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SEC Comment Letter 0000000000-24-007068 to Artiva Biotherapeutics, Inc. (ARTV)

Artiva Biotherapeutics, Inc.
Date: June 21, 2024 · CIK: 0001817241 · Accession: 0000000000-24-007068

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
June 21, 2024
Author
Fred Aslan
Form
UPLOAD
Company
Artiva Biotherapeutics, Inc.

Letter

United States securities and exchange commission logo June 21, 2024 Fred Aslan Chief Executive Officer Artiva Biotherapeutics, Inc. 5505 Morehouse Drive, Suite 100 San Diego, CA 92121 Re:Artiva Biotherapeutics, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted June 10, 2024 CIK No. 0001817241 Dear Fred Aslan: We have reviewed your amended draft registration statement and have the following comments. 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. Unless we note otherwise, any references to prior comments are to comments in our May 30, 2024 letter. Amendment No.1 to Draft Registration Statement on Form S-1 submitted June 10, 2024 Our Strengths, page 115 1.We note your response to prior comment 14, which we reissue. Please revise to define terms including "overall response rate," "complete response," "partial response," "ongoing response," "stable disease," and "progressive disease," as determined by the Lugano 2014 criteria. Additionally, explain how such responses are measured using CT and PET imaging assessments in your clinical trials or otherwise advise. AlloNK Clinical Development in LN, page 128 2.You disclose that the primary efficacy endpoint is the overall renal response rate (ORRR) defined as the proportion of subjects having either a complete renal response (CRR) or

FirstName LastNameFred Aslan Comapany NameArtiva Biotherapeutics, Inc. June 21, 2024 Page 2 FirstName LastName Fred Aslan Artiva Biotherapeutics, Inc. June 21, 2024 Page 2 partial renal response (PRR). Please revise to define terms CRR and PRR. Please contact Sasha Parikh at 202-551-3627 or Lynn Dicker at 202-551-3616 if you have questions regarding comments on the financial statements and related matters. Please contact Lauren Sprague Hamill at 303-844-1008 or Jason Drory at 202-551-8342 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Carlos Ramirez

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United States securities and exchange commission logo
June 21, 2024
Fred Aslan
Chief Executive Officer
Artiva Biotherapeutics, Inc.
5505 Morehouse Drive, Suite 100
San Diego, CA 92121
Re:Artiva Biotherapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted June 10, 2024
CIK No. 0001817241
Dear Fred Aslan:
            We have reviewed your amended draft registration statement and have the following
comments.
            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. Unless we note otherwise, any references to prior comments are to comments in our
May 30, 2024 letter.
Amendment No.1 to Draft Registration Statement on Form S-1 submitted June 10, 2024
Our Strengths, page 115
1.We note your response to prior comment 14, which we reissue. Please revise to define
terms including "overall response rate," "complete response," "partial response," "ongoing
response," "stable disease," and "progressive disease," as determined by the Lugano 2014
criteria. Additionally, explain how such responses are measured using CT and PET
imaging assessments in your clinical trials or otherwise advise.
AlloNK Clinical Development in LN, page 128
2.You disclose that the primary efficacy endpoint is the overall renal response rate (ORRR)
defined as the proportion of subjects having either a complete renal response (CRR) or

 FirstName LastNameFred Aslan
 Comapany NameArtiva Biotherapeutics, Inc.
 June 21, 2024 Page 2
 FirstName LastName
Fred Aslan
Artiva Biotherapeutics, Inc.
June 21, 2024
Page 2
partial renal response (PRR). Please revise to define terms CRR and PRR.
            Please contact Sasha Parikh at 202-551-3627 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Lauren Sprague Hamill at 303-844-1008 or Jason Drory at 202-551-8342 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Carlos Ramirez