SEC Comment Letter 0000000000-23-009752 to PSYENCE BIOMEDICAL LTD. (PBM)
PSYENCE BIOMEDICAL LTD.
Date: Sept. 4, 2023 · CIK: 0001985062 · Accession: 0000000000-23-009752
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File numbers found in text: 333-273553
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United States securities and exchange commission logo
September 4, 2023
Dr. Neil Maresky
Chief Executive Officer
Psyence Biomedical LTD
121 Richmond Street West
Penthouse Suite 1300
Toronto, Ontario M5H 2K1
Re:Psyence Biomedical LTD
Registration Statement on Form F-4
Filed August 1, 2023
File No. 333-273553
Dear Dr. Neil Maresky:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply 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 these comments, we may have additional comments.
Registration Statement on Form F-4
Cover Page
1.We note your disclosure that Pubco will apply for Nasdaq listing of the shares of Pubco
Common Shares and Pubco Public Warrants in connection with the Closing, and that there
is no assurance that Pubco will be approved for Nasdaq listing. With reference to the
disclosure on page 59, please revise the coverpage to highlight that the listing is a
waivable condition to closing and, as such, shareholders will lack certainty concerning the
listing at the time they make their voting and redemption decisions.
Market and Industry Data, page 1
2.Please revise to disclose whether you believe the sources are reliable.
FirstName LastNameDr. Neil Maresky
Comapany NamePsyence Biomedical LTD
September 4, 2023 Page 2
FirstName LastNameDr. Neil Maresky
Psyence Biomedical LTD
September 4, 2023
Page 2
Questions and Answers About the Business Combination
What happens if a substantial number of NCAC Public Shareholders vote in favor of the
Business Combination and exercise...., page 8
3.It appears that underwriting fees remain constant and are not adjusted based on
redemptions. Please revise your disclosure on page 9 to disclose the effective
underwriting fee on a percentage basis for shares at each redemption level presented in
your sensitivity analysis related to dilution.
4.We note the inclusion of Backstop Shares in the table. Please advise regarding whether
there is a Backstop arrangement in place.
5.Please revise to disclose the Minimum Cash Condition to provide context to the
Maximum Redemption Scenario discussion. Also, disclose the amount of additional
financing that the parties would need to secure in order to meet the condition under this
redemption scenario. In light of the disclosure at the bottom of page 70, it appears that
NCAC's Sponsor, officers and directors control NCAC and also hold the votes need to
approve or reject the Business Combination. As such, please revise to indicate
whether NCAC's Sponsor, officers and directors will allow the Business Combination to
close absent sufficient funding to meet the Minimum Cash Condition.
Who is Psyence?, page 8
6.Please revise to clarify and expand your disclosure that Psyence develops natural
psilocybin products and that it has commenced the clinical trial process to evaluate the
safety and efficacy of its product candidates. In this regard, please clarify that you in-
license the lead candidate, PEX010, until 2027. Also, explain, if true, that you have not
conducted preclinical or clinical trials to date for this drug candidate.
What interests do NCAC's Sponsor, current officers and directors have in the Business
Combination?, page 11
7.With reference to the disclosure at the top of page 13, please tell us how the $1,000,000
advisory fee to CCM is consistent with the representations on pages 94-95 of the final
NCAC IPO prospectus concerning limitations on payments and compensation to the
Sponsor and its affiliates.
Even if the Business Combination is consummated, Pubco will require substantial additional
funding to achieve its business goals..., page 41
8.Please tell us your basis for disclosing that the 505(b)(2) pathway would allow for a
shorter development program along with less data that is developed by Psyence, as
compared to a regular NDA submission. In this regard, we note the disclosure on page 56
indicates that there have been relatively few clinical trials pertaining to psilocybin
products. In addition, revise the Business section to discuss the 505(b)(2) regulatory
pathway and your plans to pursue that pathway.
FirstName LastNameDr. Neil Maresky
Comapany NamePsyence Biomedical LTD
September 4, 2023 Page 3
FirstName LastNameDr. Neil Maresky
Psyence Biomedical LTD
September 4, 2023
Page 3
Unaudited Pro Forma Condensed Combined Financial Information
Note 2. Basis of Presentation
Minimum Cash Closing Condition and Proposed PIPE Investment, page 81
9.You disclose here that at the time of this filing, there is no commitment for the proposed
additional financing from the PIPE Investment, and you include the PIPE proceeds as part
of your pro forma presentation to meet the Minimum Cash Condition. Please revise to
address the following:
•Elsewhere in the filing where you discuss the PIPE Investment and the Minimum
Cash Condition, revise to prominently disclose the extent to which you have or do not
have a firm commitment of such funding, and discuss any other related uncertainties.
•If true, revise your pro forma narrative and footnotes to more clearly discuss the
possible scenario that you are not able to obtain additional funding, but that you are
omitting such a scenario from your pro forma presentation because in that case the
merger would no longer be probable of completion due to the Minimum Cash
Condition.
•The ending cash balance in Scenario 2 on page 78 appears to be below $20 million.
Please tell us and revise to clarify how the current maximum redemption Scenario 2
meets the $20 million Minimum Cash Condition. In that regard we note your
disclosure that the repayment of certain debt and member payables that is expected to
be paid by Psyence immediately following the Closing does not impact the Minimum
Cash Condition.
Note 3. Accounting for the Business Combination, page 83
10.You disclose here on page 84 that the Business Combination will be accounted for as a
capital reorganization in accordance with IFRS. However, at pages 28 and 116 you refer
to it as a reverse recapitalization. Please reconcile this apparent inconsistency, and explain
to us your justification for treating the business combination as a reverse recapitalization
under IFRS considering the registrant of this Form F-4 owns the carve out clinical trial
business with the Business Combination being treated as the equivalent of Psyence
Biomed Corp. issuing shares for the net assets of NCAC as you disclosed at page 28.
Note 5. Adjustments to Unaudited Pro Forma Condensed Combined Balance Sheet as of March
31, 2023
Adjustment (I) , page 88
11.Please address the following:
•Please tell us the extent to which you have entered into an agreement with the
underwriter to waive the 50% deferred underwriter fee.
•If so, revise to disclose the date and the terms of the agreement, as well as how you
will account for the waiver.
•As part of your response, tell us and revise to disclose how the underwriting fee was
originally recorded and the extent to which it was allocated between various
FirstName LastNameDr. Neil Maresky
Comapany NamePsyence Biomedical LTD
September 4, 2023 Page 4
FirstName LastNameDr. Neil Maresky
Psyence Biomedical LTD
September 4, 2023
Page 4
securities.
•Please also explain to us your consideration to record the $6.55 million representing
the 50% deferred underwriter fee waived against accumulated deficit in your pro
forma balance sheet.
Adjustment (M), page 89
12.Please explain to us your consideration why it is appropriate under 11-02 of Regulation S-
X to include the interest earned after the balance sheet date in your pro forma balance
sheet as of March 31, 2023.
The Business Combination
The Background of the Business Combination, page 99
13.We note your disclosure that you had in-person or telephonic discussions with 19 potential
acquisition target companies. Please disclose how many potential acquisition target
companies were in the biotech industry.
14.We note your references to “among other criteria” and “inter alia” while describing the
criteria that NCAC used in evaluating potential acquisition companies. Please include all
material criteria used by NCAC in this regard.
15.Please revise to discuss where applicable, the discussions and negotiations concerning the
capital requirements of Psyence, including the amounts planned for phase 2B drug trials,
as well as the Minimum Cash Condition.
16.Please revise the disclosure on page 102 so it is presented in chronological order.
17.Please revise the November 27 entry to clarify which party made the initial proposal. Also
discuss the "sources and uses" calculation.
18.Please name the corporate advisors, and Corporate Advisor, described on pages 101 and
102, respectively.
19.With reference to the January 7 entry, please revise the Background section to explain the
negotiations concerning the terms of the Parent Support Agreement, the PIPE Financing
and Parent termination rights.
20.Please explain the provisions of the February 15, 2023 amendment.
21.Please revise the Background section, or another appropriate section of the
proxy/prospectus, to explain the material changes between the Original Business
Combination Agreement, executed on January 9, 2023, and the Amended and Restated
Business Combination Agreement, executed on July 31, 2023. Please revise the
Background section to explain which party sought to renegotiate the terms of the
arrangement. Without limitation, revise to identify and discuss the reasons for the
additional due diligence and the proposed and actual changes to the structure of the
Business Combination.
FirstName LastNameDr. Neil Maresky
Comapany NamePsyence Biomedical LTD
September 4, 2023 Page 5
FirstName LastNameDr. Neil Maresky
Psyence Biomedical LTD
September 4, 2023
Page 5
22.Revise the July 17 and July 27 entries to explain the substance of the "Parent disclosure
letter" and the reason(s) why NCAC negotiated to ensure that Parent would not conduct
"drug trials outside of Psyence and its subsidiaries" between signing and closing.
Recommendation of the NCAC Board..., page 106
23.Please revise to explain briefly here and and more extensively elsewhere, as
appropriate, Psyence's "capital efficient approach" to conducting trials and the expectation
that the trials will be run on a "capital light" basis.
Opinion of RNA Advisors, LLC
Summary of Financial Analysis, page 112
24.With regard to your disclosures for the RNA valuation approaches, including the projected
revenues and free cash flows, please address the following:
•Under the income approach, you stated that you developed an rNPV analysis based
on information provided by Psyence’s management, and presented key assumptions
for the projected revenues and cash flows. Explain to us, and revise as necessary to
disclose, how the assumptions regarding the probability of successful approval by
FDA at various stages compare to industry standards. Disclose the industry data RNA
relied upon related to FDA approval, and identify the basis for any adjustments to or
departures from industry averages based on your specific fact pattern.
•Both of the portrayals provided appear to be presented assuming commercial success
and successful regulatory approval. Explain to us whether you were provided with
and the extent to which you have considered alternative scenarios in which
significant research and development costs were incurred without achieving
regulatory approval or commercial success in your analysis. Further, discuss the
extent to which you considered other scenarios in which commercial success and
regulatory approval was not achieved until significantly later in time and at greater
cost.
•Explain to us why you present the projected revenues and free cash flows starting
from year 2027, without presenting the cash flows expected to invested in the
business in the years leading up to the point of FDA approval to properly balance the
presentation. Revise your presentation accordingly, or specifically explain how you
determined omitting such expected and necessary costs to potentially achieve
commercialization is not prohibitively unbalanced.
•Revise to disclose more prominently the limitations of the usefulness of the scenarios
presented here given there is no guarantee that the products will achieve FDA
approval and/or commercialization, and the inherent inaccuracy of any estimates of
costs to be incurred to achieve regulatory approval.
Summary of Financial Analyses
Income Approach, page 112
25.We note that RNA developed its analysis based on “information” provided by Psyence’s
FirstName LastNameDr. Neil Maresky
Comapany NamePsyence Biomedical LTD
September 4, 2023 Page 6
FirstName LastName
Dr. Neil Maresky
Psyence Biomedical LTD
September 4, 2023
Page 6
management. Please identify the information prepared by Psyence’s management and
provided to RNA in connection with its fairness opinion, and describe the material
assumptions and limitations underlying such information.
26.We note the analysis includes a projected product launch in the United States in 2027Q2
on page 113, and that both Portrayal 1 and 2 presumed regulatory approval and
commercialization. Please fully describe the assumptions that underlie the projections and
the type of market assumed in developing those assumptions, including if less favorable
outcomes were considered.
Material U.S. Federal Income Tax..., page 129
27.Please file counsel's short-form tax opinion pursuant to Regulation S-K, Item 601(b)(8).
28.Please revise to have counsel state clearly what the tax consequences are to: (i) NCAC
public holders who receive Psyence Biomedical Ltd shares at closing and (ii) NCAC
public holders who redeem their shares. In order to render the opinion, it appears that
counsel will need to determine whether it is more likely than not that (i) the Merger
qualifies as a Reorganization and (ii) PubCo will be treated as a PFIC. Refer to Refer to
Staff Legal Bulletin No. 19 (Oct. 14, 2011) for guidance concerning assumptions and
qualifications in tax opinions.
Information about Psyence, page 150
29.Please revise to explain what work Psyence has conducted to date in developing drugs
using nature-based psilocybin products. In this regard, we do not see any reference to pre-
clinical or Phase 1 trials relating to the in-licensed PEX010 product candidate.
30.Please revise, where appropriate, to discuss the costs associated with the Phase 2B clinical
trial. Also discuss the planned allocation for the proceeds to be received by the combined
company. In this regard, show the planned allocation under the various cash scenarios
outlined on page 37 and elsewhere. Given your disclosure that the Minimum Cash
Condition is a waivable condition, please also disclose the funding that the business
requires to operate for the first twelve months following the closing.
Palliative Care Clinical Trial , page 151
31.Please identify the “FDA-recommended primary endpoints” to study PEX010. Clarify
whether the referenced 75-patient trial is a trial that you plan to conduct and one that you
have discussed with FDA. Alternatively, please clarify that the referenced trial is a third-
party trial or advise.
FirstName LastNameDr. Neil Maresky
Comapany NamePsyence Biomedical LTD
September 4, 2023 Page 7
FirstName LastName
Dr. Neil Maresky
Psyence Biomedical LTD
September 4, 2023
Page 7
Information about Psyence
Licensing and commercialization of PEX010, page 152
Licensing and Commercialization of PEX010, page 152
32.Please revise to disclose all key financial terms u