SEC Comment Letter 0000000000-24-013668 to Semnur Pharmaceuticals, Inc. (SMNR)
Semnur Pharmaceuticals, Inc.
Date: Dec. 12, 2024 · CIK: 0001913577 · Accession: 0000000000-24-013668
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File numbers found in text: 333-283019
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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