<SEC-DOCUMENT>0000000000-20-005883.txt : 20200826
<SEC-HEADER>0000000000-20-005883.hdr.sgml : 20200826
<ACCEPTANCE-DATETIME>20200630180837
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000000000-20-005883
CONFORMED SUBMISSION TYPE:	UPLOAD
PUBLIC DOCUMENT COUNT:		2
FILED AS OF DATE:		20200630

FILED FOR:		

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Allovir, Inc.
		CENTRAL INDEX KEY:			0001754068
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				831971007
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		UPLOAD

	BUSINESS ADDRESS:	
		STREET 1:		139 MAIN STREET, SUITE 500
		CITY:			CAMBRIDGE
		STATE:			MA
		ZIP:			02142
		BUSINESS PHONE:		(617) 433-2605

	MAIL ADDRESS:	
		STREET 1:		139 MAIN STREET, SUITE 500
		CITY:			CAMBRIDGE
		STATE:			MA
		ZIP:			02142

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ViraCyte, Inc.
		DATE OF NAME CHANGE:	20180924
</SEC-HEADER>
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.pdf
<TEXT>
<PDF>
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<TEXT>
United States securities and exchange commission logo





                              June 30, 2020

       David Hallal
       Chief Executive Officer
       AlloVir, Inc.
       139 Main Street, Suite 500
       Cambridge, MA 02142

                                                        Re: AlloVir, Inc.
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted on June
3, 2020
                                                            CIK No. 0001754068

       Dear Mr. Hallal:

              We have reviewed your draft registration statement and have the
following comments. In
       some of our comments, we may ask you to provide us with information so
we may better
       understand your disclosure.

              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 our comments apply 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 these
comments and your
       amended draft registration statement or filed registration statement, we
may have additional
       comments.

       Draft Registration Statement on Form S-1

       Overview, page 1

   1.                                                   We note you plan to
initiate a total of six Phase 3 pivotal and Phase 2 proof-of-concept
                                                        trials. Please specify
the number of Phase 3 trials and the number of Phase 2 trials that you
                                                        plan to initiate.
   2.                                                   Please clarify in the
summary that the PRIME and RMAT designations may not lead to a
                                                        faster development
process or regulatory review and does not increase the likelihood that
                                                        a product candidate
will receive approval.
   3.                                                   Please remove all
statements throughout your prospectus that present your conclusions
                                                        regarding the safety or
efficacy of your product candidates as these determinations are
 David Hallal
AlloVir, Inc.
June 30, 2020
Page 2
         within the authority of the FDA and comparable regulatory bodies. We
note, for example,
         on pages 1, 84, 102, 109 and 113, your statements regarding having
seen "promising
         efficacy and safety data" in the patients you have treated, and your
heading "Safety
         Results" on page 118.
Our Strategy, page 4

4.       We note your disclosure that your allogeneic VST platform has been
clinically validated.
         Please provide the basis for this statement.
We are highly dependent on our key personnel and anticipate hiring new key
personnel, page 58

5.       Please expand the disclosure in this risk factor to disclose, if true,
that Messrs. Hallal
         and Sinha do not dedicate 100% of their time to your operations.
Use of Proceeds, page 75

6.       Please revise your disclosure in this section to indicate how far you
expect the proceeds
         from the offering will allow you to proceed in the separate clinical
trials for your VST
         product candidates. Please specify which candidates will be advanced
with the proceeds
         of the offering and which clinical trials will be funded. If the
anticipated proceeds from
         your offering will not be sufficient to complete those trials, please
disclose the amount and
         sources of other funds needed.
Management's Discussion and Analysis of Financial Conditions and Results of
Operations
Components of Results of Operations
Revenue, page 86

7.       Although we note you terminated the CPRIT grant, please clarify in an
appropriate
         location if this terminated CPRIT's right to receive a royalty in
perpetuity that is disclosed
         on page F-24.
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation Expense, page 97

8.     Once you have an estimated offering price or range, please explain to us
how you
       determined the fair value of the common stock underlying your equity
issuances and the
       reasons for any differences between the recent valuations of your common
stock leading
FirstName LastNameDavid Hallal
       up to the IPO and the estimated offering price. This information will
help facilitate our
Comapany   NameAlloVir,
       review              Inc. for equity issuances including stock
compensation and
               of your accounting
       beneficial
June 30, 2020 Pageconversion
                    2         features.
FirstName LastName
 David Hallal
FirstName  LastNameDavid Hallal
AlloVir, Inc.
Comapany
June       NameAlloVir, Inc.
     30, 2020
June 30,
Page 3 2020 Page 3
FirstName LastName
Limitations of Current Therapies for Immunocompromised Patients, page 108

9.       We note the disclosure in this section that you infused 118 patients
with third-party
         donor off-the-shelf VST therapies. We also note your disclosure that
you have treated
         over 275 HSCT patients with either single or multi-virus targeted
allogeneic VSTs.
         Please revise to explain the difference in the number of treated
patients.
Viralym-M Phase 2 Proof-of-concept CHARMS Clinical Results in Allo-HSCT
Patients, page
115

10.      Please revise to indicate whether this trial was powered to assess
statistical significance
         for the infections studied.
Clinical and Virologic Response, page 118

11.      We note the disclosure that 54 patients had either a partial or
complete response by 6
         weeks post infusion. Please specify the number of patients that had a
partial response and
         the number that had a complete response.
Safety Results, page 118

12.      We note the disclosure that none of the grade 5 SAEs were treatment
related. Please
         clarify whether any of the grade 4 SAEs or the de novo GVHDs were
deemed to be
         treatment related.
Respiratory Virus Infections in HSCT Patients, page 131

13.      Please clarify whether the IND that you plan to submit for ALVR106
will cover all
         respiratory viral disease or if it will be limited to certain
indications.
License Agreement, page 140

14.      Please quantify the non-refundable annual license maintenance fee
payable to the Baylor
         College of Medicine.
Redeemable Preferred Stock Redemption Agreement, page 181

15.      Please file this agreement as an exhibit and briefly disclose the
material "certain
         conditions" under which the earnout payments may be reduced. Please
also disclose the
         obligation to make these payments in your prospectus summary.
Policies for Approval of Related Party Transactions, page 183

16.      Please disclose the standards that will be applied in determining
whether to approve any
         of the transactions described in this section. Refer to Item
404(b)(1)(ii) of Regulation S-
         K.
 David Hallal
FirstName  LastNameDavid Hallal
AlloVir, Inc.
Comapany
June       NameAlloVir, Inc.
     30, 2020
June 30,
Page 4 2020 Page 4
FirstName LastName
Choice of Forum, page 190

17.      Please conform the language in this section to be consistent with the
language in the risk
         factor on page 69 regrading the applicability of the exclusive forum
provision to causes of
         action arising under the Securities Act or the Exchange Act and that
stockholders
         cannot waive compliance with the federal securities laws and the rules
and regulations
         thereunder.
Financial Statements
Consolidated Statements of Cash Flows, page F-7

18.      The Statement of Cash Flows shows a cash payment for "Redemption of
Redeemable
         Preferred Stock" for $10 million in 2018. Please tell us what other
account(s) was/were
         affected by this transaction. We do not see any a corresponding amount
on the
         Consolidated Statements of Members    Interest, Convertible Preferred
Stock and Changes
         in Members    and Stockholders    Deficit.
General

19.      Please supplementally provide us with copies of all written
communications, as defined in
         Rule 405 under the Securities Act, that you or anyone authorized to do
so on your behalf,
         present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
         not they retain copies of the communications.
        You may contact Christine Torney at (202) 551-3652 or Lisa Vanjoske at
(202) 551-
3614 if you have questions regarding comments on the financial statements and
related
matters. Please contact Chris Edwards at (202) 551-6761 or Tim Buchmiller at
(202) 551-
3635 with any other questions.



                                                               Sincerely,

                                                               Division of
Corporation Finance
                                                               Office of Life
Sciences
cc:      Danielle Lauzon, Esq.
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
