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United States securities and exchange commission logo
April 21, 2021
Martin Lehr
Chief Executive Officer
Context Therapeutics LLC
3675 Market Street, Suite 200
Philadelphia, PA 19104
Re: Context
Therapeutics LLC
Draft Registration
Statement on Form S-1
Submitted March 22,
2021
CIK No. 0001842952
Dear Mr. Lehr:
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 disclosure
here that you initiated two separate Phase 2 trials of ONA-XR in
combination with
Ibrance (palbociclib) and Femara (leterozole) in first line metastatic
breast cancer and
Faslodex (fulvestrant) in second or third line metastatic breast cancer in
2021 yet your
disclosure on page 68 indicates that the trial in combination with Ibrance is
a Phase 1b/2 trial.
Please revise or advise and make this clear in your pipeline
table. Please also
briefly explain what a window of opportunity study is in this section.
Martin Lehr
FirstName LastNameMartin
Context Therapeutics LLC Lehr
Comapany
April NameContext Therapeutics LLC
21, 2021
April 221, 2021 Page 2
Page
FirstName LastName
Development Pipeline, page 2
2. Please revise the pipeline table to add a column for Phase 3. Also, it
appears that the two
Phase 0 trials for the last two indications for ONA-XR in breast
cancer are studies in
support of the other two ONA-XR trials in breast cancer based on your
disclosure
elsewhere in the prospectus. Please tell us why you believe that the
Phase 0 trials should
be reflected on separate lines of your pipeline table as opposed to
only a narrative
summary. Please also remove the Sigma1 antagonist program from the
pipeline table
given its stage of development.
Risk Factors, page 11
3. Given the length of your risk factor section, please revise to comply
with Regulation S-K
Item 105 by relocating risks that could generically apply to any
registrant or offering to
the end of the section under the caption "General Risk Factors."
Our Company's governing documents designate the Court of Chancery of the State
of Delaware
as the sole and exclusive forum, page 41
4. Please reconcile your disclosure in this risk factor that this
exclusive forum provision does
not apply to suits brought to enforce any liability or duty created by
the Securities Act or
the Exchange Act or other federal securities laws for which there is
exclusive federal or
concurrent federal and state jurisdiction with your disclosure on page
120 stating that your
certificate of incorporation provides that, unless you consent in
writing to the selection of
an alternative forum, the federal district courts of the United States
of America shall, to
the fullest extent permitted by law, be the sole and exclusive forum
for the resolution of
any complaint asserting a cause of action arising under the Securities
Act.
Business
Advanced, Recurrent Metastatic Breast Cancer, page 88
5. Please revise to clarify whether there were any serious adverse events
experienced in the
Phase 1 trial discussed in this section and, if so, discuss the
events, including the number
of patients who experienced them.
Our Collaboration and License Agreements, page 92
6. With respect to each of the three of agreements discussed in this
section, please revise to
disclose the duration of agreement, the royalty term, the termination
provisions, and the
following payment provisions:
Up-front or execution payments received or paid;
Aggregate amounts paid or received to date under the agreement;
Aggregate future potential milestone payments to be paid or
received;
Royalty rates or a royalty range;
Profit or revenue-sharing provisions; and
Martin Lehr
Context Therapeutics LLC
April 21, 2021
Page 3
Minimum purchase requirements if the agreement involves
manufacturing.
Please also file the agreements with Arno Therapeutics and Integral
Molecular as exhibits
or tell us why you believe that you are not required to file them. Refer
to Item 601(b)(10)
of Regulation S-K.
Executive Compensation, page 108
7. Please file the consulting agreement with Mr. Rencher and the form of
Board of Director
Services Agreement as exhibits or tell us why you believe that you are
not required to file
them. Refer to Item 601(b)(10) of Regulation S-K.
General
8. With reference to the cover graphics please revise to remove the
Development Pipeline
graphics and the reference to "blockbuster products" in the Highlights
graphic. In this
regard, we note that all graphics must adhere to plain English principles
and provide
a balanced presentation of the business. For additional guidance, refer
to Securities Act
Forms Compliance and Disclosure Interpretations Question 101.02.
9. 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 Gary Newberry at (202) 551-3761 or Kevin Vaughn at
(202) 551-
3494 if you have questions regarding comments on the financial statements and
related
matters. Please contact Ada Sarmento at (202) 551-3798 or Joe McCann at (202)
551-6262
with any other questions.
Sincerely,
FirstName LastNameMartin Lehr
Division of
Corporation Finance
Comapany NameContext Therapeutics LLC
Office of Life
Sciences
April 21, 2021 Page 3
cc: Ben A. Stacke
FirstName LastName