SEC Comment Letter 0000000000-23-007460 to enGene Therapeutics Inc. (ENGN)
enGene Therapeutics Inc.
Date: July 12, 2023 · CIK: 0001980845 · Accession: 0000000000-23-007460
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United States securities and exchange commission logo
July 12, 2023
Jason Hanson
Chief Executive Officer
enGene Holdings Inc.
7171 Rue Frederick Banting
Saint-Laurent, QC H4S IZ9, Canada
Re:enGene Holdings Inc.
Draft Registration Statement on Form S-4
Submitted June 14, 2023
CIK No. 0001980845
Dear Jason Hanson:
We have reviewed your draft 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 providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. 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 the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-4
Cover Page
1.Please revise your cover page to disclose the valuation assigned to enGene for purposes of
the Business Combination.
Questions and Answers About the Business Combination and the Special Meeting
Q: Why is FEAC proposing the Business Combination, page 11
2.You state that in approving the business combination the FEAC board considered certain
factors and proceed to discuss them. Please revise your answer to balance the description
with equally prominent disclosure of regulatory and competitive challenges you face.
FirstName LastNameJason Hanson
Comapany NameenGene Holdings Inc.
July 12, 2023 Page 2
FirstName LastNameJason Hanson
enGene Holdings Inc.
July 12, 2023
Page 2
3.In the second bullet point on page 12, please specify the milestones that the FEAC Board
considered that could provide an opportunity for potential uplifts in enGene’s valuation.
Q: What interests do FEAC's current officers and directors have in the Business Combination?,
page 14
4.Please quantify any out-of-pocket expenses for which the sponsor and its affiliates are
awaiting reimbursement.
Q: What equity stake will current FEAC Shareholders, the enGene Shareholders and the
Sponsor..., page 19
5.Please add a table showing the pro forma ownership interests described in this section, as
expanded to include each group of security holders, based on all shares that may be issued
on a fully-diluted basis, including the ownership interests of the PIPE investors and the
Convertible Bridge Financing investors, based on a no redemption scenario, a 50%
redemption scenario and a maximum redemption scenario, including any needed
assumptions. Ensure your revised disclosure addresses all possible sources and extent of
dilution that shareholders who elect not to redeem their shares may experience in
connection with the business combination. Provide disclosure of the impact of each
significant source of dilution, including the amount of equity held by founders,
convertible securities, including warrants retained by redeeming shareholders, at each of
the redemption levels detailed in your sensitivity analysis, including any needed
assumptions.
6.Quantify the value of warrants, based on recent trading prices, that may be retained by
redeeming shareholders assuming maximum redemptions and identify any material
resulting risks.
7.It appears that underwriting fees remain constant and are not adjusted based on
redemptions. Revise to disclose the effective underwriting fee on a percentage basis for
shares at each redemption level presented in your sensitivity analysis related to dilution.
Q: What is the PIPE Financing?, page 24
8.Please highlight in this question and answer, and in the next question and answer
regarding the Convertible Bridge Financing, the material differences in the price of the
FEAC Shares issued at the time of the IPO and the price of the securities being issued in
the private placements at the time of the Business Combination. Disclose if the SPAC’s
sponsors, directors, officers or their affiliates will participate in the private placements.
The Non-Redemption Agreement, page 34
9.Please disclose the number of FEAC Class A Shares and FEAC Warrants (or after the
Assumption, the number of New enGene Shares and New enGene Warrants) issuable to
the FEAC Shareholders under the Non-Redemption Agreement.
FirstName LastNameJason Hanson
Comapany NameenGene Holdings Inc.
July 12, 2023 Page 3
FirstName LastNameJason Hanson
enGene Holdings Inc.
July 12, 2023
Page 3
Conditions to Closing, page 36
10.We note your disclosure that it is a condition to closing that New enGene’s initial listing
application with the Nasdaq or other exchange shall have been approved but such
condition appears to be waivable. Please revise to disclose whether the terms of the
Business Combination Agreement permit that the Nasdaq listing closing condition could
be waived without recirculation or resolicitation. If so, please revise the risk factor on
page 145 to reflect as such and describe the risks attendant to such a waiver, and revise
this section to indicate that shareholders may not have certainty at the time they vote or
make their redemption decision as to whether the New enGene’s securities will be listed
on a national securities exchange following the business combination.
Interests of enGene's Significant Shareholders, Directors and Executive Officers in the Business
Combination, page 43
11.Please expand your disclosure regarding Forbion Capital Fund III's ownership interests in
enGene. Disclose the approximate dollar value of the interests based on the transaction
value and recent trading prices as compared to the price paid for the ownership interests.
In addition, please clarify how the FEAC Board considered these interests in negotiating
and recommending the Business Combination.
Potential Purchases of Shares and/or Public Warrants, page 159
12.We note your disclosure here and on page 137 that the Sponsor, enGene and/or its
affiliates may purchase shares and/or warrants in privately negotiated transactions or in
the open market from public shareholders, or they may enter into transactions with
investors and others to provide them with incentives to acquire shares of FEAC Class A
Shares or vote their shares in favor of the Business Combination, and that the purpose of
such purchases and other transactions could be to vote such shares in favor of the Business
Combination and thereby increase the likelihood of obtaining shareholder approval. In an
appropriate location, please disclose how such purchases will comply with the
requirements of Rule 14e-5 under the Exchange Act. Refer to Tender Offer Rules and
Schedules Compliance and Disclosure Interpretation 166.01 for guidance.
Proposal No. 1 - The Business Combination Proposal
Background of the Business Combination, page 164
13.We note that in identifying enGene, FEAC's management identified 85 potential targets,
entered into 31 non-disclosure agreements, and submitted three letters of intent. Please
expand this section to discuss how such companies were identified and what criteria was
used to not consider certain companies.
14.We note you entered into three letters of intent, one being with enGene. Please provide a
general description of the other two targets and disclose when you ended discussions with
those companies.
FirstName LastNameJason Hanson
Comapany NameenGene Holdings Inc.
July 12, 2023 Page 4
FirstName LastName
Jason Hanson
enGene Holdings Inc.
July 12, 2023
Page 4
15.You state that on May 13, 2022 representatives of FEAC and representatives of enGene
met to discuss valuation and the potential size of a PIPE financing. You also state that
further meetings were held on May 22, 2022 and May 30, 2022. Please identify the
representatives of enGene that were present and include a description of the discussions
that took place on May 22, 2022 and May 30, 2022.
16.You state that on May 31, 2022 the FEAC Board convened to approve a draft non-binding
letter of interest. Please include a discussion of the key terms that were approved.
17.We note that on August 29, 2022 Morgan Lewis granted virtual data room access to
Kirkland & Elis and Davis Polk & Wardwell London LLP. Please identify who Davis
Polk is representing in this transaction.
18.You state that on September 29, 2022 and October 31, 2022 a Big Four accounting firm
was appointed advisor to FEAC. Please identify the accounting firm.
19.We note your disclosure that on March 23, 2023, Davis Polk had a telephonic meeting
with Morgan Lewis to discuss the presentation of certain of enGene’s phase 2 study data
to potential PIPE investors. Please tell us where you have disclosed that data in your
proxy statement/prospectus or revise your disclosure as appropriate.
20.We note your disclosure on page 175 that on May 14, 2023, the FEAC Board
unanimously approved the entry into the Business Combination Agreement and Ancillary
Agreements and the transactions contemplated thereby. Please disclose what the pre-
money valuation of enGene was for purposes of the Business Combination Agreement
that the FEAC Board approved. If that valuation changed from the $200 million pre-
money valuation for purposes of the May 5, 2022 initial non-binding business
combination proposal as disclosed on page 166, and the $200 million pre-money valuation
for purposes of the signed letter of intent on July 3, 2022 as disclosed on page 167, please
revise to provide a discussion as to how the material terms of the consideration evolved
during the negotiations. In your revised disclosure, please ensure that investors can tie the
valuation negotiations in the background section to the disclosure on page 186 that, for
purposes of the fairness opinion, Lincoln derived an implied enterprise value of enGene
from the Transaction of $111 million.
21.We note that FEAC's amended and restated memorandum and articles of association
waived the corporate opportunities doctrine. Please address this potential conflict of
interest and whether it impacted FEAC's search for an acquisition target.
The FEAC Board's Reasons for the Business Combination, page 176
22.We note that none of your factors in deciding to approve the proposed business
combination address the consideration to be paid for enGene in the transaction. Please
discuss whether and how the board took this factor into account in recommending the
transaction and, if not, why not.
FirstName LastNameJason Hanson
Comapany NameenGene Holdings Inc.
July 12, 2023 Page 5
FirstName LastName
Jason Hanson
enGene Holdings Inc.
July 12, 2023
Page 5
Lincoln's Fairness Opinion, page 182
23.Please supplementally provide us with copies of all materials prepared by Lincoln
International LLC and shared with the FEAC board of directors and their representatives,
including any board books, transcripts and summaries of oral presentations, that were
material to the board's decision to approve the merger and the transactions contemplated
thereby.
Survival of Representations, Warranties and Covenants, page 207
24.We note your disclosure that the representations and warranties of the parties contained in
the Business Combination Agreement do not survive the Closing and that there are no
indemnification rights. Please include appropriate risk factor disclosure.
Unaudited Pro forma Condensed Combined Financial Information
Unaudited Pro Forma Condensed Combined Balance Sheet, page 241
25.You state in Note 5b on page 250 that the $18.5 million 2022 Convertible Notes and $38.0
million 2023 convertible notes will convert into 33,127,334 enGene common shares.
Please clarify how the 33,127,334 shares were derived.
26.Please revise the explanation of adjustment 5(i) on page 251 to explain how the
121,342,000 was derived.
27.You state in adjustment 5u on page 252 that the PIPE warrants are preliminarily expected
to be equity-classified warrants as they meet the indexation requirements under ASC 815-
40. Please clarify the basis of your accounting treatment for the warrants to be issued in
connection with the PIPE financing once the terms have been finalized. Provide the
applicable paragraphs in the agreement that support your conclusion.
28.You disclose on page F-61 a forward purchase agreement in which the Sponsor has agreed
to purchase (1) an aggregate of 1,000,000 Class A ordinary shares for $10.00 per share
(the "firm forward purchase shares"), or an aggregate amount of $10,000,000 and (2) in
addition, an aggregate of up to 1,000,000 Class A ordinary shares for $10.00 per share
(the "additional forward purchase shares"), or an aggregate maximum amount of up to
$10,000,000, in each case in a private placement that may close simultaneously with the
closing of the Company’s initial Business Combination. Please provide us your
consideration of including the issuance in the pro forma information and providing
additional disclosure in the filing of the status of the agreement.
Business of enGene
Overview, page 279
29.You state that EG-70 is being developed to treat "high grade" non-muscle invasive
bladder cancer (NMIBC) that has elements of carcinoma in situ "Cis." Please define "high
grade" and "carcinoma in situ" and describe such elements. We also note in this regard
FirstName LastNameJason Hanson
Comapany NameenGene Holdings Inc.
July 12, 2023 Page 6
FirstName LastNameJason Hanson
enGene Holdings Inc.
July 12, 2023
Page 6
that you disclose here that EG-70 is being developed to treat "high grade non-
muscle invasive bladder cancer ("NMIBC") that has elements of carcinoma in situ
("Cis")" but that in other locations you disclose that EG-70 is being developed as a
monotherapy for BCG-unresponsive NMIBC with Cis. Please indicate if the potential
market for this candidate would be limited to patient populations with "high grade"
NMIBC with Cis and, if appropriate, revise your disclosure for consistency.
30.Please disclose the addressable market or patient populations for enGene's product
candidates in the countries and jurisdictions where EnGene currently intends to seek
regulatory approval. For EG-70, please include the projections referred to on page 84 for
the number of people who have the disease that the product candidate is targeting, as well
as the subset of people with the disease in a position to receive enGene's therapies, if
approved.
31.We note your disclosure that EG-70 has been given "Fast Track" designation by the FDA.
Please revise to include balancing disclosure that an accelerated approval pathway may
not lead to a faster development or regulatory review or approval process and does not
increase the likelihood that your product candidate will receive marketing approval.
Focus on advancing our lead product candidate EG-70. . . , page 280
32.You state here and on page 286 that you have followed the FDA guidance for NMIBC
treatment and have discussed your EG-70 development plan with the FDA. Please state
the status of such discussions and any feedback received from the FDA.
Fast Tracked Product Candidate in Underserved Market, page 281
33.You state that across all dose levels tested in the Phase I study of EG-70, a 3-month
complete response rate of 71% (N=21) was observed and that Phase 1 patients who were
treated in the RP2D cohort and who elected to continue treatment and receive an
additional 12-week cycle had a 57% CR rate at 6-months (4 out of 7). Please expand the
discussion to explain the statistical significance of these observations.
Our Gene Therapy Platform for Mucosal Tissues, page 281
34.At first use, please define viral vectors, AAV viral vectors, TURBT, and cystoscopic
CR in layman terms.
Product and Pipeline Development, page 282
35.We note your pipeline table on page 283 showing the current status of your product
development. Please revise the table to include columns for