Correspondence 0001104659-23-002378 from Zura Bio Ltd (ZURA)
Zura Bio Ltd
Date: Jan. 9, 2023 · CIK: 0001855644 · Accession: 0001104659-23-002378
AI Filing Summary & Sentiment
File numbers found in text: 333-267005
Referenced dates: December 27, 2022
Letter
Via Edgar Division of Corporation Finance Office of Life Sciences U.S. Securities & Exchange Commission Attention: Mr. Conlon Danberg and Ms. Celeste Murphy Re: JATT Acquisition Corp Amendment No. 3 to Registration Statement on Form S-4 Filed on December 15, 2022 File No. 333-267005
Dear Mr. Danberg and Ms. Murphy:
On behalf of our client, JATT Acquisition Corp (the “Company”), we hereby provide a response to the comments issued in a letter dated December 27, 2022 (the “Staff’s Letter”) regarding the Company’s Amendment No. 3 to the Registration Statement on Form S-4 that was submitted on December 15, 2022 (the “Amendment No. 3”).
Concurrently with the submission of this response letter, we are filing, through EDGAR, Amendment No. 4 to the Registration Statement (“Amendment No. 4”).
In order to facilitate the review by the staff of the Securities and Exchange Commission (the “Staff”) of Amendment No. 4, we have responded, on behalf of the Company, to the comments set forth in the Staff’s Letter on a point-by-point basis. The numbered paragraphs set forth below respond to the Staff’s comments and correspond to the numbered paragraph in the Staff’s 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
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 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.
Response: We acknowledge the Staff’s comment and have revised the disclosures on page 26.
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.
Response: We acknowledge the Staff’s comment and have revised the disclosures on page 228 and following to remove the reference to asthma as the “lead indication.”
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.
Response: We acknowledge the Staff’s comment and have revised the disclosures on page 207.
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.
Response: We acknowledge the Staff’s comment and have revised the disclosures on page 215 and elsewhere to remove references to torudokimab as “safe.”
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.
Response: We acknowledge the Staff’s comment and have revised the disclosures on page 311.
General
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.
Response: We acknowledge the Staff’s comment and have added the disclosures on pages 9 and 37 of Amendment No. 4. We further confirm that the Company will make additional appropriate revisions to the Registration Statement once the amount of public share redemptions are determined in connection with the Extraordinary General Meeting being held on January 12, 2023.
Please call me at (212) 407-4866 if you would like additional information with respect to any of the foregoing.
Thank you.
Sincerely,
/s/ Giovanni Caruso
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filename1.htm
Giovanni
Caruso
Partner
345 Park Avenue
New York, NY 10154
Direct 212.407.4866
Main 212.407.4000
Fax 212.937.3943
gcaruso@loeb.com
Via Edgar
January 9, 2023
Division of Corporation Finance
Office of Life Sciences
U.S. Securities & Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Attention: Mr. Conlon Danberg and Ms. Celeste
Murphy
Re:
JATT Acquisition Corp
Amendment No. 3 to Registration Statement on Form S-4 Filed on
December 15, 2022
File No. 333-267005
Dear Mr. Danberg and Ms. Murphy:
On behalf of our client, JATT Acquisition Corp
(the “Company”), we hereby provide a response to the comments issued in a letter dated December 27, 2022 (the “Staff’s
Letter”) regarding the Company’s Amendment No. 3 to the Registration Statement on Form S-4 that was submitted on December
15, 2022 (the “Amendment No. 3”).
Concurrently
with the submission of this response letter, we are filing, through EDGAR, Amendment No. 4 to the Registration Statement (“Amendment
No. 4”).
In order to facilitate the review by the staff
of the Securities and Exchange Commission (the “Staff”) of Amendment No. 4, we have responded, on behalf of the Company,
to the comments set forth in the Staff’s Letter on a point-by-point basis. The numbered paragraphs set forth below respond to the
Staff’s comments and correspond to the numbered paragraph in the Staff’s 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 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.
Response:
We acknowledge the Staff’s comment and have revised the disclosures on page 26.
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.
Response: We
acknowledge the Staff’s comment and have revised the disclosures on page 228 and following to remove the reference to asthma as the “lead indication.”
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.
Response: We
acknowledge the Staff’s comment and have revised the disclosures on page 207.
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.
Response:
We acknowledge the Staff’s comment and have revised the disclosures on page 215 and elsewhere to remove references to torudokimab as “safe.”
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.
Response:
We acknowledge the Staff’s comment and have revised the disclosures on page 311.
2
General
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.
Response:
We acknowledge the Staff’s comment and have added the disclosures on pages 9 and 37 of Amendment No. 4. We further confirm
that the Company will make additional appropriate revisions to the Registration Statement once the amount of public share redemptions
are determined in connection with the Extraordinary General Meeting being held on January 12, 2023.
Please call me at (212) 407-4866 if you would
like additional information with respect to any of the foregoing.
Thank you.
Sincerely,
/s/ Giovanni Caruso
Giovanni Caruso
Partner
3