View:
United States securities and exchange commission logo
September 10, 2021
Elisabet de los Pinos, Ph.D.
Chief Executive Officer
Aura Biosciences, Inc.
85 Bolton Street
Cambridge, MA 02140
Re: Aura Biosciences,
Inc.
Draft Registration
Statement on Form S-1
Submitted August
10, 2021
CIK No. 0001501796
Dear Dr. de los Pinos:
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
Prospectus Summary
Our Pipeline, page 2
1. Please revise your
pipeline table to reflect that you are currently in phase 2 of clinical
trials for AU-011 for
the treatment of primary choroidal melanoma. In this regard, we
note your disclosure on
pages 117 and 118 that you "are currently conducting a Phase 2
dose escalation trial
of AU-011 with SC administration in 18 patients with choroidal
melanoma" and that your
"first pivotal trial will be the Phase 2b portion of the ongoing SC
administration trial."
We note that a textual discussion of the program is likely a more
appropriate place to
make distinctions regarding different segments within a particular
phase.
Elisabet de los Pinos, Ph.D.
FirstName LastNameElisabet de los Pinos, Ph.D.
Aura Biosciences, Inc.
Comapany 10,
September NameAura
2021 Biosciences, Inc.
September
Page 2 10, 2021 Page 2
FirstName LastName
Our Team and Investors, page 3
2. We note that you identify three entities - Rock Springs Capital, Adage
Capital
Management LP, and Lundbeckfonden Ventures - as investors in your
company; however,
some do not appear to be among your principal stockholders as
disclosed on page 182.
Please remove this disclosure or explain to us why highlighting this
information in the
Summary is appropriate. Explain in your response how you will update
investors about
any changes these entities make with respect to their holdings.
Summary Financial Data, page 10
3. Please expand your disclosures for the second bullet of footnote (2)
to provide the
computation of pro forma net loss per share and pro forma weighted
average shares of
common stock for the year ended December 31, 2020 in addition to the
quarter ended
March 31, 2021.
4. Please disclose the per share price of the 50,000 shares of common
stock sold including
the date of the transaction. Disclose whether this transaction was
with a related party.
Address this comment where this transaction has been disclosed.
Use of Proceeds, page 73
5. We note your disclosure that you intend to use the proceeds from the
offering to advance
your initial product candidate (AU-011) through clinical development
and to develop your
platform. Please quantify the amount of proceeds you intend to use for
each designated
use and more specifically explain what each entails. To the extent
that you plan to use a
material portion of the proceeds to fund the development of AU-011,
please specify how
far in the clinical development for each indication you plan to reach
with the proceeds
from this offering.
Business, page 97
6. Please revise, where appropriate in the Business section, to discuss
the laser component.
For instance, discuss the laser's state of development, its key and/or
novel features, your
supply arrangements and whether you hold licenses and/or patents that
cover the laser
technology.
7. With a view to disclosure, please tell us whether your combination
products, which may
include use of a microinjector and a laser, will require you to
provide doctors with
specialized training. If so, please discuss how this impacts future
sales and marketing
efforts, and associated costs to generate commercial sales.
Pivotal trial plan in choroidal melanoma, page 118
8. We note your disclosure that you plan on conducting two pivotal trials
with AU-011.
While you disclose that the "first pivotal trial will be the Phase 2b
portion of the ongoing
SC administration trial," the second pivotal trial is not clear.
Please confirm that the
Elisabet de los Pinos, Ph.D.
Aura Biosciences, Inc.
September 10, 2021
Page 3
"registry trial" mentioned on page 119 is this second pivotal trial.
If so, please clarify that
this registry trial is the Phase 3 trial.
Our License Agreements, page 132
9. Please disclose the expiry of the last-to-expire patent licensed under
the NIH Patent
License Agreement, the LI-COR Exclusive License Agreement, and the
Clearside License
Agreement.
Executive Compensation, page 166
10. With reference to the disclosure on page 169, please file each
employment agreement with
a named executive officers or tell us why you are filing a form of
agreement.
Principal Stockholders, page 182
11. With reference to Item 403 of Regulation S-K, please identify the
natural person or
persons who directly or indirectly exercise sole or shared voting
and/or dispositive power
with respect to the common stock held by the following beneficial
owners:
Lunbeckfonden Invest A/S;
Arix Bioscience Holdings Limited;
Chiesi Ventures, LP;
Columbus Innvierte, F.C.R;
Ysios Biofund II Innvierte, F.C.R.
16. Subsequent Events, page F-26
12. We note your statement that subsequent events was evaluated through
May 5, 2021, which
you state is when the financial statements were available to be
issued. Please address this
inconsistency with the audit report date of August 9, 2021. Also
ensure that all material
subsequent events have been disclosed. In this regard, we note that
over 20 million of
stock options were granted prior to August 9, 2021 without disclosure
of the material
terms and corresponding compensation expense to be recognized over the
vesting period.
General
13. Please supplementally provide us with copies of all written
communications, as defined in
FirstName LastNameElisabet de los Pinos, Ph.D.
Rule 405 under the Securities Act, that you, or anyone authorized to do
so on your behalf,
Comapany NameAura
present Biosciences,
to potential investors Inc.
in reliance on Section 5(d) of the
Securities Act, whether or
not they
September retainPage
10, 2021 copies
3 of the communications.
FirstName LastName
Elisabet de los Pinos, Ph.D.
FirstName LastNameElisabet de los Pinos, Ph.D.
Aura Biosciences, Inc.
Comapany 10,
September NameAura
2021 Biosciences, Inc.
September
Page 4 10, 2021 Page 4
FirstName LastName
You may contact Tracey Houser at 202-551-3736 or Jeanne Baker at
202-551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Dillon Hagius at 202-551-7967 or Joe McCann at 202-551-6262 with any
other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Danielle M. Lauzon