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United States securities and exchange commission logo
June 2, 2021
Jonathan E. Lim
Chief Executive Officer
Erasca, Inc.
10835 Road to the Cure, Suite 140
San Diego, CA 92121
Re: Erasca, Inc.
Draft Registration
Statement on Form S-1
Submitted May 7,
2021
CIK No. 0001761918
Dear Dr. Lim:
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
General
1. 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. Please
contact Tonya K. Aldave at (202) 551-3601 to discuss how to
submit the materials,
if any, to us for our review.
2. We note your disclosure
on page 171 that the "key competitive factors affecting the
success of all of
[your] programs are likely to be efficacy, safety, and convenience of each
product candidate."
Please revise throughout the prospectus to remove any implication
Jonathan E. Lim
FirstName
Erasca, Inc.LastNameJonathan E. Lim
Comapany
June 2, 2021NameErasca, Inc.
June 2,
Page 2 2021 Page 2
FirstName LastName
that your product candidates are more likely than others to receive
FDA approval or
explain to us why these statements are appropriate given the stage of
your product
candidates.
Prospectus Summary, page 1
3. Please revise your pipeline table on page 4 to show separate columns
for Phases 1, 2 and 3
or tell us the basis for your belief that you will be able to conduct
Phase 1b/2 trials and
Phase 2/3 trials for all of your product candidates.
4. We note that you have nine programs in the discovery and the
IND-enabling stage. Please
explain to us why each of those programs is sufficiently material to
your business to
warrant inclusion in your pipeline table or revise your table as
appropriate.
5. Your pipeline table, which indicates that you have completed Phase 1
of HERKULES-2,
HERKULES-3 and HERKULES-4, appears to be inconsistent with your
disclosure on
page 109 that you "are planning to initiate HERKULES-2, HERKULES-3,
and
HERKULES-4 in the future. If these trials have not yet begun, please
revise your
pipeline table here and throughout the registration statement
accordingly.
6. We note your disclosure on page 4 that you in-licensed ERAS-007 based
in part on
preclinical studies that demonstrated the highest potency and longest
target residence time
of ERK inhibitors of which you are aware. Please disclose here the
ranges of the
potency and target residence time observed in the preclinical studies.
Use of Proceeds, page 78
7. We note your disclosure that you intend to use net proceeds to fund
the clinical
development of ERAS-007 in your HERKULES series of clinical trials,
fund the clinical
development of ERAS-601, and fund the ongoing discovery and
development of your
other current RAS/MAPK pathway-focused pipeline programs. 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 amount and sources of other funds needed
for each specified
purpose. Refer to Instruction 3 to Item 504 of Regulation S-K.
Managements Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies and Estimates
Common Stock Valuations, page 99
8. 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.
Jonathan E. Lim
FirstName
Erasca, Inc.LastNameJonathan E. Lim
Comapany
June 2, 2021NameErasca, Inc.
June 2,
Page 3 2021 Page 3
FirstName LastName
Business
Our innovation model, page 121
9. Please remove the reference to potential
"first-in-class/best-in-class" targeted therapies
because this description implies an expectation of regulatory approval
and is inappropriate
given the length of time and uncertainly with respect to securing
marketing approval.
ERAS-007: our ERK inhibitor, page 125
10. Please disclose the endpoints for your ERAS-007 clinical trial.
ERAS-601: our SHP2 inhibitor, page 144
11. Please disclose the endpoints and any serious adverse events
encountered during your
ERAS-601 clinical trial.
Our acquisition and license agreements
Asana BioSciences, page 165
12. We note your disclosure on page 165 that you are required to use
commercially
reasonable efforts to develop and obtain regulatory approval for
ERAS-007 in the United
States, at least one major market country in Europe, and either China
or Japan. Please
revise your government regulation section to address the approval
process in China and
Japan.
NiKang Therapeutics, page 166
13. We note your reference to tiered royalties on net sales and
sublicensing revenue sharing
fees "in the mid double-digit percentages." Please revise your
disclosure to narrow the
royalty range to no more than ten percentage points (for example,
between twenty and
thirty percent). In addition, revise your disclosure on page 170 in
the description of the
licensing agreement with the University of California, San Francisco,
where you describe
the sublicensing fees to be "in the low to low-mid double-digit
percentages."
Executive and director compensation
Summary compensation table, page 196
14. We note that your named executive officers received compensation that
appears in the
"non-equity incentive plan compensation" column of the summary
compensation table.
Please add a footnote to describe generally these compensatory
payments.
Note 7. Asset Acquisition, page F-20
15. We see that you entered into an agreement and plan of merger with
Asana and ASN
Product Development, Inc., pursuant to which ASN became its
wholly-owned subsidiary,
in November 2020. It appears that you have accounted for this
transaction as an asset
acquisition. Please revise your disclosure to clarify this fact and
explain how you
Jonathan E. Lim
Erasca, Inc.
June 2, 2021
Page 4
determined that the assets acquired did not meet the definition of a
business. Please also
revise to disclose the nature of the development milestone whereby you
will be required to
issue 4,666,667 shares of its common stock to Asana and explain how
this differs from the
$90 million in development and regulatory milestones. Lastly, please
explain your
reference to a carve-out for a specific milestone payment that may or
may not occur and
what specifically this disclosure refers to with regards to the
acquisition.
You may contact Julie Sherman at 202-551-3640 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Tonya Aldave at 202-551-3601 or Sonia Bednarowski at 202-551-3666 with
any other
questions.
FirstName LastNameJonathan E. Lim Sincerely,
Comapany NameErasca, Inc.
Division of
Corporation Finance
June 2, 2021 Page 4 Office of Life
Sciences
FirstName LastName