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UPLOAD Filing

Semnur Pharmaceuticals, Inc.
Date: May 20, 2025 · CIK: 0001913577 · Accession: 0000000000-25-005328

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File numbers found in text: 333-283019

Date
May 19, 2025
Author
Elizabeth Razzano, Esq.
Form
UPLOAD
Company
Semnur Pharmaceuticals, Inc.

Letter

Re: Denali Capital Acquisition Corp. Amendment No. 1 to Registration Statement on Form S-4 Filed April 21, 2025 File No. 333-283019 Dear Lei Huang and Jaisim Shah:

May 19, 2025

Lei Huang Chief Executive Officer Denali Capital Acquisition Corp. 437 Madison Avenue , 27th Floor New York, NY 10022

Jaisim Shah Chief Executive Officer and President Semnur Pharmaceuticals, Inc. 960 San Antonio Road Palo Alto, CA 94303

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 December 11, letter.

Amendment No. 1 to Registration Statement on Form S-4 Cover Page

1. We note your response to prior comment 6. Specifically, we note your revised disclosure that it is a condition of the consummation of the Business Combination that the New Semnur Common Stock and New Semnur Warrants after the Domestication May 19, 2025 Page 2

and prior to the Effective Time "remain listed or quoted on the applicable Stock Exchange through the Effective Time, the listing application for the listing of the New Semnur Common Stock and New Semnur Warrants following the Effective Time have been approved by Nasdaq or other Stock Exchange...." Given the recent delisting of Denali's securities from Nasdaq and the revisions to your definition of "Stock Exchange" to refer to Nasdaq and the OTC Markets, please further revise your disclosure here and throughout the registration statement as appropriate to clarify whether the listing of the New Semnur Common Stock and New Semnur Warrants on the Nasdaq Capital Market is a condition to completion of the Business Combination or whether quotation on the OTC Markets would suffice. 2. Please revise to disclose whether a new listing application has been filed with Nasdaq or the planned timing for such application, if applicable. Clarify whether Denali shareholders will know the status of the listing application and/or any waivers of the merger condition prior to voting on the proposals. Why is Scilex conducting the Business Combination and related transactions?, page 8

3. We note your response to prior comment 27 and your disclosures on pages 196 and 292. Please revise the Q&A to clarify that Syneos Health prepared the study during the 2020-2021 timeframe. With regard to the 3.6% average annual market growth rate, please clarify the applicable date range used in the Syneos study. Also, clarify the growth rate used by Semnur s management for the five-year period following commercialization (2028-2033) and briefly discuss its basis for using this growth rate. Questions and Answers about the Business Combination and the Meeting What are the possible sources and the extent of dilution that public shareholders..., page 13

4. Please tell us where you have provided the dilution disclosure required by Item 1604(c) of Regulation S-K or revise your prospectus to provide such disclosure. In this regard, Item 1604(c) requires tabular disclosure at the selected redemption levels of your net tangible book value per share, as adjusted to give effect to material probable or consummated transactions and other material effects on your net tangible book value per share from the Business Combination, compared to your IPO offering price. Proposal 1 - The Business Combination Proposal Background of the Business Combination, page 170

5. We note your added disclosure on page 176 regarding a draft of the Merger Agreement Amendment. Please revise your disclosure to briefly describe the events and discussions leading up to the Merger Agreement Amendment. Opinion of CB Capital Comparable Company Analysis, page 181

6. We note your response to prior comment 19. Please further revise your disclosures to clarify how Semnur compares with the companies identified in this section based on the criteria used for selection of such companies. For example only, we note CB Capital's use of market capitalization and financial performance in selecting the companies. May 19, 2025 Page 3

7. We note your response to prior comment 20. Specifically, we note your statement that the Denali Board gave its approval with respect to the methodologies concerning the composition of the comparable companies. Please further revise your disclosure to clearly state whether Denali's Board reviewed the list of comparable companies selected by CB Capital and agreed that these companies are comparable to Semnur. Certain Semnur Projected Financial Information, page 193

8. We note your response to prior comment 26. Please explain your basis for including revenues from Non-LR indications beginning in 2027. In particular, please explain which indications you are targeting for treatment with SP-102 and quantify the projected revenues derived from each indication for each year presented (FY2027- FY2043). Discuss whether these projections assume that you will have FDA regulatory approval for each indication and, if so, when such approval would be obtained. Revise the Business section to present any pre-clinical and/or clinical data supporting commercialization for each indication, or advise. Certain Semnur Projected Financial Information Semnur Management Projections - Best Case Projections, page 198

9. Semnur's projected operating income for FY2032 and FY2033 does not appear to be mathematically correct. Please revise to correct projected operating income for these years. Proposal 3 - The Charter Approval Proposal Reasons for the Approval of the Charter Approval Proposal, page 231

10. We note your response to prior comment 28. Please revise your disclosure in this section to disclose the number of additional authorized shares (i.e., what portion of the proposed increase in authorized shares), if any, needed to complete the Business Combination. Proposal 7 - The Nasdaq Proposal, page 245

11. We note your statement that you are required to obtain stockholder approval of the Nasdaq Proposal pursuant to Nasdaq Listing Rules 5635(a) and (b). Please revise your disclosure in this section to state that your securities have been delisted from Nasdaq and to clarify whether, given such delisting, approval of the Nasdaq Proposal is required to complete the Business Combination and whether the Nasdaq Proposal is still a Condition Precedent Proposal. Our Company, page 287

12. We refer to prior comment 29 and note your disclosures on page 288 and elsewhere concerning the Type C meeting that Scilex/Semnur had with FDA in November 2023. Please revise to explain in greater detail the specific disagreement between the parties and the guidance regarding expectations for the additional confirmatory trial needed prior to a 505(b)(2) NDA filing. In this regard, it is unclear whether FDA was concerned about the size of the completed CLEAR-1 trial, the endpoints assessed or not assessed in the trial, the results reported, or something else. 13. We refer to prior comment 29 and note your disclosures on page 288 and elsewhere May 19, 2025 Page 4

concerning the Type D meeting that Scilex/Semnur had with FDA in February 2024. Please revise to disclose in greater detail the additional guidance provided by FDA at this meeting concerning the confirmatory trial design. Also, disclose the primary endpoints, and any secondary endpoints, that have been established for the CLEAR-2 trial, or advise. Our Strategy, page 288

14. We note your revisions in response to prior comment 30 as well as the disclosures on pages 309 and 311 concerning circumstances where FDA may approve a drug product based on the results of a single adequate and well-controlled Phase 3 trial for excellent design and which provides highly reliable and statistically strong evidence of important "clinical benefit." Given your revised disclosures on pages 289 and elsewhere concerning the clinical benefit and tolerability assessed in the CLEAR- 1 trial, please tell us, and, if applicable, revise to indicate, whether Semnur s planned NDA application would seek approval on this particular basis. Also, please revise where appropriate to explain in greater detail the clinical benefit standard including how it is demonstrated. Management's Discussion and Analysis of Financial Condition and Results of Operations of Semnur Liquidity and Capital Resources, page 329

15. We note your response to prior comment 35; however, we do not see the revised disclosure you reference on page 331. Please revise or advise. Notes to the Unaudited Pro Forma Condensed Financial Information Note 1 - Description of Business Combination, page 342

16. We note your response to prior comment 36 and the revisions you made to your pro forma financial statements to include autonomous entity adjustments to reflect the operation of Semnur as a standalone reporting entity pursuant to the Transition Services Agreement to be executed in connection with closing of the Business Combination. Your disclosure on page 344, however, continues to state that no such adjustments have been provided. Please revise accordingly. Note 3 - Transaction Adjustments to Unaudited Pro Forma Condensed Combined Balance Sheet as of December 31, 2024, page 344

17. Please clarify why pro forma adjustment (I) to reflect conversions and recapitalization of Semnur historical equity into New Semnur Common and Class A Preferred Stock results in a negative $1.6 million balance for Semnur Common Stock under each redemption scenario or revise accordingly. It would appear that Semnur historical equity accounts should have a balance of zero after the recapitalization and Business Combination transactions. Please also revise to more clearly describe your pro forma equity adjustments in general such that adjustments to Semnur and Denali historical equity balances are easily discernable from adjustments for transactions occurring subsequent to the most recent balance sheet date. Future Stockholder Proposals and Nominations, page 445 May 19, 2025 Page 5

18. Please update this section as appropriate. In this regard, we note your disclosure in the first paragraph that, if the Business Combination is not completed, you anticipate the 2024 annual meeting of shareholders will be held no later than December 31, 2024. Please contact Franklin Wyman at 202-551-3660 or Angela Connell at 202-551-3426 if you have questions regarding comments on the financial statements and related matters. Please contact Jessica Dickerson at 202-551-8013 or Joe McCann at 202-551-6262 with any other questions.

Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Michael Blankenship, Esq.
Elizabeth Razzano, Esq.

Show Raw Text
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 May 19, 2025

Lei Huang
Chief Executive Officer
Denali Capital Acquisition Corp.
437 Madison Avenue , 27th Floor
New York, NY 10022

Jaisim Shah
Chief Executive Officer and President
Semnur Pharmaceuticals, Inc.
960 San Antonio Road
Palo Alto, CA 94303

 Re: Denali Capital Acquisition Corp.
 Amendment No. 1 to Registration Statement on Form S-4
 Filed April 21, 2025
 File No. 333-283019
Dear Lei Huang and Jaisim Shah:

 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 December 11,
2024
letter.

Amendment No. 1 to Registration Statement on Form S-4
Cover Page

1. We note your response to prior comment 6. Specifically, we note your
revised
 disclosure that it is a condition of the consummation of the Business
Combination that
 the New Semnur Common Stock and New Semnur Warrants after the
Domestication
 May 19, 2025
Page 2

 and prior to the Effective Time "remain listed or quoted on the
applicable Stock
 Exchange through the Effective Time, the listing application for the
listing of the New
 Semnur Common Stock and New Semnur Warrants following the Effective Time
 have been approved by Nasdaq or other Stock Exchange...." Given the
recent delisting
 of Denali's securities from Nasdaq and the revisions to your definition
of "Stock
 Exchange" to refer to Nasdaq and the OTC Markets, please further revise
your
 disclosure here and throughout the registration statement as appropriate
to clarify
 whether the listing of the New Semnur Common Stock and New Semnur
Warrants on
 the Nasdaq Capital Market is a condition to completion of the Business
Combination
 or whether quotation on the OTC Markets would suffice.
2. Please revise to disclose whether a new listing application has been
filed with Nasdaq
 or the planned timing for such application, if applicable. Clarify
whether Denali
 shareholders will know the status of the listing application and/or any
waivers of the
 merger condition prior to voting on the proposals.
Why is Scilex conducting the Business Combination and related transactions?,
page 8

3. We note your response to prior comment 27 and your disclosures on pages
196 and
 292. Please revise the Q&A to clarify that Syneos Health prepared the
study during
 the 2020-2021 timeframe. With regard to the 3.6% average annual market
growth
 rate, please clarify the applicable date range used in the Syneos study.
Also, clarify
 the growth rate used by Semnur s management for the five-year period
following
 commercialization (2028-2033) and briefly discuss its basis for using
this growth rate.
Questions and Answers about the Business Combination and the Meeting
What are the possible sources and the extent of dilution that public
shareholders..., page 13

4. Please tell us where you have provided the dilution disclosure required
by Item
 1604(c) of Regulation S-K or revise your prospectus to provide such
disclosure. In
 this regard, Item 1604(c) requires tabular disclosure at the selected
redemption levels
 of your net tangible book value per share, as adjusted to give effect to
material
 probable or consummated transactions and other material effects on your
net tangible
 book value per share from the Business Combination, compared to your IPO
offering
 price.
Proposal 1 - The Business Combination Proposal
Background of the Business Combination, page 170

5. We note your added disclosure on page 176 regarding a draft of the
Merger
 Agreement Amendment. Please revise your disclosure to briefly describe
the events
 and discussions leading up to the Merger Agreement Amendment.
Opinion of CB Capital
Comparable Company Analysis, page 181

6. We note your response to prior comment 19. Please further revise your
disclosures to
 clarify how Semnur compares with the companies identified in this
section based on
 the criteria used for selection of such companies. For example only, we
note CB
 Capital's use of market capitalization and financial performance in
selecting the
 companies.
 May 19, 2025
Page 3

7. We note your response to prior comment 20. Specifically, we note your
statement that
 the Denali Board gave its approval with respect to the methodologies
concerning the
 composition of the comparable companies. Please further revise your
disclosure to
 clearly state whether Denali's Board reviewed the list of comparable
companies
 selected by CB Capital and agreed that these companies are comparable to
Semnur.
Certain Semnur Projected Financial Information, page 193

8. We note your response to prior comment 26. Please explain your basis for
including
 revenues from Non-LR indications beginning in 2027. In particular,
please explain
 which indications you are targeting for treatment with SP-102 and
quantify the
 projected revenues derived from each indication for each year presented
(FY2027-
 FY2043). Discuss whether these projections assume that you will have FDA
 regulatory approval for each indication and, if so, when such approval
would be
 obtained. Revise the Business section to present any pre-clinical and/or
clinical data
 supporting commercialization for each indication, or advise.
Certain Semnur Projected Financial Information
Semnur Management Projections - Best Case Projections, page 198

9. Semnur's projected operating income for FY2032 and FY2033 does not
appear to be
 mathematically correct. Please revise to correct projected operating
income for these
 years.
Proposal 3 - The Charter Approval Proposal
Reasons for the Approval of the Charter Approval Proposal, page 231

10. We note your response to prior comment 28. Please revise your disclosure
in this
 section to disclose the number of additional authorized shares (i.e.,
what portion of the
 proposed increase in authorized shares), if any, needed to complete the
Business
 Combination.
Proposal 7 - The Nasdaq Proposal, page 245

11. We note your statement that you are required to obtain stockholder
approval of the
 Nasdaq Proposal pursuant to Nasdaq Listing Rules 5635(a) and (b). Please
revise your
 disclosure in this section to state that your securities have been
delisted from Nasdaq
 and to clarify whether, given such delisting, approval of the Nasdaq
Proposal is
 required to complete the Business Combination and whether the Nasdaq
Proposal is
 still a Condition Precedent Proposal.
Our Company, page 287

12. We refer to prior comment 29 and note your disclosures on page 288 and
elsewhere
 concerning the Type C meeting that Scilex/Semnur had with FDA in
November 2023.
 Please revise to explain in greater detail the specific disagreement
between the parties
 and the guidance regarding expectations for the additional confirmatory
trial needed
 prior to a 505(b)(2) NDA filing. In this regard, it is unclear whether
FDA was
 concerned about the size of the completed CLEAR-1 trial, the endpoints
assessed or
 not assessed in the trial, the results reported, or something else.
13. We refer to prior comment 29 and note your disclosures on page 288 and
elsewhere
 May 19, 2025
Page 4

 concerning the Type D meeting that Scilex/Semnur had with FDA in
February 2024.
 Please revise to disclose in greater detail the additional guidance
provided by FDA at
 this meeting concerning the confirmatory trial design. Also, disclose
the primary
 endpoints, and any secondary endpoints, that have been established for
the CLEAR-2
 trial, or advise.
Our Strategy, page 288

14. We note your revisions in response to prior comment 30 as well as the
disclosures on
 pages 309 and 311 concerning circumstances where FDA may approve a drug
product
 based on the results of a single adequate and well-controlled Phase 3
trial for excellent
 design and which provides highly reliable and statistically strong
evidence of
 important "clinical benefit." Given your revised disclosures on pages
289 and
 elsewhere concerning the clinical benefit and tolerability
assessed in the CLEAR-
 1 trial, please tell us, and, if applicable, revise to indicate, whether
Semnur s planned
 NDA application would seek approval on this particular basis. Also,
please revise
 where appropriate to explain in greater detail the clinical benefit
 standard including
 how it is demonstrated.
Management's Discussion and Analysis of Financial Condition and Results of
Operations of
Semnur
Liquidity and Capital Resources, page 329

15. We note your response to prior comment 35; however, we do not see the
revised
 disclosure you reference on page 331. Please revise or advise.
Notes to the Unaudited Pro Forma Condensed Financial Information
Note 1 - Description of Business Combination, page 342

16. We note your response to prior comment 36 and the revisions you made to
your pro
 forma financial statements to include autonomous entity adjustments to
reflect the
 operation of Semnur as a standalone reporting entity pursuant to the
Transition
 Services Agreement to be executed in connection with closing of the
Business
 Combination. Your disclosure on page 344, however, continues to state
that no such
 adjustments have been provided. Please revise accordingly.
Note 3 - Transaction Adjustments to Unaudited Pro Forma Condensed Combined
Balance
Sheet as of December 31, 2024, page 344

17. Please clarify why pro forma adjustment (I) to reflect conversions and
recapitalization
 of Semnur historical equity into New Semnur Common and Class A Preferred
Stock
 results in a negative $1.6 million balance for Semnur Common Stock under
each
 redemption scenario or revise accordingly. It would appear that Semnur
historical
 equity accounts should have a balance of zero after the recapitalization
and Business
 Combination transactions. Please also revise to more clearly describe
your pro forma
 equity adjustments in general such that adjustments to Semnur and Denali
historical
 equity balances are easily discernable from adjustments for transactions
occurring
 subsequent to the most recent balance sheet date.
Future Stockholder Proposals and Nominations, page 445
 May 19, 2025
Page 5

18. Please update this section as appropriate. In this regard, we note your
disclosure in the
 first paragraph that, if the Business Combination is not completed, you
anticipate the
 2024 annual meeting of shareholders will be held no later than December
31, 2024.
 Please contact Franklin Wyman at 202-551-3660 or Angela Connell at
202-551-3426
if you have questions regarding comments on the financial statements and
related
matters. Please contact Jessica Dickerson at 202-551-8013 or Joe McCann at
202-551-6262
with any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
cc: Michael Blankenship, Esq.
 Elizabeth Razzano, Esq.
</TEXT>
</DOCUMENT>