SEC Comment Letter 0000000000-24-006977 to Zenas BioPharma, Inc. (ZBIO) (CIK 0001953926) (ZBIO)
Zenas BioPharma, Inc. (ZBIO) (CIK 0001953926)
Date: June 18, 2024 · CIK: 0001953926 · Accession: 0000000000-24-006977
AI Filing Summary & Sentiment
Letter
United States securities and exchange commission logo June 18, 2024 Leon O. Moulder, Jr. Chief Executive Officer Zenas BioPharma, Inc. 1000 Winter Street North Building, Suite 1200 Waltham, MA 02451 Re:Zenas BioPharma, Inc. Amendment No. 2 to Draft Registration Statement on Form S-1 Submitted June 14, 2024 CIK No. 0001953926 Dear Leon O. Moulder: We have reviewed your amended draft registration statement and have the following comment. 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 a comment applies 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 this letter and your amended draft registration statement or filed registration statement, we may have additional comments. Amendment No. 2 to Draft Registration Statement on Form S-1 Prospectus Summary Our Obexelimab Program, page 2 1.We note your response to prior comment 1. We also note that disclosure in this section continues to state obexelimab was well tolerated in five completed clinical trials including trials that used intravenous infusion for the delivery of your product candidate. Please balance this statement by clarifying that you have observed serious adverse events in trials of obexelimab administered through intravenous infusion.
FirstName LastNameLeon O. Moulder, Jr. Comapany NameZenas BioPharma, Inc. June 18, 2024 Page 2 FirstName LastName Leon O. Moulder, Jr. Zenas BioPharma, Inc. June 18, 2024 Page 2 Please contact Li Xiao at 202-551-4391 or Angela Connell at 202-551-3426 if you have questions regarding comments on the financial statements and related matters. Please contact Tyler Howes at 202-551-3370 or Chris Edwards at 202-551-6761 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Nicholas Roper, Esq.
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United States securities and exchange commission logo
June 18, 2024
Leon O. Moulder, Jr.
Chief Executive Officer
Zenas BioPharma, Inc.
1000 Winter Street
North Building, Suite 1200
Waltham, MA 02451
Re:Zenas BioPharma, Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted June 14, 2024
CIK No. 0001953926
Dear Leon O. Moulder:
We have reviewed your amended draft registration statement and have the following
comment.
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 a comment applies 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 this letter and your amended
draft registration statement or filed registration statement, we may have additional comments.
Amendment No. 2 to Draft Registration Statement on Form S-1
Prospectus Summary
Our Obexelimab Program, page 2
1.We note your response to prior comment 1. We also note that disclosure in this section
continues to state obexelimab was well tolerated in five completed clinical trials including
trials that used intravenous infusion for the delivery of your product candidate. Please
balance this statement by clarifying that you have observed serious adverse events in trials
of obexelimab administered through intravenous infusion.
FirstName LastNameLeon O. Moulder, Jr.
Comapany NameZenas BioPharma, Inc.
June 18, 2024 Page 2
FirstName LastName
Leon O. Moulder, Jr.
Zenas BioPharma, Inc.
June 18, 2024
Page 2
Please contact Li Xiao at 202-551-4391 or Angela Connell at 202-551-3426 if you have
questions regarding comments on the financial statements and related matters. Please contact
Tyler Howes at 202-551-3370 or Chris Edwards at 202-551-6761 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Nicholas Roper, Esq.