United States securities and exchange commission logo
May 7, 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.
Draft Registration
Statement on Form S-1
Submitted April 9,
2021
CIK No. 0001783032
Dear Dr. Leland:
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 April 9, 2021
Prospectus Summary, page 1
1. We note statements
throughout the prospectus that imply efficacy, such as your statements
that NRG1 is "likely to
be therapeutically actionable", that seribantumab is a "potent anti-
HER monoclonal
antibody" and that seribantumab "potently inhibited ligand-dependent
activation of HER3."
Please revise your disclosure throughout your prospectus to revise
these and similar
statements to eliminate conclusions or predictions that your product
candidates are
effective as determinations of efficacy are solely within the authority of the
FDA. You may provide a
summary of the data that you used to draw these
conclusions, and such
discussion is more appropriate in the Business section where full
and proper context can
be provided.
Shawn Leland, Pharm.D., R.Ph.
FirstName LastNameShawn Leland, Pharm.D., R.Ph.
Elevation Oncology, Inc.
Comapany
May 7, 2021NameElevation Oncology, Inc.
May 7,
Page 2 2021 Page 2
FirstName LastName
Please also remove statements that you acquire assets that you believe
have "best-in-
class and/or first-in-class potential" and that seribantumab has "the
potential to be a best-
in-class approach" as such language suggests that the product
candidates are effective and
likely to be approved.
2. We note statements throughout your prospectus that imply you will be
able to successfully
progress your product candidates to commercialization in a rapid or
accelerated manner
and/or mitigate risk of unsuccessful clinical trials. As these
statements are speculative and
suggest that investors are afforded protection from loss, please
revise your disclosure here
and throughout your prospectus to remove these implications. As a
non-exhaustive list of
illustrative examples only, we note the following statements:
your approach "can allow [you] to reduce the time, costs and risks
of clinical
development" and "accelerate the drug development process in a
rigorously selected
patient population."
That you are focused on "re-designing the traditional drug
development model to
enable efficient, accelerated development of targeted
therapeutics."
that your collaborations with diagnostic providers accelerate
enrollment for [your]
Phase 2 CRESTONE trial.
[y]our clinical development strategy is designed to identify
response signals early in
development to reduce clinical development risks.
[You] designed and operationalized the Phase 2 CRESTONE trial to
proactively
address risks and inefficiencies of clinical development.
3. We note your disclosure here and elsewhere in the prospectus regarding
the "observed
safety profile" of seribantumab in humans. Since this disclosure may
imply that your
product candidate is safe, and safety determinations are solely within
the authority of the
FDA and comparable regulatory bodies, please revise your disclosure to
remove this
implication.
4. We note your disclosure on page 2 that you designed CRESTONE as a
tumor-agnostic
trial with registrational intent. Please revise to clarify what you
mean by the term
"registrational intent." Please revise to disclose whether you have
received any indication
from the FDA that your Phase 2 clinical trail will be treated as a
registrational clinical trial
such that a Phase 3 trial will not be required.
Our lead program: NRG1 fusions, page 3
5. We note your disclosure that results from your CRESTONE trial may
provide support for
the accelerated approval of seribantumab for patients with advanced
solid tumors
harboring an NRG1fusion, subject to discussions with the FDA. Please
also include
balancing disclosure that you will still be required to conduct post
confirmatory trials to
confirm the anticipated clinical benefit of your product candidate and
that the accelerated
approval process may not lead to a faster development or regulatory
review or approval
process and does not increase the likelihood that it will receive
marketing approval.
Shawn Leland, Pharm.D., R.Ph.
Elevation Oncology, Inc.
May 7, 2021
Page 3
6. We note your disclosure that the majority of adverse events observed
with seribantumab
monotherapy were transient and mild to moderate in severity. Please
balance your
discussion and include disclosure regarding any serious adverse events
that were observed
that were either related or possibly related to treatment.
Our team and investors, page 3
7. Please limit the disclosure identifying your investors to investors
identified in your
Principal Stockholder table.
The exclusive forum provision in our organizational documents may limit a
stockholder's ability
to bring a claim, page 65
8. Please revise your risk factor to disclose that there is also a risk
that your exclusive forum
provision may result in increased costs for investors to bring a
claim.
Determination of the fair value of common stock, page 88
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 initial public offering 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.
Our strategy, page 94
10. Please disclose the number of patients enrolled in the CRESTONE trial
to date.
Genomic alterations fall on a spectrum of oncogenic potential, page 97
11. Please revise your disclosure, including in the graphic on page 98, to
remove the
implication that your product candidate will follow similar clinical
development and
regulatory approval timelines as FGFR and MET inhibitors. Please also
provide the basis
for your statements that such inhibitors received "rapid" FDA
approvals.
Previous sponsor's Phase 1 monotherapy trial NCT00734305 (safety and
pharmacokinetics),
page 107
12. We note your disclosure regarding TEAEs observed in more than ten
percent of patients at
FirstName LastNameShawn Leland, Pharm.D., R.Ph.
the dose expansion phases and highest tested dose. Please expand the
discussion here to
Comapany NameElevation
discuss Oncology,
all serious adverse Inc.
events related, or possibly related, to
treatment. Please include
May 7,the nature
2021 Pageof3 each such event and the number of patients that
experienced it.
FirstName LastName
Shawn Leland, Pharm.D., R.Ph.
FirstName LastNameShawn Leland, Pharm.D., R.Ph.
Elevation Oncology, Inc.
Comapany
May 7, 2021NameElevation Oncology, Inc.
May 7,
Page 4 2021 Page 4
FirstName LastName
Our preclinical characterization, page 109
13. Please remove statements here and on page 111 that the "biologically
effective dose" was
determined, as determinations of efficacy are solely within the
authority of the FDA.
Dyax, page 116
14. We note your disclosure that in order to clinically develop or
commercialize
seribantumab, the previous sponsor obtained an additional product
license from Dyax, that
you acquired as part of the previous sponsor purchase. Please revise
your disclosure to
describe the nature and scope of the license acquired.
General
15. 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.
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.