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United States securities and exchange commission logo
April 14, 2021
Marshall Fordyce, M.D.
Chief Executive Officer and President
Vera Therapeutics, Inc.
170 Harbor Way, 3rd Floor
South San Francisco, California 94080
Re: Vera Therapeutics,
Inc.
Draft Registration
Statement on Form S-1
Submitted March 19,
2021
CIK No. 0001831828
Dear Dr. Fordyce:
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
Our Product Candidate: Atacicept, page 1
1. We note your
disclosures here and throughout the prospectus that atacicept has
demonstrated an
"acceptable" safety and tolerability profile and has demonstrated
"efficacy" in certain
indications. To the extent atacicept has not been approved for such
indications, please
revise your disclosures to remove any statements that imply that
atacicept is safe or
effective, as safety and efficacy are determinations that are solely
within the authority of
the FDA or similar foreign regulators.
2. Where you discuss the
exclusive license to atacicept from Ares Trading S.A.,
please disclose the
date that you entered into the license agreement.
Marshall Fordyce, M.D.
FirstName LastNameMarshall Fordyce, M.D.
Vera Therapeutics, Inc.
Comapany
April NameVera Therapeutics, Inc.
14, 2021
April 214, 2021 Page 2
Page
FirstName LastName
Prospectus Summary
Overview, page 1
3. Please clarify that you did not conduct the Phase 2a clinical trial of
atacicept in patients
with IgAN and are instead relying on Merck KGaA's results.
Additionally, please
disclose in this same paragraph that there were 16 patients in the
Phase 2a trial.
Atacicept in LN, page 4
4. We note your disclosure that you observed positive clinical data on
multiple measures in a
prior Phase 2 clinical trial of atacicept in SLE within the High
Disease Activity patient
segment. With reference to your disclosure on pages 109-110, please
balance the
presentation by explaining that atacicept missed its primary endpoint
in this Phase 2
clinical trial and briefly discussing the results of prior clinical
development of atacicept in
LN by Merck KGaA.
Use of Proceeds, page 75
5. Please specify how far in the clinical development of atacicept in
IgAN and LN you
expect to reach with the proceeds of this offering.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Critical Accounting Policies, Significant Judgments and Use of Estimates
Fair Value of Common Stock, page 90
6. Once you have an estimated offering price or range, please explain to
us how you
determined the fair value of the common stock underlying your equity
issuances and 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. Please discuss with the staff how
to submit your
response.
Business
Our Business Principles and Strategy, page 94
7. We note your disclosure that if the Phase 2b clinical trial data are
positive, you intend to
initiate a pivotal Phase 3 clinical trial in 2023 "with the aim of
accelerated approval in the
United States." With reference to your disclosure on pages 27-28 and
120-121, please
revise your disclosure to clarify what the accelerated approval
pathway entails.
Phase 2a JANUS Trial of Atacicept in Patients with IgAN, page 102
8. We note your disclosure that the JANUS trial was terminated earlier
than planned due to
Ares decision to deprioritize the program. Please expand your
disclosure to specify how
the early termination impacts the results from and reliability of the
study, if applicable.
Marshall Fordyce, M.D.
Vera Therapeutics, Inc.
April 14, 2021
Page 3
Atacicept Safety and Tolerability Profile in the JANUS Trial, page 105
9. We note that one patient who received atacicept 25 mg experienced a
severe treatment-
emergent adverse event ("TEAE") and one patient who received atacicept
25 mg
experienced a TEAE that led to discontinued treatment. Please clarify
whether the patient
who discontinued treatment experienced the severe TEAE. Please also
identify the severe
TEAE.
Atacicept Safety and Tolerability Profile: Integrated Analysis, page 105
10. We note that you provide a table summarizing the treatment-emergent
adverse events
observed in over 1,500 patients. Please disclose whether any of the
treatment-emergent
adverse events observed constituted a serious adverse event, and if so,
please clearly
disclose the event and the number of affected patients.
Safety and Efficacy Profile of Atacicept In SLE, page 110
11. Please expand your disclosure regarding Merck KGaA's communications with
the FDA
and EMA to clarify how the FDA and EMA "reviewed and endorsed" the Phase
3
registrational program.
General
12. 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 Christie Wong at 202-551-3684 or Vanessa Robertson at
202-551-3649
if you have questions regarding comments on the financial statements and
related
matters. Please contact Dillon Hagius at 202-551-7967 or Irene Paik at
202-551-6553 with any
other questions.
Sincerely,
FirstName LastNameMarshall Fordyce, M.D.
Division of
Corporation Finance
Comapany NameVera Therapeutics, Inc.
Office of Life
Sciences
April 14, 2021 Page 3
cc: Jodie Bourdet
FirstName LastName