July 25, 2019
George Scangos, Ph.D.
President and Chief Executive Officer
Vir Biotechnology, Inc.
499 Illinois Street, Suite 500
San Francisco, California 94158
Re: Vir Biotechnology, Inc.
Draft Registration Statement on Form S-1
Submitted June 27, 2019
CIK No. 0001706431
Dear Dr. Scangos:
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 submitted June 27, 2019
Prospectus Summary
Our Development Pipeline, page 2
1. Please revise the pipeline chart to remove the dashed arrow indicating a
planned
combination trial expected to commence in Phase 2 in 2020 or to identify
the
immunomodulatory agent(s) that will be tested in combination with
VIR-2218. To the
extent you have not identified the immunomodulatory agent(s) or the
immunomodulatory
agent has not received regulatory approval, it is premature to include
this combination
therapy in your pipeline chart.
George Scangos, Ph.D.
FirstName LastNameGeorge Scangos, Ph.D.
Vir Biotechnology, Inc.
Comapany NameVir Biotechnology, Inc.
July 25, 2019
July 25, 2019 Page 2
Page 2
FirstName LastName
Implications of Being an Emerging Growth Company, page 5
2. 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.
Use of Proceeds, page 65
3. Please revise your disclosure to clarify whether you will be able to
complete the VIR-
2218 Phase 1/2 clinical trial with the net proceeds from the offering,
together with existing
cash, cash equivalents and short-term investments. If any material
amounts of other funds
are necessary, please disclose the amount of funds needed to complete
the Phase 1/2
clinical trial. Refer to Instruction 3 to Item 504 of Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations
Comparison of the Years Ended December 31, 2017 and 2018
Research and Development Expenses, page 85
4. Please revise to disclose your research and development expenses for
each period by
product candidate. If such costs are not tracked by product candidate,
please disclose that
fact.
Critical Accounting Polices and Estimates
Stock-Based Compensation, page 90
5. 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
up to the IPO and the estimated offering price. This information will
help facilitate our
review of your accounting for equity issuances including stock
compensation and
beneficial conversion features.
Business
Antibody Platform, page 98
6. We note your disclosure that anti-Ebola virus mAb114 was identified by
your scientists
using your technology in collaboration with the NIH and others and
that it is currently
being developed by Ridgeback Biotherapeutics LP and the NIH. Please
tell us how
Ridgeback Biotherapeutics LP and the NIH attained rights to develop
mAb114 and why
you are not involved in the development of the product candidate.
George Scangos, Ph.D.
FirstName LastNameGeorge Scangos, Ph.D.
Vir Biotechnology, Inc.
Comapany NameVir Biotechnology, Inc.
July 25, 2019
July 25, 2019 Page 3
Page 3
FirstName LastName
Development Programs, page 108
7. We note your disclosure on pages 119 and 120 that the manufacture and
development of
VIR-1111 for HIV and VIR-2020 for TB, respectively, are funded by the
Bill & Melinda
Gates Foundation. Noting your disclosure on page 129 that the grant
agreements for your
HIV and TB programs expire on June 30, 2020 and your disclosure on
page 65 that you
expect your current grants will fund the manufacture and "early
clinical development of
VIR-1111 and VIR-2020," please revise your disclosure to clarify
whether the Bill
& Melinda Gates Foundation grants will fund the development of
VIR-1111 and VIR-
2020 through regulatory approval.
Functional Cure for HBV, page 108
8. We note your disclosure on page 109 that initial data demonstrate an
approximately 30-
fold reduction in HBsAg at Week 12 in the three patients who have
received two 50 mg
doses of VIR-2218. We also note that according to your chart on page
111, the trial
design calls for four chronic HBV patients in the 50 mg x 2 cohort.
Given your statement
on page 112 that Part B chronic HBV patients in the 50 mg cohort have
completed dosing,
please revise your disclosure to clarify whether a fourth patient has
completed dosing, and
if so, describe the data collected to date. Furthermore, where you
discuss the results of this
trial in the Summary, please expand to also disclose the size of the
trial.
Vaccine for HIV Prophylaxis, page 117
9. We note that VIR-1111 is a proof of concept vaccine and that changes
to the vaccine
antigen from HIV will be required before subsequent phases of clinical
development.
Please expand your disclosure to discuss how changes to the vaccine
antigen may impact
the timing of regulatory approval of this product candidate.
Our Collaboration, License and Grant Agreements, page 120
10. Please revise your description of each applicable agreement in this
section to disclose
when the patents underlying the royalty terms are expected to expire
and to quantify the
"specified number of years" portion of the duration of royalty
obligations. Please note
that we consider the royalty term to be a material term of an
agreement that should be
disclosed in the registration statement. In addition, we note that
your disclosure currently
states that the upper range of some of the royalty obligations is in
the "low double-digits."
Please revise your disclosure to provide a range that does not exceed
ten percent (e.g.,
between twenty and thirty percent).
11. We note your disclosure regarding the Visterra Agreement on page F-27.
Please disclose
the material terms of this agreement, including the intellectual
property and technology
licensed, rights and obligations of the parties, milestone payment and
royalty
obligations and termination provision and file the agreement as an
exhibit to the
George Scangos, Ph.D.
Vir Biotechnology, Inc.
July 25, 2019
Page 4
registration statement. Alternatively, please tell us why you do not
believe this is
required. See Item 601(b)(10) of Regulation S-K.
Intellectual Property, page 133
12. For each patent that you own, license or intend to apply for, please
describe the type of
patent protection represented by the application, such as composition of
matter, use or
process. In addition, please expand your disclosure regarding the
patents you own relating
to VIR-2218 to include the type of patent protection you have,
expiration dates and
jurisdictions.
General
13. Please provide us proofs of all graphics, visual, or photographic
information you
will provide in the printed prospectus prior to its use, for example in
a preliminary
prospectus. Please note that we may have comments regarding this
material.
You may contact Ibolya Ignat at 202-551-3636 or Angela Connell at
202-551-3426 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with
any other
questions.
Sincerely,
FirstName LastNameGeorge Scangos, Ph.D.
Division of
Corporation Finance
Comapany NameVir Biotechnology, Inc.
Office of
Healthcare & Insurance
July 25, 2019 Page 4
cc: Laura Berezin - Cooley LLP
FirstName LastName