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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.