# EDGAR Filing Document

**Accession Number:** 0001534133
**File Stem:** 0000000000-23-000929
**Filing Date:** 2023-1
**Character Count:** 14645
**Document Hash:** dfb9c46bcb14f294d585830751558b79
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000000000-23-000929.hdr.sgml**: 20230316

**ACCESSION NUMBER**: 0000000000-23-000929

**CONFORMED SUBMISSION TYPE**: UPLOAD

**PUBLIC DOCUMENT COUNT**: 2

**FILED AS OF DATE**: 20230127

**FILED FOR**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** GRAYBUG VISION, INC.
- **CENTRAL INDEX KEY:** 0001534133
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 452120079
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** UPLOAD

**BUSINESS ADDRESS:**
- **STREET 1:** 274 REDWOOD SHORES PARKWAY
- **STREET 2:** P.O. BOX 144
- **CITY:** REDWOOD CITY
- **STATE:** CA
- **ZIP:** 94065
- **BUSINESS PHONE:** 650-487-2800

**MAIL ADDRESS:**
- **STREET 1:** 274 REDWOOD SHORES PARKWAY
- **STREET 2:** P.O. BOX 144
- **CITY:** REDWOOD CITY
- **STATE:** CA
- **ZIP:** 94065

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** GRAYBUG, Inc.
- **DATE OF NAME CHANGE:** 20150303

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** GRAYBUG LLC
- **DATE OF NAME CHANGE:** 20111102

## Text-Extract

```

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

```

### Attached PDF Documents

**Attachment 1:** `filename1`

![img-0.jpeg](img-0.jpeg)

CORPORATION FINANCE

# UNITED STATES  
SECURITIES AND EXCHANGE COMMISSION  
WASHINGTON, D.C. 20549

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.
Graybug Vision, Inc.
January 27, 2023
Page 2

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,

Division of Corporation Finance
Office of Life Sciences

cc: Julia Forbess, Esq.