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United States securities and exchange commission logo
March 4, 2021
Brian McKelligon
President and Chief Executive Officer
Akoya Biosciences, Inc.
100 Campus Drive, 6th Floor
Marlborough, MA 01752
Re: Akoya Biosciences,
Inc.
Draft Registration
Statement on Form S-1
Submitted February
5, 2021
CIK No. 0001711933
Dear Mr. McKelligon:
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 February 5, 2021
Prospectus Summary
Overview, page 1
1. Please place the
disclosure of your CODEX and Phenoptics platforms in the appropriate
context by including
disclosure relating to your dependence on patents, know-how and
proprietary technology
licensed from Stanford.
2. Please revise the
graphic on pages 2 and 81 to indicate that the CODEX system is only for
discovery research,
whereas the Phenoptics system is only for translational and clinical
research. Currently,
the image suggests that translational research, which sits in between
Brian McKelligon
Akoya Biosciences, Inc.
March 4, 2021
Page 2
the two devices, can be conducted on either device. Alternatively, if
translational research
can be conducted on both devices, revise your narrative descriptions.
Our Competitive Strengths, page 2
3. The disclosure in the summary should be a balanced presentation of
your business. Please
balance the description of your competitive strengths with equally
prominent disclosure of
the challenges you face and the risks and limitations that could harm
your business or
inhibit your strategic plans. For example, but without limitation,
balance your discussion
of your competitive strengths with a discussion of your history of
losses since inception
and your expectation to incur losses in the future.
Industry and Market Opportunity, page 3
4. We note that you provide the overall market size for spatial biology.
Please disclose the
portion of this market that is addressable by the potential
applications of your products.
Please also clarify whether you will need FDA approval for any other
these potential
applications.
5. Please revise to disclose clearly and prominently that your products
are currently labeled
for research use only. Also revise to disclose how this designation
impacts your
addressable market.
6. The title of the pie chart on page 4 appears to be inconsistent with
the narrative
description on the prior page, which states that spatial biology is
composed of "markets
such as genomics, proteomics, cell biology, lab supplies and
analytical technologies."
Please reconcile and revise your discussion as appropriate.
Risk Factors
Risks Related to Our Business and Strategy, page 25
7. We note your disclosure that in December 2019 you experienced a
ransomware incident
which resulted in the encryption of certain of your files. Please
revise to disclose
the magnitude of the ransomware incident, including a description of
the costs and other
consequences. In your revised disclosure, please include any steps
taken to remediate the
incident or mitigate harm. Please refer to CF Disclosure Guidance:
Topic No. 2.
Use of Proceeds, page 57
FirstName LastNameBrian McKelligon
8. Please revise to clarify whether any material part of the proceeds is to
be used to discharge
Comapany NameAkoya
indebtedness. Biosciences,
If so, Inc. the disclosure required by
Instruction 4 to Item 504 of
please provide
March Regulation
4, 2021 PageS-K.
2
FirstName LastName
Brian McKelligon
FirstName LastNameBrian McKelligon
Akoya Biosciences, Inc.
Comapany
March NameAkoya Biosciences, Inc.
4, 2021
March3 4, 2021 Page 3
Page
FirstName LastName
Management s Discussion and Analysis of Financial Condition and Results of
Operations
Operating Expenses, page 70
9. Please provide a brief description of the material terms of your
Transition Services
Agreement and License Agreement with PKI and file the agreements as
exhibits to the
registration statement or tell us why it is not material. Refer to
Item 601(b)(10) of
Regulation S-K.
Business
Our Competitive Strengths, page 82
10. Please revise the graphic on page 82 to ensure that all images and
text are legible.
Intellectual Property, page 95
11. Please revise your intellectual property disclosure to clearly
describe on an individual
basis the type of patent protection granted for each product, the
expiration of
each patent held, and the jurisdiction of each patent.
Licenses, page 96
12. Please provide the current expiration date for the last-to-expire
licensed patent right under
the Stanford University and the PerkinElmer Heath Sciences, Inc.,
Cambridge Research
& Instrumentation, Inc., and VisEn Medical Inc. agreements.
13. Please file your exclusive patent license agreement with the
University of Washington as
an exhibit to the registration statement or explain why you believe
you are not required to
do so. Refer to Item 601(b)(10) of Regulation S-K.
General
14. 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.
Brian McKelligon
FirstName LastNameBrian McKelligon
Akoya Biosciences, Inc.
Comapany
March NameAkoya Biosciences, Inc.
4, 2021
March4 4, 2021 Page 4
Page
FirstName LastName
You may contact Kristin Lochhead at 202-551-3664 or Angela Connell at
202-551-3426
if you have questions regarding comments on the financial statements and
related
matters. Please contact Dillon Hagius at 202-551-7976 or Jeffrey Gabor at
202-551-2544 with
any other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Patrick J. O'Malley, Esq.