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All Filings
SEC Comment Letters
Company Responses
Letter Text
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
↓
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
↓
Company responded
2025-03-05
Outlook Therapeutics, Inc.
Summary
CORRESP · 2025-03-05
Generating summary...
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-05-01
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2024-05-01
Generating summary...
↓
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-04-03
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2024-04-03
Generating summary...
↓
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-03-28
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2024-03-28
Generating summary...
↓
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-08-22
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2023-08-22
Generating summary...
↓
Company responded
2023-08-23
Outlook Therapeutics, Inc.
Summary
CORRESP · 2023-08-23
Generating summary...
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-03-31
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2021-03-31
Generating summary...
↓
Company responded
2021-04-01
Outlook Therapeutics, Inc.
Summary
CORRESP · 2021-04-01
Generating summary...
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-04-15
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2020-04-15
Generating summary...
↓
Company responded
2020-04-16
Outlook Therapeutics, Inc.
Summary
CORRESP · 2020-04-16
Generating summary...
Outlook Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2019-06-24
Outlook Therapeutics, Inc.
Summary
CORRESP · 2019-06-24
Generating summary...
Outlook Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2019-06-21
Outlook Therapeutics, Inc.
Summary
CORRESP · 2019-06-21
Generating summary...
Outlook Therapeutics, Inc.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2019-02-27
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2019-02-27
Generating summary...
↓
Company responded
2019-04-02
Outlook Therapeutics, Inc.
Summary
CORRESP · 2019-04-02
Generating summary...
↓
Company responded
2019-04-02
Outlook Therapeutics, Inc.
Summary
CORRESP · 2019-04-02
Generating summary...
↓
Company responded
2019-04-05
Outlook Therapeutics, Inc.
Summary
CORRESP · 2019-04-05
Generating summary...
↓
Company responded
2019-04-09
Outlook Therapeutics, Inc.
Summary
CORRESP · 2019-04-09
Generating summary...
↓
Company responded
2019-04-09
Outlook Therapeutics, Inc.
Summary
CORRESP · 2019-04-09
Generating summary...
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
Company responded
2018-02-26
Outlook Therapeutics, Inc.
Summary
CORRESP · 2018-02-26
Generating summary...
↓
SEC wrote to company
2018-02-27
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2018-02-27
Generating summary...
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-09-28
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2017-09-28
Generating summary...
↓
Company responded
2017-10-03
Outlook Therapeutics, Inc.
References: September 25, 2017
Summary
CORRESP · 2017-10-03
Generating summary...
Outlook Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-09-26
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2017-09-26
Generating summary...
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
Company responded
2017-03-20
Outlook Therapeutics, Inc.
Summary
CORRESP · 2017-03-20
Generating summary...
↓
SEC wrote to company
2017-03-21
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2017-03-21
Generating summary...
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2017-02-22
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2017-02-22
Generating summary...
↓
Company responded
2017-02-23
Outlook Therapeutics, Inc.
Summary
CORRESP · 2017-02-23
Generating summary...
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2016-07-11
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2016-07-11
Generating summary...
↓
Company responded
2016-07-12
Outlook Therapeutics, Inc.
Summary
CORRESP · 2016-07-12
Generating summary...
Outlook Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2016-05-12
Outlook Therapeutics, Inc.
Summary
CORRESP · 2016-05-12
Generating summary...
Outlook Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2016-05-12
Outlook Therapeutics, Inc.
Summary
CORRESP · 2016-05-12
Generating summary...
Outlook Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2016-05-05
Outlook Therapeutics, Inc.
Summary
CORRESP · 2016-05-05
Generating summary...
Outlook Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2016-05-05
Outlook Therapeutics, Inc.
Summary
CORRESP · 2016-05-05
Generating summary...
Outlook Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2016-05-04
Outlook Therapeutics, Inc.
Summary
CORRESP · 2016-05-04
Generating summary...
Outlook Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2016-05-04
Outlook Therapeutics, Inc.
Summary
CORRESP · 2016-05-04
Generating summary...
Outlook Therapeutics, Inc.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2016-04-27
Outlook Therapeutics, Inc.
References: December 11, 2015 | January 28, 2016
Summary
CORRESP · 2016-04-27
Generating summary...
Outlook Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-02-26
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2016-02-26
Generating summary...
Outlook Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-01-28
Outlook Therapeutics, Inc.
References: December 11,
2015
Summary
UPLOAD · 2016-01-28
Generating summary...
Outlook Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2015-12-30
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2015-12-30
Generating summary...
↓
Company responded
2016-01-15
Outlook Therapeutics, Inc.
References: December 11, 2015 | December 30, 2015
Summary
CORRESP · 2016-01-15
Generating summary...
Outlook Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-12-14
Outlook Therapeutics, Inc.
Summary
UPLOAD · 2015-12-14
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-26 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | 333-285973 | Read Filing View |
| 2025-03-26 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-03-05 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-03-04 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | 333-285438 | Read Filing View |
| 2024-05-02 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-05-01 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | 333-278959 | Read Filing View |
| 2024-04-03 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | 333-278340 | Read Filing View |
| 2024-04-03 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-03-28 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-03-28 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | 333-278209 | Read Filing View |
| 2023-08-23 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-08-22 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-04-01 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-03-31 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-04-16 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-04-15 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-24 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-21 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-09 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-09 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-05 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-02 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-02 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-02-27 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-02-27 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-02-26 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-10-03 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-09-28 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-09-26 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-03-21 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-03-20 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-02-23 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-02-22 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-07-12 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-07-11 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-05-12 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-05-12 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-05-05 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-05-05 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-05-04 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-05-04 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-04-27 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-02-26 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-01-28 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-01-15 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-12-30 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-12-14 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-26 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | 333-285973 | Read Filing View |
| 2025-03-04 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | 333-285438 | Read Filing View |
| 2024-05-01 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | 333-278959 | Read Filing View |
| 2024-04-03 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | 333-278340 | Read Filing View |
| 2024-03-28 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | 333-278209 | Read Filing View |
| 2023-08-22 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-03-31 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-04-15 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-02-27 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-02-27 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-09-28 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-09-26 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-03-21 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-02-22 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-07-11 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-02-26 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-01-28 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-12-30 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-12-14 | SEC Comment Letter | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-26 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-03-05 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-05-02 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-04-03 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-03-28 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-08-23 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2021-04-01 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-04-16 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-24 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-21 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-09 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-09 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-05 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-02 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-02 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-02-26 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-10-03 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-03-20 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2017-02-23 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-07-12 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-05-12 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-05-12 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-05-05 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-05-05 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-05-04 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-05-04 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-04-27 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-01-15 | Company Response | Outlook Therapeutics, Inc. | DE | N/A | Read Filing View |
2025-03-26 - UPLOAD - Outlook Therapeutics, Inc. File: 333-285973
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 26, 2025 Lawrence Kenyon Chief Financial Officer and Interim Chief Executive Officer Outlook Therapeutics, Inc. 111 S. Wood Avenue, Unit #100 Iselin, NJ 08830 Re: Outlook Therapeutics, Inc. Registration Statement on Form S-3 Filed March 20, 2025 File No. 333-285973 Dear Lawrence Kenyon: 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 Alan Campbell at 202-551-4224 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Courtney M.W. Tygesson </TEXT> </DOCUMENT>
2025-03-26 - CORRESP - Outlook Therapeutics, Inc.
CORRESP 1 filename1.htm OUTLOOK THERAPEUTICS, INC. 111 S. Wood Avenue Unit #100 Iselin, New Jersey 08830 (609) 619-3990 March 26, 2025 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: Outlook Therapeutics, Inc. Registration Statement on Form S-3 Filed March 20, 2025 File No. 333-285973 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 Registration Statement on Form S-3 (File No. 333-285973) (the " Registration Statement ") to become effective on Friday, March 28, 2025, at 4:00 p.m., Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission (the " Staff "). The Registrant hereby authorizes David N. Braus and Robert-Joseph Davis of Outlook Therapeutics, as well as Yvan-Claude Pierre of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Robert-Joseph Davis of Outlook Therapeutics (717) 877-3197. In the case of his absence, please contact Yvan-Claude Pierre of Cooley LLP, outside counsel to the Registrant, at (212) 479-6721, or Courtney Tygesson of Cooley LLP at (312) 881-6680. Very truly yours, OUTLOOK THERAPEUTICS, INC. By: /s/ Lawrence A. Kenyon Name: Lawrence A. Kenyon Title: Chief Financial Officer and Interim Chief Executive Officer cc: Yvan-Claude Pierre, Cooley LLP Courtney Tygesson, Cooley LLP David N. Braus, Outlook Therapeutics, Inc Robert-Joseph Davis, Outlook Therapeutics, Inc
2025-03-05 - CORRESP - Outlook Therapeutics, Inc.
CORRESP 1 filename1.htm OUTLOOK THERAPEUTICS, INC. 111 S. Wood Avenue Unit #100 Iselin, New Jersey 08830 (609) 619-3990 March 5, 2025 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: Outlook Therapeutics, Inc. Registration Statement on Form S-3 Filed February 28, 2025 File No. 333-285438 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 Registration Statement on Form S-3 (File No. 333-285438) (the “Registration Statement”) to become effective on Friday, March 7, 2025, at 4:00 p.m., Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes David N. Braus and Robert-Joseph Davis of Outlook Therapeutics as well as Yvan-Claude Pierre of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Robert-Joseph Davis of Outlook Therapeutics (717) 877-3197. In the case of his absence, please contact Yvan-Claude Pierre of Cooley LLP, outside counsel to the Registrant, at (212) 479-6721, or Courtney Tygesson of Cooley LLP at (312) 881-6680. Very truly yours, OUTLOOK THERAPEUTICS, INC. By: /s/ Lawrence A. Kenyon Name: Lawrence A. Kenyon Title: Chief Financial Officer and Interim Chief Executive Officer cc: Yvan-Claude Pierre, Cooley LLP Courtney Tygesson, Cooley LLP David N. Braus, Outlook Therapeutics, Inc Robert-Joseph Davis, Outlook Therapeutics, Inc
2025-03-04 - UPLOAD - Outlook Therapeutics, Inc. File: 333-285438
March 4, 2025
Lawrence A. Kenyon
Chief Financial Officer and Interim Chief Executive Officer
Outlook Therapeutics, Inc.
111 S. Wood Avenue, Unit #100
Iselin, New Jersey 08830
Re:Outlook Therapeutics, Inc.
Registration Statement on Form S-3
Filed February 28, 2025
File No. 333-285438
Dear Lawrence A. Kenyon:
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 Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Courtney M.W. Tygesson
2024-05-02 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
OUTLOOK THERAPEUTICS, INC.
111 S. Wood Avenue
Unit #100
Iselin, New Jersey 08830
(609) 619-3990
May 2, 2024
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:
Outlook Therapeutics, Inc.
Registration Statement on Form S-3
Filed April 26, 2024
File No. 333-278959
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 Registration Statement on Form S-3 (File No. 333-278959)
(the “Registration Statement”) to become effective on Monday, May 6, 2024, at 4:00 p.m., Eastern Time, or as
soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission
(the “Staff”). The Registrant hereby authorizes Yvan-Claude Pierre of Cooley LLP, counsel to the Registrant,
to make such request on its behalf.
Once the Registration Statement has been declared effective, please
orally confirm that event with Yvan-Claude Pierre of Cooley LLP, counsel to the Registrant, at (212) 479-6721, or in his absence Courtney
Tygesson of Cooley LLP at (312) 881-6680.
Very truly yours,
OUTLOOK THERAPEUTICS, INC.
By:
/s/ Lawrence A. Kenyon
Name: Lawrence A. Kenyon
Title: Chief Financial Officer, Treasurer and Secretary
cc: Yvan-Claude Pierre, Cooley LLP
Courtney Tygesson,
Cooley LLP
2024-05-01 - UPLOAD - Outlook Therapeutics, Inc. File: 333-278959
United States securities and exchange commission logo
May 1, 2024
Lawrence A. Kenyon
Chief Financial Officer
Outlook Therapeutics, Inc.
485 Route 1 South
Building F, Suite 320
Iselin, New Jersey 08830
Re:Outlook Therapeutics, Inc.
Registration Statement on Form S-3
Filed April 26, 2024
File No. 333-278959
Dear Lawrence A. Kenyon:
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 Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Courtney M.W. Tygesson
2024-04-03 - UPLOAD - Outlook Therapeutics, Inc. File: 333-278340
United States securities and exchange commission logo
April 3, 2024
Lawrence Kenyon
Chief Financial Officer
Outlook Therapeutics, Inc.
485 Route 1 South
Building F, Suite 320
Iselin, New Jersey 08830
Re:Outlook Therapeutics, Inc.
Registration Statement on Form S-3
Filed March 28, 2024
File No. 333-278340
Dear Lawrence Kenyon:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Courtney Tygesson, Esq.
2024-04-03 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
OUTLOOK THERAPEUTICS, INC.
485 Route 1 South
Building F, Suite 320
Iselin, New Jersey 08830
(609) 619-3990
April 3, 2024
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:
Outlook Therapeutics, Inc.
Registration Statement on Form S-3
Filed March 28, 2024
File No. 333-278340
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 Registration Statement on Form S-3 (File No. 333-278340)
(the “Registration Statement”) to become effective on Friday, April 5, 2024, at 4:00 p.m., Eastern Time, or
as soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission
(the “Staff”). The Registrant hereby authorizes Yvan-Claude Pierre of Cooley LLP, counsel to the Registrant,
to make such request on its behalf.
Once the Registration Statement has been declared effective, please
orally confirm that event with Yvan-Claude Pierre of Cooley LLP, counsel to the Registrant, at (212) 479-6721, or in his absence Courtney
Tygesson of Cooley LLP at (312) 881-6680.
Very truly yours,
OUTLOOK THERAPEUTICS, INC.
By:
/s/ Lawrence A. Kenyon
Name: Lawrence A. Kenyon
Title: Chief Financial Officer, Treasurer and Secretary
cc: Yvan-Claude Pierre, Cooley LLP
Courtney Tygesson,
Cooley LLP
2024-03-28 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
OUTLOOK THERAPEUTICS, INC.
485 Route 1 South
Building F, Suite 320
Iselin, New Jersey 08830
(609) 619-3990
March 28, 2024
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:
Outlook Therapeutics, Inc.
Registration Statement on Form S-3
Filed March 25, 2024
File No. 333-278209
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 Registration Statement on Form S-3 (File No. 333-278209)
(the “Registration Statement”) to become effective on Monday, April 1, 2024, at 4:00 p.m., Eastern Time, or
as soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission
(the “Staff”). The Registrant hereby authorizes Yvan-Claude Pierre of Cooley LLP, counsel to the Registrant,
to make such request on its behalf.
Once the Registration Statement has been declared effective, please
orally confirm that event with Yvan-Claude Pierre of Cooley LLP, counsel to the Registrant, at (212) 479-6721, or in his absence Courtney
Tygesson of Cooley LLP at (312) 881-6680.
Very truly yours,
OUTLOOK THERAPEUTICS, INC.
By:
/s/ Lawrence A. Kenyon
Name:
Lawrence A. Kenyon
Title:
Chief Financial Officer, Treasurer and Secretary
cc:
Yvan-Claude Pierre, Cooley LLP
Courtney Tygesson, Cooley LLP
2024-03-28 - UPLOAD - Outlook Therapeutics, Inc. File: 333-278209
United States securities and exchange commission logo
March 28, 2024
Lawrence Kenyon
Chief Financial Officer
Outlook Therapeutics, Inc.
485 Route 1 South
Building F, Suite 320
Iselin, New Jersey 08830
Re:Outlook Therapeutics, Inc.
Registration Statement on Form S-3
Filed March 25, 2024
File No. 333-278209
Dear Lawrence Kenyon:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Courtney M.W. Tygesson, Esq.
2023-08-23 - CORRESP - Outlook Therapeutics, Inc.
CORRESP 1 filename1.htm OUTLOOK THERAPEUTICS, INC. 485 Route 1 South Building F, Suite 320 Iselin, New Jersey 08830 (609) 619-3990 August 23, 2023 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: Outlook Therapeutics, Inc. Registration Statement on Form S-3 Filed August 14, 2023 File No. 333-273979 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 Registration Statement on Form S-3 (File No. 333-273979) (the “Registration Statement”) to become effective on Thursday, August 25, 2023, at 4:00 p.m., Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes Yvan-Claude Pierre of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Yvan-Claude Pierre of Cooley LLP, counsel to the Registrant, at (212) 479-6721, or in his absence Courtney Tygesson of Cooley LLP at (312) 881-6680. Very truly yours, OUTLOOK THERAPEUTICS, INC. By: Name: Lawrence A. Kenyon Title: Chief Financial Officer, Treasurer and Secretary cc: Yvan-Claude Pierre, Cooley LLP Courtney Tygesson, Cooley LLP
2023-08-22 - UPLOAD - Outlook Therapeutics, Inc.
United States securities and exchange commission logo
August 22, 2023
Lawrence Kenyon
Chief Financial Officer
Outlook Therapeutics, Inc.
485 Route 1 South
Building F, Suite 320
Iselin, New Jersey 08830
Re:Outlook Therapeutics, Inc.
Registration Statement on Form S-3
Filed August 14, 2023
File No. 333-273979
Dear Lawrence Kenyon:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Courtney Tygesson, Esq.
2021-04-01 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
Outlook Therapeutics, Inc.
4260 U.S. Route 1
Monmouth Junction, New Jersey 08852
April 1, 2021
Division of Corporation Finance
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: Outlook Therapeutics, Inc.
Registration Statement on Form S-3
File No. 333-254778
Filed March 26, 2021
Ladies and Gentlemen:
Outlook Therapeutics, Inc. (the “Registrant”)
hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause
the above-referenced Registration Statement on Form S-3 to become effective on April 1, 2021, at 5:00 p.m., Eastern Time, or as soon thereafter
as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant
hereby authorizes each of Yvan-Claude Pierre, Marianne Sarrazin and Yoon-jee Kim of Cooley LLP, counsel to the Registrant, to make such
request on its behalf.
Once
the Registration Statement has been declared effective, please orally confirm that event with Yoon-jee Kim of Cooley LLP, counsel to
the Registrant, at (212) 479-6792, or in her absence, Marianne Sarrazin at (415) 693-2157.
[Signature Page Follows]
Very truly yours,
OUTLOOK THERAPEUTICS, INC.
By: /s/ Lawrence A. Kenyon
Name: Lawrence A. Kenyon
Title: President, Chief Executive Officer and Chief Financial Officer
cc: Yvan-Claude Pierre, Cooley LLP
Marianne Sarrazin, Cooley LLP
Yoon-jee Kim, Cooley LLP
2021-03-31 - UPLOAD - Outlook Therapeutics, Inc.
United States securities and exchange commission logo
March 31, 2021
Lawrence Kenyon
President, Chief Executive Officer and Chief Financial Officer
Outlook Therapeutics, Inc.
4260 U.S. Route 1
Monmouth Junction, New Jersey 08852
Re:Outlook Therapeutics, Inc.
Registration Statement on Form S-3
Filed March 26, 2021
File No. 333-254778
Dear Mr. Kenyon:
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 Irene Paik at 202-551-6553 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Yoon-jee Kim - Cooley LLP
2020-04-16 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
Lawrence A. Kenyon
President, CEO and CFO
7 Clarke Drive
Cranbury, NJ 08512
April 16, 2020
Via Edgar
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Chris Edwards
RE: Outlook Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-237607
Acceleration Request
Requested Date: April 17,
2020
Requested Time: 5:00 P.M.
Eastern 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 take appropriate action to cause the above-referenced Registration Statement on Form S-1 (the “Registration
Statement”) to become effective on April 17, 2020, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
Once the Registration Statement has been
declared effective, please orally confirm that event with Marianne Sarrazin of Cooley LLP at (415) 693-2157 or Pia Kaur of Cooley
LLP, at (415) 693-2135.
Very truly yours,
Outlook Therapeutics, Inc.
By:
/s/ Lawrence A. Kenyon
Lawrence A. Kenyon
President, Chief Executive Officer and Chief Financial Officer
cc: Yvan-Claude Pierre, Cooley LLP
Marianne Sarrazin, Cooley LLP
Pia Kaur, Cooley LLP
2020-04-15 - UPLOAD - Outlook Therapeutics, Inc.
April 15, 2020
Lawrence A. Kenyon
President, Chief Executive Officer and Chief Financial Officer
Outlook Therapeutics, Inc.
7 Clarke Drive
Cranbury, New Jersey 08512
Re:Outlook Therapeutics, Inc.
Registration Statement on Form S-1
Filed April 8, 2020
File No. 333-237607
Dear Mr. Kenyon:
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 Chris Edwards at (202) 551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Marianne C. Sarrazin
2019-06-24 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
Lawrence A. Kenyon
President, CEO and CFO
7 Clarke Drive
Cranbury, NJ 08512
June 24, 2019
Via
Edgar
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Sonia Bednarowski
RE: Outlook Therapeutics, Inc.
Registration Statement on Form S-3
File No. 333-231922
Acceleration Request
Requested Date: June 26,
2019
Requested Time: 5:00 P.M.
Eastern 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 take appropriate action to cause the above-referenced Registration Statement on Form S-3 (the “Registration
Statement”) to become effective on June 26, 2019, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
Once the Registration Statement has been
declared effective, please orally confirm that event with Marianne Sarrazin of Cooley LLP at (415) 693-2157 or Pia Kaur of Cooley
LLP, at (415) 693-2135.
Very truly
yours,
Outlook Therapeutics, Inc.
By:
/s/ Lawrence A. Kenyon
Lawrence A. Kenyon
President, Chief Executive Officer and Chief Financial Officer
cc:
Yvan-Claude Pierre, Cooley LLP
Marianne Sarrazin, Cooley LLP
Pia Kaur, Cooley LLP
T: 609.619.3990 | W: www.outlooktherapeutics.com | E: info@outlooktherapeutics.com
2019-06-21 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
Marianne Sarrazin
+ 1 415 693 2157
msarrazin@cooley.com
Via EDGAR
June 21, 2019
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Sonia Bednarowski
Re:
Outlook Therapeutics, Inc.
Registration Statement on Form S-3
Filed on June 3, 2019
SEC File No. 333-231922
Ladies and Gentlemen:
On behalf of our client, Outlook Therapeutics,
Inc. (the “Company”), we are providing this response letter in response to a comment conveyed orally
on June 12, 2019 (the “Comment”) by the staff (the “Staff”) of the U.S. Securities
and Exchange Commission (the “Commission”), relating to the above referenced Registration Statement on
Form S-3, as filed with the Commission on June 3, 2019 (the “Registration Statement”).
We have incorporated the Comment into
this response letter in italics.
Please confirm that you intend to comply with the requirements
of instruction I.B.6 to Form S-3 or explain why you believe you are eligible under instruction I.B.I of Form S-3.
1. Although the Company had a minimum public float in excess of $75.0 million on June 3, 2019, the date of filing the Registration
Statement (calculated based on its shares outstanding on such date held by non-affiliates and a price at which its equity was last
sold as of a date within 60 days prior to such Registration Statement filing date, and in reliance on Compliance and Disclosure
Interpretation 116.06 (“C&DI 116.06”), which contemplates that the number of shares outstanding on
the date of filing might be used, together with the average price of stock for any day within the 60-day period), the Company nevertheless
respectfully acknowledges the Staff’s concern and commentary regarding C&DI 116.06. Accordingly, we respectfully advise
the Staff that the Company intends to comply with the limitations set forth in Instruction I.B.6 to Form S-3 with respect to offerings
of its securities under the Registration Statement until such time as it is no longer subject to such limitations.
* * * *
June 21, 2019
Page 2
Please contact me at + 1 415 693 2157 or
Yvan-Claude Pierre at + 1 212 479 6721 with any questions regarding the Company’s responses to the Staff’s Comment
or if you require further information. Thank you in advance for your attention to this matter.
Very truly yours,
/s/ Marianne Sarrazin
Marianne Sarrazin
cc: Lawrence A. Kenyon, Outlook Therapeutics, Inc.
Yvan-Claude Pierre,
Cooley LLP
2019-04-09 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
Oppenheimer & Co. Inc.
85 Broad Street
New York, NY 10004
April 9, 2019
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Jeffrey Gabor
Re: Outlook Therapeutics,
Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-229761)
Ladies and Gentlemen:
In connection with
the above-captioned registration statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”),
Oppenheimer & Co. Inc., as the representative of the underwriters, hereby joins in the request of the Company that the effective
date of such registration statement be accelerated to 5:00 p.m. (New York time) on April 9, 2019, or as soon thereafter as practicable.
In making this request
the undersigned acknowledges that the underwriters are aware of their obligations under the Act as they relate to the public offering
of securities pursuant to the registration statement.
[Signature Page
Follows]
Very truly yours,
OPPENHEIMER & CO.
INC.
As the Representative of the Underwriters
By:
/s/ Eric Helenek
Name:
Eric Helenek
Title:
Managing Director
2019-04-09 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
Lawrence A. Kenyon
President, CEO and CFO
7 Clarke Drive
Cranbury, NJ 08512
April 9, 2019
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Mr. Jeff Gabor
Re: Outlook Therapeutics, Inc.
Registration
Statement on Form S-1
File No. 333-229761
Acceleration Request
Requested Date: Tuesday, April 9, 2019
Requested Time: 5:00 P.M. Eastern 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-1 (File No. 333-229761) (the “Registration Statement”) to become effective on Tuesday,
April 9, 2019, at 5:00 p.m. Eastern Time, or as soon thereafter as is practicable, or at such later time as the Registrant or its
outside counsel, Cooley LLP, 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 Marianne Sarrazin of Cooley LLP at (415) 693-2157 or Pia Kaur of Cooley
LLP, at (415) 693-2135.
Very truly yours,
Outlook Therapeutics, Inc.
By:
/s/ Lawrence
A. Kenyon
Lawrence A. Kenyon
President, Chief Executive Officer and
Chief Financial Officer
cc: Yvan-Claude Pierre, Cooley LLP
Marianne
Sarrazin, Cooley LLP
Pia Kaur, Cooley LLP
T: 609.619.3990 | W: www.outlooktherapeutics.com | E:
info@outlooktherapeutics.com
2019-04-05 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
Lawrence A. Kenyon
President, CEO and CFO
7 Clarke Drive
Cranbury, NJ 08512
Via
EDGAR
April 5, 2019
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Mr. Jeff Gabor
Re: Outlook Therapeutics, Inc.
Registration
Statement on Form S-1
File No. 333-229761
Ladies and Gentlemen:
Reference
is made to our letter, filed as correspondence with the U.S. Securities and Exchange Commission via EDGAR on April 2, 2019, in
which we requested the acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No.
333-229761) (the “Registration Statement”) to April 4, 2019 at 5:00 p.m., Eastern Time (which was later
changed orally to April 5, 2019 at 5:00 p.m., Eastern Time), in accordance with Rule 461 under the Securities Act of 1933, as
amended. We are no longer requesting that such Registration Statement be declared effective at this time and we hereby formally
withdraw our request for acceleration of the effective date thereof.
Very truly yours,
Outlook Therapeutics, Inc.
By:
/s/ Lawrence A. Kenyon
Lawrence A. Kenyon
President, Chief Executive Officer and Chief Financial Officer
cc: Yvan-Claude Pierre, Cooley LLP
Marianne
Sarrazin, Cooley LLP
Pia Kaur, Cooley LLP
T: 609.619.3990 | W: www.outlooktherapeutics.com | E: info@outlooktherapeutics.com
2019-04-02 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
Lawrence A. Kenyon
President, CEO and CFO
7 Clarke Drive
Cranbury, NJ 08512
April 2, 2019
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Mr. Jeff Gabor
Re: Outlook Therapeutics, Inc.
Registration Statement on Form S-1
File No. 333-229761
Acceleration Request
Requested Date: Thursday, April 4,
2019
Requested Time: 5:00 P.M.
Eastern 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-1 (File No. 333-229761) (the “Registration Statement”) to become effective on Thursday,
April 4, 2019, at 5:00 p.m. Eastern Time, or as soon thereafter as is practicable, or at such later time as the Registrant or its
outside counsel, Cooley LLP, 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 Marianne Sarrazin of Cooley LLP at (415) 693-2157 or Pia Kaur of Cooley
LLP, at (415) 693-2135.
Very truly
yours,
Outlook Therapeutics,
Inc.
By: /s/ Lawrence
A. Kenyon
Lawrence A. Kenyon
President, Chief
Executive Officer and Chief Financial Officer
cc: Yvan-Claude Pierre, Cooley LLP
Marianne Sarrazin, Cooley LLP
Pia Kaur, Cooley LLP
2019-04-02 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
Oppenheimer & Co. Inc.
85 Broad Street
New York, NY 10004
April 2, 2019
U.S. Securities and Exchange Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Mr. Jeff Gabor
Re:
Outlook Therapeutics, Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-229761)
Ladies and Gentlemen:
In connection with
the above-captioned registration statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”),
Oppenheimer & Co. Inc., as the representative of the underwriters, hereby joins in the request of the Company that the effective
date of such registration statement be accelerated to 5:00 p.m. (New York time) on April 4, 2019, or as soon thereafter as practicable.
In making this request
the undersigned acknowledges that the underwriters are aware of their obligations under the Act as they relate to the public offering
of securities pursuant to the registration statement.
[Signature Page Follows]
Very truly yours,
OPPENHEIMER & CO.
INC.
As the Representative of the Underwriters
By:
/s/ Eric Helenek
Name:
Eric Helenek
Title:
Managing Director
2019-02-27 - UPLOAD - Outlook Therapeutics, Inc.
February 27, 2019
Lawrence A. Kenyon
President, Chief Executive Officer and Chief Financial Officer
Outlook Therapeutics, Inc.
7 Clarke Drive
Cranbury, NJ 08512
Re:Outlook Therapeutics, Inc.
Registration Statement on Form S-1
Filed February 21, 2019
File No. 333-229761
Dear Mr. Kenyon:
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.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Pia Kaur, Esq.
2018-02-27 - UPLOAD - Outlook Therapeutics, Inc.
February 26, 2018
Lawrence A. Kenyon
Chief Financial Officer
Oncobiologics, Inc.
7 Clarke Drive
Cranbury, New Jersey 08512
Re:Oncobiologics, Inc.
Registration Statement on Form S-3
Filed February 15, 2018
File No. 333-223063
Dear Dr. Kenyon:
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 Irene Paik at 202-551-6553 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Marianne Sarrazin - Cooley LLP
2018-02-26 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
February 26, 2018
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Irene Paik
Office of Healthcare & Insurance
Re: Oncobiologics, Inc.
Registration Statement on Form S-3
Filed February 15, 2018
File No. 333-223063
Acceleration Request
Requested Date:
Wednesday, February 28, 2018
Requested Time:
4:00 P.M. Eastern Time
Ladies and Gentlemen:
In accordance with
Rule 461 under the Securities Act of 1933, as amended, Oncobiologics, Inc. (the “Registrant”) hereby
requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action
to cause the above-referenced Registration Statement on Form S-3 (File No. 333-223063) to become effective on February 28, 2018,
at 4:00 P.M., Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant or its counsel may orally
request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes
each of Yvan-Claude Pierre and Marianne Sarrazin of Cooley LLP, counsel to the Registrant, to make such request on its behalf.
In connection with
this request, the Registrant acknowledges 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 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.
7 Clarke Drive, Cranbury, NJ 08512
(609) 619-3990
Very truly yours,
Oncobiologics, Inc.
By:
/s/ Lawrence A. Kenyon
Lawrence A. Kenyon
Chief Financial Officer
cc: Pankaj Mohan, Ph.D. Oncobiologics, Inc.
Yvan-Claude Pierre, Cooley LLP
Marianne Sarrazin, Cooley LLP
2017-10-03 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
October 3, 2017
Suzanne Hayes
Office of Healthcare & Insurance
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: Oncobiologics, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed September 14, 2017
File No. 001-37759
CIK No. 0001649989
Ladies and Gentlemen:
On behalf of Oncobiologics, Inc. (the “Company”),
we submit this letter in response to the comment received from the staff (the “Staff”) of the Securities
and Exchange Commission (the “Commission”) by letter dated September 25, 2017 (the “Comment”)
with respect to the Company’s Preliminary Proxy Statement on Schedule 14A (the “PRE 14A”), initially
filed with the Commission on September 14, 2017. For the convenience of the Staff, the text of the Comment has been incorporated
into this response letter in italicized type, which is followed by the Company’s response thereto.
Preliminary Proxy Statement on Schedule
14A
We note that you are requesting shareholder
approval of the issuance of a material amount of senior securities. Please advise why you have not provided the information responsive
to Item 13(a) of Schedule 14A. See Item 11(e) and instruction 1 to Item 13 of Schedule 14A.
Response:
As discussed in the PRE 14A, the Company
is soliciting proxies to vote in favor of Proposal 3 solely to comply with the requirements of Marketplace Rules 5635(b) and 5635(d)
of the Nasdaq Stock Market (the “Nasdaq Rules”), which require stockholder approval prior to the issuance
(a) of securities when the issuance or potential issuance will result in a change of control of the company and (b) of common stock
(or securities convertible into or exercisable for common stock) equal to 20% or more of the common stock or 20% or more of the
voting power outstanding before the issuance for less than the greater of book or market value of the stock. The Company respectfully
notes for the Staff that absent the stockholder approval requirements of the Nasdaq Rules, the Company would not have filed a PRE
14A to seek stockholder approval of the issuance of (i) the remaining shares of its Series A Convertible Preferred Stock (“Series
A Preferred”) and warrants to acquire its common stock (the “Warrants”) to GMS Tenshi Holdings
Pte. Limited (the “Investor”) pursuant to that certain Purchase Agreement dated September 7, 2017 (the
“Purchase Agreement”) nor (ii) the issuance of an aggregate of 1.5 million shares of its Series B Non-Voting
Convertible Preferred Stock (“Series B Preferred”) to a senior secured noteholder in exchange for $1.5
million of its senior secured notes pursuant to that certain Purchase and Exchange Agreement dated September 7, 2017. The Company
further respectfully notes for the Staff that the Company’s Amended and Restated Certificate of Incorporation authorizes
the issuance of “blank check” preferred stock by the Company’s board of directors without stockholder approval.
Accordingly, the Company’s stockholders have already agreed that the Company could and would issue shares of preferred stock
without stockholder approval.
Cooley LLP 1114 Avenue of the Americas New
York, NY 10036
t: (212) 479-6000 f: (212) 479-6275 cooley.com
Suzanne Hayes
Division of Corporation Finance
U.S. Securities and Exchange Commission
October 3, 2017
Page Two
In light of the foregoing, and because
the Purchase Agreement contemplates the issuance of Series A Preferred and the Warrants to the Investor for cash, the Company did
not deem it necessary to include in the PRE 14A the information required by Item 13(a), as pursuant to Instruction 1 to Item 13
of Schedule 14A it did not deem such information material for the exercise of prudent judgment by its stockholders in considering
such Proposal 3.
Nevertheless, because the Company is not
seeking to deprive its stockholders of information that may be deemed relevant to an informed vote in respect of the effects of
the issuance of the remaining shares of its Series A Preferred and the Warrants to the Investor for cash, and the exchange of $1.5
million aggregate principal amount of its senior secured notes for Series B Preferred, and pursuant to a telephonic conversation
with the Staff, the Company has filed a revised preliminary proxy statement on Schedule 14A, incorporating by reference its Management’s
Discussion and Analysis of Financial Condition and Results of Operations, as well as its historical unaudited consolidated financial
statements for the three and nine months ended June 30, 2017, and its audited consolidated financial statements for the years ended
September 30, 2016 and 2015.
* * *
Please contact me at (212) 479-6721 or Marianne
Sarrazin at (415) 693-2157 with any questions or further comments regarding our response to the Staff’s comment.
Sincerely,
/s/ Yvan-Claude Pierre
Yvan-Claude Pierre
cc: Pankaj Mohan, Oncobiologics, Inc., via e-mail
Lawrence Kenyon, Oncobiologics, Inc., via e-mail
Cooley LLP 1114 Avenue of the Americas New
York, NY 10036
t: (212) 479-6000 f: (212) 479-6275 cooley.com
2017-09-28 - UPLOAD - Outlook Therapeutics, Inc.
September 28, 2017 Lawrence A. Kenyon Chief Financial Officer Oncobiologics, Inc. 7 Clarke Drive Cranbury, New Jersey 08512 Oncobiologics, Inc. Revised Preliminary Proxy Statement on Schedule 14A Filed September 27, 2017 File No. 001-37759Re: Dear Mr. Kenyon: 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 & Insurance
2017-09-26 - UPLOAD - Outlook Therapeutics, Inc.
September 25, 2017 Lawrence A. Kenyon Chief Financial Officer Oncobiologics, Inc. 7 Clarke Drive Cranbury, New Jersey 08512 Oncobiologics, Inc. Preliminary Proxy Statement on Schedule 14A Filed September 14, 2017 File No. 001-37759Re: Dear Mr. Kenyon: We have reviewed your filing 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. Preliminary Proxy Statement on Schedule 14A General 1. We note that that you are requesting shareholder approval of the issuance of a material amount of senior securities. Please advise why you have not provided the information responsive to Item 13(a) of Schedule 14A. See Item 11(e) and instruction 1 to Item 13 of Schedule 14A. 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. Lawrence A. Kenyon Oncobiologics, Inc. September 25, 2017 Page 2 Please contact Chris Edwards at (202) 551-6761 or Suzanne Hayes at (202) 551-3675 with any questions. Division of Corporation Finance Office of Healthcare & Insurance
2017-03-21 - UPLOAD - Outlook Therapeutics, Inc.
Mail Stop 4546 March 21, 2017 Lawrence Kenyon Chief Financial Officer Oncobiologics, Inc. 7 Clarke Drive Cranbury, NJ 08512 Re: Oncobiologics, Inc. Registration Statement on Form S-1 Filed March 10 , 2017 File No. 333-216610 Dear Mr. Kenyon : 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 Christine Westbrook at (202) 551 -5019 with any questions. Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Yvan -Claude Pierre , Esq. Cooley LLP
2017-03-20 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
March 20, 2017
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Ms. Suzanne Hayes
Re: Oncobiologics, Inc.
Registration Statement on Form S-1
Filed March 10, 2017
File No. 333-216610
Acceleration Request
Requested Date: Wednesday,
March 22, 2017
Requested Time: 4:00
P.M. Eastern Time
Ladies and Gentlemen:
In accordance with Rule
461 under the Securities Act of 1933, as amended, Oncobiologics, Inc. (the “Registrant”) hereby requests
that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause
the above-referenced Registration Statement on Form S-1 (File No. 333-216610) to become effective on March 22, 2017, at 4:00 P.M.,
Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant or its counsel may orally request via
telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes each of
Yvan-Claude Pierre and Marianne Sarrazin of Cooley LLP, counsel to the Registrant, to make such request on its behalf.
In connection with this
request, the Registrant acknowledges 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 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.
7 Clarke Drive, Cranbury, NJ 08512
(609) 619-3990
Very truly yours,
Oncobiologics, Inc.
By:
/s/ Lawrence A. Kenyon
Lawrence A. Kenyon
Chief Financial Officer
cc: Pankaj Mohan, Ph.D., Oncobiologics, Inc.
Yvan-Claude Pierre, Cooley LLP
Marianne Sarrazin, Cooley LLP
Pia Kaur, Cooley LLP
2017-02-23 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
February 23, 2017
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Ms. Suzanne Hayes
Re: Oncobiologics, Inc.
Registration Statement on Form S-1
Filed February 15, 2017
File No. 333-216080
Acceleration Request
Requested Date: Monday, February
27, 2017
Requested Time: 4:00
P.M. Eastern Time
Ladies and Gentlemen:
In accordance with Rule
461 under the Securities Act of 1933, as amended, Oncobiologics, Inc. (the “Registrant”) hereby requests
that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause
the above-referenced Registration Statement on Form S-1 (File No. 333-216080) to become effective on February 27, 2017, at 4:00
P.M., Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant or its counsel may orally request
via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes each
of Yvan-Claude Pierre, Daniel I. Goldberg and Marianne Sarrazin of Cooley LLP, counsel to the Registrant, to make such request
on its behalf.
In connection with this
request, the Registrant acknowledges 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 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.
7 Clarke Drive, Cranbury, NJ 08512
(609) 619-3990
Very truly yours,
Oncobiologics, Inc.
By:
/s/ Lawrence A. Kenyon
Lawrence A. Kenyon
Chief Financial Officer
cc: Pankaj Mohan, Ph.D. Oncobiologics, Inc.
Yvan-Claude Pierre, Cooley LLP
Daniel I. Goldberg, Cooley LLP
Marianne Sarrazin, Cooley LLP
2017-02-22 - UPLOAD - Outlook Therapeutics, Inc.
Mail Stop 4 546 February 22, 2017 Pankaj Mohan, Ph.D. President and Chief Executive Officer Oncobiologics, Inc. 7 Clarke Drive Cranbury, New Jersey 08512 Re: Oncobiologics, Inc. Registration Statement on Form S-1 Filed February 15, 2017 File No. 333-216080 Dear Dr. Mohan : 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 Dorrie Yale at 202 -551-8776 with any questions. Sincerely, /s/ Joseph McCann for Suzanne Hayes Assistant Director Office of Insurance and Healthcare cc: Yvan -Claude J. Pierre — Cooley LLP
2016-07-12 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
July 12, 2016
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Ms. Suzanne Hayes
Re: Oncobiologics, Inc.
Registration Statement on Form S-1
Filed June 30, 2016
File No. 333-212351
Acceleration Request
Requested Date:
Thursday, July 14, 2016
Requested Time:
4:00 P.M. Eastern Time
Ladies and Gentlemen:
In accordance with Rule
461 under the Securities Act of 1933, as amended, Oncobiologics, Inc. (the “Registrant”) hereby requests
that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause
the above-referenced Registration Statement on Form S-1 (File No. 333-212351) to become effective on July 14, 2016, at 4:00 p.m.,
Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant or its counsel may orally request via
telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes each of
Yvan-Claude Pierre, Daniel I. Goldberg and Marianne Sarrazin of Cooley LLP, counsel to the Registrant, to make such request on
its behalf.
In connection with this
request, the Registrant acknowledges 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 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.
7 Clarke Drive, Cranbury, NJ 08512
(609) 619-3990
Very truly yours,
Oncobiologics, Inc.
By:
/s/ Lawrence A. Kenyon
Lawrence A. Kenyon
Chief Financial Officer
cc:
Pankaj Mohan, Ph.D., Oncobiologics, Inc.
Yvan-Claude Pierre, Cooley LLP
Daniel I. Goldberg, Cooley LLP
Marianne Sarrazin, Cooley LLP
7 Clarke Drive, Cranbury, NJ 08512
(609) 619-3990
2016-07-11 - UPLOAD - Outlook Therapeutics, Inc.
Mail Stop 4720 July 11, 2016 Pankaj Mohan, Ph.D. President and Chief Executive Officer Oncobiologics, Inc. 7 Clarke Drive Cranbury, New Jersey 08512 Re: Oncobiologics, Inc. Registration Statement on Form S-1 Filed June 30, 2016 File No. 333-212351 Dear Dr. Mohan : 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 Pankaj Mohan, Ph.D. Oncobiologics, Inc. July 11, 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 Erin Jaskot at 202-551-3442 with any questions. Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Insurance and Healthcare cc: Yvan -Claude J. Pierre — Cooley LLP
2016-05-12 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
May 12, 2016
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Suzanne Hayes
Re:
Oncobiologics, Inc.
Registration Statement on Form S-1
File No. 333-209011
Acceleration Request
Requested Date:
May 12, 2016
Requested Time:
4:00 p.m., Eastern Time
Ladies and gentlemen:
In accordance with
Rule 461 under the Securities Act of 1933, as amended (the “Act”), Jefferies LLC and Barclays Capital
Inc., as representatives of the several underwriters, hereby join Oncobiologics, Inc. in requesting that the Securities and Exchange
Commission (the “Commission”) take appropriate action to cause the Registration Statement on Form S-1
(File No. 333-209011) to become effective on Thursday, May 12, 2016, at 4:00 p.m., Eastern Time, or as soon as practicable
thereafter.
Additionally, pursuant
to Rule 460 of the Act, we hereby advise you that the Preliminary Prospectus dated April 27, 2016, was distributed by us, as representatives
of the several underwriters, approximately as follows from April 27, 2016 through the date hereof:
Copies to underwriters
661
Copies to dealers
0
Copies to institutional investors
588
Copies to others/retail
5
Total
1,254
We have been informed
by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act
of 1934, as amended, to the extent applicable.
Very truly yours,
JEFFERIES LLC
BARCLAYS CAPITAL INC.,
As Representatives
[Signature Page Follows]
JEFFERIES LLC
By:
/s/ Matthew Kim
Name: Matthew Kim
Title: Managing Director
BARCLAYS CAPITAL INC.
By:
/s/ Victoria Hale
Name: Victoria Hale
Title: Vice President
cc:
Pankaj Mohan, Ph.D., Oncobiologics, Inc.
Lawrence A. Kenyon, Oncobiologics, Inc.
Stuart M. Cable, Goodwin Procter LLP
Edwin O’Connor, Goodwin Procter LLP
Seo Salimi, Goodwin Procter LLP
Yvan-Claude Pierre, Cooley LLP
Daniel I. Goldberg, Cooley LLP
Marianne Sarrazin, Cooley LLP
[signature page to acceleration request
letter]
2016-05-12 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
May 12, 2016
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Ms. Suzanne Hayes
Re:
Oncobiologics, Inc.
Registration Statement on Form S-1
Filed April 27, 2016
File No. 333-209011
Acceleration Request
Requested Date:
Thursday,
May 12, 2016
Requested Time:
4:00 P.M. Eastern Time
Ladies and Gentlemen:
In accordance with
Rule 461 under the Securities Act of 1933, as amended, Oncobiologics, Inc. (the “Registrant”) hereby
requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action
to cause the above-referenced Registration Statement on Form S-1 (File No. 333-209011) to become effective on May 12, 2016,
at 4:00 p.m., Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant or its counsel may orally
request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes
each of Yvan-Claude Pierre, Daniel I. Goldberg and Marianne Sarrazin of Cooley LLP, counsel to the Registrant, to make such request
on its behalf.
In connection with
this request, the Registrant acknowledges 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 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.
7 Clarke Drive, Cranbury, NJ 08512
(609) 619-3990
Very truly yours,
Oncobiologics, Inc.
By:
/s/ Pankaj Mohan
Pankaj Mohan, Ph.D.
Chairman,
President and Chief Executive Officer
cc:
Lawrence A. Kenyon, Oncobiologics, Inc.
Yvan-Claude Pierre, Cooley LLP
Daniel I. Goldberg, Cooley LLP
Marianne Sarrazin, Cooley LLP
Edwin O’Connor, Goodwin Procter LLP
Seo Salimi, Goodwin Procter LLP
7 Clarke Drive, Cranbury, NJ 08512
(609) 619-3990
2016-05-05 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
May 5, 2016
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Ms. Suzanne Hayes
Re: Oncobiologics, Inc.
Registration Statement on Form S-1
Filed April 27, 2016
File No. 333-209011
Withdrawal of Acceleration Request
Ladies and Gentlemen:
Reference is made
to our letter, filed as correspondence via EDGAR on May 4, 2016, in which we requested the acceleration of the effective date of
the above-referenced Registration Statement on Form S-1 (File No. 333-209011) for Thursday, May 5, 2016, at 4:00 p.m. Eastern Time,
in accordance with Rule 461 under the Securities Act of 1933, as amended. We are no longer requesting that such registration statement
be declared effective at this time and we hereby formally withdraw our request for acceleration of the effective date.
Very truly yours,
Oncobiologics, Inc.
By: /s/ Pankaj Mohan
Pankaj Mohan, Ph.D.
Chairman, President and Chief Executive Officer
cc: Lawrence A. Kenyon, Oncobiologics, Inc.
Yvan-Claude Pierre, Cooley LLP
Daniel I. Goldberg, Cooley LLP
Marianne Sarrazin, Cooley LLP
Edwin O’Connor, Goodwin Procter LLP
Seo Salimi, Goodwin Procter LLP
7 Clarke Drive, Cranbury, NJ 08512
(609) 619-3990
2016-05-05 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
May 5, 2016
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
Attention: Suzanne Hayes
Re: Oncobiologics, Inc. Registration
Statement No. 333-209011
Ladies and Gentlemen:
Reference is made to our letter, filed as correspondence
via EDGAR on May 4, 2016, in which we requested the acceleration of the effective date of the above-referenced Registration Statement
for May 5, 2015 at 4:00 p.m. Eastern time in accordance with Rule 461 of the Securities Act of 1933, as amended.
As representatives of the several underwriters
of the proposed public offering, we hereby respectfully withdraw our request for acceleration of the effectiveness of the above-referenced
Registration Statement set forth in our May 4, 2016 letter.
Very truly yours,
JEFFERIES LLC
By:
/s/ Ashley Delp Walker
Name: Ashley Delp Walker
Title: Managing Director
BARCLAYS CAPITAL INC.
By:
/s/ Victoria Hale
Name: Victoria Hale
Title: Vice President
cc: Pankaj Mohan, Oncobiologics, Inc.
Lawrence Kenyon, Oncobiologics, Inc.
Stuart M. Cable, Goodwin Procter LLP
Edwin O’Connor, Goodwin Procter LLP
Seo Salimi, Goodwin Procter LLP
Yvan-Claude Pierre, Cooley LLP
Daniel I. Goldberg, Cooley LLP
Marianne Sarrazin, Cooley LLP
[Signature
Page to Withdrawal of Underwriters’ Acceleration Request]
2016-05-04 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
May 4, 2016
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Suzanne Hayes
Re:
Oncobiologics, Inc.
Registration Statement on Form S-1
File No. 333-209011
Acceleration Request
Requested Date:
May 5, 2016
Requested Time:
4:00 p.m., Eastern Time
Ladies and gentlemen:
In accordance with
Rule 461 under the Securities Act of 1933, as amended (the “Act”), Jefferies LLC and Barclays Capital
Inc., as representatives of the several underwriters, hereby join Oncobiologics, Inc. in requesting that the Securities and Exchange
Commission (the “Commission”) take appropriate action to cause the Registration Statement on Form S-1
(File No. 333-209011) to become effective on Thursday, May 5, 2016, at 4:00 p.m., Eastern Time, or as soon as practicable thereafter.
Additionally, pursuant
to Rule 460 of the Act, we hereby advise you that the Preliminary Prospectus dated April 27, 2016, was distributed by us, as representatives
of the several underwriters, approximately as follows from April 27, 2016 through the date hereof:
Copies to underwriters
661
Copies to dealers
0
Copies to institutional investors
588
Copies to others/retail
5
Total
1,254
We have been informed
by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act
of 1934, as amended, to the extent applicable.
Very truly yours,
JEFFERIES LLC
BARCLAYS CAPITAL INC.,
As Representatives
[Signature Page Follows]
JEFFERIES LLC
By:
/s/ Matthew Kim
Name: Matthew Kim
Title: Managing Director
BARCLAYS CAPITAL INC.
By:
/s/ Victoria Hale
Name: Victoria Hale
Title: Vice President
cc:
Pankaj Mohan, Ph.D., Oncobiologics, Inc.
Lawrence A. Kenyon, Oncobiologics, Inc.
Stuart M. Cable, Goodwin Procter LLP
Edwin O’Connor, Goodwin Procter LLP
Seo Salimi, Goodwin Procter LLP
Yvan-Claude Pierre, Cooley LLP
Daniel I. Goldberg, Cooley LLP
Marianne Sarrazin, Cooley LLP
[signature page to acceleration request
letter]
2016-05-04 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
May 4, 2016
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Ms. Suzanne Hayes
Re:
Oncobiologics, Inc.
Registration Statement on Form S-1
Filed April 27, 2016
File No. 333-209011
Acceleration Request
Requested Date:
Thursday,
May 5, 2016
Requested Time:
4:00 P.M. Eastern Time
Ladies and Gentlemen:
In accordance with
Rule 461 under the Securities Act of 1933, as amended, Oncobiologics, Inc. (the “Registrant”) hereby
requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action
to cause the above-referenced Registration Statement on Form S-1 (File No. 333-209011) to become effective on May 5, 2016, at 4:00
p.m., Eastern Time, or as soon as practicable thereafter, or at such later time as the Registrant or its counsel may orally request
via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes each
of Yvan-Claude Pierre, Daniel I. Goldberg and Marianne Sarrazin of Cooley LLP, counsel to the Registrant, to make such request
on its behalf.
In connection with
this request, the Registrant acknowledges 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 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.
7 Clarke Drive, Cranbury, NJ 08512
(609) 619-3990
Very truly yours,
Oncobiologics, Inc.
By:
/s/ Pankaj Mohan
Pankaj Mohan, Ph.D.
Chairman,
President and Chief Executive Officer
cc:
Lawrence A. Kenyon, Oncobiologics, Inc.
Yvan-Claude Pierre, Cooley LLP
Daniel I. Goldberg, Cooley LLP
Marianne Sarrazin, Cooley LLP
Edwin O’Connor, Goodwin Procter LLP
Seo Salimi, Goodwin Procter LLP
7 Clarke Drive, Cranbury, NJ 08512
(609) 619-3990
2016-04-27 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
April 27, 2016
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: Oncobiologics, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed February 12, 2016
File No. 333-209011
CIK No. 0001649989
Ladies and Gentlemen:
On behalf of Oncobiologics,
Inc. (“Oncobiologics” or the “Company”), we submit this letter in response
to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
by letters dated January 28, 2016 (the “Second Comment Letter”) and February 26, 2016 (the “Third
Comment Letter” and together with the Second Comment Letter, the “Comment Letters”) with
respect to the Company’s Registration Statement on Form S-1, initially filed with the Commission on January 15, 2016 (to
which the Second Comment Letter relates), first amended on February 12, 2016 (to which the Second Comment Letter relates), and
since amended. Concurrently with the submission of this response letter, the Company is filing a revised Registration Statement
on Form S-1 (the “Form S-1”). In addition to addressing the comment raised by the Staff in the Third
Comment Letter, the Company has revised the Form S-1 to update other disclosures.
For the convenience
of the Staff, the numbering of the paragraphs below corresponds to the numbering of the comment in the Comment Letters, the text
of which we have incorporated into this response letter for convenience in italicized type and which is followed by the Company’s
response. In the responses below, page number references are to the Form S-1.
Second Comment Letter
Stock-Based Compensation and PSU
Obligation, page 72
We acknowledge your
response to prior comment 14 in our letter dated December 11, 2015. We note in Part II Item 15. Recent Sales of Unregistered Securities
(page II-2) that several equity transactions occurred after September 30, 2015. We may have additional comments on your accounting
for equity issuances including stock compensation and beneficial conversion features. Once you have an estimated offering price,
please provide us an analysis explaining the reasons for the differences between recent valuations of your common stock leading
up to the IPO and the estimated offering price.
Cooley LLP 1114 Avenue of the Americas New York, NY 10036
t: (212) 479-6000 f: (212) 479-6275 cooley.com
Suzanne Hayes
Division of Corporation Finance
U.S. Securities and Exchange Commission
April 27, 2016
Page Two
Response:
Offering Price Range (the “Price
Range”)
The Company advises the Staff that the
Company currently estimates, based in part on advice and input recently received from its underwriters, that the initial public
offering price per share of its currently contemplated initial public offering (“IPO”) will be between
$11.00 – $13.00 per share, which reflects an expected reverse stock split of the Company’s capital stock (the “Reverse
Stock Split”) in a ratio of 1-for-3.450 to be effected prior to the IPO. The Price Range and the impact of the Reverse
Stock Split is reflected in the Form S-1. All share numbers and per share prices in this response also give effect to the Reverse
Stock Split.
Grant Date Fair Value of Restricted Stock
Units
As discussed in Note 8 to the unaudited
interim financial statements included in the Form S-1 (page F-38), as of December 31, 2015, there were 1,066,193
restricted stock unit (“RSU”) awards outstanding. All such RSUs were granted in December 2015 under
the Company’s 2015 Equity Incentive Plan. The grant-date fair value of the RSUs was $29.05 per share which equaled the fair
value of the Company’s common stock based on the contemporaneous arms’ length transactions described in the following
paragraphs.
As discussed in the Form S-1 (pages 122,
II-2 and II-3), in December 2015 and January 2016, the Company sold an aggregate of 573,396 shares of its common stock
to 19 accredited investors for a purchase price of $29.05 per share or approximately $16.6 million in the aggregate. Jefferies
LLC, Arclight Advisors LLC and Alere Financial Partners (a division of Cova Capital Partners, LLC), each a registered broker-dealer
and member of Financial Industry Regulation Authority, Inc., served as placement agents in this offering.
The Company believes the purchase price
of $29.05 per share was the fair value of the common stock as such price was established through contemporaneous arms’ length
transactions with new investors.
Of these outstanding RSUs, 388,022
will vest on the earlier of (i) the date following the effective date of the Form S-1 on which all shares of common stock issued
or issuable under the Company’s 2015 Equity Incentive Plan are not subject to a lock-up restriction, and (ii) the closing
of a “change in control” (as defined in the Company’s 2015 Equity Incentive Plan), with the remaining 678,171
vesting upon the same events but also subject to time-based vesting periods. Because the expiration of the lock-up restriction
following the effective date of the Form S-1 or a change in control are performance conditions that are outside the Company’s
control, the Company will not recognize any stock-based compensation for the RSUs until the performance conditions have been achieved.
As of December 31, 2015, there was $21,100,000 of unamortized expense.
Cooley LLP 1114 Avenue of the Americas New York, NY 10036
t: (212) 479-6000 f: (212) 479-6275 cooley.com
Suzanne Hayes
Division of Corporation Finance
U.S. Securities and Exchange Commission
April 27, 2016
Page Three
Performance Share Units (“PSUs”)
As discussed in Note 11 to the audited financial
statements and the critical accounting policies section of the Form S-1 entitled “Management’s Discussion and Analysis
of Financial Condition and Results of Operations” (pages F-21 and 74, respectively), the Company’s PSUs have been
subject to remeasurement at fair value each reporting period. Through December 31, 2015, the Company has recorded compensation
expense for the fair value of the PSUs based on the $29.05 per share price of the Company’s common stock.
Discussion of Price Range
As is typical in IPOs, the Price Range for
the offering was not derived using a formal determination of fair value, but was determined by negotiations between us and the
underwriters. Among the factors that were considered in setting this range were the following:
· An analysis of the typical valuation ranges seen in recent IPOs for
companies in the Company’s industry.
· The general condition of the securities markets and the recent market
prices of, and the demand for, publicly traded common stock of generally comparable companies.
· An assumption about the public trading market for biosimilar and other
biotechnology companies such as us.
· An assumption about the demand for the Company’s common stock
to support an offering of the size contemplated by the Company.
The Company respectfully advises the Staff
that it believes the difference in the per share fair value of the Company’s common stock of $29.05 and the Price Range is
primarily due to the fact that the Company and the third-party investors agreed on the fair value of the common stock as a result
of arms’ length negotiations, which may differ from the more qualitative and subjective methodologies that may be used by
some public market investors to determine the price they are willing to pay in an IPO. Also, other factors may have an impact,
such as the inherent uncertainty of completing a successful IPO, current market volatility, and a lack of robust demand for IPOs
of similar companies in current markets.
Conclusion
In conclusion, the Company respectfully
submits to the Staff that the differences between the fair value of $29.05 per share and the Price Range are reasonable in light
of the considerations outlined above.
Cooley LLP 1114 Avenue of the Americas New York, NY 10036
t: (212) 479-6000 f: (212) 479-6275 cooley.com
Suzanne Hayes
Division of Corporation Finance
U.S. Securities and Exchange Commission
April 27, 2016
Page Four
Third Comment Letter
Intellectual Property, page 93
1. You state that you own two PCT patent applications directed to certain formulations and methods
of purification as well as six provisional patent applications directed to a number of methods and formulations. Similarly, on
page 36, you state that you have filed two patent applications directed to your formulations and processes for your product candidates
and others directed to aspects of your downstream manufacturing processes for various biosimilars, including ONS-3010. On page
93, you provide an expected expiration date of 2034 for one PCT application and an expected expiration date of 2036 for a U.S.
provisional patent application relating to methods of purification. Please revise your disclosure to clarify the expected expiration
dates of patents potentially issuing from the eight patent applications you describe.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 93 of the Form S-1
accordingly.
* * *
Please contact me at (212) 479-6721, Daniel
Goldberg at (212) 479-6722 or Marianne Sarrazin at (415) 693-2157 with any questions or further comments regarding our response
to the Staff’s comment.
Sincerely,
/s/ Yvan-Claude Pierre
Yvan-Claude Pierre
cc:
Pankaj Mohan, Oncobiologics, Inc., via e-mail
Lawrence Kenyon, Oncobiologics, Inc., via e-mail
Divakar Gupta, Cooley LLP, via e-mail
Edwin O’Connor, Goodwin Procter LLP, via e-mail
Thomas M. Koncsics, KPMG LLP, via e-mail
Cooley LLP 1114 Avenue of the Americas New York, NY 10036
t: (212) 479-6000 f: (212) 479-6275 cooley.com
2016-02-26 - UPLOAD - Outlook Therapeutics, Inc.
Mail Stop 4720
February 26, 2016
Pankaj Mohan, Ph.D.
President and Chief Executive Officer
Oncobiologics, Inc.
7 Clarke Drive
Cranbury, New Jersey 08512
Re: Oncobiologics, Inc.
Amendment No. 1 to Registration Statement on Form S -1
Filed February 12, 2016
File No. 333 -209011
Dear Dr. Mohan:
We have reviewed your amended registration statement 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 this letter by amending your registration statement and providing the
requested information. If you do not b elieve our comment applies to your facts and
circumstances or do not b elieve 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.
Intellectual Property, page 93
1. You state that you own two PCT patent applications directed to certain formulations and
methods of purification as well as six provisional patent applications directed to a number
of methods and formulations. Similarly, on page 36, you state tha t you have filed two
patent applications directed to your formulations and processes for your product
candidates and others directed to aspects of your downstream manufacturing processes
for various biosimilars, including ONS -3010. On page 93, you provide an expected
expiration date of 2034 for one PCT application and an expected expiration date of 2036
for a U.S. provisional patent application relating to methods of purification. Please revise
your disclosure to clarify the expected expiration dates of p atents potentially issuing from
the eight patent applications you describe.
Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
February 26, 2016
Page 2
You may contact James Peklenk at (202) 551 -3661 or Sharon Blume at (202) 551 -4407 if
you have questions regarding comments on the financial statements and related matters. Pl ease
contact Tara Keating Brooks at (202) 551 -8336, Amy Reischauer at (202) 551 -3793, or me at
(202) 551 -3675 with any other questions.
Sincerely,
/s/ Amy Reischauer for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Yvan -Claude Pierre, Cooley LLP
2016-01-28 - UPLOAD - Outlook Therapeutics, Inc.
Mail Stop 4720
January 28, 2016
Pankaj Mohan, Ph.D.
President and Chief Executive Officer
Oncobiologics, Inc.
7 Clarke Drive
Cranbury, New Jersey 08512
Re: Oncobiologics, Inc.
Registration Statement on Form S -1
Filed January 15, 2016
File No. 333 -209011
Dear Dr. Mohan :
We have reviewed your registration statement 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 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 y ou
provide in response to this comment , we may have additional comments.
Stock -Based Compensation and PSU Obligation, page 72
We acknowledge your response to prior comment 14 in our letter dated December 11,
2015. We note i n Part II Item 15. Recent Sales of Unregistered Securities (page II -2) that
several equity transactions occurred after September 30, 2015. We may have additional
comments on your accounting for equity issuances including stock compensation and
beneficial conversion features. Once you have an estimated offering price, please provide
us an analysis explaining the reasons for the differences between recent valuations of
your common stock leading up to the IPO and the estimated offering price.
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 Secur ities Act of 193 3 and
all applicable Securities Act rules require. Since the company and its management are in
Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
January 28, 2016
Page 2
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made .
Notwithstanding our comments, 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 pursua nt 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 o f 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 James Peklenk at (202) 551 -3661 or Sharon Blume at (202) 551 -4407 if
you have questions regarding comments on the financial statements and related matters. Please
contact Tara Keating Brooks at (202) 551 -8336, Amy Reischauer at (202) 551 -3793, or me at
(202) 55 1-3675 with any other questions.
Sincerely,
/s/ Amy Reischauer for
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Yvan -Claude Pierre, Cooley LLP
2016-01-15 - CORRESP - Outlook Therapeutics, Inc.
CORRESP
1
filename1.htm
January 15, 2016
Suzanne
Hayes
Assistant Director
Office of Healthcare and Insurance
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re: Oncobiologics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted December 18, 2015
CIK No. 0001649989
Ladies and Gentlemen:
On behalf of Oncobiologics,
Inc. (“Oncobiologics” or the “Company”), we submit this letter in response
to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”)
by letter dated December 30, 2015 (the “Second Comment Letter”) with respect to
the Company’s Confidential Amendment No. 1 to Draft Registration Statement on Form S-1 submitted to the Commission on December
18, 2015. We are also responding to Comment 14 of the Staff’s comment letter dated December 11, 2015 (the “First
Comment Letter,” and together with the Second Comment Letter, the “Comment Letters”) with
respect to the Company’s Confidential Draft Registration Statement on Form S-1 submitted to the Commission on November 16,
2015, which we previously have advised would be responded to supplementally. Concurrently with the submission of this response
letter, the Company is publicly filing a revised Registration Statement on Form S-1 (the “Form S-1”).
In addition to addressing the comments raised by the Staff in the Second Comment Letter, the Company has revised the Form
S-1 to update other disclosures.
For the convenience
of the Staff, the numbering of the paragraphs below corresponds to the numbering of the comment in the Comment Letters,
the text of which we have incorporated into this response letter for convenience in italicized type and which is followed by the
Company’s response. In the responses below, page number references are to the Form S-1.
Our Pipeline,
page 1
1. We refer to your table on page 1 and our prior comment 3. Please revise your disclosure in this section regarding ONS-4010
to identify the approved therapeutic use for the referenced product. In addition, please state whether you intend to seek the same
indication and how your product is intended to be delivered. If you have not determined an indication or method of delivery for
ONS-4010, please so state.
Response: The Company respectfully
acknowledges the Staff’s Comment and has revised the disclosure on page 3 of the Form S-1 to include the disclosure
from page 85 of the Form S-1 regarding the approved therapeutic use of the referenced product and the method of delivery. The Company
further advises the Staff that ONS-4010 is a preclinical biosimilar product candidate, and, as indicated on pages 3 and 85 of the
Form S-1, the Company has not yet determined the proposed therapeutic indication for which approval will initially be sought as
such determination is done in consultation with applicable regulatory authorities.
Suzanne Hayes
Division of Corporation Finance
U.S. Securities and Exchange Commission
January 15, 2016
Page 2
Risks Associated with Our Business,
page 4
2. We note your response to our prior comment 4. Please revise your disclosure in your revised bullet points to address the
risk associated with your license agreement(s) (e.g. Selexis) to include the patents licensed pursuant to the agreement(s) and
the risk associated with obtaining third party commercialization agreements.
Response: The Company
respectfully acknowledges the Staff’s Comment and has revised the disclosure on page 4 of the Form S-1 accordingly.
Collaboration and License Agreements,
page 85
3. Please revise your disclosures relating to Swiss Franc (CHF) payments to provide for the U.S. dollar equivalent.
Response: The Company
respectfully acknowledges the Staff’s Comment and has revised the disclosure on page 87 of the Form S-1 accordingly.
Intellectual Property, page 88
4. Please revise your disclosure to explain the meaning and significance of “PCT.” In that regard, describe briefly
the process of obtaining such patent, the benefits or potential protections of the pending PCT, whether patents have been granted
pursuant to a PCT for biosimiliars, and in what jurisdictions you are currently seeking patent protection.
Response: The Company
respectfully acknowledges the Staff’s Comment and has revised the disclosure on page 89 of the Form S-1 accordingly.
The Company supplementally advises the Staff that a patent cannot be granted pursuant to the PCT (patents can only be granted in
national or regional patent offices).
Agreements with our Named Executive
Officers, page 104
5. We note that your employment agreement with Dr. Mohan terminates upon the company’s initial public offering of stock.
We also note your dependence on Dr. Mohan as disclosed on page 5. Please revise your disclosure to discuss whether you intend to
enter into or extend Dr. Mohan’s current employment agreement. Please make any corresponding changes to the corresponding
risk factor on page 41.
Response: The Company
respectfully acknowledges the Staff’s Comment and has revised the disclosure on pages 42 and 106 of the Form S-1 accordingly.
Stock-Based Compensation and PSU
Obligation, page 68
14. We may have additional comments on your
accounting for equity issuances including stock compensation and beneficial conversion
features. Once you have an estimated offering price, please provide us an 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 respectfully advises the Staff that the Company’s outstanding stock-based compensation
awards as of September 30, 2015 are substantially comprised of performance-based stock units, or PSUs, which are liability classified
and therefore subject to re-measurement based on the then fair value of the Company’s common stock until the award is settled
or extinguished. As of September 30, 2015, the Company has recorded stock-based compensation expense using $7.475 per share,
which was the then fair value that was established through contemporaneous arms-length transactions with new investors purchasing
the Company’s common stock.
* * *
Suzanne Hayes
Division of Corporation Finance
U.S. Securities and Exchange Commission
January 15, 2016
Page 3
Please contact me
at (212) 479-6721, Daniel Goldberg at (212) 479-6722 or Divakar Gupta at (212) 479-6474 with any questions or further comments
regarding our response to the Staff’s comment.
Sincerely,
/s/ Yvan-Claude Pierre
Yvan-Claude Pierre
cc: Pankaj Mohan, Oncobiologics, Inc., via e-mail
Lawrence Kenyon, Oncobiologics, Inc., via e-mail
Edwin O’Connor, Goodwin Procter LLP, via e-mail
Thomas M. Koncsics, KPMG LLP, via e-mail
2015-12-30 - UPLOAD - Outlook Therapeutics, Inc.
Mail Stop 4720
December 30, 2015
Pankaj Mohan, Ph.D.
President and Chief Executive Officer
Oncobiologics, Inc.
7 Clarke Drive
Cranbury, New Jersey 08512
Re: Oncobiologics, Inc .
Amendment No. 1 to Draft Registration Statement on Form S -1
Submitted December 18, 2015
CIK No. 0001649989
Dear Dr. Mohan :
We have reviewed your amended 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 stateme nt on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Our Pipeline , page 1
1. We refer to your table on page 1 and our prior comment 3. Please revise your disclosure
in this section regarding ONS -4010 to identify the approved therapeutic use for the
referenced product. In addition, please state whether you intend to seek the same
indication and how your product is intended to be delivered. If you have not determined
an indication or method of delivery fo r ONS -4010, please so state.
Risks Associated with Our Business , page 4
2. We note your response to our prior comment 4. Please revise your disclosure in your
revised bullet points to address the risk associated with your license agreement(s) (e.g.
Pankaj Mohan, Ph.D
Oncobiologics, Inc.
December 30, 2015
Page 2
Selex is) to include the patents licensed pursuant to the agreement(s) and the risk
associated with obtaining third party commercialization agreements.
Collaboration and License Agreements , page 85
3. Please revise your disclosures relating to Swiss Franc (CH F) payments to provide for the
U.S. dollar equivalent.
Intellectual Property, page 88
4. Please revise your disclosure to explain the meaning and significance of “PCT.” In that
regard, describe briefly the process of obtaining such patent, the benefits or potential
protections of the pending PCT, whether patents have been granted pursuant to a PCT for
biosimiliars , and in what jurisdictions you are currently seeking patent protection.
Agreements with our Named Executive Officers, page 104
5. We note that your employment agreement with Dr. Mohan terminates upon the
company’s initial public o ffering of stock. We also note your dependence on Dr. Mohan
as disclosed on page 5. Please revise your disclosure to discuss whether you intend to
enter into or extend Dr. Mohan’s current employment agreement. Please make any
corresponding changes to the corresponding risk factor on page 41.
You may contact James Peklenk at (202) 551 -3661 or Sharon Blume at (202) 551 -4407 if
you have questions regarding comments on the financial statements and related matters. Please
contact Tara Keating Brooks at ( 202) 551 -8336, Amy Reischauer at (202) 551 -3793, or me at
(202) 551 -3675 with any other questions.
Sincerely,
/s/ Suzanne Hayes
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Via E -mail
Yvan -Claude Pierre
Cooley LLP
2015-12-14 - UPLOAD - Outlook Therapeutics, Inc.
Mail Stop 4720
December 11, 2015
Pankaj Mohan, Ph.D.
President and Chief Executive Officer
Oncobiologics, Inc.
7 Clarke Drive
Cranbury, New Jersey 08512
Re: Oncobiologics, Inc.
Draft Registration Statement on Form S -1
Submitted November 16, 2015
CIK No. 0001649989
Dear Dr. Mohan :
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 t o this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Overview, page 1
1. Please clarify the meaning of any significant scientific or technical terms the first time
they are used in your prospectus in order to ensure that lay readers will understand the
disclosure. For example, please define each of the following at their first use:
mAbs ;
pharmacokinetic, or PK ; and
PK bioequivalency criteria .
2. Your product pipeline table should highlight your product candidate s in development that
are reasonably likely to result in an approved product in the foreseeable future. Research
and discovery activities that precede the identification of a product candidate are too
Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
December 11, 2015
Page 2
remote to be highlighted in the pipeline table. Accordingly, please limit your table to
product candidate s where you have se lected a clone for development .
3. Please include disclosure in your prospectus summary to state the approved therapeutic
use for the referenced product and for which indications you initially intend to seek
approval for your product candidates. In addition , please disclose how the product is
intended to be delivered (e.g. pill formulation or injection).
Risk Associated with Our Business, page 3
4. Please supplement your list of bullet point risk factors to address the following:
that, t o your knowledge, th ere has been only one biosimilar product application
approved by the FDA under the 351(k) pathway to date ;
your reliance and the other material risks relating to your collaboration and
licensing agreements; and
that you have no issued patents, and the ris ks associated with any failure to obtain
and maintain protection of your own intellectual property.
The results of previous clinical trials may not be predictive of future results …, page 18
5. Please revise this risk factor to identify the indications for which you initially intend to
seek approval. If you intend to extrapolate clinical data intended to support a
demonstration of biosimilarity in one indication to support approval of your biosimilar
candidate in one or more additional indications, please s o state, and describe the risks
related to such extrapolation.
We currently engage single source suppliers for clinical trial services , page 30
6. We note this risk factor discusses the risks associated with your multiple source suppliers
for fill -finish manufacturing and does not discuss the single source suppliers for clinical
trials. In that regard, we refer to your last risk factor on page 28. Please revise your
disclosure in this or a separate risk factor to discuss the risks relating to your sole supplier
for “specialty -manufactured bags.” In addition, please disclose whether you believe
alternate sources of the specialty -manufactured bags ar e available.
If we infringe or are alleged to infringe intellectual property rights …, page 30
7. Please revise your disclosure to describe briefly the “ freedom to operate analyses ” in
layman’s terms.
We may be subject to claims that our employees …, pa ge 33
8. Please revise your disclosure to state that Genentech, former employer of Dr. Mohan and
Dr. Bahrt, developed bevacizumab (Avastin) , for which you seek to develop ONS -1045
Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
December 11, 2015
Page 3
as a biosimilar, and trastuzumab (Herceptin) , for which you seek to develop ONS -1050
as a biosimilar. In addition, please identify any similar circumstances that increase the
risk of the claims described in this risk factor.
Use of Proceeds, page 52
9. Please revise your Use of Proceeds to state w hether each of the allocated proceeds will
allow you to fund your clinical products and the expansion of your facility to completion.
If not, please describe how far in the trial process you anticipate the allocated proceeds
will allow you to reach for eac h of your product candidates and the extent of your facility
expansion .
10. Please revise your Use of Proceeds table to separate the amounts to be used to fund
research and development activities from the amounts to be used for working capital and
general cor porate purposes .
Collaboration and License Agreements
Huahai — Humira (ONS -3010) and Avastin (ONS -1045), page 61
11. Please clarify whether the strategic license agreement with Huahai is the same as the co -
development and license agreement described here and on page 86. We may have
additional comments.
Collaboration Revenues, page 63
12. Please revise to quantify, in a tabular format, the components ( i.e. upfront fees,
milestones, deferred revenues, etc.) of your collaboration revenues for each period
presented.
Research and Development Expenses , page 64
13. For each of your key research and development projects, please revise to disclose
research and deve lopment costs incurred during each period presented and inception to
date. For the remainder of projects not considered individually significant, disclose the
composition of the total R&D expense for each period presented. If you do not track
these costs by project please revise your disclosure to clarify.
Stock -Based Compensation and PSU Obligation , page 68
14. We may have additional comments on your accounting for equity issuances including
stock compensation and beneficial conversion features. Once you have an estimated
offering price, please provide us an analysis explaining the reasons for the differences
between recent valuations of your common stock leading up to the IPO and the estimated
offering price.
Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
December 11, 2015
Page 4
ONS -3010 – Adalimumab (Humira) Biosimilar, page 77
15. Please revise your disclosure to explain what “luminescence” is and how it demonstrates
potency.
16. Pleas e revise the table of most frequently reported adverse events on page 79 to clarify
what you mean by “Preferred Term.”
Our Product Candidate Portfolio , page 77
17. Please revise your disclosures for each of your clinical trials to state the jurisdiction and
the governing body pursuant to which the clinical trials were performed and where you
intend to perform your Phase 3 trials. For example, if a clinical trial was conducted in the
United States pursuant to an IND issued from the FDA, please so state and in clude the
date of the IND. In addition, include conforming disclosure in your prospectus summary.
Chemistry Manufacturing Controls, or CMC, Status , page 78
18. We note your disclosure that a novel formulation of similar stability was developed and
utilize d in the Phase 1 clinical trial . Please revise your disclosure, if applicable, to
discuss whether you will be utilizing the same formulation in your Phase 3 trials and, if
not, describe whether you believe any such change will affect your Phase 3 trials.
Selexis — Humira (ONS -3010), Avastin (ONS -1045) and Herceptin (ONS -1050) , page 82
19. We refer to your research license agreement, as amended. Please revise your prospectus
to describe the material terms of this agreement , including :
the initial fee;
milestone payments; and
aggregate amounts paid to date.
Commercial License Agreements, page 83
20. We refer to your disclosure of your commercial licensing agreements. For each of the
agreements, p lease revise your prospectus to describe the material terms , including:
up-front or execution payments;
milestone payments;
royalty termination fees ; and
aggregate amounts paid to date.
In addition, please file the se agreement s as exhibit s in accordance with Item 601 of
Regulation S -K.
Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
December 11, 2015
Page 5
IPCA — Humira (ONS -3010), Avastin (ONS -1045) and Herceptin (ONS -1050) , page 83
21. We refer to each of your license agreements described on pages 83 and 84. Please revise
your prospectus to describe the material terms of each of the agreement s, including :
up-front or execution payments;
milestone payment s;
royalty rates within 10% (e.g. low teens, twenties, etc.);
development payments;
commercialization fees ; and
aggregate amounts received to date.
In addition, please file the agreement s as e xhibit s in accordance with Item 601 of
Regulation S -K.
Liomont — Humira (ONS -3010) and Avastin (ONS -1045) , page 84
22. Please revise your prospectus to describe the material t erms of your agreement,
including:
the up-front or execution payment;
milestone paymen ts; and
royalty rates within 10% (e.g. low teens, twenties, etc.) .
In addition, please file the agreement as an exhibit in accordance with Item 601 of
Regulation S -K.
Huahai — Humira (ONS -3010) and Avastin (ONS -1045)
Co-Development and License Agreeme nt…page 86
23. Please revise your prospectus to describe the material terms of the license agreement ,
including:
the up-front or execution payment; and
milestone payment s.
In addition, please file the agreement as an exhibit in accordance with Item 601 of
Regulation S -K.
Intellectual Property, page 87
24. Please revise your disclose to identify the applicable jurisdictions and the anticipated
patent expiration dates for each of your patent applications.
25. We refer to your “Collaboration and License Agreements” on page 82. We note that you
are currently licensing rights to the Selexis Technology pursuant to your agreements with
Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
December 11, 2015
Page 6
Selexis. Please revise your disclosure in this s ection to describe any material patents and
patent applications that you license , including:
nature of the patent and the type of patent protection such as composition of matter, use
or process; and
patent expiration dates or expected expiration dates for patent applications by
jurisdiction.
Compensation Committee Interlocks and Insider Participation, page 99
26. We refer to your disclosure that none of your executive officers currently serves, or has
served during the last year, as a member of the board of directors or compensation
committee of any entity that has one or more executive officers serving as a member of
our board of directors or compensation committee . We refer to each of the biographical
disclosures for Dr. Mohan and Mr. Griffith and their r espective positions with Sonnet
Biotherapuetics, Inc. Please tell us why you believe Dr. Mohan and Mr. Griffith do not
meet the disclosure requirements of this section. In the alternative, please revise this
section to provide the relevant disclosures fo r Dr. Mohan and Mr. Griffith
Agreement with Named Executive Officers, page 103
27. Please revise your disclosure for each of your named executive officers to disclose
whether each agreement is for full or part -time services, whether the named executive
officer is currently performing their duties on a full or part time basis, term and
termination provisions.
Loans and Guarantees, page 116
28. Please revise your description of the amounts owed to Dr. Mohan to disclose any interest
accruing on such amounts.
Other Comments
29. Please submit all exhibits as soon as practicable. We may have furt her comments upon
examination of these exhibits.
30. Please confirm that the graphics included in your registration statement are the only
graphics you will use in your prospectus. If those are not the only graphics, please
provide any additional graphics prior to their use for our review.
31. Please supplementally provide us with copies of all written communications, as defined
in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your
behalf, present to potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications.
Pankaj Mohan, Ph.D.
Oncobiologics, Inc.
December 11, 2015
Page 7
You may contact James Peklenk at (202) 551 -3661 or Sharon Blume at (202) 551 -4407 if
you have questions regarding comments on the financial statemen ts and related matters. Please
contact Tara Keating Brooks at (202) 551 -8336, Amy Reischauer at (202) 551 -3793, or me at
(202) 551 -3675 with any other questions.
Sincerely,
/s/ Suzanne Hayes
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Via E -mail
Yvan -Claude Pierre
Cooley LLP