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United States securities and exchange commission logo
April 15, 2021
David Southwell
Chief Executive Officer
TScan Therapeutics, Inc.
830 Winter Street
Waltham, MA 02451
Re: TScan Therapeutics,
Inc.
Draft Registration
Statement on Form S-1
Submitted March 19,
2021
CIK No. 0001783328
Dear Mr. Southwell:
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 March 19, 2021
Overview, page 1
1. Please revise the
"Overview" section on page 1 of the Summary to highlight that your
operations are
preclinical in nature.
2. We note your disclosure
in the Summary of your early-stage collaboration with Poseida
Therapeutics, Inc. on
pages 2 and 7, as well as in the MD&A and Business
sections. However, you
also disclose on page F-22 that you have received a nominal fee
from Poseida and do not
expect future revenues to be significant since you do not have
any remaining
performance obligations under this arrangement. Please tell us why this
disclosure is relevant
for discussion under the "Our Pipeline" heading and revise your
prospectus summary to
provide more balanced disclosure by providing a brief description
David Southwell
TScan Therapeutics, Inc.
April 15, 2021
Page 2
of the material terms of your collaboration agreement with Poseida or
by providing
revised disclosure as appropriate. Please also revise your related
disclosure throughout the
filing as appropriate.
Our Approach, page 2
3. We refer to your disclosure on pages 4 and 114 that you believe your
platform analyzing
anti-cancer T cells from a wide variety of patients will allow you to
develop highly
effective TCR-T therapies. Determinations of safety and efficacy
are within the sole
authority of the FDA. Given the preclinical stage of your product
candidates, it is
premature for you to suggest that your platform and product candidates
will be determined
to be effective. Please revise your disclosure accordingly.
Our Pipeline, page 2
4. We note that you have combined the column for both Phase 2 and 3
trials in your pipeline
table. Please revise to include a separate column for Phase 3 trial.
In addition, we note the
inclusion of your TSC-102 program in the third row of your pipeline
table. Given the
status of development and limited disclosure on page 135 regarding
this program, it seems
premature to highlight this program prominently in your Summary
pipeline table.
Please remove this program from the Summary table or advise.
5. We refer to the seventh row in your pipeline table under the heading
"Partnered Program"
with Novartis. We note that while you have recognized revenue from
your collaboration
with Novartis and expect significantly more revenue this year, your
Business section
disclosure does not specify the sources of revenue recognized or
whether any targets have
been identified in performance of the Novartis Agreement. You also do
not identify a
specific target or have milestones related to future work in the
pipeline table.
Please expand your disclosure and revise the pipeline table
accordingly or remove this
program from the Summary table. We also refer to the fifth and sixth
rows of your
pipeline table under the headings "TSC-201" and "TSC-202" and note
that you do not
appear to have identified specific targets. It does not appear
appropriate to highlight these
programs in your Summary table without disclosing specified targets.
Please revise
accordingly or advise.
Our History and Team, page 7
6. Please disclose whether Drs. Stephen Elledge and Tomasz Kula remain
involved with the
company and, if so, in what capacity. In this regard, we note that your
website indicates
that you have a scientific advisory board. If material, please include
disclosure in an
FirstName LastNameDavid Southwell
appropriate location that describes the role or function of your
scientific advisory board,
Comapany NameTScan
and whether thereTherapeutics,
are any rules Inc.
of procedures governing this board.
Please also disclose
how members
April 15, 2021 Page 2 of any such board are compensated.
FirstName LastName
David Southwell
FirstName LastNameDavid Southwell
TScan Therapeutics, Inc.
Comapany
April NameTScan Therapeutics, Inc.
15, 2021
April 315, 2021 Page 3
Page
FirstName LastName
Use of Proceeds, page 92
7. To the extent known, please revise to identify the specific product
candidates for which
you intend to use the proceeds of the offering. Please also disclose
the approximate
amount of proceeds you intend to allocate toward each of the programs
identified in the
Summary pipeline table and how far the proceeds from the offering will
allow you to
proceed with the continued development of each of your programs. 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, page 104
8. Given the importance of your research and development expenses to your
operations,
please revise to include disaggregated disclosures by product
candidate or indication
and/or by nature of expenses incurred for each period. If you do not
track expenses
separately by product candidate or indication, please disclose this
fact.
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation, page 110
9. 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. Please discuss with the staff how to
submit your response.
Business, page 113
10. We note your discussion in the first bullet point on page 20 of the
potential side effect
profile of your product candidates, such as the potential adverse side
effects related to
cytokine release syndrome (CRS), neurotoxicity or rheumatologic
disorders. If material,
please revise your disclosure in this section to address these
potential side effects and
disclose whether you are observing any indications of these effects in
your preclinical
studies to date and how the development of your potential products
addresses these
potential effects.
Novel Targets Identified from Patients with Head & Neck Cancer, page 139
11. We note your disclosure that you are collaborating with investigators
at the Dana-Farber
Cancer Institute in Boston to identify anti-cancer TCRs, and
specifically T cells in tumors
of patients undergoing checkpoint inhibitor therapy. Please advise if
there a collaboration
agreement in place with the Dana-Farber Cancer Institute, and if so,
please provide a brief
description of the material terms of the arrangement and file the
agreement as an exhibit to
the registration statement or explain to us why you believe you are
not required to do
David Southwell
FirstName LastNameDavid Southwell
TScan Therapeutics, Inc.
Comapany
April NameTScan Therapeutics, Inc.
15, 2021
April 415, 2021 Page 4
Page
FirstName LastName
so. Refer to Item 601(b)(10) of Regulation S-K.
License and Collaboration Agreements, page 146
12. We note your disclosure that you have exclusively licensed certain
patent applications
from The Brigham and Women's Hospital, Inc., which is described on
page F-23 as
licensing foundational technology, and is disclosed as subject to
further negotiation and
amendment. Please provide a brief description of the material terms of
this agreement, as
such agreement may be amended, and file the agreement as an exhibit to
the registration
statement as required by Item 601(b)(10) of Regulation S-K or tell us
why it is not
material.
Collaboration and License Agreement with Novartis, page 146
13. Please clarify if you or Novartis are responsible for the clinical
development of any
Optioned Program under the collaboration agreement. If Novartis would
be responsible
for clinical development of an Optioned Program, please advise us if
the inclusion of this
partnered program in your pipeline table is the clearest way to
present this program to
investors or revise your disclosure as appropriate.
14. We note your disclosure that you have partly funded your operations
with revenue
received under your collaboration with Novartis on page 99. You also
disclose on page
104 that the $1.1 million in revenue recognized for the year ended
December 31, 2020
was primarily associated with the Novartis Agreement and that you
expect the revenue
generated under this agreement to increase significantly in 2021.
Please disclose in the
Business section the aggregate amounts received to date under the
Novartis Agreement. In
your revised disclosure, please also indicate the specific source for
any revenue received
under the Novartis Agreement. For example, we note that Novartis has
agreed to pay an
upfront fee, reimburse you for research costs, pay fees to exercise
options for up to three
target antigens, royalties, along with milestone payments.
15. We note your disclosure on page 147 of tiered royalties ranging from
mid-single to low-
double digit percentages. Please revise your disclosure to give
investors a reasonable idea
of the amount of the royalty rates that does not exceed ten percentage
points.
Option and Exclusive License Agreement with Qiagen, page 148
16. We note your disclosure on page 99 that you have partly funded your
operations with
revenue received under your licensing agreement with QIAGEN Sciences,
LLC. Please disclose in the Business section the aggregate amounts
received to date under
the Qiagen Agreement. You also disclose that Qiagen is required to pay
a low six-figure
milestone payment upon launch of the first diagnostic product. In your
revised disclosure,
please disclose the aggregate future potential milestone payments to
be received under this
agreement. Please also revise your disclosure to include the term of
the royalties under the
Qiagen Agreement.
David Southwell
TScan Therapeutics, Inc.
April 15, 2021
Page 5
Manufacturing, page 149
17. We note your disclosure on page 150 that the transposon will be
delivered as a
Nanoplasmid, which was developed by Nature Technology. Please disclose
if you have
entered into any agreement with Nature Technology with respect to the
use of their
Nanoplasmid technology. We also note that the transposon and
transposae will be
manufactured by Aldevron. Please expand your disclosure on the
materiality of your
arrangement with Aldevron. If material, please file any agreements as
exhibits to the
registration statement or provide analysis as to why it would not be
required under Item
601(b)(10) of Regulation S-K.
Intellectual Property, page 151
18. We note your disclosure that you own thirteen U.S. provisional patent
applications that are
expected to convert to utility patent applications. Please amend your
disclosure to clarify
that these patent applications related to certain SARS-CoV-2 peptides
are covered under
your Option and Exclusive License Agreement with Qiagen in your
disclosure on page
148. Please also your expand your disclosure to include the date that
each of these patent
applications were submitted and their expected expiration date. While
you disclose that
six of the thirteen patent applications are for compositions of
matter, please also specify
the types of patent protection for the remaining seven patent
applications.
19. You disclose that you have exclusively licensed one pending U.S.
patent application and
five pending foreign patent applications from The Brigham and Women's
Hospital,
Inc. Please also clearly describe on an individual basis the
expiration, the jurisdiction
(where applicable) and the type of patent protection granted for each
pending patent
application that you exclusively license with The Brigham and Women's
Hospital, Inc.
We note that you also referenced seven pending patent applications
under this license
agreement on page 69, but have disclosed six pending patent
applications elsewhere in the
filing. Please confirm and revise accordingly.
20. You also disclose that your non-exclusive patent license from
Provincial Health Services
Authority of British Columbia to a patent family consists of one
issued U.S. patent, one
pending U.S. patent application and one pending foreign patent
application. For the issued
U.S. patent, please amend this disclosure to include the type of
patent protection granted
and its expiration date. For each of the pending patent applications,
please amend this
disclosure to include the date that these patent applications were
submitted, the
jurisdiction of the foreign patent application and the expected
expiration date.
Principal
FirstNameStockholders,
LastNameDavidpage Southwell
191
Comapany
21. NameTScan
Please Therapeutics,
revise the footnotes Inc.table to identify the natural
persons who are
to your
the2021
April 15, beneficial
Page 5owners of the shares held by JMD III Holdings Limited.
FirstName LastName
David Southwell
FirstName LastNameDavid Southwell
TScan Therapeutics, Inc.
Comapany
April NameTScan Therapeutics, Inc.
15, 2021
April 615, 2021 Page 6
Page
FirstName LastName
General
22. Please provide us with supplemental 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,
have presented or expect to present to potential investors in reliance
on Section 5(d) of the
Securities Act, whether or not you retained, or intend to retain,
copies of those
communications.
You may contact Tara Harkins at 202-551-3639 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jane Park at 202-551-7439 or Tim Buchmiller at 202-551-3635 with any
other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Timothy H. Ehrlich, Esq.