SEC Comment Letter 0000000000-24-013456 to OSR Health, Inc. (OSRH)
OSR Health, Inc.
Date: Dec. 5, 2024 · CIK: 0001840425 · Accession: 0000000000-24-013456
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File numbers found in text: 333-280590
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December 5, 2024
Kuk Hyoun Hwang
Chief Executive Officer
Bellevue Life Sciences Acquisition Corp.
10900 NE 4th Street, Suite 2300
Bellevue, WA 98004
Re:Bellevue Life Sciences Acquisition Corp.
Amendment No. 1 to Registration Statement on Form S-4
Filed November 8, 2024
File No. 333-280590
Dear Kuk Hyoun Hwang:
We have reviewed your amended registration statement and have the following
comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our July 25, 2024 letter.
Amendment No. 1 to Registration Statement on Form S-4
Questions and Answers
What equity stake will current BLAC stockholders and current OSR Holdings stockholders
hold in BLAC immediately after the consummation..., page 11
We note your disclosure in the table on page 12 that 14,676,728 shares of BLAC
common stock will be issued to OSR Holdings stockholders in connection with the
business combination, which represent 60% of the aggregate shares that may be
issued to OSR Holdings stockholders. We also note your disclosure in footnote (1) to
the table which assumes that 14,676,728 shares of BLAC common stock will be
issued by BLAC to the Participating Company Stockholders at consummation of the
business combination. Please revise to explain why the remaining 9,784,486 shares,
including the 6,849,140 shares representing the 28% of shares that might be issued to 1.
December 5, 2024
Page 2
Non-Participating Company Stockholders, are not included in the total shares of
BLAC common stock to be issued to OSR Holdings stockholders in the table. In this
regard, we also note your disclosure throughout the registration statement, including
on page 10 that "[o]n the Closing Date . . . BLAC shall issue to the Participating
Company Stockholders up to an aggregate of 24,461,214 shares of BLAC common
stock," and your table should show the fully diluted share capital of the combined
company and relevant ownership levels following the consummation of the business
combination.
Unaudited Pro Forma Condensed Combined Financial Information, page 130
2.We note your response to comment 5 and have the following comments:
•Tell us your consideration for reporting as noncontrolling interest the 40% of
OSR Holdings common stock that BLAC will not own upon the consummation of
the business combination. In that regard, we note that your post-BC organization
diagram shows OSR Holdings Co. Ltd becomes a 60% owned subsidiary of OSR
Holdings Inc., the Listco. Refer to ASC 810-10.
•Also tell us your consideration for reporting as redeemable noncontrolling
interest the 28% of OSR Holdings common stock that will be held by the Non-
Participating Shareholder Joinders that contain put and call rights. With regard to
the put right, whereby the Non-Participating Company Stockholder shall have the
right to cause BLAC to purchase all of the shares under the Joinders, please revise
to clarify how BLAC is expected to "purchase" these shares, for example, with
cash payments or future share issuances. In that regard, we note that your current
disclosures state that BLAC shall issue to the Participating Company
Stockholders up to an aggregate of 24,461,214 shares of BLAC common stock
under the Business Combination Agreement, including 14,676,728 shares of OSR
Holdings representing the 60% BLAC will own upon the consummation of the
business combination. Refer to ASC 480-10-S99-1 and ASC 480-10-S99-3A.
Note 2. IFRS to U.S. GAAP Reconciliation and Assessment, page 140
3.We note your response and the revisions made to comment 6 where you made a U.S.
GAAP adjustment to eliminate goodwill of KRW 11,716,110,411 generated from the
Vaximm acquisition, to use ‘book value (carry-over basis) accounting’. Pease also tell
us how you have considered a similar adjustment for the KRW 129,971,491814
intangible assets recognized from the Vaximm acquisition as reported at F-140.
Clarify specifically whether such balance was already on the book of Vaximm before
the acquisition.
Note 5. Adjustments to Unaudited Pro Forma Condensed Combined Balance Sheet, page 143
Reference adjustment 11) which reflects $20,000,000 of PIPE financing at $90.00 per
share for 222,222 shares of Series A Preferred Stock. Tell us how you have
determined that the PIPE financing qualifies as equity to be charged to additional paid
in capital. In that regard, we also note disclosures on page 296 that "beginning on the
three-year anniversary of the Original Issue Date, any holder of Series A Preferred 4.
December 5, 2024
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Stock may demand that BLAC redeem all or a portion of such holder’s Series A
Preferred Stock in an amount equal to the Redemption Price."
BLAC and OSR Holdings Discussions regarding Business Combination, page 161
5.We note your response to comment 11. We also note your disclosure on page 178 that
the reduction of the aggregate transaction consideration due to the termination of the
LBV acquisition "was not based on any valuation methodology attributable to LBV,
but rather negotiations between the BLAC M&A Committee and OSR Holdings as to
what constituted a mutually acceptable adjustment." Please revise to further discuss
the negotiations between the M&A Committee and OSR Holdings regarding the
mutually acceptable adjustment.
6.We note your response to comment 12, including that AF did not independently
develop any financial valuation information, did not have material findings of the
underlying valuations for Vaximm and Darnatein, and summarized the financial
information that was provided to them by the parties and provided that summary to
Choloc. Please revise your disclosures on page 198, and in the risk factors, as
applicable, to note that Choloc did not review or consider the material findings of the
underlying valuations for Vaximm and Darnatein prepared by AF when considering
AF's financial models in its fairness analysis.
The BLAC M&A Committee's Reasons for the Approval of the Business Combination, page
178
7.We note your response to comment 14. We also note your disclosure on page 181 that
"the BLAC M&A Committee reviewed OSR Holdings’ asset pipeline which includes
Vaximm’s drug candidates for recurrent GBM, hepatocellular cancer, metastatic
colorectal cancer, and Darnatein’s drug candidate for osteoarthritis and believes,
based on each pipeline asset’s targeted therapy and the projected growth of the
corresponding market, that OSR Holdings’ pipeline candidates have the potential to
address the needs of these markets, subject to, at a minimum, each candidate’s ability
to obtain regulatory approval." Please revise to further discuss the specific
assumptions underlying Vaximm and Darnatein's drug candidates' ability to address
the GBM, HCC, mCRC and OA treatment market opportunities, and explain how the
M&A Committee considered these assumptions in recommending approval of the
business combination.
OSR Holdings Indicative Valuation Reports, page 184
8.We note your response to comment 16. Please expand your discussion to further
explain how the M&A Committee determined that the assumption that Darnatein
would enter into a licensing deal exceeding $2 billion is reasonable, given your
disclosure that this valuation was despite early stages of development and that no
agreements have been reached. In your discussion, please disclose the specific
assumptions and data underlying the valuation of the licensing deal.
Additional Valuation Information Obtained During Diligence, page 187
We note your responses to comments 17 and 18, including that "the M&A Committee
considered the 2020 valuation report relevant for the valuation of OSR Holdings 9.
December 5, 2024
Page 4
included in the May 2023 draft LOI given the relevant assumptions and business case
remained largely unchanged, other than with respect to the timelines that were
significantly pushed back due to COVID-19 and the macroeconomic changes
resulting therefrom." We also note your disclosure on page 201 that "[f]or RMC,
Choloc reviewed the adequacy of the key assumptions taken by Ghilin’s DCF model
and concluded that the assumptions used are reasonable for a company such as RMC,
despite the age of the Ghilin report, based on the outcome of the comparable analysis
performed by AF and the fact that the relevant assumptions and business case
remained largely unchanged, other than with respect to the timelines that were
significantly pushed back due to COVID-19 and the macroeconomic changes
resulting therefrom." Please revise your disclosures regarding the Avance valuation
report and Choloc's reliance on Ghilin's DCF model to discuss the relevant
assumptions, the significant changes to timelines, and resulting macroeconomic
changes. Also, clarify how the outcome of the comparable analysis performed by
AF supported a determination that the assumptions taken by Ghilin's DCF model are
reasonable. Finally, explain how the BLAC M&A Committee and
Choloc concluded that the relevant assumptions and business case remained largely
unchanged despite the timelines being significantly pushed back due to COVID-19
and the resulting macroeconomic changes.
Business Of OSR Holdings And Certain Information About OSR Holdings
Vaximm, page 258
10.We note your response to comment 19. Please revise to disclose the date of
the VXM01 and avelumab combination study. Please also provide additional detail
regarding the findings of the VXM01 phase 1 clinical trial and the combination study.
Specifically, please note how patients in the trial and study were selected and explain
the material findings of each, including p-values supporting the conclusions disclosed.
For example, we note your disclosure on page 261 that "no adverse effects related to
VXM01 were observed, and specific peripheral immune responses and increased T-
cell infiltration in post-vaccine tumor tissue were identified." Please briefly discuss
these specific peripheral immune responses.
Darnatein, page 264
We note your response to comment 21. Please revise your disclosures regarding
Darnatein's studies to address the following:
•We note your disclosure on page 265 that "DRT-101 was evaluated in animals by
ChemOn Inc in 2021 for toxicity and efficacy measurement, and by Biotoxtech
Inc. since 2023 using rats and beagle dogs in preparation for designing human
clinical studies." Please revise to discuss the material findings of the Biotoxtech
studies on rats and beagle dogs. Where applicable, please also note p-values,
including for the studies conducted by ChemOn Inc. since 2021 on Sprague
Dawley rats.
We note your disclosure on page 266 that, "[p]rior to conducting human clinical
trials, Darnatein completed Safety Test . . . at Korean Testing & Research Institute •11.
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(“KTR”). Darnatein also completed Intravenous Toxicity Test in Sprague Dawley
Rats, Beagles, and ICR mice with Chemon Inc. and Korea Institute of Toxicology
(“KIT”), as well as Efficacy Test in Beagle dogs, Sprague Dawley Rats, New
Zealand White Rabbit, C3H Mouse and Cynomolgus Monkeys at Seoul Boramae
Medical Center, Inha University Hospital, Korea Animal Medical Science
Institute, joint Center for Biosciences, and Pharmalegacy (China) to demonstrate
DRT-102’s safety and efficacy profiles." Please revise to note the dates of these
tests and studies, and to discuss any material findings from these tests and studies.
Please also explain how Darnatein was able to "demonstrate DRT-102's safety
and efficacy" without regulatory approval. We note that safety and efficacy are
determinations that are solely within the authority of the FDA or similar foreign
regulators. As such, please revise to remove statements of safety and efficacy for
any candidates that have not been approved by the FDA or similar foreign
regulators.
•We note your disclosure on page 266 that "DRT-102 was evaluated in a human
exploratory clinical trial with 4 patients (excluding two dropouts) conducted at
Inha University Hospital managed by DT&R CRO in 2016 ~ 2019," and that
"DRT-102 was further evaluated in a confirmation clinical trial from 2020 to
2022." Please revise to explain how patients were selected for these clinical trials
and further discuss the material findings of the clinical trials, including supporting
p-values. Please also discuss, for these and any other clinical trials and studies
disclosed, whether there were any adverse results.
RMC
Products and Related Systems, page 269
12.We note your revised disclosure that the distribution agreement with Penumbra
expired, and that you cannot predict if RMC will reach an agreement with Penumbra
or, if it does, the terms of such agreement. Please revise your risk factor disclosure to
discuss the risks related to the expiration and renegotiation of this agreement, if
material.
OSR Holdings Management's Discussion and Analysis of Financial Condition and Results of
Operations
Overview, page 294
13.We note your disclosure on page 296 that "BCM Europe AG ('BCME'), an affiliate of
Sponsor and shareholder of OSR Holdings, agreed to deposit 400,000 shares of BLAC
Common Stock into an escrow account, to be governed by a separate escrow
agreement to be entered into between Duksung and BCME." Please revise to clarify
whether BCME received any consideration for agreeing to deposit these shares into an
escrow account. Please also clarify the status of the escrow agreement, including
whether you expect the parties to enter into this agreement prior to the closing of the
business combination.
December 5, 2024
Page 6
Components and Comparison of Our Results of Operations, Comparison of the Six Months
Ended June 30, 2023 and 2024
Administrative Expenses, page 298
14.Please revise to provide more disclosure about the 70% increase in administrative
expense during the six months ended June 30, 2024. In that regard, please quantify
the amounts related to each of the increased accounting, finance and legal expenses.
Critical Accounting Policies and Estimates
Revenue Recognition, page 302
15.We reference the changes made in response to prior comment 24 regarding revenue
recognition. You state that "Variable consideration within the transaction price, if
any, reflects concessions provided to a customer such as discounts, rebates and
refunds, any potential bonuses receivable from the customer and any other contingent
events." Please revise to clarify whether these examples of variable consideration
exist within your transactions and its impact. In that regard, we note you stated in your
response that variable consideration in the sale of the RMC products have been
immaterial.
OSR Holdings Co., Ltd. and its Subsidiaries Consolidated Financial Statements for the Year
Ended December 31, 2023
Note 1. General Information, page F-98
16.We note your response to comment 26 that the financial and operational impact of
Darnatein was quantitatively and qualitatively inconsequential for the three-month
period from April 1, 2023 to June 30, 2023. However we do not see where you
considered the impact of not recording acquisition related expenses during that time
period, such as three months of amortization of the patent technology intangible asset
recorded in the business combination. Please explain how the financial results are not
materially misstated.
14. Intangible Assets, page F-124
We reference prior comment 27. We have the following comments regarding your
intangible assets:
•Tell us why you increased the amount recorded in the "acquisition and disposal"
line item to the patent technology by the same amount you recorded impairment
losses for the y