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United States securities and exchange commission logo
June 27, 2023
Axel Bolte
President and Chief Executive Officer
Inozyme Pharma, Inc.
321 Summer Street, Suite 400
Boston, MA 02210
Re: Inozyme Pharma,
Inc.
Form 10-K for the
fiscal year ended December 31, 2022
Filed March 22,
2023
File No. 001-39397
Dear Axel Bolte:
We have limited our review of your filing to the financial
statements and related
disclosures 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 these comments within ten business days by
providing the requested
information or advise us as soon as possible when you will respond. If
you do not believe our
comments apply to your facts and circumstances, please tell us why in
your response.
After reviewing your
response to these comments, we may have additional comments.
Form 10-K for the fiscal year ended December 31, 2022
Research and Development Expense, page 117
1. You disclose on page
115 that research and development activities are central to your
business model. You
also disclose that from inception through December 31, 2022, you
have incurred $142.1
million of research and development costs for INZ-701. Please
revise your future
filings to address the following to more clearly address the trends
experienced during the
periods presented:
Revise to break out
the costs incurred during each period presented for INZ-701
separately for
each indication.
If you do not track
your research and development costs by indication, please
disclose that fact
and separately quantify the total amount of expense recognized
related to INZ-701
for each period presented.
For all other
research and development expenses, provide other quantitative or
qualitative
disclosure that provides more transparency as to the type of research and
Axel Bolte
Inozyme Pharma, Inc.
June 27, 2023
Page 2
development expenses incurred (i.e. quantify by nature or type of
expense). The total
of costs broken out should reconcile to total research and
development expense on the
Statements of Operations.
Item 7. Management's Discussion and Analysis of Financial Condition and Results
of Operations
Results of Operations
General and Administrative Expenses, page 118
2. You disclose here that the increase in General and administrative
expenses from 2021 to
2022 was primarily due to an increase in personnel costs. Please
revise your future filings
to more clearly identify the drivers of the increase and to quantify
the impact of each
factor cited.
In closing, 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.
You may contact Vanessa Robertson at 202-551-3649 or Kevin Vaughn at
202-551-3494
with any questions.
FirstName LastNameAxel Bolte Sincerely,
Comapany NameInozyme Pharma, Inc.
Division of
Corporation Finance
June 27, 2023 Page 2 Office of Life
Sciences
FirstName LastName