United States securities and exchange commission logo
March 26, 2021
Kathy Lee-Sepsick
Chief Executive Officer
Femasys Inc.
3950 Johns Creek Court, Suite 100
Suwanee, GA 30024
Re: Femasys Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted March 17,
2021
CIK No. 0001339005
Dear Ms. Lee-Sepsick:
We have reviewed your amended 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.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary
Overview, page 1
1. We note your revisions
in response to prior comment 1 that the FDA will evaluate the
results of the small
IDE clinical study that you are currently conducting to determine
whether to allow you to
move forward with a pivotal trial. In the next paragraph, you state
that if the FDA
approves the IDE for the pivotal clinical trial, you will initiate a new
pivotal trial. In your
disclosure on page 13, you state that enrollment has been paused for
the pivotal trial until
the FDA approves an IDE supplement to resume the study or an IDE
for a new pivotal
trial. Please revise to clarify that here, if true, as the disclosure currently
appears to indicate
that you would only be initiating a new pivotal trial and not potentially
Kathy Lee-Sepsick
Femasys Inc.
March 26, 2021
Page 2
continuing a paused trial.
Financial Statements, page F-3
2. Given the automatic conversion upon the completion of this offering of
all of your
convertible preferred stock into shares of common stock (pages 8, 62 and
elsewhere),
please tell us how you considered providing a pro forma presentation of
the affected line
items on the face of your balance sheet as well as pro forma loss per
share on the face of
your statement of comprehensive loss. Also, revise to provide a related
footnote
discussion thereof.
You may contact Jenn Do at 202-551-3743 or Kevin Vaughn at 202-551-3494
if you
have questions regarding comments on the financial statements and related
matters. Please
contact Ada D. Sarmento at 202-551-3798 or Celeste Murphy at 202-551-3257 with
any other
questions.
Sincerely,
FirstName LastNameKathy Lee-Sepsick
Division of
Corporation Finance
Comapany NameFemasys Inc.
Office of Life
Sciences
March 26, 2021 Page 2
cc: David S. Rosenthal, Esq.
FirstName LastName