0000000000-24-006977.txt : 20241010 0000000000-24-006977.hdr.sgml : 20241010 20240618123607 ACCESSION NUMBER: 0000000000-24-006977 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20240618 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Zenas BioPharma, Inc. CENTRAL INDEX KEY: 0001953926 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD SEC FILE NUMBER: 377-07069 BUSINESS ADDRESS: STREET 1: 1000 WINTER ST, SUITE 1200 CITY: WALTHAM STATE: MA ZIP: 02451 BUSINESS PHONE: 857-271-2954 MAIL ADDRESS: STREET 1: 1000 WINTER ST, SUITE 1200 CITY: WALTHAM STATE: MA ZIP: 02451 FORMER COMPANY: FORMER CONFORMED NAME: Zenas BioPharma (Cayman) Ltd DATE OF NAME CHANGE: 20221108 PUBLIC REFERENCE ACCESSION NUMBER: 0001104659-24-006759 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4*)>+CS],*,2 P(&]B:@H\/"]#;VQO7!E+UA/8FIE8W0O5VED=&@@,30R."],96YG=&@@,S8U+T)I='-097)# M;VUP;VYE;G0@.#X^7M0Q1$1$1$1$1&3"Q\<'QA6_?__&K *98K_? 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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. Leon O. Moulder, Jr. FirstName LastNameLeon O. Moulder, Jr. Zenas BioPharma, Inc. Comapany June NameZenas BioPharma, Inc. 18, 2024 June 18, Page 2 2024 Page 2 FirstName LastName 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.