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CalciMedica, Inc. (CALC) (CIK 0001534133)
Response Received
1 company response(s)
High - file number match
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CalciMedica, Inc. (CALC) (CIK 0001534133)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-02-06
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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Company responded
2024-02-07
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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CalciMedica, Inc. (CALC) (CIK 0001534133)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-08-15
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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Company responded
2023-08-16
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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CalciMedica, Inc. (CALC) (CIK 0001534133)
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-04-10
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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Company responded
2023-04-12
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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CalciMedica, Inc. (CALC) (CIK 0001534133)
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-02-10
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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CalciMedica, Inc. (CALC) (CIK 0001534133)
Response Received
4 company response(s)
High - file number match
Company responded
2020-09-22
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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SEC wrote to company
2023-01-11
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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Company responded
2023-01-20
CalciMedica, Inc. (CALC) (CIK 0001534133)
References: January 11, 2023
Summary
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Company responded
2023-01-31
CalciMedica, Inc. (CALC) (CIK 0001534133)
References: January 27, 2023
Summary
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Company responded
2023-02-06
CalciMedica, Inc. (CALC) (CIK 0001534133)
References: February 3, 2023
Summary
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CalciMedica, Inc. (CALC) (CIK 0001534133)
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-02-03
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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CalciMedica, Inc. (CALC) (CIK 0001534133)
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-01-27
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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CalciMedica, Inc. (CALC) (CIK 0001534133)
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2020-08-28
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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Company responded
2020-09-04
CalciMedica, Inc. (CALC) (CIK 0001534133)
References: August 27, 2020
Summary
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Company responded
2020-09-08
CalciMedica, Inc. (CALC) (CIK 0001534133)
References: August 27, 2020
Summary
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Company responded
2020-09-22
CalciMedica, Inc. (CALC) (CIK 0001534133)
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-09 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | La Jolla, CA | N/A | Read Filing View |
| 2026-03-06 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | La Jolla, CA | 333-293972 | Read Filing View |
| 2024-02-07 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2024-02-06 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | 333-276793 | Read Filing View |
| 2023-08-16 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-08-15 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-04-12 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-04-10 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-02-10 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-02-03 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-01-31 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-01-27 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-01-20 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-01-11 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2020-09-22 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2020-09-22 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2020-09-08 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2020-09-04 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2020-08-28 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-06 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | La Jolla, CA | 333-293972 | Read Filing View |
| 2024-02-06 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | 333-276793 | Read Filing View |
| 2023-08-15 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-04-10 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-02-10 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-02-03 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-01-27 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-01-11 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2020-08-28 | SEC Comment Letter | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-09 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | La Jolla, CA | N/A | Read Filing View |
| 2024-02-07 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-08-16 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-04-12 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-02-06 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-01-31 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2023-01-20 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2020-09-22 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2020-09-22 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2020-09-08 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
| 2020-09-04 | Company Response | CalciMedica, Inc. (CALC) (CIK 0001534133) | DE | N/A | Read Filing View |
2026-03-09 - CORRESP - CalciMedica, Inc. (CALC) (CIK 0001534133)
CORRESP 1 filename1.htm CORRESP CALCIMEDICA, INC. 505 Coast Boulevard South, Suite 307 La Jolla, CA 92037 March 9, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Lauren S. Hamill RE: CalciMedica, Inc. Registration Statement on Form S-3 File No. 333-293972 Ladies and Gentlemen: CalciMedica, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on March 11, 2026, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Carlos Ramirez of Cooley LLP and Brittany Wightman of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Carlos Ramirez at (858) 550-6157, or in his absence, Brittany Wightman of Cooley LLP at (858) 550-6132. Very truly yours, CALCIMEDICA, INC. By: /s/ A. Rachel Leheny, Ph.D. Name: A. Rachel Leheny, Ph.D. Title: Chief Executive Officer cc: John Dunn, CalciMedica, Inc. Carlos Ramirez, Cooley LLP Brittany Wightman, Cooley LLP
2026-03-06 - UPLOAD - CalciMedica, Inc. (CALC) (CIK 0001534133) File: 333-293972
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
March 6, 2026
A. Rachel Leheny
Chief Executive Officer
CalciMedica, Inc.
505 Coast Boulevard South, Suite 307
La Jolla, CA 92037
Re: CalciMedica, Inc.
Registration Statement on Form S-3
Filed March 3, 2026
File No. 333-293972
Dear A. Rachel Leheny:
This is to advise you that we have not reviewed and will not review your
registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration.
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.
Please contact Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Carlos Ramirez
</TEXT>
</DOCUMENT>
2024-02-07 - CORRESP - CalciMedica, Inc. (CALC) (CIK 0001534133)
CORRESP 1 filename1.htm CORRESP CALCIMEDICA, INC. 505 Coast Boulevard South, Suite 307 La Jolla, CA 92037 February 7, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Mr. Tyler Howes RE: CalciMedica, Inc. Registration Statement on Form S-3 File No. 333-276793 Ladies and Gentlemen: CalciMedica, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on February 9, 2024, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Carlos Ramirez of Cooley LLP and Brittany Wightman of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Carlos Ramirez at (858) 550-6157, or in his absence, Brittany Wightman of Cooley LLP at (858) 550-6132. Very truly yours, CALCIMEDICA, INC. By: /s/ A. Rachel Leheny Name: A. Rachel Leheny, Ph.D. Title: Chief Executive Officer cc: John Dunn, CalciMedica, Inc. Carlos Ramirez, Cooley LLP Brittany Wightman, Cooley LLP
2024-02-06 - UPLOAD - CalciMedica, Inc. (CALC) (CIK 0001534133) File: 333-276793
United States securities and exchange commission logo
February 6, 2024
A. Rachel Leheny, Ph.D.
Chief Executive Officer
CalciMedica, Inc.
505 Coast Boulevard South, Suite 307
La Jolla, CA 92037
Re:CalciMedica, Inc.
Registration Statement on Form S-3
Filed January 31, 2024
File No. 333-276793
Dear A. Rachel Leheny:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Carlos Ramirez, Esq.
2023-08-16 - CORRESP - CalciMedica, Inc. (CALC) (CIK 0001534133)
CORRESP 1 filename1.htm CORRESP CALCIMEDICA, INC. 505 Coast Boulevard South, Suite 307 La Jolla, CA 92037 August 16, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Mr. Jimmy McNamara RE: CalciMedica, Inc. Registration Statement on Form S-3 File No. 333-273949 Ladies and Gentlemen: CalciMedica, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on August 18, 2023, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Carlos Ramirez of Cooley LLP and Rachel Lydon of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Carlos Ramirez at (858) 550-6157, or in his absence, Rachel Lydon of Cooley LLP at (858) 550-6107. Very truly yours, CALCIMEDICA, INC. By: /s/ A. Rachel Leheny, Ph.D. Name: A. Rachel Leheny, Ph.D. Title: Chief Executive Officer cc: John Dunn, CalciMedica, Inc. Carlos Ramirez, Cooley LLP Rachel Lydon, Cooley LLP
2023-08-15 - UPLOAD - CalciMedica, Inc. (CALC) (CIK 0001534133)
United States securities and exchange commission logo
August 15, 2023
Rachel Leheny
Chief Executive Officer
CalciMedica, Inc.
505 Coast Boulevard South, Suite 307
La Jolla, CA 92037
Re:CalciMedica, Inc.
Registration Statement on Form S-3
Filed August 11, 2023
File No. 333-273949
Dear Rachel Leheny:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Jimmy McNamara at 202-551-7349 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Tom Coll
2023-04-12 - CORRESP - CalciMedica, Inc. (CALC) (CIK 0001534133)
CORRESP 1 filename1.htm CORRESP CALCIMEDICA, INC. 505 Coast Boulevard South, Suite 307 La Jolla, CA 92037 April 12, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Ms. Cindy Polynice RE: CalciMedica, Inc. Registration Statement on Form S-3 File No. 333-271115 Ladies and Gentlemen: CalciMedica, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on April 14, 2023, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes Carlos Ramirez of Cooley LLP and Christine Turner of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Carlos Ramirez at (858) 550-6157, or in his absence, Christine Turner of Cooley LLP at (720) 566-4163. Very truly yours, CALCIMEDICA, INC. By: /s/ A. Rachel Leheny, Ph.D. Name: A. Rachel Leheny, Ph.D. Title: Chief Executive Officer cc: John Dunn, CalciMedica, Inc. Carlos Ramirez, Cooley LLP Christine Turner, Cooley LLP
2023-04-10 - UPLOAD - CalciMedica, Inc. (CALC) (CIK 0001534133)
United States securities and exchange commission logo
April 10, 2023
Dr. A. Rachel Leheny
Chief Executive Officer
CalciMedica, Inc.
505 Coast Boulevard South, Suite 307
La Jolla, California 92037
Re:CalciMedica, Inc.
Registration Statement on Form S-3
Filed April 4, 2023
File No. 333-271115
Dear Dr. A. Rachel Leheny:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. 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.
Please contact Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Carlos Ramirez, Esq.
2023-02-10 - UPLOAD - CalciMedica, Inc. (CALC) (CIK 0001534133)
United States securities and exchange commission logo
February 10, 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 completed our review of your filing. 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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Julia Forbess, Esq.
2023-02-06 - CORRESP - CalciMedica, Inc. (CALC) (CIK 0001534133)
CORRESP 1 filename1.htm SEC Response Letter 555 California Street 12th Floor San Francisco, CA 94104 415.875.2300 Fenwick.com Julia Forbess jforbess@fenwick.com | 415.875.2420 February 6, 2023 VIA EDGAR AND OVERNIGHT DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, DC 20549 Attention: Ibolya Ignat Daniel Gordon Daniel Crawford Tim Buchmiller Re: Graybug Vision, Inc. Amendment No. 2 to Preliminary Proxy Statement on Schedule 14A Filed January 31, 2023 File No. 001-39538 Ladies and Gentlemen: On behalf of Graybug Vision, Inc. (the “Company”), we are concurrently transmitting herewith the Company’s Third Revised Preliminary Proxy Statement on Schedule 14A (the “Third Revised Preliminary Proxy Statement”). In this letter, we respond to the comments of the staff of the Commission (the “Staff”) contained in the Staff’s letter dated February 3, 2023 (the “Letter”) regarding the Company’s Amendment No. 2 to Preliminary Proxy Statement on Schedule 14A as confidentially submitted by the Company to the U.S. Securities and Exchange Commission (the “Commission”) on January 31, 2023. The numbered paragraphs below correspond to the numbered comments in the Letter, and the Staff’s comments are presented in bold italics. Capitalized terms used in this letter but not otherwise defined herein have the meanings set forth in the PRER14A. U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller February 6, 2023 Page 2 Amendment No. 2 to Preliminary Proxy Statement on Schedule 14A filed January 31, 2023 Graybug’s Reasons for the Merger Recommendations of the Graybug Board, page 104 1. We note your response to comment 1. Please revise to disclose how the board, in recommending the business combination, considered the fact that the selected public companies analysis and selected IPOs analysis did not take into consideration the number of product candidates each company was developing, the stage of clinical development of each product candidate for each indication, and the potential addressable market including the expected dosing period of Auxora. In response to the Staff’s comment, the Company has revised its disclosure on page 105 of the Third Revised Preliminary Proxy Statement. Graybug Management Liquidation Analysis, page 122 2. We note your response to comment 3 and reissue in part. Given that Piper Sandler assumed a 25% chance of success and that FDA approval is a yes or no decision, it appears Piper Sandler applied a probability of success adjustment that indicated it was more probable that Auxora would not be approved by the FDA and that it was more probable to not generate any revenues. Please revise to disclose how the board took this into consideration in recommending the business combination. In response to the Staff’s comment, the Company has revised its disclosure on page 121 of the Third Revised Preliminary Proxy Statement. * * * * * * * 2 U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller February 6, 2023 Page 3 Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (415) 875-2420, or, in her absence, Rob Freedman at (206) 389-4524. Sincerely, /s/ Julia Forbess Julia Forbess FENWICK & WEST LLP Cc Frederic Guerard, Pharm.D., Chief Executive Officer Robert S. Breuil, Chief Financial Officer Graybug Vision, Inc. Effie Toshav, Esq. Rob Freedman, Esq. Fenwick & West LLP A. Rachel Leheny, Ph.D., Chief Executive Officer CalciMedica, Inc. Carlos Ramirez, Esq. Cooley LLP 3
2023-02-03 - UPLOAD - CalciMedica, Inc. (CALC) (CIK 0001534133)
United States securities and exchange commission logo
February 3, 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. 2 to Preliminary Proxy Statement on Schedule 14A
Filed January 31, 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. 2 to Preliminary Proxy Statement on Schedule 14A filed January 31, 2023
Graybug's Reasons for the Merger Recommendations of the Graybug Board, page 104
1.We note your response to comment 1. Please revise to disclose how the board, in
recommending the business combination, considered the fact that the selected public
companies analysis and selected IPOs analysis did not take into consideration the number
of product candidates each company was developing, the stage of clinical development of
each product candidate for each indication, and the potential addressable market including
the expected dosing period of Auxora.
Graybug Management Liquidation Analysis, page 122
2.We note your response to comment 3 and reissue in part. Given that Piper Sandler
assumed a 25% chance of success and that FDA approval is a yes or no decision, it
appears Piper Sandler applied a probability of success adjustment that indicated it was
more probable that Auxora would not be approved by the FDA and that it was more
FirstName LastNameFrederic Guerard, Pharm.D.
Comapany NameGraybug Vision, Inc.
February 3, 2023 Page 2
FirstName LastName
Frederic Guerard, Pharm.D.
Graybug Vision, Inc.
February 3, 2023
Page 2
probable to not generate any revenues. Please revise to disclose how the board took this
into consideration in recommending the business combination.
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.
2023-01-31 - CORRESP - CalciMedica, Inc. (CALC) (CIK 0001534133)
CORRESP 1 filename1.htm SEC Response Letter Julia Forbess jforbess@fenwick.com | 415.875.2420 January 31, 2023 VIA EDGAR AND OVERNIGHT DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, DC 20549 Attention: Ibolya Ignat Daniel Gordon Daniel Crawford Tim Buchmiller Re: Graybug Vision, Inc. Amendment No. 1 to Preliminary Proxy Statement on Schedule 14A Filed January 20, 2023 File No. 001-39538 Ladies and Gentlemen: On behalf of Graybug Vision, Inc. (the “Company”), we are concurrently transmitting herewith the Company’s Second Revised Preliminary Proxy Statement on Schedule 14A (the “Second Revised Preliminary Proxy Statement”). In this letter, we respond to the comments of the staff of the Commission (the “Staff”) contained in the Staff’s letter dated January 27, 2023 (the “Letter”) regarding the Company’s Amendment No. 1 to Preliminary Proxy Statement on Schedule 14A as submitted by the Company to the U.S. and Exchange Commission (the “Commission”) on January 20, 2023. The numbered paragraphs below correspond to the numbered comments in the Letter, and the Staff’s comments are presented in bold italics. Capitalized terms used in this letter but not otherwise defined herein have the meanings set forth in the Second Revised Preliminary Proxy Statement. U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller January 31, 2023 Page 2 Amendment No. 1 to Preliminary Proxy Statement on Schedule 14A filed January 20, 2023 Financial Analyses of CalciMedica, Inc., 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. In response to the Staff’s comment, the Company has revised its disclosure on pages 109 and 111 of the Second Revised Preliminary Proxy Statement. Certain Unaudited Financial Projections from 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. 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. In response to the Staff’s comment, the Company has revised its disclosure on pages 121 and 122 of the Second Revised Preliminary Proxy Statement. 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. In response to the Staff’s comment, the Company has revised its disclosure on pages 112 and 122 of the Second Revised Preliminary Proxy Statement, to clarify and reflect that the 25% probability of success adjustment was based on metabolic disorders (page 11 of the BIO Publication), as opposed to non-oncology (page 12 of the report). In response to the Staff’s comment regarding whether the projections considered future FDA approval of competitive products when accounting for the competitive landscape in the projections, the Company has revised its disclosure on pages 120 and 122 of the Second Revised Preliminary Proxy Statement. 2 U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller January 31, 2023 Page 3 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. In response to the Staff’s comment, the Company has revised its disclosure on page 120 of the Second Revised Preliminary Proxy Statement. 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.” In response to the Staff’s comment, the Company has revised its disclosure on pages 187, 192 and 249 of the Second Revised Preliminary Proxy Statement. 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.” In response to the Staff’s comment, the Company has revised its disclosure on pages 187, 188, 190, 206 and 250 of the Second Revised Preliminary Proxy Statement. 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. In response to the Staff’s comment, the Company has revised its disclosure on pages 39, 41, 187, 189, 190 and 192 of the Second Revised Preliminary Proxy Statement. 3 U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller January 31, 2023 Page 4 8. Please revise your pipeline table to add a footnote stating the FDA may require you to conduct a Phase 1 trial for your acute kidney injury indication. In response to the Staff’s comment, the Company has revised its disclosure on page 189 of the Second Revised Preliminary Proxy Statement. 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. In response to the Staff’s comment, the Company has revised its disclosure on page 269 of the Second Revised Preliminary Proxy Statement. * * * * * * * 4 U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller January 31, 2023 Page 5 Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (415) 875-2420, or, in her absence, Rob Freedman at (206) 389-4524. Sincerely, /s/ Julia Forbess Julia Forbess FENWICK & WEST LLP Cc Frederic Guerard, Pharm.D., Chief Executive Officer Robert S. Breuil, Chief Financial Officer Graybug Vision, Inc. Effie Toshav, Esq. Rob Freedman, Esq. Fenwick & West LLP A. Rachel Leheny, Ph.D., Chief Executive Officer CalciMedica, Inc. Carlos Ramirez, Esq. Cooley LLP 5
2023-01-27 - UPLOAD - CalciMedica, Inc. (CALC) (CIK 0001534133)
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.
FirstName LastNameFrederic Guerard, Pharm.D.
Comapany NameGraybug Vision, Inc.
January 27, 2023 Page 2
FirstName LastNameFrederic 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
FirstName LastNameFrederic Guerard, Pharm.D.
Comapany NameGraybug Vision, Inc.
January 27, 2023 Page 3
FirstName LastName
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.
2023-01-20 - CORRESP - CalciMedica, Inc. (CALC) (CIK 0001534133)
CORRESP 1 filename1.htm CORRESP 555 California Street 12th Floor San Francisco, CA 94104 415.875.2300 Fenwick.com Julia Forbess jforbess@fenwick.com | 415.875.2420 January 20, 2023 VIA EDGAR AND OVERNIGHT DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, DC 20549 Attention: Ibolya Ignat Daniel Gordon Daniel Crawford Tim Buchmiller Re: Graybug Vision, Inc. Preliminary Proxy Statement on Schedule 14A Filed December 14, 2022 File No. 001-39538 Ladies and Gentlemen: On behalf of Graybug Vision, Inc. (the “Company”), we are concurrently transmitting herewith the Company’s Revised Preliminary Proxy Statement on Schedule 14A (the “Revised Preliminary Proxy Statement”). In this letter, we respond to the comments of the staff of the Commission (the “Staff”) contained in the Staff’s letter dated January 11, 2023 (the “Letter”) regarding the Company’s Preliminary Proxy Statement on Schedule 14A as submitted by the Company to the U.S. Securities and Exchange Commission (the “Commission”) on December 14, 2022. The numbered paragraphs below correspond to the numbered comments in the Letter, and the Staff’s comments are presented in bold italics. Capitalized terms used in this letter but not otherwise defined herein have the meanings set forth in the Revised Preliminary Proxy Statement. U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller January 20, 2023 Page 2 Preliminary Proxy Statement on Schedule 14A 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. In response to the Staff’s comment, the Company has revised the prospectus to remove all references and/or implications of safety and efficacy on page 10 of the Revised Preliminary Proxy Statement. 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. In response to the Staff’s comment, the Company has revised its disclosure on pages 157 and 158 of the Revised Preliminary Proxy Statement. 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. In response to the Staff’s comment, the Company has revised its disclosure on page 28 of the Revised Preliminary Proxy Statement. 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. 2 U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller January 20, 2023 Page 3 In response to the Staff’s comment, the Company has revised its disclosure on pages 91 and page 92 of the Revised Preliminary Proxy Statement. 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. In response to the Staff’s comment, the confidential materials prepared by Piper Sandler since July 1, 2022 as presented to the board of directors of the Company (the “Graybug Board”) is being provided directly to the Staff by O’Melveny & Myers LLP, as counsel to Piper Sander, under separate cover on a confidential and supplemental basis pursuant to Rule 12b-4 under the Securities Exchange Act of 1934, as amended (the “Rule”). In accordance with such Rule, such materials are being provided together with a request that these materials be returned promptly following completion of the Staff’s review thereof. Such materials are not, and will not be, filed with or deemed to be part of the Revised Preliminary Proxy Statement, including any revisions or amendments thereto. By separate letter, request for confidential treatment of these materials pursuant to the provisions of 17 C.F.R. §200.83 will be made by Piper Sander. 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. In response to the Staff’s comment, the Company has revised its disclosure on pages 109 and 111 of the Revised Preliminary Proxy Statement. 3 U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller January 20, 2023 Page 4 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 assumptions underlying those projections. Discuss why you considered projections extending over a 16 year period to be reasonable given CalciMedica’s current stage of development. In response to the Staff’s comment regarding the BIO adjustments, the Company has revised its disclosure on page 112 of the Revised Preliminary Proxy Statement. Additionally, the Company has revised pages 119 and 120 of the Revised Preliminary Proxy Statement to describe the assumptions underlying the Financial Projections presented to the Graybug Board, including specified probability of success adjustments. In response to the Staff’s comment regarding the selection of a 16-year projection period, the Company has revised its disclosure on pages 112 and 120 of the Revised Preliminary Proxy Statement. 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. 4 U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller January 20, 2023 Page 5 In response to the Staff’s comment, the Company has revised its disclosures on page 119 of the Revised Preliminary Proxy Statement to reflect the fact that it was Piper Sandler that made the adjustments to the CalciMedica Inc. (“CalciMedica”) projections. In addition, the Company has revised its disclosure on pages 120 and 121 of the Revised Preliminary Proxy Statement to describe the assumptions underlying the Financial Projections and to disclose the limitation that regulatory approval is outside of CalciMedica’s 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. Please see the Company’s response to question 8, which the Company believes will adequately address the majority of the Staff’s disclosure request. With regard to how the Company’s management and Graybug Board relied upon the Financial Projections, the Company has revised its disclosure on pages 120 of the Revised Preliminary Proxy Statement. 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. In response to the Staff’s comment, the Company has revised its disclosure on pages 3, 17, 28, 33 and 157 of the Revised Preliminary Proxy Statement. 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. 5 U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller January 20, 2023 Page 6 In response to the Staff’s comment, the Company has revised its disclosure on pages 92, 93 and 172 of the Revised Preliminary Proxy Statement. 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. In response to the Staff’s comment, the Company has revised its disclosure on pages 10, 185, 190 and 247 of the Revised Preliminary Proxy Statement. 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. In response to the Staff’s comment, the Company has revised its disclosure on pages 185, 190 and 247 of the Revised Preliminary Proxy 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. In response to the Staff’s comment, the Company respectfully advises the Staff that the claim is a summary of the CRSPA trial results based on preliminary, unpublished data. Publication of the CRPSA trial data is planned for later this year. The Company has revised its disclosure on pages 185, 188, 204 and 248 of the Revised Preliminary Proxy Statement to state that the claim is a summary of the trial results based on preliminary, unpublished data and that this is a single arm open-label trial and no statistical analysis with a comparator group has been performed. 6 U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller January 20, 2023 Page 7 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. In response to the Staff’s comment, the Company has revised its disclosure on pages 186, 188, 190, 203, 204 and 248 of the Revised Preliminary Proxy Statement. 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. In response to the Staff’s comment, the Company has revised its disclosure on pages 41 and 188 of the Revised Preliminary Proxy Statement. 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. In response to the Staff’s comment, the Company has revised its disclosure on pages 188 and 209 of the Revised Preliminary Proxy Statement. 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. 7 U.S. Securities and Exchange Commission Attention: Ibolya Ignat, Daniel Gordon, Daniel Crawford, Tim Buchmiller January 20, 2023 Page 8 In response to the Staff’s comment, the Company has revised its disclosure on page 194 of the Revised Preliminary Proxy Statement. 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 expect
2023-01-11 - UPLOAD - CalciMedica, Inc. (CALC) (CIK 0001534133)
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.
FirstName LastNameFrederic Guerard, Pharm.D.
Comapany NameGraybug Vision, Inc.
January 11, 2023 Page 2
FirstName LastName
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
assumptions underlying those projections. Discuss why you considered projections
extending over a 16 year period to be reasonable given CalciMedica’s current stage of
development.
FirstName LastNameFrederic Guerard, Pharm.D.
Comapany NameGraybug Vision, Inc.
January 11, 2023 Page 3
FirstName LastName
Frederic Guerard, Pharm.D.
Graybug Vision, Inc.
January 11, 2023
Page 3
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.
FirstName LastNameFrederic Guerard, Pharm.D.
Comapany NameGraybug Vision, Inc.
January 11, 2023 Page 4
FirstName LastName
Frederic Guerard, Pharm.D.
Graybug Vision, Inc.
January 11, 2023
Page 4
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
FirstName LastNameFrederic Guerard, Pharm.D.
Comapany NameGraybug Vision, Inc.
January 11, 2023 Page 5
FirstName LastName
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,
Division of Corporation Finance
Office of Life Sciences
cc: Julia Forbess, Esq.
2020-09-22 - CORRESP - CalciMedica, Inc. (CALC) (CIK 0001534133)
CORRESP 1 filename1.htm CORRESP Graybug Vision, Inc. 275 Shoreline Drive, Suite 450 Redwood City, CA 94065 September 22, 2020 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Kristin Lochhead Lisa Vanjoske Jason L. Drory Mary Beth Breslin Re: Graybug Vision, Inc. Registration Statement on Form S-1 (File No. 333-248611) originally filed September 4, 2020, as amended, and corresponding Registration Statement on Form 8-A (File No. 001-39538) filed September 21, 2020 Requested Date: September 24, 2020 Requested Time: 4:00 PM Eastern Time Ladies and Gentlemen: Graybug Vision, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission take appropriate action to declare the above-captioned Registration Statements on Form S-1 and Form 8-A effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Robert Freedman or Julia Forbess, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Mr. Freedman at (650) 335-7292 or, in his absence, Ms. Forbess at (415) 875-2420. * * * Sincerely, GRAYBUG VISION, INC. By: /s/ Frederic Guerard, Pharm.D. Frederic Guerard, Pharm.D. Chief Executive Officer cc: Effie Toshav, Esq. Robert Freedman, Esq. Julia Forbess, Esq. Fenwick & West LLP [SIGNATURE PAGE TO COMPANY ACCELERATION REQUEST LETTER]
2020-09-22 - CORRESP - CalciMedica, Inc. (CALC) (CIK 0001534133)
CORRESP 1 filename1.htm CORRESP SVB Leerink LLC One Federal Street, 37th Floor Boston, Massachusetts 02110 Piper Sandler & Co. 800 Nicollet Mall, Suite 1000 Minneapolis, Minnesota 55402 September 22, 2020 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Graybug Vision, Inc. Acceleration Request for Registration Statement on Form S-1 File No. 333-248611 Dear Sir/Madam: Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several Underwriters, wish to advise you that approximately 750 copies of the Preliminary Prospectus included in the Registration Statement on Form S-1 were distributed during the period September 21, 2020 through the date hereof, to prospective underwriters, institutions, dealers and others. We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. In accordance with Rule 461 of the Act, we hereby join in the request of Graybug Vision, Inc. for acceleration of the effective date of the above-named Registration Statement so that it becomes effective at 4:00 p.m. Eastern Time on September 24, 2020, or as soon thereafter as practicable. [Remainder of page intentionally left blank] Very truly yours, By: SVB LEERINK LLC By: /s/ Irena Melnikova Name: Irena Melnikova, Ph.D. Title: Managing Director By: PIPER SANDLER & CO. By: /s/ Neil Riley Name: Neil Riley Title: Managing Director [Signature page to Acceleration Request Letter]
2020-09-08 - CORRESP - CalciMedica, Inc. (CALC) (CIK 0001534133)
CORRESP
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CORRESP
September 8, 2020
CERTAIN PORTIONS OF THIS LETTER AS FILED VIA EDGAR HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR THE OMITTED PORTIONS, WHICH HAVE BEEN REPLACED WITH THE FOLLOWING PLACEHOLDER: “[*].” THE OMITTED PORTIONS HAVE BEEN HIGHLIGHTED IN THIS UNREDACTED COPY OF THE LETTER FOR EASE OF
IDENTIFICATION.
VIA EDGAR AND OVERNIGHT DELIVERY
U.S. Securities and Exchange Commission
Division of Corporation
Finance
Office of Healthcare & Insurance
100 F
Street, NE
Washington, DC 20549
Attention: Kristin Lochhead
Lisa Vanjoske
Jason L. Drory
Mary Beth Breslin
Re: Graybug Vision, Inc.
Registration Statement on Form S-1
Filed September 4, 2020
File No. 333-248611
Ladies and Gentlemen:
On behalf of Graybug
Vision, Inc. (the “Company”), we submit this letter to assist the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in its review of the
Company’s Registration Statement on Form S-1 (File No. 333-248611) (the “Registration Statement”), to further address comment 8 of the
Staff set forth in its letter to the Company dated August 27, 2020, concerning valuation considerations related to the Company’s equity awards. For the convenience of the Staff, we are providing to the Staff by overnight delivery copies of
this letter.
Because of the commercially sensitive nature of information contained herein, this submission is accompanied by the
Company’s request for confidential treatment of selected portions of this letter pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83 and the Freedom of Information Act.
CONFIDENTIAL TREATMENT
REQUESTED BY GRAYBUG VISION, INC.
Securities and Exchange Commission
Division of Corporation Finance
September 8, 2020
Page
2
Preliminary IPO Price Range
The Company advises the Staff that the Company currently anticipates that it will include an expected price range in its preliminary prospectus
(the “Preliminary Prospectus”) for the proposed initial public offering (the “IPO”) that will be between approximately $[*] and $[*] per share (the “Preliminary Price Range”) of
the Company’s common stock, $0.0001 par value per share (the “Common Stock”), with a midpoint of the anticipated range of $[*] per share. The Company plans to effect a reverse stock split in connection with its IPO
pursuant to a future amendment of the Company’s certificate of incorporation that will be filed with the Secretary of State of the State of Delaware before filing the Preliminary Prospectus with the Commission (the “Stock
Split”). The Company expects to reflect the Stock Split in a pre-effective amendment to the Registration Statement that includes the actual price range; however, the share numbers and stock prices
set forth in this letter do not reflect the Stock Split and are all set forth on a pre-split basis.
The Preliminary Price Range has been determined based, in part, upon current market conditions, the Company’s current financial condition
and prospects, the Company’s progress in developing its pipeline of product candidates, recent public offerings of other comparable companies and input received from the lead underwriters of the proposed offering, including discussions that
took place on September [*], 2020 among senior management of the Company and representatives of SVB Leerink LLC and Piper Sandler & Co., the lead underwriters of the IPO. Prior to September 4, 2020, the Company had not held formal
discussions with the underwriters regarding a price range for the IPO. The Preliminary Price Range does not take into account the current lack of liquidity for the Common Stock and assumes a successful IPO with no weighting attributed to any
other outcome for the Company’s business, such as remaining a privately held company.
The Company expects to include a bona fide
price range in the Preliminary Prospectus (which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range) that would shortly precede the commencement of the Company’s public marketing process, which
it anticipates could occur as soon as [*]. Such price range could differ from the Preliminary Price Range based on then-current market conditions, continuing discussions with the lead underwriters and further business developments impacting the
Company. However, the Company believes that the foregoing indicative price range will not be subject to significant change.
Fair Value Determinations
Given the absence of an active market for the Common Stock, the Board of Directors of the Company (the
“Board”) was required to estimate the fair value of the Common Stock at the time of each equity-based award based upon several factors, including the Board’s consideration of input from management and third-party
valuations.
We supplementally advise the Staff that, as described on pages 85-88 of the
Registration Statement, for all periods prior to the IPO, the fair values of the Common Stock underlying the Company’s share-based awards were estimated on each grant date by the Board. To determine the fair value of the Common Stock underlying
option grants and other equity awards, the Board considered a variety of factors including, among other things, timely valuations of the Common Stock prepared by an independent third-party valuation firm in accordance with the guidance provided by
the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. Given the absence of a public trading market for the Common Stock,
the Board exercised reasonable judgment and considered a number of objective and subjective factors to determine the best estimate of the fair value of the Common Stock, including important developments in the Company’s operations, its stage of
development, valuations performed by an independent third party valuation firm, sales of the Company’s preferred stock, actual operating results and financial performance, the conditions in the life sciences and biotechnology industry sectors
and the economy in general, the stock price performance and volatility of comparable public companies, the lack of liquidity of the Common Stock, and the likelihood of achieving a liquidity event, such as an IPO or a sale of the Company.
CONFIDENTIAL TREATMENT
REQUESTED BY GRAYBUG VISION, INC.
2
Securities and Exchange Commission
Division of Corporation Finance
September 8, 2020
Page
3
The following table summarizes the grant of equity-based awards by the Company since
September 1, 2019:
Date of Grant
Number of
Shares Subject to
Equity-Based
Awards Granted
Exercise Price
Per Share
Fair Value
Per Share
Valuation Date
February 1, 2019
5,123,447
$
0.25
$
0.25
June 14, 2018
March 19, 2019
35,000
$
0.25
$
0.25
June 14, 2018
November 7, 2019
6,385,725
$
0.43
$
0.43
July 31, 2019
July 7, 2020
2,084,936
$
0.39
$
0.39
June 15, 2020
Summary of Methods Used
For each of the valuations, the Company employed a probability-weighted expected return method (“PWERM”) in combination
with an option pricing method (“OPM”), referred to as a hybrid method (“Hybrid Method”) to value the Common Stock. The Hybrid Method is appropriate when various possible future outcomes are assumed by
management of the Company. The outcomes are each assigned a probability, and a future equity value under each outcome is then estimated. Given that more than one possible future outcome was assumed for each of the valuations, the PWERM was used to
value the Common Stock for each valuation date.
The Hybrid Method is appropriate for a company expecting a near term liquidity event, but
where, due to market or other factors, the likelihood of completing the liquidity event is uncertain. The Hybrid Method considers a company’s going concern status, stage of development and the company’s ability to forecast near and
long-term future liquidity scenarios. The PWERM is a scenario-based analysis that estimates the value per share of Common Stock based on the probability-weighted present value of expected future equity values for the Common Stock, under various
possible future liquidity event scenarios, in light of the rights and preferences of each class and series of stock, discounted for a lack of marketability.
As part of the Hybrid Method, under certain scenarios, the OPM was used to estimate a value for the Company’s equity and allocate this
value among the Company’s securities using the back-solve method for inferring and allocating the equity value predicated on the most recent financing. The OPM is appropriate for a company at an early stage of development for which future
liquidity events are difficult to forecast. Application of the OPM back-solve method involves making assumptions for the expected time to liquidity, volatility and risk-free rate and then solving for the value of equity such that the value for the
referenced financing equals the amount paid.
CONFIDENTIAL TREATMENT
REQUESTED BY GRAYBUG VISION, INC.
3
Securities and Exchange Commission
Division of Corporation Finance
September 8, 2020
Page
4
Summary of Valuations
For the June 2018 valuation, the Company was valued under three scenarios: (1) OPM (80% probability); (2) IPO (10% probability); and
(3) Liquidation (10% probability). As of the June 2018 valuation, the Company had entered into preliminary discussions with investment banks regarding a potential IPO, but had not yet held an organizational meeting or hired any investment
banks. For the June 2018 valuation, the OPM allocation of total equity value was determined based on market R&D multiples and potential future sales values invested capital multiples, and calibrated to the Company’s add-on Series B convertible preferred stock financing (the “Series B Financing”) with existing investors that closed in May 2018. The Company assumed an 80% volatility rate and a two-year estimated term. The Company then reflected a probability weighted average to arrive at a $0.25 per share valuation. The Company also considered an IPO scenario reflecting the conversion of the preferred
stock to common stock at the time of the IPO, which was estimated to take place in early 2019 after expected receipt of additional Phase 1 clinical data. The valuation also incorporated a 38% discount for lack of marketability.
The Company advises the Staff that the Board determined the fair value of the shares of common stock underlying option awards granted in
February 2019 and March 2019 was $0.25 per share. At the time of these grants, the Board carefully considered all relevant information available to it, including the most recent valuation report from its third-party valuation firm, which concluded
that, as of June 14, 2018, the fair value of shares of the Company’s common stock was $0.25 per share. A retrospective valuation analysis for financial reporting purposes concluded that as of February 1, 2019, the fair value of the
shares of the Company’s common stock was $0.25 per share. The retrospective analysis took into account events in 2018 and 2019, including:
•
The completion of an open label Phase 1/2a study of GB-102 in January
2019 with mixed results;
•
No dose-limiting toxicities or ocular serious adverse events,
•
Some standard adverse events frequently seen in Wet AMD trials including vitreous floaters, and
•
9 out of 32 patients experiencing particle dispersion, with 5 of the 9 patients experiencing increased
intraocular pressure.
•
The Company’s modification of the GB-102 manufacturing approach
based on the interim results to enhance particle aggregation in late 2018 and early 2019, which approach had not yet been tested in humans.
•
The addition of a 20-patient open label trial to provide an interim
readout to validate the manufacturing enhancements related to particle aggregation, the results of which were not available as of February 1, 2019.
•
The Company’s ongoing attempt to raise additional capital to fund anticipated Phase 2b trials as of the
valuation date, at which time the Company had not secured a Series C term sheet.
For the July 2019 valuation, the
Company was valued under two scenarios: (1) OPM (85% probability); and (2) IPO (15% probability). At the time of the July 2019 valuation, the Company was still considering a potential IPO, but had not yet held an organizational meeting or
hired any investment banks. For the July 2019 valuation, the OPM allocation of total equity value was determined with reference to the contemporaneous Series C Financing, and the Company assumed a 75% volatility rate and a two-year estimated term. The Company also considered an IPO scenario reflecting the conversion of the preferred stock to common stock at the time of the IPO, which was estimated to take place in the third quarter of
2020. The valuation also incorporated a 34% discount for lack of marketability. The Company then reflected a probability weighted average to arrive at a $0.43 per share valuation.
CONFIDENTIAL TREATMENT
REQUESTED BY GRAYBUG VISION, INC.
4
Securities and Exchange Commission
Division of Corporation Finance
September 8, 2020
Page
5
For the June 2020 valuation, the Company was valued under two scenarios: (1) OPM (85%
probability); and (2) IPO (15% probability). At the time of the June 2020 valuation, the Company had hired lead investment banks and conducted an organizational meeting for the IPO, but had paused on the IPO process and had not yet
confidentially submitted an initial draft registration statement. For the June 2020 valuation, the OPM allocation of total equity value was determined based on market R&D multiples and potential future sales values invested capital multiples,
and calibrated to the Company’s Series C convertible preferred stock financing. The Company assumed an 85% volatility rate and a 1.5-year estimated term. The Company also considered an IPO scenario
reflecting the conversion of the preferred stock to common stock at the time of the IPO, which was estimated to take place in 2021 after expected receipt of additional clinical data. The valuation also incorporated a 27% discount for lack of
marketability. The Company then reflected a probability weighted average to arrive at a $0.39 per share valuation. The decline in value between valuation dates reflects the non-exercise by several Series C
investors of their option to purchase additional Series C convertible preferred stock milestone shares, the Company’s need for significant additional funding to complete clinical development of GB-102 and
potential delays in clinical trials due to COVID-19.
The Company has not granted any options
since July 7, 2020, and does not currently intend to grant any equity awards other than (i) to a new employee and an existing director at or around the time of the filing of the Preliminary Prospectus and valued at the mid-point of the range in the Preliminary Prospectus, (ii) to certain directors at pricing and valued at the public offering price of the IPO and (iii) restricted stock units to be issued to certain
officers of the Company upon the closing of the IPO. In each of (i), (ii) and (iii) the number of shares subject to such award is yet to be determined and will be issued pursuant to the equity incentive plans of the Company described in the
Registration Statement.
Comparison to Preliminary Assumed IPO Price
The Company submits that the primary reasons for the difference between the fair value per share used for the Company’s most recent stock
option grants and the midpoint of the Preliminary Price Range are:
•
Differences in the valuation methodologies, assumptions and inputs used by the underwriters in their valuation
analysis discussed with
2020-09-04 - CORRESP - CalciMedica, Inc. (CALC) (CIK 0001534133)
CORRESP
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CORRESP
Robert A. Freedman
rfreedman@fenwick.com | +1 650-335-7292
September 4, 2020
VIA EDGAR AND OVERNIGHT DELIVERY
U.S. Securities and Exchange Commission
Division of Corporation
Finance
Office of Life Sciences
100 F Street, NE
Washington, DC 20549
Attention: Kristin Lochhead
Lisa Vanjoske
Jason L. Drory
Mary Beth Breslin
Re:
Graybug Vision, Inc.
Draft Registration Statement on Form S-1
Submitted July 31, 2020
CIK No. 0001534133
Ladies and Gentlemen:
On behalf of Graybug Vision, Inc. (the
“Company”), we are concurrently transmitting herewith the Company’s Registration Statement on Form S-1 (the “Registration Statement”). In this letter, we
respond to the comments of the staff of the Commission (the “Staff”) contained in the Staff’s letter dated August 27, 2020 (the “Letter”) regarding the Company’s Confidential Draft
Registration Statement on Form S-1 as confidentially submitted by the Company to the U.S. Securities and Exchange Commission (the “Commission”) on July 31, 2020. The numbered
paragraphs below correspond to the numbered comments in the Letter, and the Staff’s comments are presented in bold italics.
In addition to
addressing the comments raised by the Staff in the Letter, the Company has revised the Registration Statement to update certain other disclosures, including the addition of the financial statements for the period ended June 30, 2020.
U.S. Securities and Exchange Commission
September 4, 2020
Page
2
Registration Statement on Form S-1
Our Pipeline, page 3
1.
Please shorten the arrows in your pipeline table to more precisely indicate the development status
of each product candidate. As one example, we note that you are currently conducting IND-enabling activities for GB-401 and expect to begin a Phase 1/2a
trial in the second half of 2021, yet the arrow indicates that you are already in Phase 1 development.
In
response to the Staff’s comment, the Company has revised the pipeline table on pages 3 and 91 of the Registration Statement.
Our Lead Program GB-102, page 4
2.
We note your statements on page 4 that GB-102 met its
primary endpoint of safety and tolerability in the ADAGIO trial and based on the data from ADAGIO you initiated a Phase 2b ALTISSIMO trial. Balance your disclosure here by disclosing that you terminated the development of the GB-102 2 mg dose in all of your clinical trials based on your safety analysis of your Phase 2a clinical trial of GB-102 in 21 patients with ME secondary to DME and
RVO.
In response to the Staff’s comment, the Company has revised its disclosure on pages 4 and 93 of the
Registration Statement.
Differentiation of our product candidates, page 5
3.
We note your statements throughout your filing that you believe
GB-102 and GB-103 may potentially be a “first-in-class” intravitreal injection.
Given the early stage of development, and your statements that your results in your preclinical studies may not be indicative of results obtained in later trials, these statements are overly speculative and inappropriate. Please remove these
statements from the descriptions of your product candidates.
In response to the Staff’s comment, the Company has
revised its disclosure on pages 4, 5, 93 and 95 of the Registration Statement.
Implications of Being an Emerging Growth Company and a Smaller
Reporting Company, page 7
4.
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.
2
U.S. Securities and Exchange Commission
September 4, 2020
Page
3
The Company acknowledges the Staff’s request and will supplementally provide the Staff with a copy of
any written communications it presents to potential investors in “testing-the-waters” meetings in reliance on Section 5(d) of the Securities Act of 1933,
as amended. The Company respectfully requests that the Staff destroy such materials upon completion of its review.
Risk Factors, page 13
5.
We note your references on page 21 and elsewhere that
GB-102 demonstrated a “favorable safety and tolerability.” Please revise your disclosure here and throughout your prospectus to remove your characterization of GB-102 as safe, as a determination of whether a product candidate is safe is solely within the authority of the U.S. Food and Drug Administration and comparable regulatory bodies. We will not
object to statements that GB-102 was well tolerated or information about the number of treatment related serious adverse events, but you should not state or imply that your product candidate is
safe.
In response to the Staff’s comment, the Company has revised its disclosure on pages 5, 21, 95 and 104 of the
Registration Statement.
Use of Proceeds, page 65
6.
Please expand your first bullet to disclose the estimated proceeds to be allocated to each
of your target indications and product candidates and clarify the stage of development you expect to be able to complete for each indication using the estimated proceeds.
In response to the Staff’s comment, the Company has revised its disclosure on page 65 of the Registration Statement.
Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations for years ended December 31, 2019
and 2018, page 78
7.
Reference your disclosure that personnel and professional service costs increased in the year
ended December 31, 2019 as compared to 2018 as a result of changes in and additions to executive management in 2019. Please revise to disclose the specific changes in and additions
to executive management and quantify the impact of each change on personnel and professional service costs. Explain how additions to executive management affected professional service costs.
In response to the Staff’s comment, the Company has revised its disclosure on pages 79 and 80 of the Registration Statement to specify the changes in and
additions to its executive management impacting such costs. In addition, the Company notes that as its former Interim Chief Financial Officer was compensated for his service through a consulting agreement between the Company and Danforth Advisors,
LLC, as discussed on page 155 of the Registration Statement, the Company’s professional service costs in the year ended December 31, 2019 were larger than those in the year ended December 31, 2018.
3
U.S. Securities and Exchange Commission
September 4, 2020
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4
Determination of Fair Value of Common Stock on Grant Dates, page 83
8.
We see that you issued 11.3 million stock options
during the year ended December 31, 2019. Please revise to disclose the fair value of common stock that was used during the fiscal year and any subsequent interim period provided in
the financial statements to determine the fair value of the stock options. In that regard, provide us the estimated offering price or range when it is available and explain to us the reasons for significant differences between recent valuations of
your common stock and the estimated offering price.
In response to the Staff’s comment, the Company has revised its
disclosure on page 86 of the Registration Statement. The Company will supplementally provide the requested information once the estimated offering price or range has been determined.
Our Product Candidates
GB-102, page 95
9.
The illustrations provided on the bottom of page 97 and the top of page 98 appear to contain text
that is illegible. In addition, certain symbols appear in the graphics without a legend such that it is unclear what they are depicting. Please revise these figures accordingly.
In response to the Staff’s comment, the Company has revised the illustrations on pages 100 and 101 of the Registration Statement.
10.
Your duration of response graph on the bottom of page 98 does not include a legend and it is
unclear what the horizontal lines and the green and yellow dots represent. Please revise your disclosure accordingly.
In
response to the Staff’s comment, the Company has revised the graph on page 101 of the Registration Statement.
Phase 2b trial of GB-102 in patients with wet AMD, page 102
11.
Please revise to clarify whether the trial design changes of the ALTISSIMO trial, including the
primary endpoint of median time to first additional anti-VEFG supportive therapy, were related to the termination of the 2mg dose in your clinical trial programs. If the modifications were made for other reasons, please disclose the
reasons.
In response to the Staff’s comment, the Company has revised its disclosure on page 106 of the Registration
Statement.
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U.S. Securities and Exchange Commission
September 4, 2020
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5
GB-401
Unmet Need, page 106
12.
We note your disclosure that 15% of glaucoma patients progress to blindness within 20 years of
diagnosis. Please disclose the source for this information.
In response to the Staff’s comment, the Company has
revised its disclosure on page 109 of the Registration Statement.
Our Future Development Plans, page 109
13.
We note your planned reliance on the 505(b)(2) approval pathway. Please identify and describe the
studies and results you intend to rely on to pursue this pathway.
In response to the Staff’s comment, the Company
has revised its disclosure on page 112 of the Registration Statement. The Company respectfully advises the Staff that it has not disclosed the active pharmaceutical ingredient (“API”) that it intends to use for GB-401 for proprietary and competitive reasons. However, the Company has outlined the clinical development plans that it believes are appropriate to support this regulatory pathway.
Description of Capital Stock, page 154
14.
You disclose here and on pages 148 and F-31, that certain
purchasers of Series C preferred stock have the option to purchase additional shares upon the achievement of certain development milestones. Please revise to describe such milestones in greater detail, and if applicable, how they will be calculated.
In addition, please provide the term and expiration period of the option to purchase.
In response to the Staff’s
comment, the Company has revised its disclosure on pages 154, 160, F-44 and F-46 of the Registration Statement.
* * * * * * *
5
U.S. Securities and Exchange Commission
September 4, 2020
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6
Should the Staff have additional questions or comments regarding the foregoing, please do not
hesitate to contact the undersigned at (650) 335-7292, or, in his absence, Julia Forbess at (415) 875-2420.
Sincerely,
/s/ Robert A. Freedman
Robert A. Freedman
Partner
FENWICK & WEST LLP
Cc
Frederic Guerard, Pharm.D., Chief Executive Officer
Robert S. Breuil, Chief Financial Officer
Graybug Vision, Inc.
Effie Toshav, Esq.
Julia
Forbess, Esq.
Fenwick & West LLP
Lisa Firenze, Esq.
Chris
Barnstable-Brown, Esq.
Wilmer Cutler Pickering Hale and Dorr LLP
6
2020-08-28 - UPLOAD - CalciMedica, Inc. (CALC) (CIK 0001534133)
United States securities and exchange commission logo
August 27, 2020
Frederic Guerard, Pharm.D.
President and Chief Executive Officer
Graybug Vision, Inc.
275 Shoreline Drive, Suite 450
Redwood City, CA 94065
Re:Graybug Vision, Inc.
Draft Registration Statement on Form S-1
Submitted July 31, 2020
CIK No. 0001534133
Dear Dr. Guerard:
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 submitted July 31, 2020
Our Pipeline, page 3
1.Please shorten the arrows in your pipeline table to more precisely indicate the
development status of each product candidate. As one example, we note that you are
currently conducting IND-enabling activities for GB-401 and expect to begin a Phase 1/2a
trial in the second half of 2021, yet the arrow indicates that you are already in Phase 1
development.
Our Lead Program GB-102, page 4
2.We note your statements on page 4 that GB-102 met its primary endpoint of safety and
tolerability in the ADAGIO trial and based on the data from ADAGIO you initiated a
FirstName LastNameFrederic Guerard, Pharm.D.
Comapany NameGraybug Vision, Inc.
August 27, 2020 Page 2
FirstName LastNameFrederic Guerard, Pharm.D.
Graybug Vision, Inc.
August 27, 2020
Page 2
Phase 2b ALTISSIMO trial. Balance your disclosure here by disclosing that you
terminated the development of the GB-102 2 mg dose in all of your clinical trials based on
your safety analysis of your Phase 2a clinical trial of GB-102 in 21 patients with ME
secondary to DME and RVO.
Differentiation of our product candidates, page 5
3.We note your statements throughout your filing that you believe GB-102 and GB-103 may
potentially be a "first-in-class" intravitreal injection. Given the early stage of
development, and your statements that your results in your preclinical studies may not be
indicative of results obtained in later trials, these statements are overly speculative and
inappropriate. Please remove these statements from the descriptions of your product
candidates.
Implications of Being an Emerging Growth Company and a Smaller Reporting Company, page 7
4.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.
Risk Factors, page 13
5.We note your references on page 21 and elsewhere that GB-102 demonstrated a
"favorable safety and tolerability." Please revise your disclosure here and throughout your
prospectus to remove your characterization of GB-102 as safe, as a determination of
whether a product candidate is safe is solely within the authority of the U.S. Food and
Drug Administration and comparable regulatory bodies. We will not object to statements
that GB-102 was well tolerated or information about the number of treatment related
serious adverse events, but you should not state or imply that your product candidate is
safe.
Use of Proceeds, page 65
6.Please expand your first bullet to disclose the estimated proceeds to be allocated to each of
your target indications and product candidates and clarify the stage of development you
expect to be able to complete for each indication using the estimated proceeds.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations for years ended December 31, 2019 and 2018, page 78
7.Reference your disclosure that personnel and professional service costs increased in the
year ended December 31, 2019 as compared to 2018 as a result of changes in and
additions to executive management in 2019. Please revise to disclose the specific changes
in and additions to executive management and quantify the impact of each change on
personnel and professional service costs. Explain how additions to executive
FirstName LastNameFrederic Guerard, Pharm.D.
Comapany NameGraybug Vision, Inc.
August 27, 2020 Page 3
FirstName LastNameFrederic Guerard, Pharm.D.
Graybug Vision, Inc.
August 27, 2020
Page 3
management affected professional service costs.
Determination of Fair Value of Common Stock on Grant Dates, page 83
8.We see that you issued 11.3 million stock options during the year ended December 31,
2019. Please revise to disclose the fair value of common stock that was used during the
the fiscal year and any subsequent interim period provided in the financial statements to
determine the fair value of the stock options. In that regard, provide us the estimated
offering price or range when it is available and explain to us the reasons for significant
differences between recent valuations of your common stock and the estimated offering
price.
Our Product Candidates
GB-102, page 95
9.The illustrations provided on the bottom of page 97 and the top of page 98 appear to
contain text that is illegible. In addition, certain symbols appear in the graphics without a
legend such that it is unclear what they are depicting. Please revise these figures
accordingly.
10.Your duration of response graph on the bottom of page 98 does not include a legend and it
is unclear what the horizontal lines and the green and yellow dots represent. Please revise
your disclosure accordingly.
Phase 2b trial of GB-102 in patients with wet AMD, page 102
11.Please revise to clarify whether the trial design changes of the ALTISSIMO trial,
including the primary endpoint of median time to first additional anti-VEFG supportive
therapy, were related to the termination of the 2mg dose in your clinical trial programs. If
the modifications were made for other reasons, please disclose the reasons.
GB-401
Unmet Need, page 106
12.We note your disclosure that 15% of glaucoma patients progress to blindness within 20
years of diagnosis. Please disclose the source for this information.
Our Future Development Plans, page 109
13.We note your planned reliance on the 505(b)(2) approval pathway. Please identify and
describe the studies and results you intend to rely on to pursue this pathway.
Description of Capital Stock, page 154
14.You disclose here and on pages 148 and F-31, that certain purchasers of Series C
preferred stock have the option to purchase additional shares upon the achievement of
certain development milestones. Please revise to describe such milestones in greater
FirstName LastNameFrederic Guerard, Pharm.D.
Comapany NameGraybug Vision, Inc.
August 27, 2020 Page 4
FirstName LastName
Frederic Guerard, Pharm.D.
Graybug Vision, Inc.
August 27, 2020
Page 4
detail, and if applicable, how they will be calculated. In addition, please provide the term
and expiration period of the option to purchase.
You may contact Kristin Lochhead at 202-551-3664 or Lisa Vanjoske at 202-551-3614 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jason L. Drory at 202-551-8342 or Mary Beth Breslin at 202-551-3625 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Julia Forbess