Correspondence 0001104659-23-102359 from PSYENCE BIOMEDICAL LTD. (PBM)
PSYENCE BIOMEDICAL LTD.
Date: Sept. 20, 2023 · CIK: 0001985062 · Accession: 0001104659-23-102359
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CORRESP 1 filename1.htm September 20, 2023 U.S. Securities & Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Li Xiao and Kevin Vaughn Dear Ms. Xiao and Mr. Vaughn: Psyence Biomedical Ltd., a corporation organized under the laws of Ontario (the “Company,” “we,” “our” or “us”), hereby transmits the Company’s response to the comment letter received from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) dated September 4, 2023, regarding the Company’s Registration Statement on Form F-4 filed with the Commission on August 1, 2023 (the “Registration Statement”). For the Staff’s convenience, we have repeated below each of the Staff’s comments in bold and have followed such comments with the Company’s response. All page references in the responses set forth below refer to page numbers in the Amendment No. 1 to the Registration Statement (“Amendment No. 1”). Registration Statement on Form F-4, Filed August 1, 2023 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 cover page 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. In response to the Staff’s comment, the Company has revised the disclosure on the cover page of Amendment No. 1. Market and Industry Data, page 1 2. Please revise to disclose whether you believe the sources are reliable. In response to the Staff’s comment, the Company has revised the disclosure on page 1 of Amendment No. 1. 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. In response to the Staff’s comment, the Company has revised the disclosure on page 11 of Amendment No. 1. 4. We note the inclusion of Backstop Shares in the table. Please advise regarding whether there is a Backstop arrangement in place. In response to the Staff’s comment, the Company has revised the disclosure on page 11 of Amendment No. 1. 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. In response to the Staff’s comment, the Company has revised the disclosure on page 11 of Amendment No. 1. 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. In response to the Staff’s comment, the Company has revised the disclosure on pages 8-10 of Amendment No. 1. 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. To date, NCAC has not paid its Sponsor, officers or directors, or any entities with which they are affiliated, any finder’s fee, consulting fee or other compensation prior to, or for any services they rendered in order to effectuate, the consummation of our initial business combination, other than as described in NCAC’s final IPO prospectus. Although inconsistent with the representations in NCAC’s final IPO prospectus concerning limitations on payments and compensation to the Sponsor and its affiliates, NCAC intends to issue the Advisory Fee in the form of equity to CCM, an affiliate of the Sponsor. NCAC is disclosing such intention and giving shareholders the opportunity to vote against the proposals presented at the special meeting and/or redeem their NCAC Public Shares. 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. In response to the Staff’s comment, the Company has revised the disclosure on pages 70 and 171-172 of Amendment No. 1. 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. In response to the Staff’s comment, the Company has revised the disclosure on pages 11, 31 and 91 of Amendment No. 1. · 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. In response to the Staff’s comment, the Company has revised the disclosure on page 90 of Amendment No. 1. · 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. In response to the Staff’s comment, the Company has revised the disclosure on page 91 of Amendment No. 1. 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. In response to the Staff’s comment, the Company has revised the disclosure on pages 32 and 127 of Amendment No. 1. 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. The underwriter has agreed via e-mail correspondence that they will waive 50% of the fee and will agree to accept payment of the un-waived portion 50% in cash and 50% in shares of the Company. · If so, revise to disclose the date and the terms of the agreement, as well as how you will account for the waiver. In response to the Staff’s comment, the Company has revised the disclosure on page 96 of Amendment No. 1. · 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 securities. The transaction costs were originally allocated on a pro rata basis between the NCAC Class A Ordinary Shares and the NCAC Public Warrants. The portion attributed to NCAC Class A Ordinary Shares was allocated to Class A ordinary share and subsequently trued up to redemption value. The portion attributed to the warrants was applied to earnings. As such the reversal of the fee was applied to accumulated deficit to reverse the effect of the original entry. · 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. Please see response above. 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. In review of the SEC rule and regulations excerpted below, management believes that the interest earned in trust as well as the extension deposit have a direct impact on the redemption price of the redeemable shares of NCAC, as such in order to properly estimate the number of shares that could be redeemed to ensure the minimum net cash requirement is met the interest earned and extension deposits should be included to properly calculate the maximum redemption scenario. Regulation S-X, Article 11 Pro Forma Financial Information Rule 11-02(a), Preparation requirements, Form and content (6) The pro forma condensed balance sheet and pro forma condensed statements of comprehensive income must include, and be limited to, the following pro forma adjustments, except as noted in paragraph (a)(7) of this section: (i) Transaction Accounting Adjustments. (A) Adjustments that depict in the pro forma condensed balance sheet the accounting for the transaction required by US Generally Accepted Accounting Principles (US GAAP) or, as applicable, International Financial Reporting Standards as issued by the International Accounting Standards Board (IFRS-IASB). Calculate pro forma adjustments using the measurement date and method prescribed by the applicable accounting standards. For a probable transaction, calculate pro forma adjustments using, and disclose, the most recent practicable date prior to the effective date (for registration statements), qualification date (for Regulation A offering statements), or the mail date (for proxy statements). (B) Adjustments that depict in the pro forma condensed statements of comprehensive income the effects of the pro forma balance sheet adjustments in paragraph (a)(6)(i)(A) of this section assuming those adjustments were made as of the beginning of the fiscal year presented. Such adjustments must be made whether or not the pro forma balance sheet is presented pursuant to paragraph (c)(1) of this section. If the condition in Rule 11-01(a) that is met does not have a balance sheet effect, then depict the accounting for the transaction required by US GAAP or IFRS-IASB, as applicable. 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. In response to the Staff’s comment, the Company has revised the disclosure on page 108 of Amendment No. 1. 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. In response to the Staff’s comment, the Company has revised the disclosure on page 108 of Amendment No. 1. 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. In response to the Staff’s comment, the Company has revised the disclosure on page 111 of Amendment No. 1. 16. Please revise the disclosure on page 102 so it is presented in chronological order. In response to the Staff’s comment, the Company has revised the disclosure on page 111 of Amendment No. 1. 17. Please revise the November 27 entry to clarify which party made the initial proposal. Also discuss the "sources and uses" calculation. In response to the Staff’s comment, the Company has revised the disclosure on page 111 of Amendment No. 1. 18. Please name the corporate advisors, and Corporate Advisor, described on pages 101 and 102, respectively. In response to the Staff’s comment, the Company has revised the disclosure on page 111 of Amendment No. 1. 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. In response to the Staff’s comment, the Company has revised the disclosure on page 113 of Amendment No. 1. 20. Please explain the provisions of the February 15, 2023 amendment. In response to the Staff’s comment, the Company has revised the disclosure on page 114 of Amendment No. 1. 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. In response to the Staff’s comment, the Company has revised the disclosure on pages 114 and 115 of Amendment No. 1. 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. In response to the Staff’s comment, the Company has revised the disclosure on page 115 of Amendment No. 1. Recommendation of the NCAC Board..., page 106 23. Please revise to explain briefly here and more extensively