OSRHW filing — read by section

UNITED STATES 
 
 SECURITIES AND EXCHANGE COMMISSION 
 
 WASHINGTON, DC 20549 
 
 FORM 10-K 
 
 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 

 For the fiscal year ended December 31 , 2024 
 
 OR 
 
 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 

 For the transition period from to 
 
 OSR HOLDINGS, INC. 
 
 (Exact name of registrant as specified in its
charter) 
 
 Delaware 001-41390 84-5052822 
 (State or other jurisdiction

of incorporation
or organization) 
 (Commission File Number) (I.R.S. Employer

Identification Number) 
 
 10900 NE 4th Street , Suite 2300 

 Bellevue , WA 
 98004 
 (Address of principal executive offices) (Zip Code) 
 
 Registrant’s telephone number, including
area code: (425) 635-7700 
 
 BELLEVUE LIFE SCIENCES ACQUISITION CORP. 
 
 (Former name or former address, if changed since
last report) 
 
 Securities registered pursuant to Section 12(b)
of the Act: 
 
 Title of Each Class: 

 Trading Symbol: 

 Name of Each Exchange

on Which Registered: 

 Common stock, par value $0.0001 per share OSRH The Nasdaq Stock Market LLC 
 Redeemable warrants, exercisable for shares of common stock at an exercise price of $11.50 per share OSRHW The Nasdaq Stock Market LLC 
 
 Securities registered pursuant to Section 12(g)
of the Act: 
 
 None 
 
 Indicate by check mark if the registrant is a well-known seasoned issuer,
as defined in Rule 405 of the Securities Act. Yes  ☐   No   ☒ 
 
 Indicate by check mark if the registrant is not required to file reports
pursuant to Section 13 or Section 15(d) of the Act. Yes  ☐   No   ☒ 
 
 Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days.  Yes   ☒  No  ☐ 
 
 Indicate by check mark whether the registrant has submitted electronically
every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes   ☒  No  ☐ 
 
 Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions
of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging
growth company” in Rule 12b-2 of the Exchange Act.
 
 Large accelerated filer ☐ Accelerated filer ☐ 
 Non-accelerated filer ☒ Smaller reporting company ☒ 
 Emerging growth company ☒ 
 
 If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act.  ☐ 
 
 Indicate by check mark whether the registrant has filed a report on
and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b)
of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.  ☐ 
 
 If securities are registered pursuant to Section 12(b) of the
Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error
to previously issued financial statements.  ☐ 
 
 Indicate by check mark whether any of those error corrections are restatements
that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during
the relevant recovery period pursuant to § 240.10D-1(b).  ☐ 
 
 Indicate by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Act). Yes  ☐ No  ☒  
 
 The aggregate market value of the voting stock held by non-affiliates
of the Registrant on June 30, 2024, based upon the closing price of $10.76 of the Registrant’s common stock as reported on
the Nasdaq Stock Market, was approximately $ 20,295,738 . Common stock held by each officer and director and by each person known to the
registrant who owned 10% or more of the outstanding voting and non-voting common stock have been excluded in that such persons may be
deemed to be affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes.
 
 As of April 15, 2025, there were 19,276,978 shares of common
stock, par value $0.0001 per share issued and outstanding.
 
 INTRODUCTORY NOTE 
 
 OSR Holdings, Inc. (the “ Company ”) is a global healthcare
company dedicated to advancing healthcare outcomes and improving the quality of life for people and their families. We aim to build and
develop a robust portfolio of innovative and potentially transformative therapies and healthcare solutions. Our current operating businesses
(through our three wholly owned subsidiaries) include (i) developing oral immunotherapies for the treatment of cancer, (ii) developing
design-augmented biologics for age-related and other degenerative diseases and (iii) neurovascular intervention medical
device and systems distribution in Korea. the Company’s vision is to acquire and operate a portfolio of innovative health-care related
companies globally.
 
 Prior to the closing of our initial business combination on February
14, 2025 (the “ Closing ”) comprising the merger via share exchange of the Company and our target company OSR Holdings,
Ltd. a corporation organized under the laws of the Republic of Korea (“ OSR ”), previously reported on Form 8-K filed
February 14, 2025 and further described below, the Company operated as a blank check company under the name Bellevue Life Sciences Acquisition
Corp.
 
 Unless the context indicates otherwise, references in this report to
“we,” “us” or the “Company” means the OSR Holdings, Inc. and our consolidated subsidiaries, and refer
to the historical operations of the Company under the name of Bellevue Life Sciences Acquisition Corp. prior to the Closing (sometimes
referred to herein as “ BLAC ”) and to the combined OSR Holdings, Inc. and its subsidiaries following the Closing. References
to “ OSR ” refer to the legacy historical operations of the OSR Holdings, Ltd. and its subsidiaries prior to the Closing.
References to our “management” or our “management team” refer to our officers and directors, and references to
the “Sponsor” refer to Bellevue Global Life Sciences Investors LLC, a Delaware limited liability company.
 
 Because we closed the Business Combination after the end of our fiscal
year, this Annual Report on Form 10-K describes our business and operations following the Closing of the Business Combination, but includes
the financial statements of BLAC and related Management’s Discussion and Analysis of Financial Condition and Results of Operations,
which describe the business, financial condition, results of operations, liquidity and capital resources of BLAC prior to the Business
Combination, and disclosure in “Item 14. Principal Accounting Fees and Services” relates to fees paid in respect of BLAC’s
financial statements. Substantially concurrently with the filing of this Annual Report on Form 10-K, we will be filing an amendment to
our Current Report on Form 8-K, initially filed on February 14, 2025, which will include the audited financial statements of OSR for the
year ended December 31, 2024 and related Management’s Discussion and Analysis of Financial Condition and Results of Operations and
the unaudited pro forma condensed combined financial information. Interested parties should refer to our Current Reports on Form 8-K for
more information.
 
 The information included within Part I of this Annual Report pertains
to the combined Company. The financial information included within Part IV of these financial statements relate to legacy BLAC.
 
 The Company was formed as a Delaware corporation on February 25,
2020 for the purpose of entering into a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization or
similar business combination with one or more businesses.
 
 On February 14, 2023, we consummated our initial public offering
(“ IPO ”) of an aggregate of 6,000,000 units, at $10.00 per unit (“ Units ”), generating gross proceeds
of $60,000,000 before underwriting discounts and expenses.
 
 Simultaneously with the closing of our IPO, our sponsor, Bellevue Global
Life Sciences Investors, LLC (“ Sponsor ”), purchased an aggregate of 430,000 units at a price of $10.00 per unit, for
an aggregate purchase price of $4,300,000 (“Private Placement Units”).
 
 In connection with our IPO, the underwriters were granted a 45-day
option from the date of our prospectus issued in connection with our IPO (the “ Over-Allotment Option ”) to purchase
up to 900,000 additional units to cover over-allotments (the “ Over-Allotment Units ”), if any. On February 21,
2023, the underwriters purchased 900,000 Over-Allotment Units fully exercising the Over-Allotment Option. The Over-Allotment Units were
sold at an offering price of $10.00 per Over-Allotment Unit, generating additional gross proceeds of $9,000,000 to the Company.
 
 Transaction costs of our IPO amounted to $2,721,126 consisting of $1,380,000
of underwriting discounts and $1,341,126 of other offering costs. Following the closing of our IPO on February 14, 2023, $61,050,000
(approximately $10.175 per Unit) from net offering proceeds of the sale of the Units in our IPO and the sale of the Private Placement
Units was placed in a trust account (the “ Trust Account ”). Following the closing of the Over-Allotment Option on February 21,
2023, and including the amount from our IPO, an aggregate amount of $70,207,500 was placed in the Company’s Trust Account established
in connection with our IPO. The proceeds held in the Trust Account are invested in United States “government securities” within
the meaning of Section 2(a)(16) of the Investment Company Act of 1940, as amended (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 which invest only in direct U.S. government treasury obligations. Except with respect to interest earned on the funds held
in the Trust Account that may be released to the Company to pay its tax obligations, the proceeds from our IPO were not to be released
from the Trust Account until the earlier of: (a) the completion of the Company’s initial business combination, (b) the
redemption of any of our public shares properly submitted in connection with a stockholder vote to amend our Amended and Restated Certificate
of Incorporation (the “ Charter ”) (1) to modify the substance or timing of our obligation to allow redemption in connection
with our initial business combination or to redeem 100% of our public shares if we do not complete our initial business combination within
the time provided in the Company’s Charter (as subject to extension), or (2) with respect to any other provision relating to
stockholders’ rights or pre-initial business combination activity; or (c) absent an initial business combination within the
time provided in the Company’s Charter (as subject to extension), our return of the funds held in the Trust Account to our public
stockholders as part of our redemption of the public shares. 
 
 On March 14, 2023, the Company announced that, commencing on March 17,
2023, the holders of Units may elect to separately trade the shares of common stock, warrants and rights included in the Units. No fractional
shares, warrants or rights would be issued upon separation of the Units and only whole shares, warrants and rights would trade. The shares
of common stock, the warrants and the rights traded on the Nasdaq Capital Market under the symbols “BLAC,” “BLACW”
and “BLACR,” respectively, and the Units not separated continued to trade on the Nasdaq Capital Market under the symbol “BLACU”
until the closing of our initial business combination on February 14, 2025 as discussed below.
 
 The Company and OSR entered into a Business Combination Agreement dated
November 16, 2023 (the “ Business Combination Agreement ”) pursuant to which, prior to the Closing each holder of
OSR Common Stock that executes a Participating Stockholder Joinder to the Business Combination Agreement on or prior to the Closing (each
such Person, a “ Participating OSR Stockholder ”), and each holder of OSR Common Stock that executes a Non-Participating Stockholder
Joinder on or prior to the Closing (each such Person, a “ Non-Participating OSR Stockholder ”) would be joined as
parties to the Business Combination Agreement, pursuant to which at the Effective Time (i) the Company would issue the Aggregate
Participating Consideration to the Participating OSR Stockholders, and (ii) the Participating OSR Stockholders would sell, transfer,
convey, assign and deliver all of their respective shares of OSR Common Stock to the Company (subclauses (i) and (ii), collectively,
the “ Share Exchange ”).
 
 As previously disclosed on the Company’s Current Report filed
on Form 8-K on February 21, 2025, on February 14, 2025 (the “ Closing Date ”), the Company completed its previously announced
business combination (the “ Business Combination ”) with OSR pursuant to the Amended and Restated Business Combination
Agreement, dated as of May 23, 2024, as amended on December 20, 2024 (the “ Business Combination Agreement ”),
by and among the Company, OSR, each stockholder of OSR that executed a Participating Joinder thereto (each such person, a “ Participating
Stockholder ”), and each stockholder of OSR that executed a Non-Participating Joinder thereto (each such person, a “ Non-Participating
Stockholder ”, and together with the Participating Stockholders, the “ OSR Stockholders ”).
 
 In connection with the Closing of the Business Combination we changed
our name from Bellevue Life Sciences Acquisition Corp. to the Company, Inc. and changed the trading symbols of our common stock and warrants
from “BLAC” and “BLACW,” to “OSRH” and “OSRHW,” respectively. In connection with the Closing,
any Units (which were trading under the symbol “BLACU”) that had not yet separated, were separated into their component shares
of common stock and warrants and ceased trading.
 
 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
 
 Certain of the statements contained in this Annual Report on Form
10-K constitute “forward-looking statements” for purposes of federal securities laws. Our forward-looking statements include,
but are not limited to, statements regarding our or our management’s expectations, hopes, beliefs, intentions or strategies regarding
the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances,
including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,”
“possible,” “potential,” “predict,” “project,” “should,” “would”
and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not
forward-looking. Forward-looking statements in this report may include, for example, statements about:
 
 ● our ability to fulfill and realize the benefits of the post-closure terms of our initial business combination for the Company and
its shareholders; 

 ● our expectations around the performance of the Company, including without limitation, the Company’s strategy, future operations,
financial performance and position, revenues, projected costs, prospects and plans; 

 ● the ability to obtain or maintain the listing of the Company’s securities on Nasdaq; 

 ● our success in retaining or recruiting, or changes required in, our officers, key employees or directors following our initial business
combination; 

 ● our officers and directors allocating their time to other businesses and potentially having conflicts of interest with our business; 

 ● our ability to successfully and efficiently integrate future expansion plans and opportunities and to grow our business in a cost-effective
manner; 

 ● future potential change in control; 

 ● the implementation, market acceptance and success of the Company’s post-merger business model; 

 ● developments and projections relating to the Company’s competitors and industry; 

 ● our expectations regarding the Company’s ability to obtain and maintain intellectual property protection and not infringe on
the rights of others; 

 ● our public securities’ potential liquidity and trading; 

 ● our expectations regarding the Company’s ability to obtain and maintain intellectual property protection and not infringe on
the rights of others; 

 ● the impact of COVID-19 type pandemics on the Company’s business; 

 ● our public securities’ potential liquidity and trading; 

 ● changes in applicable laws or regulations; 

 ● expectations regarding the time during which we will be an “emerging growth company” under the Jumpstart Our Business
Startups Act of 2012 (the “JOBS Act”); 

 ● the use of proceeds not held in the trust account or available to us from interest income on the trust account balance; 

 ● the trust account not being subject to claims of third parties; or 

 ● the outcome of any known and unknown litigation and regulatory proceedings. 

 The forward-looking statements contained in this report are based on
our current expectations and beliefs concerning future developments and their potential effects on us. Future developments affecting us
may not be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are
beyond our control) and other assumptions that may cause actual results or performance to be materially different from those expressed
or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors listed under
the heading “Risk Factors” elsewhere in this report. Should one or more of these risks or uncertainties materialize, or should
any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements.
We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or
otherwise, except as may be required under applicable securities laws.
 
 By their nature, forward-looking statements involve risks and uncertainties
because they relate to events and depend on circumstances that may or may not occur in the future. We caution you that forward-looking
statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and
developments in the industry in which we operate may differ materially from those made in or suggested by the forward-looking statements
contained in this report. In addition, even if our results or operations, financial condition and liquidity, and developments in the industry
in which we operate are consistent with the forward-looking statements contained in this report, those results or developments may not
be indicative of results or developments in subsequent periods.
 
 SUMMARY OF RISK FACTORS 
 
 Our business, our business sector and investing in our securities involve
a number of risks of which you should be aware before making an investment decision. You should read this summary together with the description
of each risk factor contained in the “ Risk Factors ” section of this Form 10-K, as well as other documents
filed from time to time with the SEC, for a more detailed discussion of certain risks that could materially adversely affect our financial
conditions and the market price of our securities. The following list describes some of the principal risk factors applicable to the Business
Combination, BLAC, OSR and the combined Company.
 
 ● 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 amplifies his conflicts of interest in determining whether the transaction is the most advantageous. 

 ● Our previously agreed and anticipated $20 million PIPE
(Private Investment in Public Equity) transaction with Toonon, was cancelled by Toonon due to macroeconomic factors specific to
Korea. As a result, the Company has not received the anticipated amount of cash at the closing of the Business Combination and the Company
was insolvent at the closing of the Business Combination and lacked sufficient cash to fund its operations or pay its outstanding expenses
and debts. The Company has entered into agreements for alternative financing, but there is no guaranty that these arrangements will be
fully consummated and/or sufficient and that the Company may not face claims from creditors (some of which have already been initiated
– see “ Litigation ” below) that could cause voluntary or involuntary bankruptcy proceedings, in which case, the
value of the stock and warrants of the Company would likely be worthless. 

 ● The Sponsor and the Company’s directors and officers
have interests that are different from or which conflict with the interests of the Company’s stockholders and that may have influenced
their analysis of whether the Business Combination with OSR is appropriate as the Company’s initial business combination. Such
interests include that the Sponsor will lose its entire investment in the Company if the Business Combination is not completed. 

 ● 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 obligations. 

 ● The level of due diligence conducted in connection with the
Business Combination may not be as high as would have been the case if OSR were to raise capital through an underwritten public offering,
which could result in defects with OSR’s business or problems with OSR’s management to have been overlooked. 

 ● The price of the Company’s Common Stock and warrants
may be volatile. 

 ● 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. 

 ● An active, liquid trading market for the Company Common Stock
and warrants may not develop or persist, which may limit your ability to sell the Company Common Stock and warrants. 

 ● 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. 

 ● The Company will likely incur significant operating losses
for the foreseeable future and may never achieve or maintain profitability. 

 ● We may not be successful in our efforts to acquire, in-license or
discover and develop new product candidates. 

 ● 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. 

 ● Our investment strategy and future growth relies on a number
of assumptions, some or all of which may not be realized. 

 ● We will require substantial additional capital to finance
our operations. 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. 

 ● 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 practices. 

 ● The Company’ management team has limited experience
managing and operating a U.S. public company. 

 ● If economic conditions in South Korea deteriorate, our current
business and future growth could be materially and adversely affected. 

 ● 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. 

 ● We currently outsource, and intend to continue to outsource,
much of our discovery, clinical development, and manufacturing functions to third-party providers or consultants. Outsourcing 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. 

 ● 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. 

 The risks summarized above or described in full below are not the only
risks that we face. Additional risks and uncertainties not presently known to us, or that we currently deem to be immaterial, may also
materially adversely affect our business, financial condition, results of operations, and future growth prospects.
 
 TABLE OF CONTENTS 
 
 PART I 
 1 

 Item 1. 
 Business 
 1 

 Item 1A. 
 Risk Factors 
 30 

 Item 1B. 
 Unresolved Staff Comments 
 79 

 Item 1C. 
 Cybersecurity 
 79 

 Item 2. 
 Properties 
 79 

 Item 3. 
 Legal Proceedings 
 79 

 Item 4. 
 Mine Safety Disclosures 
 79 

 PART II 
 80 

 Item 5. 
 Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 
 80 

 Item 6. 
 [Reserved] 
 83 

 Item 7. 
 Management’s Discussion and Analysis of Financial Condition and Results of Operations 
 83 

 Item 7A. 
 Quantitative and Qualitative Disclosures About Market Risk 
 92 

 Item 8. 
 Financial Statements and Supplementary Data 
 92 

 Item 9. 
 Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 
 92 

 Item 9A. 
 Controls and Procedures 
 92 

 Item 9B. 
 Other Information 
 93 

 Item 9C. 
 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 
 93 

 PART III 
 94 

 Item 10. 
 Directors, Executive Officers and Corporate Governance 
 94 

 Item 11. 
 Executive Compensation 
 101 

 Item 12. 
 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 
 102 

 Item 13. 
 Certain Relationships and Related Transactions, and Director Independence 
 105 

 Item 14. 
 Principal Accountant Fees and Services 
 110 

 PART IV 
 111 

 Item 15. 
 Exhibits and Financial Statement Schedules 
 111 

 Item 16. 
 Form 10-K Summary 
 114 

 Signatures 
 115 

 i 

 PART I 
 
 Item 1. Business 
 
 Company and Business Strategy Overview 
 
 As a global healthcare holding company, with operations in South Korea
and Switzerland and an office in the United States, we intend to leverage our existing and expanding network of academic and industry
leaders and investor network, including venture capital and private equity, in major healthcare markets globally to identify, lead and
support the growth of our subsidiaries and subsidiary candidates based on innovative research. Subsidiary candidates are companies that
are either already existing entities or new companies formed in connection with acquiring or licensing existing assets from pharmaceutical
firms. We expect to attract industry partners either as co-investors or through technology licensing deals and may raise capital
directly from private, strategic or public investors. We seek to chart a potentially more efficient and optimal route by pairing what
we believe are the right team and pharmaceutical or medical device technologies that have the potential to treat diseases and improve
healthcare outcomes with the necessary financial and other resources. Since our target markets feature large established global businesses
with abundant capital that acquire healthcare companies, we hope to realize additional liquidity through the sale of our subsidiaries
from time to time.
 
 We are a data-driven company. We evaluate our subsidiary candidate
opportunities by better understanding the target indications toward identifying new approaches and technologies to improve treatment outcomes.
We collaborate with academic and industry leaders to promote a seamless integration and partnership between entrepreneurial scientists
and seasoned business development and leadership teams. These technical and scientific experts from academia and industry bring innovative
contributions and a high level of enthusiasm. Our holding company leadership team supports and empowers each subsidiary to transform their
potentially breakthrough discoveries into impactful and viable commercial products.
 
 Our company’s collective expertise from industry veterans, seasoned
scientists, capital market and legal professionals provides the core foundation of our global healthcare holding company. the Company
operates as a hub-and-spoke business model with a centralized executive team partnering with subsidiary management teams to ensure
overall program and corporate alignment by and between subsidiaries and holding company. Our overarching goal is to enhance value creation
for our subsidiaries by continuously assessing optimal development options and exploring partnership and fundraising opportunities. We
encourage cooperation and knowledge sharing among our subsidiaries to enhance our synergistic business model. We believe our strong foundational
scientific conviction, entrepreneurial acumen and opportunistic approach positions us as a differentiated global company advancing pharmaceutical
and medical device technologies in an efficient, cost-effective and meaningful manner. Our interdisciplinary team of accomplished
scientists and entrepreneurial business leaders promotes the development and commercialization of a risk diversified portfolio to address
unmet medical needs with resilience and efficiency.
 
 1 

 Our corporate organization and ownership of subsidiaries is illustrated
by the following chart*:
 
 Portfolio Overview 
 
 OSR’s subsidiaries (other than RMC) have diverse scientific and
technological developments, and are engaged in distinct areas of therapeutics research and development, including oral T-cell immunotherapies
and recombinant biologics. This approach not only provides the Company with a broader scope of potential therapeutic solutions but also
reduces the risks associated with a singular-asset approach.
 
 Figure 2 below summarizes our three subsidiaries, two of which have
their own drug development pipelines.
 
 Portfolio Company 
 
 Science, Technology and Platform 

 T-cell immunotherapies based on a live attenuated, safe, orally, available bacterial vaccine strain, genetically modified to develop and elicit patients’ cytotoxic T-cells against specific pre-defined targets 

 Platform integrating different protein domain sequences linking into a Design augmented recombinant biologic with enhanced biological functionality 

 Neurovascular surgical devices 

 Figure 2. the Company portfolio
company snapshot. 
 
 2 

 Intellectual Property Overview 
 
 We own or have in-licensed numerous patents and intellectual property
underlying patent applications and possess substantial know-how and trade secrets relating to the development and commercialization
of therapeutic product candidates in development by our portfolio companies, including related manufacturing processes and technologies.
As of December 31, 2024, the patent portfolio of our subsidiaries includes 10 patent families of issued patents and pending patent
applications in various stages of prosecution. Generally, the patents issued and patent applications pending are in multiple jurisdictions
including the United States, Europe, Japan, India, and China, with anticipated expiration between 2032 to 2041, without considering
patent term adjustments or patent term extensions. The below table summarizes the seven patent families that have been issued to-date for
our subsidiary companies:
 
 Company

Assignee 
 
 Family 
 
 Status 
 
 Type 
 
 Granted

Regions 
 
 Expiration

Year 

 Vaximm 
 
 Manufacturing (1)

 WO 2013/091898, Method for Producing High Yield Attenuated Salmonella
 Strains
 
 Owned 
 
 Manufacturing 
 
 AU, CA, CN, EP, IN, JP, KR, US, ZA 
 
 2032 

 VXM01 – dosing (2)

 WO 2014/005683, DNA Vaccine for Use in Pancreatic Cancer Patients
 
 Owned 
 
 Formulation 
 
 AU, CN, EP, JP, KR, US, ZA 
 
 2033 

 VXM06 – WT1 (3)

 WO 2014/173542, Salmonella-based vectors for cancer immunotherapy
 targeting Wilms’ tumor gene
 
 Owned 
 
 Composition of Matter 
 
 EP, JP, US 
 
 2034 

 VXM04-MSLN (4)

 WO 2015/090584, Novel MSLN targeting DNA vaccine for cancer immunotherapy
 
 Owned 
 
 Composition of Matter 
 
 EP, JP, US 
 
 2034 

 VXM01 – combination (5)

 WO 2016/202459, VEGFR-2 targeting DNA vaccine for combination
 therapy
 
 Owned 
 
 Composition of Matter; Method of Use 
 
 AU, CA, CN, EP, IN, US, ZA 
 
 2036 

 VXM01 Tumor expression (7)

 WO 2018/149982, Novel VEGFR-2 targeting immunotherapy approach
 
 Owned 
 
 Composition of Matter 
 
 AU, US 
 
 2038 

 Darnatein 
 
 Designer ligands of TGF-ß superfamily (0)

 WO 2010/099219
 
 Exclusive License 
 
 Composition of Matter 
 
 EP, KR, JP 
 
 2030 

 Individual patents are in force for varying periods of time, depending
upon the date of filing of the patent application, the date of patent issuance, and the legal term of patents in the countries in which
they are obtained. Generally, patents issued for applications filed in the United States are in force for 20 years from the
earliest nonprovisional filing date. In addition, in certain instances, a patent term can be adjusted or extended to recapture a portion
of the term effectively lost as a result of the USPTO delay or the FDA regulatory review period (a patent term adjustment or patent term
extension, respectively). The restoration period for FDA delay cannot be longer than five years and the total patent term, including
the restoration period, must not exceed 14 years following FDA approval. The duration of patents outside of the United States
varies in accordance with provisions of applicable local law, but typically is also 20 years from the earliest nonprovisional filing
date. However, the actual protection afforded by a patent varies on a product-by-product basis, from country-to-country, and depends
upon many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the
availability of legal remedies in a particular country, and the validity and enforceability of the patent.
 
 When appropriate, we seek to protect aspects of our technology and
business not amenable to, or that we do not consider appropriate for, patent protection as trade secrets. We seek to protect this intellectual
property, in part, as trade secrets, by entering into confidentiality agreements with those who have access to our confidential information,
including our employees, contractors, consultants, collaborators, and advisors.
 
 3 

 Vaximm 
 
 Vaximm Corporate Overview 
 
 Vaximm is developing innovative oral immunotherapies for the treatment
of cancer and immunological disorders. Based on over 20 years of research, Vaximm’s customizable immunotherapy platform has
the potential to be efficiently and effectively adapted to treat various diseases and address specific patient needs. Vaximm currently
has three clinical and pre-clinical drug candidates targeting diseases ranging from glioblastoma to gastrointestinal stromal tumor
to ocular diseases.
 
 Vaximm’s flagship asset, VXM01, is a late clinical-stage (NCT037500701)
immuno-oncology candidate for glioblastoma, which early-stage clinical trials suggest may be a potentially specific and effective
treatment. VXM01 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency
(EMA) for both glioblastoma and pancreatic cancer on August 31, 2017 from FDA and August 23, 2017 from EMA. An Orphan Drug
Designation will permit Vaximm to receive additional years of market exclusivity upon regulatory approval, which provides a significant
competitive advantage. See “ Government Regulation — Orphan Drug Designation and Exclusivity .”
While VXM01 moves into planned phase 2 clinical trials, we are continuing to advance Vaximm’s other preclinical candidates in investigational
new drug (IND)-enabling studies.
 
 ● VXM04: A preclinical-stage oral T-cell vaccine
targeting mesothelin 

 ● VXM06: A preclinical-stage oral T-cell vaccine
targeting Wilms Tumor Protein (WT1) 

 ● VXM08: A preclinical-stage oral T-cell vaccine
targeting CEA(Carcinoembryonic antigen) 

 ● VXM10 : A preclinical-stage oral T-cell vaccine
targeting PD-L1 

 These products are currently undergoing preclinical studies to evaluate
their safety, immunogenicity, and anti-tumor efficacy. Vaximm will need to complete these preclinical studies and submit Investigational
New Drug (IND) applications to the relevant regulatory authorities before initiating clinical trials for each of these product candidates.
 
 While Vaximm has direct experience advancing a therapeutic candidate
from preclinical to late-stage clinical trials and developed a pipeline of other preclinical therapeutic candidates, other than receiving
Orphan Drug Designation for VSMO1, Vaximm has limited experience in applying for regulatory or marketing approval for any of its product
candidates. As Vaximm continues to advance its line of oral immunotherapies, it will remain flexible and opportunistic to explore partnering
options.
 
 Opportunity 
 
 Current approaches to targeted immunotherapies have various limitations,
such as drug biodistribution, off-target effects, immunotolerance, and evasion. The complex and diverse makeup of tumor microenvironments
creates further difficulties. Production of targeted immunotherapies is expensive and time-intensive, making tailor-made therapies
challenging to produce and manufacture at scale and, thus, not readily accessible. Optimally, the development of innovative new strategies
can overcome drug resistance, enhance druggability, and improve drug biodistribution to maximize treatment efficacy.
 
 Vaximm seeks to overcome these limitations by leveraging our foundational
science and innovative platform of attenuated bacterial strains to produce effective, customizable, oral vaccines efficiently and cost-effectively.
Vaximm’s lead product candidate, VXM01, targets the tumor vasculature and specific tumor antigens. VXM01 is currently being evaluated
in a Phase 2 clinical trial in Europe for the treatment of recurrent glioblastoma. Vaximm also plans to initiate a new clinical trial
of VXM01 in recurrent glioblastoma patients in the United States.
 
 If VXM01 demonstrates efficacy in the treatment of recurrent glioblastoma,
Vaximm intends to expand by developing oral cancer vaccines targeting other solid tumor indications. The company’s strategy generally
involves the following key steps:
 
 1. Identify novel tumor-specific antigens: Vaximm will leverage
its expertise in antigen discovery to identify new tumor-specific antigens that can be targeted by Vaximm’s platform. 

 2. Conduct preclinical studies with the FDA’s good laboratory
practice (“GLP” regulations): Before testing any drug or biological product candidate in humans, the product candidate must
undergo rigorous pre-clinical testing. The pre-clinical developmental stage generally involves laboratory evaluations of drug
chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to assess the potential for adverse events
and, in some cases, to establish a rationale for therapeutic use. The conduct of pre-clinical studies is subject to federal regulations
and requirements, including GLP regulations for safety/toxicology studies. Vaximm will perform preclinical studies to evaluate the safety,
immunogenicity, and anti-tumor efficacy of its oral cancer vaccine candidates in line with the GLP regulations that the FDA requires. 

 4 

 3. File an Investigational New Drug (IND) application: Upon the
successful completion of preclinical studies, Vaximm will submit an IND application to regulatory authorities such as the FDA. IND
is a request for authorization from the FDA to ship an investigation product and then administer it to humans and must be allowed to
proceed by the FDA before human clinical trials may begin. This submission includes all relevant data from preclinical studies and outlines
the proposed clinical trial protocols. The IND review period typically takes 30 days, during which the regulatory agency evaluates
the submission to ensure the safety of proceeding to human trials. 

 4. Initiate clinical trials: Based on the preclinical data and
IND approval, the company will design and conduct additional Phase 1/2 clinical trials to assess the safety, tolerability, and preliminary
efficacy of its oral cancer vaccines in other cancer indications. 

 5. Conduct Phase 3 clinical trials: Phase 3 trials are
large-scale, randomized, controlled studies designed to provide additional supporting evidence of the efficacy and safety of therapeutic
candidates. These trials typically involve hundreds to thousands of patients and are conducted at multiple sites worldwide. Vaximm will
work closely with clinical investigators, regulatory authorities, and patient advocacy groups to design and execute Phase 3 clinical
trials for its oral cancer vaccine candidates. 

 6. Seek regulatory approval: Following the successful completion
of Phase 3 clinical trials, the result of the pre-clinical studies and clinical trials, together with detailed information
relating to the product’s chemistry, manufacture, controls, and proposed labeling, among other things, are submitted to authorities,
such as the FDA or EMA. This stage is known as the New Drug Application (NDA) review. 

 Regulatory Steps 
 
 New Drug Application 
 
 A New Drug Application (NDA) tells the full story of a drug. Its purpose
is to demonstrate that a drug is safe and effective for its intended use in the population studied.
 
 A drug developer must include everything about a drug — from
preclinical data to Phase 3 trial data — in an NDA. Developers must include reports on all studies, data, and
analyses. Along with clinical results, developers must include proposed labeling, safety updates, drug abuse information, patent information,
any data from studies that may have been conducted in other countries, institutional review board compliance information and directions
for use
 
 NDA Review 
 
 Once each authority such as FDA or EMA receives an NDA, the review
team decides if it is complete. If it is not complete, the review team can refuse to file the NDA. If it is complete, the review
team has 6 to 10 months to make a decision on whether to approve the drug. The process includes the following:
 
 ● Each member of the review team conducts a full review of his
or her section of the application. For example, the medical officer and the statistician review clinical data, while a pharmacologist
reviews the data from animal studies. Within each technical discipline represented on the team, there is also a supervisory review. 

 ● FDA or EMA inspectors travel to clinical study sites to conduct
a routine inspection. The Agency looks for evidence of fabrication, manipulation, or withholding of data. 

 ● The project manager assembles all individual reviews and other
documents, such as the inspection report, into an “action package.” This document becomes the record for NDA review. The
review team issues a recommendation, and a senior official makes a decision. 

 NDA Approval 
 
 In cases where FDA or EMA determines that a drug has been shown to
be safe and effective for its intended use, it is then necessary to work with the applicant to develop and refine prescribing information.
This is referred to as “labeling.” Labeling accurately and objectively describes the basis for approval and how best to use
the drug.
 
 5 

 FDA Advisory Committees 
 
 Often, the NDA contains sufficient data for FDA or EMA to determine
the safety and effectiveness of a drug. Sometimes, though, questions arise that require additional consideration. In these cases, FDA
or EMA may organize a meeting of one of its Advisory Committees to get independent, expert advice and to permit the public to make comments.
These Advisory Committees include a Patient Representative that provides input from the patient perspective.
 
 The estimated timeframe for this process is as follows:
 
 ● Antigen discovery and vaccine formulation: 1-2 years 

 ● Preclinical studies: 1-2 years 

 ● IND filing and review: 1 month 

 ● Phase 1/2 clinical trials: 2-3 years 

 ● Phase 3 clinical trials: 2-3 years 

 ● Regulatory approval (including NDA review): 1 year 

 Based on this timeline, Vaximm anticipates that its first oral cancer
vaccine candidate beyond VXM01 could enter clinical trials within the next 3-5 years, with potential regulatory approval in
the next 7-9 years.
 
 Clinical Trials 
 
 Overview of VXM01 clinical trial 
 
 A phase1 clinical trial of VXM01 in Glioblastoma was initiated in May 2016
(ClinicalTrials.gov ID: NCT02718443). The trial was conducted at the Neurology Clinic and National Center for Tumor Diseases in Heidelberg,
Germany, and the principal investigator is Dr. Wolfgang Wick, MD, who is a professor at the Neurology Clinic and National Center
for Tumor Diseases.
 
 The phase I clinical trial was evaluated for 14 patients with
recurrent glioblastoma who had progressed after standard treatment and were candidates for reoperation. The primary objective of the study
was to examine the safety and tolerability of the investigational VEGFR2 DNA vaccine VXM01 after four vaccinations in glioblastoma patients.
The secondary objective was to examine the immune and biomarker response to the vaccine. During the course of this clinical trial, 7 patients
were alive and survived for more than 12 months after initiation of treatment. No adverse effects related to VXM01 were observed.
 
 source : Wick, W et al. “P01.031 VXM01 phase I study in
patients with progressive glioblastoma — final results.” Neuro-Oncology vol. 20, Suppl 3 (2018): iii235.
doi:10.1093/neuonc/noy139.073
 
 As the Phase 1 trial progressed, VXM01 was granted orphan drug
status by the FDA and EMA in 2017 for the treatment of glioma.
 
 Authority 
 
 Orphan

Designation 
 
 Designation date 
 
 Source 

 FDA 
 
 Treatment of Malignant glioma 
 
 08/31/2017 
 
 https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=596117 

 EMA 
 
 Treatment of glioma 
 
 23/08/2017 
 
 https://ec.europa.eu/health/documents/community-register/html/o1909.htm 

 As a next step, on November 21, 2018, a combination study of
VXM01 and anti-PD-L1 checkpoint inhibitor avelumab in 28 patients with relapsed glioblastoma began (ClinicalTrials.gov ID NCT03750071).
The trial included 25 patients with non-resectable tumors and 3 with resectable tumors. The main objective of the study is to evaluate
the safety and tolerability of VXM01 vaccine treatment in combination with avelumab.
 
 Dr. Wolfgang Wick, the principal investigator for the Phase I
clinical trial, also conducted this combination study.
 
 This Phase I/II clinical trial was not sized or designed to yield
advanced comparative statistical results. Larger patient cohorts and additional design features typical of Phase 2/PoC studies (including
randomization, Blinding, control groups) are required to obtain data yielding advanced statistics and guide the design of registrational
(Ph3) studies. Initiation of such trials is planned for 2026.
 
 VXM01 Phase I clinical trial — Patient selection
criteria
 
 Patients were selected by a third-party clinical trial provider, each
of whom met the following criteria:
 
 ● Diagnosis: anaplastic astrocytoma (WHO Grade III)
or glioblastoma (WHO Grade IV) located above the tentorium cerebelli in the brain. 

 6 

 ● Age: 18 years or older. 

 ● Sex: men or women who were post-menopausal for
at least 2 years or surgically sterile. 

 ● Disease progression: evidence of tumor growth
after at least one treatment regimen containing radiation and temozolomide chemotherapy. 

 ● Resectable tumor: eligible for a repeat surgery
to remove the tumor, with the surgery able to be delayed for 30 days. 

 ● General health: good bone marrow, liver, and
kidney function (as determined by blood and urine tests); able to undergo MRI scans; no active infection at the time of vaccination;
Karnofsky performance status greater than 70; and adequate blood counts. 

 ● No recent clinical trials: no participation in
another clinical trial within 30 days before screening. 

 ● No specific infections: negative test results
for Hepatitis B, Hepatitis C, and HIV. 

 ● No interfering conditions: no other medical or
social conditions that might interfere with the study or make it unsafe for the patient to participate. 

 The study included 14 white patients with a mean age of 56.8 years.
The majority of participants (64.3%) were male.
 
 VXM01 phase I clinical trial — Tumor response
 
 The tumor response was assessed by objective response rate (ORR) according
to immunotherapy Response Assessment for Neuro-Oncology (iRANO; 2015).
 
 Overall, the tumor response to VXM01 was mixed, with some patients
showing signs of stable disease or even tumor shrinkage, while others experienced disease progression. These findings highlight the variability
in treatment response and the challenges of managing glioblastoma. The extension study results provide further insights into the potential
for long-term disease control in some patients, but also underscore the need for further research to optimize treatment strategies
and identify those most likely to benefit.
 
 Best Overall Response 
 
 10 6 CFU (N=7) n (%) 
 
 10 7 CFU (N=6) n (%) 
 
 Total (N=13) n (%) 

 CR 
 
 1 (14.3) 
 
 — 
 
 1 (7.1) 

 PR 
 
 1 (14.3) 
 
 — 
 
 1 (7.1) 

 SD 
 
 5 (71.4) 
 
 5 (83.3) 
 
 10 (76.9) 

 PD 
 
 — 
 
 1 (16.7) 
 
 1 (7.1) 

 ORR (%) [95% CI] 
 
 28.6 [3.7 – 71.0] 
 
 0.0 [0.0 – 45.9] 
 
 15.4 [1.9 – 45.4] 

 DCRR (%) [95% CI] 
 
 100.0 [59.0 – 100.0] 
 
 83.3 [35.9 – 99.6] 
 
 92.3 [64.0 – 99.8] 

 Note: A hyphen (-) indicates no events were reported. n = number
of patients with an event; N = number of patients; NR = non-resectable. Percentages are based on the number of patients. CR = complete
response; PR = partial remission; SD = stable disease; PD = progressive disease; ORR = objective response rate (CR and PR);
DCR = disease control rate (CR, PR, and SD). 
 
 In this study, we assessed clinical response using several measures,
including progression-free survival (PFS) and overall survival (OS). PFS ranged from 9 to 366 days, with a median PFS of 0.8 months
in the 10 7 CFU dose group and 2.6 months in the 10 6 CFU dose group. OS ranged from 67 to 416 days,
with a median OS of greater than 14 months in the 10 6 CFU group and 7.6 months in the 10 7 CFU
group.
 
 For the 3 patients who entered the prolongation phase, PFS ranged between
30 and 960 days, and overall survival ranged between 776 and 1147 days. These findings suggest a potential advantage in terms
of PFS and OS for the lower dose group, although they may be influenced by the slightly better baseline status of the patients in the
10 6 CFU dose group.
 
 VXM01 phase I clinical trial — Immune response
 
 The effect of VXM01 was explored by evaluating the VEGFR-2 specific
T cell response and frequency of immune cells in peripheral blood, and by staining of immune- and biomarkers in tumor tissue obtained
during resection.
 
 Peripheral T-cell response: 
 
 All 9 tested patients showed a VEGFR2-specific T-cell and
IFN-γ immune response, with a clear increase observed after the initial vaccination and further increases after the first booster
dose. This indicates that VXM01 effectively stimulated an immune response against VEGFR2, a protein involved in tumor growth.
 
 7 

 ELISpot assay was used to measure the number of these T cells that
produced interferon gamma (IFN-γ) when stimulated with different fragments of the VEGFR-2 protein.
 
 Mean difference count pool-all minus negative control 
 
 10 6 CFU; mean ± SD (N) 
 
 10 7 CFU; mean ± SD (N) 
 
 Total; mean ± SD (N) 

 Day 0 
 
 4.5 ± 6.22 (3) 
 
 18.1 ± 17.64 (5) 
 
 13.0 ± 15.46 (8) 

 Day 21 
 
 14.5 ± 10.35 (3) 
 
 10.4 ± 17.13 (4) 
 
 12.2 ± 13.68 (7) 

 Day 35 
 
 8.4 ± 7.06 (3) 
 
 13.4 ± 15.36 (5) 
 
 11.6 ± 12.48 (8) 

 Week 12 + 10 days 
 
 -17.5 (2) 
 
 30.6 ± 20.96 (5) 
 
 16.9 ± 30.39 (7) 

 Week 24 + 10 days 
 
 -2.0 (1) 
 
 -4.5 ± 9.57 (4) 
 
 -4.0 ± 8.36 (5) 

 Week 36 + 10 days 
 
 20.4 (1) 
 
 27.0 (2) 
 
 24.8 ± 4.45 (3) 

 Week 48 + 10 days 
 
 29.6 (1) 
 
 28.7 (1) 
 
 29.2 (2) 

 Brain Tumor Immunohistochemistry: 
 
 An analysis of tumor tissue from 8 re-operated patients showed
a statistically significant increase in CD8 T-cells (immune cells that kill cancer cells) after vaccination with VXM01. Specifically,
the mean number of CD8 T-cells increased from 159 cells/mm² in the primary tumor to 296 cells/mm² in the recurrent tumor,
with a P-value of 0.0239 (paired t-test). Additionally, there was a decrease in regulatory T-cells (Treg), which are immune
cells that suppress immune responses. The median number of Treg cells dropped from 32 cells/mm² in the primary tumor to 12 cells/mm²
in the recurrent tumor. This resulted in a higher CD8:Treg ratio, which has been associated with better clinical outcomes in other studies.
 
 VXM01 phase I clinical trial — Safety result
 
 In this trial, there were no notable differences observed between the
two dose groups (10 6 CFU and 10 7 CFU).
 
 All patients experienced at least one treatment-emergent adverse
event (TEAE), but most were mild or moderate in severity and considered unrelated to VXM01. The most common TEAEs were consistent with
the underlying disease or progression of disease, and included aphasia, hemiparesis, fatigue, headache, and lymphopenia.
 
 No treatment-limiting toxicities (TLTs) were observed. Four TEAEs
(flatulence, dizziness, fatigue, and nausea) were considered related to VXM01, but all were mild and resolved without intervention. All
serious adverse events (SAEs) and deaths were attributed to the underlying disease or disease progression.
 
 Adverse after prime and boosting doses 
 
 10 6 CFU (N=7) n (%) E 
 
 10 7 CFU (N=6) n (%) E 

 Drug related TEAEs 
 
 1 (14.3) 2 
 
 2 (33.3) 2 

 Drug related SAEs 
 
 — 
 
 — 

 Drug related Treatment-Emergent SAEs 
 
 — 
 
 — 

 TLTs Related to VXM01 
 
 — 
 
 — 

 Treatment Discontinuations Due to AEs 
 
 — 
 
 — 

 Study Discontinuations Due to AEs 
 
 — 
 
 — 

 Note: A hyphen (-) indicates no events were reported. E = number
of events; n = number of patients with an event; N = number of patients. Percentages are based on the number of patients. CFU: colony
forming units. 
 
 VXM01 phase I/II clinical trial — Patient selection
criteria
 
 Patients were selected by a third party clinical trial provider, each
of whom met the following criteria:
 
 ● Diagnosis: confirmed glioblastoma (WHO Grade IV)
located above the tentorium cerebelli in the brain. 

 ● Disease progression: evidence of tumor growth
after receiving standard treatment with radiation and temozolomide chemotherapy. 

 ● Prior treatment: completion of radiotherapy at
least 3 months before entering the trial. 

 ● Resectable tumors (subset of patients): eligible
for a repeat surgery to remove the tumor, with the surgery able to be delayed for 30 days. 

 ● General health: good bone marrow, liver, and
kidney function; able to undergo MRI scans; no active serious infections; and a Karnofsky performance status of 70 or higher (meaning
they could mostly care for themselves). 

 8 

 ● Tumor samples: availability of tumor tissue for
analysis. 

 ● Sex: men were eligible. Women had to be post-menopausal or
surgically sterile due to a lack of safety data on the vaccine’s potential impact on reproduction. 

 With these criteria, the trial recruited 25 patients with non-resectable tumors
and 3 with resectable tumors. Overall, the mean age of participants was 58 years, with the majority (78.6%) being male.
 
 VXM01 phase I/II clinical trial — Tumor response
 
 The tumor response was assessed by Objective Response Rate (ORR) and
Duration of Response (DoR) according to immunotherapy Response Assessment for Neuro-Oncology (iRANO; 2015)
 
 Overall, in the non-resectable patients the ORR was 12.0% (95%
CI: 2.5 – 31.2), with 3 responders out of 25 patients (12.0%) who had a partial remission. Of the patients with a
partial remission, 1 patient in the 10 6 CFU/mL group had a DoR of 5.6 months, while the patients in the 10 7 CFU/mL
group had a DoR of 2.7 and 11.1 months. All patients who had stable disease (n=3) received 10 7 CFU/mL VXM01.
 
 Best Overall Response 
 
 10 6 CFU/mL (N=3) n (%) 
 
 10 7 CFU/mL (N=25) n (%) 
 
 Total NR (N=25) n (%) 

 PR 
 
 1 (33.3) 
 
 2 (8.0) 
 
 3 (12.0) 

 SD 
 
 — 
 
 3 (12.0) 
 
 1 (4.0) 

 PD 
 
 2 (66.7) 
 
 20 (80.0) 
 
 21 (84.0) 

 ORR (%) [95% CI] 
 
 33.3 [0.8 – 90.6] 
 
 8.0 [1.0 – 26.0] 
 
 12.0 [2.5 – 31.2] 

 DCRR (%) [95% CI] 
 
 33.3 [0.8 – 90.6] 
 
 20.0 [6.8 – 40.7] 
 
 16.0 [4.5 – 36.1] 

 Note: A hyphen (-) indicates no events were reported. n = number
of patients with an event; N = number of patients; NR = non-resectable. Percentages are based on the number of patients. CR = complete
response; PR = partial remission; SD = stable disease; PD = progressive disease; ORR = objective response rate (CR and PR); DCR = disease
control rate (CR, PR, and SD). 
 
 The clinical response was assessed by recurrence-free survival
after re-operation (RFS) (in the 10 7 CFU/mL resectable group), time-to-progression (TTP), progression free survival
(PFS), and overall survival (OS). In the patients who underwent tumor resection (10 7 CFU/mL resectable group), disease
progression occurred only in Patient 01-17 with an RFS of 1.8. Patient 01-14 was censored with an RFS of 20.9 months.
The results for TTP and PFS were identical, with an overall median of 2.7 months and range of 1.2 to 13.8 months in the non-resected patients
(Total NR group). The median OS in the Total NR group was 11.1 months (95% CI: 8.5 – 15.1) with a range of 3.8 to
38.2 months. At the time of database lock, 1 patient in the 10 7 CFU/mL resectable group was alive and had stable
disease without post-resection recurrence, while 3 patients in the 10 7 CFU/mL non-resectable group were alive
with progressive disease in longterm follow-up.
 
 VXM01 phase I/II clinical trial — Immune response
 
 The effect of VXM01 plus avelumab was explored by evaluating the VEGFR-2 specific
T cell response and frequency of immune cells in peripheral blood, and by staining of immune- and biomarkers in tumor tissue obtained
during resection.
 
 ELISpot assay was used to measure the number of these T cells that
produced interferon gamma (IFN-γ) when stimulated with different fragments of the VEGFR-2 protein.
 
 VEGFR-2 specific ELISpot counts were calculated as the ELISpot
count per peptide pool minus the negative control. The VEGFR-2 specific T cell response was defined positive when the test peptide
pool had at least two-fold higher spot counts compared to the negative control and the difference of the triplicates was significant
in an unpaired two-tailed student’s t-test .
 
 Overall, 12 of 28 patients (42.9%, all in the 10 7 CFU/mL
non-resctable group) had a VEGFR-2 specific T cell response classified as negative for all peptides at all time points tested.
The VEGFR-2 specific T cell response was decreased on Day 21 compared with baseline in 6 patients, was increased in 4 patients (all
10 7 CFU/mL non-resectable group), and remained at the same level compared with baseline in 5 patients. At Week 16,
the VEGFR-2 specific T cell response was increased compared with baseline in 7 patients (1 patient in 10 6 CFU/mL
group, 6 patients in 10 7 CFU/mL group), decreased in 5 patients (all 10 7 CFU/mL group), and remained the
same in 3 patients.
 
 9 

 VXM01 phase I/II clinical trial — Safety result
 
 The majority of reported events in this trial being mild to moderate
severity in nature but would need to be assessed in a larger patient population. Notably, while SAEs were observed during the study period,
all of them were target disease-related rather than treatment-related. The observed SAEs included brain edema, epilepsy, stroke,
hyponatremia, gait disturbance, and pulmonary embolism, which are commonly reported symptoms in patients with brain tumors or severe illnesses
as their disease progresses and were not attributable to VXM01 administration. A safety evaluation will be determined following review
of all safety data by relevant regulatory agencies.
 
 All patients (n=28; 100%) experienced multiple AEs, but no treatment-limiting toxicities
(TLT) related to VXM01 or avelumab, or infusion-related adverse events (AEs) were recorded for any group. No treatment-related SAEs
were recorded for the 10 6 CFU/mL and 10 7 CFU/mL resectable groups. No VXM01- or avelumab-related SAEs
or treatment-emergent SAEs were recorded for any group. One patient discontinued study treatment due to rheumatoid arthritis which
occurred after the first 5 weeks of treatment. This adverse event was assessed as unrelated to VXM01 administration and occurred
independently of the patient’s underlying condition, thus it was not reported as TLT. Four patients experienced a total of 5 (five)
immune-related AEs (irAEs). These immune-related AEs included hypothyroidism, autoimmune thyroiditis, fatigue, and the aforementioned
rheumatoid arthritis. As with other reported events, these immune-related AEs were assessed and determined to be unrelated to VXM01
administration.
 
 Adverse Event Category 
 
 10 6 CFU/mL (N=3) n (%) E 
 
 10 7 CFU/mL (N=25) n (%) E 

 Drug related SAEs 
 
 — 
 
 — 

 Drug related Treatment-Emergent SAEs 
 
 — 
 
 — 

 TLT Related to VXM01 
 
 — 
 
 — 

 TLT Related to avelumab 
 
 — 
 
 — 

 Infusion-related Adverse Events 
 
 — 
 
 — 

 Immune-related Adverse Events 
 
 — 
 
 4 (16.0) 5 

 Treatment Discontinuations Due to AEs 
 
 — 
 
 1 (4.0) 1 

 Study Discontinuations Due to AEs 
 
 — 
 
 — 

 Note: A hyphen (-) indicates no events were reported. E = number
of events; n = number of patients with an event; N = number of patients. Percentages are based on the number of patients. 
 
 Intellectual Property 
 
 Vaximm actively maintains 8 patent families relating to Vaximm’s
portfolio of assets, in the United States and in other major markets as described shown in the tables below of specific patents within
each patent family that have been issued or are under examination. All patents within each of the active patent families have been issued
or are currently under various stages of nationalization and are owned or in-licensed patent families by Vaximm and cover composition
of matter, formulation and/or methods of use, are shown in the table below.
 
 Manufacturing (1)

WO 2013/091898, Method for Producing High Yield Attenuated Salmonella Strains 
 
 Country Code 
 Type 
 Filing date 
 Filing no. 
 Grant Date 
 Grant no. 
 Publ. No. 
 Expiry 
 Status 

 WO 
 PCT 
 21/12/2012 
 PCT/EP2012/005364 
 
 2013/091898 
 — 
 
 AU 
 PCT 
 21/12/2012 
 2012359166 
 23/11/2017 
 2012359166 
 2012359166 
 21/12/2032 
 granted 

 CA 
 PCT 
 21/12/2012 
 2,853,656 
 29/12/2020 
 2,853,656 
 2,853,656 
 21/12/2032 
 granted 

 CN 
 PCT 
 21/12/2012 
 201280064144.2 
 19/04/2017 
 104066834 
 104066834 
 21/12/2032 
 granted 

 EP* 
 PCT 
 21/12/2012 
 12 808 264.1 
 30/08/2017 
 2 794 849 
 2 794 849 
 21/12/2032 
 granted 

 IN 
 PCT 
 21/12/2012 
 5386/DELNP/2014 
 10/06/2019 
 313960 
 IN05386DN2014 
 21/12/2032 
 granted 

 JP 
 PCT 
 21/12/2012 
 2014-547768 
 01/12/2017 
 6251179 
 2015-502162 
 21/12/2032 
 granted 

 KR 
 PCT 
 21/12/2012 
 10-2014-7020387 
 23/08/2019 
 10-2015932 
 10-2014-0105028 
 21/12/2032 
 granted 

 US 
 PCT 
 21/12/2012 
 14/366,186 
 15/11/2016 
 9,493,738 
 2014-0349274 
 21/12/2032 
 granted 

 ZA 
 PCT 
 21/12/2012 
 2014/04501 
 24/02/2016 
 2014/04501 
 2014/04501 
 21/12/2032 
 granted 

 10 

 VXM01 — dosing (2)

WO 2014/005683, DNA Vaccine for Use in Pancreatic Cancer Patients 
 
 Country Code 
 Type 
 Filing date 
 Filing no. 
 Grant Date 
 Grant no. 
 Publ. No. 
 Expiry 
 Status 

 WO 
 PCT 
 26/06/2013 
 PCT/EP2013/001882 
 
 2014/005683 
 — 
 
 AU 
 PCT 
 26/06/2013 
 2013286335 
 07/12/2017 
 2013286335 
 2013286335 
 26/06/2033 
 granted 

 AU 
 DIV 
 26/06/2013 
 2017258877 
 14/03/2019 
 201725887 
 2631924 
 26/06/2033 
 granted 

 CA 
 PCT 
 26/06/2013 
 2,877,938 
 
 2,877,938 
 26/06/2033 
 under examination 

 CN 
 PCT 
 26/06/2013 
 201380035905.6 
 30/10/2020 
 CN201380035905.6A 
 104519908 
 26/06/2033 
 granted 

 EP* 
 PCT 
 26/06/2013 
 13 732 833.2 
 25/09/2019 
 2 869 836 
 2 869 836 
 26/06/2033 
 granted 

 IN 
 PCT 
 26/06/2013 
 180/DELNP/2015 
 
 IN00180DN2015 
 26/06/2033 
 under examination 

 JP 
 PCT 
 26/06/2013 
 2015-518890 
 20/04/2018 
 6325534 
 2015-522263 
 26/06/2033 
 granted 

 KR 
 PCT 
 26/06/2013 
 10-2015-7002939 
 12/03/2020 
 10-2090612 
 10-2015-0036361 
 26/06/2033 
 granted 

 US 
 PCT 
 26/06/2013 
 14/409,434 
 16/08/2016 
 9,415,098 
 2015-0165011 
 26/06/2033 
 granted 

 US 
 CON2 
 31/05/2018 
 15/994,766 
 21/05/2019 
 10,293,037 
 2019-0008936 
 26/06/2033 
 granted 

 ZA 
 PCT 
 26/06/2013 
 2014/09156 
 27/07/2016 
 2014/09156 
 2014/09156 
 26/06/2033 
 granted 

 VXM06 — WT1 (3)

WO 2014/173542, Salmonella-based vectors for cancer immunotherapy targeting Wilms’ tumor gene 
 
 Country Code 
 Type 
 Filing date 
 Filing no. 
 Grant Date 
 Grant no. 
 Publ. No. 
 Expiry 
 Status 

 WO 
 PCT 
 24/04/2014 
 PCT/EP2014/001099 
 
 2014/173542 
 — 
 
 EP* 
 PCT 
 24/04/2014 
 14 721 208.8 
 06/06/2018 
 2 988 762 
 2 988 762 
 24/04/2034 
 granted 

 JP 
 PCT 
 24/04/2014 
 2016-509326 
 12/10/2018 
 6416877 
 2016-518835 
 24/04/2034 
 granted 

 US 
 PCT 
 24/04/2014 
 14/786,652 
 20/03/2018 
 9,920,297 
 14/786,652 
 24/04/2034 
 granted 

 US 
 CON 
 24/04/2014 
 15/872,750 
 27/10/2020 
 10,815,455 
 2018/0163169 
 24/04/2034 
 granted 

 VXM04-MSLN (4)

WO 2015/090584, Novel MSLN targeting DNA vaccine for cancer immunotherapy 
 
 Country Code 
 Type 
 Filing date 
 Filing no. 
 Grant Date 
 Grant no. 
 Publ. No. 
 Expiry 
 Status 

 WO 
 PCT 
 17/12/2014 
 PCT/EP2014/003403 
 
 2015/090584 
 — 
 
 EP* 
 PCT 
 17/12/2014 
 14 821 508.0 
 28/08/2019 
 3 082 850 
 3 082 850 
 17/12/2034 
 granted 

 JP 
 PCT 
 17/12/2014 
 2016-559513 
 14/01/2020 
 6662787 
 2017-502692 
 17/12/2034 
 granted 

 US 
 CON 
 17/12/2014 
 15/785,743 
 15/10/2019 
 10,441,645 
 2018/0064794 
 17/12/2034 
 granted 

 VXM01 — combination (5)

WO 2016/202459, VEGFR-2 targeting DNA vaccine for combination therapy 
 
 Country Code 
 Type 
 Filing date 
 Filing no. 
 Grant Date 
 Grant no. 
 Publ. No. 
 Expiry 
 Status 

 WO 
 PCT 
 16/06/2016 
 PCT/EP2016/001004 
 
 2016/202459 
 — 
 
 AU 
 PCT 
 16/06/2016 
 2016278588 
 31/03/2022 
 AU2016278588A 
 2016278588 
 16/06/2036 
 granted 

 CA 
 PCT 
 16/06/2016 
 2989247 
 17/10/2023 
 CA2989247A 
 2989247 
 16/06/2036 
 granted 

 CN 
 PCT 
 16/06/2016 
 201680035593.2 
 13/07/2021 
 CN201680035593.2A 
 107995868 
 16/06/2036 
 granted 

 EP 
 PCT 
 16/06/2016 
 16736381.1 
 06/11/2019 
 3 310 379 
 3 310 379 
 16/06/2036 
 granted 

 EPHK 
 PCT 
 
 118111736.6 
 11/12/2020 
 HK1252435 
 HK1252435 
 16/06/2036 
 granted 

 EP(T1) 
 DIV 
 
 19205420.3 
 
 3626262 
 16/06/2036 
 under examination 

 IN 
 PCT 
 16/06/2016 
 201717043556 
 08.11.2023 
 467201 
 201717043556 A 
 16/06/2036 
 granted 

 JP 
 PCT 
 16/06/2016 
 2017-565248 
 21.09.2021 
 JP2017565248A 
 2018517419 
 16/06/2036 
 under examination 

 11 

 Country Code 
 Type 
 Filing date 
 Filing no. 
 Grant Date 
 Grant no. 
 Publ. No. 
 Expiry 
 Status 

 US 
 PCT 
 16/06/2016 
 15/737,659 
 02/02/2021 
 10,905,752 
 US 2018/0250345 
 16/06/2036 
 granted 

 US 
 CON 
 16/06/2016 
 17/107,203 
 
 US20210077605A1 
 16/06/2036 
 pending 

 ZA 
 PCT 
 16/06/2016 
 2017/08439 
 26/05/2021 
 2017/08439 
 
 16/06/2036 
 granted 

 VXM01 Tumor expression (7)

WO 2018/149982, Novel VEGFR-2 targeting immunotherapy approach 
 
 Country Code 
 Type 
 Filing date 
 Filing no. 
 Grant Date 
 Grant no. 
 Publ. No. 
 Expiry 
 Status 

 WO 
 PCT 
 16/02/2018 
 PCT/EP2018/053918 
 
 WO 2018/149982 
 — 
 
 AU 
 PCT 
 16/02/2018 
 2018222777 
 01/02/2024 
 2018222777B9 
 2018222777 A 
 16/02/2038 
 granted 

 CA 
 PCT 
 16/02/2018 
 305833 
 
 305833 A 
 16/02/2038 
 under examination 

 CN 
 PCT 
 16/02/2018 
 201880012318.8 
 
 110291187 A 
 16/02/2038 
 under examination 

 EP 
 PCT 
 16/02/2018 
 18 704 568.7 
 
 3 583 200 A 
 16/02/2038 
 under examination 

 IN 
 PCT 
 16/02/2018 
 201917030262 
 
 201917030262 a 
 16/02/2038 
 under examination 

 JP 
 PCT 
 16/02/2018 
 2019-544614 
 
 16/02/2038 
 under examination 

 US 
 PCT 
 16/02/2018 
 16/486,425 
 20/04/2021 
 10980868B2 
 2020038496 A 
 16/02/2038 
 granted 

 VXM10 — PD-L1 (8)

WO 2018/167290, Novel PD-L1 targeting DNA vaccine for cancer immunotherapy 
 
 Country Code 
 Type 
 Filing date 
 Filing no. 
 Grant Date 
 Grant no. 
 Publ. No. 
 Expiry 
 Status 

 WO 
 PCT 
 16/02/2018 
 PCT/EP2018/056721 
 
 WO 2018/167290 
 — 
 
 CN 
 PCT 
 16/02/2018 
 201880018761.6 
 
 110430893 
 16/02/2038 
 under examination 

 EP 
 PCT 
 16/02/2018 
 18710879 
 
 3 595 704 
 16/02/2038 
 under examination 

 JP 
 PCT 
 16/02/2018 
 2019-550795 
 
 2020-511139 
 16/02/2038 
 under examination 

 VXM01 in combination with an antibiotic (9)

WO 2021/144254, Salmonella-based DNA vaccines in combination with an antibiotic 
 
 Country Code 
 Type 
 Filing date 
 Filing no. 
 Grant Date 
 Grant no. 
 Publ. No. 
 Expiry 
 Status 

 WO 
 PCT 
 12/01/2021 
 PCT/EP2021/050470 
 
 WO 2021/144254 
 — 
 
 AU 
 PCT 
 12/01/2021 
 2021208400 
 
 2121208400 
 12/01/2041 
 under examination 

 CA 
 PCT 
 12/01/2021 
 3162994 
 
 3162994 
 12/01/2041 
 under examination 

 CN 
 PCT 
 12/01/2021 
 202180008543.6 
 
 114980871 
 12/01/2041 
 under examination 

 EP 
 PCT 
 12/01/2021 
 21700697 
 
 4090321 
 12/01/2041 
 under examination 

 IN 
 PCT 
 12/01/2021 
 202217033481 
 
 202217033481 
 12/01/2041 
 under examination 

 JP 
 PCT 
 12/01/2021 
 2022542046 
 
 2023510770 
 12/01/2041 
 under examination 

 KR 
 PCT 
 12/01/2021 
 1020227027291 
 
 1020220128638 
 12/01/2041 
 under examination 

 US 
 PCT 
 12/01/2021 
 17791282 
 
 20230121528 
 12/01/2041 
 under examination 

 12 

 Darnatein 
 
 Corporate Overview 
 
 Darnatein is developing design-augmented (DA) biologics for age-related and
other degenerative diseases, such as osteoarthritis and spine and joint disorders. Darnatein’s lead DA biologics are intended to
be injected directly into pathological tissues to promote regeneration of target tissues such as bone or cartilage cells. Leveraging these
innovative DA biologics to regenerate bone and cartilage has the potential to restore functionality and reduce pain across several degenerative
conditions.
 
 Darnatein has identified and advanced two therapeutic candidates, DRT-102,
a clinical-stage asset for spinal fusion, and DRT-101, a pre-clinical stage asset for osteoarthritis. A small exploratory, clinical
trial of 15 patients with DRT-102 indicated potential efficacy compared to a placebo, with no serious adverse events reported. Safety
and efficacy evaluation will be determined following review of all safety data by relevant regulatory agencies. Larger clinical trials
will be required to provide more extensive and accurate data on the safety and effectiveness of DRT102. A pre-clinical (non-human)
trial of DRT-101 demonstrated cartilage regeneration and joint healing in animals, with no serious adverse events reported. Based
on these preliminary results, Darnatein intends to continue the development and testing of DRT-101 and, when additional resources
are available, DRT-102. Darnatein has not previously advanced any therapeutic candidates into late-stage clinical trials nor received
regulatory and marketing approvals for any commercial sales of its products.
 
 Opportunity 
 
 Age-related degeneration, such as osteoarthritis and spine disorders,
is a naturally occurring process that may be accelerated due to chronic and cumulative impact over time. Limited therapeutic options exist
and only offer limited and temporary symptomatic relief with no cure currently available.
 
 Beyond therapeutic options, invasive surgical procedures may be available
for spine and joint disorders but are not readily accessible and may not be a curative, pain-free, long-term solution. Additionally,
neither symptomatic therapies nor invasive and costly surgical procedures address the underlying cause of chronic and age-related degenerative
diseases. Darnatein’s novel Design Augmented (DA) approach has the potential to overcome these limitations of spine and joint disorders
and osteoarthritis with a regenerative therapy to overcome degeneration in bone and cartilage.
 
 Design-Augmented Biologics Program 
 
 In recent years, scientists have studied the role of bone morphogenetic
proteins (BMPs) in healing bone and cartilage. BMPs have been used clinically in orthopedic procedures but they are typically administered
at high, supra-physiological concentrations that have been linked to undesirable local and systemic side effects. BMPs engineered
to have enhanced therapeutic potency may circumvent this problem and provide the desired effects of healing bone and cartilage while minimizing
the likelihood of adverse events.
 
 DRT-101 for Cartilage and Joint Recovery
 
 DRT-101 is a synthetic bio-signaling molecule that replaces
BMPRII-binding segments of BMP-7, one of the bone-forming proteins, with high affinity ActRII binding segments of Activin A,
a member of the transforming growth factor ß (TGF-ß). In nature, endogenous BMP7 promotes chondrogenesis in damaged cartilage
tissue by signaling primarily via the type II receptor BMPRII and to a lesser extent via the activin type II receptor ActRII,
which it binds with lower affinity. DRT-101 amplifies intracellular regeneration signaling capacity compared to natural BMP-7 and
allows for regeneration and restoration of mechanically depleted cartilage cells to normal levels.
 
 DRT-101 pre-clinical study in animals
 
 DRT-101 was evaluated in Sprague Dawley rats by ChemOn Inc. in
2021 for toxicity measurement. This study was conducted to assess the approximate lethal dose (ALD) and the dose-range finding(DRF)
of the test substance DRT-101, when administered intravenously.
 
 The table below lists the type, species, purpose and results of our
completed pre-clinical toxicology studies from 2021-2022. These studies were conducted with the assistance of Chemon Inc., a
GLP-licensed third-party vendor.
 
 13 

 Type of Study 
 
 Species 
 
 Purpose 
 
 Results 
 
 Period 

 Single Dose Intravenous Toxicity Test of DRT-101 in Sprague-Dawley Rats 
 
 Sprague Dawley Rats 
 
 Assess the toxicity of the test substance DRT-101 when administered intravenously to Sprague-Dawley Rats 
 
 The approximate lethal dose (ALD) was determined to exceed 10mg/kg for both males and females. 
 
 2021.03.05-

2021.05.11 

 Single Dose Intravenous Toxicity Test of DRT-101 in Sprague-Dawley Rats 
 
 Sprague Dawley Rats 
 
 Investigate the toxicity and histopathological changes at the administration route 
 
 The approximate lethal dose exceeded 0.625 mg/kg for both males and females, and toxicologically adverse changes including dysplasia and hypertrophy of cartilage at the injection area were observed. 
 
 2021.04.29-

2021.11.01 

 Two-Week Repeated Dose Intravenous Toxicity Test of DRT-101 in Sprague-Dawley Rats 
 
 Sprague Dawley Rats 
 
 Investigate the toxicity of DRT-101 when administered intravenously to Sprague-Dawley rats repeatedly for two weeks, with the aim of determining dosage for subsequent intravenous toxicity tests 
 
 DRT-101 was injected at dose of 0.069, 0.208, and 0.625 mg/kg/day. Swelling at the administration area (tail) was observed in male and female rats in dose groups above 0.208 mg/kg/day. Induration at the administration area was observed in all test substance groups of both sexes. The induration is speculated to be dysplasia and hypertrophy of cartilage in the tail. Accordingly, it is recommended to set 0.069 mg/kg/day as the high-dose group for the next repeated intravenous toxicity studies. 
 
 2021.12.07-

2022.02.10 

 Currently, the toxicity test of DRT-101 is ongoing with BiotoxTech.
The purpose of this study is to evaluate the potential toxicity and determine the dose levels for a repeated toxicity study of DRT-101,
when given Intra-articular injection to rats and Beagles(non-rodents)
 
 The table below outlines the type, species, purpose and results of
the pre-clinical toxicology studies so far conducted with the assistance of BiotoxTech
 
 Type of study 
 
 Species 
 
 Purpose 
 
 Results 
 
 Date of

Completion 

 30-Day Repeated Intraarticular Injection (total 2 times) Dose Range Finding Study 
 
 Sprague-

Dawley Rats 
 
 To evaluate the potential toxicity and determine the dose levels for a repeated toxicity study of DRT-101, when given Intra-articular injection to the Sprague-Dawley rats. 
 
 There were no DRT-101-related effects on body weight, food consumption,
 clinical pathology, or organ weight.

 In external and macroscopic evaluations, thickening in the injection
 site was observed in both sexes of the 3, 9 and 30 µg/animal groups in a dose-dependent manner.

 p-values < 0.05 (Anova&Dunnett)
 
 2024.09.13 

 14 

 Type of study 
 
 Species 
 
 Purpose 
 
 Results 
 
 Date of

Completion 

 30-Day Repeated Intraarticular Injection (total 2 times) Dose Range Finding Study 
 
 Beagle dogs 
 
 To evaluate the potential toxicity of DRT-101 when administered via intra-articular injection to Beagle dogs 2 times with an interval of 4 weeks, and to determine the dose levels for a 6-week repeated toxicity study. 
 
 No deaths occurred during the course of the study. In clinical observations, all animals in DRT-101 dosing groups exhibited edemas at injection sites and abnormal gait after dosing. Edemas were exhibited in a broad area around the injection site, the right stifle joint, gradually recovering in 10 days for the 0.05 and 0.15 mg/animal dose groups, and in 24 days for the 0.5 mg/animal dose group. 
 
 2024.09.03 

 DRT-102 for Bone Regeneration
 
 DRT-102 is an investigational product classified as a medical
device product by the Ministry of Food and Drug Safety of the Republic of Korea (“MFDS”). DRT-102 is composed of freeze-dried AB204
protein, that promotes bone formation, and a synthetic bone graft in granular form.
 
 The AB protein (AB204) is a synthetic protein, created by fusing Activin
and BMP-2, both members of the BMP (Bone Morphogenetic Protein) family, growth factors by Darnatein’s segmental reassembly technology.
AB204 combines BMP’s type II receptor binding with activin A’s high-affinity type II receptor binding. It induces
significantly greater and longer-lasting Smad 1/5/8 phosphorylation in osteoblastic cells compared to BMP2, promoting mineral calcium
nodule formation crucial for bone apatite formation. Unlike BMP2, AB204 is unaffected by noggin by design and also inhibits activin signaling,
which further enhances its bone formation and is noteworthy since activin antagonism itself can promote bone formation. When used in conjunction
with existing synthetic bone grafts, it facilitates the generation of new bone and can aid in fracture healing.
 
 The synthetic bone graft uses approved products and is composed of
hydroxyapatite and beta-tricalcium phosphate, with internal pores connected in a three-dimensional structure. By coating a highly
bioactive and absorbable ß -TCP on an HA scaffold that can support structurally for a long period with excellent biocompatibility
and slow biodegradation, it enables rapid initial bone bonding and long-term support dynamics.
 
 DRT-102 pre-clinical study for toxicity measurement in animal
models
 
 The toxicity test of DRT-102 was conducted with multiple institutions
including KTR (Korea Chemical Corporation), KIT (Korea Institute of Toxicology), and ChemOn. The purpose of this study is to evaluate
the potential toxicity and determine the dose levels for a repeated toxicity study of DRT-102, when intravenously administered to rats
and Beagles(non-rodents)
 
 The table below outlines the type, species, purpose and results of
the pre-clinical toxicology studies so far.
 
 Type of study 
 
 Species 
 
 Purpose 
 
 Results 
 
 Date 
 
 Institution 
 
 Dose Range Finding Study: 2-Week Repeated Intravenous Injection 
 
 Sprague-

Dawley Rats 
 
 To evaluate the potential toxicity and determine the dose levels for a repeated toxicity study of DRT-102, when intravenously injected to the Sprague-Dawley rats. 
 
 No deaths were observed. A slight dose-dependent increase in the absolute and relative weights of the spleen and liver was noted in female rats administered 0.25 and 0.5 mg/kg/day. Therefore, it was determined to set the high dose for the 4-week repeated intravenous toxicity study at 0.5 mg/kg/day 
 
 2013.11.11

~

2014.05.07 
 
 ChemOn 
 
 15 

 Type of study 
 
 Species 
 
 Purpose 
 
 Results 
 
 Date 
 
 Institution 

 Single Intravenous Injection 
 
 Sprague-

Dawley Rats 
 
 To evaluate the potential toxicity of DRT-102 when administered intravenously single time 
 
 The approximate lethal dose (ALD) of AB204 was determined to exceed 10 mg/kg (400 times the clinically intended dose) for both males and females. 
 
 2012.02.02

~

2012.04.09 
 
 ChemOn 

 4-Week Repeated Intravenous Injection with 2-Week Recovery Period for Rodents 
 
 Sprague-

Dawley Rats 
 
 To evaluate the characteristics of DRT-102 when administered intravenously to Sprague-Dawley rats repeatedly for 4 weeks and to assess its recovery potential through a 2-week recovery period. 
 
 No deaths were observed, and no toxicologically adverse changes were detected. Under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) of the test substance DRT-102 in rats was determined to be 0.32 mg/kg/day. 
 
 2014.01.02

~

2014.06.16 
 
 ChemOn 

 Dose Range Finding Study: 2-Week Repeated Intravenous Injection for Non-Rodents 
 
 Beagle dog 
 
 To evaluate the characteristics of DRT-102 when administered intravenously to Beagle dog repeatedly for 2 weeks. 
 
 No changes attributable to the test substance were observed. Therefore, in the upcoming 4-week repeated intravenous toxicity study, the high dose will be set at 0.5 mg/kg/day 
 
 2013.11.25

~

2014.02.13 
 
 ChemOn 

 4-Week Repeated Intravenous Injection with 2-Week Recovery Period for Non-Rodents Following PK Sampling 
 
 Beagle dog 
 
 To examine the characteristics of DRT-102 when administered intravenously to Beagle dogs repeatedly for 4 weeks, and to assess its recovery potential through a 2-week recovery period 
 
 No toxicological changes were observed. Therefore, under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was determined to be 0.32 mg/kg/day for both males and females. 
 
 2014.02.11

~

2014.07.18 
 
 ChemOn 

 Safety Test – Cardiovascular System 
 
 Beagle Dog 
 
 To evaluate the effects of a single intravenous administration of DRT-102 to male Beagle dogs on cardiovascular function, including blood pressure, heart rate, and electrocardiogram (ECG), using a telemetry device for remote monitoring. 
 
 No adverse effect on cardiovascular function, including blood pressure, heart rate, and electrocardiogram (ECG) was observed. 
 
 2014.07.17

~

2014.08.07 
 
 KIT (Korea Institute of Toxicology) 

 Safety Test – Respiratory System 
 
 Sprague-

Dawley Rats 
 
 To evaluate the effects of a single intravenous administration of the test substance AB204 on the respiratory system by measuring the respiratory rate and volume in Sprague-Dawley rats. 
 
 When DRT-102 is administered as a single intravenous dose of 0.8 mg/kg or lower, the test substance does not affect the respiratory system. 
 
 2014.07.17

~

2014.08.07 
 
 ChemOn 

 16 

 Type of study 
 
 Species 
 
 Purpose 
 
 Results 
 
 Date 
 
 Institution 
 
 Safety Test – Central Nervous System 
 
 ICR Mouse 
 
 To evaluate the effects of a single intravenous administration of DRT-102 on the central nervous system by observing the animals’ body temperature and systemic behaviors in ICR mice. 
 
 When DRT-102 was administered as a single intravenous dose of 0.8 mg/kg or lower to ICR mice, no changes in body temperature or systemic behaviors were observed. 
 
 2014.03.25

~

2014.04.29 
 
 ChemOn 
 
 Biological Safety Tests 
 
 — 
 
 Cytotoxicity test (Elution method) 
 
 Grade 2 (mildly cytotoxic) 
 
 2014.0924

~

2014.10.28 
 
 KTR (Korea Chemical Corporation) 
 
 NZW rabbits 
 
 Intracutaneous reactivity 
 
 No signs of erythema or edema. 
 
 Dunkin Hartley guinea pigs 
 
 Skin Irritation test 
 
 No skin reactions after sensitization, indicating weak skin sensitization. 
 
 ICR mice 
 
 Acute toxicity test 
 
 No systemic toxicity changes observed within 72 hours after administration 
 
 NZW rabbits 
 
 Fever test 
 
 No body temperature increase of 0.5°C or higher. 
 
 — 
 
 Genotoxicity Test

(Microbial Reversion Mutation) 
 
 Negative 
 
 — 
 
 Genotoxicity Test (Mammalian Chromosome) 
 
 Negative 
 
 Pre-clinical study of DRT-102 for efficacy measurement
in animal models
 
 Efficacy test of DRT-102 was conducted with multiple institution
including Joint Center for Bioscience, Inha University Hospital, Seoul Borame Medical Center, and Pharmalegacy (China). The purpose of
this study is to evaluate the potential efficacy of DRT-102, when intravenously administered.
 
 17 

 The table below outlines the type, species, purpose and results of
the pre-clinical efficacy studies so far.
 
 Type of study 
 
 Species 
 
 Purpose 
 
 Results 
 
 Date 
 
 Institution 

 Beagle dog spinal fusion 
 
 Beagle dog 
 
 To evaluate the efficacy of DRT-102 by tibial bone Fusion 
 
 – Test group implanted with DRT-102 showed a significantly
 higher fusion rate compared to the rhBMP-2 control group

 – Histological examination revealed that the AB204 group exhibited
 superior new bone formation and bone trabecular formation compared to both the rhBMP-2 and Osteon groups.
 
 2013.07.01

~

2014.06.30 
 
 Seoul Boramae Medical Center 

 Rat spinal fusion 
 
 CD Rats 
 
 To evaluate the efficacy of DRT-102 by spinal bone Fusion 
 
 – 3 µg Implantation: In the group implanted with AB204,
 fusion rates were 50% at week 4 and 75% at week 8. In contrast, the rhBMP-2 group showed fusion rates of 25% at both week 4 and week
 8.

 – 6 µg Implantation: In the AB204 group, fusion rates reached
 100% at both week 4 and week 8. For the rhBMP-2 group, fusion rates were 25% at week 4 and 50% at week 8.

 – 10 µg Implantation: The AB204 group showed a 100% fusion
 rate at week 4, whereas the rhBMP-2 group showed only 75% fusion at week 4.

 2012.10.01

~

2014.03.31 
 
 Inha University Hospital 

 – DRT-102 showed a concentration-dependent increase in new bone formation, with no pathological abnormalities observed. 
 
 Type of study 
 
 Species 
 
 Purpose 
 
 Results 
 
 Date 
 
 Institution 
 
 Rabbit tibial defect fusion 
 
 NZW Rabbit 
 
 To evaluate the efficacy of DRT-102 by tibial bone Fusion 
 
 – Histopathological evaluation of non-decalcified bone sections from the 8-week necropsy group, using Goldner’s Trichrome staining, revealed that the bone area surrounding the test substance was greatest in the rhBMP-2 (positive control) group. The DRT-102 (100µg) group exhibited a slightly higher bone area around the test substance compared to the negative control group. Additionally, when measuring the length of osteoid relative to the area of new bone, the AB204 (100µg) group showed the highest ratio. 
 
 2014.06.

05 ~ 2014.

12.31 
 
 Korea Animal

Medical Institute 
 
 Mouse calvaria & Tibial defect fusion 
 
 C3H Rats 
 
 to evaluate the bone healing property of DRT-102 on Calvaria and Tibia osteotomy compared to rhBMP-2 in mouse. 
 
 – DRT-102 facilitates the healing of the CSD (critical-sized defect)
 in the tibia of rats.

 – CT scans and histological analyses showed that only DRT-102 was
 effective in healing the segment.
 
 2011.10.

01 ~ 2014.

9.31 
 
 JCB (joint center for biosciences) 
 
 – Bone generated by BMP2 did not integrate well with the existing bone, with visible boundaries, whereas bone newly formed by DRT-102 completely fused with the existing bone without visible differences. 
 
 – The fidelity of the newly formed bone was particularly observed in Villanueva-stained tissue slides, which showed osteoblasts and mineralized bone. 
 
 In Vitro – Efficacy Test 
 
 MC3T3-E1 cell 
 
 To evaluate osteoinductivity of DRT-102 in MC3T3-E1 preosteblastic cells 
 
 – DRT-102 was not toxic to the cells.

 – DRT-102 promoted calcium nodule formation three times
 more than BMP2

 – DRT-102 also increased ALP activity, another measure of
 osteogenic potential, by over 135% compared to BMP2
 
 2011.10.

01 ~ 2014.

09.31 
 
 JCB (joint center for biosciences) 
 
 Monkey fibular defect fusion 
 
 Cynomolgus Monkey 
 
 To evaluate the efficacy of DRT-102 on primates’ tibial bone defect 
 
 – When 5 mg of AB204/DBM was administered, it produced more than twice the amount of mineralized tissue compared to the 5 mg BMP-2/DBM treatment. 
 
 2014.06.

01 ~ 2014.

10.31 
 
 Pharmalegacy (China) 
 
 18 

 Type of study 
 
 Species 
 
 Purpose 
 
 Results 
 
 Date 
 
 Institution 
 
 Mouse Calvaria Defect 
 
 C3H mouse 
 
 To evaluate the bone healing property of DRT-102 on Calvaria and Tibia osteotomy compared to rhBMP-2 in mouse. 
 
 – No animals died due to surgery

 – No individuals showed abnormal changes in body weight.

 – Bone remodeling was observed in X-ray images after
 2 months post-surgery

 – The volume of new bone and the area of osteoid forming the
 new bone were more prominent than control group
 
 2014.08 ~

2014.10.15 
 
 JCB (joint center for biosciences) 
 
 Clinical trial of DRT-102
 
 Darnatein is conducting a single-blind, active-controlled, randomized,
multicenter confirmatory trial to evaluate the efficacy of DRT-102 for the treatment of Lumbar Spinal Fusion. The trial is being
conducted at Boramae Medical Center of Seoul National University, Inha University Hospital, and Soonchunhyang University Seoul Hospital.
 
 The clinical trial of DRT-102 includes both exploratory and confirmatory
phases. The patient selection criteria for both studies are as follows:
 
 Inclusion Criteria:
 
 (1) Age between 30-80 years
old.
 
 (2) Patients requiring one-level posterior
decompression and fusion between L1 and S1 due to severe spinal stenosis, spondylolisthesis, spondylosis, or retrolisthesis.
 
 Exclusion Criteria:
 
 (1) Average spine T-score< -2.5
on dual-energy X-ray absorptiometry (DEXA),
 
 (2) History of cancer,
 
 (3) Patient unable to discontinue anticoagulation
therapy,
 
 19 

 (4) Female patients of childbearing
potential,
 
 (5) Patients testing positive for DRT-102 antibody,
 
 (6) Specific conditions, including
psychological problems.
 
 Patients were regularly followed up at 2, 12, 24 and 48 weeks
postoperatively. Patients were divided into two groups: TLIF (Transforaminal Lumbar Interbody Fusion) performed with or without the use
of DRT-102.
 
 2 mg of DRT-102 was reconstituted using sterile water and
the resulting solution was used to soak 6cc of Osteon II (Genoss, #OT7G2030600) were inserted into PEEK (polyetheretherketone) cages
before placement into the prepared disc space. No autogenous grafts were used in the investigational group, while the control group received
autograft in cages.
 
 Exploratory clinical trial of DRT-102 
 
 DRT-102 was evaluated in a exploratory clinical trial with 4 patients
(excluding two dropouts) conducted at Inha University Hospital managed by DT&R CRO in 2016 ~ 2019.
 
 The primary objective of this study was to evaluate the bone fusion
rate of DRT-102 for patients with severe spinal stenosis, spondylolisthesis, spondylosis, or retrolisthesis, all of whom required
posterior decompression and fusion.
 
 Source: Choi, Seung-hyun, et al. “Evaluation of Posterolateral
Lumbar Fusion with Composite Bone Graft AB204-sp: A Preliminary Comparative Study and Therapeutic Exploratory Trial.” Korea Health
Industry Development Institute, Mar. 2019. National R&D Research Report, TRKO202000003168, scienceon.kisti.re.kr/srch/selectPORSrchReport.do?cn=TRKO202000003168.
Accessed 21 Oct. 2024.
 
 To assess the bone fusion rate, a CT scan was conducted for 6 months
postoperatively to measure the fusion status.
 
 The criteria for determining bone fusion were as follows:
 
 a. Formation of continuous
trabeculation between the adjacent vertebral body and the graft bone.
 
 b. Evidence of remodeling
between the adjacent vertebral body and the graft bone.
 
 c. Absence of radiolucent
areas between the adjacent vertebral body and the graft bone.
 
 Fusion was determined successful if at least two of the criteria (a,
b, or c) were met. In cases where only one criterion was met or none were satisfied, non-fusion was diagnosed.
 
 The secondary evaluation parameters included the bone fusion rate observed
on X-rays 6 months postoperatively, the rate of bone degeneration assessed on MRI 6 months postoperatively, the
improvement in Visual Analog Scale (VAS) scores, and the improvement in the Oswestry Disability Index (ODI).
 
 SN003 
 
 SN004 
 
 SN005 
 
 SN006 

 Visit 1

(Screwening) 
 
 Visit 2

(6 month) 
 
 Visit 1

(Screening) 
 
 Visit 2

(6 month) 
 
 Visit 1

(Screening) 
 
 Visit 2

(6 month) 
 
 Visit 1

(Screening) 
 
 Visit 2

(6 month) 

 Procedure Site 
 
 L4 – L5 
 
 L4 – L5 
 
 L4 – L5 
 
 L4 – L5 

 X-ray 
 
 Y 
 
 Y 
 
 Y 
 
 Y 
 
 Y 
 
 Y 
 
 Y 
 
 Y 

 CT-scan 
 
 — 
 
 Y

 a, c
 
 — 
 
 Y

 a, c
 
 — 
 
 Y

 100%

 fusion

 on rt.

 side &
 
 — 
 
 Y

 a, c
 
 satisfied 
 
 satisfied 
 
 50%

fusion

on lt.

side 
 
 satisfied 

 MRI 
 
 — 
 
 Y 
 
 — 
 
 Y 
 
 — 
 
 Y 
 
 — 
 
 Y 

 VAS(mm) 
 
 Lumbar 
 
 100 
 
 45 
 
 95 
 
 94 
 
 32 
 
 17 
 
 93 
 
 74 

 Lt. leg 
 
 100 
 
 41 
 
 94 
 
 9 
 
 0 
 
 18 
 
 91 
 
 74 

 Rt. leg 
 
 0 
 
 0 
 
 64 
 
 68 
 
 0 
 
 16 
 
 40 
 
 50 

 ODI 
 
 44 
 
 17 
 
 34 
 
 26 
 
 12 
 
 13 
 
 19 
 
 15 

 20 

 NOTE: a: Formation of continuous trabeculation between the adjacent
vertebral body and the graft bone, b: Evidence of remodeling between the adjacent vertebral body and the graft bone, c: Absence of
radiolucent areas between the adjacent vertebral body and the graft bone. 
 
 This study has indicated that all patients exhibited strong spine fusion
through X-ray, CT and MRI. Three patients (SN003, SN004, SN005) exhibited 100% spinal fusion at the procedure site. For patient
SN005, 100% fusion was observed on the right side, while 50% fusion was observed on the left side.
 
 Significant improvements were also observed in VAS and ODI scores.
In the case of VAS, pain levels decreased from severe to worst pain levels to mild to moderate pain levels. For ODI, which measures discomfort
in daily activities, scores improved from moderate to severe disability to minimal to moderate disability, indicating an enhancement in
quality of life.
 
 During the course of this clinical trial, no drug-related adverse
effects or toxicity were observed.
 
 Confirmatory clinical trial of DRT-102
 
 DRT-102 was further evaluated in a confirmatory clinical trial
from 2020 to 2022. This study involved 15 total patients and was conducted at Inha University, SNU Medical School Boramae Hospital,
and SoonChunHyang Medical School Hospital. This trial was managed by DT&R CRO.
 
 The primary objective of this study was to evaluate the bone fusion
rate of DRT-102 in a larger patient population.
 
 Primary efficacy endpoint was evaluated with bone fusion rate (%) as
observed on CT scans at 24-weeks post-surgery.
 
 Bone fusion is determined when at least two out of the following three
criteria are satisfied:
 
 a. Continuous trabeculation
formation
 
 b. Evidence of bone remodeling
 
 c. Absence of radiolucent
areas
 
 [Bone Fusion Rate Based on CT Scans
at 24 Weeks Post-Surgery] 
 
 Control 
 
 CT Scan 
 
 Test 
 
 CT Scan 

 Fufilled

Critera 
 
 Bone Fusion 
 
 Fufilled

Critera 
 
 Bone Fusion 

 1 
 
 — 
 
 F 
 
 1 
 
 a, b, c 
 
 S 

 2 
 
 — 
 
 F 
 
 2 
 
 b 
 
 F 

 3 
 
 — 
 
 F 
 
 3 
 
 a, b, c 
 
 S 

 4 
 
 — 
 
 F 
 
 4 
 
 a, b 
 
 S 

 5 
 
 a, b 
 
 S 
 
 5 
 
 a, b, c 
 
 S 

 6 
 
 a, b 
 
 S 
 
 6 
 
 a, b, c 
 
 S 

 7 
 
 b 
 
 F 
 
 7 
 
 b 
 
 F 

 8 
 
 a, b, c 
 
 S 

 Success 
 
 Fail 
 
 Total 

 Control 
 
 2 (25%) 
 
 5 (71.4%) 
 
 7 (46.7%) 

 Test 
 
 6 (75%) 
 
 2 (28.6%) 
 
 8 (53.3%) 

 Note: S = Bone Fusion Success; F = Bone Fusion Failure; a = Continuous
trabeculation formation; b = Evidence of bone remodeling; c = Absence of radiolucent areas 
 
 The bone fusion rate in the test group was 75%, while it was 28.57%
in the control group, resulting in a difference of 46.43% between the two groups.
 
 Secondary efficacy endpoints included Bone fusion rate (%) based on X-rays at
24 weeks post-surgery.
 
 21 

 Bone fusion rate (%) based on X-rays at 24 weeks post-surgery 
 
 The number of successful and failed bone fusions was observed on X-rays post-surgery in
the experimental and control groups, along with the bone fusion success rates. The difference in bone fusion rates between the two groups
was evaluated using the chi-square test.
 
 Evaluation Criteria
 
 a. Formation of bridging
callus
 
 b. Absence of bone spurs
connecting the two vertebrae at the surgical site.
 
 Control Group 
 
 X-ray 
 
 X-ray 

 Fulfilled

Criteria 
 
 Bone 

Fusion 
 
 Test Group 
 
 Fulfilled

Criteria 
 
 Bone 

Fusion 

 1 
 
 F 
 
 1 
 
 a, b 
 
 S 

 2 
 
 F 
 
 2 
 
 F 

 3 
 
 F 
 
 3 
 
 a, b 
 
 S 

 4 
 
 F 
 
 4 
 
 a, b 
 
 S 

 5 
 
 a, b 
 
 S 
 
 5 
 
 a, b 
 
 S 

 6 
 
 a 
 
 S 
 
 6 
 
 a, b 
 
 S 

 7 
 
 F 
 
 7 
 
 F 

 8 
 
 a, b 
 
 S 

 Success 
 
 Fail 
 
 Total 

 Control 
 
 2 (25 
 %) 
 
 5 (71.4 
 %) 
 
 7 (46.7 
 %) 

 Test 
 
 6 (75 
 %) 
 
 2 (28.6 
 %) 
 
 8 (53.3 
 %) 

 Total 
 
 8 (100 
 %) 
 
 7 (100 
 %) 
 
 5 (100 
 %) 

 Note: S = Bone Fusion Success; F = Bone Fusion Failure; a = Continuous
trabeculation formation; b = Evidence of bone remodeling; c = Absence of radiolucent areas 
 
 [Changes in p-value according to the number of subjects]
 
 Success 
 Fail 
 # of 
 patients 
 p-value 
 
 Success 
 Fail 
 # of 
 patients 
 p-value 

 Control 
 2 
 5 
 7 
 
 Control 
 3 
 8 
 11 
 
 Test 
 6 
 2 
 8 
 0.132 
 Test 
 9 
 3 
 2 
 0.039 

 15 
 
 23 
 
 Success 
 Fail 
 # of 
 patients 
 p-value 
 
 Success 
 Fail 
 # of 
 patients 
 p-value 

 Control 
 4 
 0 
 4 
 
 Control 
 9 
 9 
 28 
 
 Test 
 2 
 4 
 6 
 0.026 
 Test 
 24 
 8 
 32 
 0.002 

 30 
 
 60 
 
 Note: S = Bone Fusion Success; F = Bone Fusion Failure; a = Continuous
trabeculation formation; b = Evidence of bone remodeling; c = Absence of radiolucent areas 
 
 22 

 The clinical trial results indicate that the success rate in the test
group was significantly higher at 75%, compared to only 25% in the control group. Additionally, the failure rate in the control group
was 71.4%, which was markedly higher than the 28.6% observed in the test group. These findings demonstrate that the test group, which
received DRT-102, exhibited a substantially better outcome in terms of bone fusion compared to the control group. Overall, the data strongly
suggest that DRT-102 is more effective than the control treatment in promoting bone fusion.
 
 The chi-square test of the study demonstrates how the p-value changes
with varying sample sizes in the clinical trial, comparing the control and test groups. Initially, with a smaller sample size of 15 patients,
the p-value is 0.132, indicating no statistically significant difference between the two groups. However, as the sample size increases
to 23 patients, the p-value drops to 0.039, suggesting a statistically significant difference favoring the test group.
 
 With a moderate sample size of 30 patients, the p-value further
decreases to 0.026, indicating stronger statistical evidence of the difference in success rates between the control and test groups.
Finally, in the largest sample size of 60 patients, the p-value reaches 0.002, demonstrating a statistically significant difference.
Throughout the analysis, the test group outperformed the control group in success rates.
 
 Development plans for DRT-101 and DRT-102
 
 Based on preliminary tests of DRT-101 and DRT-102, Darnatein intends
to expand the potential application of DRT-101 to other cartilage regeneration targets, including spinal cartilage in the treatment
of lower back pain. Darnatein may, depending upon securing additional financial resources and other opportunities requiring investment,
expand the potential application of DRT-102 to other bone regeneration targets, including non-fusion bone fracture in the treatment
of deformed bone tissue. Darnatein’s strategy generally involves the following key steps:
 
 1. Identify novel drug
candidate for cartilage- and bone-degenerative disorders: Darnatein will leverage its expert knowledge and experience in tissue regenerative
medicine to identify new cartilage- and bone-degenerative disorders that can be targeted by Darnatein’s DRT-101 and DRT-102 platforms.
 
 2. Conduct preclinical
studies with the FDA’s good laboratory practice (“GLP”) regulations: Before testing any drug or biological product candidate
in humans, the product candidate must undergo rigorous pre-clinical testing. The pre-clinical developmental stage generally
involves laboratory evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to
assess the potential for adverse events and, in some cases, to establish a rationale for therapeutic use. The conduct of pre-clinical studies
is subject to federal regulations and requirements, including GLP regulations for safety/toxicology studies. Darnatein will first perform
preclinical studies to evaluate the safety, immunogenicity, and efficacy of regenerating the new target tissue candidates.
 
 3. File an Investigational
New Drug (IND) application: Upon the successful completion of preclinical studies, Darnatein will submit an IND application to regulatory
authorities such as the FDA. IND is a request for authorization from the FDA to ship an investigation product and then administer
it to humans and must be allowed to proceed by the FDA before human clinical trials may begin. This submission includes all relevant data
from preclinical studies and outlines the proposed clinical trial protocols. The IND review period typically takes 30 days, during
which the regulatory agency evaluates the submission to ensure the safety of proceeding to human trials.
 
 4. Initiate clinical trials:
Based on the preclinical data, Darnatein will design and conduct additional Phase 1 clinical trials to assess the safety, tolerability,
and preliminary efficacy of its regeneration of those new tissue candidates.
 
 5. Conduct Phase 2
and Phase 3 clinical trials: Phase 2 trials are designed to determine if the new treatment has sufficiently promising efficacy
to warrant further investigation in a large-scale randomized phase 3 trial, as well as to further assess safety. These studies
usually involve a few hundred patients. Phase 2 trials also generate insights on adverse events and their management, the diseases
in which the treatment is effective, and the best regimen for future use in a later phase, depending on the trial design.
 
 Phase 3 trials are large-scale, randomized, controlled
studies designed to provide additional supporting evidence of the efficacy and safety of therapeutic candidates. These trials typically
involve hundreds to thousands of patients and are typically conducted at multiple hospital sites worldwide.
 
 Darnatein will work closely with clinical investigators, regulatory
authorities, and patient advocacy groups to design and execute initially Phase 2 and seek to continue with Phase 3 clinical
trials based on evaluation of Phase 2 studies for its tissue targets.
 
 6. Seek regulatory approval:
Following the successful completion of Phase 3 clinical trials, the result of the pre-clinical studies and clinical trials,
together with detailed information relating to the product’s chemistry, manufacture, controls, and proposed labeling, among other
things, are submitted to authorities, such as the FDA or EMA. This stage is known as the New Drug Application (NDA) review.
 
 23 

 Based on these steps and the timeline for regulatory approvals, Darnatein
anticipates that its first therapeutic regimen to enter clinical trials within the next 2 – 3 years, with potential
regulatory approval in the next 8 – 11 years.
 
 For a description of the regulatory steps for the implementation of
Darnatein’s strategy described above, see “Business of the Company and Certain Information About the
Company — Vaximm — Regulatory Steps”. 
 
 Intellectual Property 
 
 Darnatein owns exclusive intellectual property rights covered under
2 patent families relating to DRT-101, DRT-102 and other associated candidates filed in the United States and across major markets,
including Europe, China, India, and Japan. This patent family covers composition of matter, with a priority date of 2019 and estimated
expiry in 2039, not including potential patent term adjustments or patent term extensions.
 
 Designer ligands of TGF-ß superfamily
(Licensed Patent Rights) (0)

WO 2010/099219, Exclusive License Agreement between Joint Center for Biosciences and Darnatein 
 
 Country

Code 
 
 Type 
 
 Filing date 
 
 Filing no. 
 
 Grant Date 
 
 Grant no. 
 
 Publ. No. 
 
 Expiry 
 
 Status 

 WO 
 
 PCT 
 
 24/02/2010 
 
 PCT/US2010/025260 
 
 2010/099219 
 
 EP 
 
 PCT 
 
 24/02/2010 
 
 10746779 
 
 10/02/2016 
 
 2401293B1 
 
 2401293 
 
 24/02/2030 
 
 granted 

 KR 
 
 PCT 
 
 24/02/2010 
 
 1020117021911 
 
 12/10/2015 
 
 1015586420000 
 
 1020110121642 
 
 24/02/2030 
 
 granted 

 CA 
 
 PCT 
 
 24/02/2010 
 
 2752647A1 
 
 2752647 
 
 24/02/2030 
 
 Under Examination 

 JP 
 
 PCT 
 
 24/02/2010 
 
 2011551315 
 
 20/11/2015 
 
 5841845 
 
 2012518420 
 
 24/02/2030 
 
 granted 

 DRT-101 (SAB-704) (1)

WO 2020/101366, Activin/bmp7 chimeras: super-active sab704 and sab715, and their respective noggin-sensitized variants,
nab704 and nab715; and nab204 
 
 Country

Code 
 
 Type 
 
 Filing date 
 
 Filing no. 
 
 Grant Date 
 
 Grant no. 
 
 Publ. No. 
 
 Expiry 
 
 Status 

 WO 
 
 PCT 
 
 13/11/2019 
 
 PCT/KR2019/015478 
 
 2020/101366 
 
 — 
 
 US 
 
 PCT 
 
 13/11/2019 
 
 20210395322 
 
 20210395322 
 
 13/11/2039 
 
 Under Examination 

 EP 
 
 PCT 
 
 13/11/2019 
 
 19885240 
 
 3880695 
 
 13/11/2039 
 
 Under Examination 

 KR 
 
 PCT 
 
 13/11/2019 
 
 1020217018273 
 
 30/10/2025 
 
 10-2725896 
 
 1020210077790 
 
 13/11/2039 
 
 granted 

 CN 
 
 PCT 
 
 13/11/2019 
 
 201980075594.3 
 
 14/7/2025 
 
 7795027 
 
 113039199 
 
 13/11/2039 
 
 granted 

 RMC 
 
 Corporate Overview 
 
 RMC is a Korea-based neurovascular intervention medical device
and systems distribution company exclusively serving the Korea market currently. RMC distributes, but does not design or manufacture,
commercial medical products, including cerebral surgical devices.
 
 Opportunity 
 
 RMC distributes cerebrovascular surgery equipment in South Korea and
seeks growth opportunities in South Korea for other medical device products and systems.
 
 As a rapidly aging country, demand for medical equipment is expected
to accompany the rise in cerebrovascular diseases such as strokes. RMC has established close relationships with leading university hospitals
and general hospitals in Korea to supply cerebrovascular surgery equipment. These relationships provide opportunities for continued sales
of products distributed by RMC as well as assisting RMC in identifying demand for other medical devices that RMC may add to enhance its
product portfolio. This is expected to enhance RMC’s competitiveness in South Korea.
 
 24 

 RMC has established a nationwide sales network and logistics system,
enabling it to swiftly and efficiently supply products to any region in the country. This serves as a significant strength compared to
competitors and is expected to contribute to building long-term trust with medical institutions.
 
 Products and Related Systems 
 
 The table below shows the products and related systems currently distributed
by RMC.
 
 Company 
 
 Product and System 
 
 Function of Product/System 

 Asahi Intecc 
 
 Chikai Guide Wire 
 
 This product is designed to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during endovascular therapy and is intended for use in the neurovascular field. It is used as a guidewire for stent delivery catheters, coil delivery microcatheters, carotid stent delivery catheters and balloon catheters used in cerebral aneurysm coil embolization. 

 Fubuki Guide Catheter 
 
 This catheter is used to guide neurovascular interventional devices to sites for percutaneous endovascular procedures in neurovascular vessels; also used for contrast injection. This catheter is designed to guide therapeutic cerebrovascular catheters to lesions or sites for percutaneous endovascular procedures in the cerebral vasculature. 

 Microport Neurotech 
 
 Numen coil system 
 
 This product is a single-use device for endovascular embolization of intracranial aneurysms and other neurovascular malformations such as arteriovenous fistulas. It is used to dye blood vessels in the neurovascular system to permanently block blood flow to aneurysms or other vascular malformations, or for arterial and venous embolization in peripheral vessels. 

 Since 2015, RMC has also distributed neuro-intervention medical
device equipment manufactured by Penumbra Inc. RMC’s distribution agreement with Penumbra Inc. for the resale of its reperfusion
catheter, neuron delivery catheter and related tubing and canister, expired on June 30, 2024. The parties’ negotiations for
a new (or extended) agreement terminated on November 20, 2024. RMC will not purchase additional Penumbra products. Certain issues,
such as whether RMC may continue to sell its existing inventory of Penumbra products or whether Penumbra will repurchase RMC’s inventory,
have not as yet been resolved. To replace sales of Penumbra products, RMC intends to seek to become the sales representative of other
neuro-intervention medical device equipment manufacturers, as well as expand sales of products offered by companies it currently
represents.
 
 Intellectual Property 
 
 Except for trade secrets related to operating a medical product distribution
business, there is no significant intellectual property owned or licensed by RMC.
 
 25 

 Competition in our Industry 
 
 Competition for Product Candidates 
 
 We face competition with respect to our current product candidates
and will face competition with respect to future product candidates, from pharmaceutical and biotechnology companies to public and private
research institutions, among others.
 
 If our current and/or our future product candidates do not offer sustainable
advantages over competing products, we may otherwise not be able to successfully compete against current and future competitors.
 
 Our competitors may obtain regulatory approval of their products more
rapidly than we may or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize
our product candidates. Our competitors may also develop drugs that are more effective, more convenient, more widely used and less costly
or have a better safety profile than our products and these competitors may also be more successful than us in manufacturing and marketing
their products.
 
 The most common methods of treating patients with cancer are surgery,
radiation and drug therapy, including chemotherapy, hormone therapy and targeted drug therapy or a combination of such methods. There
are a variety of available drug therapies marketed for cancer. In many cases, these drugs are administered in combination to enhance efficacy.
Our product candidates, if any are approved, may compete with these existing drug and other therapies.
 
 The table below summarizes the main competitors we have identified
for Vaximm’s VXM01. Each of these identified competitors are developing therapies for glioblastoma and have active clinical trials
ongoing assessing the safety and efficacy of their product candidates.
 
 Drug Name 
 
 Company 
 
 Mechanism 
 
 Indication 
 
 Clinical

Phase 
 
 NCT

Number(s) 

 Depatuxizumab mafodotin (ABT-414) 
 
 AbbVie 
 
 Antibody-drug conjugate targeting EGFR 
 
 Newly diagnosed glioblastoma 
 
 Phase 2/3 
 
 NCT02573324 

 Durvalumab (MEDI4736) 
 
 AstraZeneca 
 
 PD-L1 checkpoint inhibitor 
 
 Newly diagnosed and recurrent glioblastoma 
 
 Phase 2 
 
 NCT02336165 

 Regorafenib 
 
 Bayer 
 
 Multi-kinase inhibitor 
 
 Recurrent glioblastoma 
 
 Phase 2 
 
 NCT02926222 

 Tasadenoturev( DNX-2401) 
 
 DNAtrix 
 
 Oncolytic adenovirus 
 
 Recurrent glioblastoma 
 
 Phase 2 
 
 NCT03178032 

 Ofranergene obadenovec (VB-111) 
 
 VBL Therapeutics 
 
 Dual-targeted gene therapy 
 
 Recurrent glioblastoma 
 
 Phase 3 
 
 NCT02511405 

 AV-GBM-1 
 
 Aivita Biomedical 
 
 Personalized dendritic cell vaccine 
 
 Newly diagnosed glioblastoma 
 
 Phase 2 
 
 NCT03400917 

 VAL-083 
 
 Kintara Therapeutics 
 
 DNA-targeting agent 
 
 Recurrent and newly diagnosed glioblastoma 
 
 Phase 2/3 
 
 NCT02717962, NCT03050736 

 With respect to Darnatein, competition takes two forms: pharmaceutical
products (drugs) that address the underlying causes of osteoarthritis, and orthopedic solutions involving bone graft and other products.
Several pharmaceutical companies and research institutions are actively working on developing Disease-Modifying Osteoarthritis Drugs
(DMOADs) to address the underlying causes of osteoarthritis (current treatments primarily focus on symptom management). There are currently
no approved DMOAD treatments for osteoarthritis but the table below identifies drugs under development:
 
 The table below summarizes the main competitors we have identified
for Darnatein’s DRT-101. Each of these identified competitors are developing therapies for osteoarthritis and have active clinical
trials ongoing assessing the safety and efficacy of their product candidates.
 
 Drug Name 
 
 Company 
 
 Mechanism 
 
 Indication 
 
 Clinical

Phase 
 
 NCT

Number(s) 

 Invossa 
 
 Kolon TissueGene 
 
 Cell and gene therapy (TGF-ß1 expressing chondrocytes) 
 
 Osteoarthritis 
 
 Phase 3 
 
 NCT03383471 

 Lorecivivint 
 
 Biosplice Therapeutics 
 
 CLK/DYRK1A inhibitor 
 
 Osteoarthritis 
 
 Phase 3 
 
 NCT03928184 

 Sprifermin 
 
 Merck KGaA/EMD serono 
 
 Recombinant human fibroblast growth factor 18 
 
 Osteoarthritis 
 
 Phase 2 
 
 NCT01919164

 NCT01033994
 
 26 

 The table below summarizes the main competitors we have identified
for Darnatein’s DRT-102. Each of these identified competitors are commercialized orthopedic solutions.
 
 Drug Name 
 
 Company 
 
 Mechanism 
 
 Indication 

 Infuse Bone Graft 
 
 Medtronic 
 
 rhBMP-2 and collagen sponge 
 
 Spinal fusion, long bone fractures, orthopedic surgery 

 Osteocel Plus 
 
 NuVasive 
 
 Demineralized bone matrix (DBM) and mesenchymal stem cells (MSC) 
 
 Spinal fusion, bone defects 

 Bio 4 
 
 Stryker 
 
 A viable bone matrix containing endogenous bone forming cells 
 
 Bone repair and regeneration 

 i-Factor 
 
 Cerapedics 
 
 P-15 peptide and anorganic bone matrix 
 
 Spinal fusion, bone defects 

 Novabone IRM 
 
 Novabone 
 
 Composed of bioactive glass, chemically bonds with bone and promotes new bone formation 
 
 Bone defects, dental grafting 

 With aging populations comes a higher number of cerebrovascular disease
patients. There are a number of potential treatments such as drug therapy and open surgery. Minimally invasive procedures, such as neurovascular
intervention, have been growing. Various international medical device brands are competing for market share.
 
 The table below summarizes the main competitors we have identified
for RMC:
 
 Device Name 
 
 Company 
 
 Mechanism 
 
 Indication 

 React catheter 
 
 Medtronic 
 
 Reperfusion catheter 
 
 Treatment of acute ischemic stroke 

 AXS infinity catheter 
 
 Stryker 
 
 Neurovascular Delivery catheter 
 
 Delivery of therapeutic devices in neurovascular procedures 

 AXS catalyst 7 distal access catheter 
 
 Stryker 
 
 Distal access support canister 
 
 Neurovascular access and support for device delivery 

 Synchro wire 
 
 Stryker 
 
 Neurovascular guide wire 
 
 Navigation through neurovascular anatomy 

 Traxcess wire 
 
 Microvention 
 
 Neurovascular guide wire 
 
 Navigation through neurovascular anatomy 

 Envoy guide catheter 
 
 Cerenovous 
 
 Neurovascular guide catheter 
 
 Support and delivery of neurointerventional devices 

 Guider soft tip guide catheter 
 
 Boston scientific 
 
 Soft tip neurovascular Guide catheter 
 
 Support and delivery of neurointerventional devices 

 Microplex coil system 
 
 Microvention 
 
 Detachable embolization coil system 
 
 Embolization of intracranial aneurysms 

 GDC coil system 
 
 Stryker 
 
 Detachable Coil system 
 
 Embolization of intracranial aneurysms 

 Axium prime coil system 
 
 Medtronic 
 
 Detachable Coil system 
 
 Embolization of intracranial aneurysms 

 Manufacturing 
 
 We do not have any manufacturing facilities or personnel at this time,
except that Darnatein maintains and uses manufacturing facilities owned by Joint Center for Biosciences, Darnatein’s affiliate and
the Company’s shareholder, for purposes of R&D and clinical and preclinical materials for its sole use. We currently rely on
CMOs for the manufacture of our product candidates for preclinical and clinical testing in non-commercial quantities.
 
 Our product candidates include small molecules, vaccines, and monoclonal
and bispecific antibodies. Several contract manufacturing facilities exist that have expertise in each product type and we anticipate
that our product candidates can be produced by them at scale and in a cost-effective manner. As needed, we also expect to rely on
CMOs for the manufacturing of companion diagnostics, which are assays or tests to identify an appropriate patient population. Depending
on the technology solutions we choose, we may rely on multiple third parties to manufacture and sell a single test.
 
 Vaximm has a master service agreement with Richter-Helm BioLogics
GmbH & Co. KG (“RHB”), a CMO located in Germany, for the manufacture of Vaximm’s product candidates. RHB will
provide cell line development, process development, manufacturing, and related services for Vaximm’s product candidates. The agreement
became effective April 10, 2012, and will remain in effect until terminated by either party. Vaximm pays RHB for services rendered
based on agreed-upon rates specified in individual work orders. Vaximm retains ownership of all intellectual property related to
its product candidates, while RHB owns IP related to manufacturing processes developed under the agreement.
 
 27 

 Commercialization 
 
 We will objectively assess and choose each program’s commercialization
option that maximizes potential value for patients and for our stockholders. We anticipate optimizing commercial value through various
options, including internal advancement, strategic partnerships, and spin-outs or public offerings. If we opt to commercialize a
particular candidate ourselves, we anticipate assembling a commercialization team inclusive of sales and marketing operations to promote
and sell our products. Our focus will be the community of relevant medical practitioners who are the key specialists in treating the patient
populations for which our product candidates are being developed. We may also enter into distribution and other marketing arrangements
with third parties for any of our product candidates that obtain marketing approval.
 
 We currently do not have marketing and sales management operations
for any of our pharmaceutical products and will rely, at least initially, on third parties for support. The responsibilities of marketing
operations would include developing educational initiatives with respect to approved products and establishing relationships with researchers
and practitioners in relevant fields of medicine. We will reevaluate the sales operations from time to time and may eventually build an
in-house marketing and sales management organization.
 
 Our Management Team 
 
 Members of our management team are not obligated to devote any specific
number of hours to our matters but they intend to devote as much of their time as they, in the exercise of their respective business judgement,
deem necessary to our affairs until we have completed our initial business combination. The amount of time that any member of our management
team will devote in any time period will vary based on whether a target business has been selected for our initial business combination
and the current stage of the business combination process. We do not have an employment agreement with any member of our management team.
 
 We believe our management team’s operating and transaction experience
and relationships with companies will provide us with a substantial number of potential business combination targets. Over the course
of their careers, the members of our management team have developed a broad network of contacts and corporate relationships in the healthcare
and biotechnology industry. This network has grown through the activities of our management team sourcing, acquiring and financing businesses,
our management team’s relationships with sellers, financing sources and target management teams and the experience of our management
team in executing transactions under varying economic and financial market conditions. See “Item 10. Directors, Executive Officers
and Corporate Governance” for a more complete description of our management team’s experience.
 
 Status as a Public Company 
 
 We are an “emerging growth company,” as defined in Section 2(a)
of the Securities Act of 1933, as amended (the “Securities Act”), as modified by the JOBS Act. As such, we are eligible to
take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging
growth companies” including, but not limited to, not being required to comply with the independent registered public accounting
firm attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation
in our periodic reports and proxy statements, and exemptions from the requirements of holding a non-binding advisory vote on executive
compensation and stockholder approval of any golden parachute payments not previously approved. If some investors find our securities
less attractive as a result, there may be a less active trading market for our securities and the prices of our securities may be more
volatile.
 
 In addition, Section 107 of the JOBS Act also provides that an
“emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the
Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay
the adoption of certain accounting standards until those standards would otherwise apply to private companies. We intend to take advantage
of the benefits of this extended transition period.
 
 We will remain an emerging growth company until the earlier of (1) the
last day of the fiscal year (a) following the fifth anniversary of the completion of our IPO, (b) in which we have total annual
gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market
value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th, and (2) the date on
which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.
 
 Additionally, we are a “smaller reporting company” as defined
in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including,
among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last
day of the fiscal year in which (1) the aggregate worldwide market value of our common stock held by non-affiliates equaled or exceeded
$250 million as of the prior June 30th and (2) our annual revenues equaled or exceeded $100 million during such completed
fiscal year or the aggregate worldwide market value of our common stock held by non-affiliates equaled or exceeded $700 million as
of the prior June 30th.
 
 28 

 Facilities 
 
 Our executive offices are located at 10900 NE 4th Street, Suite 2300,
Bellevue, WA 98004 and Hoedong-gil, 37-36, 3F, Paju, Gyeonggi-do, 10881 Korea, and our telephone number is (425) 635-7700 and +82 31
948 9419 respectively. Our executive offices are provided to us by an affiliate of our Sponsor. Commencing on March 1, 2023, we
agreed to pay an affiliate of our Sponsor a total of $7,500 per month for office space, utilities and secretarial and administrative
support. We consider our current office space adequate for our current operations.
 
 Website 
 
 We maintain a corporate website at www.osr-holdings.com. Our website
and information contained on, or that can be accessed through, our website is not deemed to be incorporated by reference in, and is not
considered part of, this report. You should not rely on any such information in making your decision whether to invest in our securities.
 
 Employees 
 
 We currently have five officers. These individuals are not obligated
to devote any specific number of hours to our matters but they intend to devote as much of their time as they deem necessary, in the exercise
of their respective business judgement, to our affairs until we have completed our initial business combination. The amount of time they
will devote in any time period will vary based on whether a target business has been selected for our initial business combination and
the stage of the initial business combination process we are in. We do not have an employment agreement with any member of our management
team.
 
 Periodic Reporting and Financial Information 
 
 We have registered our common stock and warrants under the Exchange
Act and have reporting obligations, including the requirement that we file annual, quarterly and current reports with the SEC. In accordance
with the requirements of the Exchange Act, our annual reports will contain financial statements audited and reported on by our independent
registered public accountants. These filings are available to the public via the Internet at the SEC’s website located at http://www.sec.gov.
You may request a copy of our filings with the SEC (excluding exhibits) at no cost by writing or telephoning us at the following address
or telephone number:
 
 OSR Holdings, Inc.
 
 10900 NE 4th Street, Suite 2300
 
 Bellevue, WA 98004
 
 Telephone: (425) 635-7700
 
 We will provide stockholders with audited financial statements of the
prospective target business as part of the tender offer materials or proxy solicitation materials sent to stockholders to assist them
in assessing the target business. In all likelihood, these financial statements will need to be prepared in accordance with, or reconciled
to, GAAP, or IFRS, depending on the circumstances, and the historical financial statements may be required to be audited in accordance
with the standards of the PCAOB. These financial statement requirements may limit the pool of potential targets we may conduct an initial
business combination with because some targets may be unable to provide such statements in time for us to disclose such statements in
accordance with federal proxy rules and complete our initial business combination within the prescribed time frame. We cannot assure you
that any particular target business identified by us as a potential business combination candidate will have financial statements prepared
in accordance with GAAP or that the potential target business will be able to prepare its financial statements in accordance with the
requirements outlined above. To the extent that these requirements cannot be met, we may not be able to acquire the proposed target business.
While this may limit the pool of potential business combination candidates, we do not believe that this limitation will be material.
 
 We will be required to evaluate our internal control procedures for
the fiscal year ending December 31, 2024 as required by the Sarbanes-Oxley Act. Only in the event we are deemed to be a large accelerated
filer or an accelerated filer will we be required to have our internal control procedures audited. A target company may not be in compliance
with the provisions of the Sarbanes-Oxley Act regarding adequacy of their internal controls.
 
 29 

 The development of the internal controls of any such entity to achieve
compliance with the Sarbanes-Oxley Act may increase the time and costs necessary to complete any such business combination. Prior to
the date of our prospectus in connection with our IPO, we filed a registration statement on Form 8-A with the SEC to voluntarily register
our securities under Section 12 of the Exchange Act. As a result, we are subject to the rules and regulations promulgated under
the Exchange Act. We have no current intention of filing a Form 15 to suspend our reporting or other obligations under the Exchange Act
prior or subsequent to the consummation of our initial business combination.
 
 We will remain an emerging growth company until the earlier of (1) the
last day of the fiscal year (a) following the fifth anniversary of the completion of our IPO, (b) in which we have total annual
gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market
value of our shares of common stock that are held by non-affiliates exceeds $700 million as of the prior June 30th, and (2) the
date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
 
 Additionally, we are a “smaller reporting company” as defined
in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including,
among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last
day of the fiscal year in which (1) the aggregate worldwide market value of our common stock held by non-affiliates equaled or exceeded
$250 million as of the prior June 30th and (2) our annual revenues equaled or exceeded $100 million during such completed
fiscal year or the aggregate worldwide market value of our common stock held by non-affiliates equaled or exceeded $700 million as
of the prior June 30th.
 
 Item 1A. Risk Factors 
 
 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
Agreement 
 
 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. Mr. 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. Mr. 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.
 
 30 

 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
combination. 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
obligations. 
 
 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. The Company
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. This may
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,
and 

 ● 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. There
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).
 
 31 

 Risks Related to the Company Securities 
 
 The price of the Company’ Common Stock and warrants may
be volatile. 
 
 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
operates; 

 ● 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; and 

 ● 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. As a result,
the Company will be a “controlled company” within the meaning of the corporate governance standards of Nasdaq. Under
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; and 

 ● 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
has control. 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.
 
 32 

 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. 
 
 33 

 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
Act.
 
 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
thereunder. 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; and 

 ● 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
of the DGCL.
 
 34 

 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. A “business
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; or 

 ● 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. The Company’
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; and 

 ● 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.
 
 35 

 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
exchange. 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. In
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
approved. 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.
 
 36 

 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
period. If and when the public warrants become redeemable by the Company, it may exercise its redemption right even if it is unable to
register or qualify the underlying securities for sale under all applicable state securities laws. 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
warrants. 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
Date”). 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. 
 
 37 

 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. Except for a
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. Since
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; and 

 ● 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. Before
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
launch. 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.
 
 38 

 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
treatments; 

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

 ● the convenience and ease of administration compared to alternative
treatments; 

 ● 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; and 

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

 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. We cannot be
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.
 
 39 

 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; and 

 ● 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
rights.
 
 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
benefits. 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.
 
 40 

 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. While we
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
stock price.
 
 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”
basis. 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.
 
 41 

 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
developing. 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. RMC’s
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. 
 
 42 

 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
investment. 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. If any
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
consuming. 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
populations. 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
uncertain. 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.
 
 43 

 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
expansion.
 
 Risks Related to the Company’s Requirements for Additional
Capital 
 
 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
operations. 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
programs. 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
candidates; 

 ● the timelines of our clinical trials and the overall costs to
finish the clinical trials; 

 ● the number and characteristics of product candidates that we
develop; 

 ● 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; 

 44 

 ● 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; and 

 ● the cost of establishing sales, marketing and distribution capabilities
for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our
own. 

 Until we can generate sufficient revenue to finance our cash requirements,
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. If they
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.
 
 45 

 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. If we raise
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. If
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
approvals; and 

 ● 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. As a
result, substantial doubt exists about the Company’s ability to continue as a going concern.
 
 46 

 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
practices. 
 
 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
condition. 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. If
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. As a U.S. 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
of U.S. 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. public
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.
 
 47 

 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
to us. 
 
 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. Delaware
law generally provides that a corporation may indemnify such person if such person acted in good faith and in a manner such person reasonably
believed to be in or not opposed to the best interests of the registrant and, with respect to any criminal proceeding, had no reasonable
cause to believe such person’s conduct was unlawful; 

 ● 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; and 

 ● 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
trials; 

 ● 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; and 

 ● interruption or delays in the operations of the FDA, European
Medicines Agency or other regulatory authorities, which may impact review and approval timelines. 

 48 

 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
the disease.
 
 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
recently. 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,
Inc. 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.
 
 49 

 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
as flooding. 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
the years. 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.
 
 50 

 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. Prohibitions
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
candidates. 
 
 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; 

 51 

 ● 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; and 

 ● 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
the U.S. 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. The
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.
 
 52 

 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. Hwang, are
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
of interest. 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; adhere
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
countries; or accurately report financial information or disclose unauthorized activities.
 
 Risks Related to International Operations of the Company’s
Business 
 
 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. 
 
 53 

 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. As
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. dollar. 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. dollar
has fluctuated, and may continue to fluctuate and is affected by, among other things, changes in political and economic conditions. Since
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. S. 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. dollars. 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
operations. 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.
 
 54 

 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
interest. 
 
 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. corporation.
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. Since
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
the Closing; (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.
 
 55 

 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 Korea. 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
activities. 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
in Korea.
 
 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. Hwang, our
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
are Korean. 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.
 
 56 

 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
receivable; 

 ● 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
with us; 

 ● imposition of restrictions on currency conversion or the transfer
of funds; 

 ● 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;
and 

 ● government appropriations of assets. 

 We may not be able to adequately address these additional risks. If
we were unable to do so, our operations might suffer, which may adversely impact our results of operations and financial condition. Many
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 .
 
 57 

 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. Clinical
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
penalties. We expect the data protection laws will increase our compliance costs and potential liability.
 
 58 

 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. The U.S. 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
officials. 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. As we
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
Candidates 
 
 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
diseases. 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. These
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.
 
 59 

 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
products.
 
 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;
or 

 ● 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.
 
 60 

 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
trial site; 

 ● 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
may conduct; 

 ● 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; and 

 ● 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. The
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
candidates.
 
 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
entirely. 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.
 
 61 

 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. The FDA,
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. The FDA may
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
trials. 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. regulatory
authorities and, ultimately, our ability to commercialize our product candidates, if approved, and generate product revenues. Even if
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. regulatory
authorities and even fewer are approved for commercialization.
 
 62 

 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
evaluated. 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. Interim
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. Any failure
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
FDA. 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.
 
 63 

 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
competitive. 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. These
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
the market. 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
in:
 
 ● 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; 

 64 

 ● significant costs to defend the related litigation; 

 ● substantial monetary awards to trial participants or patients; 

 ● loss of revenue; and 

 ● 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. Outsourcing
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
development. 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
candidates. 
 
 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. If we
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.
 
 65 

 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
programs. 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. If these
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
supplies. 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. We will also
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
budget.
 
 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; 

 66 

 ● requirements to cease distribution or to recall batches of
our product candidates; and 

 ● 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.
 
 67 

 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
claims. 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. As
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. We may also
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.
 
 68 

 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. The
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. Furthermore,
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
and abroad. 
 
 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. or
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.
 
 69 

 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
date. 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.
 
 70 

 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
patents.
 
 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. The
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. Even
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. and non-U.S. patent
agencies and to take the necessary action to comply with these requirements with respect to our licensed intellectual property. While
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. and non-U.S. issued
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.
 
 71 

 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. In
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. In addition,
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
technology. 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.
 
 72 

 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. In addition,
U.S. 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
history. 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
claims. 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
question. 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. Third
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. For
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.
 
 73 

 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
portfolios. 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
companies. 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
U.S. 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 Europe,
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
system.
 
 74 

 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
parties. 
 
 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
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.
OSR Health, Inc. 10-K
