View:
January 8, 2020
Jacob Chacko, M.D.
President and Chief Executive Officer
Oric Pharmaceuticals, Inc.
240 E. Grand Ave, 2nd Floor
South San Francisco, CA 94080
Re: Oric Pharmaceuticals, Inc.
Draft Registration Statement on Form S-1
Submitted December 13, 2019
CIK No. 0001796280
Dear Dr. Chacko:
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
Prospectus summary
Overview, page 1
1. We note your references throughout your registration statement to your
product candidates
as potentially "first-in-class." This term suggests that your product
candidates are
effective and likely to be approved. Further, it is inappropriate for
you to state or imply
that you will achieve a given market share given the length of time and
uncertainty with
respect to securing marketing approval for your product candidates.
Please delete these
references. If your use of this term was intended to convey your belief
that the products
are further along in the development process, you may discuss that you
are not aware of
competing products that are further along in the development process.
Statements such as
Jacob Chacko, M.D.
Oric Pharmaceuticals, Inc.
January 8, 2020
Page 2
these should be accompanied by cautionary language that the statements
are not intended
to give any indication that the product candidates have been proven
effective or that they
will receive regulatory approval.
2. Your pipeline table appears to include every in-house development
program. Please
revise the table to include only those programs that are material to
the company. If you
believe that every program listed is material, please provide us with
an analysis explaining
your belief. In particular, to the extent your lead optimization
program is material to the
company, please discuss this in your analysis.
3. We note your reference to Drs. Sawyers and Lowe as "founders." We also
note your
website describes Dr. Sawyers as a member of your Scientific Advisory
Board and Dr.
Lowe as a consultant. Please revise the Prospectus Summary and other
applicable
sections of the registration statement to clearly explain the extent
of your "founders"
involvement with your company including contractual relationships. In
your revised
disclosure, please also explain what it means to be a "founder." A
"founder" who is not a
principal stockholder or employee does not appear to have a current
connection to the
company. In this regard, please explain whether Drs. Sawyers and Lowe
has maintained
or transferred their initial interest and other rights in the company.
4. We note that your lead product candidate, ORIC-101, builds on academic
work from Dr.
Sawyers laboratory at Memorial Sloan Kettering Cancer Center. Please
clarify the nature
and scope of any engagement with Dr. Sawyers and/or Memorial Sloan
Kettering Cancer
Center to include what entitlement, if any, you have to intellectual
property deriving from
Dr. Sawyers and/or Memorial Sloan Kettering Cancer Center.
Our strategy, page 5
5. We note your strategy to "[r]apidly" advance your lead product
candidate through clinical
development. Please revise your disclosure and similar statements
throughout your
registration statement to remove any implication that you will be
successful in
commercializing your product candidates in a rapid or accelerated
manner as these
statements are speculative for you to make.
Risk Factors
Intellectual property discovered through government funded programs may be
subject to federal
regulations..., page 62
6. We note that you may be subject to federal regulations such as march-in
rights. Please
provide additional disclosure regarding:
the technology or technologies subject to march-in rights;
FirstName LastNameJacob Chacko, M.D. would be affected by the exercise of
march-in rights;
the portion of your business that
Comapany andNameOric Pharmaceuticals, Inc.
January 8, 2020 Page 2 how you may be compensated in the event such rights are
exercised.
whether and
FirstName LastName
Jacob Chacko, M.D.
FirstName LastNameJacob Chacko, M.D.
Oric Pharmaceuticals, Inc.
Comapany2020
January 8, NameOric Pharmaceuticals, Inc.
Page 3
January 8, 2020 Page 3
FirstName LastName
Market, industry and other data, page 78
7. Please delete the statement that you have not separately verified data
from third parties or
revise your disclosure to specifically state that you are liable for
the data included in the
registration statement.
Use of proceeds, page 79
8. Please expand your disclosure to specify the intended use of proceeds,
including the
amount you intend to allocate to ORIC-201 and the other research and
development
activities, individually. Additionally, please revise to state how far
the net proceeds are
expected to allow you to continue in the development for each of your
product
candidates. Refer to Item 504 of Regulation S-K.
Managements discussion and analysis of financial condition and results of
operations
Critical accounting policies and significant judgments and estimates
Stock-based compensation , page 97
9. Once you have an estimated offering price or range, please explain to
us 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.
Business
GR antagonist program: ORIC-101, page 104
10. We note that you have developed a proprietary immunohistochemistry
(IHC) assay that
measures GR protein expression levels as well as a proprietary GR gene
activation
signature that measures GR signaling activity, both of which are being
utilized in your two
ongoing Phase 1b clinical trials of ORIC-101. On page 32, you note
that the FDA has
required marketing approval of all companion diagnostic tests for
cancer therapies. In the
business section, please revise your disclosure to explain how
approval of your diagnostic
tools for ORIC-101 impacts the timing of approval and/or
commercialization of ORIC-
101. Please also disclose the impact to approval and/or marketing of
ORIC-101 if the
diagnostic tool is not approved.
Background on cancer resistance, page 107
11. Please revise your discussion of innate resistance to clearly provide
that basis for your
belief that innate resistance targets have a "higher probability of
technical success than
other cancer targets" and "the potential for rapid clinical
development and approval
timelines."
Jacob Chacko, M.D.
FirstName LastNameJacob Chacko, M.D.
Oric Pharmaceuticals, Inc.
Comapany2020
January 8, NameOric Pharmaceuticals, Inc.
Page 4
January 8, 2020 Page 4
FirstName LastName
The glucocorticoid receptor as a mechanism of resistance, page 113
12. At first use, please provide a brief explanation of the disclosed
p-value and how it is used
to measure statistical significance. Please also explain the relevance
of statistical
significance to the FDA's evidentiary standards for drug approval.
ORIC-101 differentiation, page 115
13. We note that you conducted a series of in vitro experiments evaluating
ORIC-101,
mifepristone and relacorilant with determinations of more favorable,
comparable, or less
favorable. Please provide context for these studies by providing the
specific details and
parameters of the studies from which this data was drawn, including
endpoints, duration
of treatment, comparison against placebo or standard treatment,
metrics utilized, statistical
significance, etc. Without this contextual information, it may be
difficult for the reader to
draw an accurate and balanced assessment of these favorable results.
If you cannot
provide this information, please remove these comparisons.
Our collaboration and license agreements, page 130
14. We note your disclosure that you have entered into agreements with
Memorial Sloan
Kettering Cancer Center and Washington University in St. Louis. To the
extent that these
agreements are material, please describe the material terms and file
them as exhibits to the
registration statement, or tell us why this is not required. See Item
601(b)(10) of
Regulation S-K.
Intellectual property, page 132
15. We note that you have licensed certain pending patents from Memorial
Sloan Kettering
Cancer Center. Please amend your disclosure to discuss the material
terms of this license
agreement. In your description of this agreement you should
specifically identify, to the
extent material:
each party s rights and obligations;
nature and scope of intellectual property transferred if the
agreement involves a
license;
duration of agreement and royalty term, if applicable;
termination provisions; and
payment provisions.
In addition, please file the agreement as an exhibit to your
registration statement as
required under Item 601(b)(10) of Regulation S-K.
16. Please revise your disclosure to identify the applicable foreign
jurisdictions for your
pending patent applications.
Jacob Chacko, M.D.
FirstName LastNameJacob Chacko, M.D.
Oric Pharmaceuticals, Inc.
Comapany2020
January 8, NameOric Pharmaceuticals, Inc.
Page 5
January 8, 2020 Page 5
FirstName LastName
Executive compensation, page 157
17. Please update your disclosure to include the disclosures required by
Item 402 of
Regulation S-K for your last completed fiscal year.
General
18. 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,
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 Ibolya Ignat at 202-551-3636 or Kevin Vaughn at
202-551-3494 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jeffrey Gabor at 202-551-2544 or Celeste Murphy at 202-551-3257 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Melissa Rick, Esq.