0000000000-22-013930.txt : 20230328 0000000000-22-013930.hdr.sgml : 20230328 20221227173003 ACCESSION NUMBER: 0000000000-22-013930 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20221227 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: Zura Bio Ltd CENTRAL INDEX KEY: 0001855644 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: E9 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 4225 EXECUTIVE SQUARE STREET 2: SUITE 600 CITY: LA JOLLA STATE: CA ZIP: 92037 BUSINESS PHONE: 858-247-0520 MAIL ADDRESS: STREET 1: 4225 EXECUTIVE SQUARE STREET 2: SUITE 600 CITY: LA JOLLA STATE: CA ZIP: 92037 FORMER COMPANY: FORMER CONFORMED NAME: JATT Acquisition Corp DATE OF NAME CHANGE: 20210407 PUBLIC REFERENCE ACCESSION NUMBER: 0001104659-22-077459 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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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. Unless we note otherwise, our references to prior comments are to comments in our November 4, 2022 letter. Amendment No. 3 to Registration Statement on Form S-4 filed December 15, 2022 Summary of the Proxy Statement The Parties to the Business Combination Zura, page 24 1. We note your revised disclosure regarding Zura and re-issue comment 7 from our August 3, 2022 letter in part. Please balance your disclosure regarding Zura to: state that Zura was recently formed on January 18, 2022 and that it has not conducted any clinical tests itself, nor have any clinical tests been conducted during the period since its inception; state that Zura does not have any product candidates approved for sale and has not Verender Badial FirstName LastNameVerender Badial JATT Acquisition Corp Comapany27, December NameJATT 2022 Acquisition Corp December Page 2 27, 2022 Page 2 FirstName LastName generated any revenue from product sales to date; note that the completed Phase 2 trial for torudokimab was conducted in patients with atopic dermatitis and that following an interim analysis of the study, the sponsor determined that the efficacy data observed did not warrant continuation of the trial and the study was terminated; and provide the current status of the planned randomized phase 2 studies with torudokimab and ZB-168, including whether Zura has made an IND submission with the FDA for such studies. Additionally, we note your statement on page 228 that asthma is "[y]our lead indication" and that your planned randomized Phase 2 studies "will include asthma and may include additional autoimmune indications." Please revise your summary description of Zura to indicate that asthma is your lead indication. In this regard, we note that the current disclosure states that your planned Phase 2 studies "may include asthma" among other indications. Our Vision and Our Strategy, page 190 2. We note your statement that you are "among the leaders in exploring the therapeutic benefit of blocking IL33 with torudokimab, which has the potential to be a best in class mechanism based on the head to head potency of torudokimab vs other IL33 inhibitors in vitro." Please expand on this statement to discuss the details of any head to head comparisons of torudokimab vs other IL33 inhibitors that have been completed to date. Clinical trial Overview Phase 1a single ascending dose trial Safety and Tolerability, page 199 3. We refer to your statement that "[o]verall, single and multiple doses of torudokimab were safe and well tolerated by all subjects" and reissue comment 28 from our August 3, 2022 letter. Determinations with respect to safety and efficacy are within the sole authority of the FDA, EMA or equivalent foreign regulator. Please revise your registration statement to remove the reference to doses of torudokimab being "safe" as well as any other statements relating to safety and efficacy in instances where you have not yet received full approval for your product candidates. Certain Relationships and Related Party Transactions of Zura Put-Call Letter Agreement, page 295 4. We note your description of the Put-Call Letter Agreement entered into on December 8, 2022. Please revise this description to include the name of the investor and the number of shares subject to the agreement. General Verender Badial JATT Acquisition Corp December 27, 2022 Page 3 5. We note your revised disclosure regarding the January 16, 2023 Outside Date to consummate a business combination. It appears that you have also filed a proxy statement for an extraordinary general meeting of shareholders to be held on January 12, 2023 to seek shareholder approval of an extension of the Outside Date from January 16, 2023 to April 17, 2023. In your next amendment, please include disclosure regarding this meeting and reflect any associated events such as redemptions that may occur in connection with the extension amendment. You may contact Christie Wong at 202-551-3684 or Lynn Dicker at 202-551-3616 if you have questions regarding comments on the financial statements and related matters. Please contact Conlon Danberg at 202-551-4466 or Celeste Murphy at 202-551-3257 with any other questions. Sincerely, FirstName LastNameVerender Badial Division of Corporation Finance Comapany NameJATT Acquisition Corp Office of Life Sciences December 27, 2022 Page 3 cc: Giovanni Caruso, Esq. FirstName LastName