SEC Comment Letter 0000000000-25-000916 to Kalaris Therapeutics, Inc. (KLRS)
Kalaris Therapeutics, Inc.
Date: Jan. 28, 2025 · CIK: 0001754068 · Accession: 0000000000-25-000916
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-283678
Letter
January 28, 2025 Diana Brainard, M.D. Chief Executive Officer AlloVir, Inc. PO Box 44, 1661 Massachusetts Avenue Lexington, MA 02420 Re:AlloVir, Inc. Amendment No. 1 to Registration Statement on Form S-4 Filed January 17, 2025 File No. 333-283678 Dear Diana Brainard M.D.: We have reviewed your amended registration statement and have the following comment(s). Please respond to this letter by amending your registration statement and providing the requested information. 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 any amendment to your registration statement and the information you provide in response to this letter, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our January 6, 2025 letter. Amendment No. 1 to Registration Statement on Form S-4 Business Kalaris' ongoing Phase 1 clinical trial of TH103, page 333 We note your revised disclosure here, and similar disclosure on page 321, that "Part 2 of the Phase 1 trial is designed to enroll and treat with TH103 up to 12 treatment naïve-patients, aged 50 years and older, with a CST measurement greater than 325 microns." We also note your disclosure that "[t]reatment with TH103 will be administered if the following criteria are met: (1) patient responds to one to three injections of aflibercept as determined by complete resolution of fluid measured by OCT and (2) within 90 days there is an emergence of fluid in the retina." Please clarify if the disclosed criteria applies to Part 2 of the Phase 1 clinical trial, and, if so, clarify how the patients who had previously received injections of aflibercept would 1.
January 28, 2025 Page 2 be considered treatment naïve. Also, if you expect to seek regulatory approval of TH103 as a second-line treatment for nAMD please make that clear. Please contact Ibolya Ignat at 202-551-3636 or Daniel Gordon at 202-551-3486 if you have questions regarding comments on the financial statements and related matters. Please contact Daniel Crawford at 202-551-7767 or Tim Buchmiller at 202-551-3635 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc:Tevia K. Pollard, Esq.
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January 28, 2025
Diana Brainard, M.D.
Chief Executive Officer
AlloVir, Inc.
PO Box 44, 1661 Massachusetts Avenue
Lexington, MA 02420
Re:AlloVir, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed January 17, 2025
File No. 333-283678
Dear Diana Brainard M.D.:
We have reviewed your amended registration statement and have the following
comment(s).
Please respond to this letter by amending your registration statement and providing
the requested information. 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 any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments. Unless we note
otherwise, any references to prior comments are to comments in our January 6, 2025 letter.
Amendment No. 1 to Registration Statement on Form S-4
Business
Kalaris' ongoing Phase 1 clinical trial of TH103, page 333
We note your revised disclosure here, and similar disclosure on page 321, that "Part 2
of the Phase 1 trial is designed to enroll and treat with TH103 up to 12 treatment
naïve-patients, aged 50 years and older, with a CST measurement greater than 325
microns." We also note your disclosure that "[t]reatment with TH103 will be
administered if the following criteria are met: (1) patient responds to one to three
injections of aflibercept as determined by complete resolution of fluid measured by
OCT and (2) within 90 days there is an emergence of fluid in the retina." Please
clarify if the disclosed criteria applies to Part 2 of the Phase 1 clinical trial, and, if so,
clarify how the patients who had previously received injections of aflibercept would 1.
January 28, 2025
Page 2
be considered treatment naïve. Also, if you expect to seek regulatory approval of
TH103 as a second-line treatment for nAMD please make that clear.
Please contact Ibolya Ignat at 202-551-3636 or Daniel Gordon at 202-551-3486 if you
have questions regarding comments on the financial statements and related matters. Please
contact Daniel Crawford at 202-551-7767 or Tim Buchmiller at 202-551-3635 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Tevia K. Pollard, Esq.