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United States securities and exchange commission logo
October 16, 2020
Sean Bohen
Chief Executive Officer
Olema Pharmaceuticals, Inc.
512 2nd Street, 4th Floor
San Francisco, CA 94107
Re: Olema
Pharmaceuticals, Inc.
Draft Registration
Statement on Form S-1
Submitted September
21, 2020
CIK No. 0001750284
Dear Dr. Bohen:
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. Please disclose here
when you commenced the ongoing trial of OP-1250 for the treatment
of recurrent, locally
advanced or metastatic ER-positive, or ER+, human epidermal
growth factor receptor
2-negative, or HER2-, breast cancer.
2. Please revise the
pipeline chart here and on page 99 to include individual columns for
each of the three
phases of clinical development. In addition, for the trials you anticipate
commencing in 2022,
more than a year from now, please either tell us why you believe it
is appropriate to
include them in the table or remove them. Finally, for those trials that are
not likely to commence
in the near term, please adjust the arrow graphic in the non-
clinical column so as
to avoid conveying that all non-clinical work has been performed.
Sean Bohen
Olema Pharmaceuticals, Inc.
October 16, 2020
Page 2
Our product candidate, page 2
3. We note your comparisons to fulvestrant, an approved drug, and similar
comparisons on
page 98. We also note some similar comparisons to tamoxifen, another
approved
drug. Please tell us on what basis you believe you are able to make
these comparisons
given your early stage of development and the lack of any head-to-head
clinical trials or,
alternatively, delete these inappropriate comparisons. Please revise
the prospectus
throughout accordingly.
Implications of being an emerging growth company, page 6
4. 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 the staff member associated with the
review of this filing
to discuss how to submit the materials, if any, to us for our review.
The outbreak of the novel coronavirus disease, COVID-19, could adversely impact
our business,
page 37
5. Please revise to specifically discuss if and how COVID-19 has actually
impacted your
clinical trials. In this regard, we note this risk factor appears
generic and does not
specifically discuss if and how your clinical trials have been
impacted.
Use of proceeds, page 76
6. We note your disclosure that you intend to use the net proceeds
received from the offering
to fund the clinical development of OP-1250 and other ongoing research
and development
activities, and for general corporate purposes, including working
capital, operating
expenses and capital expenditures. Please revise to disclose in
greater detail the principal
purposes for which the net proceeds are intended to be used and the
approximate amount
intended to be used for each such purpose.
You may contact Jeanne Bennett at 202-551-3606 or Kate Tillan at
202-551-3604 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Donald Field at 202-551-3680 or Dietrich King at 202-551-8071 with any
other
questions.
FirstName LastNameSean Bohen Sincerely,
Comapany NameOlema Pharmaceuticals, Inc.
Division of
Corporation Finance
October 16, 2020 Page 2 Office of Life
Sciences
FirstName LastName