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All Filings
SEC Comment Letters
Company Responses
Letter Text
Avalo Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
↓
Avalo Therapeutics, Inc.
Awaiting Response
0 company response(s)
High
Avalo Therapeutics, Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2024-07-02
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2024-07-02
Generating summary...
↓
Company responded
2024-07-11
Avalo Therapeutics, Inc.
References: July 2, 2024
↓
Company responded
2024-07-29
Avalo Therapeutics, Inc.
References: July 2, 2024 | July 24, 2024
↓
Avalo Therapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-07-24
Avalo Therapeutics, Inc.
References: July 2, 2024
Avalo Therapeutics, Inc.
Response Received
5 company response(s)
High - file number match
Company responded
2017-05-19
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2017-05-19
Generating summary...
↓
SEC wrote to company
2018-05-14
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2018-05-14
Generating summary...
↓
Company responded
2018-05-25
Avalo Therapeutics, Inc.
References: May 14, 2018
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2018-05-25
Generating summary...
↓
Company responded
2018-06-22
Avalo Therapeutics, Inc.
References: June 15, 2018
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2018-06-22
Generating summary...
↓
Company responded
2018-07-27
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2018-07-27
Generating summary...
↓
Company responded
2024-07-11
Avalo Therapeutics, Inc.
References: July 2, 2024
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2024-07-11
Generating summary...
Avalo Therapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-07-02
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2024-07-02
Generating summary...
Avalo Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-04-13
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2023-04-13
Generating summary...
↓
Company responded
2023-04-28
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2023-04-28
Generating summary...
Avalo Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-03-15
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2021-03-15
Generating summary...
↓
Company responded
2021-03-18
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2021-03-18
Generating summary...
Avalo Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-05-13
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2020-05-13
Generating summary...
↓
Company responded
2020-05-14
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2020-05-14
Generating summary...
Avalo Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-12-27
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2019-12-27
Generating summary...
↓
Company responded
2019-12-30
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2019-12-30
Generating summary...
Avalo Therapeutics, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2019-10-09
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2019-10-09
Generating summary...
↓
Company responded
2019-10-18
Avalo Therapeutics, Inc.
References: October 9, 2019
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2019-10-18
Generating summary...
↓
Company responded
2019-10-22
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2019-10-22
Generating summary...
Avalo Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
Company responded
2019-02-07
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2019-02-07
Generating summary...
↓
SEC wrote to company
2019-02-08
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2019-02-08
Generating summary...
Avalo Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2018-08-21
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2018-08-21
Generating summary...
↓
Company responded
2018-10-03
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2018-10-03
Generating summary...
Avalo Therapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-06-15
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2018-06-15
Generating summary...
Avalo Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-06-06
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2017-06-06
Generating summary...
↓
Company responded
2017-06-07
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2017-06-07
Generating summary...
Avalo Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-05-22
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2017-05-22
Generating summary...
Avalo Therapeutics, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2016-11-18
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2016-11-18
Generating summary...
↓
Company responded
2016-12-01
Avalo Therapeutics, Inc.
References: November 18, 2016
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2016-12-01
Generating summary...
↓
Company responded
2016-12-05
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2016-12-05
Generating summary...
Avalo Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2016-09-23
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2016-09-23
Generating summary...
↓
Company responded
2016-09-26
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2016-09-26
Generating summary...
Avalo Therapeutics, Inc.
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2015-10-09
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2015-10-09
Generating summary...
↓
Company responded
2015-10-09
Avalo Therapeutics, Inc.
References: October 9, 2015
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2015-10-09
Generating summary...
↓
Company responded
2015-10-09
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2015-10-09
Generating summary...
↓
Company responded
2015-10-09
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2015-10-09
Generating summary...
Avalo Therapeutics, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2015-09-18
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2015-09-18
Generating summary...
↓
Company responded
2015-09-22
Avalo Therapeutics, Inc.
References: September 17, 2015
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2015-09-22
Generating summary...
↓
Company responded
2015-10-01
Avalo Therapeutics, Inc.
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2015-10-01
Generating summary...
Avalo Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2015-09-04
Avalo Therapeutics, Inc.
References: January 16, 2014 | June 22, 2015
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2015-09-04
Generating summary...
Avalo Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-06-22
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2015-06-22
Generating summary...
Avalo Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2015-05-21
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2015-05-21
Generating summary...
↓
Company responded
2015-06-12
Avalo Therapeutics, Inc.
References: May 21, 2015
Filing - Correspondence from Avalo Therapeutics, Inc.
CORRESP · 2015-06-12
Generating summary...
Avalo Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2014-05-14
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2014-05-14
Generating summary...
Avalo Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2014-01-16
Avalo Therapeutics, Inc.
Filing - SEC Comment Letter to Avalo Therapeutics, Inc.
UPLOAD · 2014-01-16
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-15 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2026-01-14 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | 333-292614 | Read Filing View |
| 2024-08-06 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | 001-37590 | Read Filing View |
| 2024-08-01 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-29 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-24 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | 333-279992 | Read Filing View |
| 2024-07-11 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-11 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-02 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | 001-37590 | Read Filing View |
| 2024-07-02 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | 333-279992 | Read Filing View |
| 2023-04-28 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-04-13 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-03-18 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-03-15 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-05-14 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-05-13 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-12-30 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-12-27 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-10-22 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-10-18 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-10-09 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-02-08 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-02-07 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-10-03 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-08-21 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-07-27 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-06-22 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-06-15 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-05-25 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-05-14 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-06-07 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-06-06 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-05-22 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-05-19 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-12-05 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-12-01 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-11-18 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-09-26 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-09-23 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-09 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-09 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-09 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-09 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-01 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-09-22 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-09-18 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-09-04 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-06-22 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-06-12 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-05-21 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2014-05-14 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2014-01-16 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-14 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | 333-292614 | Read Filing View |
| 2024-08-06 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | 001-37590 | Read Filing View |
| 2024-07-24 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | 333-279992 | Read Filing View |
| 2024-07-02 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | 001-37590 | Read Filing View |
| 2024-07-02 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | 333-279992 | Read Filing View |
| 2023-04-13 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-03-15 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-05-13 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-12-27 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-10-09 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-02-08 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-08-21 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-06-15 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-05-14 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-06-06 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-05-22 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-11-18 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-09-23 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-09 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-09-18 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-06-22 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-05-21 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2014-05-14 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2014-01-16 | SEC Comment Letter | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-15 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-08-01 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-29 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-11 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-07-11 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-04-28 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-03-18 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-05-14 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-12-30 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-10-22 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-10-18 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-02-07 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-10-03 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-07-27 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-06-22 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-05-25 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-06-07 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-05-19 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-12-05 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-12-01 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-09-26 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-09 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-09 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-09 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-01 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-09-22 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-09-04 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-06-12 | Company Response | Avalo Therapeutics, Inc. | DE | N/A | Read Filing View |
2026-01-15 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Avalo Therapeutics, Inc. 1500 Liberty Ridge Drive, Suite 321 Wayne, Pennsylvania 19087 January 15, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Avalo Therapeutics, Inc. Registration Statement on Form S-3 (File No. 333-292614) Request for Acceleration of Effective Date Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the " Act "), Avalo Therapeutics, Inc. (the " Company ") hereby respectfully requests that the effective date of the Company's Registration Statement on Form S-3 (File No. 333-292614) (the " Registration Statement "), be accelerated by the Securities and Exchange Commission to 9:00 a.m. Eastern time, on January 20, 2026, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. We request that we be notified of such effectiveness by a telephone call to Jennifer Porter of Goodwin Procter LLP at (445) 207-7806 and that such effectiveness also be confirmed in writing. Very truly yours, Avalo Therapeutics, Inc. By: /s/ Christopher Sullivan Name: Christopher Sullivan Title: Chief Financial Officer cc: Rachael Bushey, Goodwin Procter LLP Jennifer Porter, Goodwin Procter LLP Jesse Fishman, Goodwin Procter LLP
2026-01-14 - UPLOAD - Avalo Therapeutics, Inc. File: 333-292614
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> January 14, 2026 Garry Neil Chief Executive Officer Avalo Therapeutics, Inc. 1500 Liberty Ridge Drive, Suite 321 Wayne, PA 19087 Re: Avalo Therapeutics, Inc. Registration Statement on Form S-3 Filed January 8, 2026 File No. 333-292614 Dear Garry Neil: 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 Jason Drory at 202-551-8342 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jennifer Porter </TEXT> </DOCUMENT>
2024-08-06 - UPLOAD - Avalo Therapeutics, Inc. File: 001-37590
August 6, 2024
Christopher Sullivan
Chief Financial Officer
Avalo Therapeutics, Inc.
540 Gaither Road, Suite 400
Rockville, MD 20850
Re:Avalo Therapeutics, Inc.
Form 10-K for Fiscal Year Ended December 31, 2023
Amendment No. 1 to Form 10-Q for Fiscal Quarter Ended March 31, 2024
File No. 001-37590
Dear Christopher Sullivan:
We have completed our review of your filings. 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:Andrew Gibbons
2024-08-01 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Document 540 Gaither Road, Suite 400 Rockville, Maryland 20850 August 1, 2024 VIA EDGAR Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street N.E. Washington, DC 20549 Attention: Lauren Hamill Alan Campbell Division of Corporation Finance Office of Life Sciences Re: Avalo Therapeutics, Inc. Registration Statement on Form S-3 Filed June 6, 2024, as amended on July 11, 2024 and July 29, 2024 File No. 333-279992 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Avalo Therapeutics, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to accelerate the effective date of the above-referenced registration statement (the “Registration Statement”) so as to become effective on Monday, August 5, 2024, at 4:00 p.m. Eastern Time, or as soon thereafter as practicable. Once the Registration Statement is effective, please orally confirm the event with our counsel, Wyrick Robbins Yates & Ponton LLP, by calling Andrew Gibbons at (919) 781-4000. We also respectfully request that a copy of the written order from the Commission verifying the effective date and time of the Registration Statement be sent to Mr. Gibbons via email at agibbons@wyrick.com. Very truly yours, AVALO THERAPEUTICS, INC. By: /s/ Christopher Sullivan Chief Financial Officer cc: Andrew Gibbons, Wyrick Robbins Yates & Ponton LLP
2024-07-29 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Document Wyrick Robbins Yates & Ponton LLP 4101 Lake Boone Trail, Suite 300 Raleigh, North Carolina 27607 July 29, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Lauren Hamill Alan Campbell Division of Corporation Finance Office of Life Sciences Re: Avalo Therapeutics, Inc. Amendment No. 1 to Registration Statement on Form S-3 Filed July 11, 2024 File No. 333-279992 Ladies and Gentlemen: We write this letter on behalf of our client Avalo Therapeutics, Inc. (the “Company”) in response to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the above-captioned filing (the “Amendment No. 1 to Registration Statement”), as set forth in the Staff’s letter dated July 24, 2024 (the “Comment Letter”). The text of the Comment Letter has been reproduced herein in bold with our response below the numbered comments. The Company is concurrently filing an Amendment No. 2 to the Registration Statement on Form S-3 (the “Registration Statement Amendment”) with this letter, which addresses the Staff’s comments and updates or clarifies certain other information in the Amendment No. 1 to Registration Statement. Amendment No. 1 to Registration Statement on Form S-3 Risk Factors, page 10 1.We note your response to prior comment 8 from our letter dated July 2, 2024 related to your Annual Report on Form 10-K for the year ended December 31, 2023 and Form 10-Q for the quarter ended March 31, 2024, which we reissue in part with respect to this registration statement. Based on your revised patent disclosures in the tables throughout the section captioned “Pipeline” beginning on page 4 of this S-3, it appears that certain patents related to AVTX-009 and AVTX-002 will expire in 2026 and in 2027 and 2028, respectively. Please revise this registration statement to provide additional risk factor disclosure discussing the extent to which the Company faces any material risk(s) stemming from the expiration of its patents, or otherwise advise. 1 Division of Corporation Finance July 29, 2024 The Company respectfully acknowledges the Staff’s comment and will revise the disclosure in future filings. The Company also has revised the section under the heading “Risk Factors” on pages 10-11 of the Registration Statement Amendment to disclose the additional material risks the Company will face upon the anticipated expiration of its patents in 2026, 2027, and 2028. The additional risk factors under the heading “Risks Related to Intellectual Property” state in part that “Certain of our composition of matter patents for AVTX-009 and AVTX-002 currently expire in 2026, 2027, or 2028. If we are unable to obtain extensions to our patents or other means of regulatory exclusivity for our products, the expiration of patents might create opportunities for competitors to enter the market for our target indications, which could have a material negative impact on our financial results. Without patent protection, we are susceptible to competitors bringing similar products to market, obtaining FDA approval, and achieving regulatory exclusivity prior to us. Both AVTX-009 and AVTX-002 are biologic products, which would allow the Company to receive biologics reference product exclusivity in both the United States (twelve years) and Europe (ten years) if and upon receiving marketing approval for the products. Once our composition of matter patents expire, we plan to rely on such exclusivity to protect our intellectual property, which has its associated risks. See the risk factor below titled “As appropriate, we intend to seek all available periods of regulatory exclusivity for our product candidates. However, there is no guarantee that we will be granted these periods of regulatory exclusivity or that we will be able to maintain these periods of exclusivity” for more information regarding the risks of relying on regulatory exclusivity.” * * * * * 2 Division of Corporation Finance July 29, 2024 The Company respectfully submits that the foregoing is appropriately responsive to the Staff’s comments. If the Staff has any further comments, please direct them to the undersigned by email at agibbons@wyrick.com or by telephone at (919) 786-4038. Sincerely, WYRICK ROBBINS YATES & PONTON By: /s/ Andrew J. Gibbons Andrew J. Gibbons cc: Dr. Garry A. Neil Chief Executive Officer and Chairman of the Board Avalo Therapeutics, Inc. (gneil@avalotx.com) Mr. Christopher Sullivan Chief Financial Officer Avalo Therapeutics, Inc. (csullivan@avalotx.com) 3
2024-07-24 - UPLOAD - Avalo Therapeutics, Inc. File: 333-279992
July 24, 2024
Garry Neil
Chief Executive Officer
Avalo Therapeutics, Inc.
540 Gaither Road, Suite 400
Rockville, MD 20850
Re:Avalo Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-3
Filed July 11, 2024
File No. 333-279992
Dear Garry Neil:
We have reviewed your amended registration statement and have the following comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe a comment applies to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing any amendment to your registration statement and the information you
provide in response to this letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our July 2, 2024 letter.
Amendment No. 1 to Registration Statement on Form S-3
Risk Factors, page 10
1.We note your response to prior comment 8 from our letter dated July 2, 2024 related to
your Annual Report on Form 10-K for the year ended December 31, 2023 and Form 10-Q
for the quarter ended March 31, 2024, which we reissue in part with respect to this
registration statement. Based on your revised patent disclosures in the tables throughout
the section captioned "Pipeline" beginning on page 4 of this S-3, it appears that certain
patents related to AVTX-009 and AVTX-002 will expire in 2026 and in 2027 and 2028,
respectively. Please revise this registration statement to provide additional risk factor
disclosure discussing the extent to which the Company faces any material risk(s)
stemming from the expiration of its patents, or otherwise advise.
Please contact Gary Newberry at 202-551-3761 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
July 24, 2024
Page 2
contact Lauren Hamill at 303-844-1008 or Alan Campbell at 202-551-4224 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Andrew Gibbons
2024-07-11 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Document Wyrick Robbins Yates & Ponton LLP 4101 Lake Boone Trail, Suite 300 Raleigh, North Carolina 27607 July 11, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Gary Newberry Lynn Dicker Division of Corporation Finance Office of Life Sciences Re: Avalo Therapeutics, Inc. Registration Statement on Form S-3 Filed June 6, 2024 File No. 333-279992 Ladies and Gentlemen: We write this letter on behalf of our client Avalo Therapeutics, Inc. (the “Company”) in response to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the above-captioned filing (the “Initial Registration Statement”), as set forth in the Staff’s letter dated July 2, 2024 (the “Comment Letter”). The text of the Comment Letter has been reproduced herein in bold with our response below the numbered comments. The Company is concurrently filing an Amendment No. 1 to the Registration Statement on Form S-3 (the “Amendment”) with this letter, which addresses the Staff’s comments and updates or clarifies certain other information in the Initial Registration Statement. Registration Statement on Form S-3 Cover Page 1.Please revise the prospectus cover page header to quantify the number of warrants being registered. Please also revise your prospectus cover page to reflect your disclosure on page 8 that the Series C non-voting convertible preferred stock and warrants are not convertible or exercisable for shares of common stock without the approval of your stockholders and therefore may not have any value. The Company respectfully acknowledges the Staff’s comment and has revised the cover page of the Amendment to quantify the number of warrants to be registered. The Company has also disclosed on the cover page of the Amendment that stockholder approval is required for the Series C non-voting 1 Division of Corporation Finance July 11, 2024 convertible preferred stock and the warrants to convert into shares of common stock, and that without such approval, both the Series C non-voting convertible preferred stock and the warrants may not have any value. Further, the Company has disclosed the number of warrants being registered in the following sections of the Amendment: Prospectus Summary (page 3), The Offering (page 9), Use of Proceeds (page 14), and the Description of Securities to be Registered (page 26). Selling Stockholders, page 13 2.With respect to the shares to be offered for resale by each selling stockholder that is a legal entity, please disclose the natural person(s) who exercise the sole or shared voting and/or dispositive powers with respect to the shares to be offered by that stockholder. The Company respectfully acknowledges the Staff’s comment and has revised its disclosure on pages 17-21 of the Amendment to disclose the natural person or persons who exercise the sole or shared voting and/or dispositive powers with respect to the shares to be offered for resale by each selling stockholder that is a legal entity. General 3.As you are aware, the staff is currently reviewing your Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and has issued comments in connection with that review. Please note that we will not be in a position to declare this registration statement effective until you have resolved all comments on the Form 10-K, including making conforming revisions to this S-3 with respect to any comments that also pertain to your disclosures in this registration statement. The Company respectfully acknowledges the Staff’s comment. Please see our separate response letter submitted to the Staff on July 11, 2024 which addresses the Staff’s comments on the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and indicates where conforming revisions have been made in the Amendment to address any comments that also pertain to the disclosures in the Initial Registration Statement. * * * * * 2 Division of Corporation Finance July 11, 2024 The Company respectfully submits that the foregoing is appropriately responsive to the Staff’s comments. If the Staff has any further comments, please direct them to the undersigned by email at agibbons@wyrick.com or by telephone at (919) 786-4038. Sincerely, WYRICK ROBBINS YATES & PONTON By: /s/ Andrew J. Gibbons Andrew J. Gibbons cc: Dr. Garry A. Neil Chief Executive Officer and Chairman of the Board Avalo Therapeutics, Inc. (gneil@avalotx.com) Mr. Christopher Sullivan Chief Financial Officer Avalo Therapeutics, Inc. (csullivan@avalotx.com) 3
2024-07-11 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Document Wyrick Robbins Yates & Ponton LLP 4101 Lake Boone Trail, Suite 300 Raleigh, North Carolina 27607 July 11, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Gary Newberry Lynn Dicker Division of Corporation Finance Office of Life Sciences Re: Avalo Therapeutics, Inc. Form 10-K for Fiscal Year Ended December 31, 2023 Form 10-Q for Fiscal Quarter Ended March 31, 2024 File No. 001-37590 Ladies and Gentlemen: We write this letter on behalf of our client Avalo Therapeutics, Inc. (the “Company”) in response to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission with respect to the above-captioned filings, as set forth in the Staff’s letter dated July 2, 2024 (the “Comment Letter”). The text of the Comment Letter has been reproduced herein in bold with our response below the numbered comments. The Company is concurrently filing an Amendment No. 1 to the Form 10-Q for the fiscal quarter ended March 31, 2024 and an Amendment No. 1 to the Registration Statement on Form S-3 (the “Registration Statement Amendment”), which addresses the Staff’s comments and updates or clarifies certain other information requested by the Staff. Form 10-K for Fiscal Year Ended December 31, 2023 Item 1. Business. Our Strategy, page 1 1.Please confirm that you will revise this disclosure in future filings to clarify that there is no guarantee that your products will receive regulatory approval and to describe the additional steps and clinical trials that you must complete before you can submit applications for regulatory approval. The Company respectfully acknowledges the Staff’s comment and will revise this disclosure in future filings. 1 Division of Corporation Finance July 11, 2024 The Company also has revised the section under the heading “Our Strategy” on page 4 of the Registration Statement Amendment to disclose that there is no guarantee that the Company’s products will obtain regulatory approval in the United States or elsewhere. The additional disclosure in this section outlines the additional steps and clinical trials that must be completed prior to submission of applications for regulatory approval. Pipeline - Overview, Competition, and Intellectual Property, page 2 2.We note that the Next Generation IL-1B (extended half-life), AVTX-002 (anti-LIGHT mAb) and AVTX-008 (BTLA agonist fusion protein) product candidates appear in your pipeline table with undisclosed target indications, and that there is either minimal or no discussion of the status of these programs in your disclosure. Please confirm that you will address the following in future filings, as appropriate: •To the extent these are currently material programs, disclose the targets and provide more fulsome descriptions of these programs. If you have not yet identified target indications that you are currently pursuing, please remove them from the table or explain the basis for your belief that they are material and should be included in your pipeline table. •In an appropriate place in the Business section, revise to explain what you mean when you say that AVTX-002 and AVTX-008 are "under strategic review," and disclose the current status of such reviews. To the extent you are not currently developing and/or do not plan to further develop these product candidates, please remove them from your pipeline table in future filings. Please note that we will not object to a narrative discussion of your aspirational plans for such product candidates or next steps with respect to these programs in your Summary and Business sections. The Company respectfully acknowledges the Staff’s comment and will not include Next Generation IL-1β, AVTX-002, or AVTX-008 in the pipeline table in future filings until and if the products have target indications that the Company is pursuing. Accordingly, the Company has revised the pipeline table in the Registration Statement Amendment (page 4) by removing references to the Next Generation IL-1B (extended half-life), AVTX-002 (anti-LIGHT mAb) and AVTX-008 (BTLA agonist fusion protein) product candidates. Further, the Company has included a new section in the Registration Statement Amendment (and will do so in future filings where responsive) under the heading “Other Product Candidates Under Strategic Review” (page 6). In this section, the Company explains what it means to be “under strategic review” and discloses the current status of the Company’s strategic review of AVTX-002 and AVTX-008. 3.Please revise your pipeline table in future filings as follows: •Revise the "Anticipated Milestones" column so that it only includes the next step in the regulatory process. To the extent your Phase 2 trial of AVTX-009 has not commenced, please remove references here and elsewhere to when Phase 2 data is expected. •To the extent you have not identified a specific autoimmune indication for AVTX- 009, please remove this row from your pipeline table in future filings. 2 Division of Corporation Finance July 11, 2024 The Company respectfully acknowledges the Staff’s comment and will revise this disclosure in future filings. The Company also has revised the “Anticipated Milestones” column in the Registration Statement Amendment (page 4) to only include the next step of the regulatory process. Further, the Registration Statement Amendment does not reference the anticipated timing of Phase 2 data and has removed the row referencing an autoimmune indication for AVTX-009 from the table on page 4. 4.Please confirm that in future filings you will revise your disclosure regarding each of your license agreements to include a discussion of all material terms, including quantifying the following as appropriate: •amounts paid to date, such as upfront fees and any installments thereof; •annual or maintenance fees payable; •the applicable royalty rates to be paid by each party. In the event a range is provided in place of the actual royalty rate, each such range should be within ten percentage points. By way of example only and not limitation, you should revise your disclosure that under the terms of the Lilly License Agreement, the Company will be responsible for paying royalties equal to a "mid-single digit-to-low double digit" percentage of Avalo or its sublicensees’ annual net sales; •the duration of the agreement and royalty term; and •termination provisions. The Company respectfully acknowledges the Staff’s comment and will revise this disclosure in future filings. The Company also has revised the “Pipeline” section in the Registration Statement Amendment (pages 4-8) to discuss the material terms of the Company’s licensing agreements. The Company’s revised disclosure in the Registration Statement Amendment includes disclosing the items above for each of the licensing agreements. 5.Please confirm that with respect to all completed clinical trials of AVTX-009 and AVTX- 002 referenced in this section, you will revise future filings to provide results within proper context. In this regard: •Please disclose the sponsor, the date(s) of the trials and the location(s), indication(s) studied, the trial phase, the primary and any secondary endpoints, the number of trial participants, the results observed relative to the endpoints, any serious adverse events, and whether statistical significance was demonstrated, including supporting p-values as appropriate. •Disclose the prior names used for AVTX-009, if any. •With respect to AVTX-002, please explain what you mean when you state you observed "positive trends" in an open-label study of Chron's Disease, and a reduction in "asthma-related events" in a Phase 2 trial in patients with poorly controlled NEA. The Company respectfully acknowledges the Staff’s comment and will revise this disclosure in future filings. The Company also has revised its disclosure of AVTX-002 in the Registration Statement Amendment to eliminate references to clinical trials. Such references originally appeared in the “Overview” section under the heading “Quisovalimab (AVTX-002): Anti-LIGHT mAb targeting immune-inflammatory 3 Division of Corporation Finance July 11, 2024 diseases,” but such references are now not included in the Registration Statement Amendment. Additionally, the Company has disclosed the prior names of AVTX-009 on page 4 of the Registration Statement Amendment. Quisovalimab (AVTX-002): Anti-LIGHT mAb targeting immune-inflammatory diseases. Overview, page 2 6.We note your disclosure that Quisovalimab (AVTX-002) has shown "a favorable safety and tolerability profile, in all indications studied..." As safety and efficacy determinations are solely within the authority of the FDA and comparable regulatory bodies, please confirm that you will remove any statements that state or imply that your product candidates are safe or effective from future filings. We will not object to statements that your drug candidates were well-tolerated or that no serious adverse events deemed to be study related were reported, if true. The Company respectfully acknowledges the Staff’s comment and will revise this disclosure in future filings. The Company also has removed this language in the Registration Statement Amendment. The disclosure of AVTX-002 beginning on page 6 of the Registration Statement Amendment does not include statements regarding a favorable safety and tolerability profile, nor do any such statements appear elsewhere in the Registration Statement Amendment. Intellectual Property Overview, page 3 7.Please confirm that in future filings you will revise your disclosure with respect to the Company's material patents to clearly describe on an individual or patent family basis the type of patent protection granted for each product candidate or technology (composition of matter, use, or process), whether such patent is owned or licensed, the expiration year of each patent, and the jurisdiction, including any foreign jurisdiction, of each material pending or issued patent. The Company respectfully acknowledges the Staff’s comment and will revise this disclosure in future filings. The Company also has revised its disclosure in the “Pipeline” section of the Registration Statement Amendment (pages 4-8) with respect to the Company’s material patents. The revised disclosure in the Registration Statement Amendment includes tabular presentation of the following for each of the Company’s material patents: •Type of patent protection granted (composition of matter, use, or process); •Whether such patent is owned or licensed; •Expiration year; and •Jurisdiction (including foreign jurisdiction). The tables disclosing such information appear on page 6 (AVTX-009), page 7 (AVTX-002), and page 8 (AVTX-008) of the Registration Statement Amendment. 4 Division of Corporation Finance July 11, 2024 Item 1A. Risk Factors, page 12 8.We note your disclosure on page 3 that certain patents related to quisovalimab (AVTX- 002) that are exclusively licensed from KKC may provide exclusivity in the United States through 2028 absent any extension. Please confirm that you will revise future filings as appropriate to explain the material impact, if any, of the patent expiration on your business. In this regard, we note your disclosure on page 3 that your success depends in part on your ability to obtain and maintain proprietary protection for the technology and know-how upon which your product candidates are based. The Company respectfully acknowledges the Staff’s comment and will revise this disclosure in future filings. In addition to updating the Risk Factor disclosure in future filings, the Company also has revised its disclosure on pages 5, 7, and 8 of the Registration Statement Amendment to clearly disclose that the Company plans to primarily rely on biologics data or market exclusivity to protect its intellectual property. Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited., page 13 9.Please confirm that you will revise future filings to revise this risk factor to quantify the NOLs accumulated through the end of 2017 and any other tax attributes that are or may become subject to limitation. The Company respectfully acknowledges the Staff’s comment and will revise this disclosure in future filings. We intend to conduct clinical trials for certain of our product candidates at sites outside the United States..., page 23 10.Please confirm that in future filings you will revise this risk factor, the Business section, and elsewhere throughout as appropriate to disclose, to extent known, any jurisdiction(s) outside the United States where you intend to conduct or are conducting clinical trials for any candidate, including the indication. The Company respectfully acknowledges the Staff’s comment and will revise this disclosure in future filings. Please note that since the Company filed its initial registration statement, it has announced that its Investigational New Drug Application for AVTX-009 for the treatment of hidradenitis suppurativa is now active. The Company has disclosed this development under the heading “Recent Events” on pages 3-4 and under the heading “Pipeline” on page 4 of the Registration Statement Amendment, and has disclosed the locations where it intends to conduct its Phase 2 (LOTUS) clinical trial for AVTX-009. 5 Division of Corporation Finance July 11, 2024 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. Overview, page 49 11.Please confirm that you will revise future filings, as appropriate, to support your statement here and elsewhere throughout that recently acquired product candidate AVTX-009 is “Phase 2-ready.” In this regard, we note that it is unclear from your disclosure whether you have an active IND for this product candidate in the indications you state you are currently pursuing. The Company respectfully acknowledges the Staff’s comment and will revise this disclosure in future filings. Form 10-Q for Fiscal Quarter Ended March 31, 2024 Exhibit 32.1, page 40 12.We note that the 906 Certification in Exhibit 32.1 is incorrectly dated March 13, 2024. In a full amended filing, please provide a correctly dated Section 906 certification along with currently dated Section 302 certifications. The Company respectfully acknowledges the Staff’s comment and has filed a full amended filing on Form 10-Q for the fiscal quarter ended March 31, 2024 that includes all items of the form as well as a currently dated Section 906 certification and Section 302 certifications. * * * * * The Company respectfully submits that the foregoing is appropriately responsive to the Staff’s comments. If the Staff has any further comments, please direct them to the undersigned by email at agibbons@wyrick.com or by telephone at (919) 786-4038. Sincerely, WYRICK ROBBINS YATES & PONTON By: /s/ Andrew J. Gibbons Andrew J. Gibbons cc: Dr. Garry A. Neil Chief Executive Officer and Chairman of the Board Avalo Therapeutics, Inc. (gneil@avalotx.com) Mr. Christopher Sullivan Chief Financial Officer Avalo Therapeutics, Inc. (csullivan@avalotx.com) 6
2024-07-02 - UPLOAD - Avalo Therapeutics, Inc. File: 001-37590
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
July 2, 2024
Christopher Sullivan
Chief Financial Officer
Avalo Therapeutics, Inc.
540 Gaither Road, Suite 400
Rockville, MD 20850
Re: Avalo Therapeutics, Inc.
Form 10-K for Fiscal Year Ended December 31, 2023
Form 10-Q for Fiscal Quarter Ended March 31, 2024
File No. 001-37590
Dear Christopher Sullivan:
We have reviewed your filings and have the following comments.
Please respond to this letter 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 a
comment applies to your facts and circumstances, please tell us why in your
response.
After reviewing your response to this letter, we may have additional
comments.
Form 10-K for Fiscal Year Ended December 31, 2023
Item 1. Business.
Our Strategy, page 1
1. Please confirm that you will revise this disclosure in future filings to
clarify that there is
no guarantee that your products will receive regulatory approval and to
describe the
additional steps and clinical trials that you must complete before you
can submit
applications for regulatory approval.
Pipeline - Overview, Competition, and Intellectual Property, page 2
2. We note that the Next Generation IL-1B (extended half-life), AVTX-002
(anti-LIGHT
mAb) and AVTX-008 (BTLA agonist fusion protein) product candidates
appear in your
pipeline table with undisclosed target indications, and that there is
either minimal or no
discussion of the status of these programs in your disclosure. Please
confirm that you will
address the following in future filings, as appropriate:
To the extent these are currently material programs, disclose the
targets and provide
more fulsome descriptions of these programs. If you have not yet
identified target
July 2, 2024
Page 2
indications that you are currently pursuing, please remove them from
the table or
explain the basis for your belief that they are material and should
be included in your
pipeline table.
In an appropriate place in the Business section, revise to explain
what you mean when
you say that AVTX-002 and AVTX-008 are "under strategic review," and
disclose
the current status of such reviews. To the extent you are not
currently developing
and/or do not plan to further develop these product candidates,
please remove them
from your pipeline table in future filings.
Please note that we will not object to a narrative discussion of your
aspirational plans for
such product candidates or next steps with respect to these programs in
your Summary
and Business sections.
3. Please revise your pipeline table in future filings as follows:
Revise the "Anticipated Milestones" column so that it only includes
the next step in
the regulatory process. To the extent your Phase 2 trial of AVTX-009
has not
commenced, please remove references here and elsewhere to when Phase
2 data is
expected.
To the extent you have not identified a specific autoimmune
indication for AVTX-
009, please remove this row from your pipeline table in future
filings.
4. Please confirm that in future filings you will revise your disclosure
regarding each of your
license agreements to include a discussion of all material terms,
including quantifying the
following as appropriate:
amounts paid to date, such as upfront fees and any installments
thereof;
annual or maintenance fees payable;
the applicable royalty rates to be paid by each party. In the event
a range is provided
in place of the actual royalty rate, each such range should be
within ten percentage
points. By way of example only and not limitation, you should revise
your disclosure
that under the terms of the Lilly License Agreement, the Company
will be responsible
for paying royalties equal to a "mid-single digit-to-low double
digit" percentage of
Avalo or its sublicensees annual net sales;
the duration of the agreement and royalty term; and
termination provisions.
5. Please confirm that with respect to all completed clinical trials of
AVTX-009 and AVTX-
002 referenced in this section, you will revise future filings to
provide results within
proper context. In this regard:
Please disclose the sponsor, the date(s) of the trials and the
location(s), indication(s)
studied, the trial phase, the primary and any secondary endpoints,
the number of trial
participants, the results observed relative to the endpoints, any
serious adverse events,
and whether statistical significance was demonstrated, including
supporting p-values
as appropriate.
Disclose the prior names used for AVTX-009, if any.
With respect to AVTX-002, please explain what you mean when you
state you
observed "positive trends" in an open-label study of Chron's
Disease, and a reduction
July 2, 2024
Page 3
in "asthma-related events" in a Phase 2 trial in patients with
poorly controlled NEA.
Quisovalimab (AVTX-002): Anti-LIGHT mAb targeting immune-inflammatory diseases.
Overview, page 2
6. We note your disclosure that Quisovalimab (AVTX-002) has shown "a
favorable safety
and tolerability profile, in all indications studied..." As safety and
efficacy determinations
are solely within the authority of the FDA and comparable regulatory
bodies, please
confirm that you will remove any statements that state or imply that
your product
candidates are safe or effective from future filings. We will not
object to statements that
your drug candidates were well-tolerated or that no serious adverse
events deemed to be
study related were reported, if true.
Intellectual Property Overview, page 3
7. Please confirm that in future filings you will revise your disclosure
with respect to the
Company's material patents to clearly describe on an individual or
patent family basis the
type of patent protection granted for each product candidate or
technology (composition
of matter, use, or process), whether such patent is owned or licensed,
the expiration year
of each patent, and the jurisdiction, including any foreign
jurisdiction, of each material
pending or issued patent.
Item 1A. Risk Factors, page 12
8. We note your disclosure on page 3 that certain patents related to
quisovalimab (AVTX-
002) that are exclusively licensed from KKC may provide exclusivity in
the United States
through 2028 absent any extension. Please confirm that you will revise
future filings as
appropriate to explain the material impact, if any, of the patent
expiration on your
business. In this regard, we note your disclosure on page 3 that your
success depends in
part on your ability to obtain and maintain proprietary protection for
the technology and
know-how upon which your product candidates are based.
Our ability to use our net operating loss carryforwards and certain other tax
attributes may be
limited., page 13
9. Please confirm that you will revise future filings to revise this risk
factor to quantify the
NOLs accumulated through the end of 2017 and any other tax attributes
that are or may
become subject to limitation.
We intend to conduct clinical trials for certain of our product candidates at
sites outside the
United States..., page 23
10. Please confirm that in future filings you will revise this risk factor,
the Business section,
and elsewhere throughout as appropriate to disclose, to extent known,
any jurisdiction(s)
outside the United States where you intend to conduct or are conducting
clinical trials for
any candidate, including the indication.
Item 7. Management s Discussion and Analysis of Financial Condition and
Results of Operations.
Overview, page 49
11. Please confirm that you will revise future filings, as appropriate, to
support your statement
here and elsewhere throughout that recently acquired product candidate
AVTX-009 is
July 2, 2024
Page 4
Phase 2-ready. In this regard, we note that it is unclear from
your disclosure whether
you have an active IND for this product candidate in the indications you
state you are
currently pursuing.
Form 10-Q for Fiscal Quarter Ended March 31, 2024
Exhibit 32.1, page 40
12. We note that the 906 Certification in Exhibit 32.1 is incorrectly dated
March 13, 2024. In
a full amended filing, please provide a correctly dated Section 906
certification along with
currently dated Section 302 certifications.
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 Gary Newberry at 202-551-3761 or Lynn Dicker at
202-551-3616 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Lauren Hamill at 303-844-1008 or Alan Campbell at 202-551-4224 with any
other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Andrew Gibbons
</TEXT>
</DOCUMENT>
2023-04-28 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Document 540 Gaither Road, Suite 400 Rockville, MD 20850 April 28, 2023 VIA EDGAR Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street N.E. Washington, DC 20549 Attention: Joshua Gorsky Division of Corporation Finance Office of Life Sciences Re: Avalo Therapeutics, Inc. Registration Statement on Form S-3 Filed April 12, 2023 File No. 333-271225 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Avalo Therapeutics, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to accelerate the effective date of the above-referenced registration statement (the “Registration Statement”) so as to become effective on Tuesday, May 2, 2023, at 4:15 p.m. Eastern Time, or as soon thereafter as practicable. Once the Registration Statement is effective, please orally confirm the event with our counsel, Wyrick Robbins Yates & Ponton LLP, by calling Alexander M. Donaldson at (919) 781-4000. We also respectfully request that a copy of the written order from the Commission verifying the effective date and time of the Registration Statement be sent to Mr. Donaldson via email at adonaldson@wyrick.com. Very truly yours, AVALO THERAPEUTICS, INC. By: /s/ Christopher Sullivan Christopher Sullivan Chief Financial Officer cc: Alexander M. Donaldson, Wyrick Robbins Yates & Ponton LLP
2023-04-13 - UPLOAD - Avalo Therapeutics, Inc.
United States securities and exchange commission logo
April 13, 2023
Christopher Sullivan
Chief Financial Officer
Avalo Therapeutics, Inc.
540 Gaither Road, Suite 400
Rockville, Maryland 20850
Re:Avalo Therapeutics, Inc.
Registration Statement on Form S-3
Filed April 12, 2023
File No. 333-271225
Dear Christopher Sullivan:
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 Joshua Gorsky at 202-551-7836 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Andrew J. Gibbons
2021-03-18 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Document 540 Gaither Road, Suite 400 Rockville, MD 20850 March 18, 2021 VIA EDGAR Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Attn: Abby Adams Re: Cerecor Inc. Registration Statement on Form S-3 Filed March 8, 2021 File No. 333-254000 Ladies and Gentlemen: Cerecor Inc., a Delaware corporation (the “Registrant”), hereby requests that the Securities and Exchange Commission take appropriate action to make the Registration Statement on Form S-3 (File No. 333-254000) effective as of 4:05 p.m. Eastern Time, Friday, March 19, 2021, or as soon thereafter as practicable. Please advise our corporate counsel, Brian Katz at (215) 981-4000, of any questions. The Registrant understands that the Commission will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement. Very truly yours, CERECOR INC. By: /s/ Schond L. Greenway Schond L. Greenway Chief Financial Officer
2021-03-15 - UPLOAD - Avalo Therapeutics, Inc.
United States securities and exchange commission logo
March 15, 2021
Schond L. Greenway
Chief Financial Officer
Cerecor Inc.
540 Gaither Road, Suite 400
Rockville, Maryland 20850
Re:Cerecor Inc.
Registration Statement on Form S-3
Filed March 8, 2021
File No. 333-254000
Dear Mr. Greenway:
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 Abby Adams at (202) 551-6902 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian Katz, Esq.
2020-05-14 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Document 540 Gaither Road, Suite 400 Rockville, MD 20850 May 14, 2020 VIA EDGAR Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Attn: Tim Buchmiller Re: Cerecor Inc. Registration Statement on Form S-3 Filed May 12, 2020 File No. 333-238197 Ladies and Gentlemen: Cerecor Inc., a Delaware corporation (the “Registrant”), hereby requests that the Securities and Exchange Commission take appropriate action to make the Registration Statement on Form S-3 (File No. 333-238197) effective as of 4:05 p.m. Eastern Time, Monday, May 18, 2020, or as soon thereafter as practicable. The Registrant respectfully requests that its legal counsel be notified when this request for acceleration has been granted by contacting via telephone call or email, Andrew J. Gibbons (Tel: 919-786-4038; E-mail: agibbons@wyrick.com). The Registrant understands that the Commission will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement. Very truly yours, CERECOR INC. By: /s/ Christopher Sullivan Name: Christopher Sullivan Title: Interim Chief Financial Officer
2020-05-13 - UPLOAD - Avalo Therapeutics, Inc.
United States securities and exchange commission logo
May 13, 2020
Christopher Sullivan
Interim Chief Financial Officer
Cerecor Inc.
540 Gaither Road, Suite 400
Rockville, Maryland 20850
Re:Cerecor Inc.
Registration Statement on Form S-3
Filed May 12, 2020
File No. 333-238197
Dear Mr. Sullivan:
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 Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Donald R. Reynolds, Esq.
2019-12-30 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm 540 Gaither Road, Suite 400 Rockville, MD 20850 December 30, 2019 VIA EDGAR Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Attn: Ada D. Sarmento Re: Cerecor Inc. Registration Statement on Form S-4 File No. 333-235666 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, Cerecor Inc., a Delaware corporation (the “Registrant”), hereby requests that the Securities and Exchange Commission take appropriate action to make the Registration Statement on Form S-4 (File No. 333-235666) effective as of 4:05 p.m. Eastern Time, Tuesday, December 31, 2019, or as soon thereafter as practicable. The Registrant respectfully requests that its legal counsel be notified when this request for acceleration has been granted by contacting via telephone call or email, Andrew J. Gibbons (Tel: 919-786-4038; E-mail: agibbons@wyrick.com) The Registrant understands that the Commission will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement. Very truly yours, CERECOR INC. By: /s/ Joseph M. Miller Name: Joseph M. Miller Title: Chief Financial Officer
2019-12-27 - UPLOAD - Avalo Therapeutics, Inc.
December 27, 2019
Joseph Miller
Chief Financial Officer
Cerecor Inc.
540 Gaither Road, Suite 400
Rockville, MD 20850
Re:Cerecor Inc.
Registration Statement on Form S-4
Filed December 20, 2019
File No. 333-235666
Dear Mr. Miller:
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 Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Donald R. Reynolds, Esq.
2019-10-22 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Document 540 Gaither Road, Suite 400 Rockville, MD 20850 October 22, 2019 VIA EDGAR Division of Corporation Finance United States Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Attn: Gregory Dundas Re: Cerecor Inc. Registration Statement on Form S-3 Filed September 27, 2019, as amended on October 18, 2019 File No. 333-233978 Ladies and Gentlemen: Cerecor Inc., a Delaware corporation (the “Registrant”), hereby requests that the Securities and Exchange Commission take appropriate action to make the Registration Statement on Form S-3 (File No. 333-233978) effective as of 4:05 p.m. Eastern Time, Thursday, October 24, 2019, or as soon thereafter as practicable. Please advise our corporate counsel, Andrew J. Gibbons at (919) 781-4000, of any questions. The Registrant understands that the Commission will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement. Very truly yours, CERECOR INC. By: /s/ Joseph M. Miller Name: Joseph M. Miller Title: Chief Financial Officer
2019-10-18 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Document Wyrick Robbins Yates & Ponton LLP ATTORNEYS AT LAW 4101 Lake Boone Trail, Suite 300, Raleigh, NC 27607 PO Drawer 17803, Raleigh, NC 27619 P: 919.781.4000 F: 919.781.4865 www.wyrick.com October 18, 2019 VIA EDGAR AND OVERNIGHT DELIVERY United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Gregory Dundas Celeste Murphy Division of Corporation Finance Office of Life Sciences Re: Cerecor Inc. Registration Statement on Form S-3 Filed September 27, 2019 File No. 333-233978 Ladies and Gentlemen: We write this letter on behalf of our client Cerecor Inc. (the “Company”) in response to the comment of the staff (the “Staff”) of the U.S. Securities and Exchange Commission with respect to the above-captioned filing, as set forth in the Staff’s letter dated October 9, 2019. Concurrently with the submission of this letter, the Company has revised the Registration Statement with an Amendment No. 1 (“Amendment No. 1”) to the Registration Statement, as set forth below. For ease of review, we have set forth below in italics the comment of the Staff’s letter and have followed the comment with the Company’s response thereto. Form S-1 filed September 27, 2019 Choice of Forum, page 14 1. We note that your amended and restated certificate of incorporation identifies the Court of Chancery of the State of Delaware as the exclusive form for certain litigation, including any “derivative action.” Please disclose whether this provision applies to actions arising under the Securities Act or Exchange Act. In that regard, we note that Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder and Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. If the provision applies to Securities Act U.S. Securities and Exchange Commission October 18, 2019 Page 2 claims, please also revise your prospectus to state that there is uncertainty as to whether a court would enforce such provision and that investors cannot waive compliance with federal securities law and the rules and regulations thereunder. The Company’s amended and restated certificate of incorporation provides that, unless the Company consents in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for any derivative action or proceeding brought on behalf of the Company; any action asserting a claim of breach of a fiduciary duty; any action asserting a claim against the Company arising pursuant to any provision of the Delaware General Corporation Law, the amended and restated certificate of incorporation of the Company or the bylaws of the Company; or any action asserting a claim against the Company governed by the internal affairs doctrine. This provision follows established Delaware case law and legislation and is not intended to apply to claims arising under the federal securities laws and the rules and regulations thereunder, including the Securities Act of 1933, as amended (the “Securities Act”), and the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Accordingly, while any person or entity purchasing or otherwise acquiring any interest in any of the Company’s securities shall be deemed to have notice of and consented to these provisions, the Company’s exclusive forum provision will not relieve the Company of its duties to comply with the federal securities laws and the rules and regulations thereunder, and the Company’s stockholders will not be deemed to have waived the Company’s compliance with these laws, rules and regulations. In response to the Staff’s comment, the Company has added an expanded description of the exclusive forum provision to the subsection titled “Choice of Forum,” under “Description of Our Capital Stock” in Amendment No. 1 to clearly and prominently describe the provision for investors. For the Staff’s convenience, the full text of the subsection is copied below, with the new language in bold for your ease of reference: “Choice of Forum Our amended and restated certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware is the exclusive forum for: • any derivative action or proceeding brought on our behalf; • any action asserting a claim of breach of a fiduciary duty; • any action asserting a claim against us arising pursuant to any provision of the DGCL, our amended and restated certificate of incorporation or our amended and restated bylaws; or • any action asserting a claim against us that is governed by the internal affairs doctrine. The enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible that, in connection with any action, a court could find the choice of forum provisions contained in our amended and restated certificate of incorporation to be inapplicable or unenforceable in such action. These provisions would not apply to suits brought to enforce a duty or liability created by the Exchange Act, Securities Act or any other claim for which the federal courts have exclusive or concurrent jurisdiction. Any person or entity purchasing or otherwise acquiring any interest in our securities shall be deemed to have notice of and consented to these provisions. Our exclusive forum provision will not relieve us of our duties to comply with the federal securities laws and the rules and regulations thereunder, and our shareholders will not be deemed to have waived our compliance with these laws, rules and regulations. U.S. Securities and Exchange Commission October 18, 2019 Page 3 The provisions of the DGCL, our amended and restated certificate of incorporation and our amended and restated bylaws could have the effect of discouraging others from attempting hostile takeovers and may also have the effect of preventing changes in our management. It is possible that these provisions could make it more difficult to accomplish transactions that stockholders may otherwise deem to be in their best interests.” * * * * * The Company respectfully submits that the foregoing is appropriately responsive to the Staff’s comments. If the Staff has any further comments, please direct them to the undersigned. Sincerely, /s/ Andrew J. Gibbons Andrew J. Gibbons cc: Joseph Miller, Chief Financial Officer, Cerecor Inc.
2019-10-09 - UPLOAD - Avalo Therapeutics, Inc.
October 9, 2019
Joseph Miller
Chief Financial Officer
Cerecor Inc.
540 Gaither Road, Suite 400
Rockville, Maryland 20850
Re:Cerecor Inc.
Registration Statement on Form S-3
Filed September 27, 2019
File No. 333-233978
Dear Mr. Miller:
We have limited our review of your registration statement to those issues we have
addressed in our 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 amending your registration statement and providing the
requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Form S-3 filed September 27, 2019
Choice of Forum, page 14
1.We note that your amended and restated certificate of incorporation identifies the Court of
Chancery of the State of Delaware as the exclusive form for certain litigation, including
any “derivative action.” Please disclose whether this provision applies to actions arising
under the Securities Act or Exchange Act. In that regard, we note that Section 27 of the
Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any
duty or liability created by the Exchange Act or the rules and regulations thereunder and
Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts
over all suits brought to enforce any duty or liability created by the Securities Act or the
rules and regulations thereunder. If the provision applies to Securities Act claims, please
also revise your prospectus to state that there is uncertainty as to whether a court would
FirstName LastNameJoseph Miller
Comapany NameCerecor Inc.
October 9, 2019 Page 2
FirstName LastName
Joseph Miller
Cerecor Inc.
October 9, 2019
Page 2
enforce such provision and that investors cannot waive compliance with federal securities
law and the rules and regulations thereunder.
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.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Gregory Dundas, Attorney Adviser, at (202) 551-3436 or Celeste
Murphy, Legal Branch Chief, at (202) 551-3257 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Andrew J. Gibbons
2019-02-08 - UPLOAD - Avalo Therapeutics, Inc.
February 7, 2019
Joe Miller
Chief Financial Officer
Cerecor Inc.
400 E. Pratt Street, Suite 606
Baltimore, Maryland 21202
Re:Cerecor Inc.
Registration Statement on Form S-3
Filed January 17, 2019
File No. 333-229283
Dear Mr. Miller:
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 Todd Schiffman at 202-551-3491 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-02-07 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm 540 Gaither Road, Suite 400 Rockville, MD 20850 February 7, 2019 VIA EDGAR Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street N.E. Washington, DC 20549 Attn: Todd Schiffman Re: Cerecor Inc. Registration Statement on Form S-3 Filed January 17, 2019 File No. 333-229283 Ladies and Gentlemen: Cerecor Inc., a Delaware corporation (the “Registrant”), hereby requests that the Securities and Exchange Commission take appropriate action to make the Registration Statement on Form S-3 (File No. 333-229283) effective as of 4:00 p.m. Eastern Time, Monday, February 11, 2019, or as soon thereafter as practicable. Please advise our corporate counsel, Andrew J. Gibbons at (919) 781-4000, of any questions. The Registrant understands that the Commission will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement. Very truly yours, CERECOR INC. By: /s/ Joseph Miller Name: Joseph Miller Title: Chief Financial Officer
2018-10-03 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm 400 E. Pratt Street, Suite 606 Baltimore, Maryland 21202 October 3, 2018 VIA EDGAR Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street N.E. Washington, DC 20549 Attn: Dorie Yale Re: Cerecor Inc. Registration Statement on Form S-3 Filed September 7, 2018, as amended October 2, 2018 File No. 333-227227 Ladies and Gentlemen: Cerecor Inc., a Delaware corporation (the “Registrant”), hereby requests that the Securities and Exchange Commission take appropriate action to make the Registration Statement on Form S-3 (File No. 333-227227) effective as of 4:30 p.m. Eastern Time, Friday, October 5, 2018, or as soon thereafter as practicable. Please advise our corporate counsel, Alexander M. Donaldson at (919) 781-4000, of any questions. The Registrant understands that the Commission will consider this request for acceleration of the effective date of the Registration Statement as a confirmation of the fact that the Registrant is aware of its responsibilities under the Securities Act and the Securities Exchange Act of 1934, as amended, as they relate to the proposed public offering of the securities specified in the Registration Statement. Very truly yours, CERECOR INC. By: /s/ Joseph Miller Name: Joseph Miller Title: Chief Financial Officer
2018-08-21 - UPLOAD - Avalo Therapeutics, Inc.
August 21, 2018
Mariam Morris
Chief Financial Officer
Cerecor Inc.
400 E. Pratt Street, Suite 606
Baltimore, MD 21202
Re:Cerecor Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed April 2, 2018
File No. 001-37590
Dear Ms. Morris:
We have completed our review of your filings. 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 Healthcare & Insurance
2018-07-27 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Wyrick Robbins Yates & Ponton LLP ATTORNEYS AT LAW 4101 Lake Boone Trail, Suite 300, Raleigh, NC 27607 PO Drawer 17803, Raleigh, NC 27619 P: 919.781.4000 F: 919.781.4865 www.wyrick.com July 27, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Vanessa Robertson Re: Cerecor Inc. Form 10-K for the Fiscal Year Ended December 31, 2017 Filed April 2, 2018 Form 10-K/A for the Fiscal Year Ended December 31, 2017 Filed May 25, 2018 Form 10-Q for the Fiscal Quarter Ended March 31, 2018 (“Form 10-Q”) Filed May 11, 2018 File No. 001-37590 Ladies and Gentlemen: We write this letter on behalf of our client Cerecor Inc. (the “Company”) in response to the comment of the staff (the “Staff”) of the U.S. Securities and Exchange Commission with respect to the above-captioned filings, as delivered to us in a telephone conversation on July 16, 2018. In response to the Staff’s comment, the Company proposes to amend Part I, Item 4 “Controls and Procedures” in the Company’s Form 10-Q for the fiscal quarter ended March 31, 2018 to read as follows: “Item 4. Controls and Procedures. Evaluation of Disclosure Controls and Procedures As required by Rule 13a-15(b) and Rule 15d-15(b) of the Exchange Act, our management, including our principal executive officer and our principal financial officer, conducted an evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q of the effectiveness of the design and operation of our disclosure controls and procedures. In designing and evaluating our disclosure controls and procedures, our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were not effective at the reasonable assurance level because they did not facilitate that certain information required to be disclosed by us in our SEC filings was recorded, processed, and accurately summarized and reported within the time periods specified in the SEC’s rules and regulations. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Our principal executive and principal financial officers’ conclusion that our disclosure controls and procedures were not effective as of the end of the period covered by this Quarterly Report on Form 10-Q is due to the following errors and inconsistencies in the reports that we filed under the Exchange Act: · On March 2, 2018, we filed our Annual Report on Form 10-K (“Original Form 10-K”), which did not provide a clear conclusory statement, under Item 9A “Controls and Procedures”, as to whether our principal executive and principal financial officers believed our disclosure controls and procedures were or were not effective as of the end of the period covered by the Original Form 10-K, namely December 31, 2017; · The Original Form 10-K also correctly contained a conclusion that the Company had a material weakness in internal control over financial reporting as of December 31, 2017 due to a failure to prevent an unauthorized cash disbursement (the “Material Weakness”); · On May 11, 2018, we filed a Quarterly Report on Form 10-Q that incorrectly concluded that because of the Material Weakness the Company’s disclosure controls and procedures were not effective as required under Rules 13a-15(e) and 15d-15(e) under the Exchange Act at March 31, 2018; and · On May 25, 2018, in response to an SEC comment on the Original Form 10-K, we filed an amended Annual Report on Form 10-K to correct the disclosure contained in Item 9A “Controls and Procedures” and provided a clear conclusory statement that the principal executive and principal financial officers believed our disclosure controls and procedures were effective as of December 31, 2017. Due to the above errors and inconsistencies in the Company’s filings, our principal executive and principal financial officers were unable to conclude that our disclosure controls and procedures were effective as of the end of the period covered by this Quarterly Report on Form 10-Q. Changes in Internal Control Over Financial Reporting Management had previously determined that the Company’s internal controls did not operate effectively to prevent or timely detect an unauthorized cash disbursement during the quarter ended 2 December 31, 2017. Specifically, these controls were not adequate to safeguard the Company’s cash assets from unauthorized transfers resulting from the failure of certain members of the finance organization to exercise appropriate skepticism and oversight for disbursement of company-owned funds. This Material Weakness in the Company’s controls resulted in the inability to prevent and timely detect the fraud loss. Remediation of the Material Weakness Upon identification of the Material Weakness, management began the immediate implementation of the following actions: · enhanced approval requirements for electronic disbursements; · increased centralization and levels of review for the processing of disbursements; · implemented limits on the amount of cash available for disbursement; · increased internal communications to improve security awareness and to emphasize the importance of exercising professional skepticism; and · established communications protocols for attempted fraudulent disbursements. Management completed the remediation of the Material Weakness during the Company’s fiscal quarter ended March 31, 2018. Other than the changes associated with our remediation efforts described above, there was no change in the Company’s internal control over financial reporting that occurred during the Company’s fiscal quarter ended March 31, 2018 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting. * * * * * The Company respectfully submits that the foregoing discussion is appropriately responsive to the Staff’s comment. If the Staff has any further comments, please direct them to the undersigned. Sincerely, /s/ Donald R. Reynolds Donald R. Reynolds cc: Joseph Miller, Chief Financial Officer, Cerecor Inc. 3
2018-06-22 - CORRESP - Avalo Therapeutics, Inc.
CORRESP
1
filename1.htm
Wyrick Robbins Yates & Ponton LLP
ATTORNEYS AT LAW
4101 Lake Boone Trail, Suite 300, Raleigh, NC 27607
PO Drawer 17803, Raleigh, NC 27619
P: 919.781.4000 F: 919.781.4865 www.wyrick.com
June 22, 2018
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Vanessa Robertson and Kevin Vaughn
Re: Cerecor Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed April 2, 2018
Form 10-K/A for the Fiscal Year Ended December 31, 2017
Filed May 25, 2018
File No. 001-37590
Ladies and Gentlemen:
We write this letter on behalf of our client Cerecor Inc. (the “Company”) in response to the comment of the staff (the “Staff”) of the U.S. Securities and Exchange Commission with respect to the above-captioned filings, as set forth in the Staff’s letter dated June 15, 2018 (“Staff’s Letter”). For ease of review, we have set forth below in italics the comment of the Staff’s letter and have followed the comment with the Company’s response thereto.
Form 10-K/A for the Fiscal Year Ended December 31, 2017
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures, page 83
1. Please address the following regarding the disclosure you added to the amended Form 10-K which states that management concluded disclosure controls and procedures (DCP) were effective as of December 31, 2017:
· Please tell us how you determined that a conclusion that your internal control over financial reporting (ICFR) was not effective as of December 31, 2017, did not impact your conclusion regarding the effectiveness of your DCP, as defined in Exchange Act Rules 13a-15(e) and 15d-15(e). Please refer to SEC Release No. 33-8238, Final Rule: Management’s Report on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, which states that disclosure controls and procedures will include those components of internal control over financial reporting that provide reasonable assurances that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles.
· Please explain how you determined that the material weaknesses in your ICFR was not
one of the components of ICFR that is also included in disclosure controls and procedures.
· Explain how you concluded that your DCP were effective as of December 31, 2017 but were not effective as of March 31, 2018.
The Company acknowledges the Staff’s comment and the statements in SEC Release No. 33-8238. The Company’s management determined that the Company’s DCP were effective as of December 31, 2017, notwithstanding the existence of a material weakness identified in its ICFR, based primarily on: (1) the weakness in ICFR being related only to the safeguarding and not the reporting of assets; and (2) the limited nature and volume of transactions effected by the material weakness.
As disclosed in the Company’s Form 10-K filed on April 2, 2018 and Form 10-K/A filed on May 25, 2018, the Company’s management had previously determined that the Company’s internal controls did not operate effectively to prevent or timely detect an unauthorized cash disbursement during the fiscal year ended December 31, 2017 (the “Covered Period”).
The material weakness was detected after one unauthorized cash disbursement during the Covered Period, and it was detected by Company personnel well before the preparation of the Company’s next required SEC filing involving its DCP. Promptly after identifying the unauthorized cash disbursement, the Company, with the assistance of outside counsel and its auditors, Ernst & Young LLP, analyzed the situation, including where it fit in the analyses of weaknesses in both ICFR and DCP, and also implemented timely and effective remedial actions to fix the material weakness identified. The Company also audited all cash disbursements made during the Covered Period and determined that this was an isolated incident. Remediation of the material weakness, as outlined in the Company’s Form 10-Q for the quarter ended March 31, 2018, were completed during the first quarter of 2018.
The Company has again reviewed Exchange Act Rules 13a-15(e) and 15d-15(e) and the SEC Release No. 33-8238, Final Rule: Management’s Report on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports (“Adopting Release”). The Company acknowledges that there is substantial overlap between a company’s DCP and its ICFR. However, as noted above the Company maintains that the material weakness identified in its ICFR does not fall into the elements of its DCP.
The Adopting Release, in part, says “…there are both some elements of disclosure controls and procedures that are not subsumed by internal controls over financial reporting and sole elements of internal control that are not subsumed by the definition of disclosure controls and procedures.” It goes on to say: “For example, a company might have developed internal control over financial reporting that includes as a component of safeguarding of assets dual signature requirements or limitations on signature authority on checks. That company could nonetheless determine that this component is not a part of disclosure controls and procedures.”
The Company views its material weakness in a similar light to the example given in the Adopting Release, with the former involving verification of wire transfer instructions and the latter restricting issuance of checks. The weakness identified was a part of safeguarding assets, and did not involve the reporting of such assets. The material weakness did not affect the controls and procedures of the Company that were designed to ensure that information required to be disclosed by the Company in the reports it files or submits under the Exchange Act is recorded, processed, summaries and reported, within the time periods specified in the
2
SEC’s rules and forms. Therefore, the identified material weakness in ICFR is not one of the components included in the Company’s DCP.
The last bullet point of the Staff’s Letter identifies a discrepancy in the disclosure covering the Covered Period appearing in the Company’s Form 10-K and 10-K/A, on the one hand, and the disclosure covering the Company’s quarter ended March 31, 2018 appearing in the Company’s Form 10-Q, on the other. The Company acknowledges the Staff’s comment and will amend its Form 10-Q for the quarter ended March 31, 2018 to conform to the disclosure appearing in its Form 10-K for the Covered Period. Based on our telephone conversation with Vanessa Robertson of the Staff on June 20, 2018, the Company will wait to amend its Form 10-Q until after the Staff has responded to this letter.
* * * * *
The Company respectfully submits that the foregoing discussion is appropriately responsive to the Staff’s comment. If the Staff has any further comments, please direct them to the undersigned.
Sincerely,
/s/ Donald R. Reynolds
Donald R. Reynolds
cc: Mariam Morris, Chief Financial Officer, Cerecor Inc.
3
2018-06-15 - UPLOAD - Avalo Therapeutics, Inc.
June 15, 2018
Mariam Morris
Chief Financial Officer
Cerecor Inc.
400 E. Pratt Street, Suite 606
Baltimore, MD 21202
Re:Cerecor Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed April 2, 2018
Form 10-K/A for the Fiscal Year Ended December 31, 2017
Filed May 25, 2018
File No. 001-37590
Dear Ms. Morris:
We have reviewed your May 25, 2018 response to our comment letter and have the
following comment. In our comment, we may ask you to provide us with information so we may
better understand your disclosure.
Please respond to the comment 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
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-K/A for the Fiscal Year Ended December 31, 2007
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures, page 3
1.Please address the following regarding the disclosure you added to the amended Form 10-
K which states that management concluded disclosure controls and procedures (DCP)
were effective as of December 31, 2017:
•Please tell us how you determined that a conclusion that your internal control
over financial reporting (ICFR) was not effective as of December 31, 2017, did not
impact your conclusion regarding the effectiveness of your DCP, as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e). Please refer to SEC Release No. 33-
FirstName LastNameMariam Morris
Comapany NameCerecor Inc.
June 15, 2018 Page 2
FirstName LastName
Mariam Morris
Cerecor Inc.
June 15, 2018
Page 2
8238, Final Rule: Management’s Report on Internal Control Over Financial Reporting
and Certification of Disclosure in Exchange Act Periodic Reports, which states that
disclosure controls and procedures will include those components of internal
control over financial reporting that provide reasonable assurances that transactions
are recorded as necessary to permit preparation of financial statements in accordance
with generally accepted accounting principles.
•Please explain how you determined that the material weaknesses in your ICFR was not
one of the components of ICFR that is also included in disclosure controls and
procedures.
•Explain how you concluded that your DCP were effective as of December 31, 2017
but were not effective as of March 31, 2018.
You may contact Vanessa Robertson at 202-551-3649 or Kevin Vaughn at 202-551-3494
with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
2018-05-25 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Wyrick Robbins Yates & Ponton LLP ATTORNEYS AT LAW 4101 Lake Boone Trail, Suite 300, Raleigh, NC 27607 PO Drawer 17803, Raleigh, NC 27619 P: 919.781.4000 F: 919.781.4865 www.wyrick.com May 25, 2018 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Vanessa Robertson and Kevin Vaughn Re: Cerecor Inc. Form 10-K for the Fiscal Year Ended December 31, 2017 Filed April 2, 2018 File No. 001-37590 Ladies and Gentlemen: We write this letter on behalf of our client Cerecor Inc. (the “Company”) in response to the comment of the staff (the “Staff”) of the U.S. Securities and Exchange Commission with respect to the above-captioned filing, as set forth in the Staff’s letter dated May 14, 2018. For ease of review, we have set forth below in italics the comment of the Staff’s letter and have followed the comment with the Company’s response thereto. Form 10-K for the Fiscal Year Ended December 31, 2017 Item 9A. Controls and Procedures Evaluation of Disclosure Controls and Procedures, page 83 1. Please amend your Form 10-K to provide clear conclusory statements as to whether your principal executive and principal financial officers believe your disclosure controls and procedures were or were not effective as of the end of the period covered by the report. Refer to Item 307 of Regulation S-K. The Company acknowledges the Staff’s comment, and as requested, has filed an amended Annual Report on Form 10-K that contains revised disclosure that provides clear conclusory statements as to whether the Company’s principal executive and principal financial officers believe the Company’s disclosure controls and procedures were or were not effective as of the end of the period covered by the report. In part, the revised disclosure states: “Based on their evaluation, our principal executive officer and principal financial officer concluded that as of December 31, 2017 our disclosure controls and procedures were designed to, and were effective to, provide assurance at a reasonable level that the information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosures as of December 31, 2017.” * * * * * The Company respectfully submits that the foregoing discussion is appropriately responsive to the Staff’s comment. If the Staff has any further comments, please direct them to the undersigned. Sincerely, /s/ Donald R. Reynolds Donald R. Reynolds cc: Mariam Morris, Chief Financial Officer, Cerecor Inc. 2
2018-05-14 - UPLOAD - Avalo Therapeutics, Inc.
May 14, 2018
Mariam Morris
Chief Financial Officer
Cerecor Inc.
400 E. Pratt Street, Suite 606
Baltimore, MD 21202
Re:Cerecor Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed April 2, 2018
File No. 001-37590
Dear Ms. Morris:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment.
Please respond to the comment 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
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2017
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures, page 83
1.Please amend your Form 10-K to provide clear conclusory statements as to whether your
principal executive and principal financial officers believe your disclosure controls and
procedures were or were not effective as of the end of the period covered by the report.
Refer to Item 307 of Regulation S-K.
In closing, 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.
FirstName LastNameMariam Morris
Comapany NameCerecor Inc.
May 14, 2018 Page 2
FirstName LastName
Mariam Morris
Cerecor Inc.
May 14, 2018
Page 2
You may contact Vanessa Robertson at 202-551-3649 or Kevin Vaughn at 202-551-3494
with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
2017-06-07 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Document June 7, 2017 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance 100 F Street, N.E. Washington, D.C. 20549 Attn: Jeffrey Gabor Re: Cerecor Inc. Registration Statement on Form S-3 File No. 333-218252 Acceleration Request Requested Date: Friday, June 9, 2017 Requested Time: 4:30 P.M. Eastern Standard Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-218252) (the “Registration Statement”) to become effective on Friday, June 9, 2017, at 4:30 p.m. Eastern Standard 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 (the “Staff”). Once the Registration Statement has been declared effective, please orally confirm that event with Brent B. Siler of Cooley LLP, counsel to the Registrant, at (202) 728-7040, or in his absence, Madison Jones at (202) 728-7087. [Signature page follows] Very truly yours, Cerecor Inc. By: /s/ Mariam E. Morris Mariam E. Morris Chief Financial Officer cc: Uli Hacksell, Ph.D., Cerecor Inc. Brent B. Siler, Cooley LLP
2017-06-06 - UPLOAD - Avalo Therapeutics, Inc.
June 6, 2017
Uli Hacksell
President and Chief Executive Officer
Cerecor Inc.
400 E. Pratt Street, Suite 606
Baltimore, Maryland 21202
Cerecor Inc.
Registration Statement on Form S-3
Filed May 26, 2017
File No. 333-218252Re:
Dear Dr. Hacksell:
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 Jeffrey Gabor at (202) 551-2544 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
2017-05-22 - UPLOAD - Avalo Therapeutics, Inc.
May 22, 2017
Uli Hacksell
President and Chief Executive Officer
Cerecor Inc.
400 E. Pratt Street, Suite 606
Baltimore, Maryland 21202
Cerecor Inc.
Preliminary Proxy Statement on Schedule 14A
Filed May 12, 2017
File No. 001-37590Re:
Dear Dr. Hacksell:
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 by the staff.
Division of Corporation Finance
Office of Healthcare and
Insurance
2017-05-19 - CORRESP - Avalo Therapeutics, Inc.
CORRESP
1
filename1.htm
Document
Madison A. Jones
+1 202 728 7087
madison.jones@cooley.com
May 19, 2017
Via EDGAR and Electronic Mail
Mr. Jeffrey Gabor
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Cerecor Inc.
Preliminary Proxy Statement on Schedule 14A
Filed May 12, 2017
File No. 001-37590
Ladies and Gentlemen:
On behalf of Cerecor Inc. (the “Company”), this letter is being transmitted in response to a comment received from the staff (the “Staff”) of the Securities and Exchange Commission, by telephone on May 19, 2017 (the “Comment”), regarding the Company’s Preliminary Proxy Statement on Schedule 14A, filed on May 12, 2017 (the “Proxy Statement”). The text of the Staff’s comment has been included in this letter in italics for your convenience.
Proposal 5: Approval of the Authorized Share Reduction Proposal
1.
Please revise the disclosure in the preliminary proxy statement to discuss any other plans, agreements, arrangements or understandings with regard to the increase of authorized shares as a result of the planned reverse stock split.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure to page 23 of the Proxy Statement.
***
Mr. Jeffrey Gabor
May 19, 2017
Page Two
Please contact me at (202) 728-7087 with any questions or further comments regarding the Company’s response to the Comment Letter.
Sincerely,
/s/ Madison A. Jones
Madison A. Jones
cc:
Uli Hacksell, Cerecor Inc.
Mariam Morris, Cerecor Inc.
Brent B. Siler, Cooley LLP
145833740 v1
2016-12-05 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm cerc_Current_Folio_CORRESP_Comment_Letter December 5, 2016 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 4546 Washington, D.C. 20549 Attn: Suzanne Hayes Scot Foley Mary Beth Breslin Re: Cerecor Inc. Registration Statement on Form S-3 File No. 333-214507 Acceleration Request Requested Date: Wednesday, December 7, 2016 Requested Time: 4:30 P.M. Eastern Standard Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-214507) (the “Registration Statement”) to become effective on Wednesday, December 7, 2016, at 4:30 p.m. Eastern Standard 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 (the “Staff”). Once the Registration Statement has been declared effective, please orally confirm that event with Brent B. Siler of Cooley LLP, counsel to the Registrant, at (202) 728-7040, or in his absence, Madison Jones at (202) 728-7087. [Signature page follows] Very truly yours, Cerecor Inc. By: /s/ Mariam E. Morris Mariam E. Morris Chief Financial Officer cc: Uli Hacksell, Ph.D., Cerecor Inc. Brent B. Siler, Cooley LLP Cooley LLP 1299 Pennsylvania Avenue, NW, Suite 700 Washington, DC 20004-2400 t: (202) 842-7800 f: (202) 842-7899 cooley.com
2016-12-01 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm cerc_Current_Folio_CORRESP_Comment_Letter Brent B. Siler +1 202 728 7040 bsiler@cooley.com December 1, 2016 Via EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 4720 Washington, D.C. 20549 Attention: Suzanne Hayes Scot Foley Mary Beth Breslin Re: Cerecor Inc. Registration Statement on Form S-3 Filed November 8, 2016 File No. 333-214507 Ladies and Gentlemen: On behalf of Cerecor Inc. (the “Company”), we are submitting this letter and the following information in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission, by letter dated November 18, 2016 (the “Comment Letter”), regarding the Company’s Registration Statement on Form S-3, filed on November 8, 2016 (the “Registration Statement”). We are also electronically submitting Amendment No. 1 to the Form S-3 (the “Amended Registration Statement”), which has been amended in response to the Staff’s comments. Set forth below are the Company’s responses to the Staff’s comments. For the Staff’s convenience, we have incorporated your comments into this response letter in italics. Prospectus Cover Page 1. It appears that you are relying on General Instruction I.B.6 of Form S-3 for this offering. If so, please revise your prospectus cover page to disclose the calculation of the aggregate market value of your outstanding voting and nonvoting common equity and the amount of all securities offered pursuant to General Instruction I.B.6 during the prior 12 calendar month period that ends on, and includes, the date of the prospectus. We refer you to Instruction 7 to General Instruction I.B.6. Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on the prospectus cover page of the Amended Registration Statement accordingly. Cooley LLP 1299 Pennsylvania Avenue, NW, Suite 700 Washington, DC 20004-2400 t: (202) 842-7800 f: (202) 842-7899 cooley.com December 1, 2016 Page 2 Exhibit Index 2. We note that you have submitted an application for confidential treatment relating to an exhibit filed with your quarterly report on Form 10-Q on November 8, 2016. Please be advised that this application is being processed and that we will not be in a position to grant effectiveness to your registration statement until such time as the application has completed processing and comments to it, if any, have been resolved. Response: The Company respectfully acknowledges the Staff’s comment. 3. We note that you indicate that your Statement of Eligibility of Trustee under the Indenture will be filed by amendment or incorporated by reference to a report filed under the Exchange Act. Please be advised that you should file this Form T-1 not with a post-effective amendment or as incorporated by reference to an Exchange Act filing, but rather under form type “305B2.” For guidance, please refer to Trust Indenture Act of 1939 Compliance & Disclosure Interpretation 206.01, available on the Commission’s website. Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure in the Exhibit Index of the Amended Registration Statement accordingly. *** Please contact me at (202) 728-7040 or Madison Jones at (202) 728-7087 with any questions or further comments regarding the Company’s response to the Comment Letter. Sincerely, Cooley LLP Brent B. Siler, Esq. cc:Uli Hacksell, Ph.D., Cerecor Inc. 139520203 v2 Cooley LLP 1299 Pennsylvania Avenue, NW, Suite 700 Washington, DC 20004-2400 t: (202) 842-7800 f: (202) 842-7899 cooley.com
2016-11-18 - UPLOAD - Avalo Therapeutics, Inc.
Mail Stop 4 546 November 18 , 2016 Uli Hacksell, Ph.D. President and Chief Executive Officer Cerecor Inc. 400 E. Pratt Street, Suite 606 Baltimore, Maryland 21202 Re: Cerecor Inc. Registration Statement on Form S-3 Filed November 8 , 2016 File No. 333 -214507 Dear D r. Hacksell : We have limited our review of your registration statement to those issues we have addressed in our 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 amending your registration statement and providing the requested information. 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 any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Prospectus Cover Page 1. It appears that you are re lying on General Instruction I.B.6 of Form S -3 for this offering. If so, please revise your prospectus cover page to disclose the calculation of the aggregate market value of your outstanding voting and nonvoting common equity and the amount of all securities offered pursuant to General I nstruction I.B.6 during the prior 12 calendar month period that ends on, and includes, the date of the prospectus. We refer you to Instruction 7 to General Instruction I.B.6. Exhibit Index 2. We n ote that you have submitted an application for confidential treatment relating to an exhibit filed with your quarterly report on Form 10 -Q on November 8, 2016. Please be advised that this application is being processed and that we will not be in a position to Uli Hacksell, Ph.D. Cerecor Inc. November 18 , 2016 Page 2 grant effectiveness to your registration statement until such time as the application has completed processing and comments to it, if any, have been resolved . 3. We note that you indicate that your Statement of Eligibility of Trustee under the Indenture will be filed by amendment or incorporated by reference to a report filed under the Exchange Act. Please be advised that you should file this Form T -1 not with a post - effective amendment or as incorporated by reference to an Exchange Act filing, but rather under form type “305B2.” For guidance, please refer to Trust Indenture Act of 1939 Compliance & Disclosure Interpretatio n 206.01 , available on the Commission ’s website. 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. Refer to Rules 460 and 461 regarding requests for acceleration . Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Scot Foley at (202) 551 -3383 or Mary Beth Breslin at (202) 551 -3625 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Brent B. Siler , Esq.
2016-09-26 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm cerc_Current_Folio_CORRESP Cerecor Inc. 400 E. Pratt Street, Suite 606 Baltimore, Maryland 21202 (410) 522-8707 September 26, 2016 Via Edgar United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Cerecor Inc Registration Statement on Form S-1 Filed: September 16, 2016 File No. 333-213676 Ladies and Gentlemen: Pursuant to Rules 460 and 461 under the Securities Act of 1933, as amended, Cerecor Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-1 to become effective at 5:00 p.m. Eastern Time on Wednesday, September 28, 2016, or as soon thereafter as is practicable. The Registrant also hereby requests a copy of the written order verifying the effective date. In connection with this request, the Registrant hereby acknowledges that: · should the Commission or the staff of the Commission (the “Staff”), acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; · the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and · the Registrant may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Sincerely, Cerecor Inc. By: /s/ Uli Hacksell Uli Hacksell Chief Executive Officer
2016-09-23 - UPLOAD - Avalo Therapeutics, Inc.
Mail Stop 4 546 September 23, 2016 Uli Hacksell, Ph.D. President and Chief Executive Officer Cerecor Inc. 400 E. Pratt Street, Suite 606 Baltimore, M D 21202 Re: Cerecor Inc. Registration Statement on Form S-1 Filed September 16, 2016 File No. 333-213676 Dear Dr. Hacksell : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action wit h respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation Uli Hacksell, Ph.D. Cerecor Inc. September 23, 2016 Page 2 of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . Please contact Dorrie Yale at 202 -551-8776 and Joseph McCann at 202 -551-6262 with any questions. Sincerely, /s/ Joseph McCann for Suzanne Hayes Assistant Director Office of Insurance and Healthcare cc: Brent B. Siler , Esq. — Cooley LLP
2015-10-09 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Morgan, Lewis & Bockius LLP 1701 Market Street Philadelphia, PA 19103-2921 Tel. +1.215.963.5000 Fax: +1.215.963.5001 www.morganlewis.com Joanne R. Soslow Partner +1.215.963.5262 jsoslow@morganlewis.com October 9, 2015 VIA FEDEX Suzanne Hayes Assistant Director Office of Healthcare and Insurance Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Cerecor Inc. Amendment No. 3 to Registration Statement on Form S-1 Filed on October 1, 2015 File No. 333-204905 Dear Ms. Hayes: On behalf of our client, Cerecor Inc. (the “Company”), we are responding to the comment of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in your letter dated October 9, 2015 (the “Comment Letter”) to Dr. Paterson, President and Chief Executive Officer of the Company, with respect to Amendment No. 3 to the Company’s Registration Statement on Form S-1 referred to above (the “Registration Statement”). In response to your Comment Letter, set forth below is your comment in bold followed by the Company’s response. The page numbers in the bold caption refer to the page in the Registration Statement. All terms used but not defined herein have the meanings assigned to such terms in the Registration Statement. Capitalization, page 69 1. You disclose that you assume the warrants included in your units will be accounted for as equity instruments and that you will not make your final determination on classification until prior to the issuance of your next quarterly financial statements. Please tell us what information is not currently available in order to conclude that Almaty Astana Beijing Boston Brussels Chicago Dallas Dubai Frankfurt Hartford Houston London Los Angeles Miami Moscow New York Orange County Paris Philadelphia Pittsburgh Princeton San Francisco Santa Monica Silicon Valley Singapore Tokyo Washington Wilmington the warrants would not be accounted for as equity and whether, and, if so, to what extent that information will inform as to the appropriateness of an alternative accounting for the warrants. Notwithstanding, you indicate, in the last risk factor on page 62, that if a registration statement is not available upon the exercise of the warrants the holders will receive restricted shares upon exercise. Please confirm that your warrants explicitly provide for settlement in unregistered shares if a registration statement is not available. Otherwise, tell us why classification of the warrants as liabilities under the guidance in ASC 815-40-25-11 through 25-16 is not appropriate under the operation of the U.S. securities laws regarding the settlement of publicly issued warrants. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Response: The Company has reviewed the provisions of the Class A Warrant Agreement and Class B Warrant Agreement (together, the “Warrants”) and has completed its analysis of the equity classification criterion and concluded that the Warrants will be accounted for as equity instruments. Specifically as to your request to confirm that the Warrants explicitly provide for settlement in unregistered shares if a registration statement is not available, the Company has considered the following: · Section 3.3.2 of the Warrants enables the holders to exercise the Warrants for unregistered shares in the event the Company does not maintain an effective registration statement with the Commission. The ability to utilize the cashless exercise feature is the holder’s sole remedy against the Company for failure to maintain the effectiveness of the registration statement and the sole method of exercise of the Warrants during the period an effective registration statement does not exist. In addition, the last sentence of Section 3.3.4 of the Warrants provides that in no event will the Company be obligated to pay the holder any cash consideration upon exercise. · Section 3.3.2 provides: · Notwithstanding anything contained herein to the contrary, if on the date of exercise of the Warrants there is no effective registration statement registering the Warrant Shares, or the prospectus contained therein is not available for the resale of the Warrant Shares, if the Registered Holder desires to exercise the Warrants, the Registered Holder may only exercise the Warrants in whole or in part in lieu of making a cash payment, by providing notice to the Chief Financial Officer of 2 the Company in a subscription form of its election to utilize cashless exercise, in which event the Company shall issue to the Holder the number of Warrant Shares determined as follows: · X = Y [(A-B)/A] · where: · X = the number of Warrant Shares to be issued to the Holder. · Y = the number of Warrant Shares with respect to which this Warrant is being exercised. · A = the fair market value of one share of Common Stock. · B = the Warrant Price. · The last sentence of Section 3.3.4 provides: · In addition, in no event will the Company be obligated to pay such Registered Holder any cash consideration upon exercise or otherwise “net cash settle” the Warrant. As a result, the Company has deleted the wording on pages 15 and 69 of the S-1 stating that “our final determination as to their classification will occur upon completion of a detailed analysis, which will occur prior to the issuance of our next quarterly financial statements”. For the convenience of the Staff’s review, copies of this letter and Amendment No. 4 to the Registration Statement, marked to reflect changes against the Registration Statement, are being delivered to Mr. Scot Foley. If you have any questions, please feel free to contact me at (215) 963-5262 or Kevin Shmelzer at (215) 963-5716. Sincerely, /s/ Joanne R. Soslow Joanne R. Soslow JRS/avg c: Blake M. Paterson, M.D. Kevin S. Shmelzer Mitchell S. Nussbaum Tahra T. Wright 3
2015-10-09 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm MAXIM GROUP, LLC 405 Lexington Avenue New York, NY 10174 October 9, 2015 Securities and Exchange Commission 100 F. Street, NE Washington, D.C. 20549 Re: Cerecor, Inc. (the “Company”) Registration Statement on Form S-1 (No. 333-204905) VIA EDGAR Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended, Maxim Group LLC, as representative of the underwriters, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective on Wednesday, October 14, 2015, at 5:00 p.m. Eastern Time, or as soon thereafter as practicable, or at such later time as the Company may orally request via telephone call to the staff. Pursuant to Rule 460 under the Act, please be advised that we have distributed approximately 1,075 copies of the Preliminary Prospectus dated October 1, 2015 (the “Preliminary Prospectus”) through the date hereof, to underwriters, dealers, institutions and others. The undersigned confirms that it has complied with and will continue to comply with, and it has been informed or will be informed by participating dealers that they have complied with or will comply with, Rule 15c2-8 promulgated under the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issue. [Signature Page Follows] MAXIM GROUP, LLC, as Representative of the Underwriters By: /s/ Clifford A. Teller Name: Clifford A. Teller Its: Executive Managing Director Head of Investment Banking
2015-10-09 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Cerecor Inc. 400 E. Pratt Street, Suite 606 Baltimore, Maryland 21202 October 9, 2015 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attn: Jeffrey P. Riedler, Assistant Director Re: Cerecor Inc. Registration Statement on Form S-1 (No. 333-204905) Ladies and Gentlemen: In accordance with Rule 461 promulgated under the Securities Act of 1933, as amended (the “Act”), Cerecor Inc. (the “Company”) hereby requests the acceleration of the effective date of the above referenced Registration Statement on Form S-1 so that it will be declared effective on Wednesday, October 14, 2015, at 5:00 p.m. Eastern Time, or as soon thereafter as practicable, or at such later time as the Company may orally request via telephone call to the staff. The Company hereby authorizes Joanne R. Soslow or Kevin S. Shmelzer, counsel to the Company, to make such request on its behalf. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act as they relate to the proposed public offering of the securities specified in the above-captioned Registration Statement. Once the Registration Statement is effective, please orally confirm the event with our counsel, Morgan, Lewis & Bockius LLP by calling Mr. Shmelzer at (215) 963-5716. In connection therewith, the Company acknowledges that: · should the Commission or the staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the filing; · the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and · the Company may not assert comments of the Commission or the staff and the declaration of effectiveness of the filing as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, CERECOR INC. By: /s/ Blake Paterson Name: Blake Paterson Title: President and Chief Executive Officer cc: Joanne R. Soslow (Morgan, Lewis & Bockius LLP) Kevin S. Shmelzer (Morgan, Lewis & Bockius LLP) Mitchell Nussbaum (Loeb & Loeb LLP) Tahra Wright (Loeb & Loeb LLP)
2015-10-01 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Morgan, Lewis & Bockius LLP 1701 Market Street Philadelphia, Pennsylvania 19103 Tel: (215) 963-5000 / Fax: (215) 963-5001 October 1, 2015 By Electronic Submission and Federal Express Division of Corporate Finance Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 ATTN: Jeffrey P. Riedler Re: Cerecor Inc. — Amendment No. 3 to Registration Statement on Form S-1 (File No. 333-204905) Ladies and Gentlemen: On behalf of Cerecor Inc. (the “Company”), transmitted via the Securities and Exchange Commission’s EDGAR System for filing pursuant to the Securities Act of 1933, as amended, is Amendment No. 3 to the Registration Statement on Form S-1 (the “Registration Statement”) of the Company relating to the registration of the offer and sale of the Company’s units. For the convenience of the Staff’s review, the Registration Statement, marked to reflect changes against Amendment No. 2, are being delivered to Mr. Scot Foley. Please contact the undersigned at (215) 963-5716 with any questions or comments you may have regarding this submission. Very truly yours, /s/ Kevin S. Shmelzer Kevin S. Shmelzer, Esquire
2015-09-22 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Morgan, Lewis & Bockius LLP 1701 Market Street Philadelphia, PA 19103-2921 Tel. +1.215.963.5000 Fax: +1.215.963.5001 www.morganlewis.com Joanne R. Soslow Partner +1.215.963.5262 jsoslow@morganlewis.com September 22, 2015 VIA EDGAR AND FEDEX Jeffrey P. Riedler Assistant Director Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Cerecor Inc. Amendment No. 1 to Registration Statement on Form S-1 Filed on September 8, 2015 File No. 333-204905 Dear Mr. Riedler: On behalf of our client, Cerecor Inc. (the “Company”), we are responding to the comment of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in your letter dated September 17, 2015 (the “Comment Letter”) to Dr. Paterson, President and Chief Executive Officer of the Company, with respect to Amendment No. 1 to the Company’s Registration Statement on Form S-1 referred to above (the “Registration Statement”). In response to your Comment Letter, set forth below is your comment in bold followed by the Company’s response. The page numbers in the bold caption refer to the page in the Registration Statement. All terms used but not defined herein have the meanings assigned to such terms in the Registration Statement. Use of Proceeds, page 63 1. You disclose that you expect the net proceeds of your offering at an assumed offering price of $6.50 to be approximately $24.8 million or $26.1 million if the underwriters exercise their overallotment option. Please tell us how you computed each of these amounts as we cannot re-compute them based on the number of shares you expect to sell in each scenario coupled with reasonable underwriters’ Almaty Astana Beijing Boston Brussels Chicago Dallas Dubai Frankfurt Harrisburg Hartford Houston London Los Angeles Miami Moscow New York Orange County Paris Philadelphia Pittsburgh Princeton San Francisco Santa Monica Silicon Valley Singapore Tokyo Washington Wilmington commissions and the other offering expenses you disclose on page II-1. In your response, tell us why the exercise of the overallotment results in only a $1.3 million increase in estimated net proceeds equating to approximately $2.05 per overallotment share when the gross proceeds for these 634,615 shares at $6.50 per share is approximately $4.1 million. Response: The Company acknowledges the Staff’s comment and advises the Staff that the calculation of the net proceeds from the Company’s issuance and sale of 4,230,769 shares of the Company’s common stock, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by the Company, was incorrect in the Registration Statement. Specifically, the Company failed to deduct all of the estimated offering expenses in calculating the net proceeds with respect to the sale of the 4,230,769 shares of the Company’s common stock that the Company will be obligated to pay, but such expense amounts were included in calculating net proceeds if the overallotment option was exercised. The Company estimates that the net proceeds from its issuance and sale of 4,230,769 shares of the Company’s common stock in the offering will be approximately $22.7 million, assuming an initial public offering price of $6.50 per share, which is the midpoint of the price range set forth on the cover page of the prospectus included as part of the Registration Statement, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by the Company. If the underwriters exercise their over-allotment option in full, the Company estimates that the net proceeds from the offering will be approximately $26.5 million, assuming an initial public offering price of $6.50 per share. As a result, if the overallotment is exercised, the Company expects to receive an estimated increase in net proceeds of approximately $3.8 million, or $5.99 per overallotment share. Set forth below is a reconciliation of estimated gross proceeds to net proceeds: No Overallotment Overallotment Exercised Gross Proceeds @ $6.50/share $27.5M $31.6M UW Discount and Commission (7.5%) $(2.063M) $(2.37M) UW Unallocated Expense Reimbursement (1.5%) $(.413M) $(0.474M) UW Legal Reimbursement $(0.1M) $(0.1M) Company Expenses $(2.2M) $(2.2M) Net Proceeds $22.7M $26.5M Disclosed in Registration Statement $24.8M $26.1M Difference $(2.076M) or (8.37)% $0.4M or 1.37% The Company acknowledges that although there is a decrease of approximately $2.076 million as it relates to the estimated net proceeds of the sale of 4,230,769 shares of the Company’s common 2 stock, the Company believes it can accomplish the business objectives contemplated in the preliminary prospectus with the proceeds currently anticipated from the offering. The Company has filed an issuer free writing prospectus that updates the first paragraph on page 63 of the Registration Statement as well as the other instances where the incorrect amount of net proceeds was disclosed. The Company will also file Amendment No. 2 to the Registration Statement that will include the updated language as set forth in the issuer free writing prospectus. For the convenience of the Staff’s review, copies of this letter and Amendment No. 2 to the Registration Statement, marked to reflect changes against the Registration Statement, are being delivered to Mr. Scot Foley. If you have any questions, please feel free to contact me at (215) 963-5262 or Kevin Shmelzer at (215) 963-5716. Very truly yours, /s/ Joanne R. Soslow Joanne R. Soslow c: Blake M. Paterson, M.D. Kevin S. Shmelzer Mitchell S. Nussbaum Tahra T. Wright 3
2015-09-18 - UPLOAD - Avalo Therapeutics, Inc.
September 17 , 2015 Via E -mail Blake M. Patterson, M.D. President and Chief Executive Officer Cerecor Inc. 400 E. Pratt Street, Suite 606 Baltimore, Maryland 21202 Re: Cerecor Inc. Amendment No.1 to Registration Statement on Form S -1 Filed September 8, 2015 File No. 333 -204905 Dear Dr. Patterson : We have reviewed your amended registration statement and have the following comment. P lease respond to this letter by amending your registration statement again and providing the requested information . If you do not believe this comment is applicable to yo ur facts and circumstances or do not believe another amendment is appropriate, please tell us why in a response. After reviewing any further amendment to your registration statement and the information you provide in response to this comment, we may have additional comments. Use of Proceeds, page 63 1. You disclose that you expect the net proceeds of your offering at an assumed offering price of $6.50 to be approximately $24.8 million or $26.1 million if the underwriters exercise their overallotment opt ion. Please tell us how you computed each of these amounts as we cannot re -compute them based on the number of shares you expect to sell in each scenario coupled with reasonable underwriters’ commissions and the other offering expenses you disclose on page II-1. In your response, tell us why the exercise of the overallotment results in only a $1.3 million increase in estimated net proceeds equating to approximately $2.05 per overallotment share when the gross proceeds for these 634,615 shares at $6.50 per s hare is approximately $4.1 million. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act r ules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Blake M. Patterson, M.D. Cerecor Inc. September 17, 2015 Page 2 Notwithstanding our comment, in the event you re quest acceleration of the effective date of the pending regist ration statement, please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date o f the registration statement. You may contact Mark Brunhofer at (202) 551 -3613 or James Rosenberg at (202) 551-3679 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (202) 551 -3383 or me at (202) 551 -3675 with any other questions. Sincerely, Jeffrey P. Riedler Assistant Director cc: Joanne R. Soslow, Esq. Kevin S. Shmelzer, Esq. Morgan, Lewis & Bockius LLP 1701 Market Street Philadelphia, PA 19103
2015-09-04 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Morgan, Lewis & Bockius LLP 1701 Market Street Philadelphia, PA 19103-2921 Tel. +1.215.963.5000 Fax: +1.215.963.5001 www.morganlewis.com Joanne R. Soslow Partner +1.215.963.5262 jsoslow@morganlewis.com September 8, 2015 VIA E-MAIL Jeffrey P. Riedler Assistant Director Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Cerecor Inc. Registration Statement on Form S-1 Filed on June 12, 2015 File No. 333-204905 Dear Mr. Riedler: On behalf of our client, Cerecor Inc. (the “Company”), we are responding to the comment of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in your letter dated June 22, 2015 (the “New Comment Letter”) to Dr. Paterson, President and Chief Executive Officer of the Company, with respect to the Company’s Registration Statement on Form S-1 filed on June 12, 2015 (the “Registration Statement”). The Company is concurrently filing via EDGAR a redacted copy of this letter (as discussed below) and Amendment No. 1 to the Registration Statement (the “First Amendment”), which includes changes in response to the Staff’s comment. In addition, the purpose of this letter is to provide supplemental information to the Staff regarding the preliminary estimated public offering price per share for the Company’s proposed initial public offering and to provide a further response to comment 21 in the Staff’s letter to the Company dated January 16, 2014 (the “Previous Comment Letter” and together with the New Comment Letter, the “Comment Letters”). All terms used but not defined herein have the meanings assigned to such terms in the First Amendment. In response to your Comment Letters, set forth below are your comments in bold followed by the Company’s responses. Except for the page reference appearing in the Almaty Astana Beijing Boston Brussels Chicago Dallas Dubai Frankfurt Harrisburg Hartford Houston London Los Angeles Miami Moscow New York Orange County Paris Philadelphia Pittsburgh Princeton San Francisco Santa Monica Silicon Valley Singapore Tokyo Washington Wilmington Jeffrey P. Riedler September 8, 2015 Page 2 headings below (which reference is to the Registration Statement (as it relates to the New Comment Letter) and to the Company’s Draft Registration Statement submitted on December 20, 2013 (as it relates to the Previous Comment Letter)), the page references herein correspond to the page of the First Amendment. For the convenience of the Staff’s review, copies of this letter and the First Amendment, marked to reflect changes against the Registration Statement, are being delivered to Mr. Bryan J. Pitko. New Comment Letter Risk Factors Risks Related to this Offering and Ownership of Our Common Stock, page 52 1. We note that your amended and restated certificate of incorporation includes a provision requiring that the Court of Chancery in the State of Delaware be the sole and exclusive forum for various stockholder litigation matters. Please revise your risk factor discussion to include a separate risk factor noting the specific types of actions subject to the exclusive forum provision. Please also highlight that such provisions may limit a shareholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with directors, officers or other employees, and may discourage lawsuits with respect to such claims. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 59 of the First Amendment to disclose a separate risk factor noting the specific types of actions subject to the exclusive forum provision and highlighting that such provisions may limit a shareholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with directors, officers or other employees, and may discourage lawsuits with respect to such claims. Previous Comment Letter Stock-Based Compensation Fair Market Value Estimates, page 68 21. We may have additional comments on your accounting for stock compensation and related disclosure once you have disclosed an estimated offering price. Please provide quantitative and qualitative disclosures explaining the difference between the estimated offering price and the fair value of the common share at the August 29, 2013 issuance. Also, please update your filing to disclose any new equity issuance through the date you request effectiveness of your registration statement. Jeffrey P. Riedler September 8, 2015 Page 3 Response: The Company advises the Staff that it presently estimates, based in part on input the Company recently received in August from representatives of Maxim Group, LLC, the lead managing underwriter (the “Underwriter”) for the Company’s initial public offering of the Company’s common stock (the “IPO”), as well as taking into consideration current market conditions and information currently available, the public offering price per share for the IPO will be, before any consideration for the reverse stock split that was effected immediately prior to the filing of the Company’s First Amendment, based on a pre-money equity value range of $35 million to $45 million. The pre-money equity value range is based on 170,112,243 shares outstanding as of June 30, 2015, which includes common stock issuable upon the automatic conversion of all outstanding shares of the Company’s convertible preferred stock, and results in a range of common stock value of $0.206 to $0.265 per share. The following response is a quantitative and qualitative analysis explaining the difference between the estimated offering price and the Company’s most recent valuation exercise. The Company advises the Staff that, as described beginning on page 80 of the First Amendment, the Company performs contemporaneous valuations of the Company’s common stock to assist the Company’s Board of Directors (the “Board”) and the Compensation Committee of the Board (the “Committee”) in determining the common stock’s fair value for purposes of granting stock-based awards. The Board and Committee consider numerous objective and subjective factors in determining the exercise price of such stock-based awards, including the factors set forth on page 81 of the First Amendment, the Company’s IPO as the only possible future event and the most recent valuation reports prepared by an unrelated third-party valuation specialist. The Board and Committee, as applicable, also determine whether the assumptions and inputs used in connection with such contemporaneous valuations reflect the Board’s and Committee’s, as applicable, and management’s best estimate of the business condition, prospects and operating performance of the Company at each valuation date. Since December 2014, the exercise price of such stock-based awards have been higher than the contemporaneous valuations performed by third-party valuation specialist engaged by the Company. In recognition of the Staff’s interest in understanding the factors affecting the difference between the anticipated offering price and the exercise price of the prior stock option grants, the Company is providing the information set forth below. The Company has issued the following stock options during the period January 1, 2014 through the date of this letter as follows: Jeffrey P. Riedler September 8, 2015 Page 4 Grant Date Number of Shares Underlying Stock Options Granted Exercise Price Per Share of Common Stock Estimated Offering Price Per Share of Common Stock per Underwriters May 13, 2014 1,250,000 $ 0.36 $0.206-$0.265 July 10, 2014 1,521,897 $ 0.60 $0.206-$0.265 July 10, 2014 2,198,000 $ 0.36 $0.206-$0.265 April 30, 2015 100,000 $ 0.233 $0.206-$0.265 June 2, 2015 1,560,000 $ 0.219 $0.206-$0.265 June 2, 2015 325,000 $ 0.219 $0.206-$0.265 June 2, 2015 55,000 $ 0.219 $0.206-$0.265 The exercise price per share of common stock represents the determination by the Company’s Board of a price that is considered fair to the grantee as of the date of the grant, taking into consideration various objective and subjective factors, including the conclusion of the most recent independent valuation of the Company’s common stock. The Company’s contemporaneously estimated fair market values of a share of common stock, prepared by an unrelated third-party valuation specialist over the above period, were as follows: · December 31, 2013 $0.480 per share · December 31, 2014 $0.191 per share · March 31, 2015 $0.176 per share Jeffrey P. Riedler September 8, 2015 page 5 As can be seen from the information set forth above, the exercise price of all of the options granted during the 2014 fiscal year were above the estimated range of the offering price per share of common stock, while the exercise price of options granted thus far during the 2015 fiscal year were within the range of the estimated offering price per share of common stock. Also, the exercise price of options granted in 2015 was in excess of the fair market value per share of common stock per the then most recent valuation prepared by an unrelated third-party valuation specialist. The Company believes that the difference in fair value between the midpoint of the preliminary price range, which is $0.235 and the estimated per share common stock fair value on March 31, 2015 (and the exercise price of the options granted subsequent to that date) is primarily the result of the change in the probability of a near term IPO to virtually 100% (which is implicit in the preliminary price range), thus the discount applied for the lack of marketability in the estimated per share common stock fair value on March 31, 2015 would no longer be applicable. The primary factors that allowed the Company to progress towards an IPO from March 31, 2015, when the Board only attributed a 75% probability of being able to achieve a near-term IPO, to being in a position to determine the preliminary price range in late August 2015, were the public filing of the registration statement in June 2015 and additional due diligence, legal and accounting review by the Underwriter. In conclusion, the Company respectfully submits that the difference between the exercise price of options granted since January 1, 2014 (as well as the latest valuation) and the estimated midpoint of the price range for the IPO is reasonable in light of the considerations outlined above. If you have any questions, please feel free to contact me at (215) 963-5262 or Kevin Shmelzer at (215) 963-5716. Very truly yours, /s/ Joanne R. Soslow Joanne R. Soslow c: Blake M. Paterson, M.D. Kevin S. Shmelzer Mitchell S. Nussbaum Tahra T. Wright
2015-06-22 - UPLOAD - Avalo Therapeutics, Inc.
June 22 , 2015 Via E -mail Blake M. Patterson, M.D. President and Chief Executive Officer Cerecor Inc. 400 E. Pratt Street, Suite 606 Baltimore, Maryland 21202 Re: Cerecor Inc. Registration Statement on Form S -1 Filed June 12 , 2015 File No. 333 -204905 Dear Dr. Patterson : We have reviewed your registration statement and have the following comment . Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe this comment is applicable to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to this comment, we may have additional comments. Risk Factors Risks Related to this Offering and Ownership of Our Common Stock , page 52 1. We note that your amended and restated certificate of incorporation includes a provision requiring that the Court of Chancery in the State of Delaware be the sole and exclusive forum for various stockholder litigation matters. Please revise your risk factor discussion to include a separate risk factor noting the specific types of actions subject to the exclusive forum provision. Please also highlight that such provisions may limit a shareholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with directors, officers or other employees, and may discourage lawsuits with respect to such claims. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Blake M. Patterson, M.D. Cerecor Inc. June 22 , 201 5 Page 2 Notwithstanding our comment, in the event you request acceleration of the effective date of the pending regist ration statement, please provide a written statement from the company acknowledging that: should the Commission or the staff, acti ng pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding i nitiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Mark Brunhofer at (202) 551 -3613 or James Rosenberg at (202) 551 - 3679 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (202) 551 -3383 , Bryan Pitko at (202) 551 -3203 or me at (202) 551 - 3715 with any other questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: Joanne R. Soslow, Esq. Kevin S. Shmelzer, Esq. Morgan, Lewis & Bockius LLP 1701 Market Street Philadelphia, PA 19103
2015-06-12 - CORRESP - Avalo Therapeutics, Inc.
CORRESP 1 filename1.htm Morgan, Lewis & Bockius LLP 1701 Market Street Philadelphia, PA 19103-2921 Tel. +1.215.963.5000 Fax: +1.215.963.5001 www.morganlewis.com Joanne R. Soslow Partner +1.215.963.5262 jsoslow@morganlewis.com June 12, 2015 VIA E-MAIL Jeffrey P. Riedler Assistant Director Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Cerecor Inc. Amendment No. 2 to Confidential Draft Registration Statement on Form S-1 Submitted April 29, 2015 CIK No. 0001534120 Dear Mr. Riedler: On behalf of our client, Cerecor Inc. (the “Company”), we are responding to the comments of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in your letter dated May 21, 2015 to Dr. Paterson, President and Chief Executive Officer of the Company, with respect to the Company’s confidential submission of Amendment No. 2 to the Confidential Draft Registration Statement on Form S-1 referred to above (the “Draft Registration Statement”). The Company is concurrently filing via EDGAR this letter and its revised Registration Statement on Form S-1 (the “Registration Statement”), which includes changes in response to the Staff’s comments. For the convenience of the Staff’s review, copies of this letter and the Registration Statement, marked to reflect changes against the Draft Registration Statement that was confidentially submitted on April 29, 2015, are being delivered to Mr. Bryan J. Pitko. In response to your letter, set forth below are your comments in bold followed by the Company’s responses. Except for page references appearing in the headings and the Staff’s comments below (which are references to the Draft Registration Statement), all page references herein correspond to the page of the revised Registration Statement. Almaty Astana Beijing Boston Brussels Chicago Dallas Dubai Frankfurt Harrisburg Hartford Houston London Los Angeles Miami Moscow New York Orange County Paris Philadelphia Pittsburgh Princeton San Francisco Santa Monica Silicon Valley Singapore Tokyo Washington Wilmington For the convenience of the Staff’s review, copies of this letter and the Registration Statement, marked to reflect changes against the Draft Registration Statement that was confidentially submitted, are being delivered to Mr. Bryan J. Pitko. Prospectus Summary Product Candidates and Platform, page 2 1. Please remove the row concerning the COMTi platform from this table and the corresponding one on page 90. Unless and until you are able to advance a product candidate from the platform into preclinical studies, as you have done with CERC-406, the information included in this row is too inchoate to be included in a chart intended to summarize your product pipeline. Response: The Company acknowledges the Staff’s comment and has revised the disclosure in the Registration Statement to remove the row concerning the COMTi platform from the table on page 2 in the Prospectus Summary and the corresponding table on page 93. 2. Please disclose from whom you acquired CERC-501 in this summary. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on page 4 of the Prospectus Summary to disclose that the Company acquired CERC-501 from Eli Lilly and Company. Risk Factors Risks Related to Our Business and Industry “Our product candidates may cause undesirable side effects…,” page 24 3. Please amend the risk factor to state the adverse effects that were identified in the Clin301-201 clinical study and whether they were the same or similar to the ones you anticipate. Also, as you intend to increase the dosage of CERC-301 in the Clin301-203 study, please disclose that the risk of serious adverse events will also increase. Response: The Company acknowledges the Staff’s comment and has revised the disclosure beginning on page 25 of the Registration Statement to state the adverse effects that were identified in the Clin301-201 clinical study and that such adverse effects were similar to the ones the Company had anticipated. Further, the Company also revised the disclosure to state that as the Company increases the dosage of CERC-301 as expected in the Clin301-203 study, the risk of serious adverse events will also increase. 2 Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates Determination of the Fair Market Value of Common Stock, page 79 4. We acknowledge your April 18, 2014 response to comment 21 of our January 16, 2014 letter. Once you have an estimated offering price, please provide us a separate analysis explaining the reasons for the differences between recent valuations of your common stock leading up to the IPO and the estimated offering price. Response: The Company acknowledges the Staff’s comment and the Company will provide such explanation when the estimated offering price is disclosed explaining the difference between the estimated offering price and the recent valuations of our common stock leading up to the IPO. If you have any questions, please feel free to contact me at (215) 963-5262 or Kevin Shmelzer at (215) 963-5716. Very truly yours, /s/ Joanne R. Soslow Joanne R. Soslow c: Blake M. Paterson, M.D. Kevin S. Shmelzer Mitchell S. Nussbaum Tahra T. Wright 3
2015-05-21 - UPLOAD - Avalo Therapeutics, Inc.
May 21, 2015 Via E -mail Blake M. Patterson, M.D. President and Chief Executive Officer Cerecor Inc. 400 E. Pratt Street, Suite 606 Baltimore, Maryland 21202 Re: Cerecor Inc. Amendment No. 2 to Confidential Draft Registration Statement on Form S -1 Submitted April 29, 2015 CIK No. 0001534120 Dear Dr. Patterson : We have reviewed your amended draft registration statement and have the following comments. 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 circumst ances or do not believe another amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your next amended draft registration statement or filed registration statement, we may have additional comments. Prospectus Summary Product Candidates and Platform, page 2 1. Please remove the row concerning the COMTi platform from this table and the corresponding one on page 90. Unless and until you are able to advance a product candidate from the platform into preclinical studies, as you have done with CERC -406, the information included in this row is too inchoate to be included in a chart intended to summarize your product pipeline. 2. Please disclose from whom you acquired CERC -501 in this summary. Risk Factors Risks Related to Our Business and Industry “Our product candidates may cause undesirable side effects . . .,” page 24 3. Please amend this risk factor to state the adverse effec ts that were identified in the Clin301 -201 clinical study and whether they were the same or similar to the ones you Blake M. Patterson, M.D. Cerecor Inc. May 21, 2014 Page 2 anticipate . Also, as you intend to increase the dosage of CERC -301 in the Clin301 -203 study, please disclose that the risk of serious adve rse events will also increase . Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Signif icant Judgments and Estimates Determination of the Fair Market Value of Common Stock, page 79 4. We acknowledge your April 18, 2014 response to comment 21 of our January 16, 2014 letter. Once you have an estimated offering price, please provide us a separate analysis explaining the reasons for the differences between recent valuations of your common stock leading up to the IPO and the estimated offering price. If you intend to respond to these comments with an amended draft registration statement , please submit it and any associated correspondence in accordance with the guidance we provide in the Division’s October 11, 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm . Please ke ep in mind that we may publicly post filing review correspondence in accordance with our December 1, 2011 policy (http://www.sec.gov/divisions/corpfin/cfannouncements/edgarcorrespondence.htm ). If you intend to use Rule 83 (17 CFR 200.83) to request confid ential treatment of information in the correspondence you submit on EDGAR, please properly mark that information in each of your confidential submissions to us so we do not repeat or refer to that information in our comment letters to you. You may conta ct Mark Brunhofer at (202) 551 -3613 or James Rosenberg at (202) 551 - 3679 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (202) 551 -3383 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Joanne R. Soslow, Esq. Kevin S. Shmelzer, Esq. Morgan, Lewis & Bockius LLP 1701 Market Street Philadelphia, PA 19103
2014-05-14 - UPLOAD - Avalo Therapeutics, Inc.
May 13, 2014 Via E -mail Blake M. Patterson, M.D. President and Chief Executive Officer Cerecor Inc. 400 E. Pratt Street, Suite 606 Baltimore, Maryland 21202 Re: Cerecor Inc. Amendment No. 1 to Confidential Draft Registration Statement on Form S -1 Submitted April 21 , 2014 CIK No. 0001534120 Dear Dr. Patterson : We have reviewed your amended draft registration statement and have the following comments. 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 circumst ances or do not believe another amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your next amended draft registration statement or filed registration statement, we may have additional comments. Prospectus Summary Risks Associated with Our Business, page 4 1. Please revise your second bullet point to highlight that recurring operating losses and a lack of current sources of revenue have raised substantial doubt as to your ability to continue as a going concern. Please also highlight that you have received a going concern opinion from your i ndepend ent registered public accountant. 2. Please include a bullet point in this discussion that addresses your failure to mai ntain effective internal control over financial reporting, as discussed in the risk factor you have added to page 50. Blake M. Patterson, M.D. Cerecor Inc. May 13, 2014 Page 2 Business Overview, page 82 3. We note your response to prior comment 7. Please also revise your disclosure to provide the basis fo r your belief that your portfolio of clinical and preclinical compoun ds is “best - in-class” on page 82 or remove this statement. Notes to Financial Statements Note 9. Convertible Preferred Stock and Stockholders’ Equity Series A -1 Convertible Preferred Stock Transaction, page F -20 4. We acknowledge your response to previous comment 26. Please address the following additional comments: Please tell us why it is appropriate to accrete your Series A -1 convertible preferred stock over 31 years; Please tell us why you have accreted only $1 at both September 30, 2013 and December 31, 2013; and Please tell us how you intend to handle the unamortized discount associated with the Series A -1 convertible preferred stock upon conversion prior to your IPO. 5. You disc lose on page F -21 and F -44 that the fair value allocated to the warrants was $300,000 million where it appears that the amount was $300,000. Please revise your filing accordingly. Unaudited Financial Statements, page F -28 6. Please tell us why you contin ue to present interim financial information throughout your filing as of September 30, 2013 and for the nine months then ended and for the comparable period in 2012. Reference for us the authoritative guidance you rely upon to present this information. If you intend to respond to these comments with an amended draft registration statement , please submit it and any associated correspondence in accordance with the guidance we provide in the Division’s October 11, 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm . Please keep in mind that we may publicly post filing review correspondence in accordance with our December 1, 2011 policy (http://www.sec.gov/divisions/corpfin/cfannouncements /edgarcorrespondence.htm ). If you intend to use Rule 83 (17 CFR 200.83) to request confidential treatment of information in the correspondence you submit on EDGAR, please properly mark that information in each of your Blake M. Patterson, M.D. Cerecor Inc. May 13, 2014 Page 3 confidential submissions to us so we do not repeat or refer to that information in our comment letters to you. You may contact Dana Hartz at (202) 551 -3652 or Mark Brunhofer at (202) 551 -3613 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (202) 551 -3383, Bryan Pitko at (202) 551 -3203 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedl er Assistant Director cc: Joanne R. Soslow, Esq. Kevin S. Shmelzer, Esq. Morgan, Lewis & Bockius LLP 1701 Market Street Philadelphia, PA 19103
2014-01-16 - UPLOAD - Avalo Therapeutics, Inc.
January 16, 2014 Via Email Blake M. Paterson, M.D. President and Chief Executive Officer Cerecor Inc. 400 E. Pratt Street, Suite 606 Baltimore, Maryland 21202 Re: Cerecor Inc. Draft Registration Statement on Form S -1 Submitted December 20, 2013 CIK No. 0001534120 Dear Dr. Paterson: 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 comme nts. General 1. We note that you have yet to submit any of your exhibits. Please be advised that we may have further comments upon examination of these exhibits once they have been submitted by amendment. 2. Please provide us proofs of all graphic, visual or photographic information you will provide in the printed prospectus prior to its use, for example in a preliminary prospectus. Please note that we may have comments regarding this material. 3. Please supplementally provide us with copies of all written c ommunications, 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 communication s. Similarly, please Blake M. Paterso n, M.D. Cerecor Inc. January 16, 2014 Page 2 supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any b roker or dealer that is participating or will participate in your offering. Table of Contents , page ii 4. Please revise your disclosure with respect to the statistical and other industry and market data presented in the prospectus to remove your statement t hat you have not independently verified this data. It is not appropriate to directly or indirectly disclaim liability for information in the registration statement. Prospectus Summary Overview, page 1 5. Please explain the significance of a “fast track de signation” at your first reference in the summary. 6. Please explain the term “acute suicidality .” 7. In light of the early stage of development of your COMTi product program and the fact that you have not yet selected lead candidates for development under th is program, please remove your statements throughout the prospectus that such product candidates are potentially best -in-class. Product Candidate and Platform General 8. Please revise your summary to include your product pipeline table as provided on page 82. Please also include a brief description of FP01 and i ts clinical development status. 9. Please revise your summary to disclose that you have licensed both CERC -301 and the COMTi platform from Merck. CERC -301, page 1 10. Please define the term “suicida l ideation” in this summary. 11. When you refer to “multiple recent controlled clinical studies” please indicate the parties that conducted the trials you refer to and when they were conducted . 12. In your discussion of ketamine here and in your Business sect ion, please briefly explain the ramifications of being classified as a Schedule III drug. Blake M. Paterso n, M.D. Cerecor Inc. January 16, 2014 Page 3 Management, page 3 13. Please revise your disclosure to provide the date on which your IND for CERC -301 was filed. Risks Associated with Our Business, page 3 14. In your second bullet point, please include the amount of your accumulated deficit to date. 15. In your fifth bullet point, please state that FP01 failed to meet its primary endpoint in two Phase 2 clinical studies . Summary Financial Data, page 8 Selected Financia l Data, page 61 16. Please revise your presentation to also disclose the pro forma loss per share information for the latest complete fiscal year. Risk Factors Risks Related to Our Financial Position and Capital Needs “If we fail to attract and keep manageme nt and other key personnel . . .,” page 34 17. Please include in this risk factor the name(s) and title(s) of the members of your management team and any other key personnel whose departure you believe may result in serious adverse consequences. Risks Relate d to Our Business and Industry General 18. Please include a risk factor that addresses how you obtained CERC -301 and your COMT inhibitors through license agreements with Merck , your reliance on such licenses to continue development of your product candidates , and the potential impact on the Company in the event either or both agreements is terminated. Risks Related to this Offering and Ownership of Our Common Stock “We will incur increased costs as a result of operating as a public company . . .,” page 49 19. Please include in this risk factor an estimate of the annual costs you will incur as a result of your reporting obligations. Blake M. Paterso n, M.D. Cerecor Inc. January 16, 2014 Page 4 Use of Proceeds, page 63 20. Please separate the amount of your net proceeds that you intend to allocate toward research and devel opment under the COMTi platform and the amount you intend to allocate toward your preclinical product candidates. Stock -Based Compensation Fair Market Value Estimates, page 68 21. We may have additional comments on your accounting for stock compensation and related disclosure once you have disclosed an estimated offering price. Please provide quantitative and qualitative disclosures explaining the difference between the estimated offering price and the fair value of the common share at the August 29, 2013 issuance. Also, please update you filing to disclose any new equity issuance through the date you request effectiveness of your registration statement. Business Product Pipeline, page 82 22. Where you reference p -values in your discussion of your clinical tr ials please explain what the p-values represent and whether the results of your trials indicate statistical significance. Study Clin301 -201, page 85 23. Please revise your disclosure to indicate the number of subjects who have been enrolled in your trial thus f ar and where the trial is being conducted. 24. Please revise your disclosure to indicate how you determined that HAMD -17 was the appropriate end -point for your study of CERC -301. In this discussion, please explain the differences between the respective dep ression assessment tools and why results obtained under one assessment tool might differ from another. Intellectual Property, page 94 25. We note that you have entered into an exclusive worldwide license with Johns Hopkins Medical Institute to develop and market FP01. Please revise your disclosure to describe any material financial obligations under your agreement. You should also identify the duration of the agreement and the circumstances in which the license could be terminated. Please also file your license agreement as an exhibit to the registration statement. Blake M. Paterso n, M.D. Cerecor Inc. January 16, 2014 Page 5 Note 8. Convertible Preferred Stock and Stockholders’ Equity, page F -37 26. Please revise your filing to discuss how you allocated the proceeds from your August 2013 private equity offering be tween the Series A -1 Convertible Preferred Stock and warrants. Please disclose whether you recognize any related beneficial conversion feature, and if so, the amount and accretion period. Exhibits and Financial Statement Schedules, page II -4 27. We note the disclosure regarding your entry into an agreement with Fells Laboratories LLC, an entity owned 50% by your CEO , and that such agreement provided you with access to various assets related to FP01. As this agreement appears to represent a material contract to which your CEO is a party, please file this agreement as an exhibit to the registration statement pursuant to Item 601(b)(10)(ii)(A) of Regulation S -K. General If you intend to respond to these comments with an amended draft registration statement , please submit it and any associated correspondence in accordance with the guidance we provide in the Division’s October 11 , 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm . Please keep in mind that we may publicly post filing review correspondence in accordance with our December 1, 2011 policy (http://www.sec.gov/divisions/corpfin/cfannouncements/edgarcorrespondence.htm ). If you intend to use Rule 83 (17 CFR 200.83) to request conf idential treatment of information in the correspondence you submit on EDGAR, please properly mark that information in each of your confidential submissions to us so we do not repeat or refer to that information in our comment letters to you. You may con tact Dana Hartz at (202) 551 -3652 or Mark Brunhofer at (202) 551 -3613 if you have questions regarding comments on the financial statements and related matters. Please contact Scot Foley at (202) 551 -3383, Bryan Pitko at (202) 551 -3203 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: Joanne R. Soslow, Esq. Kevin S. Shmelzer, Esq. Morgan, Lewis & Bockius LLP Blake M. Paterso n, M.D. Cerecor Inc. January 16, 2014 Page 6 1701 Market Street Philadelphia, PA 19103
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