United States securities and exchange commission logo
May 2, 2021
Hugh Y. Rienhoff, Jr., M.D.
Chief Executive Officer
Imago BioSciences, Inc.
329 Oyster Point Blvd., 3rd Floor
South San Francisco, CA 94080
Re: Imago BioSciences,
Inc.
Draft Registration
Statement on Form S-1
Submitted April 5,
2021
CIK No. 0001623715
Dear Dr. Rienhoff:
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.
DRS S-1 filed April 5, 2021
Prospectus Summary
Overview, page 1
1. Please make the
following revisions on this page:
clarify that the
data from your two Phase 2 trials for MF and ET is interim data;
state how many
patients are in each interim data set; and
clarify that the
"pivotal" trials for MF and ET will be Phase 3 trials.
Hugh Y. Rienhoff, Jr., M.D.
FirstName LastNameHugh
Imago BioSciences, Inc. Y. Rienhoff, Jr., M.D.
Comapany
May 2, 2021NameImago BioSciences, Inc.
May 2,
Page 2 2021 Page 2
FirstName LastName
Bomedemstat Overview, page 2
2. We note your disclosure that bomedemstat received orphan and Fast
Track designation for
MF and ET. Please expand your disclosure to explicitly state that fast
track designation
does not guarantee an accelerated review by the FDA.
Pipeline Table, page 2
3. Please provide additional disclosure about why the first three arrows
in this pipeline table
are different lengths when it appears that all of these Phase 2
clinical trials are still
enrolling patients. While we understand that your website is not
incorporated by
reference into the prospectus, we note that the pipeline table on your
website breaks down
these three Phase 2 trials into Phases 2a and 2b. Please consider
whether similar
disclosure, either in the pipeline table itself or a separate
narrative description, would be
appropriate in this prospectus.
4. We note that you have not yet identified a chemical entity to study
for
your hemoglobinopathies and solid tumor programs. Please remove these
programs from
the table or explain the basis for your belief that they are material
and should be included
in your pipeline table.
Additional Programs Targeting LSD1, page 3
5. Please provide additional narrative description about your ongoing
investigator-sponsored
trial is evaluating bomedemstat in patients with PV such as its
current phase (which your
pipeline table suggests is Phase 2) and any other material information
about the trial,
including how many patients it will enroll. Please mirror these
additional disclosures in
your Business section.
Bomedemstat in ET, page 3
6. Please balance you disclosure that "[t]here have been no serious
adverse events, or SAEs,
safety signals, dose-limiting toxicities or deaths related to drug as
of the cut-off date" in
your ongoing Phase 2 trial of bomedemstat in EF trial with your
disclosure on page 20
that eight patients (80%) in your ongoing Phase 2 EF trial have
reported 67 adverse
events.
Bomedemstat in MF, page 3
7. Please balance your disclosure that "there have been no safety
signals, dose limiting
toxicities or deaths related to drug as of the cut-off date" in your
ongoing Phase 2 trial of
bomedemstat in MF with your disclosures on pages 20 and 87 that 55
patients (89%) in
this trial have reported 1,001 adverse events (of which 63 were
serious adverse events)
and and that eight of these serious adverse events were deemed by
investigators as
possibly related to bomedemstat.
Hugh Y. Rienhoff, Jr., M.D.
FirstName LastNameHugh
Imago BioSciences, Inc. Y. Rienhoff, Jr., M.D.
Comapany
May 2, 2021NameImago BioSciences, Inc.
May 2,
Page 3 2021 Page 3
FirstName LastName
Our product candidates or any future product candidates may be associated with
undesirable side
effects or adverse events. . . ., page 20
8. You disclose that 55 patients (89%) in your ongoing Phase 2 MF trial
have reported 1,001
adverse events (of which 63 were serious adverse events) and that
eight patients (80%) in
your ongoing Phase 2 EF trial have reported 67 adverse events. Please
provide further
disclosure about why you have determined there there are no safety
signals or dose-
limiting toxicities attributed to bomedemstat, especially considering
that eight of these
serious adverse events in the Phase 2 MF trial were deemed by
investigators as possibly
related to bomedemstat.
Our amended and restated certificate of incorporation and amended and restated
bylaws will
provide that the Court of Chancery. . . ., page 54
9. Please revise this 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.
Use of Proceeds, page 60
10. Please specify how far in the clinical development of bomedemstat for
MF and EF you
expect to reach with the proceeds of this offering.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Polices and Estimates
Common Stock Valuations, page 76
11. 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. Please
discuss with the staff how to submit your response.
Intellectual Property, page 94
12. You disclose that you own seven patent families for bomedemstat, but
you only provide
disclosure about two of these families. For the other five families of
patents,
please include the type of patent protection granted (i.e.,
composition of matter, use, or
process), their expiration date, and their jurisdiction. Additionally,
please provide the
patent expiration date and its jurisdiction for the patent family
related to your irreversible
LSD1 inhibitors.
General
13. 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,
Hugh Y. Rienhoff, Jr., M.D.
Imago BioSciences, Inc.
May 2, 2021
Page 4
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 Li Xiao at 202-551-4391 or Angela Connell at
202-551-3426 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Dillon Hagius at 202-551-7967 or Chris Edwards at 202-551-6761 with any
other
questions.
Sincerely,
FirstName LastNameHugh Y. Rienhoff, Jr., M.D.
Division of
Corporation Finance
Comapany NameImago BioSciences, Inc.
Office of Life
Sciences
May 2, 2021 Page 4
cc: Benjamin A. Potter
FirstName LastName