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United States securities and exchange commission logo
July 17, 2020
Nello Mainolfi, Ph.D.
President and Chief Executive Officer
Kymera Therapeutics, Inc.
300 Technology Square, 2nd Floor
Cambridge, MA 02139
Re: Kymera
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted June 22,
2020
CIK No. 0001815442
Dear Dr. Mainolfi:
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
Overview, page 1
1. Define or explain these
terms the first time you use them in the document:
"IL-1R/TLR" and
"JAK/STAT" (page 1);
"E3 ligase" (page
2);
"hidradenitis
suppurativa" (page 3);
"JAKs" (page 3);
PK/PD modeling
(page 4);
cereblon and von
Hippel-Lindau, or VHL (at pages 100, 103); and
TPD (page 105).
Nello Mainolfi, Ph.D.
FirstName LastNameNello
Kymera Therapeutics, Inc. Mainolfi, Ph.D.
Comapany
July NameKymera Therapeutics, Inc.
17, 2020
July 17,
Page 2 2020 Page 2
FirstName LastName
2. Your pipeline appears to include every in-house development program as
well as the
program you have licensed to Vertex. Please revise the table to
include only those
programs that are material to the company. If you believe that every
program listed is
material, please provide us an analysis explaining your belief. To the
extent the Pegasus
Platform remains in your table, revise the disclosure to correspond to
the appropriate
column of development.
3. Please revise your table to include columns showing the various
material phases of the
development of your potential products, including, as applicable,
discovery, preclinical,
development and the various phases of clinical development. Also
include an arrow
indicating the phase each of your product candidates is in for the
various stages of
development for each indicated disease area.
4. You mention in your summary and highlight in the pipeline table that
other potential
targets for your KT-474 product, which is the farthest product you
have in development,
are atopic dermatitis (AD) and rheumatoid arthritis (RA). You also
state, however, that
your product is not targeting these indications. As such, revise your
summary and
pipeline table to remove these references or provide your analysis of
why they are
material and appropriate for disclosure here.
Our IRAK4, IRAKIMiD, and STAT3 Programs, page 3
5. Please revise your statements on pages 3, 125 and elsewhere in the
prospectus that certain
of your product candidates are first-in-class. These statements
imply an expectation of
regulatory approval and are inappropriate given the length of time and
uncertainty with
respect to securing marketing approval.
6. For KT-474 and IRAKIMiD you state you will submit an IND and initiate
phase 1 trial in
first half of 2021, and for IRAKIMiD, you state you expect to do both
in the second half
of 2021. As you have more control over when you submit the IND, revise
to clarify when
you expect that to occur for each product.
Corporate Information, page 6
7. Please 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.
Risk Factors
Risks Related to Intellectual Property, page 43
8. We note the risk factor on page 46 related to objections to the name
Kymera and Kymera
Therapeutics. You disclose that "If we are unable to obtain a
registered trademark or
establish name recognition based on our trademarks and trade names, we
may not be able
to compete effectively and our business may be adversely affected." Is
it also true that
Nello Mainolfi, Ph.D.
Kymera Therapeutics, Inc.
July 17, 2020
Page 3
you could be forced to change your name and incur additional
significant related
expenses? Revise the risk factor to further disclose the potential
material risks.
9. On page 53, you disclose that "the Leahy-Smith Act has transformed the
U.S. patent
system into a first inventor to file system. The
first-inventor-to-file provisions, however,
only became effective on March 16, 2013. Accordingly, it is not yet
clear what, if any,
impact the Leahy-Smith Act will have on the operation of our
business." (Emphasis
Added). As your company was first incorporated in December 2015,
clarify why the Act's
application to you remains unclear.
Use of Proceeds, page 70
10. You state the proceeds will be used for the "advancement" of each of
your products.
Please expand your disclosure regarding the proceeds to be used for
your product
candidates to describe how far in the development process you estimate
the allocated
proceeds from this offering will enable you to reach.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Components of Our Results of Operations, page 83
11. It appears from page F-24 you have a collaboration agreement with an
entity other than
Vertex, or a prior, separate collaboration agreement with Vertex.
Revise to disclose that
collaboration or provide your analysis why disclosure is not required.
Critical Accounting Policies and Estimates
Determination of the Fair Value of Common Stock, page 94
12. 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
Overview, page 97
13. Here and on pages 103 and 104 you refer to "potent activity" of your
potential degraders,
your "highly efficient, selective and potent degraders" with
"appropriate pharmaceutical
FirstName LastNameNello Mainolfi, Ph.D.
properties" and "potent and specific degraders." Given the stage of your
product
Comapany NameKymera
development, Therapeutics,
it appears prematureInc.
to describe your product candidates
as potent, which
implies they
July 17, 2020 Page 3are effective. Please revise or advise why this disclosure
is appropriate.
FirstName LastName
Nello Mainolfi, Ph.D.
FirstName LastNameNello
Kymera Therapeutics, Inc. Mainolfi, Ph.D.
Comapany
July NameKymera Therapeutics, Inc.
17, 2020
July 17,
Page 4 2020 Page 4
FirstName LastName
Our Strategy, page 99
14. Given the current state of development of your product candidates, it
is unclear if you
have a basis for your statements that you have industry-leading
expertise" (at page 99
and 137) and "significant competitive advantages" and dominant
intellectual property
position (at page 137). Please clarify.
15. Revise Figures 8-10 and 18 to better explain what each depicts. For
Figures 8-9 in
particular, the point of the graphics are unclear beyond reinforcing
your product by
association.
16. On page 113, you defined hPMBC. Then, starting on page 117 and going
forward, you
identify the generic word blood as PMBC. Please clarify any
distinction.
17. We note the blog and press release on your website related to the
findings reported at the
American Association of Cancer Research virtual meeting held June 22,
2020, the date of
this registration statement. To the extent you have not done so,
revise the document to
include material information included on your website.
Collaborations, page 136
18. On your website you list several Academic Collaborators
including Yale, Columbia,
New York University and the Dana-Farber Cancer Institute, and
Partners, including
GlaxsoSmithKline, Vertex and the Leukemia & Lymphoma Society. Only the
Vertex
agreement is discussed here. Advise us of your collaborations or
partnerships with these
entities and provide your analysis regarding whether they are required
to be disclosed
here.
19. Revise to disclose your collaboration with Sanofi as discussed in your
July 9, 2020 press
release. Avoid use of the term first-in-class," used in the press
release, for the reasons
cited above.
Intellectual Property, page 138
20. Revise the paragraph addressing "Target-Specific Degrader Patent
Families" to disclose
the number of patents and their location. Revise this section to
clarify whether you own
or license the patents disclosed, clarify the types of patents you
have, and identify the
jurisdictions in which you have foreign patents. We note some of this
disclosure in the
risk factor on page 43.
Facilities, page 156
21. You disclose in the notes of the financial statements that you
terminated a lease effective
July 31, 2020. It appears that is the Cambridge lease, as the lease
you have included as an
exhibit extends until May 2023. You state you lease and expect to
occupy the property
in Watertown. Revise your disclosure in this section to clarify your
current and expected
facilities. Refer to Item 102 of Regulation S-K
Nello Mainolfi, Ph.D.
Kymera Therapeutics, Inc.
July 17, 2020
Page 5
Executive Compensation
Employment Agreements with our Named Executive Officers, page 169
22. File the employment agreements with each of the named executive
officers as required by
Item 601(b)(10) of Regulation S-K.
Certain Relationships and Related Party Transactions, page 182
23. File the Vertex Participation Agreement as an exhibit. Refer to Item
601(b)(10) of
Regulation S-K.
Description of Capital Stock
Choice of Forum, page 193
24. Here you state, that your "choice of forum provision does not apply to
any causes of
action arising under the Securities Act or the Exchange Act." in the
risk factor on page
62, however, you state, "The Delaware Forum Provision will not apply
to any causes of
action arising under the Securities Act or the Exchange Act," but then
state, "the United
States District Court for the District of Massachusetts shall be the
sole and exclusive
forum for resolving any complaint asserting a cause of action arising
under the Securities
Act," calling that the "Federal Forum Provision." We note that Section
22 of the
Securities Act creates concurrent jurisdiction for federal and state
courts over all suits
brought to enforce any duty or liability created by the Securities Act
or the rules and
Regulations thereunder, and Section 27 of the Exchange Act creates
exclusive federal
jurisdiction over all suits brought to enforce any duty or liability
created by the Exchange
Act or the rules and regulations thereunder. Clarify whether there are
forum restrictions
for Exchange Act claims.
You may contact Vanessa Robertson at (202) 551-3649 or Daniel Gordon at
(202) 551-
3486 if you have questions regarding comments on the financial statements and
related
matters. Please contact Abby Adams at (202) 551-6902 or Celeste Murphy at (202)
551-
3257 with any other questions.
FirstName LastNameNello Mainolfi, Ph.D. Sincerely,
Comapany NameKymera Therapeutics, Inc.
Division of
Corporation Finance
July 17, 2020 Page 5 Office of Life
Sciences
FirstName LastName