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United States securities and exchange commission logo
March 15, 2021
Paul Peter Tak, M.D., Ph.D.
Chief Executive Officer and President
Candel Therapeutics, Inc.
117 Kendrick St Suite 450
Needham, MA 02494
Re: Candel
Therapeutics, Inc.
Draft Registration
Statement on Form S-1
Submitted February
16, 2021
CIK No. 0001841387
Dear Dr. Tak:
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.
Form S-1(DRS) submitted on February 16, 2021
General
1. 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.
Prospectus Summary
Overview, page 1
2. Please revise
throughout to remove any inference regarding regulatory approval of your
product candidates. You
may describe how your product candidates differ from those
Paul Peter Tak, M.D., Ph.D.
Candel Therapeutics, Inc.
March 15, 2021
Page 2
offered by your competitors and, if true, you may disclose that you
are not aware of
competing products being further along in the development process. In
this regard, we
note the following illustrative statements, and others like them:
"[b]ased on the broad
range of data that [you] have generated from [your] preclinical models
and clinical trials,
[you] believe that [your] approach leads to a systemic, durable immune
response against
locally injected tumors and their distant metastases;" "clinical
results to date from CAN-
2409 and CAN-3110 suggest that these candidates have the
potential to address
significant unmet patient need and improve clinical outcomes;" and
"our product
candidates... have demonstrated the capacity to induce systemic immune
response in our
preclinical studies."
Use of Proceeds, page 77
3. We note your risk factor on page 12 disclosing that you expect your
expenses to
significantly increase in connection with your ongoing activities and
that, accordingly,
you will need to obtain substantial additional funding in connection
with our continuing
operations. Please expand your disclosure to indicate how far the
proceeds from the
offering will allow you to proceed with the continued development of
each of your
programs, or clarify.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development Expenses, page 91
4. Please consider presenting the components of your research and
development expenses for
each of your major research and development projects for each period
presented. If you do
not maintain any research and development costs by project, please
disclose that fact and
explain why and provide other quantitative or qualitative disclosure
to indicate the amount
of resources being used on the projects. Refer to the Division of
Corporation Finance
Current Issues and Rulemaking Projects Quarterly Update under
section VIII Industry
Specific Issues Accounting and Disclosure by Companies Engaged in
Research and
Development Activities. You can find it at the following website
address:
http://www.sec.gov/divisions/corpfin/cfcrq032001.htm#secviii.
Critical Accounting Policies and Estimates
Determination of fair value of common stock, page 95
5. Please explain to us how you determined the fair value of the common
stock underlying
your recent equity issuances and the reasons for any differences between
recent sales of
equity and the fair value of the common stock. This information will
help facilitate our
FirstName LastNamePaul Peter Tak, M.D., Ph.D.
review of your accounting for equity issuances, including stock
compensation and
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March 15, 2021 Page 2
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IP, page 122
6. For the patents you own and license, please disclose the specific
product candidate or
platform technology the patents relate to, discuss the durations of
the patents and identify
the type of patent application (such as composition of matter, use or
process).
Executive Compensation
Employment Agreements in Place During Fiscal Year 2020 for Our Named Executive
Officers,
page 149
7. Please file the individual employment arrangements with each of your
named executive
officers as an exhibit to the registration statement, or advise. See
Item 601(b)(10) of
Regulation S-K for guidance.
Principal Stockholders, page 161
8. Please expand your disclosure to identify the natural person(s) with
voting and/or
dispositive power over the shares owned by the EAC Descendants
Irrevocable Trust and
the LKA Descendants Irrevocable Trust.
You may contact David Burton at 202-551-3626 or Kate Tillan at
202-551-3604 if you
have questions regarding comments on the financial statements and related
matters. Please
contact David Gessert at 202-551-2326 or Celeste Murphy at 202-551-3257 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Robert E. Puopolo, Esq.