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SEC Comment Letter 0000000000-25-000096 to Kalaris Therapeutics, Inc. (KLRS)

Kalaris Therapeutics, Inc.
Date: Jan. 6, 2025 · CIK: 0001754068 · Accession: 0000000000-25-000096

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File numbers found in text: 333-283678

Date
January 6, 2025
Author
Not clearly detected
Form
UPLOAD
Company
Kalaris Therapeutics, Inc.

Letter

January 6, 2025 Diana Brainard, M.D. Chief Executive Officer AlloVir, Inc. PO Box 44, 1661 Massachusetts Avenue Lexington, MA 02420 Re:AlloVir, Inc. Registration Statement on Form S-4 Filed December 9, 2024 File No. 333-283678 Dear Diana Brainard M.D.: We have reviewed your registration statement and have the following comments. 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. 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. Question and Answers about the Merger Q: Why are the two companies proposing to merge?, page 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 2.

January 6, 2025 Page 2 the merger. 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. 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. 5.Please revise to identify "the first-in-class U.S. Food and Drug Administration- approved anti-VEGF agent launched in ophthalmology." 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. 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. Opinion of Leerink Partners LLC (AlloVir's Financial Advisor) Summary of Financial Analyses, 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. Certain Unaudited Prospective Financial Information, page 190 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 9.

January 6, 2025 Page 3 through 2070 was reasonable. 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. 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. 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. Kalaris' Product Candidate, page 313 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. 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.

January 6, 2025 Page 4 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. 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. Intellectual Property, page 330 17.Please revise to disclose the type of patent protection covered for Kalaris' third patent family and to disclose if the third patent family is owned or in-licensed. Also revise to disclose all material foreign countries where Kalaris has issued and pending patents for each patent family. License Agreement with The Regents of the University of California, page 332 18.Please revise to disclose the total aggregate milestone payments made to date, if any, pursuant to the UCSD license agreement. AlloVir Management's discussion and analysis of financial condition and results of operation Results of Operations Comparison of the three months ended September 30, 2024 and 2023 Research and Development Expenses, page 363 19.Please expand your disclosure to quantify and more fully discuss the items reported within the $(0.2) million research and development costs. If the only item reported in this amount is the final settlement with AlloVir’s CRO, please clarify. Please tell us and disclose the terms of the settlement with AlloVir's CRO, if material, or direct us to existing disclosures. Explain to us why it was considered appropriate to report the settlement within research and development expense. Comparison of the nine months ended September 30, 2024 and 2023, page 364 20.Please tell us why it is appropriate to report the $5.6 million gain on lease termination and remeasurement during the nine months ended September 30, 2024 as an offset of your research and development expenses. Revise your critical accounting estimates disclosure in MD&A on page 370 and in Note 2, Summary of Significant Accounting Policies, to disclose your accounting policy for negative (offsetting) amounts reported within research and development costs. Reference the authoritative literature you relied upon to support your accounting and presentation. Unaudited Pro Forma Condensed Combined Financial Data, page 409 Please provide us an analysis concerning whether AlloVir will become a shell company as defined in Rule 12b-2 of the Exchange Act prior to the closing of the Merger. We note disclosure that AlloVir has stopped clinical development of ALVR106 and ALVR107 pending the outcome of AlloVir’s review of strategic 21.

January 6, 2025 Page 5 alternatives; please explain the plans for these and any other remaining development programs. Revise your disclosures as necessary to support the reverse recapitalization accounting planned for the Merger. 22.Please explain to us why the unaudited pro forma combined financial information does not give effect to the proposed reverse stock split that is expected to be approved during the special meeting of AlloVir stockholders planned for January 9, 2025. Refer to Rule 11-02(a)(10) of Regulation S-X. We note that effecting the reverse stock split is a condition for the consummation of the merger. Notes to Unaudited Pro Forma Combined Financial Statements 4. Proforma Adjustments, Adjustment F, page 419 23.Please revise to include a pro forma earnings per share calculation. It appears that the calculation should include additional scenarios to present the effect of AlloVir's planned reverse stock split. Kalaris Therapeutics, Inc. Condensed Financial Statements for the 9 months ended on September 30, 2024 (unaudited) Notes to the Unaudited Condensed Financial Statements 5. Significant Agreements Royalty Agreement with Samsara – Related Party, page F-93 24.Your disclosure on page F-89 indicates that you evaluated the criteria in ASC 730- 20 to account for your royalty agreement with Samsara. In Note 5 you disclose that you recorded the fair value of the long-term liability related to the obligation to make royalty payments to Samsara, $32.1 million, and recorded $32.0 million as a research and development expense. Please summarize for us the significant terms of your royalty agreement, highlighting the items that you analyzed in order to determine the accounting for the elements of agreement. In your response, please cite the specific paragraphs within ASC 730-20 you utilized that support your accounting treatment. Address ASC 730-20-05-6 and 05-9 and/or any other paragraph as necessary in your response. Exhibits 25.Please revise to add the Oxtoby Offer Letter and Nau Offer Letter as exhibits or otherwise advise. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. 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

January 6, 2025 Page 6 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.

Show Raw Text
January 6, 2025
Diana Brainard, M.D.
Chief Executive Officer
AlloVir, Inc.
PO Box 44, 1661 Massachusetts Avenue
Lexington, MA 02420
Re:AlloVir, Inc.
Registration Statement on Form S-4
Filed December 9, 2024
File No. 333-283678
Dear Diana Brainard M.D.:
            We have reviewed your registration statement and have the following comments.
            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.
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.
Question and Answers about the Merger
Q: Why are the two companies proposing to merge?, page 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 2.

January 6, 2025
Page 2
the merger.
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.
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.
5.Please revise to identify "the first-in-class U.S. Food and Drug Administration-
approved anti-VEGF agent launched in ophthalmology."
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.
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.
Opinion of Leerink Partners LLC (AlloVir's Financial Advisor)
Summary of Financial Analyses, 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.
Certain Unaudited Prospective Financial Information, page 190
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 9.

January 6, 2025
Page 3
through 2070 was reasonable.
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.
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.
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.
Kalaris' Product Candidate, page 313
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.
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.

January 6, 2025
Page 4
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.
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.
Intellectual Property, page 330
17.Please revise to disclose the type of patent protection covered for Kalaris' third patent
family and to disclose if the third patent family is owned or in-licensed. Also revise to
disclose all material foreign countries where Kalaris has issued and pending patents
for each patent family.
License Agreement with The Regents of the University of California, page 332
18.Please revise to disclose the total aggregate milestone payments made to date, if any,
pursuant to the UCSD license agreement.
AlloVir Management's discussion and analysis of financial condition and results of operation
Results of Operations
Comparison of the three months ended September 30, 2024 and 2023
Research and Development Expenses, page 363
19.Please expand your disclosure to quantify and more fully discuss the items reported
within the $(0.2) million research and development costs. If the only item reported in
this amount is the final settlement with AlloVir’s CRO, please clarify. Please tell us
and disclose the terms of the settlement with AlloVir's CRO, if material, or direct us
to existing disclosures. Explain to us why it was considered appropriate to report the
settlement within research and development expense.
Comparison of the nine months ended September 30, 2024 and 2023, page 364
20.Please tell us why it is appropriate to report the $5.6 million gain on lease termination
and remeasurement during the nine months ended September 30, 2024 as an offset of
your research and development expenses. Revise your critical accounting estimates
disclosure in MD&A on page 370 and in Note 2, Summary of Significant Accounting
Policies, to disclose your accounting policy for negative (offsetting) amounts reported
within research and development costs. Reference the authoritative literature you
relied upon to support your accounting and presentation.
Unaudited Pro Forma Condensed Combined Financial Data, page 409
Please provide us an analysis concerning whether AlloVir will become a shell
company as defined in Rule 12b-2 of the Exchange Act prior to the closing of the
Merger. We note disclosure that AlloVir has stopped clinical development of
ALVR106 and ALVR107 pending the outcome of AlloVir’s review of strategic 21.

January 6, 2025
Page 5
alternatives; please explain the plans for these and any other remaining development
programs. Revise your disclosures as necessary to support the reverse recapitalization
accounting planned for the Merger.
22.Please explain to us why the unaudited pro forma combined financial information
does not give effect to the proposed reverse stock split that is expected to be approved
during the special meeting of AlloVir stockholders planned for January 9, 2025. Refer
to Rule 11-02(a)(10) of Regulation S-X. We note that effecting the reverse stock
split is a condition for the consummation of the merger.
Notes to Unaudited Pro Forma Combined Financial Statements
4. Proforma Adjustments, Adjustment F, page 419
23.Please revise to include a pro forma earnings per share calculation. It appears that the
calculation should include additional scenarios to present the effect of AlloVir's
planned reverse stock split.
Kalaris Therapeutics, Inc.
Condensed Financial Statements for the 9 months ended on September 30, 2024 (unaudited)
Notes to the Unaudited Condensed Financial Statements
5. Significant Agreements
Royalty Agreement with Samsara – Related Party, page F-93
24.Your disclosure on page F-89 indicates that you evaluated the criteria in ASC 730-
20 to account for your royalty agreement with Samsara. In Note 5 you disclose that
you recorded the fair value of the long-term liability related to the obligation to make
royalty payments to Samsara, $32.1 million, and recorded $32.0 million as a research
and development expense. Please summarize for us the significant terms of your
royalty agreement, highlighting the items that you analyzed in order to determine
the accounting for the elements of agreement. In your response, please cite the
specific paragraphs within ASC 730-20 you utilized that support your accounting
treatment. Address ASC 730-20-05-6 and 05-9 and/or any other paragraph as
necessary in your response.
Exhibits
25.Please revise to add the Oxtoby Offer Letter and Nau Offer Letter as exhibits or
otherwise advise.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence
of action by the staff.
            Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
            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

January 6, 2025
Page 6
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.