afforded to stockholders of companies that are subject to all of the corporate governance

requirements of Nasdaq.

If the Company ceases to be a “controlled company” in the

future, it will be required to fully comply with the Nasdaq Listing Rules, which may require replacing a number of its directors and may

require development of certain other governance-related policies and practices.

These and any other actions necessary to achieve

compliance with such rules may increase the Company’ legal and administrative costs, will make some activities more difficult, time-consuming,

and costly and may also place additional strain on the Company’ personnel, systems and resources.

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.

Although Company stock and warrants were listed on Nasdaq under the

ticker symbols “OSRH” and “OSRHW,” respectively, upon Closing of the Business Combination, a sufficiently liquid

or active trading market for the Company Common Stock and warrants may never develop or be sustained going forward.

A public trading market

having the desirable characteristics of depth, liquidity and orderliness depends upon the existence of willing buyers and sellers at any

given time, such existence being dependent upon the individual decisions of buyers and sellers over which neither we nor any market maker

The failure of an active and liquid trading market to develop and continue would likely have a material adverse effect on

the value of the Company Common Stock and warrants.

An inactive market may also impair our ability to raise capital to continue to fund

operations by issuing the Company Common Stock and warrants.

In addition, the price of the Company securities can vary due to general

economic conditions and forecasts, its general business condition and the release of its financial reports.

Additionally, if its securities

are not listed on, or becomes delisted from, Nasdaq for any reason, and are quoted on the OTC Bulletin Board, an inter-dealer automated

quotation system for equity securities that is not a national securities exchange, the liquidity and price of its securities may be more

limited than if it were quoted or listed on Nasdaq or another national securities exchange.

You may be unable to sell your securities

unless a market can be established or sustained.

The Company does not intend to pay dividends on its common stock

so any returns will be limited to the value of our stock.

The Company currently anticipates that it will retain future earnings

for the development, operation and expansion of the Company’ 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

of dividends that may be declared or paid on the Company’ Common Stock.

Any return to stockholders will therefore be limited to

the appreciation of their stock.

Future sales, or the perception of future sales, of the Company

Common Stock by the Company or its stockholders in the public market could cause the market price for the Company Common Stock to decline.

The sale of shares of the Company Common Stock in the public market,

or the perception that such sales could occur, by the Company or its stockholders or warrant holders could harm the prevailing market

price of shares of New Holdings Common Stock.

These sales, or the possibility that these sales may occur, also might make it more difficult

for the Company to sell equity securities in the future at a time and at a price that it deems appropriate.

If the Company issues additional equity securities or debt securities,

those securities offerings may adversely affect the market price of the Company Common Stock and warrants to purchase shares of the Company

Common Stock and may be dilutive to existing stockholders.

In the future, the Company is likely to issue additional shares of

common stock or issue preferred stock or incur debt.

Debt and preferred stock will generally have priority upon liquidation.

Such securities

also may be governed by an indenture or other instrument containing covenants restricting our operating flexibility.

Additionally, any

convertible or exchangeable securities that the Company issues in the future may have rights, preferences and privileges more favorable

than those of the Company Common Stock.

Because the decision to issue debt or equity in the future will depend on market conditions and

other factors beyond the Company’ control, we cannot predict or estimate the amount, timing, nature or success of our future capital

raising efforts.

As a result, future capital raising efforts may reduce the market price of the Company Common Stock and warrants to purchase

the Company Common Stock and be dilutive to existing stockholders.

The Company granted registration rights to certain stockholders

and others and the future exercise of such rights may adversely affect the market price of our common stock.

Pursuant to an agreement entered into in connection with the issuance

and sale of the securities in the Company IPO, certain of the Company’s stockholders and their permitted transferees can demand

that the Company register the placement warrants, the placement rights, the shares of common stock issuable upon exercise of the placement

warrants, the shares of common stock included in the placement units, and the shares of common stock underlying the placement rights.

Additionally, holders of units that may be issued upon conversion of working capital loans can demand that the Company register the warrants

and rights included in such units, the shares of common stock issuable upon exercise of such warrants, the shares of common stock included

in such units, and the shares of common stock underlying such rights.

The Company will bear the cost of registering these securities.

The registration and availability of such a significant number of securities for trading in the public market may have an adverse effect

on the market price of the Company Common Stock.

The abovementioned risks are specifically relevant to Company’s

recent Equity Line of Credit (“ELOC”) Agreement

In on February 25, 2025 we entered into an equity purchase agreement

and 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)

$80,000,000 in aggregate gross purchase price of newly issued shares of the Company’s common stock, par value $0.0001 per share,

and (ii) the Exchange Cap, in each case, subject to certain limitations and conditions set forth in the Common Stock Purchase Agreement.

A more detailed discussion of this agreement is included in Part II, Item 7, “ Management’s Discussion and Analysis of Financial

Condition and Results of Operations – Liquidity and Capital Resources .”

The ELOC Agreement is central to the Company’s business strategy

and financing needs, and therefore central to its risk profile.

Depending upon how, when and at what level this facility is utilized by

the Company, the ELOC Agreement could result in significant dilution for existing holders of Company Common Stock as well as having a

potential negative impact upon the market price of such shares.

The same and other factors create significant uncertainty as to the Company’s

ability to rely upon, and have access to funds from, the ELOC Agreement facility.

The Amended Bylaws require, to the fullest extent permitted by

law, that derivative actions brought in our name, as applicable, against their respective directors, officers, other employees or stockholders

for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery in the State of Delaware, which may

have the effect of discouraging lawsuits against our directors, officers, other employees or stockholders, as applicable.

The Amended Bylaws provide that unless we consent in writing to the

selection of an alternative forum, the Court of Chancery in the State of Delaware shall be the sole and exclusive forum for (A) any

derivative action or proceeding brought on our behalf, (B) any action asserting a claim of breach of fiduciary duty owed by any of

our directors, officers or employees to us or our stockholders, (C) any civil action to interpret, apply or enforce any provision

of the DGCL, (D) any civil action to interpret, apply, enforce or determine the validity of the provisions of the Amended Charter

or the Amended Bylaws or (E) any action asserting a claim governed by the internal affairs doctrine.

In the event, however, that

the Court of Chancery of the State of Delaware lacks jurisdiction over any of the foregoing actions, the Amended Bylaws provide that the

sole and exclusive forum for such action shall be another state or federal court located in the State of Delaware, subject to such court

having personal jurisdiction over the indispensable parties named as defendants.

The Amended Bylaws expressly provide that the foregoing

provisions do not apply to the resolution of any complaint asserting a cause of action under the Securities Act.

The Amended Bylaws also provide that unless we consent in writing to

the selection of an alternative forum, the federal district courts of the United States of America shall, to the fullest extent permitted

by applicable law, be the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities

The Amended Bylaws expressly provide that the foregoing provisions

do not apply to any action asserting a claim arising under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

The Delaware forum provision and the federal forum provision described

above may impose additional litigation costs on stockholders who assert that such provision is not enforceable and may impose more general

additional litigation costs in pursuing claims subject to such, particularly if the stockholders do not reside in or near the State of

Delaware or the United States District Courts.

In addition, these forum selection clauses in the Amended Bylaws may limit our stockholders’

ability to bring a claim in a judicial forum that they find favorable for disputes with us or our directors, officers or employees, which

may discourage such lawsuits against us and our directors, officers and employees even though an action, if successful, might benefit

our stockholders.

If the federal forum provision is found to be unenforceable, we may incur additional costs associated with resolving

such matters.

The federal forum provision may also impose additional litigation costs on stockholders who assert the provision is not

enforceable or invalid.

The Court of Chancery of the State of Delaware and the United States District Courts may also reach different

judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise

choose to bring the action, and such judgments may be more or less favorable to us than our stockholders.

Section 22 of the Securities Act creates concurrent jurisdiction

for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations

Accordingly, both state and federal courts have jurisdiction to entertain such claims.

As noted above, the Amended Bylaws

provides that the United States District Court will be the exclusive forum for the resolution of any complaint asserting a cause

of action arising under the Securities Act.

While the Delaware Supreme Court ruled in March 2020 that federal forum selection provisions

purporting to require claims under the Securities Act be brought in federal court were “facially valid” under Delaware law,

there is uncertainty as to whether other courts will enforce the federal forum provision in the Amended Bylaws.

Investors also cannot

waive compliance with the federal securities laws and the rules and regulations thereunder.

Anti-takeover provisions contained in the Company Charter

and the Company Bylaws, as well as provisions of Delaware law, could impair a takeover attempt.

The Amended Charter and the Amended Bylaws contain provisions that

could delay or prevent a change of control of our company or changes in our board of directors that our stockholders might consider favorable.

Some of these provisions include:

● 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;

● advance notice requirements for stockholder proposals and nominations

for election to our board of directors;

● 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

Charter and the Company Bylaws could make it more difficult for stockholders or potential acquirers to obtain control of our board of

directors or delay or impede a merger, tender offer or proxy contest involving the Company.

These provisions could also discourage proxy

contests and make it more difficult for you and other stockholders to elect directors of your choosing or cause the Company to take other

corporate actions you desire.

Any delay or prevention of a change of control transaction or changes in the Company’ board of directors

could cause the market price of our common stock to decline.

In addition, because we are incorporated in Delaware and our certificate

of incorporation has not opted out of the application of Section 203 of the DGCL, we are governed by the provisions of Section 203

In general, Section 203 of the DGCL prohibits a Delaware corporation

that is listed on a national securities exchange or held of record by more than 2,000 stockholders from engaging in a “business

combination” with an “interested stockholder” for a three-year period following the time such stockholder becomes

an interested stockholder, unless the business combination is approved in one of the manners described below.

combination” includes, among other things, certain mergers, asset or stock sales or other transactions together resulting in a financial

benefit to the interested stockholder.

An “interested stockholder” is a person who, together with affiliates and associates,

owns, or did own within three years prior to the determination of interested stockholder status, 15% or more of the corporation’s

outstanding voting stock.

Under Section 203 of the DGCL, a business combination between a corporation and an interested stockholder

is prohibited unless it satisfies one of the following conditions:

● 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;

● 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;

● 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 % of the outstanding voting stock which is not owned by the

interested stockholder.

Under certain circumstances, Section 203 of the DGCL will make

it more difficult for a person who would be an “interested stockholder” to effect various business combinations with the corporation

for a three-year period.

This provision may encourage persons interested in acquiring the Company to negotiate in advance with the

board of directors of the Company.

Section 203 of the DGCL also may have the effect of preventing changes in the Company board of

directors and may make it more difficult to accomplish transactions which stockholders may otherwise deem to be in their best interests.

If, following the Business Combination, securities or industry

analysts do not publish or cease publishing research or reports about the Company, its business, or its market, or if they change their

recommendations regarding the Company securities adversely, then the price and trading volume of the Company securities could decline.

The trading market for the Company securities will be influenced by

the research and reports that industry or securities analysts may publish about the Company, its business, its market, or its competitors.

Securities and industry analysts may never publish research on the Company.

If no securities or industry analysts commence coverage of

the Company, the securities price and trading volume would likely be negatively impacted.

If any of the analysts who may cover the Company

change their recommendation regarding the Company securities adversely, or provide more favorable relative recommendations about the Company’

competitors, the price of the Company’ securities would likely decline.

If any analyst who may cover the Company were to cease coverage

of the Company or fail to regularly publish reports on it, the Company could lose visibility in the financial markets, which could cause

the Company’ 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.

The Company failure to meet the continued listing requirements of Nasdaq could result

in a delisting of the Company Common Stock and warrants.

Effective at the time of the Business Combination the Company Common

Stock and warrants were listed on Nasdaq under the symbols “OSRH” and “OSRHW,” respectively.

eligibility for listing on Nasdaq depends on its ability to comply with Nasdaq’s continued listing standards, including requirements

relating to the trading price and trading volume of its securities, and other corporate governance requirements.

If the Company is not

able to comply with the continued listing standards 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;

● reduced liquidity for the Company securities;

● 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;

● a decreased ability to issue additional securities or obtain

additional financing in the future.

The National Securities Markets Improvement Act of 1996,

which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered

securities.” As long as the Company’s Common Stock and warrants are listed on Nasdaq, they will be considered covered securities.

If the Company’ securities were no longer listed on Nasdaq, the securities would not be covered securities and would therefore be

subject to regulation in each state in which the Company offers its securities.

If, after listing, the Company fails to satisfy the continued listing

requirements of Nasdaq such as the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps

to delist the Company’ securities.

Such a delisting would likely have a negative effect on the price of the securities and would

impair your ability to sell or purchase the securities when you wish to do so.

In the event of a delisting, and no assurance can be provided

that any action taken to restore compliance with listing requirements would allow the securities to become listed again, stabilize the

market 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.

Additionally, if the Company’ 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

the Company securityholders may be unable to sell their securities unless a market can be established or sustained.

On February 15, 2024, the Company received a written notice (the

“ Notice ”) from the Nasdaq Listing Qualifications Department indicating that the Company was not in compliance with

Nasdaq Listing Rule 5550(a)(3), which requires the Company to have at least 300 public holders for continued listing on the Nasdaq

Capital Market (the “Minimum Public Holders Rule”).

The Notice is only a notification of deficiency, not of imminent delisting,

and has no current effect on the listing or trading of the Company’s securities on the Nasdaq Capital Market.

The Company submitted

a plan to regain compliance with the Minimum Public Holders Rule to Nasdaq on April 1, 2024.

On April 17, 2024, the Company

received written notice from Nasdaq granting an extension to August 13, 2024 to regain compliance with the Minimum Public Holders

Rule (the “Compliance Period”).

On August 20, 2024, the Company received written notice (the “Second Notice”)

from Nasdaq stating that the Company had not regained compliance with the Minimum Public Holders Rule within the Compliance Period.

accordance with the Second Notice, BLAC timely requested a hearing before the Hearings Panel (the “Panel”) which automatically

stayed any suspension or delisting action of the Company’s securities and was held on October 1, 2024.

On October 4, 2024,

the Panel granted the Company’s request for continued listing on the Nasdaq, subject to the requirement that on or before February 17,

2025, the Company shall demonstrate compliance with Listing Rule 5505, and that during the exception period, the Company shall provide

prompt notification of any significant events that occur during this time that may affect the Company’s compliance with Nasdaq requirements.

On March 7, 2025, the Hearings Advisor from the Nasdaq Office of General Counsel sent a letter noting that on February 13, 2025, the Company

had completed its Business Combination and finding that “[t]he post transaction entity demonstrated compliance with the requirements

for initial listing under Listing Rule 5505 and the securities of OSRH began trading on the Nasdaq Capital Market February 18, 2025.

[a]ccordingly, the Panel has determined to continue the listing of the Company’s securities on The Nasdaq Stock Market LLC and is closing

this matter.” However, this is no guaranty that the Company will be able to maintain compliance with Nasdaq continued listing standards

going forward.

We anticipate that the Company will qualify as an “emerging

growth company” as well as a “smaller reporting company” within the meaning of the Securities Act, and if the Company

takes advantage of certain exemptions from disclosure requirements available to emerging growth companies, this could make its securities

less attractive to investors and may make it more difficult to compare its performance with other public companies.

We anticipate the Company will qualify as an “emerging growth

company” within the meaning of Section 2(a)(19) of the Securities Act, as modified by the JOBS Act.

As such, the Company

may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not

emerging growth companies for as long as it continues to be an emerging growth company, including, but not limited to, (i) not being

required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, (ii) reduced disclosure

obligations regarding executive compensation in our periodic reports and proxy statements and (iii) exemptions from the requirements

of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously

As a result, the Company stockholders may not have access to certain information they may deem important.

the Company would

remain an emerging growth company until the earliest of (i) the last day of the fiscal year in which the market value of the

Company Common Stock that is held by non-affiliates exceeds $700,000,000 as of the end of that year’s second fiscal quarter,

(ii) the last day of the fiscal year in which the Company has total annual gross revenue of $1,235,000,000 or more during such

fiscal year (as indexed for inflation), (iii) the date on which the Company has issued more than $1,000,000,000 in non-convertible debt

in the prior three-year period or (iv) the last day of the fiscal year following the fifth anniversary of the date of the

first sale of the Company Common Stock, as defined by the JOBS Act.

Investors may find the Company’ securities less attractive because

it may rely on these exemptions.

If some investors find the Company’ securities less attractive as a result of its reliance on these

exemptions, the trading prices of its securities may be lower than they otherwise would be, there may be a less active trading 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

reporting company” as defined in Item 10(f)(1) of Regulation S-K promulgated by the SEC.

Smaller reporting

companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years

of audited financial statements.

the Company will remain a smaller reporting company for so long as the market value of its common stock

held by non-affiliates is less than $250,000,000 measured on the last business day of its second fiscal quarter, or its annual

revenue is less than $100,000,000 during the most recently completed fiscal year and the market value of its common stock held by non-affiliates is

less than $700,000,000 measured on the last business day of its second fiscal quarter.

To the extent the Company takes advantage

of such reduced disclosure obligations, it may also make comparison of its financial statements with other public companies difficult

or impossible.

The Company may redeem unexpired public warrants after they become

exercisable and prior to their exercise at a time that is disadvantageous to the holders, thereby making your public warrants worthless.

The Company has the ability to redeem outstanding public warrants at

any time after they become exercisable and prior to their expiration, at a price of $0.01 per warrant, provided that the last reported

sales price of the Company Common Stock equals or exceeds $16.50 per share for any 20 trading days within a 30-trading day period

ending on the third trading day prior to the date the Company give notice of redemption.

The Company will not redeem the warrants

as described above unless a registration statement under the Securities Act covering the shares of the common stock issuable upon exercise

of such warrants is effective and a current prospectus relating to shares of the common stock is available throughout the 30-day redemption

If and when the public warrants become redeemable by the Company, it may exercise its redemption right even if it is unable to

Redemption of the outstanding public

warrants could force the holders (i) to exercise their public warrants and pay the exercise price therefor at a time when it may

be disadvantageous for them to do so, (ii) to sell their public warrants at then-current market price when you might otherwise

wish to hold your public warrants or (iii) to accept the nominal redemption price which, at the time the outstanding public warrants

are called for redemption, is likely to be substantially less than the market value of their public warrants.

The value received upon

exercise of the public warrants (1) may be less than the value the holders would have received if they had exercised their public

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

The fair value of 6,900,000 public warrants as of April 11, 2025 is $243,922.

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

are not transferable, assignable or salable until after the completion of a Business Combination, subject to certain limited exceptions,

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

permitted transferees.

In the event the Company determines to redeem the warrants, holders

of our redeemable warrants would be notified of such redemption as described in the Warrant Agreement.

Specifically, in the event that

the Company elects to redeem all of the redeemable warrants as described above, the Company will fix a date for the redemption (the “Redemption

Notice of redemption will be mailed by first class mail, postage prepaid, by the Company not less than 30 days prior

to the Redemption Date to the registered holders of the redeemable warrants to be redeemed at their last addresses as they appear on

the registration books.

Any notice mailed in the manner provided in the Warrant Agreement will be conclusively presumed to have been

duly given whether or not the registered holder received such notice.

Accordingly, if a holder fails to actually receive the notice of

or otherwise 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

$16.50 per share for any of the 30 trading days prior to the date of this proxy statement/prospectus.

Risks Related to the Company Business and Operations

The following risk factors reference the risks and uncertainties

relating to the business and operations of OSR, which, following the closing of the Business Combination, are the business and operations

of the Company.

References in this section to “we,” “us,” and “our” refer to OSR prior to the closing

of the Business Combination and to the Company after closing.

The Company’s limited operating history, the early stage

of its development programs and the inherent uncertainties and risks involved in pharmaceutical product development may make it difficult

for it to execute on its business model.

We are a global drug development company with a limited operating history

upon which you can evaluate our business and prospects.

Our operations to date have been limited to organizing and staffing our company,

business planning, raising capital, acquiring our portfolio companies, establishing our intellectual property portfolio and performing

research and development in support of our product candidates.

We have no pharmaceutical product candidates approved for commercial sale

and our product candidates have not generated any revenue.

Our approach to the discovery and development of product candidates from early

stage to drug launch is unproven, and we do not know whether we will be able to develop any products of commercial value.

few clinical stage candidates in our portfolio, most of our other candidates are in the preclinical stages of development and will require

additional preclinical studies and future clinical development as well as regulatory review and approval, which may not be granted.

we are still in preclinical and clinical development, we would need to receive regulatory approvals, gain access to sufficient commercial

manufacturing capacity and implement marketing efforts before we could begin generating revenue from product sales or arrange for a third

party to do so on our behalf.

The Company will likely incur significant operating losses for

the foreseeable future and may never achieve or maintain profitability.

We have never generated any operating profits and incurred operating

losses of KRW 784.7 million and KRW 14.8 billion for years ending 2022 and 2023, respectively, and operating

loss of KRW 15.9 billion for the year ending December 31, 2024.

We have an accumulated deficit of KRW 28.18 billion as

of December 31, 2024.

We are likely to continue to incur operating losses in the future.

While our RMC subsidiary generated revenues of

KRW 4.38 billion and KRW 4.81 billion in the years ending December 31, 2023 and 2024, respectively, none of our other subsidiaries

have generated any revenues from product sales because none of their current product candidates have received marketing or other required

regulatory approvals anywhere in the world.

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

that we advance into clinical trials and ultimately commercial distribution, which will require managing complex scientific, regulatory,

management, sales, licensing and other issues.

Our ability to execute on our business model and generate revenues

depends on a number of factors including our ability to:

● successfully develop new product candidates through our drug

development strategy and advance those product candidates into pre-clinical studies and clinical trials;

● 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;

● add operational, financial and management information systems

and personnel, including personnel to support clinical, pre-clinical manufacturing and planned future commercialization efforts

and operations;

● 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.

If we cannot successfully execute any one of the foregoing, our business

may not succeed and the price of our common shares and warrants may be negatively impacted.

If one or more of our product candidates encounters safety or efficacy

problems, development delays, regulatory issues or other problems, our development plans and business could be significantly harmed.

we can generate any revenue from sales of any of our product candidates, we must undergo additional preclinical and clinical development,

regulatory review and approval in one or more jurisdictions.

In addition, if one or more of our product candidates are approved, we must

ensure access to sufficient commercial manufacturing capacity and conduct significant marketing efforts in connection with any commercial

These efforts will require substantial investment, and we may not have the financial resources to continue development of our

product candidates.

Drug development is a highly speculative business requiring substantial

investments that may not ever generate operating cash flow.

Investment in drug development is highly speculative because it entails

substantial upfront capital and operating expenditures and significant risk that any potential product candidate will fail to demonstrate

adequate efficacy or an acceptable safety profile, gain regulatory approval and become commercially viable.

In addition, as a business

with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown

factors and risks frequently experienced by early-stage drug development companies in rapidly evolving fields.

Our product candidates will require substantial development time — including

extensive clinical, and in many cases pre-clinical, research and development — and resources before we would

be able to apply for or receive applicable regulatory approvals and begin generating revenue from product sales.

Because of the numerous

risks and uncertainties associated with drug development, we are unable to predict precisely the timing or amount of increased expenses,

or when we will be able to generate any meaningful revenue or achieve or maintain profitability, if ever.

If we obtain regulatory approval for any of our product candidates,

we still may never achieve profitability.

If we do successfully obtain regulatory approval to market product

candidates, our revenue will be dependent upon, in part and among other things, the size of the markets in the geographic areas for which

we gain regulatory approval, the number of competitors in such markets, the accepted price for product candidates and whether we own the

commercial rights for those territories.

If the indication approved by regulatory authorities is narrower than expected, or the treatment

population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of

our product candidates, even if approved (especially for products receiving orphan drug designations).

We cannot assure you that we will

be profitable even if we successfully commercialize our product candidates.

Even if a product candidate we develop receives regulatory approval,

it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical

community necessary for commercial success.

Even if a product candidate we own or develop receives regulatory approval,

it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, such as Medicare and Medicaid

programs and managed care organizations, and others in the medical community.

In addition, the availability of coverage by third-party payors

may be affected by existing and future health care reform measures designed to reduce the cost of health care.

If the product candidates

we develop do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable.

The degree of market acceptance of any product candidate, if approved

for commercial sale, will depend on a number of factors, including:

● the efficacy and potential advantages compared to alternative

● the ability to offer our products, if approved, for sale at

competitive prices;

● the convenience and ease of administration compared to alternative

● the willingness of the target patient population to try new

therapies and of physicians to prescribe these therapies;

● the price we pay or any of our future collaborators charge for

our products;

● 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;

● the ability to obtain sufficient third-party coverage and

adequate reimbursement;

● the prevalence and severity of any side effects;

● the size and effectiveness of our sales, marketing and distribution

If government and other third-party payors do not provide coverage

and adequate reimbursement levels for any products we commercialize, market acceptance and commercial success would be reduced.

Coverage and reimbursement may be limited or unavailable for

our product candidates, if approved, which could make it difficult for us to sell any product candidates profitably.

Significant uncertainty exists as to the insurance coverage and reimbursement

status of any products for which we may obtain regulatory approval.

In the United States, sales of any products for which we may

receive regulatory approval will depend, in part, on the availability of coverage and reimbursement from third-party payors.

Third-party payors

include government authorities such as Medicare, Medicaid, TRICARE, and the Veterans Administration, managed care providers, private health

insurers, and other organizations.

Patients who are provided medical treatment for their conditions generally rely on third-party payors

to reimburse all or part of the costs associated with their treatment.

Coverage and adequate reimbursement from governmental healthcare

programs, such as Medicare and Medicaid, and commercial payors are critical to new product acceptance.

Patients are unlikely to use our

product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost.

sure that coverage and reimbursement will be available for, or accurately estimate the potential revenue from, our product candidates

or assure that coverage and reimbursement will be available for any product that we may develop.

Government authorities and other third-party payors decide which

drugs and treatments they will cover and the amount of reimbursement.

Coverage and reimbursement by a third-party payor may depend

upon a number of factors, including the third-party payor’s determination that use of a product is:

● a covered benefit under its health plan;

● safe, effective and medically necessary;

● appropriate for the specific patient;

● cost-effective;

● neither experimental nor investigational.

In the United States, no uniform policy of coverage and reimbursement

for products exists among third-party payors.

As a result, obtaining coverage and reimbursement approval of a product from a government

or other third-party payor is a time-consuming and costly process that could require us to provide to each payor supporting

scientific, clinical and cost-effectiveness data for the use of our products, with no assurance that coverage and adequate reimbursement

will be obtained.

Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for

us to achieve or sustain profitability or may require co-payments that patients find unacceptably high.

Additionally, third-party payors

may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of product

candidates, once approved.

It is difficult to predict what third-party payors will decide with respect to the coverage and reimbursement

for our product candidates, if approved.

Additionally, our ability to obtain and maintain coverage for our products

by certain government health care programs may depend on our participation in certain government pricing programs, such as the Medicaid

Drug Rebate Program and the 340B program.

These programs often include complex reporting and payment obligations, which are subject to

frequent change.

If we fail to provide timely and accurate information under these programs or comply with any rebate or discount pricing

requirements, we may have reimbursement obligations or be subject to penalties or other sanctions.

Changes to currently applicable laws and state and federal healthcare

reform measures that may be adopted in the future may result in additional reductions in Medicare and other healthcare funding and otherwise

affect the prices we may obtain for any product candidates for which we may obtain regulatory approval or the frequency with which any

such product candidate is prescribed or used.

Because we have multiple programs and product candidates under

development and are pursuing a variety of target indications and treatment modalities, we may expend our limited resources to pursue a

particular product candidate and fail to capitalize on development opportunities or product candidates that may be more profitable or

for which there is a greater likelihood of success.

We have two subsidiaries and expect to have multiple subsidiaries with

their own drug development plans, all of which will compete for financial resources to advance their development and commercialization.

Due to our constrained financial and personnel resources, we will likely be unable to fund all of those opportunities.

For example, under

our current budget, our development plans focus on Darnatein’s DRT 101 drug candidate but not DRT 102.

As a result, we may need

to postpone or cancel the pursuit of potential target conditions or product candidates that may later prove to have higher commercial

potential compared to those we actually fund.

Our investments in ongoing and upcoming research and development programs

might not yield any commercially viable candidates in the future.

In addition, we may fail to accurately assess the commercial potential

or target market for a particular product candidate leading us to relinquish valuable rights to that candidate through collaborations,

licensing, or royalty arrangements, even when it would have been more advantageous for us to retain exclusive development and commercialization

We plan to license or acquire early or development-stage technologies

or programs, which introduces additional risks for our company.

Identifying, selecting, and acquiring product candidates demands significant

technical, financial, and human resources expertise.

These efforts may not lead to the acquisition or licensing of a viable product candidate,

potentially resulting in the diversion of our management’s time and the expenditure of resources without any resulting tangible

If we struggle to identify programs that eventually result in successful commercial products, we could spend substantial amounts

of our capital and resources on evaluating, acquiring, and developing products that ultimately do not generate returns on our investments.

We may not be successful in our efforts to build a robust pipeline

of product candidates with commercial value.

A key element of our strategy is to acquire companies, programs, product

candidates, technologies or intellectual property that we believe are novel, employ differentiated mechanisms of action, are more advanced

in development than competitors, or have a combination of these attributes.

In addition, we plan to seek strategic alliances, create joint

ventures or collaborations, or enter into licensing arrangements with third parties.

We face significant competition in these opportunities,

and the negotiation process is time-consuming and complex.

We may not be successful in our efforts in building a robust pipeline

of product candidates through acquisitions, licensing or through internal development or in progressing these product candidates through

clinical development.

Although we analyze whether we can replicate scientific results observed

prior to our acquisition or investment in a product candidate, we may not be successful in doing so after our investment.

Even if we are

successful in building our pipeline of product candidates, the potential product candidates that we identify may not be suitable for clinical

development or generate acceptable clinical data, including as a result of unacceptable toxicity or other characteristics that indicate

that they are unlikely to receive approval from the U.S.

Food and Drug Administration (“ FDA ”) or other regulatory

authorities or achieve market acceptance.

If we do not successfully develop and commercialize product candidates, we will not be able

to generate product revenue in the future, which likely would result in significant harm to our financial position and adversely affect

our stock price.

The market opportunities for our product candidates may vary

widely as we intend to develop product candidates to address unmet diseases, with some product candidates having smaller target markets,

and our estimates of the prevalence of our target patient populations may be inaccurate.

We have acquired, and seek to create or acquire, companies or select

intellectual property with the potential as breakthrough designations for unmet diseases, including rare or orphan diseases.

believe our efforts can result in commercial success, if our estimates of the target patient populations are too optimistic, if the target

patient population is relatively small, or if our drug candidates do not address the entire target patient population of a rare disease

for example, such drug candidates may not generate significant product revenue and could adversely affect our financial position and our

Our subsidiaries may become a party to certain agreements that

provide our licensors, collaborators or other stockholders in our subsidiaries with rights that could delay or impact the potential sale

of our subsidiaries or could impact the ability of our subsidiaries to sell assets, or enter into strategic alliances, collaborations

or licensing arrangements with other third parties.

Our subsidiaries may directly or indirectly license intellectual property

from third parties and may be partially or majority owned by third party investors.

These third parties may have certain rights that could

delay collaboration, licensing or other arrangements with another third party, and the existence of these rights may adversely impact

the ability to attract an acquirer or partner.

We may form additional subsidiaries and enter into similar agreements

with future partners or investors, or our subsidiaries may enter into further agreements, that in each case may contain similar provisions

or other terms that are not favorable to us.

Although we currently own 100% of our subsidiaries (i.e., there

are no third-party, minority investors), we may, in the future, acquire companies that have minority shareholders or we may make

investments where we are a minority shareholder.

Where we are the majority shareholder, we will have certain duties to minority shareholders,

which may limit our ability to integrate operations with our other subsidiaries.

If we make an investment as a minority investor, we are

unlikely to exert much, if any, control over the business and we may be limited in our ability to realize value from those investments.

We currently own wholly-owned subsidiaries, and plan to be the

majority owner of future subsidiaries.

In the event that we acquire a majority ownership interest or make an investment in another company,

or if any of our subsidiaries require additional capital and such additional capital is obtained from third party investors rather than

from us, we may be (or may become) a minority shareholder and unable to control the business and operations of those companies.

If the companies in which we are a minority shareholder conduct their

business in a manner detrimental to our interests, business, or reputation, our returns may be adversely affected.

Companies in which

we are a minority shareholder may not consult us on business decisions and could take actions without our consent, which could have an

adverse impact on our returns.

If we acquire less than all of the ownership interests in a subsidiary

or if we reduce our interest in a wholly-owned subsidiary, our resulting majority ownership will create additional risks because

we must be sure that any contracts between such subsidiaries and our company or any of our other subsidiaries are conducted on an “arms-length”

As a result, we will be unable to manage majority-owned subsidiaries in the same fashion as our wholly-owned subsidiaries

(where contracts with affiliates need not be on an arms-length basis).

These constraints may require management to incur time and

resources to determine “arms-length” provisions of contracts with majority-owned subsidiaries.

Minority shareholders

of majority-owned subsidiaries may, after the fact, claim breach of fiduciary duties with respect to contracts that they assert are

not “arms-length” or not fair to the minority shareholders.

These types of claims may result in judgments or settlements that

require us or our subsidiaries to pay damages to the minority shareholders.

A single or limited number of portfolio companies may comprise

a large proportion of our value.

A large proportion of our value may, at any time, reside in one or

two of our subsidiaries, including intellectual property rights and the value ascribed to the product candidate or program that it is

Our consolidated financial condition and prospects may be materially diminished if the clinical development or potential commercialization

prospects of a subsidiary’s product candidate or program or one or more of the intellectual property rights held by a specific subsidiary

becomes impaired.

Furthermore, a large proportion of our consolidated revenue may at any time be derived from one, or a small number of,

licensed technologies, and termination or expiration of licenses to these technologies would likely have a material adverse effect on

our consolidated revenue.

Any material adverse impact on the value of a particular subsidiary, including its intellectual property rights

or the clinical development of its product candidate or program, could have a material adverse effect on our consolidated business, financial

condition, results of operations or prospects.

The business of our subsidiary that is a distributor of medical

products is subject to other risks, including risks related to its customer concentration, its holding inventory that may decline in value,

foreign exchange rate fluctuations, its dependency on sales agency agreements and the risks relating to economic conditions and government

regulation of the healthcare industry in Korea.

Our Korean subsidiary, RMC, is a distributor of medical products currently

serving only the Korea market.

Three customers of RMC have in recent years represented approximately 95% of RMC’s total sales.

This customer concentration creates risks for RMC (and OSR) in the event that one or more of those customers terminates its distribution

agreement with RMC, one of which occurred on November 20, 2024, when Penumbra Inc.

and RMC terminated negotiations for a new (or

extended) distribution agreement.

Sales of Penumbra’s reperfusion catheter, neuron delivery catheter and related tubing and canister

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,

2023 and 2024, respectively.

While RMC may continue to sell its existing inventory of Penumbra products (Penumbra will not repurchase

RMC’s inventory), RMC may be unable to sell its inventory or to sell it without discounting the prices.

If RMC is unable to sell

its inventory and is required by accounting rules to write off the inventory, RMC may incur losses.

Since RMC is OSR’s only revenue

producing subsidiary, with the termination of RMC’s distribution agreement with Penumbra, OSR expects its revenue to decrease substantially

in 2025 and possibly longer, until RMC can replace sales of Penumbra’s products by increasing sales of products from other manufacturers.

While RMC intends to replace sales of Penumbra products by becoming the sales representative of other neuro-intervention medical

device equipment manufacturers, as well as expanding sales of products offered by companies it currently represents, such efforts may

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

minimum purchases of products, which if not sold may decline in value and require RMC to write-down the value under accounting standards.

In addition, failure to meet sales goals may result in termination of RMC’s contracts with medical product manufacturers.

sales are currently exclusively to hospitals, hospital networks and physicians across Korea, so that its business is highly dependent

upon economic conditions and government regulation of the healthcare industry in Korea.

Our principal assets are our interests in our various subsidiaries,

and accordingly, we will depend on distributions and dividends from our subsidiaries to make additional cash investments, pay taxes and

cover our corporate and other overhead expenses.

We are a holding company and have no material assets other than our

ownership interests in our subsidiaries.

We are dependent on our subsidiaries for generating revenue or cash flow and have no other means

of generating revenue or operating cash flow.

In the future, we may be limited, however, in our ability to cause our subsidiaries to make

dividend payments or other distributions to us due to restrictions contained in any credit agreement to which our subsidiaries are bound.

To the extent that we need funds and our subsidiaries are restricted from making dividend payments or other distributions under applicable

law or regulation or under the terms of their financing arrangements or are otherwise unable to provide such funds, our liquidity and

financial condition could be adversely affected.

The Company has identified material weaknesses in its internal

control over financial reporting, which could adversely affect its ability to report its financial condition and results of operations

accurately and on a timely basis.

Management has concluded that the Company’s internal control over financial reporting

was not effective as of December 31, 2024, due to the identification of material weaknesses.

These include (i) improper use of Trust

Account funds for general operating expenses in violation of the Trust Agreement, (ii) failure to obtain timely Audit Committee approval

for related party transactions, (iii) inadequate documentation of related party financing transactions, and (iv) insufficient personnel

in the accounting and financial reporting functions.

These weaknesses could result in material misstatements not being prevented or detected

in a timely manner.

Although the Company has taken certain remedial actions, there can be no assurance that the material weaknesses will

be fully remediated or that additional material weaknesses will not be identified in the future.

Risks Related to the Company’s Strategy to Grow the Business

The following risk factors reference the risks and uncertainties

relating to the growth strategy of OSR, which, following the closing of the Business Combination, relate to the growth strategy of the

Company going forward.

References in this section to “we,” “us,” and “our” refer to OSR prior to the

closing of the Business Combination and to the Company after closing.

We may not be successful in our efforts to acquire, in-license or

discover and develop new product candidates.

The success of our business is highly dependent on our ability to successfully

identify new product candidates, whether through acquisitions or in-licensing transactions, or through our internal capabilities.

Our acquisition and in-licensing efforts focus on identifying assets in development by third parties across a diverse range

of therapeutic areas.

Our strategy often entails designing optimal, efficient studies that result in quick “go/no-go” decisions

when deciding whether or how to proceed with future development for a given asset.

We may decide to proceed with the development of a

drug candidate on this basis and later determine that the more costly and time intensive trials do not support the initial value the product

was thought to hold.

Even if a product candidate does prove to be valuable, its value may be less than anticipated at the time of initial

We may also face competition for attractive investment opportunities.

A number of entities compete with us for such opportunities,

many of which have considerably greater financial and technical resources.

If we are unable to identify a sufficient number of such product

candidates, or if the product candidates that we identify do not prove to be as valuable as anticipated, we will not be able to generate

returns and implement our investment strategy and our business and results of operations may suffer materially.

We currently have no marketing and sales organization for pharmaceutical

products and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these

capabilities.

If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and

sell our pharmaceutical products, we may not be able to generate pharmaceutical product revenue.

We have no internal sales, marketing or distribution capabilities for

pharmaceutical products (one subsidiary markets and sells medical products and devices), nor have we commercialized a product.

of our pharmaceutical product candidates ultimately receive regulatory approval, we expect to establish either an internal or external

pharmaceutical marketing and sales organization with technical expertise and supporting distribution capabilities to commercialize each

such product in applicable major markets, which will be expensive and, to the extent we establish such an organization in-house, time

We have no prior experience as a company in the marketing, sale and distribution of pharmaceutical products and there are significant

risks involved in establishing or managing a sales organization, including our ability to hire, retain and incentivize qualified individuals,

generate sufficient sales leads, provide adequate training to sales and marketing personnel and effectively manage a geographically dispersed

sales and marketing team.

Any failure or delay in the development of our internal or external pharmaceutical sales, marketing and distribution

capabilities would adversely impact the commercialization of these products.

If we choose to collaborate with third parties that have

direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of

our own sales force and distribution systems, we may not be able to enter into collaborations or hire consultants or external service

providers to assist us in pharmaceutical product sales, marketing and distribution functions on acceptable financial terms, or at all.

In addition, our pharmaceutical product revenues and our profitability, if any, may be lower if we rely on third parties for these functions

than if we were to market, sell and distribute any pharmaceutical products that we develop ourselves.

We likely will have little control

over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our pharmaceutical

products effectively.

If we are not successful in commercializing our pharmaceutical products, either on our own or through arrangements

with one or more third parties, we may not be able to generate any future pharmaceutical product revenue and we would incur significant

additional losses.

Our investment strategy and future growth relies on a number

of assumptions, some or all which may not be realized.

Our strategy for investment and plans for future expansion are founded

upon a range of assumptions.

These assumptions, particularly for our pharmaceutical product candidates, include considerations related

to the adoption of a specific therapy, the price at which the product candidate might be sold (or reimbursed by third party payors), the

occurrence of a particular medical condition, the preference for our product candidate over competing therapies, and the size of patient

Some or all of these assumptions might prove to be inaccurate because our ability to predict whether our product candidates

will attain significant market acceptance or if a market for our product candidates will indeed materialize as anticipated, is inherently

If any of these assumptions turn out to be incorrect or overly optimistic, it could have a substantial and adverse impact on

our results and future prospects.

Our future success depends on our ability to retain key employees,

directors, consultants and advisors and to attract, retain and motivate qualified personnel.

We heavily depend on the expertise of our executive officers, directors,

and scientific teams for their expertise in areas such as management, research and development, drug development, finance, and business

development, both for the Company and our subsidiaries and investments.

Their departure could adversely impact our research, development,

and our licensing pursuits, and impede the execution of our business strategy.

We do not carry “key person” insurance for

our executives or staff so that replacing them might be challenging due to our inability to pay premium salaries or signing bonuses, together

with the scarcity of individuals with the required breadth of skills and experience in our industry.

We might struggle to attract, train,

retain, or motivate them given the numerous competing pharmaceutical and biotechnology companies.

Our reliance on a central team consisting of a limited number

of employees who provide various administrative, research and development and other services to all our subsidiaries presents operational

challenges that may adversely affect our business.

As of December 31, 2024, we had 19 full-time employees and

two part-time employees whom we rely on for drug development planning, employee relations, financing accounting matters and other

support services for our company and all of its subsidiaries.

These individuals may not have sufficient time and bandwidth to perform

effectively their respective responsibilities, potentially hindering the achievement of our goals and jeopardizing the execution of our

business strategy.

While our current structure helps us minimize certain overhead expenses, the relatively small size of our central team

limits our ability to allocate enough personnel, time, and resources to effectively manage our subsidiaries and investments creation of

effective drug development plans, employee recruitment and retention, and overseeing financial and accounting matters.

Members of our

central team may lack sufficient information about various aspects of our subsidiaries’ business and operations to adequately address

these responsibilities.

We will need to expand our organization, and we may experience

difficulties in managing this growth, which could disrupt our operations.

We anticipate expanding our roster of full-time employees, which

will require significant management time and attention to hire qualified employees, which will divert a disproportionate amount of attention

away from our daily operations and dedicate significant time to overseeing these growth initiatives.

We will face challenges in effectively

managing the expansion of our operations, which could lead to operational errors, missed business prospects, employee attrition, and decreased

productivity among those who remain.

Anticipated growth could necessitate substantial capital investments and potentially divert financial

resources from other projects, including the advancement of additional product candidates.

If our management team struggles to manage

our growth effectively, it could lead to higher-than-expected expenses, curtailed revenue generation and growth capabilities, and

potential obstacles in executing our business strategy.

The success of our future financial performance and our ability to effectively

bring product candidates to market and maintain competitiveness will hinge, in part, on our capacity to adeptly manage any forthcoming

Risks Related to the Company’s Requirements for Additional

The following risk factors reference the risks and uncertainties

relating to additional capital requirements of OSR, which, following the closing of the Business Combination, will be the additional capital

requirements of the Company.

References in this section to “we,” “us,” and “our” refer to OSR prior

to the closing of the Business Combination and to the Company after closing.

We will require substantial additional capital to finance our

If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate

one or more of our research and drug development programs, future commercialization efforts and/or other operations.

Developing pharmaceutical products, including conducting preclinical

studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years.

OSR’s operations,

through its subsidiaries, have consumed substantial amounts of cash since inception.

We currently do not have sufficient committed sources

of additional capital to fund our current development plans.

We expect our expenses to increase in connection with our ongoing activities,

particularly as we advance our preclinical and clinical development programs, seek regulatory approvals for our product candidates, and

launch and commercialize any products for which we receive regulatory approval.

We also expect to incur additional costs associated with

operating as a public company.

Accordingly, we will need to obtain substantial additional funding in order to implement our current development

plans or expand them.

If we are unable to raise capital when needed or on acceptable terms, we may be forced to delay, reduce or eliminate

one or more of our research and drug development programs or future commercialization efforts.

Based on our current operating plan, and in part due to the cancellation

of our previously anticipated PIPE Investment, following the closing of our Business Combination there still remains some doubt as to

our ability to fund our operating expenses and capital expenditure going forward, and, as noted by our auditor, our ability to survive

as a going concern.

A more detailed discussion of this agreement is included in Part II, Item 7, “ Management’s Discussion

and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources .” Despite the fact that

we appear to have obtained alternative financing under our ELOC Agreement, our actual capital requirements may also vary significantly

from what we expect, and we will in any event require additional capital in order to complete clinical development of any of our current

Our monthly spending levels will vary based on new and ongoing development and corporate activities.

Because the length of time

and necessary activities associated with the development of our product candidates are highly uncertain, we are unable to estimate the

actual funds we will require for development, marketing and commercialization activities.

Our future funding requirements, both near and

long-term, will depend on many factors, including, but not limited to:

● 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;

● the clinical development plans we establish for these product

● the timelines of our clinical trials and the overall costs to

finish the clinical trials;

● the number and characteristics of product candidates that we

● the outcome, timing and cost of meeting regulatory requirements

established by the FDA, European Medicines Agency and other comparable foreign regulatory authorities;

● the cost of filing, prosecuting, defending and enforcing our

patent claims and other intellectual property rights;

● the cost of defending intellectual property disputes, including

patent infringement actions brought by third parties against us or our product candidates;

● 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;

● the cost and timing of completion of commercial-scale outsourced

manufacturing activities;

● 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

Until we can generate sufficient revenue to finance our cash requirements,

which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings,

collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements.

This additional funding

may not be sufficient for us to fund any of our products through regulatory approval.

To the extent that we raise additional capital through the sale of

common stock or securities convertible or exchangeable into common stock, your ownership interest will be diluted.

In addition, any debt

financing may subject us to fixed payment obligations and covenants limiting or restricting our ability to take specific actions, such

as incurring additional debt, making capital expenditures or declaring dividends.

If we raise additional capital through marketing and

distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish

certain valuable intellectual property or other rights to our product candidates, technologies, future revenue streams or research programs

or grant licenses on terms that may not be favorable to us.

We also may be required to seek collaborators for any of our product candidates

at an earlier stage than otherwise would be desirable or relinquish our rights to product candidates or technologies that we otherwise

would seek to develop or commercialize ourselves.

Market volatility and unforeseen events, such as the COVID-19 pandemic and the

conflict between Russia and Ukraine or in the Middle East, could also adversely impact our ability to access capital as and when needed.

If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale

back or discontinue the development or commercialization of one or more of our product candidates or one or more of our other research

and development initiatives.

Any of the above events could significantly harm our business, prospects, financial condition and results

of operations and cause the price of our common stock to decline.

We may be unable to obtain additional financing to adequately

capitalize the Company following the Business Combination or to fund the operations and growth of OSR and its subsidiaries, which could

adversely affect the future prospects of the Company.

We do not expect to have substantial proceeds from the Company’s

IPO in which to provide capital to the Company and fund its growth following the Business Combination.

In part because the PIPE Investment

was not consummated (a more detailed discussion of this agreement is included in Part II, Item 7, “ Management’s Discussion

and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources ”) we will be required

to seek additional financing to provide such operating capital.

We cannot assure you that such financing will be available on acceptable

terms, if at all.

We may require such financing to fund the operations or growth of the Company.

The failure to secure additional financing

could have a material adverse effect on the continued development or growth of the Company.

None of the Company’s Sponsor, officers,

directors or their affiliates is required to provide any financing to us in connection with or after the Business Combination.

elect to do so, their additional contributions of capital to the Company may require them to first sell a portion of their founders shares

or other Company common stock holdings in qualified insider transactions, which may impact the market price levels of Company common stock.

We will require additional capital to fund our operations, and

if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our product candidates.

We expect to spend substantial capital to complete the development

of, seek regulatory approvals for and commercialize our pharmaceutical product candidates.

We are unable to estimate the actual funds

we will require to execute on our strategy because the length of time and activities associated with successful development of our pharmaceutical

product candidates is highly uncertain, and due to the inherent challenges and uncertainties associated with the development of novel

healthcare technologies.

The additional capital that we need to fund our operations may

not be available at all, or on terms that allow us to continue operations or provide any hope of generating future profits.

We cannot be certain that additional capital will be available on acceptable

terms, or at all.

If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly

delay, scale back or discontinue the development or commercialization of any product candidate, delay the launch or expansion of a given

product or potentially discontinue our operations altogether.

In addition, attempting to secure additional capital may divert the time

and attention of our management from day-to-day activities and harm our business.

Because of the numerous risks and uncertainties

associated with our business, we are unable to estimate the amounts of increased capital outlays, operating expenditures and capital requirements

associated with our current product development programs and technology products.

Our future cash flows from operations are unlikely to satisfy

our capital needs so that 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.

Until such time, if ever, that we can generate substantial operating

revenues, we expect to continue to finance our cash needs through a combination of equity offerings, debt financings, strategic alliances

and license and development agreements or other collaborations.

To the extent that we raise additional capital by issuing equity securities

at the parent or subsidiary level, our existing stockholders’ ownership, or our ownership in our subsidiaries, may experience substantial

dilution, and the terms of these securities may include liquidation or other preferences that could harm the rights of our stockholders.

Additionally, any agreements for future debt or preferred equity financings, if available, may involve covenants limiting or restricting

our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties,

we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or technologies, or grant

licenses on terms that may not be favorable to us.

The foregoing restrictions associated with potential sources of additional capital

may make it more difficult for us to raise additional capital or to pursue business opportunities, including potential acquisitions.

we are unable to obtain adequate financing or financing on terms satisfactory to us, if and when we require it, our ability to grow or

support our business and to respond to business challenges could be significantly limited.

If we enter into acquisitions or strategic partnerships, this

may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us

to other risks.

We may engage in various acquisitions and strategic partnerships in

the future, including licensing or acquiring new product candidates, intellectual property rights, technologies or businesses.

Any acquisition

or strategic partnership may entail numerous risks, including:

● increased operating expenses and cash requirements;

● the assumption of indebtedness or contingent liabilities;

● the issuance of our or our subsidiaries’ equity securities

which would result in dilution to our stockholders;

● assimilation of operations, intellectual property, products

and product candidates of an acquired company, including difficulties associated with integrating new personnel;

● the diversion of our management’s attention from our existing

product programs and initiatives in pursuing such an acquisition or strategic partnership;

● retention of key employees, the loss of key personnel and uncertainties

in our ability to maintain key business relationships;

● 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

● 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

to continue as a going concern, which could prevent the Company from executing its business plan and adversely affect its financial condition

and stock price.

The Company has incurred recurring operating losses and negative cash

flows since its inception and expects to continue to do so for the foreseeable future.

The Company will need to raise additional capital

through equity or debt financings, collaborations, or other sources, and there is no assurance that such capital will be available on

favorable terms or at all.

Failure to raise sufficient capital as and when needed would significantly impair the Company’s ability

to operate its business and could result in a reduction of workforce, suspension or termination of programs, or even bankruptcy.

result, substantial doubt exists about the Company’s ability to continue as a going concern.

Risks Related to the Company’s Management of the Business

and Operations

The following risk factors reference the risks and uncertainties

relating to the management of the business and operations of OSR, which, following the closing of the Business Combination, will be the

management of the business and operations of the Company.

References in this section to “we,” “us,” and “our”

refer to OSR prior to the closing of the Business Combination and to the Company after closing.

We will 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

As a public company, we will incur significant legal, accounting and

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

growth company, as defined in Section 2(a) of the Securities Act.

We are subject to the reporting requirements of the Exchange Act

which require, among other things, that we file with the SEC annual, quarterly and current reports with respect to our business and financial

In addition, the Sarbanes-Oxley Act, as well as rules subsequently adopted by the SEC and Nasdaq to implement provisions

of the Sarbanes-Oxley Act, impose significant requirements on public companies, including requiring establishment and maintenance

of effective disclosure and financial reporting controls and changes in corporate governance practices.

Further, in July 2010, the

Dodd-Frank Wall Street Reform and Consumer Protection Act, or the Dodd-Frank Act, was enacted.

There are significant corporate

governance and executive compensation related provisions in the Dodd-Frank Act that require the SEC to adopt additional rules and

regulations in these areas such as “say on pay” and proxy access.

EGCs are permitted to implement many of these requirements

over a longer period.

Stockholder activism, government intervention and regulatory reform may lead to substantial new regulations and

disclosure obligations, which may lead to additional compliance costs and impact the manner in which we operate our business in ways we

cannot currently anticipate.

We expect the rules and regulations applicable to public companies

to substantially increase our legal and financial compliance costs and to make some activities more time-consuming and costly.

these requirements divert the attention of our management and personnel from other business concerns, they could have an adverse effect

on our business.

The increased costs will decrease our net income, if any, and/or increase our net loss, and may require us to reduce

costs in other areas of our business or increase the prices of our products or services.

We cannot predict or estimate the amount or timing

of additional costs we may incur to respond to these requirements.

The impact of these requirements could also make it more difficult

for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers.

The Company’s management team has limited experience managing

and operating a U.S.

public company.

Members of the Company’s management team have limited experience

managing and operating a U.S.

publicly traded company, interacting with U.S.

public company investors, and complying with the

increasingly complex laws pertaining to U.S.

public companies.

public company, the Company will be subject to significant

regulatory oversight and reporting obligations under the U.S.

federal securities laws and the continuous scrutiny of securities analysts

and investors.

These new obligations and constituents will require significant attention from its senior management and could divert their

attention away from the day-to-day management of its business.

the Company may not have adequate personnel with the appropriate

level of knowledge, experience, and training in the accounting policies, practices or internal controls over financial reporting required

public companies.

The development and implementation of the standards and controls necessary for the Company to achieve the

level of accounting standards required of a public company may require costs greater than expected.

To support its operations as a U.S.

company, the Company plans to recruit additional qualified employees or external consultants with relevant experience, which will increase

its operating costs in future periods.

Our ability to successfully operate the business following the

Business Combination will depend largely upon the efforts of certain key personnel, including the key personnel of OSR and its subsidiaries,

all of whom we expect to remain employed (or retained as consultants) with the Company or its subsidiaries following the Business Combination.

The loss of such key personnel could adversely affect the operations and profitability of the Company’ business.

Our ability to recognize certain benefits of the Business Combination

and successfully operate the Company’s business following the Business Combination will depend upon the efforts of its key personnel.

Although we expect all of such key personnel to remain with the Company following the Business Combination, the unexpected loss of key

personnel may adversely affect its operations and profitability.

In addition, the Company’s future success depends in part on its

ability to identify and retain key personnel to succeed senior management.

Furthermore, while we have closely scrutinized the skills,

abilities and qualifications of the key OSR’ or its subsidiaries’ personnel that will be employed by the Company, our assessment

may not prove to be correct.

If such personnel do not possess the skills, qualifications or abilities we expect or those necessary to

manage a public company, the operations and profitability of the Company’s business may be negatively impacted.

Claims for indemnification by our directors and officers may

reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available

The Amended Bylaws provide that we will indemnify our directors and

officers, in each case to the fullest extent permitted by Delaware law.

In addition, as permitted by Section 145 of the DGCL, the

Amended Bylaws and the indemnification agreements that we will enter into with our directors and officers provide that:

● 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.

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;

● we may, in our discretion, indemnify employees and agents in

those circumstances where indemnification is permitted by applicable law;

● 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;

● 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;

● 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

recent experience with COVID-19, could adversely impact our business, including our preclinical studies and clinical trials.

In December 2019, a novel strain of the coronavirus disease, COVID-19,

was identified in Wuhan, China.

The virus spread globally and government measures taken in response had a significant impact, both direct

and indirect, on businesses and commerce, resulting in worker shortages, disruption of supply chains, and closure of offices, laboratories,

and production facilities.

Demand for certain goods and services, such as medical services and supplies, spiked, while demand for other

goods and services, such as travel, fell dramatically.

If a new disease began to spread, we may experience disruptions that could severely

impact our business, including:

● interruptions in preclinical studies due to restricted or limited

operations at our laboratory facilities or at facilities of our collaborators;

● 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;

● 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;

● interruption or delays to outsourced research and discovery

and clinical activities;

● delays in receiving authorizations from regulatory authorities

to initiate our planned clinical trials;

● 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;

● 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

● 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;

● 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

future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of any

disease, the duration of any pandemic, travel restrictions and social distancing in the United States and other countries, business

closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat

Shareholder litigation and regulatory inquiries and investigations

are expensive and could harm the Company’s business, financial condition and operating results and could divert management attention.

Since securities class action litigation and/or stockholder derivative

litigation and inquiries or investigations by regulatory authorities often follows significant business transactions, such as the sale

of a company or announcement of any other strategic transaction, such as the Business Combination, we may become subject to those types

of lawsuits or investigations.

Shareholder activism, which could take many forms or arise in a variety of situations, has been increasing

Any stockholder litigation, stockholder activism, including potential proxy contests, and/or regulatory investigations against

the Company, whether or not resolved in the Company’s favor, could result in substantial costs and divert the Company’s management’s

attention from other business concerns, which could adversely affect the Company’s business and cash resources and the ultimate

value the Company’s shareholders receive as a result of the Business Combination.

We may be the target of securities class action and derivative

lawsuits which could result in substantial costs.

Our share price may be volatile and, in the past, companies that have

experienced volatility in the market price of their stock have been subject to securities litigation, including class action litigation.

We may be the target of this type of litigation in the future.

Even if the lawsuits are without merit, defending against these claims

can result in substantial costs and divert management time and resources.

An adverse judgment could result in monetary damages, which

could have a negative impact on our liquidity and financial condition.

We cannot predict whether any such lawsuits will be filed.

The outcome of any future claims and litigation could have a

material adverse impact on our business, financial condition and results of operations.

We may, from time to time, be subject to claims and may become party

to litigation in the normal course of business, including class action lawsuits.

Such claims and litigation proceedings may be brought

by third parties, including our customers, competitors, advisors, service providers, partners or collaborators, employees, and governmental

or regulatory bodies.

The final outcome of these claims and litigation, including any settlements, may be significant and may differ substantially

from our expectations.

We may not be able to determine the amount of any potential losses and other costs we may incur due to the inherent

uncertainties of litigation and settlement negotiations.

In the event we are required or decide to pay amounts in connection with any

claims or lawsuits, such amounts could be significant and could have a material adverse impact on our liquidity, business, financial condition

and results of operations.

In March of 2025 Company Management became aware of a civil action filed against the Company by Benjamin Securities,

in Supreme Court, New York County, seeking $500,000.00 in brokerage fees and costs the plaintiff alleges are due and owing.

Our internal computer systems, or those used by our third-party research

institution collaborators, CROs or other contractors or consultants, may fail or suffer security breaches.

Despite having security measures in place, both our internal computer

systems and those of our future CROs, contractors, collaborators and consultants could be susceptible to potential damage, disruption

or failure as a result of hardware malfunctions, power outages, natural disasters, computer viruses, cyber-attacks, employee theft or

misuse and other unauthorized access.

While we don’t believe we have experienced any significant system failures or security breaches

to date, the occurrence of such an event could lead to substantial disruptions in our development programs and overall business operations

and subject us to governmental sanctions and private causes of action.

For instance, the loss of clinical trial data, whether from completed,

ongoing, or future trials, could lead to delays in our efforts to gain regulatory approval and result in substantial costs to recover

or reproduce the lost data.

We could be held liable for monetary damages resulting from

security 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

information, especially personal identifying information or personal health data.

Specific data breaches may necessitate reporting to

affected individuals, governmental bodies, and, in some instances, the media, under regulations like the Health Insurance Portability

and Accountability Act (“ HIPAA ”) and other U.S.

federal and state laws, as well as requirements from non-U.S.

jurisdictions.

Our existing insurance policies might not be sufficient to cover potential losses stemming from breaches, system failures, catastrophic

events, or other forms of disruption to our infrastructure.

Additionally, there’s a possibility that such insurance may not be available

to us in the future on economically viable terms, or at all.

Furthermore, our insurance might not cover all claims brought against us,

and the process of defending a lawsuit, regardless of its merit, could be both expensive and divert management’s focus.

We or the third parties upon whom we depend on may be adversely

affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Our operating subsidiaries are located in South Korea and Switzerland.

South Korea is subject to various natural disaster risks, including flooding, storms and typhoons, primarily during the summer season,

and to a more infrequent extent, earthquakes.

Switzerland, due to its topography, is particularly vulnerable to natural disasters such

Natural disasters could cause significant disruptions to the operations of our subsidiaries, which could seriously impact

our business, financial condition, results of operations, and future prospects.

Our ability to sustain our business operations might be

challenging, and in some cases, impossible for a considerable duration.

Our current disaster recovery and business continuity plans have

limitations and might not be sufficient to address a severe disaster or similar occurrence effectively.

We might incur substantial expenses

due to the inherent limitations of our disaster recovery and business continuity plans.

The combination of these limitations along with

our lack of earthquake insurance could lead to a significant adverse impact on our business.

Tensions with North Korea could have an adverse effect on our

business, financial condition, and results of operations, and the price per share of our common stock.

Relations between South Korea and North Korea have fluctuated over

Tension between South Korea and North Korea may increase or change abruptly as a result of current and future events.

In particular, there have been heightened security concerns in recent years stemming from North Korea’s nuclear weapon and

ballistic missile programs as well as its hostile military actions against South Korea.

North Korea’s economy also faces severe challenges, which may

further aggravate social and political pressures within North Korea and affect South Korea.

Beginning in 2018, North Korea held a series

of bilateral summit meetings with South Korea and the United States to discuss peace and denuclearization of the Korean peninsula.

However, those discussions have ended and North Korea has since resumed its missile testing and bellicose statements, heightening tensions,

and increasing uncertainty.

Further tensions in North Korean relations could develop due to a leadership

crisis, breakdown in high-level inter-Korea contacts or military hostilities.

Alternatively, tensions may be resolved through

reconciliatory efforts, which may include peace talks, alleviation of sanctions or reunification.

We cannot assure that future negotiations

will even occur and, if they do, result in any lasting resolution of key issues, such as North Korea’s nuclear program, or that

the level of tensions between South Korea and North Korea will not escalate.

Any increase in the level of tension between South Korea

and North Korea, an outbreak in military hostilities or other actions or occurrences, could adversely affect our business, prospects,

financial condition, and results of operations and could lead to a decline in the price per share of our common stock.

Except with respect to RMC, our Korean subsidiary engaged in

the sale and distribution of medical products in Korea, we do not expect to carry any business interruption insurance or any other insurance

(except for director and officer liability insurance).

As a result, we may incur uninsured losses, increasing the possibility that you

would lose your entire investment in the Company.

Our pharmaceutical products may expose us to product liability or

other product claim risks.

We currently do not have product liability or other insurance for such claims and may not be able to obtain

such insurance on acceptable terms or that any insurance we do obtain will be sufficient to protect us against potential claims or that

insurance will be available in the future in amounts sufficient to protect us.

A product liability claim or other claim, as well as any

claims for uninsured liabilities or in excess of insured liabilities, could have a material adverse effect on our business, financial

condition, results of operations and prospects.

Our relationships with healthcare providers and physicians and third-party payors

will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to

criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

The contracts and other arrangements that pharmaceutical manufacturers

have with third-party payors, health care providers and customers create risk that the pharmaceutical manufacturers may violate broadly

applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute

(“ AKS ”) and the federal False Claims Act (“ FCA ”).

Those laws and regulations may constrain the business

or financial arrangements and relationships through which pharmaceutical manufactures sell, market and distribute pharmaceutical products.

In particular, the research of our product candidates, as well as the promotion, sales and marketing of healthcare items and services,

as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks,

self-dealing and other abusive practices.

If we do not strictly comply with these laws and regulations, we may be found to be criminally

or civilly liable for violations under those laws and regulations, including a false or fraudulent claim, which could subject us (and,

potentially, our employees) from significant fines and penalties, including prison.

The scope and enforcement of each of these laws may be uncertain and

subject to rapid change in the current environment of healthcare reform.

Ensuring business arrangements comply with applicable healthcare

laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert

a company’s attention from the business.

If we are not successful in defending ourselves or asserting our rights,

governmental or other actions could have a significant impact on our business, including the imposition of significant civil, criminal

and administrative penalties, damages, fines, disgorgement, imprisonment, reputational harm, possible exclusion from participation in

federal and state funded healthcare programs, contractual damages and the curtailment or restricting of our operations, as well as additional

reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations

of non-compliance with these laws.

Any action for violation of these laws, even if successfully defended, could cause a pharmaceutical

manufacturer to incur significant legal expenses and divert management’s attention from the operation of the business.

or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way.

Even if we receive regulatory approval of any product candidates,

we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense

and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product

If any of our product candidates are approved, they will be subject

to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping,

conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal

and state requirements in the United States and requirements of comparable foreign regulatory authorities, all of which will require

us to incur significant costs and expenses.

In addition, we will be subject to continued compliance with the Current Good Manufacturing

Practices (“ cGMP ”) and Good Clinical Practices (“ GCP ”) requirements for any clinical trials that

we conduct post-approval.

If we do not comply with regulatory requirements and applicable standards

or if problems occur after a product reaches the market, the FDA or European Medicines Agency may impose consent decrees or withdraw approval.

Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency,

or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in,

among other things:

● restrictions on the marketing or manufacturing of our products,

withdrawal of the product from the market or voluntary or mandatory product recalls;

● manufacturing delays and supply disruptions where regulatory

inspections identify observations of noncompliance requiring remediation;

● revisions to the labeling, including limitation on approved

uses or the requirement of additional warnings, contraindications or other safety information, including boxed warnings;

● imposition of a Risk Evaluation and Mitigation Strategy (“ REMS ”),

which may include distribution or use restrictions;

● requirements to conduct additional post-market clinical

trials to assess the safety of the product;

● fines, warning letters or holds on clinical trials;

● refusal by the FDA to approve pending applications or supplements

to approved applications filed by us or suspension or revocation of license approvals;

● 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.

The FDA’s, European Medicines Agency’s and other regulatory

authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory

approval of our product candidates.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future

legislation or administrative action, either in the United States or abroad.

If we are slow or unable to adapt to changes in existing

requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any

marketing approval that we may have obtained and we may not achieve or sustain profitability.

The FDA, European Medicines Agency and other regulatory agencies

actively enforce the laws and regulations prohibiting the promotion of off-label uses.

The FDA, European Medicines Agency and other regulatory agencies strictly

regulate the post-approval marketing, labeling, advertising, and promotion of products that are placed on the market.

The FDA, European

Medicines Agency and other regulatory agencies impose stringent restrictions on sponsors’ communications regarding off-label use.

Products may be promoted only for the approved indications and in accordance with the provisions of the approved label.

However, companies

may share truthful and not misleading information that is not inconsistent with the labeling.

The FDA, European Medicines Agency and other

agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses and a company that is found to have

improperly promoted off-label uses may be subject to significant liability.

The federal government has levied large civil and criminal

fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion.

Violation of the Federal Food, Drug, and Cosmetic Act and other statutes, including the FCA, and equivalent legislation in other countries

relating to the promotion and advertising of prescription products may also lead to investigations or allegations of violations of federal

and state and other countries’ health care fraud and abuse laws and state consumer protection laws.

Even if it is later determined

we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions and

have to divert significant management resources from other matters.

If we cannot successfully manage the promotion of our product candidates,

if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

The Affordable Care Act and the Inflation Reduction Act, as well

as other ongoing healthcare legislative and regulatory reform measures, may have a material adverse effect on our business and results

of operations.

Congress and regulatory agencies in the United States (and to

a lesser extent, state legislatures) have in recent years proposed and sometimes adopted substantial changes in laws and regulations

that affect the healthcare and pharmaceutical industry.

These laws, including what is known as the Affordable Care Act (the “ ACA ”),

and the IRA, have substantially changed the way health care is financed by both governmental and private insurers, and significantly impacted

biopharmaceutical industry, including permitting the Centers for Medicare and Medicaid Services (the “ CMS ”),

for the first time, to negotiate prices with pharmaceutical companies for selected drugs.

Many legislative and regulatory proposals have sought to reduce drug

prices, increase competition, lower out-of-pocket drug costs for patients, and increase patient access to lower-cost generic

and biosimilar drugs.

These legislature and regulatory changes may significantly adversely impact our business and profitability.

The IRA was passed on August 16, 2022 and, among other things,

allows for CMS to negotiate prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D,

beginning with ten high-cost drugs paid for by Medicare Part D starting in 2026, followed by up to 15 Part D drugs in

2027, up to 15 Part B or Part D drugs in 2028, and up to 20 Part B or Part D drugs in 2029 and beyond.

The legislation

subjects drug manufacturers to civil monetary penalties and a potential excise tax for failing to comply with the legislation by offering

a price that is not equal to or less than the negotiated “maximum fair price” under the law or for taking price increases

that exceed inflation.

The legislation also caps Medicare beneficiaries’ annual out-of-pocket drug expenses at $2,000.

effect of the IRA on our business and the healthcare industry in general is not yet known.

We cannot predict how CMS will interpret the

IRA or how the provisions of the law will affect our business once fully implemented.

At the state level, legislatures are increasingly passing legislation

and implementing regulations designed to control pharmaceutical and biologic product pricing, including price or patient reimbursement

constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, requirements for

substitution of generic products, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

These laws, and future state and federal healthcare reform measures

that may be adopted in the future, could adversely affect the prices we may obtain for any of our product candidates or the frequency

with which any such product candidate is prescribed or used.

We expect to experience pricing pressures in connection with the sale of

any future approved product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations,

cost containment initiatives and additional legislative changes, all of which may adversely affect our business and future profits.

If the Company’s officers and directors serve as directors

or officers of majority-owned subsidiaries, those individuals will have fiduciary and other duties to those subsidiaries and

their minority stockholders, potentially causing conflicts of interest between their duties to the Company and their duties to those subsidiaries.

Certain of our directors or officers, including Mr.

also directors and/or officers of one or more of our subsidiaries and, if those subsidiaries were to become majority-owned subsidiaries

(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

(including future subsidiaries).

The conflicts of interest that arise from such duties could interfere with the management of those subsidiaries

and their programs and product candidates, or result in disagreements with our majority-owned subsidiaries’ other stockholders.

For example, an individual who is both our director and a director of one of our subsidiaries, owes fiduciary duties to the subsidiary

and to us, and such individual may encounter circumstances in which his or her decision or action may benefit the subsidiary while having

a detrimental impact on us, or vice versa, or on another subsidiary.

Further, our officers and directors who are also officers and directors

of any majority-owned subsidiaries will need to allocate his or her time to responsibilities owed to us and each of the subsidiaries

for which he or she serves as an officer or director, and will make decisions on behalf of one entity that may negatively impact others.

In addition, disputes could arise between us and our subsidiaries’ other directors, officers and stockholders regarding a conflict

Those stockholders also may disagree with the amount and quality of resources that we devote to the subsidiary in which they

are invested.

Any such disputes or disagreements could lead to claims, and potential damages, of breach of fiduciary duties, and distract

our management, interfere with our relations with those stockholders, and take significant time to resolve.

Those issues could disrupt

the development of our product candidates, delay our potential commercialization efforts, result in increased costs or make it less likely

that other third parties will choose to partner with us in the future.

Our employees, independent contractors, consultants, and partners

may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We face the potential risk of encountering fraudulent activities, misconduct,

or other unlawful behaviors involving our employees, independent contractors, consultants, commercial partners, and vendors.

This misconduct

could encompass intentional, reckless, or negligent actions that result in failure to:

adhere to the regulations of the FDA or similar

foreign regulatory bodies;

provide accurate and complete information to the FDA and equivalent foreign regulatory authorities;

to the manufacturing standards we have established;

comply with healthcare fraud and abuse laws in the United States and similar

fraudulent misconduct laws in other countries;

adhere to applicable privacy and data security laws in the United States and in other

or accurately report financial information or disclose unauthorized activities.

Risks Related to International Operations of the Company’s

The following risk factors reference the risks and uncertainties

relating to the international operations of OSR, which, following the closing of the Business Combination, will be the international operations

of the Company.

References in this section to “we,” “us,” and “our” refer to OSR prior to the closing

of the Business Combination and to the Company after closing.

If political and economic conditions in South Korea deteriorate,

our current business and future growth could be materially and adversely affected.

OSR is headquartered in the Republic of Korea (“ Korea ”)

and significant operations and assets are located in Korea.

There is currently a high level of political unrest occurring in Korea.

a result, we are subject to political, economic, legal and regulatory risks specific to Korea, and our performance and successful fulfilment

of our operational strategies are dependent in part on the overall Korean economy.

The economic indicators in Korea in recent years

have shown mixed signs of growth and uncertainty, and the current political environment in Korea is expected to continue to result in

an erosion of the currency exchange rate between the Korean Won and the U.S.

As a result, future growth of the Korean economy

is subject to many factors beyond our control, including developments in the global economy.

The Korean economy is closely tied to, and is affected by developments

in, the global economy.

In recent years, adverse conditions and volatility in the worldwide financial markets, fluctuations in oil

and commodity prices, and the COVID-19 pandemic, have contributed to the uncertainty of global economic prospects in general

and have adversely affected, and may continue to adversely affect, the Korean economy.

Due to liquidity and credit concerns and volatility

in the global financial markets, the value of the Korean Won relative to the U.S.

dollar and other foreign currencies and the stock

prices of Korean companies have fluctuated significantly in recent years.

Further declines in the Korea Composite Stock Price Index,

and large amounts of sales of Korean securities by foreign investors and subsequent repatriation of the proceeds of such sales may adversely

affect the value of the Korean Won, the foreign currency reserves held by financial institutions in Korea, and the ability of Korean companies

to raise capital.

Any future deterioration of the Korean economy or the global economy could adversely affect our business, financial

condition, and results of operations.

Fluctuations in exchange rates could result in foreign currency

exchange losses to us.

The value of the Korean Won and other currencies against the U.S.

has fluctuated, and may continue to fluctuate and is affected by, among other things, changes in political and economic conditions.

late 2024, there has been an increased level of political unrest in Korea, including the impeachment and arrest of the Korean President

and the exchange rate between the Korean Won and the U.

dollar has been adversely affected.

It is difficult to predict how market forces

or Korean or U.S.

government policy, including interest rate changes by the U.S.

Federal Reserve, may impact the exchange rate between

the Korean Won and the U.S.

dollar in the future.

A substantial percentage of our revenue and costs are denominated in

Korean Won, and a significant portion of our financial assets are also denominated in Korean Won, while we anticipate that a substantial

portion of any debt incurred will be denominated in U.S.

We are a holding company and we may receive dividends, loans and

other distributions on equity paid by our operating subsidiaries in Korea.

Any significant fluctuations in the value of the Korean Won

may materially and adversely affect our liquidity and cash flows.

For example, the depreciation of the Korean Won and other foreign currencies

against the U.S.

dollar typically results in a material increase in the cost of hosting services and equipment purchased from outside

of Korea and the cost of servicing debt denominated in currencies other than the Korean Won.

As a result, any significant depreciation

of the Korean Won or other major foreign currencies against the U.S.

dollar may have a material adverse effect on our results of

If we decide to convert our Korean Won into U.S.

dollars for the purpose of repaying principal or interest expense on

any future U.S.

dollar-denominated debt, making payments for dividends on our common stock, or other business purposes, depreciation

of the Korean Won or other foreign currencies against the U.S.

dollar would have a negative effect on the U.S.

dollar amount

we would receive.

Conversely, to the extent that we need to convert U.S.

dollars into Korean Won for our operations, appreciation

of the Korean Won against the U.S.

dollar would have an adverse effect on the Korean Won amount we would receive.

There are special risks involved with investing in Korean companies,

including the possibility of restrictions being imposed by the Korean government in emergency circumstances, accounting and corporate

disclosure standards that differ from those in other jurisdictions, and the risk of direct or vicarious criminal liability for executive

officers of our Korean affiliates.

OSR is a Korean company and operates in a business and cultural environment

that is different from that of other countries.

For example, under the Foreign Exchange Transaction Act of Korea, if the Korean

government determines that in certain emergency circumstances, including sudden fluctuations in interest rates or exchange rates, extreme

difficulty in stabilizing the balance of payments or substantial disturbance in the Korean financial and capital markets are likely to

occur, it may impose any necessary restriction such as requiring Korean or foreign investors to obtain prior approval from the Minister

of Economy and Finance of Korea prior to entering into a capital markets transaction, repatriating interest, dividends or sales proceeds

arising from Korean securities or from the disposition of such securities or other transactions involving foreign exchange.

Although investors

will hold shares of the Company Common Stock, its majority owned subsidiary, OSR, may experience adverse risks and in turn could adversely

impact the Company’s business, prospects, financial condition, and results of operations and could lead to a decline in the price

per share of its common stock.

In addition, under Korean law, there are circumstances in which certain

executive officers of a company may be investigated or held criminally liable either directly or vicariously for the actions of the company

and its executives and employees.

For example, complaints alleging infringement of intellectual property rights, breaches of certain

Korean laws ( e.g.

, labor standards laws and fair trade laws), and product-related claims may be investigated and prosecuted

as criminal offenses with both the company and the company’s executive officers being named as defendants in such proceedings.

As a result of these current and changing risks, OSR’ executive

officers may be named in the future in criminal investigations or proceedings stemming from its operations.

In Korea, company executive

officers being named in such investigations or proceedings are a common occurrence, even though in practice many such cases result in

no liability to the individual.

If OSR’ 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,

and results of operations may be harmed.

OSR is subject to certain requirements and restrictions under

Korean law that may, in certain circumstances, require it to act in a manner that may not be in the Company’s or its stockholders’ best

Under applicable Korean law, directors of a Korean company, such as

OSR, owe a fiduciary duty to the company itself rather than to its stockholders.

This fiduciary duty obligates directors of a Korean company

to perform their duties faithfully for the good of the company as a whole.

In addition, while the facts and circumstances of each case

will differ, the duty of care required of a director under Korean law may not be the same as the fiduciary duty of a director of a U.S.

Although the “business judgment rule” concept exists in Korea, there is insufficient case law or precedent to provide guidance

to the management and stockholders as to how it should be applied or interpreted.

As a result, if circumstances arise in which the best

interests of OSR conflicts 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.

Approval by the board of directors of a Korean company is required

for, among other things, all transactions between a director or major stockholder (including a 10% or more stockholder) and the company

for the director’s or the major stockholder’s account.

As a result, intercompany transactions between the Company and OSR

(or any other Korean subsidiary we may own, from time to time), could arise in the future in which the directors of the Korean subsidiary

are not able to act in the Company or its stockholders’ best interest as a result of competing interests of the subsidiary.

substantially all of our operations are conducted by OSR, any such occurrence with respect to OSR could adversely affect our business,

financial condition, and results of operations.

OSR’ transactions with related parties are subject to close

scrutiny by the Korean tax authorities, which may result in adverse tax consequences.

Under Korean tax law, there is an inherent risk that OSR’ transactions

with its subsidiaries, affiliates or any other person or company that is related to us may be challenged by the Korean tax authorities

if such transactions are viewed as having been made on terms that were not on an arm’s-length basis.

If the Korean tax authorities

determine that any of its transactions with related parties were on other than arm’s-length terms, it may not be permitted

to deduct as expenses, or may be required to include as taxable income, any amount which is found to be undue financial support between

related parties in such transaction, which may have adverse tax consequences for us and, in turn, may adversely affect our business, financial

condition, and results of operations.

If we are deemed to have a “place of effective

management” in Korea, we will be treated as a Korean company for the purpose of Korean corporate income tax with regards to

our worldwide income.

Under Korean law, a corporation having a “place of effective

management” in Korea will be subject to Korean corporate income tax.

The “place of effective management” is determined

on a case-by-case basis, taking into account factors such as the place where meetings of the board of directors are usually held,

the place where the key executives usually perform their duties, the place where the day-to-day management of senior managers

is carried out, and the place where accounting documents are routinely recorded and kept, etc.

Because many of our directors and executive officers are located in

Korea, it is possible that the Company will have a “place of effective management” in Korea.

Additionally, the Company and

certain of its subsidiaries will have physical business offices in Korea, where several of our key executive officers will conduct business.

Further, our board of directors includes several Korean citizens who will make significant decisions regarding our business, including

decisions regarding capital raising and acquisitions.

Additional reasons the Korean tax authorities may conclude that we

have a “place of effective management” in Korea include that (i) Mr.

Kuk Hyoun Hwang, OSR’ Chairman of the

Board of Directors, is a Korean national, and Mr.

Hwang spends most of the year working in Korea and will continue to do so after

(ii) most of the members of the board of directors of our largest subsidiary, OSR, are Korean;

and (iii) after

the Closing, important documents, including the accounting documents of our domestic business, may be maintained and controlled in Korea.

If we are deemed to have a “place of effective management” in Korea, we will be required to file annual corporate income tax

returns with the Korean tax authorities and be subject to Korean corporate income tax.

Currently, the applicable rates are 11% (inclusive

of local corporate taxes) for taxable income up to 200 million Korean Won, 22% (inclusive of local corporate taxes) for taxable income

exceeding 200 million Korean Won and less than 20 billion Korean Won, 24.2% (inclusive of local corporate taxes) for taxable

income greater than 20 billion won and less than 300 billion Korean Won, and 27.5% (inclusive of local corporate tax) for taxable

income greater than 300 billion Korean Won.

Taxable income would include any worldwide income, such as dividends we receive from

our Korean operating company and any interest income earned outside of Korea.

If we are required to pay Korean corporate income tax, it

may reduce our cash flow and negatively impact the returns to investors.

If we are deemed to have a “permanent establishment” in

Korea, we will be subject to Korean corporate income tax with regards to any Korean source income attributable to or effectively connected

with such permanent establishment.

Under Korean law, where a foreign corporation has a fixed place for

the operation of all or part of its domestic business, the foreign corporation shall be deemed to have a “permanent establishment”

In addition, even if a foreign corporation does not have a physical fixed place of business in Korea, it is deemed to have a

“permanent establishment” in Korea if it operates the business in Korea through persons (the “Dependent Agent(s)”)

who are authorized to conclude business contracts under the name of the foreign corporation.

According to the Supreme Court of Korea, in order for a foreign corporation

to be considered to have a physical “permanent establishment” in Korea, the foreign corporation must have a fixed place of

business, such as a building or facility in Korea that the foreign corporation has the right to dispose of or use, and the employees or

persons under its direction must carry out essential and important business activities, rather than preliminary or auxiliary business

In addition, in order for a foreign corporation to be deemed to have a “permanent establishment” in Korea through

a Dependent Agent, the agent must exercise the right to enter into contracts in the name of the foreign corporation on a regular basis

in Korea, and the authority must be essential and important to the business activities, rather than preliminary or auxiliary.

We do not expect that we are likely to be deemed as having a “permanent

establishment” in Korea, because we do not have a principal office, branch office or any other form of business office in Korea,

nor do we have any physical fixed place of business in Korea that we have the right to dispose of or use.

Further, our essential and important

business activities, including the acquisition of companies, are made in the United States through the decisions of our board and

we have not authorized any person or entity to make decisions regarding whether or not to enter into a business acquisition agreement

However, we cannot rule out, on a conservative basis, the possibility

that we may be deemed to have a “permanent establishment” in Korea after the Closing given that (i) Mr.

Chairman of the Board of OSR, is a Korean national and will continue to perform his duties primarily in Korea and (ii) most of the

members of the board of directors of OSR who will be performing substantial functions in connection with our business after the Closing

If we are deemed to have a “permanent establishment” as defined under Korean tax law, we would be required to

file annual corporate income tax returns with the Korean tax office and be subject to Korean corporate income tax.

The applicable rates

are 9% (inclusive of local corporate taxes) for taxable income up to 200 million Korean Won, 19% (inclusive of local corporate taxes)

for taxable income exceeding 200 million Korean Won and less than 20 billion Korean Won, 21% (inclusive of local corporate taxes)

for taxable income greater than 20 billion won and less than 300 billion Korean Won, and 24% (inclusive of local corporate tax)

for taxable income greater than 300 billion Korean Won.

Taxable income includes any Korean source income attributable to or effectively

connected with such permanent establishment, such as dividends we receive from our Korean operating company.

If we are required 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

or the interpretation thereof in South Korea could adversely affect our results of operations and financial condition in the future.

New tax laws and regulations, and uncertainties with respect to future

tax policies pose risks to us.

Changes in tax-related laws and regulations, and interpretations thereof, can create additional tax

burdens on us and our businesses by increasing tax rates and fees, creating new taxes, limiting tax deductions, and/or eliminating tax-based incentives

and non-taxed income.

In addition, tax authorities and competent courts may interpret tax regulations differently than us, which

could result in tax litigation and associated costs and penalties in part due to the novelty and complexity of new regulation.

A focus on regulating copyright and patent infringement by the

Korean government subjects OSR to extra scrutiny in its operations and could subject OSR to sanctions, fines, or other penalties, which

could adversely affect the Company’s business and operations in Korea.

The Korean government has recently focused on addressing copyright

and patent infringement in Korea.

Despite measures we have taken to address copyright and patent infringement, the Korean government may

subject us to sanctions, fines, or other penalties, which could adversely affect our business and operations in Korea.

We are a global organization with business operations in the

United States, Korea, Switzerland, and in other European Union countries, which makes us subject to a variety of additional risks

that may negatively impact our operations, many of which have already manifested and are likely to increase, given recent executive action

in the United States .

We and currently all of our subsidiaries and investments conduct operations

outside of the United States, so that we are subject to the special considerations or risks associated with companies operating in

the United States and in an international setting, including any of the following:

● 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;

● laws governing the manner in which future business combinations

may be effected;

● tariffs and trade barriers;

● regulations related to customs and import/export matters;

● longer payment cycles and challenges in collecting accounts

● tax issues, including but not limited to tax law changes and

variations in tax;

● currency fluctuations and exchange controls;

● rates of inflation;

● cultural and language differences;

● employment regulations;

● trade restrictions including limitations on imports or exports

of components or assembled products, unilaterally or bilaterally;

● trade sanctions and related regulatory enforcement actions and

other proceedings;

● potential trade wars;

● 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

● imposition of restrictions on currency conversion or the transfer

● expropriation of private entities;

● ineffective legal protection of our intellectual property rights

in certain countries;

● crime, strikes, riots, civil disturbances, terrorist attacks,

natural disasters and wars;

● deterioration of political relations with the United States;

● government appropriations of assets.

We may not be able to adequately address these additional risks.

we were unable to do so, our operations might suffer, which may adversely impact our results of operations and financial condition.

of the foregoing risks have already manifested, and are likely to increase in scope and impact in light of the recent public posture

and executive action of the new presidential administration in the United States .

Even if we obtain FDA approval of any of our product candidates,

we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize

their full market potential.

In order to market any products outside of the United States,

we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy.

trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country

does not mean that regulatory approval will be obtained in any other country.

Approval procedures vary among countries and can involve

additional product testing and validation and additional administrative review periods.

Seeking foreign regulatory approvals could result

in significant delays, difficulties and costs for us and may require additional preclinical studies or clinical trials which would be

costly and time-consuming.

Regulatory requirements can vary widely from country to country and could delay or prevent the introduction

of our products in those countries.

Satisfying these and other regulatory requirements is costly, time-consuming, uncertain and subject

to unanticipated delays.

In addition, our failure to obtain regulatory approval in any country may delay or have negative effects on the

process for regulatory approval in other countries.

We do not have any product candidates approved for sale in any jurisdiction, including

international markets, and we do not have experience in obtaining regulatory approval in international markets.

If we fail to comply with

regulatory requirements in international markets or to obtain and maintain required approvals, our ability to realize the full market

potential of our products will be harmed.

EU drug marketing and reimbursement regulations may materially

affect our ability to market and receive coverage for our products in the European member states.

We intend to seek approval to market our product candidates in both

the United States and in selected foreign jurisdictions, where we will become subject to rules and regulations in those jurisdictions.

In some foreign countries, particularly those in the EU, the pricing of drugs is subject to governmental control and other market regulations

which could put pressure on the pricing and usage of our product candidates.

In these countries, pricing negotiations with governmental

authorities can take considerable time after obtaining marketing approval of a product candidate.

In addition, market acceptance and sales

of our product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party payors

for our product candidates and may be affected by existing and future health care reform measures.

There can be no assurance that any

country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing

arrangements for any of our products.

The EU and other companies have adopted legislation or regulations

that, much like the U.S.

AKS, restricts the provision of benefits or advantages to physicians to induce or encourage the prescription,

recommendation, endorsement, purchase, supply, order or use of medicinal products.

Violations of these laws could result in substantial

fines and imprisonment.

Failure to comply with these requirements could also result in reputational risk, public reprimands, administrative

penalties, fines or imprisonment.

We may incur substantial costs in our efforts to comply with

evolving global data protection laws and regulations, and any failure or perceived failure by us to comply with such laws and regulations

may harm our business and operations.

The global data protection landscape is rapidly evolving, and we may

be or become subject to or affected by numerous federal, state and foreign laws and regulations, as well as regulatory guidance, governing

the collection, use, disclosure, transfer, security and processing of personal data, such as information that we collect about participants

and healthcare providers (including information relating to their representatives) in connection with clinical trials.

Processing of personal

data, including health related information, is increasingly subject to legislation and regulations in numerous jurisdictions around the

world, including General Data Protection Regulation (“ GDPR ”) and each of the California Consumer Privacy Act of 2018

and HIPAA in the United States, among many others.

The application and enforcement of data protection laws and regulations

may create uncertainty in our business, affect our or our service providers’ ability to operate in certain jurisdictions or to collect,

store, transfer use and share personal data, result in liability or impose additional compliance or other costs on us.

Any failure or

perceived failure by us to comply with federal, state, or foreign laws or self-regulatory standards could result in negative publicity,

diversion of management time and effort and proceedings against us by governmental entities or others, including potential significant

We expect the data protection laws will increase our compliance costs and potential liability.

Additional laws and regulations governing international operations

could negatively impact or restrict our operations.

We must dedicate additional resources to comply with numerous laws

and regulations in each jurisdiction in which we plan to operate.

Foreign Corrupt Practices Act (“ FCPA ”)

prohibits any U.S.

individual or business entity from paying, offering, authorizing payment or offering of anything of value, directly

or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign

entity in order to assist the individual or business in obtaining or retaining business.

The FCPA also obligates companies whose securities

are listed in the United States to comply with certain accounting provisions requiring the company to maintain books and records

that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain

an adequate system of internal accounting controls for international operations.

Compliance with the FCPA is expensive and difficult, particularly in

countries in which corruption is a recognized problem.

In addition, the FCPA presents particular challenges in the pharmaceutical industry,

because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign

Certain payments to hospitals and healthcare providers in connection with clinical trials and other work have been deemed to

be improper payments to government officials and have led to FCPA enforcement actions.

Apart from the FCPA, we are subject to various other anti-bribery and

anti-money laundering laws in the countries in which we conduct activities.

Anti-corruption and anti-bribery laws have

been enforced aggressively in recent years and broadly prohibit companies, their employees and third-party intermediaries to

authorize, offer or provide, directly or indirectly, improper payments or benefits to recipients in the public or private sector.

increase our international sales and business, we may engage with business partners and third-party intermediaries to market our

products and to obtain necessary permits, licenses, and other regulatory approvals.

In addition, we or our third-party intermediaries

may have direct or indirect interactions with officials and employees of government agencies or state-owned or -affiliated entities.

We could be held liable for the corrupt or other illegal activities of these third-party intermediaries, our employees, representatives,

contractors, partners, and agents, even if we do not explicitly authorize such activities.

Various laws, regulations and executive orders also restrict the use

and dissemination outside of the United States, or the sharing with certain non-U.S.

nationals, of information products classified

for national security purposes, as well as certain products, technology and technical data relating to those products.

If we expand our

presence outside of the United States, it will require us to dedicate additional resources to comply with these laws, and these laws

may preclude us from developing, manufacturing, or selling certain products and product candidates outside of the United States,

which could limit our growth potential and increase our development costs.

The failure to comply with laws governing international business practices

may result in substantial civil and criminal penalties and suspension or debarment from government contracting.

The SEC also may suspend

or bar issuers from trading securities on U.S.

exchanges for violations of the FCPA’s accounting provisions.

Risks Related to the Development of the Company’s Product

The following risk factors reference the risks and uncertainties

relating to the development of product candidates by OSR, which, following the closing of the Business Combination, will be the development of

product candidates by the Company.

References in this section to “we,” “us,” and “our” refer to OSR

prior to the closing of the Business Combination and to the Company after closing.

Our business includes subsidiaries that are developing oral immunotherapies

for the treatment of cancer and design-augmented biologics.

These companies have a limited operating history, and their programs

are in early stages of development.

This may make it difficult to evaluate our prospects and likelihood of success.

Our business includes subsidiaries that are (i) developing oral

immunotherapies for the treatment of cancer, and (ii) developing design-augmented biologics for age-related and other degenerative

Each of these subsidiaries is an early-stage company with a limited operating history, has no pharmaceutical products approved

for commercial sale and has not generated any revenue from sales of its products.

Our approach to the discovery and development of any

therapeutic product candidates is unproven, and we do not know whether we will be able to develop any products of commercial value.

product candidates will require substantial additional development and clinical research time and resources before we would be able to

apply for or receive regulatory approvals and begin generating revenue from product sales.

We do not yet have substantial experience progressing

therapeutic product candidates through clinical trials.

We may be unable to demonstrate safety and efficacy in clinical trials, obtain

regulatory approval, manufacture at a commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing

activities necessary for successful product commercialization of any of our product candidates.

We have not yet demonstrated the ability to progress any therapeutic

product candidate through clinical trials to regulatory approval.

Our oral immunotherapy candidates and design-augmented biologics

are still in early-stage development and may not be able to obtain regulatory approval.

Neither OSR nor any of its subsidiaries have

(1) manufactured any product on a commercial scale, (2) contracted with a third party to produce any product on a commercial

scale (we have contracted with a third party for limited quantities of our products necessary for testing and clinical trials), or (3) conducted

sales and marketing activities for approved therapeutic products (RMC does conduct sales and marketing activities for medical devices

designed and manufactured by third parties).

Investment in drug development is highly speculative because it entails

substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy

or an acceptable safety profile, gain regulatory approval and become commercially viable.

In addition, as a business with a limited operating

history, we may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors and risks frequently

experienced by early-stage companies in rapidly evolving fields.

Consequently, we have no meaningful history of drug development

operations experience upon which to evaluate our drug development business, and predictions about its future success or viability may

not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing therapeutic

Our product candidates will, of necessity, be subjected to pre-clinical and

clinical trials prior to commercialization.

Delays in those trials, or if the results of the trials raise regulatory issues, may adversely

impact our results of operations and financial condition.

We may experience setbacks that could delay or prevent regulatory approval

of, or our ability to commercialize, our product candidates, including:

● timely completion of our preclinical studies and clinical trials;

● 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;

● 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;

● 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;

● 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;

● inadequate supply or quality of product candidates or other

materials necessary for the conduct of our clinical trials;

● greater than anticipated clinical trial costs;

● inability to compete with other therapies;

● poor efficacy of our product candidates during clinical trials;

● unfavorable FDA or other regulatory agency inspection and review

of a clinical trial site;

● 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;

● delays related to the impact of recessions, man-made and/or

natural disasters, pandemics, and/or any other such events;

● 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;

● varying interpretations of data by the FDA and similar foreign

regulatory agencies.

We do not have complete control over many of these factors, including

certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and

our manufacturing, marketing, distribution and sales efforts or that of any future collaborator.

We may incur additional costs or experience delays in completing,

or ultimately be unable to complete, the development of any of our product candidates, which may adversely impact our results of operations

and financial condition.

We may experience delays in initiating or completing clinical trials.

Clinical trials can be delayed or terminated for a variety of reasons, including:

● 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

● 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;

● 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;

● 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;

● 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;

● we may need to address any safety concerns that arise during

the course of a clinical trial;

● 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;

● the cost of clinical trials of our product candidates may be

greater than we anticipate;

● logistical issues relating to any future clinical trials we

● 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;

● 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;

● 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;

● 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

terminated by us, by the IRBs or ethics committees of the institutions in which such clinical trials are being conducted, or by the FDA

or other regulatory authorities.

Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure

to conduct the clinical trial in accordance with regulatory requirements or our clinical trial protocols, inspection of the clinical trial

operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety

issues or adverse side effects, failure to demonstrate a benefit from the product candidates, changes in governmental regulations or administrative

actions or lack of adequate funding to continue the clinical trial.

Moreover, principal investigators for our clinical trials may serve

as scientific advisors or consultants to us from time to time and receive compensation in connection with such services.

Under certain

circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities.

FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has

created a conflict of interest or otherwise affected interpretation of the study.

The FDA or comparable foreign regulatory authority

may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial

itself may be jeopardized.

This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable

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

Our product development costs will increase if we experience additional

delays in preclinical or clinical testing or in obtaining marketing approvals.

We do not know whether any of our clinical trials will

begin as planned, will need to be restructured or will be completed on schedule, or at all.

If we do not achieve our product development

goals in the time frames we announce and expect, the approval and commercialization of our product candidates may be delayed or prevented

Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize

our product candidates and may allow our competitors to bring products to market before we do, potentially impairing our ability to successfully

commercialize our product candidates and harming our business and results of operations.

Any delays in our clinical development programs

may harm our business, financial condition and results of operations significantly.

Clinical trials and pre-clinical studies are very expensive, time-consuming,

and difficult to design and implement and involve uncertain outcomes.

We may encounter substantial delays in clinical trials, or may not

be able to conduct or complete clinical trials or pre-clinical studies on the expected timelines, if at all.

Clinical trials and pre-clinical studies are very expensive,

time-consuming and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.

an IRB or other regulatory authorities may not agree with the proposed analysis plans or trial design for the clinical trials of our product

candidates, and during any such review, may identify unexpected efficacy or safety concerns, which may delay the approval of a New Drug

Application (“ NDA ”), a Biologic License Application (“ BLA ”) or similar application.

also find that the benefits of any product candidate in any applicable indication do not outweigh its risks in a manner sufficient to

grant regulatory approval or may find that our proposed development program is not sufficient to support a marketing authorization application,

or that the proposed indication is considered to be too broad.

Moreover, the FDA or other regulatory authorities may also refuse or impose

certain restrictions on our reliance on data supporting our marketing authorization application should such data originate from studies

outside of the relevant jurisdiction.

In each case, this could delay the clinical development timeline for a given product candidate.

Our principal investigators for our clinical trials may also

serve as scientific advisors or consultants to our subsidiaries and investments, which may raise regulatory issues with the FDA or other

regulatory authorities.

Principal investigators for our clinical trials may serve as scientific

advisors or consultants to us from time to time and receive compensation in connection with such services.

Under certain circumstances,

we may be required to report some of these relationships to the FDA or other regulatory authorities.

The FDA or other regulatory authorities

may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected

the integrity of the study.

The FDA or other regulatory authority may therefore question the integrity of the data generated at the applicable

clinical trial site and the utility of the clinical trial itself may be jeopardized.

This could result in a delay in approval, or rejection,

of our marketing applications by the FDA or other regulatory authority, as the case may be, and may ultimately lead to the denial of marketing

approval of any of our product candidates.

Negative results or safety signals in our clinical trials may

make it difficult or impossible to recruit and retain patients in our clinical trials.

Any negative results or new safety signals we may report in clinical

trials of our product candidates may make it difficult or impossible to recruit and retain patients in other clinical trials we are conducting.

Similarly, negative results reported by our competitors about their drug candidates may negatively affect patient recruitment in our clinical

Also, marketing authorization of competitors in this same class of drugs may impair our ability to enroll patients into our clinical

trials, delaying or potentially preventing us from completing recruitment of one or more of our trials.

Delays or failures in planned

patient enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability

to develop our product candidates, or could render further development impossible.

The results of our clinical trials may not support our proposed

claims for our product candidates, or regulatory approvals on a timely basis or at all, and the results of earlier studies and trials

may not be predictive of future trial results.

The results of pre-clinical studies and early clinical trials

of our product candidates may not be predictive of the results of later-stage clinical trials.

Product candidates in later stages

of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through pre-clinical and

initial clinical trials.

In addition, results from clinical trials or pre-clinical studies may require further evaluation,

delaying the next stage of development or submission of an NDA/BLA or similar application.

A future failure of a clinical trial to meet

its pre-specified endpoints would likely cause us to abandon our product candidates.

Any delay in, or termination of, our clinical

trials will delay the submission of an NDA/BLA or other similar applications to the FDA or other relevant comparable non-U.S.

authorities and, ultimately, our ability to commercialize our product candidates, if approved, and generate product revenues.

our clinical trials are completed as planned, we cannot be certain that their results will support our claims for differentiation or

the effectiveness or safety of our product candidates.

The FDA has substantial discretion in the review and approval process and may

disagree that our data support the differentiated claims we propose.

In addition, only a small percentage of product candidates under

development result in the submission of an NDA/BLA or other similar application to the FDA and other comparable non-U.S.

authorities and even fewer are approved for commercialization.

Interim, top-line or preliminary data from our clinical

trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification

procedures that could result in material changes in the final data.

From time to time, we may publicly disclose preliminary or top-line data

from our clinical trials, which is based on a preliminary analysis of then-available top-line data, and the results and related

findings and conclusions are subject to change following a full analysis of all data related to the particular trial.

We also make assumptions,

estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully

and carefully evaluate all data.

As a result, the preliminary and top-line results that we report may differ from future results

of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully

Top-line data also remain subject to audit and verification procedures that may result in the final data being materially

different from the top-line data we previously published.

As a result, preliminary and top-line data should be viewed

with caution until the final data are available.

From time to time, we may also disclose interim data from our clinical trials.

data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change

as patient enrollment continues and more patient data become available.

Adverse differences between preliminary, top-line or

interim data and final data could significantly harm our business prospects.

We may not be able to file INDs or IND amendments or comparable

applications to commence clinical trials on the timelines we expect, and even if we are able to, the FDA or other regulatory authorities

may not permit us to proceed.

We may not be able to file Investigational New Drug (“ IND ”)

applications or other comparable applications for our product candidates on the timelines we expect.

For example, we or our third party

collaborators may experience manufacturing delays or other delays with IND-enabling studies or FDA or other regulatory authorities

may require additional preclinical studies that we did not anticipate.

Moreover, we cannot be sure that submission of an IND or other

comparable application will result in the FDA or other regulatory authorities allowing clinical trials to begin, or that, once begun,

issues will not arise that result in a decision by us, by institutional review boards or independent ethics committees, or by the FDA

or other regulatory authorities to suspend or terminate clinical trials, including as a result of a clinical hold.

Additionally, even

if FDA or other regulatory authorities agree with the design and implementation of the clinical trials set forth in an IND or comparable

application, we cannot guarantee that they will not change their requirements or expectations in the future.

These considerations also

apply to new clinical trials we may submit as amendments to existing INDs or to a new IND or other comparable application.

to file INDs or other comparable applications on the timelines we expect or to obtain regulatory approvals for our trials may prevent

us from completing our clinical trials or commercializing our products on a timely basis, if at all.

We may in the future seek orphan drug designation for our product

candidates, but we may be unable to obtain orphan drug designation and, even if we obtain such designation, we may not be able to realize

or maintain the benefits of such designation, including potential marketing exclusivity of our product candidates, if approved.

Regulatory authorities in some jurisdictions, including the United States

and other major markets, may designate products intended to treat conditions or diseases affecting relatively small patient populations

as orphan drugs.

Under the Orphan Drug Act of 1983, the FDA may designate a drug or biologic product candidate as an orphan

drug if it is intended to treat a rare disease or condition, which is generally defined as having a patient population of fewer than 200,000

individuals in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable

expectation that the cost of developing the product will be recovered from sales in the United States.

Orphan drug designation must

be requested before submitting a marketing application.

In the United States, orphan drug designation entitles a party to financial

incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.

After the FDA

grants orphan drug designation, the generic identity of the drug or biologic and its potential orphan use are disclosed publicly by the

Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

Generally, if a product candidate with an orphan drug designation

receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing

exclusivity, which precludes the FDA or foreign regulatory authorities from approving another marketing application for a product that

constitutes the same drug treating the same indication for a period of seven (7) years, except in limited circumstances, such as

a showing of clinical superiority to the product with orphan drug exclusivity or where the manufacturer is unable to assure sufficient

product quantity.

Orphan drug exclusivity may be revoked if any regulatory agency determines that the request for designation was materially

defective or 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

candidates in which there is a medically plausible basis for the use of these products.

We may be unable to obtain and maintain orphan

drug designation and, even if we obtain such designation, we may not be able to realize the benefits of such designation, including potential

marketing exclusivity of our product candidates, if approved.

Even if we obtain orphan drug exclusivity for a product candidate,

that exclusivity may not effectively protect the product candidate from competition because different drugs can be approved for the same

condition in the United States.

Even after an orphan drug is approved, the FDA may subsequently approve another drug for the same

condition if the FDA concludes that the latter drug is not the same drug or is clinically superior in that it is shown to be safer, more

effective or makes a major contribution to patient care.

We face substantial competition, which may result in others discovering,

developing or commercializing products before or more successfully than us.

The development and commercialization of new drug products is highly

We may face competition with respect to any product candidates that we seek to develop or commercialize in the future from

major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide.

Potential competitors also

include academic institutions, venture capital firms, hedge funds, government agencies, and other public and private research organizations

that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and

commercialization.

There are a number of large pharmaceutical and biotechnology companies

that are currently pursuing the development of products, or already have products in the market, for the diseases in oncology and immunology.

Although we believe that our approaches are or will be unique, there is no assurance that they will demonstrate advantages or even parity

against competitive products from other companies .

Many of our current or potential competitors, either alone or with

their strategic partners, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical

testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do.

Mergers and acquisitions in the pharmaceutical and biotechnology industries

may result in even more resources being concentrated among a smaller number of our competitors.

Smaller or early-stage companies

may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial

sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,

more convenient, or less expensive than any products that we may develop.

Furthermore, products currently approved for other indications

could be discovered to be effective treatments as well, which could give such products significant regulatory and market timing advantages

over our product candidates.

Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we

may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter

Additionally, products or technologies developed by our competitors may render our potential product candidates uneconomical

or obsolete and we may not be successful in marketing any product candidates we may develop against competitors.

The availability of competitive

products could limit the demand, and the price we are able to charge, for any products that we may develop and commercialize.

Product liability lawsuits against us could cause us to incur

substantial liabilities and could limit commercialization of any product candidates that we may develop.

We face an inherent risk of product liability exposure related to the

testing of product candidates in human clinical trials.

If we cannot successfully defend ourselves against claims that our product candidates

or medicines caused injuries, we could incur substantial liabilities.

Regardless of merit or eventual outcome, liability claims may result

● decreased demand for any product candidates or medicines

that we may develop;

● injury to our reputation and significant negative media attention;

● withdrawal of clinical trial participants;

● significant costs to defend the related litigation;

● substantial monetary awards to trial participants or patients;

● loss of revenue;

● the inability to out-license our product candidates.

Although we intend to maintain product liability insurance, including

coverage for clinical trials that we sponsor, it may not be adequate to cover all liabilities that we may incur.

We anticipate that we

will need to increase our insurance coverage as we commence additional clinical trials.

The market for insurance coverage is increasingly

expensive, and the costs of insurance coverage will increase as our clinical programs increase in size.

We may not be able to maintain

insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Risks Related to the Company’s Reliance on Third Parties

The following risk factors reference the risks and uncertainties

relating to the reliance on third parties by OSR, which, following the closing of the Business Combination, will be the reliance on third

parties by the Company.

References in this section to “we,” “us,” and “our” refer to OSR prior to

the closing of the Business Combination and to the Company after closing.

We currently outsource, and intend to continue to outsource,

much of our discovery, clinical development, and manufacturing functions to third-party providers or consultants.

these functions has significant risks, and our failure to manage these risks successfully could materially adversely affect our business,

results of operations, and financial condition.

Our business model relies upon the use of third parties, such as vendors

and consultants, to conduct our drug discovery, preclinical testing, clinical trials, manufacturing, and all other aspects of clinical

While our reliance on third parties allows us to purposely employ a small number of full-time employees, we may not

be able to effectively manage and oversee the third parties that our business depends upon and we have less control over our operations

due to our reliance on third parties.

While we believe our business model significantly reduces overhead cost, we may not realize the

efficiencies of this arrangement if we are unable to effectively manage third parties or if our employees are unable to manage the operations

of each of our subsidiaries, including the development of their programs and product candidates.

The failure to successfully and efficiently

outsource operational functions or appropriately manage the operations of our subsidiaries could materially adversely affect our business,

results of operations, and financial condition.

We rely on third parties to conduct important aspects of our

preclinical studies and clinical trials.

If these third parties do not successfully carry out their contractual duties, meet expected

deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product

We depend upon third parties to conduct important aspects of our preclinical

studies and clinical trials, under agreements with CROs, CMOs, strategic collaborators and others.

We expect to continue to negotiate

budgets and contracts with such third parties, which may result in delays to our development timelines and increased costs.

We will rely heavily on third parties over the course of our preclinical

studies and clinical trials, and, as a result, we control only certain aspects of their activities.

When working with third parties, we

have less direct control over the conduct, timing and completion of our preclinical studies and clinical trials and the management of

data developed through preclinical studies and clinical trials than would be the case if we relied entirely upon our own staff.

Nevertheless,

we are responsible for ensuring that each of our studies and trials are conducted in accordance with the applicable protocol, legal and

regulatory requirements and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities.

We and these third parties are required to comply with GCP and cGMP requirements, which are regulations and guidelines enforced by the

FDA and comparable foreign regulatory authorities for product candidates in clinical development.

Regulatory authorities enforce these

GCP and cGMP requirements through periodic inspections of trial sponsors, clinical investigators, manufacturers and trial sites.

or any of these third parties fail to comply with applicable GCP or cGMP requirements, the clinical data generated in our clinical trials

may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to suspend or terminate these trials

or perform additional preclinical studies or clinical trials or determine that our clinical trials do not comply with the GCP or cGMP

requirements.

Failure by us or by third parties we engage to comply with regulatory requirements can also result in fines, adverse publicity,

and civil and criminal sanctions.

Any third parties conducting aspects of our preclinical studies, clinical

trials or manufacturing process will not be our employees and, except for remedies that may be available to us under our agreements with

such third parties, we cannot control whether or not they devote sufficient time and resources to our preclinical studies and clinical

These third parties may also have relationships with other commercial entities, including our competitors, for whom they may

also be conducting clinical trials or other product development activities, which could affect their performance on our behalf.

third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced

or if the quality or accuracy of the preclinical or clinical data they obtain is compromised due to the failure to adhere to our protocols

or regulatory requirements or for other reasons or if due to federal or state orders or absenteeism they are unable to meet their contractual

and regulatory obligations, our development timelines, including clinical development timelines, may be extended, delayed or terminated

and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates.

As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and

our ability to generate revenue could be delayed.

If any of our relationships with these third-party CROs, CMOs

or others terminate, we may not be able to enter into arrangements with alternative CROs, CMOs or other third parties in a timely manner

or to do so on commercially reasonable terms.

Switching or adding additional CROs or CMOs involves additional cost and requires extensive

time and focus of our management.

As a result, delays may occur, which can materially impact our ability to meet our desired development

timelines which may have a material adverse impact on our business, financial condition and prospects.

Because we rely on third-party manufacturing and supply

vendors, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may

not be of satisfactory quantity or quality.

We rely on third-party contract manufacturers to manufacture our

product candidates for preclinical studies and clinical trials.

We do not own manufacturing facilities for producing any commercial product

There can be no assurance that our preclinical and clinical development product supplies will not be limited, interrupted, or

of satisfactory quality or continue to be available at acceptable prices.

For example, the COVID-19 pandemic would have significantly

impacted our ability to procure sufficient supplies for the development of our product candidates.

Any future pandemic or similar public

health crisis may create delays or gaps in supply of materials driven by the response to any pandemic or similar public health crisis.

In particular, any replacement of a contract manufacturer could require significant effort and expertise because there may be a limited

number of qualified replacements.

The manufacturing process for a product candidate is subject to FDA

and foreign regulatory authority review.

Suppliers and manufacturers must meet applicable manufacturing requirements and undergo rigorous

facility and process validation tests required by regulatory authorities in order to comply with regulatory standards, such as cGMPs.

In the event that any of our manufacturers fails to comply with such requirements or to perform its obligations to us in relation to quality,

timing or otherwise, or if our supply of components or other materials become limited or interrupted for other reasons, we may be forced

to manufacture the materials ourselves, for which we currently do not have the capabilities or resources, or enter into an agreement with

another third-party, which we may not be able to do on reasonable terms, if at all.

In some cases, the technical skills or technology

required to manufacture our product candidates may be unique or proprietary to the original manufacturer and we may have difficulty transferring

such skills or technology to another third-party and a feasible alternative may not exist.

These factors would increase our reliance

on such manufacturer or require us to obtain a license from such manufacturer in order to have another third-party manufacture our

product candidates.

If we are required to change manufacturers for any reason, we will be required to verify that the new manufacturer

maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines.

need to verify, such as through a manufacturing comparability or bridging study, that any new manufacturing process will produce our product

candidate according to the specifications previously submitted to the FDA or another regulatory authority.

The delays associated with

the verification of a new manufacturer could negatively affect our ability to develop product candidates in a timely manner or within

To the extent that we enter into future manufacturing arrangements

with third parties, we will depend on these third parties to perform their obligations in a timely manner consistent with contractual

and regulatory requirements, including those related to quality control and assurance.

If we are unable to obtain or maintain third-party manufacturing

for product candidates, or to do so on commercially reasonable terms, we may not be able to develop and commercialize our product candidates

successfully.

Our or a third-party’s failure to execute on our manufacturing requirements and comply with cGMPs could adversely

affect our business in a number of ways, including:

● an inability to initiate or continue clinical trials of product

candidates under development;

● delay in submitting regulatory applications, or receiving

regulatory approvals, for product candidates;

● loss of the cooperation of an existing or future collaborator;

● subjecting third-party manufacturing facilities or our

manufacturing facilities to additional inspections by regulatory authorities;

● requirements to cease distribution or to recall batches of

our product candidates;

● 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

may result in additional costs or delay.

As product candidates progress through preclinical to late stage clinical

trials to marketing approval and commercialization, it is common that various aspects of the development program, such as manufacturing

methods and formulation, are optimized along the way in an effort to improve yield, manufacturing batch size, minimize costs and achieve

consistent quality and results.

Such changes carry the risk that they will not achieve these intended objectives.

Any of these changes

could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials

conducted with the altered materials.

This could delay completion of clinical trials, require the conduct of bridging clinical trials

or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and jeopardize

our ability to commercialize our product candidates and generate revenue.

In addition, there are risks associated with large scale manufacturing

for clinical trials or commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility,

stability issues, compliance with good manufacturing practices, lot consistency and timely availability of raw materials.

Even if we obtain

marketing approval for any of our product candidates, there is no assurance that our manufacturers will be able to manufacture the approved

product to specifications acceptable to the FDA or other comparable foreign regulatory authorities, to produce it in sufficient quantities

to meet the requirements for the potential commercial launch of the product or to meet potential future demand.

Additionally, if we advance

a biological candidate into IND-enabling studies, the manufacturing processes for biological products is more complex and expensive

than with small molecule products and additional manufacturing suppliers may be needed to manufacture clinical supplies for these programs.

If our manufacturers are unable to produce sufficient quantities for clinical trials or for commercialization, our development and commercialization

efforts would be impaired, which would have an adverse effect on our business, financial condition, results of operations and growth prospects.

The manufacture of drug products, and particularly biologics,

is complex and our third-party manufacturers may encounter difficulties in production.

If any of our third-party manufacturers

encounter such difficulties, our ability to provide supply of our current product candidates or any future product candidates for clinical

trials or our products for patients, if approved, could be delayed or prevented.

Manufacturing drugs, particularly biologics, especially in large

quantities, is often complex and may require the use of innovative technologies to handle living cells.

Each lot of an approved

biologic must undergo thorough testing for identity, strength, quality, purity and potency.

Manufacturing biologics requires

facilities specifically designed for and validated for this purpose, and sophisticated quality assurance and quality control

procedures are necessary.

Slight deviations anywhere in the manufacturing process, including filling, labeling, packaging, storage

and shipping and quality control and testing, may result in lot failures, product recalls or spoilage.

When changes are made to the

manufacturing process, we may be required to provide preclinical and clinical data showing the comparable identity, strength,

quality, purity or potency of the products before and after such changes.

If microbial, viral or other contaminations are discovered

at the facilities of our manufacturers, such facilities may need to be closed for an extended period of time to investigate and

remedy the contamination, which could delay clinical trials and adversely harm our business.

In addition, there are risks associated with large scale manufacturing

for clinical trials or commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility,

stability issues, compliance with good manufacturing practices, lot consistency and timely availability of raw materials.

Even if we obtain

marketing approval for any of our current product candidates or any future product candidates, there is no assurance that our manufacturers

will be able to manufacture the approved product to specifications acceptable to the FDA or other comparable foreign regulatory authorities,

to produce it in sufficient quantities to meet the requirements for the potential commercial launch of the product or to meet potential

future demand.

If our manufacturers are unable to produce sufficient quantities for clinical trials or for commercialization, our development

and commercialization efforts would be impaired, which would have an adverse effect on our business, financial condition, results of operations

and growth prospects.

Risks Related to the Company’s Intellectual Property

The following risk factors reference the risks and uncertainties

relating to the intellectual property of OSR, which, following the closing of the Business Combination, will be the intellectual property

of the Company.

References in this section to “we,” “us,” and “our” refer to OSR prior to the closing

of the Business Combination and to the Company after closing.

If we are unable to obtain and maintain patent and other intellectual

property protection for our technology and product candidates or if the scope of the intellectual property protection obtained is not

sufficiently broad, we may not be able to compete effectively in our markets.

We rely upon a combination of patents, trademarks, trade secret protection

and confidentiality agreements with employees, consultants, collaborators, advisors and other third parties to protect the intellectual

property related to our product candidates.

Our success depends in large part on our ability to obtain and maintain patent protection

in the United States and other countries with respect to our product candidates and any future product candidates.

We also seek to

protect our proprietary position by in-licensing or acquiring intellectual property and filing patent applications in the United States

and abroad related to our development programs and product candidates.

The patent prosecution process is expensive and time-consuming,

and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.

Furthermore, there is always a risk that our licensed or owned issued patents and any pending and future patent applications may not protect

our product candidates, in whole or in part, and may not effectively prevent others from commercializing competitive product candidates,

or that an alteration to product candidates or processes may provide sufficient basis for a competitor to avoid infringing our patent

The risks associated with patent rights generally apply to patent rights that we in-license now or in the future, as

well as patent rights that we may own now or in the future.

It is also possible that we will fail to identify patentable aspects

of our research and development output before it is too late to obtain patent protection.

Although we enter into non-disclosure and

confidentiality agreements with parties who have access to confidential or patentable aspects of their research and development output,

such as employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors and

other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby

jeopardizing our ability to obtain patent protection.

In addition, while we will have pre-publication review procedures in effect,

premature or inadvertent publication of potentially patentable subject matter could preclude our ability to obtain patent protection.

We may choose not to seek patent protection for certain innovations

or product candidates and may choose not to pursue patent protection in certain jurisdictions, and under the laws of certain jurisdictions,

patents or other intellectual property rights may be unavailable and, in any event, any patent protection we obtain may be limited.

a result, product candidates may not be protected by patents in all jurisdictions.

We generally apply for patents in those countries where

we intend to make, have made, use, offer for sale, or sell product candidates and where we assess the risk of infringement to justify

the cost of seeking patent protection.

However, we do not seek protection in all countries where we intend to sell product candidates

and we may not accurately predict all the countries where patent protection would ultimately be desirable.

If we fail to timely file a

patent application in any such country, we may be precluded from doing so at a later date.

The patent applications that we own or in-license may

fail to result in issued patents with claims that cover product candidates in the United States or in other countries.

inadvertently make statements to regulatory agencies during the regulatory approval process that may be inconsistent with positions that

have been taken during prosecution of our patents, which may result in such patents being narrowed, invalidated or held unenforceable.

The patent applications that we own or in-license may fail

to result in issued patents with claims that cover our product candidates or any future product candidate in the United States or

in other countries.

Our pending PCT patent applications are not eligible to become issued patents until, among other things, we file

a national stage patent application within 30 months in the countries in which we seek patent protection.

If we do not timely file

any national stage patent applications, we may lose our priority date with respect to our PCT patent applications and any patent protection

on the inventions disclosed in such PCT patent applications.

We cannot guarantee any current or future patents will provide us with any

meaningful protection or competitive advantage.

There is no assurance that all of the potentially relevant prior art relating to our

patents and patent applications have been found, which can prevent a patent from issuing from a pending patent application or be used

to invalidate an issued patent.

The examination process may require us to narrow our claims, which may limit the scope of patent protection

that we may ultimately obtain.

Even if patents do successfully issue and even if such patents cover our product candidates or any future

product candidate, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowly

construed, invalidated, or held unenforceable, any of which could limit our ability to prevent competitors and other third parties from

developing and marketing similar product candidates or limit the length of terms of patent protection we may have for our product candidates

and technologies.

Other companies may also design around technologies we have patented, licensed or developed.

In addition, the issuance

of a patent does not give us the right to practice the patented invention.

Third parties may have blocking patents that could prevent

us from marketing product candidates or practicing our own patented technology or impose a substantial royalty burden to do so.

Any successful

opposition to these patents or any other patents owned by or licensed to us could deprive us of rights necessary for the successful commercialization

of any product candidates that we may develop.

Further, if we encounter delays in regulatory approvals, the period of time during which

we could market a product candidate under patent protection could be reduced.

If any of our patents are challenged, invalidated, circumvented

by third parties or otherwise limited or expire prior to the commercialization of our product candidates, and if we do not own or have

exclusive rights to other enforceable patents protecting our product candidates or other technologies, competitors and other third parties

could market product candidates and use processes that are substantially similar to, or superior to, ours and our business would suffer.

If the patent applications we hold or have in-licensed with

respect to our product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide

meaningful exclusivity for our product candidates or any future product candidate, it could dissuade companies from collaborating with

us to develop product candidates, and threaten our ability to commercialize, future drugs.

Any such outcome could have a materially adverse

effect on our business.

The patent position of biotechnology and pharmaceutical companies generally

is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation.

standards that the U.S.

Patent and Trademark Office (the “USPTO”) and its counterparts in other countries use to grant

patents are not always applied predictably or uniformly.

In addition, the laws of countries other than the United States may not

protect our rights to the same extent as the laws of the United States, and many companies have encountered significant problems

in protecting and defending such rights in such jurisdictions.

For example, European patent law restricts the patentability of methods

of treatment of the human body more than United States law does.

Other parties have developed technologies that may be related or competitive

to our own technologies and such parties may have filed or may file patent applications, or may have received or may receive patents,

claiming inventions that may overlap or conflict with those claimed in our own or licensed patent applications or issued patents.

publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States

and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all.

Therefore, we cannot

know with certainty whether we or our licensors were the first to make the inventions claimed in our owned or licensed patents or pending

patent applications, or that we or our licensors were the first to file for patent protection of such inventions.

As a result, the issuance,

scope, validity, enforceability and commercial value of our patent rights are highly uncertain.

Our pending and future patent applications

may not result in patents being issued which protect our technology or product candidates, in whole or in part, or which effectively prevent

others from commercializing competitive technologies and product candidates.

Changes in either the patent laws or interpretation of the

patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.

Patent reform legislation in the United States, including the

Leahy-Smith America Invents Act (the “ Leahy-Smith Act ”), could increase those uncertainties and costs surrounding

the prosecution of our patent applications and the enforcement or defense of our issued patents.

The Leahy-Smith Act made significant

changes to U.S.

patent law, including the way patent applications are prosecuted, redefined prior art and provided more efficient

and cost-effective avenues for competitors to challenge the validity of patents.

The Leahy-Smith Act and its implementation

could increase the uncertainties and costs surrounding the prosecution of our patent applications, our ability to obtain future patents,

and the enforcement or defense of our issued patents, all of which could harm our business, financial condition, results of operations

and prospects.

The issuance of a patent is not conclusive as to its inventorship,

scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States

Any patents that we have or may be issued provide us some protections

but the patent issuance may be challenged on multiple grounds.

We may in the future be subject to third-party pre-issuance submissions

of prior art to the USPTO or its equivalents and we or our licensors have in the past, and may in the future, become involved in opposition,

derivation, reexamination, inter partes review, post-grant review or interference proceedings in the U.S.

in other jurisdictions challenging our patent rights or the patent rights of others.

A third party may also claim that our owned or licensed

patent rights are invalid or unenforceable in a litigation.

The outcome following legal assertions of invalidity and unenforceability

is unpredictable.

An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate,

our patent rights, allow third parties to commercialize our technology or product candidates and compete directly with us, without payment

to us, result in our inability to manufacture or commercialize product candidates without infringing third-party patent rights or

result in our breach of agreements pursuant to which we license such rights to our collaborators or licensees.

In addition, if the breadth

or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating

with us to license, develop or commercialize current or future product candidates.

Such challenges may result in loss of exclusivity

or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others

from using or commercializing similar or identical technology and product candidates, or limit the duration of the patent protection

of our technology and product candidates.

Such challenges also may result in substantial cost and require significant time from our scientists

and management, even if the eventual outcome is favorable to us.

Any of the foregoing could have a material adverse effect on our business,

financial condition, results of operations and prospects.

Even if they are unchallenged, our owned and licensed patents and pending

patent applications, if issued, may not provide us with any meaningful protection or prevent competitors from designing around our patent

claims to circumvent our owned or licensed patents by developing similar or alternative technologies or therapeutics in a non-infringing manner.

For example, a third party may develop a competitive product that provides benefits similar to one or more of our product candidates but

that falls outside the scope of our patent protection.

Moreover, patents have a limited lifespan.

In the United States, the natural

expiration of a patent is generally 20 years after it is filed.

Various extensions may be available;

however the life of a patent,

and the protection it affords, is limited.

Without patent protection for our current or future product candidates, it may be open to competition

from generic versions of such product candidates.

Given the amount of time required for the development, testing and regulatory review

of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing

product candidates similar or identical to our own and, which could have a material adverse effect on our business, financial condition,

results of operations and prospects.

Patent terms and their scope may be inadequate to protect our

competitive position on current and future product candidates for an adequate amount of time.

Patents have a limited lifespan.

In the United States, if all

maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S.

non-provisional filing

In certain instances, the patent term may be adjusted to add additional days to compensate for delays incurred by the USPTO

in issuing the patent.

Also, the patent term may be extended for a period of time to compensate for at least a portion of the time a product

candidate was undergoing FDA regulatory review.

However, the life of a patent, and the protection it affords, is limited.

Even if patents

covering product candidates are obtained, once the patent life has expired, we may be open to competition from competitive product candidates,

including generics or biosimilars.

Given the amount of time required for the development, testing and regulatory review of new product

candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

We do not currently and may not in the future own or license

any issued composition of matter patents covering certain of our product candidates, and we cannot be certain that any of our other issued

patents will provide adequate protection for such product candidates.

Composition-of-matter patents on the active pharmaceutical ingredient

(“ API ”) in prescription drug products are generally considered to be the strongest form of intellectual property protection

for drug products because those types of patents provide protection without regard to any particular method of use or manufacture or formulation

of the API used.

While we generally seek composition of matter patents for our product candidates, such patents may not be available for

all of our product candidates.

Method-of-use patents protect the use of a product for the specified

method and formulation patents cover formulations of the API.

These types of patents do not prevent a competitor or other third party

from developing or marketing an identical product for an indication that is outside the scope of the patented method or from developing

a different formulation that is outside the scope of the patented formulation.

Moreover, with respect to method-of-use patents,

even if competitors or other third parties do not actively promote their product for our targeted indications or uses for which we may

obtain patents, physicians may recommend that patients use these products off-label, or patients may do so themselves.

Although off-label use

may infringe or contribute to the infringement of method-of-use patents, the practice is common, and this type of infringement

is difficult to prevent or prosecute.

Our owned and licensed patents and pending patent applications, if

issued, may not adequately protect our intellectual property or prevent competitors or others from designing around our patent claims

to circumvent our owned or licensed patents by developing similar or alternative technologies or therapeutics in a non-infringing manner.

If the breadth or strength of protection provided by the patents and patent applications we own or license with respect to our product

candidates is not sufficient to impede such competition or is otherwise threatened, it could dissuade companies from collaborating with

us to develop, and threaten our ability to commercialize, our product candidates.

Any of the foregoing could have a material adverse effect

on our business, financial condition, results of operations and prospects.

If we do not obtain protection under the Hatch-Waxman Amendments

by extending the patent term, our business may be harmed.

Our commercial success will largely depend on our ability to obtain

and maintain patent and other intellectual property in the United States and other countries with respect to our proprietary technology,

product candidates and our target indications.

Given the amount of time required for the development, testing and regulatory review of

new product candidates, patents protecting our product candidates might expire before or shortly after such candidate begins to be commercialized.

We expect to seek extensions of patent terms in the United States and, if available, in other countries where we are prosecuting

Depending upon the timing, duration and specifics of FDA marketing

approval of product candidates, one or more of our U.S.

patents may be eligible for a limited patent term extension (“ PTE ”)

under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments.

Hatch-Waxman Amendments permit a patent restoration term of up to five years beyond the normal expiration of the patent as compensation

for patent term lost during development and the FDA regulatory review process, which is limited to the approved indication (and potentially

additional indications approved during the period of extension) covered by the patent.

This extension cannot extend the remaining term

of a patent beyond a total of 14 years from the date of product approval and is limited to only one patent that covers the approved

product, the approved use of the product, or a method of manufacturing the product.

However, the applicable authorities, including the

FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may refuse to grant extensions

to our patents, or may grant more limited extensions than we request.

We may not be granted an extension because of, for example, failing

to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable

requirements.

Moreover, the applicable time-period or the scope of patent protection afforded could be less than we request.

if we are able to obtain an extension, the patent term may still expire before or shortly after we receive FDA marketing approval.

If we are unable to extend the expiration date of our existing patents

or obtain new patents with longer expiry dates, our competitors may be able to take advantage of our investment in development and clinical

trials by referencing our clinical and pre-clinical data to obtain approval of competing product candidates following our patent

expiration and launch their product earlier than might otherwise be the case.

Obtaining and maintaining our patent protection depends on compliance

with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent

protection could be reduced or eliminated as a result of non-compliance with these requirements.

Periodic maintenance fees on any issued patent are due to be paid to

the USPTO and other patent agencies in other jurisdictions in several stages over the lifetime of the patent.

The USPTO and various national

or international patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions

during the patent application process.

In certain circumstances, we rely on our licensing partners to pay these fees due to U.S.

agencies and to take the necessary action to comply with these requirements with respect to our licensed intellectual property.

an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there

are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or

complete loss of patent rights in the relevant jurisdiction(s).

Non-compliance events that could result in abandonment or lapse

of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our

international patent applications, failure to respond to official actions within prescribed time limits, non-payment of fees

and failure to properly legalize and submit formal documents.

If we or our licensors fail to maintain the patents and patent applications

covering our product candidates or any future product candidate, our competitors might be able to enter the market earlier than anticipated,

which would have an adverse effect on our business.

Third party claims or litigation alleging infringement, misappropriation

or other violations of third-party patents or other proprietary rights or seeking to invalidate our patents or other proprietary

rights, may delay or prevent the development and commercialization of our product candidates and any future product candidate.

Our commercial success depends in part on our avoidance of infringement,

misappropriation and other violations of the patents and proprietary rights of third parties.

However, our research, development and

commercialization activities may be subject to claims that we infringe, misappropriate or otherwise violate patents or other intellectual

property rights owned or controlled by third parties.

Our competitors or other third parties may assert infringement claims against us,

alleging that our product candidates are covered by their patents.

We cannot be certain that we do not infringe existing patents or that

we will not infringe patents that may be granted in the future.

There is a substantial amount of litigation, both within and outside

the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including

patent infringement lawsuits, interferences, derivation and administrative law proceedings, inter partes review, and

post-grant review before the USPTO, as well as oppositions and similar processes in other jurisdictions.

Numerous U.S.

patents and pending patent applications, which are owned by third parties, exist in the fields in which we and our collaborators are

developing product candidates.

As the biotechnology and pharmaceutical industries expand and more patents are issued, and as we gain

greater visibility, the risk increases that our product candidates or other business activities may be subject to claims of infringement

of the patent and other proprietary rights of third parties.

Third parties may assert that we are infringing their patents or employing

their proprietary technology without authorization.

There may be third-party patents or patent applications with claims to materials,

formulations, 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

to issue, there may be currently pending patent applications which may later result in issued patents that our product candidates may

infringe that we are not aware of.

In addition, third parties may obtain patents in the future and claim that use of our technologies

infringes upon these patents.

If any third-party patents were held by a court of competent jurisdiction to cover any of our product

candidates, the holders of any such patents may be able to block our ability to commercialize such product candidate unless we obtained

a license under the applicable patents, or until such patents expire.

Similarly, if any third-party patent were held by a court of competent

jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including combination therapy, the holders

of any such patent may be able to block our ability to develop and commercialize the applicable product candidate unless we obtained a

license or until such patent expires.

In either case, such a license may not be available on commercially reasonable terms or at all.

Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact

on our business.

In addition, we may be subject to claims that we are infringing other intellectual property rights, such as trademarks

or copyrights, or misappropriating the trade secrets of others, and to the extent that our employees, consultants or contractors use intellectual

property or proprietary information owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and

inventions, which could be time-consuming and divert the attention of senior management.

Parties making claims against us may obtain injunctive or other

equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates.

Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion

of employee resources from our business, as well as potentially be liable for substantial, or even treble, damages.

Persons may seek injunctive or other equitable relief, which may prevent

us from continuing to develop and commercialize our product candidates.

The defense costs to such actions are substantial and require

management and other knowledge employees to divert their attention from existing operations to defending such claims.

In the event of

a successful infringement or other intellectual property claim against it, we may have to pay substantial damages, including treble damages

and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our affected

product candidates, which may be impossible or require substantial time and monetary expenditure.

We cannot predict whether any such license

would be available at all or whether it would be available on commercially reasonable terms.

Furthermore, even in the absence of litigation,

we may need to obtain licenses from third parties to advance our research or allow commercialization of our product candidates, and we

have done so from time to time.

We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all.

that event, we would be unable to further develop and commercialize one or more of our product candidates, which could harm our business

significantly.

We cannot provide any assurances that third-party patents do not exist which might be enforced against our product

candidates, resulting in either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties

and/or other forms of compensation to third parties.

Some of our competitors may be able to sustain the costs of complex

intellectual property litigation more effectively than we can because the competitors have substantially greater resources.

intellectual property litigation, regardless of its outcome, may cause negative publicity, adversely impact prospective customers, cause

product shipment delays, or prohibit us from manufacturing, marketing or otherwise commercializing our product candidates, services, and

Any uncertainties resulting from the initiation and continuation of any litigation could adversely impact our ability to raise

additional funds or otherwise harm our business, results of operation, financial condition or cash flows.

Furthermore, because of the substantial amount of discovery required

in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by

disclosure during this type of litigation.

There could also be public announcements of the results of hearings, motions or other interim

proceedings or developments, which could adversely impact the price of our common shares.

We may not identify relevant third-party patents or

may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might harm our ability to develop

and market our product candidates.

We cannot guarantee that any of our or our licensors’ patent

searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents,

are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application

in the United States and abroad that is or may be relevant to or necessary for the commercialization of product candidates in any

jurisdiction.

Patent applications in the United States and elsewhere are not published until approximately 18 months after the

earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date.

patent applications filed before November 29, 2000 and certain U.S.

patent applications filed after that date that

will not be filed outside the United States remain confidential until patents issue.

Therefore, patent applications covering our

product candidates could have been filed by others without our knowledge.

Additionally, pending patent applications that have been published

can, subject to certain limitations, be later amended in a manner that could cover product candidates or the use of our product candidates.

The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution

Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively

impact our ability to market our product candidates.

We may incorrectly determine that our product candidates are not covered by a third-party patent

or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope.

Our determination

of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect and we may incorrectly

conclude that a third-party patent is invalid or unenforceable.

Our failure to identify and correctly interpret relevant patents

may negatively impact our ability to develop and market our product candidates.

If we fail to identify and correctly interpret relevant patents, we

may be subject to infringement claims.

We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement

If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from

commercializing any of our product candidates that are held to be infringing.

We might, if possible, also be forced to redesign product

candidates or services so that we no longer infringe the third-party intellectual property rights.

Any of these events, even if we

were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able

to devote to our business.

We may be involved in lawsuits to protect or enforce our patents,

the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.

Competitors may infringe, misappropriate or otherwise violate our patents,

the patents of our licensors or our other intellectual property rights.

To counter infringement or unauthorized use, we may be required

to file and prosecute legal claims against one or more third parties, which can be expensive and time-consuming, even if ultimately successful.

In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid or is unenforceable,

or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in

As a result, we cannot predict with certainty how much protection, if any, will be given to our patents if we attempt to enforce

them and they are challenged in court.

Further, even if we prevail against an infringer in U.S.

district court, there is always the

risk that the infringer will file an appeal and the district court judgment will be overturned at the appeals court and/or that an adverse

decision will be issued by the appeals court relating to the validity or enforceability of our patents.

An adverse result in any litigation

or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent

applications at risk of not issuing.

The initiation of a claim against a third party may also cause the third party to bring counter claims

against us such as claims asserting that our patents are invalid or unenforceable.

In patent litigation in the United States, defendant

counterclaims alleging invalidity or unenforceability are commonplace.

Grounds for a validity challenge could be an alleged failure to

meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or lack of written description

or statutory subject matter.

Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution

of the patent withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution.

parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, inter

partes review, or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with

litigation or even outside the context of litigation.

The outcome following legal assertions of invalidity and unenforceability is unpredictable.

We cannot be certain that there is no invalidating prior art, of which it and the patent examiner were unaware during prosecution.

the patents and patent applications that we have licensed, we may have limited or no right to participate in the defense of any licensed

patents against challenge by a third party.

If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we

would lose at least part, and perhaps all, of any future patent protection on our current or future product candidates.

Such a loss of

patent protection could harm our business.

Additionally, any adverse outcome could allow third parties to commercialize our products and

compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing

third-party patent rights.

Even if we establish infringement, the court may decide not to grant

an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy.

We may not be able to detect or prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly

in countries where the laws may not protect those rights as fully as in the United States.

Any litigation or other proceedings to

enforce our intellectual property rights may fail, and even if successful, may result in substantial costs and distract our management

and other employees.

Furthermore, because of the substantial amount of discovery required

in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by

disclosure during this type of litigation.

There could also be public announcements of the results of hearings, motions or other interim

proceedings or developments.

If securities analysts or investors perceive these results to be negative, it could have an adverse effect

on the price of our common shares.

We may not have sufficient financial or other resources to adequately

conduct such litigation or proceedings.

Some of our competitors or other third parties may be able to sustain the costs of such litigation

or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property

Because of the expense and uncertainty of litigation, we may conclude that even if a third party is infringing our issued

patent, any patents that may be issued as a result of our pending or future patent applications or other intellectual property rights,

the risk-adjusted cost of bringing and enforcing such a claim or action may be too high or not in the best interest of our company

or our stockholders.

In such cases, we may decide that the more prudent course of action is to simply monitor the situation or initiate

or seek some other non-litigious action or solution.

Because many of the patents we own are owned by our subsidiaries

and investments, and in certain cases by subsidiaries or investments that are not or will not be directly commercializing products, we

may not be in a position to obtain a permanent injunction against a third party that is found to infringe our patents.

Many patents that we own are assigned to our subsidiaries or investment

If a third party is found to be infringing such patents, we and our direct subsidiaries may not be able to permanently enjoin

the third party from making, using, offering for sale or selling the infringing product or activity for the remaining life of such patent

in the United States or other jurisdictions when the patent is assigned to a subsidiary, which is not the entity that is or would

be commercializing a potentially competitive product or service.

In such a circumstance, such third party may be able to compete with

us or our subsidiaries or investment companies, which could have a material adverse effect on our competitive position, business, financial

condition, results of operations, and prospects.

Changes in U.S.

patent law or the patent law of other countries

or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

As is the case with other biopharmaceutical companies, the Company’s

success is heavily dependent on intellectual property, particularly patents.

Obtaining and enforcing patents in the biopharmaceutical

industry involves both technological and legal complexity and is costly, time-consuming and inherently uncertain.

For example, on

September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law.

The Leahy-Smith Act

included a number of significant changes to U.S.

patent law, including provisions that affect the way patent applications will be

prosecuted and that may also affect patent litigation.

In particular, under the Leahy-Smith Act, the United States transitioned

in March 2013 to a “first to file” system in which the first inventor to file a patent application is typically entitled

to the patent.

Third parties are allowed to submit prior art before the issuance of a patent by the USPTO, and may become involved in

post-grant proceedings, including opposition, derivation, reexamination, inter partes review or interference proceedings challenging

our patent rights or the patent rights of others.

An adverse determination in any such submission, proceeding or litigation could reduce

the scope or enforceability of, or invalidate, our patent rights, which could adversely affect the Company’s competitive position.

In addition, The U.S.

Supreme Court has ruled on several patent

cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights

of patent owners in certain situations.

In addition to increasing uncertainty with regard to our ability to obtain patents in the future,

this combination of events has created uncertainty with respect to the value of patents, once obtained.

Depending on decisions by the

Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that

would weaken the Company’s ability to obtain new patents or to enforce patents that it might obtain in the future.

Similarly, changes in patent law and regulations in other countries

or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces

patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we have licensed or that we may obtain

in the future.

For example, the complexity and uncertainty of European patent laws have also increased in recent years.

in June 2023, a new unitary patent system was introduced, which will significantly impact European patents, including those granted

before the introduction of the system.

Under the unitary patent system, after a European patent is granted, the patent proprietor can

request unitary effect, thereby getting a European patent with unitary Effect, or a Unitary Patent.

Each Unitary Patent is subject to

the jurisdiction of the Unitary Patent Court, or the UPC.

As the UPC is a new court system, there is no precedent for the court,

increasing the uncertainty of any litigation.

Patents granted before the implementation of the UPC will have the option of opting out

of the jurisdiction of the UPC and remaining as national patents in the UPC countries.

Patents that remain under the jurisdiction of the

UPC may be potentially vulnerable to a single UPC-based revocation challenge that, if successful, could invalidate the patent in

all countries who are signatories to the UPC.

We cannot predict with certainty the long-term effects of the new unitary patent

We cannot predict future changes in the interpretation of patent laws

or changes to patent laws that might be enacted into law by United States and non-U.S.

legislative bodies.

Those changes

may materially affect our patents or patent applications and our ability to obtain additional patent protection in the future.

The validity, scope and enforceability of any patents listed

in the Orange Book that cover our product candidates or patents that cover our biologic product candidates can be challenged by third

If one of our product candidates is approved by the FDA and if a third

party files an application under Section 505(b)(2) or an abbreviated new drug application (“ ANDA ”) under

Section 505(j) for a generic product containing any of our product candidates, and relies in whole or in part on studies conducted

by or for us, the third party will be required to certify to the FDA that either:

(1) there is no patent information listed in the

FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “ Orange Book ”) with respect to our

NDA for the applicable approved product candidate;

(2) the patents listed in the Orange Book have expired;

(3) the listed patents

have not expired, but will expire on a particular date and approval is sought after patent expiration;

or (4) the listed patents

are invalid or will not be infringed by the manufacture, use or sale of the third party’s generic product.

A certification under

21 CFR § 314.94(a)(12)(i)(A)(4) that the new product will not infringe the Orange Book-listed patents for the applicable

approved product candidate, or that such patents are invalid, is called a paragraph IV certification.

If the third party submits

a paragraph IV certification to the FDA, a notice of the paragraph IV certification must also be sent to us once the third party’s

ANDA is accepted for filing by the FDA.

We may then initiate a lawsuit to defend the patents identified in the notice.

of a patent infringement lawsuit within 45 days of receipt of the notice automatically prevents the FDA from approving the third

party’s ANDA until the earliest of 30 months or the date on which the patent expires, the lawsuit is settled, or the court

reaches a decision in the infringement lawsuit in favor of the third party.

If we do not file a patent infringement lawsuit within the

required 45-day period, the third party’s ANDA will not be subject to the 30-month stay of FDA approval.

Moreover, a third party may challenge the current patents, or patents

that may issue in the future, within our portfolio, which could result in the invalidation of some or all of the patents that might otherwise

be eligible for listing in the Orange Book for one of our products.

If a third party successfully challenges all of the patents that might

otherwise be eligible for listing in the Orange Book for one of our products before an ANDA or 505(b)(2) NDA is filed we will be

unable to obtain a 30-month stay of FDA approval of a 505(b)(2) or ANDA.

For biologics, the BPCIA provides a mechanism for one or more third

parties to seek FDA approval to manufacture or sell a biosimilar or interchangeable versions of brand name biological product candidates.

Due to the large size and complexity of biological product candidates, as compared to small molecules, a biosimilar must be “highly

similar” to the reference product with “no clinically meaningful differences between the two.” The BPCIA does not require

reference product sponsors to list patents in the FDA’s Orange Book and does not include an automatic 30-month stay of

FDA approval upon the timely filing of a lawsuit.

The BPCIA, however, does require a formal pre-litigation process which includes

the exchange of information between a biosimilar applicant and a reference biologic sponsor that includes the identification of relevant

patents and each parties’ basis for infringement and invalidity.

After the exchange of this information, we may then initiate a

lawsuit within 30 days to defend the patents identified in the exchange.

If the biosimilar applicant successfully challenges the

asserted patent claims, it could result in the invalidation of, or render unenforceable, some or all of the relevant patent claims or

result in a finding of non-infringement.

If we are unsuccessful in enforcing our patents against generics or

biosimilars, our products could face competition prior to the expiration of the patents which cover such products, which could have a

material adverse effect on our business, financial condition, results of operations and prospects.

Furthermore, any such litigation or

other proceedings to enforce or defend intellectual property rights are often very complex in nature, may be very expensive and time-consuming,

may divert management’s attention from our core business, and may result in unfavorable results that could limit our ability to

prevent third parties from competing with product candidates.

We may not be able to protect our intellectual property rights

throughout the world.

Filing, prosecuting and defending patents on product candidates in

all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the

United States can be less extensive than those in the United States.

The requirements for patentability may differ in certain

countries, particularly developing countries, and the breadth of patent claims allowed can be inconsistent.

In addition, the laws of some

countries do not protect intellectual property rights to the same extent as laws of the United States.

Consequently, we may not be

able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing

product candidates made using our inventions in and into the United States or other jurisdictions.

Competitors may use our technologies

in jurisdictions where we have not obtained patent protection to develop their own product candidates and may also export infringing product

candidates to territories where we have patent protection, but enforcement is not as strong as that in the United States.

These product

candidates may compete with our product candidates and our patents or other intellectual property rights may not be effective or sufficient

to prevent them from competing.

We do not have patent rights in all countries in which a market may

Moreover, in jurisdictions where we do have patent rights, proceedings to enforce such rights could result in substantial costs

and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted

narrowly, and our patent applications at risk of not issuing.

Additionally, such proceedings could provoke third parties to assert claims

We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially

Thus, we may not be able to stop a competitor from marketing and selling in other countries product candidates and services

that are the same as or similar to our product candidates and services, and our competitive position would be harmed.

Many companies have encountered significant problems in protecting

and defending intellectual property rights in other jurisdictions.

The legal systems of certain countries, particularly certain developing

countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating

to biotechnology product candidates, which could make it difficult for us to stop the infringement of our patents or marketing of competing

product candidates in violation of our proprietary rights generally.

Proceedings to enforce our patent rights in other jurisdictions,

whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business,

could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could

provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate and the damages or other remedies

awarded, if any, may not be commercially meaningful.

Accordingly, our efforts to enforce our intellectual property rights around the world

may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Many countries, including European Union countries, India, Japan and

China, have compulsory licensing laws under which a patent owner may be compelled under specified circumstances to grant licenses to third

In addition, many countries limit the enforceability of patents against government agencies or government contractors.

countries, we may have limited remedies, which could materially diminish the value of those patents.

This could limit our potential revenue

opportunities.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant

commercial advantage from the intellectual property that we develop or license.

If we are unable to protect the confidentiality of any trade

secrets, our business and competitive position would be harmed.

In addition to seeking patents for any product candidates, we may rely

on trade secrets, including know-how, technology and other proprietary information, to maintain our competitive position.

We seek to protect

this information, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them,

such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other

third parties.

We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants.

Because we rely and expect to continue to rely on third parties to

manufacture our product candidates and future product candidates, and we collaborate and expect to continue to collaborate with third

parties on the development of current and future product candidates, we must, at times, share trade secrets with them.

If we conduct joint

research and development programs, we may be required to share trade secrets under the terms of our research and development partnerships

or similar agreements.

We seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable,

material transfer agreements, consulting agreements or other similar agreements with our advisors, employees, third-party contractors

and consultants prior to beginning research or disclosing proprietary information.

These agreements typically limit the rights of the

third parties to use or disclose our confidential information, including our trade secrets.

Despite the contractual provisions employed

when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade

secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation

of these agreements.

Any disclosure, either intentional or unintentional, by our employees, the employees of third parties with whom we

share facilities or third-party consultants and vendors that we engage to perform research, clinical trials or manufacturing activities,

or misappropriation by third parties (such as through a cybersecurity breach) of our trade secrets or proprietary information could enable

competitors to duplicate or surpass our technological achievements, thus eroding our competitive position in the market.

Further, adequate

remedies may not exist in the event of unauthorized use or disclosure.

Given that our proprietary position is based, in part, on our know-how and

trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive

position and may have an adverse effect on our business and results of operations.

In addition, these agreements typically restrict the ability of our

advisors, employees, third-party contractors and consultants to publish data potentially relating to our trade secrets, although

our agreements may contain certain limited publication rights.

Policing unauthorized use of our or our licensors’ intellectual property

is difficult, expensive and time-consuming, and we may be unable to determine the extent of any unauthorized use.

Moreover, enforcing

a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome

is unpredictable.

In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets.

Despite our efforts to protect our trade secrets, our competitors and other third parties may discover our trade secrets, including our

proprietary software, either through breach of our agreements with third parties, independent development or publication of information

by any of our third-party collaborators.

A competitor’s or other third party’s discovery of our trade secrets, including

our proprietary software, would impair our competitive position and have an adverse impact on our business.

We cannot guarantee that we have entered into non-disclosure, confidentiality

agreements, material transfer agreements or consulting agreements with each party that may have or have had access to our trade secrets

or proprietary software, technology and processes.

Despite these efforts, any of these parties may breach the agreements and disclose

our proprietary information, including our trade secrets and proprietary software, and we may not be able to obtain adequate remedies

for such breaches.

Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether

the steps we have taken to protect our intellectual property will be effective.

In addition, we may not be able to obtain adequate remedies

for any such breaches.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and

time-consuming, and the outcome is unpredictable.

In addition, some courts inside and outside the United States are less willing

or unwilling to protect trade secrets.

If any of our trade secrets, including our proprietary software, were to be lawfully obtained or

independently developed by a competitor or other third party, we would have no right to prevent them, or those to whom they communicate

it, from using that technology or information to compete with us.

If any of our trade secrets, including our proprietary software, were

to be disclosed to or independently developed by a competitor or other third party, our competitive position would be harmed.

We may be subject to claims challenging the inventorship or ownership

of our patents and other intellectual property.

We rely on a combination of internally developed and in-licensed intellectual

property rights and we or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest

in our owned or in-licensed patents, trade secrets, or other intellectual property as an inventor or co-inventor.

example, we or our licensors may have inventorship disputes arise from conflicting obligations of employees, consultants or other third

parties who are involved in developing product candidates.

Litigation may be necessary to defend against these and other claims challenging

inventorship or our or our licensors’ ownership of our owned or in-licensed patents, trade secrets or other intellectual

If we or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual

property rights, such as exclusive ownership of, or right to use, intellectual property that is important to product candidates.

if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management

and other employees.

Any of the foregoing could harm our business, financial condition, results of operations and prospects.

In addition, while it is our policy to require our employees, contractors

and other third parties who may be involved in the development of intellectual property to execute agreements assigning such intellectual

property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that

we regard as our own.

Our invention assignment agreements may not be self-executing or may be breached, and we may not have adequate

remedies for any such breach.

Additionally, we may be forced to bring claims against third parties, or defend claims they may bring against

us, to determine the ownership of what we regard as our intellectual property.

Furthermore, individuals executing agreements with us may

have pre-existing or competing obligations to a third party, such as an academic institution, and thus an agreement with us may be

ineffective in perfecting ownership of inventions developed by that individual.

Any trademarks we have obtained or may obtain may be infringed

or successfully challenged, resulting in harm to our business.

We rely on trademarks as one means to distinguish product candidates

that are approved for marketing from the product candidates of our competitors.

Our current and future trademark applications in the United States

and in other jurisdictions may not be allowed or may subsequently be opposed, challenged, infringed, circumvented, declared generic or

determined to be infringing other marks.

Additionally, once we select new trademarks and apply to register them, our trademark applications

may not be approved.

Third parties have in the past opposed, are currently opposing and may in the future oppose or attempt to cancel

our trademark applications or trademarks, or otherwise challenge our use of the trademarks.

In the event that our trademarks are successfully

challenged, we could be forced to rebrand product candidates, which could result in loss of brand recognition and could require us to

devote resources to advertising and marketing new brands.

Our competitors may infringe our trademarks and we may not have adequate resources

to enforce our trademarks.

If we attempt to enforce our trademarks and assert trademark infringement claims, a court may determine that

the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior

rights to the marks in question.

In this case, we could ultimately be forced to cease use of such trademarks.

We may not be able to protect our rights to these trademarks and trade

names, which we need to build name recognition among potential partners or customers in our markets of interest.

At times, competitors

may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market

In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks

or trademarks that incorporate variations of our registered or unregistered trademarks or trade names.

Over the long term, if we are unable

to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business

may be adversely affected.

Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names,

copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources.

the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

Intellectual property rights do not necessarily address all potential

threats to our competitive advantage.

Once granted, patents may remain open to invalidity challenges including

opposition, interference, re-examination, post-grant review, inter partes review, nullification or derivation

action in court or before patent offices or similar proceedings for a given period after allowance or grant, during which time third parties

can raise objections against such grant.

In the course of such proceedings, which may continue for a protracted period of time, the patent

owner may be compelled to limit the scope of the allowed or granted claims thus attacked, or may lose the allowed or granted claims altogether.

In addition, the degree of future protection afforded by our intellectual

property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, provide

a barrier to entry against our competitors or potential competitors, or permit us to maintain our competitive advantage.

Moreover, if a third party has intellectual property rights that cover

the practice of our technology, we may not be able to fully exercise or extract value from our intellectual property rights.

The following

examples are illustrative:

● 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;

● 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

● 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;

● we or our licensor or any collaborators might not have been

the first to file patent applications covering certain of our inventions;

● others may independently develop similar or alternative technologies

or duplicate any of our technologies without infringing our intellectual property rights;

● 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;

● 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;

and we may not develop additional proprietary technologies

that are patentable;

● 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;

● 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;

● we may not develop or in-license additional proprietary

technologies that are patentable;

● 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;

● 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

Should any of these events occur, they could significantly harm our

business and results of operations.

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What changed 10-K

Item 1A. Risk Factors