United States securities and exchange commission logo
June 16, 2021
Shawn Leland, Pharm.D., R.Ph.
Chief Executive Officer
Elevation Oncology, Inc.
888 Seventh Ave., 12th Floor
New York, NY 10106
Re: Elevation Oncology,
Inc.
Registration
Statement on Form S-1
Filed June 4, 2021
File No. 333-256787
Dear Dr. Leland:
We have reviewed your 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 amending your registration
statement and providing the
requested information. 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 any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-1 filed June 4, 2021
Overview, page 1
1. We note your revised
disclosure in response to prior comment 1. Please disclose whether
you have received any
indication from the FDA that your Phase 2 clinical trial will be
treated as a
registrational clinical trial such that a Phase 3 trial will not be required.
Alternatively, please
revise the disclosure to make it clear that even if you receive positive
data from the CRESTONE
trial, you cannot be certain that the FDA or other regulators
will find such data
sufficient to support a BLA submission or that the FDA or other
regulators will not
require you to conduct additional trials.
Shawn Leland, Pharm.D., R.Ph.
FirstName LastNameShawn Leland, Pharm.D., R.Ph.
Elevation Oncology, Inc.
Comapany
June NameElevation Oncology, Inc.
16, 2021
June 16,
Page 2 2021 Page 2
FirstName LastName
Our Lead Program, page 102
2. We note your revised disclosure in response to prior comment 3. Please
revise to remove
the reference to addressing "risks" of clinical development within
rare, genomically-
defined patient populations, as it appears premature and speculative.
In this regard, we
note that you have not completed clinical development or obtained
regulatory approval for
any product candidate.
CRESTONE dose and schedule optimization, page 155
3. We note your disclosure that the criteria of no more than 1 DLT was
met in both of the
initial safety run-in induction cohorts, supporting advancement
towards 3 grams weekly
for full duration of therapy. Please revise to clarify whether you
observed any serious
adverse events that were related or possibly related to treatment in
your safety run-in and
dose schedule optimization phase of your CRESTONE trial.
General
4. We note that you filed a collaboration agreement with Caris MPI, Inc.
with your last
amendment. Please include a description of the material terms of this
agreement in the
prospectus, including rights and obligations, financial terms
including amounts paid to
date, aggregate milestone amounts to be paid or received, the royalty
range and term, as
applicable, term and termination provisions. With regard to the
royalty range, please
disclose a royalty range of not more than 10 percentage points.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please
allow adequate
time for us to review any amendment prior to the requested effective date of
the registration
statement.
You may contact Gary Newberry at 202-551-3761 or Kevin Kuhar at
202-551-3662 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Deanna Virginio at 202-551-4530 or Christopher Edwards at 202-551-6761
with any
other questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Julia Forbess, Esq.