United States securities and exchange commission logo
August 22, 2023
Jason Hanson
Chief Executive Officer
enGene Holdings Inc.
7171 Rue Frederick Banting
Saint-Laurent, QC H4S IZ9, Canada
Re: enGene Holdings
Inc.
Registration
Statement on Form S-4
Filed August 9,
2023
File No. 333-273851
Dear Jason Hanson:
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.
Amendment No.1 to Registration Statement on Form S-4
Questions and Answers about the Business Combination...
What is the PIPE Financing?, page 28
1. We note your response
to our prior comment 8. Please include the portion of such
response that indicates
the material differences in the price per share 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.
Proposal No. 1 - The Business Combination Proposal
Background of Business Combination, page 175
2. We note your response
to our prior comment 15 and reissue in part. Please include a
description of the
discussions that took place in the May 30, 2022 meeting.
Jason Hanson
FirstName LastNameJason Hanson
enGene Holdings Inc.
Comapany
August 22, NameenGene
2023 Holdings Inc.
August
Page 2 22, 2023 Page 2
FirstName LastName
3. We note your revisions in response to prior comment 21. Please further
expand your
disclosure to indicate if the waiver of the corporate opportunities
doctrine impacted
FEAC's search for an acquisition target.
Business of enGene
Fast Tracked Product Candidate in Underserved Market, page 297
4. You make some assertions regarding the safety of EG-70 including your
statement that the
EG-70 "3-month data collected from all patients in the Phase 1 portion
of the ongoing
LEGEND trial demonstrated a favorable safety profile[.]" Safety is a
determination that is
within the authority of the FDA. Please revise or remove these
statements and similar
statements throughout your prospectus. Note that you may state your
product candidate
has been well tolerated, if accurate.
Our Strategy, page 298
5. We note your response to our previous comment 32 specifically where
you state that you
attempted to follow FDA guidance for the design of clinical studies
for development of
novel NMIBC treatments. On page 303 you affirmatively state that you
have followed
such guidance. Please clarify if during the FDA discussion of your
EG-70 development
plan the FDA made changes that allowed you to be in compliance with
such guidance.
Product and Pipeline Development, page 300
6. We note your response to our previous comment 35 and reissue. Please
revise the pipeline
table on page 300 to include columns for Phase 1, 2 and 3 clinical
trials.
Legend: A Phase 1/2 Study of EG-70 in NMIBC
Phase 2 Trial, page 307
7. We note your response to our previous comment 34 and reissue in part.
At first use please
define cystoscopic CR in layman terms.
Analysis if intravesical mEG-70 treatment..., page 311
8. We note your response to our previous comment 40. Please revise your
tables on pages
312 and 315 so that all text is legible. Specifically, the key to the
mouse chart on page 312
and 315 as well as the text within the table at the bottom of page
315.
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.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
Jason Hanson
enGene Holdings Inc.
August 22, 2023
Page 3
You may contact Sasha Parikh at 202-551-3627 or Mary Mast at
202-551-3613 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Doris Stacey Gama at 202-551-3188 or Tim Buchmiller at 202-551-3635
with any other
questions.
Sincerely,
FirstName LastNameJason Hanson
Division of Corporation
Finance
Comapany NameenGene Holdings Inc.
Office of Life Sciences
August 22, 2023 Page 3
cc: Howard A. Kenny, Esq.
FirstName LastName