View:
United States securities and exchange commission logo
January 11, 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.
Preliminary Proxy
Statement on Schedule 14A
Filed December 14,
2022
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.
Preliminary Proxy Statement on Schedule 14A filed December 14, 2022
CalciMedica, Inc., page 10
1. We note your disclosure
that Auxora has demonstrated a favorable safety profile. Please
note that
determinations of safety and efficacy are solely within the authority of the
FDA
and comparable
regulatory bodies; therefore, please revise your prospectus to remove all
references and/or
implications of safety and efficacy.
Summary
Private Placement, page 17
2. We note your
description of the securities purchase agreement here and on page 156. In
your description of the
agreement, please identify each purchaser who is purchasing
shares pursuant to such
agreement and who is expected to be a beneficial owner of 5% or
more of the outstanding
shares of the combined company following the financing and
merger.
Frederic Guerard, Pharm.D.
Graybug Vision, Inc.
January 11, 2023
Page 2
Risks Related to the Merger, page 23
3. We note your disclosure on page 143 that the representations and
warranties contained in
the merger agreement will terminate at the effective time of the
merger. Please include
appropriate risk factor disclosure.
The bylaws of the combined company will provide that the Court of Chancery of
the State of
Delaware is the exclusive forum..., page 90
4. Please revise your risk factor to disclose that there is also a risk
that your
exclusive forum provision may result in increased costs for
stockholders to bring a claim.
Opinion of Graybug's Financial Advisor, page 106
5. Please supplementally provide us with copies of all materials prepared
by Piper Sandler
and shared with your board of directors and their representatives,
including any board
books, transcripts and summaries of oral presentations, that were
material to the board's
decision to approve the merger and the transactions contemplated
thereby.
Financial Analyses of CalciMedica, page 108
6. Please revise to disclose whether Piper Sandler excluded any companies
or transactions
meeting the selection criteria from its selected public companies
analysis and its selected
IPOs analysis. If so, revise to state why Piper Sandler excluded the
companies or
transactions. If Piper Sandler used additional factors in its
selection criteria other than
professional judgment and companies with small molecule drug
development that targeted
specialty indications (excluding oncology) with lead product
candidates in Phase 2 stage
clinical trials, discuss those factors. For example, without
limitation, 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.
Discounted Cash Flows Analysis, page 110
7. Please expand your disclosure here to provide the industry standards
published by BIO of
the statistical probability in achieving specified development
milestones by biotechnology
companies that Graybug used to adjust CalciMedica's estimates. Revise to
explain how
Graybug applied these statistical probabilities to adjust the
CalciMedica projections.
Revise to provide the CalciMedica projections provided to the Board and
the data and
FirstName LastNameFrederic Guerard, Pharm.D.
assumptions underlying those projections. Discuss why you considered
projections
Comapany NameGraybug
extending over a 16Vision, Inc. to be reasonable given CalciMedica
s current stage of
year period
Januarydevelopment.
11, 2023 Page 2
FirstName LastName
Frederic Guerard, Pharm.D.
FirstName LastNameFrederic Guerard, Pharm.D.
Graybug Vision, Inc.
Comapany
January 11,NameGraybug
2023 Vision, Inc.
January
Page 3 11, 2023 Page 3
FirstName LastName
Graybug-Adjusted CalciMedica Management Projections, page 117
8. Disclose and explain the bases for and the nature of the material
assumptions referenced
in the first full paragraph on page 118 that underlie the line items
presented in the
Financial Projections summary table. Please ensure that the level of
detail provided is
sufficient for a shareholder to evaluate and understand the
reasonableness of the
assumptions, uncertainties and/or contingencies underlying the
projections as well as the
inherent limitations on the reliability of projections in order to
make informed decisions.
In regard to the total revenue and EBITDA projected amounts, please
specifically address
the growth rates as well as disclose your assumptions as to which
product candidates were
assumed to have received approvals and identify the jurisdictions in
which such approvals
were assumed to be received by period. Clearly disclose the limitation
that regulatory
approval is outside of your control.
9. You note on page 118 that the Financial Projections cover multiple
years, and that this
information by its nature becomes subject to greater uncertainty with
each successive
year. With respect to the length of the projections, please disclose
the basis for
projections beyond year five, including if the forecasts reflect more
than simple
assumptions about growth rates. Explain how management and the board
relied upon the
Financial Projections and how they determined that they are
reasonable, particularly in
light of the extensive length of the forecasts and since CalciMedica
is a clinical stage
company with limited operations and no approved products.
Specifically, address the
reliability of the projections related to the later years presented.
Conditions to the Completion of the Merger, page 136
10. Please clarify whether the CalciMedica private placement for an
aggregate purchase price
of $10.3 million is a condition to closing and, if so, whether such
condition is waivable.
Plan Administration, page 170
11. We note your disclosure that the combined company s board of
directors generally has the
authority, without the approval of stockholders, to reprice
outstanding options or stock
appreciation rights. Please include appropriate disclosure as to
whether proxy advisory
firms could find such repricing without stockholder approval contrary
to a performance-
based pay philosophy.
CalciMedica Business
Overview, page 183
12. Please revise to remove statements that CalciMedica is developing
first-in-class
therapeutics as such statement are speculative given CalciMedica s
current stage of
development.
Frederic Guerard, Pharm.D.
FirstName LastNameFrederic Guerard, Pharm.D.
Graybug Vision, Inc.
Comapany
January 11,NameGraybug
2023 Vision, Inc.
January
Page 4 11, 2023 Page 4
FirstName LastName
13. We note CalciMedica states on pages 183, 188, and 244 that it believes
it is the leading
company in the discovery and development of CRAC channel inhibitors.
Please revise to
provide the basis for this statement.
14. We note the statement on page 183 and elsewhere regarding
CalciMedica's CRSPA trial
that "all patients who have received a full course of therapy have had
rapid resolution of
their symptoms." Please revise to provide the data supporting this
claim, including the
typical timeframe for symptom resolution using the current standard of
care. Please also
indicate whether the results of this trial for the first cohort were
statistically significant.
15. We note your disclosure on page 183 and elsewhere that you intend to
seek an accelerated
approval designation from the FDA. Please revise to include balancing
disclosure that an
accelerated approval pathway may not lead to a faster development or
regulatory review
or approval process and does not increase the likelihood that your
product candidate will
receive marketing approval.
Our Pipeline, page 184
16. We note your disclosure on page 39 that you plan to conduct a
significant portion of the
ongoing CARPO trial in India. Please revise to disclose the regulatory
status and any
development and marketing plans for CalciMedica s product candidates
for AP in
India. To the extent that you are conducting your clinical trials in
foreign jurisdictions
and plan to seek FDA approval, please include risk factor disclosure
indicating that the
FDA may require you to conduct additional trials if it does not accept
data from your trials
or believes that additional data is necessary to supplement your trial
data.
Auxora for the treatment of Acute Kidney Injury, page 186
17. Please disclose the basis for your disclosure that you may be in a
position to initiate a
Phase 2 trial for your acute kidney injury indication without having
to conduct a phase 1
clinical trial.
Auxora, a Selective CRAC Channel Inhibitor, page 192
18. Please revise your disclosure on page 192 to remove the statement that
Auxora is
particularly well-suited for the treatment of acute critical illnesses
because it creates an
improper inference that Auxora is safe and effective and such
determinations may only be
made by the FDA or similar regulator.
Unaudited Pro Forma Condensed Combined Financial Statements, page 261
19. You disclose that while Graybug is planning to to sell its technology,
such sale has not
been finalized as of the date of your proxy statement, and is only
expected to occur shortly
after the consummation of the planned merger. Accordingly, the sale
transaction is not
reflected in the unaudited pro forma condensed combined financial
statements. Please tell
us why you believe the merger should be accounted for as a reverse
recapitalization, and
Frederic Guerard, Pharm.D.
Graybug Vision, Inc.
January 11, 2023
Page 5
your consideration of accounting for the transaction under ASC 805, given
that Graybug
Vision Inc. does not appear to be a public shell. Explain to us your
consideration of the
criteria in ASC 805-10-55-10 through 55-15 in establishing the accounting
for the planned
merger. In addition, please tell us why it was considered appropriate to
not present pro
forma adjustments for non-recurring items separately.
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 11, 2023 Page 5
cc: Julia Forbess, Esq.
FirstName LastName