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United States securities and exchange commission logo
January 27, 2023
Frederic Guerard, Pharm.D.
President and Chief Executive Officer
Graybug Vision, Inc.
203 Redwood Shores Parkway, Suite 620
Redwood City, CA 94065
Re: Graybug Vision,
Inc.
Amendment No. 1 to
Preliminary Proxy Statement on Schedule 14A
Filed January 20,
2023
File No. 001-39538
Dear Frederic Guerard:
We have reviewed your filing 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 these comments within ten business days by
providing the requested
information or advise us as soon as possible when you will respond. If
you do not believe our
comments apply to your facts and circumstances, please tell us why in
your response.
After reviewing your
response to these comments, we may have additional comments.
Amendment No. 1 to Preliminary Proxy Statement on Schedule 14A filed
January 20, 2023
Financial Analyses of CalciMedica, page 109
1. We note your revised
disclosure in response to prior comment 6. Please continue to revise
your disclosure to
address the portion of our prior comment that requested you describe
whether Piper Sandler
considered the number of product candidates each company was
developing, the
clinical development of each product candidate for each indication and
how Piper Sandler
considered the addressable market (including the expected dosing
period of Auxora) in
the selection criteria since CalMedica appears to be pursuing acute
indications where the
dosing period could be shorter than the comparison indications.
Certain Unaudited Financial Projections and Liquidation Analysis, page
119
2. Your revised disclosure
indicates that financial projections were prepared by the
management of
CalciMedica and feedback was provided by the management of Graybug,
and that following such
feedback, CalciMedica sent revised projections to Piper Sandler.
Frederic Guerard, Pharm.D.
FirstName LastNameFrederic Guerard, Pharm.D.
Graybug Vision, Inc.
Comapany
January 27,NameGraybug
2023 Vision, Inc.
January
Page 2 27, 2023 Page 2
FirstName LastName
As requested by our prior comment 7, please disclose the CalciMedica
financial
projections and indicate how those projections were revised following
feedback from
Graybug management and disclose the reasons for the material
differences.
3. We note your revised disclosure in response to prior comment 8 and
reissue in part. Your
disclosure in clause (iv) in the fourth paragraph on page 121
indicates that all projected
revenues were adjusted to reflect a 25% probability of success. Given
the range of data in
the BIO Publication, and that 17.2% of non-oncology phase 2 clinical
trials ultimately
receive FDA approval (page 12 of the report), please discuss the
reasonableness and risks
in assuming a 25% probability of success. Also, revise to state
whether the projections
considered future FDA approval of competitive products when accounting
for the
competitive landscape in the projections.
4. We note your disclosure that revenue projections were based on an
assumption that
pricing of your product candidates, if approved, would be based on the
avoided cost of
emergency care and hospitalization over time. As requested by prior
comment 8, please
provide a sufficient explanation for this assumption and ensure that
the level of detail
provided is sufficient for a shareholder to evaluate and understand
the reasonableness of
this assumption.
CalciMedica Business
Overview, page 185
5. We note your response to comment 13 and reissue. Please revise
throughout to provide
the basis for the statement that CalciMedica is "a leading company in
the discovery and
development of CRAC channel inhibitors."
6. We note your response to comment 14 and reissue in part. Please revise
to provide the
data supporting the claim that patients in the CRSPA trial had rapid
resolution of their
symptoms, including the typical timeframe for symptom resolution using
the current
standard of care and the data from the trial supporting the statement
that the resolution of
symptoms was "rapid."
Our Pipeline, page 186
7. We note your revised disclosure that you are currently conducting
CARPO, a Phase 2b
clinical trial in 216 patients with AP and accompanying SIRS, and plan
to conduct a
significant portion of the CARPO trial in India and have submitted to
the Central Drugs
Standard Control Organization the documents necessary to conduct the
trial in India and
are awaiting approval. Please revise to clarify the jurisdiction in
which you are
conducting the current CARPO trial and, if your trial is being
conducted in India, and the
documents for the trial are awaiting approval, please clarify the
regulatory status of your
current trial in India. For all other trials being conducted, or which
have been completed,
please indicate the regulatory jurisdiction of those trials.
8. Please revise your pipeline table to add a footnote stating the FDA
may require you to
Frederic Guerard, Pharm.D.
Graybug Vision, Inc.
January 27, 2023
Page 3
conduct a Phase 1 trial for your acute kidney injury indication.
Unaudited Pro Forma Condensed Combined Balance Sheet, page 267
9. Please revise to correct the total for other current liabilities. There
appears to be a cross
footing error.
We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.
You may contact Ibolya Ignat at 202-551-3636 or Daniel Gordon at
202-551-3486 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Daniel Crawford at 202-551-7767 or Tim Buchmiller at 202-551-3635 with
any other
questions.
Sincerely,
FirstName LastNameFrederic Guerard, Pharm.D.
Division of
Corporation Finance
Comapany NameGraybug Vision, Inc.
Office of Life
Sciences
January 27, 2023 Page 3
cc: Julia Forbess, Esq.
FirstName LastName