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April 11, 2019
J. Mel Sorensen, M.D.
Chief Executive Officer
Galera Therapeutics, Inc.
2 W Liberty Blvd #100
Malvern, PA 19355
Re: Galera Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted on March 15, 2019
CIK No. 0001563577
Dear Dr. Sorensen:
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
Overview, page 1
1. Regarding the last sentence of the first paragraph, please clarify or
otherwise emphasize
that, to date, the FDA has not approved GC4419 for any indication.
Please make
conforming revisions, as necessary, throughout the prospectus.
Background on Superoxide Dismutases and Our Dismutase Mimetics , page 2
2. In the last sentence of the second paragraph please clarify, if true,
that you are developing
dismutase mimetics to have the essential features you note. In this
regard, we note the
FDA has not yet approved any of your product candidates as being safe
and effective for
any indication. Please make conforming revisions, as necessary,
throughout the
J. Mel Sorensen, M.D.
FirstName LastNameJ. Mel Sorensen, M.D.
Galera Therapeutics, Inc.
Comapany NameGalera Therapeutics, Inc.
April 11, 2019
April 2 2019 Page 2
Page 11,
FirstName LastName
prospectus.
Implications of Being an Emerging Growth Company, page 7
3. 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, page 12
4. Please add risk factor disclosure addressing the risks to investors
posed by the exclusive
forum provision in your fifth amended and restated certificate of
incorporation. Please
note that we may have additional comments once you file the
certificate of incorporation
and we review it.
Use of Proceeds, page 72
5. We note your disclosure that you intend to use net proceeds to fund
the clinical
development of GC4419 and GC4711. Please specify how far in the
development of each
of the listed clinical trials you expect to reach with the proceeds of
the offering. If any
material amounts of other funds are necessary to accomplish the
specified purposes, state
the amounts and sources of other funds needed for each specified
purpose and the
sources. Refer to Instruction 3 to Item 504 of Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies
Share Based Compensation
Estimating the Value of Common Stock, page 92
6. Please revise your disclosure to include the dates the common stock
valuations were
performed, as well as the estimated fair value of your common stock as
determined by a
third party valuation and BOD consideration of the objective and
subjective factors
described at page 92.
7. 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.
Choice of Forum, page 155
8. We note that your forum selection provision will identify the Court of
Chancery of the
State of Delaware as the exclusive forum for certain litigation,
including any "derivative
J. Mel Sorensen, M.D.
Galera Therapeutics, Inc.
April 11, 2019
Page 3
action." Please disclose whether this provision applies to actions
arising under the
Exchange Act. In that regard, we note that 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. If this
provision does not
apply to actions arising under the Exchange Act, please also ensure that
the exclusive
forum provision in the governing documents states this clearly.
Notes to Consolidated Financial Statements
10. Stock Based Compensation, page F-18
9. Please disclose the policy choice made for either estimating expected
forfeitures or
recognizing forfeitures as they occur. Refer to ASC paragraph
718-10-50-2(m).
You may contact Christine Torney at (202) 551-3652 or Lisa Vanjoske at
(202) 551-
3614 if you have questions regarding comments on the financial statements and
related
matters. Please contact Tonya K. Aldave at (202) 551-3601 or Dietrich King at
(202) 551-
8071 with any other questions.
Sincerely,
FirstName LastNameJ. Mel Sorensen, M.D.
Division of
Corporation Finance
Comapany NameGalera Therapeutics, Inc.
Office of
Healthcare & Insurance
April 11, 2019 Page 3
cc: Nathan Ajiashvili, Esq.
FirstName LastName