United States securities and exchange commission logo
November 10, 2020
Shalabh Gupta, M.D.
Chief Executive Officer, President and Chairman
Unicycive Therapeutics, Inc.
5150 El Camino Real, Suite A-32
Los Altos, CA 94022
Re: Unicycive
Therapeutics, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted November
2, 2020
CIK No. 0001766140
Dear Dr. Gupta:
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 submitted
November 2, 2020
PROSPECTUS SUMMARY
Overview, page 1
1. We note your response
to prior comment 1 and that UNI 494 was initially developed
by Sphaera
Pharmaceuticals. Please revise the business section to clearly disclose the
discovery/preclinical
work conducted by Sphaera Pharmaceuticals.
Business
Background on Renazorb, page 52
2. We note your response
to prior comment 2 and your revised disclosure here and
throughout the
registration statement that your candidate has "the potential to be
Shalabh Gupta, M.D.
Unicycive Therapeutics, Inc.
November 10, 2020
Page 2
effective." Please revise the prospectus to remove any statements that
suggest the efficacy
of your candidate, as these determinations are the exclusive authority of
the FDA or other
regulators.
Clinical Trial Experience, page 53
3. We note your response to prior comment 8 and reissue. For the clinical
trial discussed in
this section, please disclose the phase; the date(s) of the trial and the
location; duration of
treatment and dosage information (both amount and frequency); the
specific endpoints
established by the trial protocol; and actual results observed, including
whether statistical
significance was demonstrated and the p-values supporting statistical
significance.
General
4. We note your response to prior comment 14. The pipeline table on page 49
and on your
website indicates that Renazorb has completed Phase 3 clinical trials.
However, we note
your disclosure on page 1 that "Spectrum conducted a Phase 1 clinical
trial with Renazorb
in 2012 prior to the grant of [your] license in 2018." To the extent that
you have
completed Phase 2 and 3 clinical trials, please include disclosure that
complies with
comment 3 above. Otherwise, revise the pipeline table on page 49 and on
your website to
illustrate the product candidate's current status.
You may contact Ibolya Ignat at 202-551-3636 or Brian Cascio at
202-551-3676 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,
FirstName LastNameShalabh Gupta, M.D.
Division of
Corporation Finance
Comapany NameUnicycive Therapeutics, Inc.
Office of Life
Sciences
November 10, 2020 Page 2
cc: Jeffrey Fessler, Esq.
FirstName LastName