SecProbe.io

CORRESP
1
filename1.htm

CORRESP

 Goodwin Procter

100 Northern Avenue

Boston, Massachusetts 02210

goodwinlaw.com

 +1 617 570
1000

 VIA EDGAR

January 17, 2025

 United States Securities and Exchange
Commission

 Division of Corporation Finance

 Office of Life
Sciences

 100 F Street, N.E.

 Washington, D.C. 20549-3628

 Attention: Daniel Crawford, Tim Buchmiller, Ibolya Ignat and Daniel Gordon

Re:
 AlloVir, Inc.

Registration Statement on Form S-4

Filed December 9, 2024

File No. 333-283678

Ladies and Gentlemen,

 On behalf of AlloVir, Inc. (the
“Company”), we are submitting this letter to the Securities and Exchange Commission (the “SEC”) via EDGAR in response to the comment letter from the staff of the SEC (the “Staff”), dated
January 6, 2025 (the “Comment Letter”), pertaining to the Company’s above-referenced Registration Statement on Form S-4 (the “Registration Statement”). In connection
with such responses, the Company is concurrently filing Amendment No. 1 to the Registration Statement (the “Amended Registration Statement”).

For your convenience, the Staff’s comments are summarized in this letter, and each comment is followed by the applicable responses on behalf of the
Company. Unless otherwise indicated, page references in the responses correspond to the page numbers in the Amended Registration Statement, and page references otherwise correspond to the page numbers in the Registration Statement. Capitalized terms
used in this letter but otherwise not defined herein shall have the meanings set forth in the Amended Registration Statement.

 Registration
Statement on Form S-4

 Cover Page

1.
 Please disclose the title and amount of securities being offered, as required by Item 501(b)(2) of
Regulation S-K, as referenced in Item 1 of Form S-4. Also, please clearly disclose the estimated Exchange Ratio as of a recent practicable date on the cover page and the
assumptions related to such estimate.

 Response: The Company respectfully acknowledges the Staff’s
comment and advises the Staff that it has revised the disclosure on the Cover Page of the Amended Registration Statement in response to the Staff’s comment.

 U.S. Securities and Exchange Commission

Division of Corporation Finance

 Office of Life Sciences

January 17, 2025

  Page
 2

 Questions and Answers about the Merger

Q: Why are the two companies proposing to merge?, page 2

2.
 We note your disclosure that the merger will result in a combined company with a robust pipeline focused on
developing Kalaris’ lead product candidate, TH103. Please clarify that the Kalaris pipeline consists of one product candidate for multiple indications only one of which is in Phase 1 clinical trials. Also clearly state whether the combined
company expects to pursue any of the AlloVir product candidates after the merger.

 Response: The Company
respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on page 2 of the Amended Registration Statement in response to the Staff’s comment.

Q: Who will be the executive officers of the combined company immediately following the merger?, page 6

3.
 We note it does not appear the combined company will have a Chief Financial Officer. Please revise page 6
and elsewhere as appropriate to disclose you currently do not plan to have a Chief Financial Officer, identify who will serve as the company’s Principal Financial Officer and Principal Accounting Officer and revise your Risk Factors as
appropriate or otherwise advise.

 Response: The Company respectfully acknowledges the Staff’s comment and
advises the Staff that it has revised the disclosures on pages 6, 20, 148, and 399 of the Amended Registration Statement in response to the Staff’s comment.

Prospectus Summary

 Kalaris Therapeutics,
Inc., page 13

4.
 Please revise to disclose the sources and data relied on for Kalaris’ $14 billion 2023 global
branded market estimation for the treatment of prevalent exudative and neovascular retinal diseases.

Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosures on
pages 13, 318, 319, 323 and 326 of the Amended Registration Statement in response to the Staff’s comment.

 U.S. Securities and Exchange Commission

Division of Corporation Finance

 Office of Life Sciences

January 17, 2025

  Page
 3

5.
 Please revise to identify “the
first-in-class U.S. Food and Drug Administration approved anti-VEGF agent launched in ophthalmology”.

Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosures on
pages 13 and 318 of the Amended Registration Statement in response to the Staff’s comment.

 The Merger

Background of the Merger, page 164

6.
 Please revise under this heading to disclose how the parties came to the agreement that “each
unexercised and outstanding AlloVir option with an exercise price per share equal to or greater than $4.00 (before giving effect to the reverse stock split) shall be cancelled for no consideration.” Include, without limitation, who proposed the
$4.00 amount, whether different dollar amounts were proposed and who proposed them.

 Response: The Company
respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosures on pages 179 and 180 of the Amended Registration Statement in response to the Staff’s comment.

AlloVir Reasons for the Merger, page 179

7.
 Please disclose whether AlloVir’s board considered the possibility that the parties may waive the
Nasdaq condition set forth in the merger agreement, resulting in the combined company’s stock to not be listed on a national exchange.

Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosure on
page 186 of the Amended Registration Statement in response to the Staff’s comment.

 Opinion of Leerink Partners LLC (AlloVir’s Financial
Advisor)

 Summary of Financial Analysis, page 187

8.
 We note on page 189 you state Leerink Partners used “levered and unlevered betas for certain companies
deemed by Leerink Partners to be comparable to Kalaris.” Please revise to identify the comparable companies, Leerink Partners’ methodology for selecting comparable companies, whether Leerink Partners omitted any companies that met the
selection criteria, and if so, disclose the identities of the omitted companies and the reasons for the omissions.

Response: We note the Staff’s comment. With respect to disclosure of information underlying the components of the discount rate
methodology used in a discounted cash flow analysis, we respectfully advise the Staff that the current disclosure regarding the discount rate utilized by Leerink Partners is (i) consistent with disclosures in other recent transaction involving
Leerink Partners (we refer you, for example, to the disclosures in Reneo Pharmaceuticals (filing dated August 26, 2024), Eliem Therapeutics, Inc. (filing dated June 4, 2024) and Graphite Bio, Inc. (filing dated February 13, 2024)),
(ii) consistent with, or more detailed than, the level of information in opinion disclosures of other financial advisors in more than 50 definitive proxy

 U.S. Securities and Exchange Commission

Division of Corporation Finance

 Office of Life Sciences

January 17, 2025

  Page
 4

statements and effective registration statements on Form S-4 filed since June 1, 2024 and (iii) inclusive of all material information relating to
Leerink Partners’ discounted cash flow methodology. We respectfully advise the Staff that, in our view, disclosure of the requested additional information underlying the discount rate methodology applied in Leerink Partners’ discounted
cash flow analysis is not material to investors.

 Certain Unaudited Prospective Financial Information, page 190

9.
 We note your disclosure on page 190 and elsewhere that your management team prepared Kalaris financial
forecasts through 2070. Please revise to disclose why the management team decided to generate financial forecasts through 2070 as opposed to a shorter timeframe and how management concluded generating financial forecasts.

Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the
disclosures on pages 192, 194 and 197 of the Amended Registration Statement in response to the Staff’s comment.

 AlloVir Liquidation Analysis,
page 194

10.
 We note your disclosure on page 194 that “stockholders are cautioned not to place undue reliance, if
any, on the AlloVir forecasts.” Please revise to remove “if any” as it appears investors may rely on these projections, among other reasons, as part of the basis relied upon by Leerink Partners to deliver its fairness opinion to your
board of directors.

 Response: The Company respectfully acknowledges the Staff’s comment and advises the
Staff that it has revised the disclosure on page 198 of the Amended Registration Statement in response to the Staff’s comment.

 Kalaris’
Business

 Overview, page 312

11.
 We note your disclosure that “[a]lthough newer anti-VEGF drugs and a higher-dose version of an existing
drug have been approved for treatment, registrational studies for these drugs were not designed to demonstrate a reduction in treatment burden compared to existing therapies, and there remains a significant unmet need for a longer acting anti-VEGF
agent.” In an appropriate location, please indicate whether Kalaris anticipates that its registrational study will be designed to demonstrate a reduction in treatment burden compared to existing therapies and indicate the anticipated interval
of treatment that Kalaris will study. In this regard, we note your disclosure in the table on page 320 that the FDA-approved dosing frequency for the reference biologic therapeutics currently used to treat
nAMD is up to every 8 to 16 weeks.

 Response: The Company respectfully acknowledges the Staff’s comment
and advises the Staff that it has revised the disclosure on page 321 of the Amended Registration Statement to remove the characterization of the design of the registrational studies for approved anti-VEGF compounds and has revised the disclosure on
page 333 of the Amended Registration Statement to describe its current plans with respect to the design of any registrational studies Kalaris may conduct for TH103.

 U.S. Securities and Exchange Commission

Division of Corporation Finance

 Office of Life Sciences

January 17, 2025

  Page
 5

12.
 Please revise where Kalaris discusses Dr. Ferrara’s development of TH103 to disclose the services
Dr. Ferrara currently provides to Kalaris as a consultant including the approximate amount of time Dr. Ferrara commits a week to developing TH103.

Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosures on
pages 318 and 413 of the Amended Registration Statement in response to the Staff’s comment.

 Kalaris’ Product Candidate, page 131

13.
 We note Kalaris’ disclosure on page 316 that it is “evaluating the potential development of TH103
to treat additional VEGF-mediated neovascular and/or exudative diseases of the retina including DME, DR, RVO and retinopathy of prematurity.” To the extent Kalaris is not currently developing TH103 for the indications listed in its pipeline
table, please revise to remove those rows from the pipeline table. To the extent Kalaris is developing TH103 in such indications, please revise where appropriate to disclose the work that has been done to date to submit INDs for each indication and
what remaining work Kalaris must complete to submit INDs. Revise the progress arrows so they do not enter the “Phase 1” column for the “DME/DR” and “RVO & other Retinal Diseases” indications. Revise to remove
“& other Retinal Diseases” and only disclose specific indications Kalaris is currently developing in the pipeline table.

Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the pipeline table on
page 319 of the Amended Registration Statement in response to the Staff’s comment. The Company also respectfully advises the Staff that all of Kalaris’ preclinical studies of TH103 in support of its IND for nAMD are supportive of
planned IND submissions for DME/DR and RVO. Kalaris’ preclinical studies of TH103 evaluated safety, tolerability, and toxicokinetics in multiple animal species and those studies were not indication-specific. Those data will be supportive of any
IND submission for an intraocular indication for TH103, and Kalaris expects to include those data in its planned IND submissions for DME/DR and RVO. In addition, the primary objective of Kalaris’ ongoing Phase 1 clinical trial of TH103 for nAMD
is to evaluate the safety, tolerability, dose range and pharmacokinetic of TH103. Such clinical data would also be included with, and supportive of, IND submissions for TH103 for any intraocular indication, including DME/DR and RVO. As a result,
subject to favorable data from its ongoing Phase 1 clinical trial of TH103 and IND submission and clearance for the applicable indication, Kalaris would expect to commence the clinical development of TH103 for DME/DR and RVO in a Phase 2 clinical
trial rather than an additional Phase 1 clinical trial. This clinical development plan is consistent with the clinical development that was undertaken by the sponsors of the leading anti-VEGF compounds that have been approved by the FDA, including
Lucentis (ranibizumab), Eylea/Eylea HD (aflibercept) and Vabysmo (faricimab), all of which initially conducted clinical development for nAMD and subsequently proceeded to Phase 2 clinical development for
follow-on intraocular indications. The Company advises the Staff that it has revised the disclosure on page 333 of the Amended Registration Statement to clarify Kalaris’ clinical development plans in this
regard.

 U.S. Securities and Exchange Commission

Division of Corporation Finance

 Office of Life Sciences

January 17, 2025

  Page
 6

 Clinical, page 315

14.
 Revise under this heading and elsewhere where you discuss your Phase 1 trial design to disclose the dosage
levels for each cohort and disclose the number of patients you have enrolled and intend to enroll.

 Response:
The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosures on pages 321 and 333 of the Amended Registration Statement in response to the Staff’s comment. Additionally, the Company
respectfully advises the Staff that Kalaris does not plan to provide updated enrollment numbers given the early stage of its ongoing Phase 1 clinical trial of TH103. Kalaris has disclosed when it expects to report initial clinical data from Part 1
of the Phase 1 clinical trial, at which time it also expects to disclose patient enrollment numbers as of the data cut-off date.

15.
 Please revise where Kalaris states it intends to initiate a Phase 2 clinical trial for nAMD in the first
half of 2026 to disclose the Phase 1 results may not support continuing development of TH103.

 Response: The
Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised the disclosures on pages 321, 322 and 333 of the Amended Registration Statement in response to the Staff’s comment.

Manufacturing, page 328

16.
 We note your disclosure that Kalaris relies on third-party contract manufacturers for the manufacture of its
product candidate for its ongoing and planned clinical trials, and, if Kalaris receives marketing approval, Kalaris intends to rely on such third parties for commercial manufacture. Please expand your disclosure to include the names of Kalaris’
principal suppliers.

 Response: The Company respectfully acknowledges the Staff’s comment and advises the
Staff that it has revised the disclosures on pages 334 and 335 of the Amended Registration S