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Semnur Pharmaceuticals, Inc.
Response Received
6 company response(s)
High - file number match
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Company responded
2025-04-21
Semnur Pharmaceuticals, Inc.
References: December 11, 2024
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Company responded
2025-06-11
Semnur Pharmaceuticals, Inc.
References: May 19, 2025
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Company responded
2025-07-02
Semnur Pharmaceuticals, Inc.
References: June 26, 2025 | October 8, 2024
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Company responded
2025-07-23
Semnur Pharmaceuticals, Inc.
References: July 16, 2025
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Company responded
2025-08-08
Semnur Pharmaceuticals, Inc.
References: August 6, 2025
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Semnur Pharmaceuticals, Inc.
Awaiting Response
0 company response(s)
High
Semnur Pharmaceuticals, Inc.
Awaiting Response
0 company response(s)
High
Semnur Pharmaceuticals, Inc.
Awaiting Response
0 company response(s)
High
Semnur Pharmaceuticals, Inc.
Awaiting Response
0 company response(s)
High
Semnur Pharmaceuticals, Inc.
Awaiting Response
0 company response(s)
High
Semnur Pharmaceuticals, Inc.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2025-03-25
Semnur Pharmaceuticals, Inc.
References: March 25, 2025
Semnur Pharmaceuticals, Inc.
Response Received
2 company response(s)
Medium - date proximity
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-11 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-08-08 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-08-07 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 333-283019 | Read Filing View |
| 2025-07-23 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-07-16 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 333-283019 | Read Filing View |
| 2025-07-02 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-06-26 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 333-283019 | Read Filing View |
| 2025-06-11 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-05-20 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 333-283019 | Read Filing View |
| 2025-04-21 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-03-28 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 001-41351 | Read Filing View |
| 2025-03-25 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 001-41351 | Read Filing View |
| 2025-03-25 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2024-12-12 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 333-283019 | Read Filing View |
| 2022-04-04 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2022-04-04 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2022-03-10 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-07 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 333-283019 | Read Filing View |
| 2025-07-16 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 333-283019 | Read Filing View |
| 2025-06-26 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 333-283019 | Read Filing View |
| 2025-05-20 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 333-283019 | Read Filing View |
| 2025-03-28 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 001-41351 | Read Filing View |
| 2025-03-25 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 001-41351 | Read Filing View |
| 2024-12-12 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | 333-283019 | Read Filing View |
| 2022-03-10 | SEC Comment Letter | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-11 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-08-08 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-07-23 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-07-02 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-06-11 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-04-21 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2025-03-25 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2022-04-04 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
| 2022-04-04 | Company Response | Semnur Pharmaceuticals, Inc. | DE | N/A | Read Filing View |
2025-08-11 - CORRESP - Semnur Pharmaceuticals, Inc.
CORRESP 1 filename1.htm CORRESP Denali Capital Acquisition Corp. 437 Madison Avenue, 27th Floor New York, NY 10022 August 11, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Franklin Wyman, Angela Connell, Jessica Dickerson, Joe McCann Re: Denali Capital Acquisition Corp. Registration Statement on Form S-4, as amended File No. 333-283019 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Denali Capital Acquisition Corp. (the “ Company ”) hereby respectfully requests that the effectiveness of the Registration Statement on Form S-4 (File No. 333-283019) of the Company, initially filed with the Securities and Exchange Commission on November 6, 2024 (as amended, the “ Registration Statement ”), be accelerated so that such Registration Statement shall become effective at 5:00 p.m., Eastern Time, on August 12, 2025, or as soon as possible thereafter. It would be appreciated if, promptly after the Registration Statement has become effective, you would so inform our outside counsel, Michael Blankenship of Winston & Strawn LLP, by telephone at (713) 651-2678 or by email at MBlankenship@winston.com. The Company hereby authorizes Mr. Blankenship to orally modify or withdraw this request for acceleration. Sincerely, Denali Capital Acquisition Corp. By: /s/ Lei Huang Lei Huang Chief Executive Officer cc: Michael Blankenship, Winston & Strawn LLP Jeff Hartlin, Paul Hastings LLP Elizabeth Razzano, Paul Hastings LLP Jaisim Shah, Chief Executive Officer and President, Semnur Pharmaceuticals, Inc.
2025-08-08 - CORRESP - Semnur Pharmaceuticals, Inc.
CORRESP 1 filename1.htm CORRESP Denali Capital Acquisition Corp. August 8, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Franklin Wyman, Angela Connell, Jessica Dickerson, Joe McCann Re: Denali Capital Acquisition Corp. Semnur Pharmaceuticals, Inc. Amendment No. 4 to Registration Statement on Form S-4 Filed July 23, 2025 File No. 333-283019 Ladies and Gentlemen: Denali Capital Acquisition Corp., a Cayman Islands exempted company (the “ Company ”), files herewith Amendment No. 5 (“ Amendment No. 5 ”) to the above-referenced registration statement on Form S-4 filed on November 6, 2024, as previously amended by Amendment No. 1 filed on April 21, 2025, by Amendment No. 2 filed on June 11, 2025, by Amendment No. 3 filed on July 2, 2025 and by Amendment No. 4 filed on July 23, 2025 (the “ Registration Statement ”). Set forth below are the responses of the Company to the comments of the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission (the “ Staff ”) with respect to the Registration Statement contained in the Staff’s letter dated August 6, 2025 (the “ Comment Letter ”). For ease of reference, each comment contained in the Comment Letter is printed below and is followed by the Company’s response. All page references in the responses set forth below refer to page numbers in Amendment No. 5. All capitalized terms used but not defined in this response letter have the meanings ascribed to such terms in Amendment No. 5. Amendment No. 4 to Registration Statement on Form S-4 Denali’s Net Tangible Book Value Per Share as Adjusted and Dilution, page 16 1. Please revise your calculation of pro forma NTBV per share to include the 30,500,000 shares to be issued to consultants in the calculation of the denominator. Alternatively, explain your basis for excluding these transactions from this presentation, given your statement that “Dilution per share to the original investors in Denali is determined by Denali’s net tangible book value per share, as adjusted, excluding the Business Combination itself and giving effect to material probable or consummated transactions and other material effects on the net tangible book value per share, from the initial public offering price per share paid by original investors in Denali.” Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 16-18 of Amendment No. 5 in response to the Staff’s comment. Semnur Merger Agreement, page 311 2. We note your disclosure that, pursuant to the Semnur Merger Agreement related to the Semnur Merger in 2019, Scilex agreed to pay the former holders of Semnur’s capital stock up to $280.0 million in aggregate milestone payments, which amounts are expected to be charged back to Semnur through an intercompany arrangement. Please revise your disclosure to clarify how these obligations will be addressed following completion of the Business Combination. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 200-201, 203 and 310 of Amendment No. 5 in response to the Staff’s comment. 1 U.S. Securities and Exchange Commission August 8, 2025 Exhibits 3. We note the removal of Exhibit 8.1 from the Exhibit Index on page II-2. Please file a tax opinion as an exhibit to the registration statement, or tell us why you do not believe you are required to do so. Refer to Section III of Staff Legal Bulletin No. 19 (CF). Response : The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has filed a copy of the Winston & Strawn LLP tax opinion with Amendment No. 5. General 4. We note that you have added a resale registration for shares beneficially owned by Scilex Holding Company. Please refer to Question 212.15 and Question 612.09 of the Securities Act Rules Compliance and Disclosure Interpretations and remove the resale transaction from the registration statement. Response : The Company acknowledges the Staff’s comment and respectfully advises the Staff that it has removed the resale transaction from Amendment No. 5. * * * 2 U.S. Securities and Exchange Commission August 8, 2025 Please do not hesitate to contact Michael Blankenship of Winston & Strawn LLP at (713) 651-2678 with any questions or comments regarding this letter. Sincerely, By: /s/ Lei Huang Lei Huang Chief Executive Officer cc: Michael Blankenship, Winston & Strawn LLP Jeff Hartlin, Paul Hastings LLP Elizabeth Razzano, Paul Hastings LLP Jaisim Shah, Chief Executive Officer and President, Semnur Pharmaceuticals, Inc. 3
2025-08-07 - UPLOAD - Semnur Pharmaceuticals, Inc. File: 333-283019
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 6, 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. 4 to Registration Statement on Form S-4 Filed July 23, 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 July 16, 2025 letter. Amendment No. 4 to Registration Statement on Form S-4 Denali's Net Tangible Book Value Per Share as Adjusted and Dilution, page 16 1. Please revise your calculation of pro forma NTBV per share to include the 30,500,000 shares to be issued to consultants in the calculation of the denominator. Alternatively, explain your basis for excluding these transactions from this presentation, given your statement that "Dilution per share to the original investors in Denali is determined by August 6, 2025 Page 2 Denali s net tangible book value per share, as adjusted, excluding the Business Combination itself and giving effect to material probable or consummated transactions and other material effects on the net tangible book value per share, from the initial public offering price per share paid by original investors in Denali." Semnur Merger Agreement, page 311 2. We note your disclosure that, pursuant to the Semnur Merger Agreement related to the Semnur Merger in 2019, Scilex agreed to pay the former holders of Semnur s capital stock up to $280.0 million in aggregate milestone payments, which amounts are expected to be charged back to Semnur through an intercompany arrangement. Please revise your disclosure to clarify how these obligations will be addressed following completion of the Business Combination. Exhibits 3. We note the removal of Exhibit 8.1 from the Exhibit Index on page II-2. Please file a tax opinion as an exhibit to the registration statement, or tell us why you do not believe you are required to do so. Refer to Section III of Staff Legal Bulletin No. 19 (CF). General 4. We note that you have added a resale registration for shares beneficially owned by Scilex Holding Company. Please refer to Question 212.15 and Question 612.09 of the Securities Act Rules Compliance and Disclosure Interpretations and remove the resale transaction from the registration statement. 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>
2025-07-23 - CORRESP - Semnur Pharmaceuticals, Inc.
CORRESP 1 filename1.htm CORRESP Denali Capital Acquisition Corp. July 23, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Franklin Wyman, Angela Connell, Jessica Dickerson, Joe McCann Re: Denali Capital Acquisition Corp. Semnur Pharmaceuticals, Inc. Amendment No. 3 to Registration Statement on Form S-4 Filed July 2, 2025 File No. 333-283019 Ladies and Gentlemen: Denali Capital Acquisition Corp., a Cayman Islands exempted company (the “ Company ”), files herewith Amendment No. 4 (“ Amendment No. 4 ”) to the above-referenced registration statement on Form S-4 filed on November 6, 2024, as previously amended by Amendment No. 1 filed on April 21, 2025, by Amendment No. 2 filed on June 11, 2025 and by Amendment No. 3 filed on July 2, 2025 (the “ Registration Statement ”). Set forth below is the Company’s response to the comment of the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission (the “ Staff ”) with respect to the Registration Statement contained in the Staff’s letter dated July 16, 2025 (the “ Comment Letter ”). For ease of reference, the comment contained in the Comment Letter is printed below and is followed by the Company’s response. The page reference in the response set forth below refers to the page number in Amendment No. 4. All capitalized terms used but not defined in this response letter have the meanings ascribed to such terms in Amendment No. 4. Amendment No. 3 to Registration Statement on Form S-4 Business of Semnur Clinical Development Overview Interpreting Clinical Meaningfulness of SP-102…, page 304 1. We note your response to prior comment 3. Please remove the statement in the penultimate paragraph of this section stating that safety assessments demonstrate that SP-102 was “safe” for both single and repeat injections, as safety determinations are solely within the authority of the FDA and comparable foreign regulatory authorities. Response : The Company respectfully advises the Staff that it has removed the referenced statement on page 305 of Amendment No. 4 in response to the Staff’s comment. * * * 1 U.S. Securities and Exchange Commission July 23, 2025 Please do not hesitate to contact Michael Blankenship of Winston & Strawn LLP at (713) 651-2678 with any questions or comments regarding this letter. Sincerely, By: /s/ Lei Huang Lei Huang Chief Executive Officer cc: Michael Blankenship, Winston & Strawn LLP Jeff Hartlin, Paul Hastings LLP Elizabeth Razzano, Paul Hastings LLP Jaisim Shah, Chief Executive Officer and President, Semnur Pharmaceuticals, Inc. 2
2025-07-16 - UPLOAD - Semnur Pharmaceuticals, Inc. File: 333-283019
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 16, 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. 3 to Registration Statement on Form S-4 Filed July 2, 2025 File No. 333-283019 Dear Lei Huang and Jaisim Shah: We have reviewed your amended registration statement and have the following comment. 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 June 26, 2025 letter. Amendment No. 3 to Registration Statement on Form S-4 Business of Semnur Clinical Development Overview Interpreting Clinical Meaningfulness of SP-102..., page 304 1. We note your response to prior comment 3. Please remove the statement in the penultimate paragraph of this section stating that safety assessments demonstrate that July 16, 2025 Page 2 SP-102 was "safe" for both single and repeat injections, as safety determinations are solely within the authority of the FDA and comparable foreign regulatory authorities. 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>
2025-07-02 - CORRESP - Semnur Pharmaceuticals, Inc.
CORRESP 1 filename1.htm CORRESP Denali Capital Acquisition Corp. July 2, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Franklin Wyman, Angela Connell, Jessica Dickerson, Joe McCann Re: Denali Capital Acquisition Corp. Semnur Pharmaceuticals, Inc. Amendment No. 2 to Registration Statement on Form S-4 Filed June 11, 2025 File No. 333-283019 Ladies and Gentlemen: Denali Capital Acquisition Corp., a Cayman Islands exempted company (the “ Company ”), files herewith Amendment No. 3 (“ Amendment No. 3 ”) to the above-referenced registration statement on Form S-4 filed on November 6, 2024, as previously amended by Amendment No. 1 filed on April 21, 2025 and by Amendment No. 2 filed on June 11, 2025 (the “ Registration Statement ”). Set forth below are the responses of the Company to the comments of the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission (the “ Staff ”) with respect to the Registration Statement contained in the Staff’s letter dated June 26, 2025 (the “ Comment Letter ”). For ease of reference, each comment contained in the Comment Letter is printed below and is followed by the Company’s response. All page references in the responses set forth below refer to page numbers in Amendment No. 3. All capitalized terms used but not defined in this response letter have the meanings ascribed to such terms in Amendment No. 3. Amendment No. 2 to Registration Statement on Form S-4 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 1. The total share amounts presented in your tabular disclosure on page 14 differ from those presented on pages iv, 61, 214 and 344. Further, your disclosure on page 14 includes certain items that will not result in shares outstanding after the Business Combination until the related options or warrants are exercised (e.g., shares underlying public and private warrants and shares underlying Semnur options). Please revise to explain the basis for these differences and/or revise your presentations accordingly. Response : The Company respectfully advises the Staff that the different tabular disclosure on pages 14-15 is intended to provide the reader with the fully-diluted capitalization of New Semnur, in addition to the non-fully diluted capitalization and voting power information provided elsewhere in the prospectus and the Company has revised the disclosure on pages iv, 14-15, 61, 214 and 345 of Amendment No. 3 in response to the Staff’s comment to clarify that point. U.S. Securities and Exchange Commission July 2, 2025 Selected Historical Financial Data of Denali, page 269 2. Please expand this presentation to include financial data for the three months ended March 31, 2025. Response : The Company respectfully advises the Staff that it has revised the disclosure on page 269 of Amendment No. 3 in response to the Staff’s comment. Business of Semnur Our Product Candidate – SP-102 Clinical Development Overview, page 298 3. We note from a Scilex Holding Company press release, dated May 16, 2025, that Scilex presented post-hoc analysis of the CLEAR trial on clinical meaningfulness of safety and efficacy of SP-102 for the treatment of lumbosacral radicular pain. Please revise your prospectus/proxy statement to disclose the analysis or advise. Response : The Company respectfully advises the Staff that it has added new disclosure on page 304 of Amendment No. 3 in response to the Staff’s comment. Government Regulation and Product Approval, page 311 4. We note your response to prior comment 14. Please further revise your disclosure on page 314 to disclose, consistent with your response, that Semnur’s planned NDA application will not seek approval 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.” In this regard, we note your disclosures throughout the prospectus regarding the “clinical benefit” of SP-102. Response : The Company respectfully advises the Staff that it has revised the disclosure on page 315 of Amendment No. 3 in response to the Staff’s comment. Management’s Discussion and Analysis of Financial Condition and Results of Operations of Semnur Liquidity and Capital Resources Future Liquidity Needs, page 335 5. We note your response to prior comment 15. Specifically, we note your statement that, in the 12 months following the consummation of the Business Combination, you expect New Semnur’s primary sources of liquidity to include, among other things, continued support from Scilex pursuant to the Transition Services Agreement. Please further revise your disclosure to quantify the liquidity deriving from the Transition Services Agreement. In this regard, we note your disclosures elsewhere in the prospectus that, under the Transition Services Agreement, New Semnur will be required to pay service fees to Scilex and to reimburse Scilex for its out of pocket fees, costs or expenses. Please also file a form of the Transition Services Agreement or explain what aspects of the arrangement have not been determined to date. Response : The Company respectfully advises the Staff that it has revised the disclosure on page 337 of Amendment No. 3 and filed the form of Transition Services Agreement as Exhibit 10.26 in response to the Staff’s comment. Semnur Pharmaceuticals, Inc. Notes to Financial Statements Note 7. Commitments and Contingencies Subsidiary Guarantee to Oramed Note, page F-80 6. Please explain your assertion that “following the execution of the amended and restated security agreement with Oramed on October 8, 2024 and subject to completion of the Business Combination, the Company will no longer be a Guarantor under the Subsidiary Guarantee,” particularly given Scilex’s expected 92.4% ownership of the continuing company. Refer us to the supporting legal agreements. Response : The Company acknowledges the Staff’s comment and respectfully refers to the Staff to (i) the definition of “Excluded Subsidiary” in the Form of Tranche B Senior Secured Convertible Note issued by Scilex Holding Company, filed as Exhibit 4.1 to the Form 8-K filed with the Commission by Scilex Holding Company on October 8, 2024 (the “ October Form 8-K ”) and (ii) Section 22 of the Amended and Restated Security Agreement, dated October 8, 2024, by and among Scilex Holding Company, the Subsidiaries of Scilex Holding Company party thereto, Oramed Pharmaceuticals Inc. and Acquiom Agency Services LLC (the “ Security Agreement ”), filed as Exhibit 10.8 to the October Form 8-K. The Company respectfully advises the Staff that pursuant to Section 22 of the Security Agreement, upon completion of the Business Combination, as an “Excluded Subsidiary”, Semnur will no longer be a Guarantor under the Subsidiary Guarantee. * * * 2 U.S. Securities and Exchange Commission July 2, 2025 Please do not hesitate to contact Michael Blankenship of Winston & Strawn LLP at (713) 651-2678 with any questions or comments regarding this letter. Sincerely, By: /s/ Lei Huang Lei Huang Chief Executive Officer cc: Michael Blankenship, Winston & Strawn LLP Jeff Hartlin, Paul Hastings LLP Elizabeth Razzano, Paul Hastings LLP Jaisim Shah, Chief Executive Officer and President, Semnur Pharmaceuticals, Inc. 3
2025-06-26 - UPLOAD - Semnur Pharmaceuticals, Inc. File: 333-283019
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 26, 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. 2 to Registration Statement on Form S-4 Filed June 11, 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 May 19, 2025 letter. Amendment No. 2 to Registration Statement on Form S-4 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 1. The total share amounts presented in your tabular disclosure on page 14 differ from those presented on pages iv, 61, 214 and 344. Further, your disclosure on page 14 includes certain items that will not result in shares outstanding after the Business June 26, 2025 Page 2 Combination until the related options or warrants are exercised (e.g., shares underlying public and private warrants and shares underlying Semnur options). Please revise to explain the basis for these differences and/or revise your presentations accordingly. Selected Historical Financial Data of Denali, page 269 2. Please expand this presentation to include financial data for the three months ended March 31, 2025. Business of Semnur Our Product Candidate - SP-102 Clinical Development Overview, page 298 3. We note from a Scilex Holding Company press release, dated May 16, 2025, that Scilex presented post-hoc analysis of the CLEAR trial on clinical meaningfulness of safety and efficacy of SP-102 for the treatment of lumbosacral radicular pain. Please revise your prospectus/proxy statement to disclose the analysis or advise. Government Regulation and Product Approval, page 311 4. We note your response to prior comment 14. Please further revise your disclosure on page 314 to disclose, consistent with your response, that Semnur's planned NDA application will not seek approval 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." In this regard, we note your disclosures throughout the prospectus regarding the "clinical benefit" of SP-102. Management's Discussion and Analysis of Financial Condition and Results of Operations of Semnur Liquidity and Capital Resources Future Liquidity Needs, page 335 5. We note your response to prior comment 15. Specifically, we note your statement that, in the 12 months following the consummation of the Business Combination, you expect New Semnur's primary sources of liquidity to include, among other things, continued support from Scilex pursuant to the Transition Services Agreement. Please further revise your disclosure to quantify the liquidity deriving from the Transition Services Agreement. In this regard, we note your disclosures elsewhere in the prospectus that, under the Transition Services Agreement, New Semnur will be required to pay service fees to Scilex and to reimburse Scilex for its out of pocket fees, costs or expenses. Please also file a form of the Transition Services Agreement or explain what aspects of the arrangement have not been determined to date. Semnur Pharmaceuticals, Inc. Notes to Financial Statements Note 7. Commitments and Contingencies Subsidiary Guarantee to Oramed Note, page F-80 6. Please explain your assertion that "following the execution of the amended and restated security agreement with Oramed on October 8, 2024 and subject to June 26, 2025 Page 3 completion of the Business Combination, the Company will no longer be a Guarantor under the Subsidiary Guarantee," particularly given Scilex's expected 92.4% ownership of the continuing company. Refer us to the supporting legal agreements. 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>
2025-06-11 - CORRESP - Semnur Pharmaceuticals, Inc.
CORRESP 1 filename1.htm CORRESP Denali Capital Acquisition Corp. June 11, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Franklin Wyman, Angela Connell, Jessica Dickerson, Joe McCann Re: Denali Capital Acquisition Corp. Semnur Pharmaceuticals, Inc. Amendment No. 1 to Registration Statement on Form S-4 Filed April 21, 2025 File No. 333-283019 Ladies and Gentlemen: Denali Capital Acquisition Corp., a Cayman Islands exempted company (the “ Company ”), files herewith Amendment No. 2 (“ Amendment No. 2 ”) to the above-referenced registration statement on Form S-4 filed on November 6, 2024, as previously amended by Amendment No. 1 filed on April 21, 2025 (the “ Registration Statement ”). Set forth below are the responses of the Company to the comments of the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission (the “ Staff ”) with respect to the Registration Statement contained in the Staff’s letter dated May 19, 2025 (the “ Comment Letter ”). For ease of reference, each comment contained in the Comment Letter is printed below and is followed by the Company’s response. All page references in the responses set forth below refer to page numbers in Amendment No. 2. All capitalized terms used but not defined in this response letter have the meanings ascribed to such terms in Amendment No. 2. 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 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. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages iv and xiii of the cover page and pages 41, 140, 149, 158-160, 227 and 420 of Amendment No. 2 in response to the Staff’s comment. U.S. Securities and Exchange Commission June 11, 2025 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. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages iv and xiii of the cover page and pages 140, 149 and 420 of Amendment No. 2 in response to the Staff’s comment. 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. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 8, 199-200 and 202 of Amendment No. 2 in response to the Staff’s comment. 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. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 15-16 of Amendment No. 2 in response to the Staff’s comment. 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. Response : The Company respectfully advises the Staff that it has revised the disclosure on page 179 of Amendment No. 2 in response to the Staff’s comment. 2 U.S. Securities and Exchange Commission June 11, 2025 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. Response : The Company respectfully advises the Staff that it has revised the disclosure on page 185 of Amendment No. 2 in response to the Staff’s comment. 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. Response : The Company respectfully advises the Staff that the disclosure in Amendment No. 1 inadvertently conveyed that the Denali Board gave separate, specific approval to CB Capital’s methodologies concerning the composition of the comparable companies included in its analysis. The phrase “to which the Denali Board gave their approval” was intended to refer to the Denali Board’s approval of the Merger Agreement and the Business Combination as a whole, not to a separate, specific approval of CB Capital’s methodologies concerning the composition of the comparable companies included in its analysis. The Company respectfully advises the Staff that it has revised the disclosure on page 186 of Amendment No. 2 to clarify the nature of the Denali Board’s approval, the scope and nature of the Denali Board’s review of CB Capital’s comparable company analysis, and to directly address the Staff’s inquiry regarding whether the Denali Board agreed that the selected companies were 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. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 199-200 and 202 of Amendment No. 2 to explain Semnur’s basis for including revenues from Non-LR indication beginning in 2027. The Company further advises the Staff that Semnur (i) is not currently targeting or otherwise seeking FDA approval for the use of SP-102 for any Non-LR indications but rather that Semnur management believes that SP-102 will be used “off-label” for certain indications (as described in Amendment No. 2), given that corticosteroid injections are commonly used off-label for the management of various types of pain, and (ii) has not quantified projected revenues for each such indication and has only done so on an aggregate basis, as a percentage of estimated gross sales. The Company further respectfully advises the Staff that it has revised the disclosure on pages 199-200 and 202 of Amendment No. 2 to clarify the foregoing. 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. Response : The Company respectfully advises the Staff that it has revised the disclosure on page 201 of Amendment No. 2 in response to the Staff’s comment. 3 U.S. Securities and Exchange Commission June 11, 2025 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. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 234-235 of Amendment No. 2 in response to the Staff’s comment. 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. Response : The Company respectfully advises the Staff that it has revised the disclosure on page 249 of Amendment No. 2 in response to the Staff’s comment. 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. Response : The Company acknowledges the Staff’s comment and respectfully advises the Staff that the FDA did not express disagreement with, or concerns about, the size, the endpoints, or results of the completed CLEAR-1 trial. In fact, the FDA had not yet been provided with full access to the clinical data of the CLEAR-1 trial prior to the Type C meeting. As a precautionary measure, the FDA requested a confirmatory CLEAR-2 trial, which request was due to the fact that there are currently no FDA-approved epidural steroid products for the treatment of sciatica. In response to the Staff’s comment, the Company has revised the disclosure on pages 87-88, 114 and 292 of Amendment No. 2 to clarify the foregoing and to provide more detail with respect to the guidance provided by the FDA regarding the CLEAR-2 trial. 4 U.S. Securities and Exchange Commission June 11, 2025 13. We refer to prior comment 29 and note your disclosures on page 288 and elsewhere 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. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 87-88, 114 and 292 of Amendment No. 2 in response to the Staff’s comment. 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. Response : The Company respectfully advises the Staff that Semnur’s planned NDA application will not seek approval 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.” The Company further advises the Staff that it has revised the disclosure on page 314 of Amendment No. 2 to explain the “clinical benefit” standard and 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. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 335-336 of Amendment No. 2 in response to the Staff’s comment. 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. 5 U.S. Securities and Exchange Commission June 11, 2025 Response : The Company acknowledges the Staff’s comment and respectfully advises the Staff that the autonomous entity adjustments were included in the unaudited pro forma condensed combined statements of operations. However, no such adjustments were made to the unaudited pro forma condensed combined balance sheet, as such adjustments are not required to be made as management does not anticipate any net asset impact. The Company has revised the disclosure on page 352 of Amendment No. 2 in response to the Staff’s comment to further clarify this point. Note 3 - Transaction Adjustments to Unaudited Pro Forma Condensed Combined Balance Sheet as of December
2025-05-20 - UPLOAD - Semnur Pharmaceuticals, Inc. File: 333-283019
<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>
2025-04-21 - CORRESP - Semnur Pharmaceuticals, Inc.
CORRESP 1 filename1.htm CORRESP Denali Capital Acquisition Corp. April 21, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Franklin Wyman, Angela Connell, Jessica Dickerson, Joe McCann Re: Denali Capital Acquisition Corp. Semnur Pharmaceuticals, Inc. Registration Statement on Form S-4 Filed November 6, 2024 File No. 333-283019 Ladies and Gentlemen: Denali Capital Acquisition Corp., a Cayman Islands exempted company (the “ Company ”), files herewith Amendment No. 1 (“ Amendment No. 1 ”) to the above-referenced registration statement on Form S-4 filed on November 6, 2024 (the “ Registration Statement ”). Set forth below are the responses of the Company to the comments of the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission (the “ Staff ”) with respect to the Registration Statement contained in the Staff’s letter dated December 11, 2024 (the “ Comment Letter ”). For ease of reference, each comment contained in the Comment Letter is printed below and is followed by the Company’s response. All page references in the responses set forth below refer to page numbers in Amendment No. 1. All capitalized terms used but not defined in this response letter have the meanings ascribed to such terms in Amendment No. 1. Cover Page 1. Please revise the prospectus cover page to include disclosure highlighting the number and each type of security being registered, including disclosure as to how you arrived at the number of securities being registered. In this regard, we note from the header on the prospectus cover page that you are registering 262,684,337 shares of common stock, 524,622 units, 6,000,000 shares of Series A Preferred Stock, and 8,760,000 warrants of New Semnur. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages ii-iii of the prospectus cover page of Amendment No. 1 to include the requested disclosure. U.S. Securities and Exchange Commission April 21, 2025 2. On page i, you state that holders of Denali Class A Ordinary Shares will be asked to approve and adopt the Merger Agreement. With reference to the disclosure on page 46, please revise your disclosure to clarify that holders of Denali Class A Ordinary Shares and holders of Denali Class B Ordinary Shares, voting together as a single class, will be asked to approve and adopt the Merger Agreement, or otherwise advise. Response : The Company respectfully advises the Staff that it has revised the disclosure on page i of the cover page of Amendment No. 1 in response to the Staff’s comment. 3. Please revise the sponsor compensation disclosure on pages iii and iv to also include any compensation received or to be received by the directors and officers of Denali, as well as the Denali underwriters. Refer to Item 1604(a)(3) of Regulation S-K. Please make similar revisions as appropriate in the sponsor compensation disclosure on pages 42-43 and 86. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages v-vii of the cover page and pages 48-50 and 206-207 of Amendment No. 1 in response to the Staff’s comment. 4. We note your disclosure on page ii and throughout the prospectus that, from and after the Effective Time, and for so long as Scilex beneficially owns any shares of New Semnur Series A Preferred Stock, Scilex will have the right, but not the obligation, to designate each director to be nominated, elected or appointed to the New Semnur Board. However, we further note your disclosure elsewhere in the prospectus that, upon and following consummation of your initial business combination, the Sponsor will be entitled to nominate three individuals for appointment to the board of directors as long as the Sponsor holds any securities covered by an April 6, 2022 registration rights agreement. Please revise your disclosures throughout the prospectus as appropriate to clarify who will have the right to designate and/or nominate directors to the New Semnur Board. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 352 and 399 of Amendment No. 1 in response to the Staff’s comment. 5. Please revise the table on page iii, and elsewhere as applicable, to clarify the postcombination holdings of Scilex Holding Company. In this regard, it should be clear that Scilex will own nearly all of Semnur’s equity securities following the combination and that this stake will not be held by multiple stockholders. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages iii and v of the cover page and pages 12, 15-16, 58, 153 and 210 of Amendment No. 1 in response to the Staff’s comment. 6. We note your disclosure on page viii that Denali intends to list the New Semnur Common Stock and warrants on the Nasdaq Capital Market upon completion of the Business Combination. Please disclose here whether completion of the Business Combination is contingent on this listing approval. 2 U.S. Securities and Exchange Commission April 21, 2025 Response : The Company respectfully advises the Staff that it has revised the disclosure on page xiii of the cover page of Amendment No. 1 in response to the Staff’s comment. 7. On page viii, you disclose that the Denali Board determined that it is advisable to consummate the Business Combination. Please also disclose, if true, that the Board determined the Business Combination was in the best interests of Denali and its shareholders. In this regard, we note a similar statement on pages 47 and 175. Refer to Item 1604(a)(1) and Item 1606(a) of Regulation S-K. Response : The Company respectfully advises the Staff that it has revised the disclosure on page xiii of the cover page of Amendment No. 1 in response to the Staff’s comment. 8. Please revise the prospectus cover page to include the information required by Item 1604(a)(2) of Regulation S-K. Please make similar revisions to the summary of the proxy statement in accordance with Item 1604(b)(5). Response : The Company respectfully advises the Staff that it has revised the disclosure on pages x-xii of the cover page and pages 51-52 of Amendment No. 1 in response to the Staff’s comment. About this Proxy Statement/Prospectus, page viii 9. You state that the prospectus is with respect to the Denali Class A Ordinary Shares to be issued to Semnur’s stockholders under the Merger Agreement. However, the prospectus cover page refers to shares of common stock, units, shares of Series A Preferred Stock, and warrants. Please revise your disclosures as appropriate. Response : The Company respectfully advises the Staff that it has revised the disclosure on page viii under the section titled “About this Proxy Statement/Prospectus” of Amendment No. 1 in response to the Staff’s comment. Questions and Answers about the Business Combination and the Meeting Questions and Answers about the Business Combination, page 7 10. Please revise the disclosure on pages 7-8 to include a new Q&A that explains the reason(s) why Scilex is conducting the Business Combination and related transactions, as well as its plans for Semnur in the short term and the long term. For instance, please explain here, and in the Background section, why Scilex determined to retain 96% or greater of Semnur’s equity as opposed to spinning-off all of the Semnur equity. With reference to the potential 10% stock dividend referenced on page 13 and the Oramed debt, revise to discuss whether Scilex plans to distribute additional Semnur stock to its shareholders and, as applicable, the factors that will determine the timing and size of such distributions. Also explain why Scilex is opting to merge Semnur with a SPAC given the amount of proceeds currently in the Trust Account and the prospects for additional redemptions. 3 U.S. Securities and Exchange Commission April 21, 2025 Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 8, 9 and 175 of Amendment No. 1 in response to the Staff’s comment. 11. With reference to your disclosures on pages 110, 298 and 304, please add a new Q&A that discusses Scilex’s continued operational and voting control over Semnur following the Business Combination as well as Semnur’s reliance on funding and services provided by Scilex. Highlight the risk that the interests of Scilex and certain officers and directors who jointly serve as officers/directors at Scilex and Semnur may not be aligned with those of other Semnur stockholders and this could lead to actions that may not be in the best interests of Semnur stockholders. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 19-21 of Amendment No. 1 in response to the Staff’s comment. What equity stake will current Denali shareholders and Semnur stockholders hold..., page 10 12. We note your disclosure in the second paragraph that the ownership percentage with respect to New Semnur after the closing of the Business Combination does not take into account the potential dilutive effect of several different securities, including the Public Warrants, the Denali Class A Ordinary Shares and Public Warrants underlying the Public Units, and the Denali Private Placement Shares and Denali Private Placement Warrants underlying the Denali Private Placement Units. Please tell us why you have excluded these from the ownership percentage post-closing, particularly the Denali Class A Ordinary Shares underlying the Public Units and the Denali Private Placement Shares underlying the Denali Private Placement Units. Response : The Company respectfully advises the Staff that it has revised the disclosure on page iii of the cover page and pages 12-14, 58, 153-154 and 210-212 of Amendment No. 1 in response to the Staff’s comment. Did the Denali Board obtain a third-party valuation or fairness opinion in determining whether to proceed with the Business Combination?, page 14 13. We note the disclosure here and on the cover page highlighting the $2.5 billion valuation of Semnur. To the extent that you highlight this valuation, please revise to provide balance and context by also disclosing the current market capitalization for Semnur’s parent company, Scilex Holdings. Response : The Company respectfully advises the Staff that it has revised the disclosure on page ii of the cover page and pages 8, 16, 47, 141, 175, 209 and 271 of Amendment No. 1 in response to the Staff’s comment. Summary of the Proxy Statement Semnur Pharmaceuticals, Inc., page 29 4 U.S. Securities and Exchange Commission April 21, 2025 14. In the second paragraph, you state that SP-102 has been granted fast track designation by the FDA. We note similar disclosure on pages 262 and 263. When discussing the fast track designation, please also disclose that such designation may not lead to a faster development or regulatory review process and that it does not increase the likelihood that SP-102 will receive marketing approval. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 35, 287, 289 and 326 of Amendment No. 1 in response to the Staff’s comment. Summary of the Proxy Statement The Meeting Record Date; Outstanding Shares; Shareholders Entitled to Vote, page 46 15. You state that each holder of Denali Ordinary Shares is entitled to one vote per share on each proposal. However, on page 355, you state that, in a vote to continue Denali in a jurisdiction outside the Cayman Islands, holders of the Denali Class B Ordinary Shares will have ten votes for every Denali Class B Ordinary Share. Please revise your disclosures to reconcile this apparent inconsistency with respect to the Domestication Proposal. Response : The Company respectfully advises the Staff that it has revised the disclosure on page iv of the cover page and pages 23, 24, 56, 57, 166, 167, 228, 229, 380, 382, 385 and 386 of Amendment No. 1 in response to the Staff’s comment. Proposal 1 - The Business Combination Proposal Background of the Business Combination, page 154 16. Please revise the Background section so that it also presents similar information from Scilex’s perspective. Response : The Company respectfully advises the Staff that it has revised the disclosure on page 172 of Amendment No. 1 in response to the Staff’s comment. 17. We note that you previously received shareholder approval for a different proposed business combination and subsequently terminated the related merger agreement shortly before entering into the merger agreement for the now proposed Business Combination. Please briefly describe the reasons for the termination of the prior merger agreement and clarify when you first began discussions with Semnur. In this regard, we note you disclose that Henry Ji, Ph.D., the Executive Chairperson of Semnur, met your Chief Executive Officer at your principal executive offices on May 30, 2024 to discuss a potential business combination between Semnur and Denali. However, it is unclear how the parties were introduced and what prompted this meeting. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 171 and 172 of Amendment No. 1 in response to the Staff’s comment. 5 U.S. Securities and Exchange Commission April 21, 2025 Opinion of CB Capital, page 160 18. Disclose the instructions received by the financial advisor from DECA or the Sponsor, including any limitations imposed by DECA or the Sponsor on the scope of the activities conducted by the financial advisor in connection with the financial opinion. Refer to Item 1607(b)(6) of Regulation S-K. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 176-177 of Amendment No. 1 in response to the Staff’s comment. 19. Please revise to explain the criteria that CB Capital used to identify these companies so that it is clear why these companies were deemed comparable to Semnur and why other companies were not selected. Based on the information provided, we note that all of the companies selected are commercial stage companies. Please explain why CB Capital did not choose one or more pre-commercial stage companies for purposes of its valuation analysis. From your revised disclosure, it should be clear how CB Pharma came to select some of the largest pharmaceutical companies (by revenues, profits and market capitalization) in the world (e.g., Eli Lily, Pfizer, AbbVie, Amgen, etc.) as companies that are comparable to Semnur. Response : The Company respectfully advises the Staff that it has revised the disclosure on pages 181-182 of Amendment No. 1 in response to the Staff’s comment. 20. Please revise to discuss whether Denali’s board reviewed the list of comparable companies selected by CB Capital and agreed that these companies are comparable to Semnur. Response : The Company respectfully advises the Staff that it has revised the disclosure on page 182 of Amendment No. 1 in response to the Staff’s comment. 21. We note that the financial opinion filed as Exhibit 99.4 includes language that the opinion letter is “provided to DECA for its sole use in considering the proposed Transaction” and that the letter “is not to be used for any other purpose” without the prior written consent of the financial advisor. Please remove these statements. Alternatively, disclose the legal basis for DECA’s and the financial advisor’s belief that shareholders cannot rely on the opinion to bring state law actions, including a description of any state law authorities on such a defense. If no such authority exists, please disclose that this issue will be resolved by a court, resolution of this issue will have no effect on the rights and responsibilities of DECA’s board under state law, and the
2025-03-28 - UPLOAD - Semnur Pharmaceuticals, Inc. File: 001-41351
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 28, 2025 Lei Huang Chief Executive Officer Denali Capital Acquisition Corp. 437 Madison Avenue, 27th Floor New York, NY 10022 Re: Denali Capital Acquisition Corp. Preliminary Proxy Statement on Schedule 14A Filed March 20, 2025 File No. 001-41351 Dear Lei Huang: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Michael Blankenship, Esq. </TEXT> </DOCUMENT>
2025-03-25 - UPLOAD - Semnur Pharmaceuticals, Inc. File: 001-41351
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 25, 2025 Lei Huang Chief Executive Officer Denali Capital Acquisition Corp. 437 Madison Avenue, 27th Floor New York, NY 10022 Re: Denali Capital Acquisition Corp. Preliminary Proxy Statement on Schedule 14A Filed March 20, 2025 File No. 001-41351 Dear Lei Huang: We have reviewed your filing and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response and any amendment you may file in response to this letter, we may have additional comments. Preliminary Proxy Statement on Schedule 14A General 1. We note that you are seeking to extend your termination date to December 11, 2025, a date which is 44 months from your initial public offering. We also note that you are listed on The Nasdaq Global Market and that Nasdaq IM-5101-2 requires that a special purpose acquisition company complete one or more business combinations within 36 months of the effectiveness of its IPO registration statement. Please revise to explain that the proposal to extend your termination deadline to December 11, 2025 does not comply with this rule, or advise, and to disclose the risks of your non- compliance with this rule, including that your securities may be subject to suspension and delisting from The Nasdaq Global Market. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. March 25, 2025 Page 2 Please contact Jason Drory at 202-551-8342 or Joshua Gorsky at 202-551-7836 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Michael Blankenship, Esq. </TEXT> </DOCUMENT>
2025-03-25 - CORRESP - Semnur Pharmaceuticals, Inc.
CORRESP 1 filename1.htm Denali Capital Acquisition Corp. 437 Madison Avenue, 27 th Floor New York, New York 10022 March 25, 2025 Division of Corporation Finance Office of Life Sciences U.S. Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549 Attention: Jason Drory Joshua Gorsky Re: Denali Capital Acquisition Corp. Preliminary Proxy Statement on Schedule 14A Filed March 20, 2025 File No. 001-41351 Dear Mr. Drory and Mr. Gorsky: Denali Capital Acquisition Corp. (the "Company") hereby provides a response to the comment issued by the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission (the "Staff") in a letter dated March 25, 2025 regarding the Company's Preliminary Proxy Statement on Schedule 14A filed on March 20, 2025. Contemporaneously, we are filing a revised Preliminary Proxy Statement on Schedule 14A via Edgar (the "Amended Proxy Statement"). Preliminary Proxy Statement on Schedule 14A General 1. We note that you are seeking to extend your termination date to December 11, 2025, a date which is 44 months from your initial public offering. We also note that you are listed on The Nasdaq Global Market and that Nasdaq IM-5101-2 requires that a special purpose acquisition company complete one or more business combinations within 36 months of the effectiveness of its IPO registration statement. Please revise to explain that the proposal to extend your termination deadline to December 11, 2025 does not comply with this rule, or advise, and to disclose the risks of your noncompliance with this rule, including that your securities may be subject to suspension and delisting from The Nasdaq Global Market. Response: In response to the Staff's comment, the Company has revised its disclosures on pages 2, 3, 16, 17, 18 and 19 of the Amended Proxy Statement. ****** If you have any questions, please do not hesitate to call our counsel, Mike Blankenship, Esq., of Winston & Strawn LLP, at (713) 651-2678. Very truly yours, By: /s/ Lei Huang Lei Huang Chief Executive Officer cc: Mike Blankenship, Esq. Winston & Strawn LLP
2024-12-12 - UPLOAD - Semnur Pharmaceuticals, Inc. File: 333-283019
December 11, 2024
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.
Registration Statement on Form S-4
Filed November 6, 2024
File No. 333-283019
Dear Lei Huang and Jaisim Shah:
We have reviewed your 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.
Registration Statement on Form S-4 filed November 6, 2024
Cover Page
1.Please revise the prospectus cover page to include disclosure highlighting the number
and each type of security being registered, including disclosure as to how you arrived
at the number of securities being registered. In this regard, we note from the header on
the prospectus cover page that you are registering 262,684,337 shares of common
stock, 524,622 units, 6,000,000 shares of Series A Preferred Stock, and 8,760,000
warrants of New Semnur.
December 11, 2024
Page 2
2.On page i, you state that holders of Denali Class A Ordinary Shares will be asked to
approve and adopt the Merger Agreement. With reference to the disclosure on page
46, please revise your disclosure to clarify that holders of Denali Class A Ordinary
Shares and holders of Denali Class B Ordinary Shares, voting together as a single
class, will be asked to approve and adopt the Merger Agreement, or otherwise advise.
3.Please revise the sponsor compensation disclosure on pages iii and iv to also include
any compensation received or to be received by the directors and officers of Denali, as
well as the Denali underwriters. Refer to Item 1604(a)(3) of Regulation S-K. Please
make similar revisions as appropriate in the sponsor compensation disclosure on
pages 42-43 and 86.
4.We note your disclosure on page ii and throughout the prospectus that, from and after
the Effective Time, and for so long as Scilex beneficially owns any shares of New
Semnur Series A Preferred Stock, Scilex will have the right, but not the obligation, to
designate each director to be nominated, elected or appointed to the New Semnur
Board. However, we further note your disclosure elsewhere in the prospectus that,
upon and following consummation of your initial business combination, the Sponsor
will be entitled to nominate three individuals for appointment to the board of directors
as long as the Sponsor holds any securities covered by an April 6, 2022 registration
rights agreement. Please revise your disclosures throughout the prospectus as
appropriate to clarify who will have the right to designate and/or nominate directors to
the New Semnur Board.
5.Please revise the table on page iii, and elsewhere as applicable, to clarify the post-
combination holdings of Scilex Holding Company. In this regard, it should be clear
that Scilex will own nearly all of Semnur’s equity securities following the
combination and that this stake will not be held by multiple stockholders.
6.We note your disclosure on page viii that Denali intends to list the New Semnur
Common Stock and warrants on the Nasdaq Capital Market upon completion of the
Business Combination. Please disclose here whether completion of the Business
Combination is contingent on this listing approval.
7.On page viii, you disclose that the Denali Board determined that it is advisable to
consummate the Business Combination. Please also disclose, if true, that the Board
determined the Business Combination was in the best interests of Denali and its
shareholders. In this regard, we note a similar statement on pages 47 and 175. Refer to
Item 1604(a)(1) and Item 1606(a) of Regulation S-K.
8.Please revise the prospectus cover page to include the information required by Item
1604(a)(2) of Regulation S-K. Please make similar revisions to the summary of the
proxy statement in accordance with Item 1604(b)(5).
About this Proxy Statement/Prospectus, page viii
9.You state that the prospectus is with respect to the Denali Class A Ordinary Shares to
be issued to Semnur’s stockholders under the Merger Agreement. However, the
prospectus cover page refers to shares of common stock, units, shares of Series A
Preferred Stock, and warrants. Please revise your disclosures as appropriate.
December 11, 2024
Page 3
Questions and Answers about the Business Combination and the Meeting
Questions and Answers about the Business Combination, page 7
10.Please revise the disclosure on pages 7-8 to include a new Q&A that explains the
reason(s) why Scilex is conducting the Business Combination and related
transactions, as well as its plans for Semnur in the short term and the long term. For
instance, please explain here, and in the Background section, why Scilex determined
to retain 96% or greater of Semnur’s equity as opposed to spining-off all of the
Semnur equity. With reference to the potential 10% stock dividend referenced on page
13 and the Oramed debt, revise to discuss whether Scilex plans to distribute additional
Semnur stock to its shareholders and, as applicable, the factors that will determine the
timing and size of such distributions. Also explain why Scilex is opting to merge
Semnur with a SPAC given the amount of proceeds currently in the Trust Account
and the prospects for additional redemptions.
11.With reference to your disclosures on pages 110, 298 and 304, please add a new Q&A
that discusses Scilex’s continued operational and voting control over Semnur
following the Business Combination as well as Semnur’s reliance on funding and
services provided by Scilex. Highlight the risk that the interests of Scilex and certain
officers and directors who jointly serve as officers/directors at Scilex and Semnur may
not be aligned with those of other Semnur stockholders and this could lead to actions
that may not be in the best interests of Semnur stockholders.
What equity stake will current Denali shareholders and Semnur stockholders hold..., page 10
12.We note your disclosure in the second paragraph that the ownership percentage with
respect to New Semnur after the closing of the Business Combination does not take
into account the potential dilutive effect of several different securities, including the
Public Warrants, the Denali Class A Ordinary Shares and Public Warrants underlying
the Public Units, and the Denali Private Placement Shares and Denali Private
Placement Warrants underlying the Denali Private Placement Units. Please tell us why
you have excluded these from the ownership percentage post-closing, particularly the
Denali Class A Ordinary Shares underlying the Public Units and the Denali Private
Placement Shares underlying the Denali Private Placement Units.
Did the Denali Board obtain a third-party valuation or fairness opinion in determining
whether to proceed with the Business Combination?, page 14
13.We note the disclosure here and on the cover page highlighting the $2.5 billion
valuation of Semnur. To the extent that you highlight this valuation, please revise to
provide balance and context by also disclosing the current market capitalization for
Semnur’s parent company, Scilex Holdings.
Summary of the Proxy Statement
Semnur Pharmaceuticals, Inc., page 29
In the second paragraph, you state that SP-102 has been granted fast track designation
by the FDA. We note similar disclosure on pages 262 and 263. When discussing the
fast track designation, please also disclose that such designation may not lead to a
faster development or regulatory review process and that it does not increase the 14.
December 11, 2024
Page 4
likelihood that SP-102 will receive marketing approval.
Summary of the Proxy Statement
The Meeting
Record Date; Outstanding Shares; Shareholders Entitled to Vote, page 46
15.You state that each holder of Denali Ordinary Shares is entitled to one vote per share
on each proposal. However, on page 355, you state that, in a vote to continue Denali
in a jurisdiction outside the Cayman Islands, holders of the Denali Class B Ordinary
Shares will have ten votes for every Denali Class B Ordinary Share. Please revise
your disclosures to reconcile this apparent inconsistency with respect to the
Domestication Proposal.
Proposal 1 - The Business Combination Proposal
Background of the Business Combination, page 154
16.Please revise the Background section so that it also presents similar information from
Scilex’s perspective.
17.We note that you previously received shareholder approval for a different proposed
business combination and subsequently terminated the related merger agreement
shortly before entering into the merger agreement for the now proposed Business
Combination. Please briefly describe the reasons for the termination of the prior
merger agreement and clarify when you first began discussions with Semnur. In this
regard, we note you disclose that Henry Ji, Ph.D., the Executive Chairperson of
Semnur, met your Chief Executive Officer at your principal executive offices on May
30, 2024 to discuss a potential business combination between Semnur and Denali.
However, it is unclear how the parties were introduced and what prompted this
meeting.
Opinion of CB Capital, page 160
18.Disclose the instructions received by the financial advisor from DECA or the Sponsor,
including any limitations imposed by DECA or the Sponsor on the scope of the
activities conducted by the financial advisor in connection with the financial opinion.
Refer to Item 1607(b)(6) of Regulation S-K.
19.Please revise to explain the criteria that CB Capital used to identify these companies
so that it is clear why these companies were deemed comparable to Semnur and why
other companies were not selected. Based on the information provided, we note that
all of the companies selected are commercial stage companies. Please explain why CB
Capital did not choose one or more pre-commercial stage companies for purposes of
its valuation analysis. From your revised disclosure, it should be clear how CB
Pharma came to select some of the largest pharmaceutical companies (by revenues,
profits and market capitalization) in the world ( e.g., Eli Lily, Pfizer, AbbVie, Amgen,
etc.) as companies that are comparable to Semnur.
20.Please revise to discuss whether Denali's board reviewed the list of comparable
companies selected by CB Capital and agreed that these companies are comparable to
Semnur.
We note that the financial opinion filed as Exhibit 99.4 includes language that the 21.
December 11, 2024
Page 5
opinion letter is "provided to DECA for its sole use in considering the proposed
Transaction" and that the letter "is not to be used for any other purpose" without the
prior written consent of the financial advisor. Please remove these statements.
Alternatively, disclose the legal basis for DECA’s and the financial advisor’s belief
that shareholders cannot rely on the opinion to bring state law actions, including a
description of any state law authorities on such a defense. If no such authority exists,
please disclose that this issue will be resolved by a court, resolution of this issue will
have no effect on the rights and responsibilities of DECA’s board under state law, and
the availability or non-availability of these defense has no effect on the rights and
responsibilities of either the financial advisor or DECA’s board under the federal
securities laws.
22.We note the disclosure on page 162 that CB Capital assumed that the projections
relating to Semnur’s asset portfolio were reasonably prepared based on assumptions
reflecting the best currently available estimates and good-faith judgments of Denali’s
management as to the most likely future performance of Semnur’s asset portfolio and
that Denali’s management did not have any information or belief that would make any
such projections incomplete or misleading. Please revise where appropriate to disclose
whether Denali’s management determined that Semnur’s base case projections
represented the most likely future performance for Semnur.
23.Please file the consent of your financial advisor to be named in the registration
statement and to the filing of the fairness opinion as an exhibit to the registration
statement. Refer to Section 7 of the Securities Act and Securities Act Rule 436.
Certain Semnur Projected Financial Information, page 175
24.We note that the Semnur Management Projections were prepared in August 2024 by
Semnur's management with respect to Semnur as a standalone company.
Please disclose whether or not Semnur has affirmed to Denali that its projections
continue to reflect the view of Semnur's management about its future performance and
ensure that such disclosure remains updated through the effectiveness of this
registration statement. Refer to Item1609(c) of Regulation S-X.
Given that the Semnur Managment Projections differ from historical operating trends
and the extended forecast period, please expand your disclosure to address why the
change in trends is appropriate or the assumptions are reasonable. Please also address
the following:
•Explain the assumptions underlying Semnur's expectation that SP-102 will receive
regulatory approval in the first half of 2027 and the milestones that will need to be
satisfied in order for SP-102 to achieve this timeline. Describe and quantify the
nature and timing of additional clinical, regulatory and commercialization
activities necessary to successfully launch SP-102. In this regard, we note that
Scilex issued a press release on November 2, 2023 announcing that FDA provided
guidance regarding preclinical and clinical data needed prior to an NDA filing and
that as a result, an open-label multi-center safety and efficacy trial enrolling
approximately 700 patients was planned for the first half of 2024. Clarify the
status of this trial and whether it is reflected in the Semnur projections.
Provide quantification of the significant assumptions underlying Semnur's •25.
December 11, 2024
Page 6
revenue projections, including price per unit, annual growth rate and market share
penetration, under the base case and best-case scenarios for each year presented.
More clearly explain Semnur's assumptions around the current and future
competitive landscape and why they do not expect revenues to be materiality
impacted by the loss of patent exclusivity in 2036. Reconcile this outlook with
the competition disclosure provided on page 277.
•Describe the risk that the expectations of unusually high and sustained future
growth may be unrealistic, given the assumptions as to future events, and may
have resulted in inflated valuation conclusions.
•Provide quantification of the significant assumptions underlying Semnur's gross
profit projections, including cost of sales, future milestone and royalty payments
under the August 2013 Shah Assignment Agreement and March 2019 Semnur
Merger Agreement, for each period presented.
•To the extent feasible, provide a breakdown of projected operating expenses by
major category and identify key factors driving material period-to-period changes
in each expense category.
•Confirm that all associated costs have been included in Semnur’s financial
projections, including any costs to finance additional clinical, regulatory and
commercial activities.
Semnur Management Projections - Base Case Projection, page 177
26.We refer to page 142 of Scilex Holdings’s Form S-4, filed on 10/26/2022, which
relates to a prior SPAC merger involving Scilex. We note that Scilex’s management in
2021 projected that SP-102 would be commercialized in 2022 and would achieve
reve
2022-04-04 - CORRESP - Semnur Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
April 4, 2022
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
Office of Manufacturing
100 F Street, N.E.
Washington, D.C. 20549
Attention: Joseph Ambrogi
Re: Denali Capital Acquisition Corp.
Registration Statement on Form S-1, as amended
File No. 333-263123
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and
Regulations under the Securities Act of 1933, as amended (the “Act”), the undersigned hereby joins in the request of
Denali Capital Acquisition Corp. that the effective date of the above-referenced Registration Statement be accelerated so as to
permit it to become effective at 4:30 p.m., Eastern Time, on April 6, 2022, or as soon thereafter as practicable, or at such other
time as the Company or its outside counsel, Sidley Austin LLP, request by telephone that such Registration Statement be declared
effective.
Pursuant to Rule 460 of the General Rules and Regulations of the
Securities and Exchange Commission under the Securities Act of 1933, as amended, please be advised that there will be distributed
to each underwriter or dealer, who is reasonably anticipated to participate in the distribution of the security, as many copies
of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned advises that the several underwriters have complied
and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
* * *
[Signature Page Follows]
Very truly yours,
US TIGER SECURITIES, INC.
as representatives of the several underwriters
By:
/s/ Tony Tian
Name:
Tony Tian
Title:
Head of Capital Markets
EF HUTTON,
division of Benchmark Investments, LLC
as representatives of the several underwriters
By:
/s/ Sam Fleischman
Name:
Sam Fleischman
Title:
Supervisory Principal
[Signature Page to Underwriters’ Acceleration
Request Letter]
2022-04-04 - CORRESP - Semnur Pharmaceuticals, Inc.
CORRESP
1
filename1.htm
DENALI CAPITAL ACQUISITION CORP.
437 Madison Avenue, 27th Floor
New York, New York 10022
(646) 978-5180
April 4, 2022
Via Edgar
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-4628
Attn: Joseph Ambrogi
Re: Denali Capital Acquisition Corp.
Registration Statement on Form S-1, as amended (File No. 333–263123)
Dear Mr. Ambrogi:
Denali Capital Acquisition
Corp. (the “Registrant”) hereby requests, pursuant to Rule 461 of the rules and regulations promulgated
under the Securities Act of 1933, as amended, the acceleration of the effective date of the above-captioned Registration Statement,
as amended, to 4:30 p.m., Washington D.C. time, on April 6, 2022, or as soon as practicable thereafter, unless the Registrant notifies
you otherwise prior to such time.
Very Truly Yours,
Denali Capital Acquisition Corp.
By:
/s/ Lei Huang
Lei Huang
Chief Executive Officer
cc: David Ni, Sidley Austin LLP
Michael J. Blankenship, Winston & Strawn LLP
2022-03-10 - UPLOAD - Semnur Pharmaceuticals, Inc.
United States securities and exchange commission logo
March 10, 2022
Lei Huang
Chief Executive Officer
Denali Capital Acquisition Corp.
437 Madison Avenue, 27th Floor
New York, NY 10022
Re:Denali Capital Acquisition Corp.
Registration Statement on Form S-1
Filed March 1, 2022
File No. 333-263123
Dear Mr. Huang:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Joseph Ambrogi at 202-551-4821 with any questions.
Sincerely,
Division of Corporation Finance
Office of Real Estate & Construction
cc: David Ni, Esq.