SEC Comment Letter 0000000000-23-006836 to Inozyme Pharma, Inc. (CIK 0001693011)
Inozyme Pharma, Inc. (CIK 0001693011)
Date: June 27, 2023 · CIK: 0001693011 · Accession: 0000000000-23-006836
AI Filing Summary & Sentiment
File numbers found in text: 001-39397
Letter
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
FirstName LastNameAxel Bolte Comapany NameInozyme Pharma, Inc. June 27, 2023 Page 2 FirstName LastName 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. Sincerely, Division of Corporation Finance Office of Life Sciences
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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
FirstName LastNameAxel Bolte
Comapany NameInozyme Pharma, Inc.
June 27, 2023 Page 2
FirstName LastName
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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences