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Letter Text
Opus Genetics, Inc.
Response Received
1 company response(s)
High - file number match
↓
Opus Genetics, Inc.
Response Received
3 company response(s)
High - file number match
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Company responded
2025-04-07
Opus Genetics, Inc.
References: February 26, 2025
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
Opus Genetics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-01-19
Opus Genetics, Inc.
Summary
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Company responded
2024-01-22
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-07-12
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Response Received
13 company response(s)
High - file number match
SEC wrote to company
2009-02-25
Opus Genetics, Inc.
Summary
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Company responded
2009-03-02
Opus Genetics, Inc.
References: February 25, 2009
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Company responded
2010-10-01
Opus Genetics, Inc.
References: September 17, 2010
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Company responded
2010-10-15
Opus Genetics, Inc.
References: September 17, 2010
Summary
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Company responded
2010-11-24
Opus Genetics, Inc.
References: October 15, 2010 | September 17, 2010
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Company responded
2010-12-03
Opus Genetics, Inc.
References: October 15, 2010 | September 17, 2010
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Company responded
2011-01-06
Opus Genetics, Inc.
References: December 21, 2010
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Company responded
2011-01-19
Opus Genetics, Inc.
References: December 21, 2010 | December 3, 2010
Summary
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Company responded
2011-03-18
Opus Genetics, Inc.
References: January 19, 2011
Summary
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Company responded
2011-03-22
Opus Genetics, Inc.
References: March 18, 2011
Summary
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Company responded
2016-10-14
Opus Genetics, Inc.
References: September 30, 2016
Summary
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Company responded
2018-07-18
Opus Genetics, Inc.
References: July 13, 2018
Summary
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Company responded
2019-07-26
Opus Genetics, Inc.
References: July 12, 2019
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-06-28
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2021-02-10
Opus Genetics, Inc.
Summary
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Company responded
2021-02-11
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2020-08-03
Opus Genetics, Inc.
Summary
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Company responded
2020-08-27
Opus Genetics, Inc.
References: August 2, 2020
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Company responded
2020-09-15
Opus Genetics, Inc.
References: September 10, 2020
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Company responded
2020-09-30
Opus Genetics, Inc.
References: September 24, 2020
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-09-24
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2020-09-10
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-10-07
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-07-12
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
Opus Genetics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-06-02
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-11-15
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2016-09-30
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2014-06-05
Opus Genetics, Inc.
Summary
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Company responded
2014-06-25
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-03-23
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-12-22
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-09-17
Opus Genetics, Inc.
Summary
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Opus Genetics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-03-02
Opus Genetics, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-21 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2026-03-17 | SEC Comment Letter | Opus Genetics, Inc. | DE | 333-294295 | Read Filing View |
| 2025-04-09 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2025-04-08 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2025-04-07 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2025-03-28 | SEC Comment Letter | Opus Genetics, Inc. | DE | 001-34079 | Read Filing View |
| 2025-02-26 | SEC Comment Letter | Opus Genetics, Inc. | DE | 333-285038 | Read Filing View |
| 2024-01-22 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2024-01-19 | SEC Comment Letter | Opus Genetics, Inc. | DE | 333-276462 | Read Filing View |
| 2023-07-12 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2023-07-07 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2023-06-28 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2021-02-11 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2021-02-10 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-09-30 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-09-30 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-09-24 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-09-15 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-09-10 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-08-27 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-08-03 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2019-10-07 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2019-07-26 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2019-07-12 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2018-07-19 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2018-07-18 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2018-07-13 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2017-07-07 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2017-06-02 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2016-11-15 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2016-10-14 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2016-09-30 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2014-06-25 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2014-06-05 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2011-03-23 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2011-03-22 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2011-03-18 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2011-01-19 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2011-01-06 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2010-12-22 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2010-12-03 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2010-11-24 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2010-10-15 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2010-10-01 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2010-09-17 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2009-03-02 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2009-03-02 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2009-02-25 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-17 | SEC Comment Letter | Opus Genetics, Inc. | DE | 333-294295 | Read Filing View |
| 2025-03-28 | SEC Comment Letter | Opus Genetics, Inc. | DE | 001-34079 | Read Filing View |
| 2025-02-26 | SEC Comment Letter | Opus Genetics, Inc. | DE | 333-285038 | Read Filing View |
| 2024-01-19 | SEC Comment Letter | Opus Genetics, Inc. | DE | 333-276462 | Read Filing View |
| 2023-07-12 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2023-06-28 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2021-02-10 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-09-24 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-09-10 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-08-03 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2019-10-07 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2019-07-12 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2018-07-19 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2018-07-13 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2017-06-02 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2016-11-15 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2016-09-30 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2014-06-05 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2011-03-23 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2010-12-22 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2010-09-17 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2009-03-02 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2009-02-25 | SEC Comment Letter | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-21 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2025-04-09 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2025-04-08 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2025-04-07 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2024-01-22 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2023-07-07 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2021-02-11 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-09-30 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-09-30 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-09-15 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2020-08-27 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2019-07-26 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2018-07-18 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2017-07-07 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2016-10-14 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2014-06-25 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2011-03-22 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2011-03-18 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2011-01-19 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2011-01-06 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2010-12-03 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2010-11-24 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2010-10-15 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2010-10-01 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
| 2009-03-02 | Company Response | Opus Genetics, Inc. | DE | N/A | Read Filing View |
2026-04-21 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
April 21, 2026
Via EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-3720
Attention:
Jessica Dickerson
Re:
Opus Genetics, Inc.
Registration Statement on Form S-3
File No. 333-294295
Acceleration Request
Requested Date: April 22, 2026
Requested Time: 4:00 P.M., Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Opus Genetics, Inc. (the “Company”) hereby requests that the effective
date of the above-referenced Registration Statement on Form S-3 (as amended, the “Registration Statement”), be accelerated so that the Registration Statement will become effective at 4:00
P.M., Eastern Time, on April 22, 2026, or as soon thereafter as practicable or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the U.S. Securities and
Exchange Commission.
Please contact Nick DeAngelis of Sidley Austin LLP at (214) 969-3563 with any questions regarding the foregoing and to confirm the effectiveness of the Registration Statement.
Very truly yours,
/s/ Dr. George Magrath
Dr. George Magrath
Chief Executive Officer
Opus Genetics, Inc.
cc:
Robert Gagnon, Opus Genetics, Inc.
Asher Rubin, Sidley Austin LLP
Istvan A. Hajdu, Sidley Austin LLP
Nick DeAngelis, Sidley Austin LLP
2026-03-17 - UPLOAD - Opus Genetics, Inc. File: 333-294295
March 17, 2026
George Magrath
Chief Executive Officer
Opus Genetics, Inc.
8 Davis Drive, Suite 220
Durham, NC 27713
Re:Opus Genetics, Inc.
Registration Statement on Form S-3
Filed March 13, 2026
File No. 333-294295
Dear George Magrath:
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 Jessica Dickerson at 202-551-8013 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Istvan A. Hajdu, Esq.
2025-04-09 - CORRESP - Opus Genetics, Inc.
CORRESP 1 filename1.htm Opus Genetics, Inc. 8 Davis Drive, Suite 220 Durham, North Carolina April 9, 2025 VIA EDGAR Division of Corporation Finance Office of Life Sciences Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-7010 Attn: Joshua Gorsky; Joe McCann Re: Opus Genetics, Inc. Registration Statement on Form S-3 File No. 333-285038 Dear Messrs. Gorsky and McCann, Reference is made to the letter submitted by Sidley Austin LLP (“Sidley”) on behalf of Opus Genetics, Inc. (the “Company”), filed as correspondence via EDGAR on April 8, 2025, in which Sidley requested, on behalf of the Company, the acceleration of the effective date of the above-referenced Registration Statement on Form S-3, as amended (File No. 333-285038) (the “Registration Statement”), so that the Registration Statement would be declared effective on April 10, 2025, or as promptly as practicable. The Company hereby formally withdraws such request and substitutes it with the following request. Pursuant to Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests acceleration of effectiveness of the Registration Statement, so that it will be declared effective at 3:00 P.M., Eastern Time, on April 10, 2025, or as promptly thereafter as practicable. Please contact Andrea Reed of Sidley via telephone at (312) 853-7881 with any questions regarding the foregoing and to confirm the effectiveness of the Registration Statement. Sincerely, /s/ George Magrath George Magrath Chief Executive Officer Opus Genetics, Inc. cc: Andrea Reed, Sidley Austin LLP
2025-04-08 - CORRESP - Opus Genetics, Inc.
CORRESP 1 filename1.htm SIDLEY AUSTIN LLP ONE SOUTH DEARBORN STREET CHICAGO, IL 60603 +1 312 853 7000 +1 312 853 7036 FAX AMERICA • ASIA PACIFIC • EUROPE +1 312 853 7881 ANDREA.REED@SIDLEY.COM April 8, 2025 VIA EDGAR Division of Corporation Finance Office of Life Sciences Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-7010 Attn: Joshua Gorsky; Joe McCann Re: Opus Genetics, Inc. Registration Statement on Form S-3 File No. 333-285038 Dear Messrs. Gorsky and McCann, Pursuant to Rule 461 under the Securities Act of 1933, as amended, Opus Genetics, Inc. (the “Company”) hereby respectfully requests acceleration of effectiveness of its Registration Statement on Form S-3, as amended (File No. 333-285038) (the “Registration Statement”), so that it will be declared effective on April 10, 2025, or as promptly as practicable. Please contact me, as an attorney with the Company’s outside legal counsel, Sidley Austin LLP, via telephone at (312) 853-7881 with any questions regarding the foregoing. Sincerely, /s/ Andrea Reed Andrea Reed cc: George Magrath, Chief Executive Officer, Opus Genetics, Inc.
2025-04-07 - CORRESP - Opus Genetics, Inc.
CORRESP 1 filename1.htm SIDLEY AUSTIN LLP ONE SOUTH DEARBORN STREET CHICAGO, IL 60603 +1 312 853 7000 +1 312 853 7036 FAX +1 312 853 7881 AMERICA • ASIA PACIFIC • EUROPE ANDREA.REED@SIDLEY.COM April 7, 2025 VIA EDGAR Division of Corporation Finance Office of Life Sciences Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-7010 Attn: Joshua Gorsky; Joe McCann Re: Opus Genetics, Inc. Registration Statement on Form S-3 Filed February 18, 2025 File No. 333-285038 Dear Messrs. Gorsky and McCann, Opus Genetics, Inc. (referred to herein as “ we ,” “ our ,” “ us ,” or the “ Company ”) is in receipt of your letter dated February 26, 2025 regarding the Company’s Form S-3 filed February 18, 2025 (the “ Registration Statement ”). This letter sets forth the response of the Company to the comments of the Staff of the Division of Corporation Finance of the Securities and Exchange Commission (the “ Staff ”). For your convenience, each response is prefaced with the exact text of the corresponding comment from the Staff in italicized text. On April 7, 2025, the Company filed an amendment to the Registration Statement (the “ Amendment ”). Capitalized terms used herein and not otherwise defined have the same meaning as set forth in the Amendment. Registration Statement on Form S-3 Cover Page 1. Comment: We note your disclosure on the cover page that this prospectus relates to “the issuance by [you] of up to 19,382,437 shares of [y]our common stock” and that you will “not receive any proceeds from the issuance or sale of shares of Common Stock pursuant to this prospectus.” Please revise your cover page to clarify that this offering relates to a resale of shares of common stock by the selling securityholders. Securities and Exchange Commission April 7, 2025 Page 2 Response: The Company acknowledges the Staff’s comment and has revised the cover page of the Amendment accordingly to clarify that the offering covered thereby relates only to a resale of Common Stock by the selling securityholders. The original reference to the issuance of Common Stock on the cover page of the Registration Statement was related to the anticipated issuance of Common Stock upon conversion of the shares of Series A Non-Voting Convertible Preferred Stock, such conversion being subject to and contingent upon the affirmative vote of holders of a majority of shares of Common Stock present or represented and entitled to vote at a meeting of stockholders of the Company. 2. Comment: Please revise to include financial statements for the fiscal year ended December 31, 2024 or advise. Response: The Company acknowledges the Staff’s comment and has included financial statements for the fiscal year ended December 31, 2024 in the Amendment by incorporating the Company’s Annual Report on Form 10-K covering such period by reference. Please direct any questions or comments regarding the foregoing to me at (312) 853-7881. Sincerely, /s/ Andrea Reed Andrea Reed cc: George Magrath, Chief Executive Officer, Opus Genetics, Inc.
2025-03-28 - UPLOAD - Opus Genetics, Inc. File: 001-34079
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 28, 2025 Mina Sooch Nominating Shareholder Opus Genetics, Inc. 6894 Lakemont Circle West Bloomfield, MI 48323 Re: Opus Genetics, Inc. PREC14A Filed March 21, 2025 Filed by Mina Sooch et al. File No. 001-34079 Dear Mina Sooch: We have reviewed your filing and have the following comments. Please respond to these comments by providing the requested information or advise us as soon as possible when you will respond. If you do not believe our comments apply to your facts and circumstances, please tell us why in your response. After reviewing your response to these comments, we may have additional comments. All defined terms used herein have the same meaning as in your proxy statement. PREC14A Filed March 21, 2025 General 1. On the preliminary proxy card and on pages 3 and 32, you indicate that the proxy card will be voted based on the Restore Value Slate s recommendations if the proxy card is properly executed and delivered, but does not specify voting instructions. Please revise to clarify whether you are describing an entirely unmarked, but signed proxy card, or one that is signed and marked as to other matters but not marked as to the particular proposal addressed in your disclosure. 2. We note the following disclosure, which appears both on page 3 and page 37: "IMPORTANTLY, IF YOU MARK MORE THAN NINE (9) 'FOR' AND/OR 'WITHHOLD' BOXES WITH RESPECT TO THE ELECTION OF DIRECTORS, ALL OF YOUR VOTES FOR THE ELECTION OF DIRECTORS WILL BE DEEMED INVALID." It is our understanding that only "FOR" votes are relevant when it comes to the possibility of invalidation. Please revise accordingly, or otherwise advise. In this regard, see the Company's disclosure on "over-votes," which March 28, 2025 Page 2 appears on page 9 of the Company's preliminary proxy statement, as well as the related instruction on your own preliminary proxy card, which also suggests that only "FOR" votes are relevant. Background to Solicitation, page 6 3. We note your statement on page 16 that the Board has failed to articulate the full commercial potential of the Viatris license agreement for Ryzumvi despite industry valuations by analysts and similarly situated competitors with a sole-focus on presbyopia, suggesting it could be worth hundreds of millions of dollars. Please revise to provide further support for the valuations referenced here, including the identities of the analysts and similarly situated competitors mentioned. 4. We note your statement on page 17 that APX3330 is a promising late-stage asset. Please revise to provide further support for this statement and to reflect, if true, that APX3330 failed to meet its primary endpoint during its ZETA-1 Phase 2 clinical trial for diabetic retinopathy and that it has not been approved for Phase 3 clinical trials at this time. Reasons for the Solicitation, page 10 5. We note the following statement on page 15: [T]he Board expanded the C-suite from three to seven named executive officers, dramatically increasing overhead without a clear corresponding benefit to stockholders. We also note the reference to two additional Named Executive Officers (SVP of Corporate Development and SVP of Finance) on page 19. Please revise to clarify that you are referring to the Company s executive officers, as defined in Rule 3b-7, and not its named executive officers, as defined in Item 402 of Regulation S-K, or otherwise advise. Proposal One, page 24 6. Please revise this section to include Mr. Weber's present principal occupation and a description of his business experience over the past five years. See Items 5(b)(1)(ii) and 7(b) of Schedule 14A and Item 401(e)(1) of Regulation S-K. Proposal Two, page 33 7. We note that disclosure in this section indicates that "WE MAKE NO RECOMMENDATION WITH RESPECT TO THIS PROPOSAL," whereas the proxy card indicates that the Restore Value Slate "RECOMMENDS YOU VOTE 'FOR' PROPOSAL 2." Please revise to clarify whether you are making a recommendation on Proposal 2. Votes Required for Approval, page 40 8. We note the disclosure in this section indicates that "[b]roker discretionary voting is permitted" on Proposal 2. Please revise to clarify that broker discretionary voting is not permitted if a stockholder receives proxy materials from the Restore Value Slate and the Company. March 28, 2025 Page 3 Solicitation of Proxies, page 42 9. We note the following statement on page 42: Solicitations may be made by certain of the respective directors, officers, members and employees of Ms. Sooch . . . . Since Ms. Sooch is a natural person, please revise to clarify the potential solicitors being referenced in this statement. 10. According to this section, the entire expense of soliciting proxies is being borne by Ms. Sooch. However, the description of the Group Agreement on page 27 indicates that the Participants have agreed to share all expenses incurred in connection with the Participant s activities. Please revise to clarify whether any Participants other than Ms. Sooch are bearing the cost of the solicitation. See Item 4(b)(5) of Schedule 14A. We remind you that the filing persons are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please direct any questions to Shane Callaghan at 202-551-6977 or David Plattner at 202-551-8094. Sincerely, Division of Corporation Finance Office of Mergers & Acquisitions </TEXT> </DOCUMENT>
2025-02-26 - UPLOAD - Opus Genetics, Inc. File: 333-285038
February 26, 2025
George Magrath
Chief Executive Officer
Opus Genetics, Inc.
8 Davis Drive, Suite 220
Durham, NC 27709
Re:Opus Genetics, Inc.
Registration Statement on Form S-3
Filed February 18, 2025
File No. 333-285038
Dear George Magrath:
We have conducted a limited review of your registration statement and have the
following comments.
Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information
you provide in response to this letter, we may have additional comments.
Registration Statement on Form S-3
Cover Page
1.We note your disclosure on the cover page that this prospectus relates to "the issuance
by [you] of up to 19,382,437 shares of [y]our common stock" and that you will "not
receive any proceeds from the issuance or sale of shares of Common Stock pursuant
to this prospectus." Please revise your cover page to clarify that this offering relates to
a resale of shares of common stock by the selling securityholders.
General
2.Please revise to include financial statements for the fiscal year ended December 31,
2024 or advise.
February 26, 2025
Page 2
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence
of action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Joshua Gorsky at 202-551-7836 or Joe McCann at 202-551-6262 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Andrea Reed
2024-01-22 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
January 22, 2024
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: Lauren Hamill
Re:
Ocuphire Pharma, Inc.
Registration Statement on Form S-3
File No. 333-276462
Acceleration Request
Requested Date:
January 23, 2024
Requested Time:
4:30 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Ocuphire Pharma, Inc. (the “Company”) hereby respectfully requests that the above-referenced Registration Statement on Form S-3 (File No. 333-276462) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as practicable thereafter, or at such later time as the Company or its counsel may
orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. The Company hereby authorizes each of Emily Johns and Lauren Legner of Honigman LLP, counsel to the Company, to make
such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Emily Johns of Honigman LLP by telephone at (616) 649-1908 or Lauren Legner of
Honigman LLP by telephone at (313) 465-7119.
[Signature page follows]
****
Sincerely,
Ocuphire Pharma, Inc.
/s/ Amy Rabourn
Amy Rabourn
SVP of Finance
cc:
Emily Johns, Honigman LLP
Lauren Legner, Honigman LLP
2024-01-19 - UPLOAD - Opus Genetics, Inc. File: 333-276462
United States securities and exchange commission logo
January 19, 2024
George Magrath
Chief Executive Officer
Ocuphire Pharma, Inc.
7000 Grand River Avenue, Suite 120
Farmington Hills, MI 48335
Re:Ocuphire Pharma, Inc.
Registration Statement on Form S-3
Filed January 10, 2024
File No. 333-276462
Dear George Magrath:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Emily Johns
2023-07-12 - UPLOAD - Opus Genetics, Inc.
United States securities and exchange commission logo
July 12, 2023
Richard Rodgers
Interim President and Chief Executive Officer
Ocuphire Pharma, Inc.
37000 Grand River Avenue, Suite 120
Farmington Hills, MI 48335
Re:Ocuphire Pharma, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2022
Filed March 30, 2023
File No. 001-34079
Dear Richard Rodgers:
We have completed our review of your filings. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2023-07-07 - CORRESP - Opus Genetics, Inc.
CORRESP
1
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Ocuphire Pharma, Inc.
37000 Grand River Avenue, Suite 120
Farmington Hills, MI 48335
July 7, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention: Tara Harkins and Kevin Kuhar
Re:
Ocuphire Pharma, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2022
Filed March 30, 2023
File No. 001-34079
Dear Ms. Harkins and Mr. Kuhar:
This letter responds to the comment letter (the “Comment Letter”) dated June 28, 2023 regarding the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to
the above-referenced Annual Report on Form 10-K for the fiscal year ended December 31, 2022 of Ocuphire Pharma, Inc. (the “Company”). For the convenience of the Staff, we reproduce in bold the text of each numbered paragraph in the Comment Letter and
follow with our own responses.
Form 10-K for the Fiscal Year Ended December 31, 2022
Results of Operations
Research and Development, page 111
1.
We note the discussion on page 109 that your Nyxol and APX3330 will have higher development costs due to later-stage clinical trials and that you expect research and development costs to
increase over the next several years. Please revise future filings to disclose the costs incurred during each period presented for each of your key research and development products/projects. If you do not track your research and development
costs by project, disclose that fact and explain why you do not maintain and evaluate research and development costs by project. Provide other quantitative or qualitative disclosure that provides more transparency as to the type of research
and development expenses incurred (i.e., by nature or type of expense) which should reconcile to total research and development expense on the Consolidated Statements of Operations.
Response:
The Company acknowledges the Staff’s comment. In its filings with the Commission, commencing with the Quarterly Report on Form 10-Q for the period ended June 30, 2023, the Company will disclose the costs incurred
during such period presented for each of our key research and development products/projects. Additionally, we will provide other quantitative or qualitative disclosure, as appropriate, that provides more transparency as to the type of research and
development expenses incurred which should reconcile to total research and development expense on the Consolidated Statements of Operations.
Please advise us if we can provide any further information or assistance on this matter. If the Staff should have any questions, or would like further information, concerning the response above, please do not hesitate
to contact Phillip D. Torrence at (269) 337-7702 or ptorrence@honigman.com. We thank you in advance for your attention to the above.
Sincerely,
/s/ Richard Rodgers
Richard Rodgers
Interim President and Chief Executive Officer
Ocuphire Pharma, Inc.
cc:
Phillip D. Torrence, Honigman LLP
Emily J. Johns, Honigman LLP
Amy Rabourn, Ocuphire Pharma, Inc.
2023-06-28 - UPLOAD - Opus Genetics, Inc.
United States securities and exchange commission logo
June 28, 2023
Richard Rodgers
Interim President and Chief Executive Officer
Ocuphire Pharma, Inc.
37000 Grand River Avenue, Suite 120
Farmington Hills, MI 48335
Re:Ocuphire Pharma, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2022
Filed March 30, 2023
File No. 001-34079
Dear Richard Rodgers:
We have reviewed your filings and have the following comment. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2022
Results of Operations
Research and Development, page 111
1.We note the discussion on page 109 that your Nyxol and APX3330 will have higher
development costs due to later-stage clinical trials and that you expect research and
development costs to increase over the next several years. Please revise future filings to
disclose the costs incurred during each period presented for each of your key research and
development products/projects. If you do not track your research and development costs
by project, disclose that fact and explain why you do not maintain and evaluate research
and development costs by project. Provide other quantitative or qualitative disclosure that
provides more transparency as to the type of research and development expenses incurred
(i.e., by nature or type of expense) which should reconcile to total research and
development expense on the Consolidated Statements of Operations.
FirstName LastNameRichard Rodgers
Comapany NameOcuphire Pharma, Inc.
June 28, 2023 Page 2
FirstName LastName
Richard Rodgers
Ocuphire Pharma, Inc.
June 28, 2023
Page 2
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
You may contact Tara Harkins at (202) 551-3639 or Kevin Kuhar, Accounting Branch
Chief, at (202) 551-3662 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-02-11 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
February 11, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, NE
Washington, D.C. 20549
Attention: Jason Drory
Re:
Ocuphire Pharma, Inc.
Registration Statement on Form S-3
File No. 333-252715
Acceleration Request
Requested Date:
February 12, 2021
Requested Time:
4:30 P.M. Eastern Time
Ladies and Gentlemen:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Ocuphire Pharma, Inc. (the “Company”) hereby respectfully requests that the
above-referenced Registration Statement on Form S-3 (File No. 333-252715) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon as
practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. The Company hereby authorizes each of
Phillip Torrence and Emily Johns of Honigman LLP, counsel to the Company, to make such request on its behalf.
Please confirm the effectiveness of the Registration Statement with Phillip Torrence of Honigman LLP by telephone at (269) 337-7702 or Emily Johns of Honigman LLP by telephone at (616) 649-1908.
[Signature page follows]
****
Sincerely,
Ocuphire Pharma, Inc.
/s/ Mina Sooch
Mina Sooch
Chief Executive Officer
cc:
Phillip Torrence, Honigman LLP
Emily Johns, Honigman LLP
2021-02-10 - UPLOAD - Opus Genetics, Inc.
United States securities and exchange commission logo
February 10, 2021
Mina Sooch
Chief Executive Officer
Ocuphire Pharma, Inc.
37000 Grand River Avenue, Suite 120
Farmington Hills, MI 48335
Re:Ocuphire Pharma, Inc.
Registration Statement on Form S-3
Filed February 4, 2021
File No. 333-252715
Dear Ms. Sooch:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jason L. Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Emily Johns, Esq.
2020-09-30 - CORRESP - Opus Genetics, Inc.
CORRESP
1
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Hogan Lovells US LLP
Harbor East
100 International Drive
Suite 2000
Baltimore, MD 21202
T +1 410 659 2700
F +1 410 659 2701
www.hoganlovells.com
September 30, 2020
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
Attention:
Abby Adams
Dorrie Yale
Re:
Rexahn Pharmaceuticals, Inc.
Amendment No. 2 to Registration Statement on Form S-4
Filed September 16, 2020
File No. 333-239702
Dear Ms. Adams and Ms. Yale:
On behalf of Rexahn Pharmaceuticals, Inc. (“Rexahn”), this letter is in response to your letter dated September 24, 2020 (the “Comment Letter”) to Douglas J. Swirsky, relating to Rexahn’s Registration
Statement on Form S-4 (File No. 333-239702), initially filed with the Securities and Exchange Commission (the “Commission”) on July 6, 2020 and amended by Amendment No. 1 filed on August 27, 2020 and Amendment No. 2 filed on September 16, 2020
(as amended, the “Registration Statement”). Rexahn is concurrently filing Amendment No. 3 to the Registration Statement (“Amendment No. 3”). For your convenience, we have included the text of the applicable comment from the Comment
Letter in bold immediately before our response. Except as otherwise noted below, all page references contained in our responses below are to the pages of Amendment No. 3.
Amendment No. 2 to Registration Statement on Form S-4
Exhibits
1.
In its consent filed as Exhibit 99.5, Oppenheimer & Co. Inc. disclaims that it comes within the category of persons whose consent is required under Section 7 of the Securities Act of 1933. Please obtain and
file a revised consent that does not include this disclaimer. Refer to Securities Act Section 7(a) and Securities Act Rules CDI 233.01.
In response to the Staff’s comment, Rexahn has filed a revised consent of Oppenheimer & Co. Inc. as Exhibit 99.5 to Amendment No. 3 that does not include the referenced disclaimer.
Securities and Exchange Commission
- 2 -
September 30, 2020
Rexahn respectfully requests the Staff’s assistance in completing the review of the Registration Statement as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your
review. If the Staff should have any questions, or would like further information, concerning any of the responses above, please do not hesitate to contact the undersigned at (410) 659-2778. We thank you in advance for your attention to the above.
Sincerely,
/s/ William I. Intner
William I. Intner
cc:
Douglas J. Swirsky, President and CEO, Rexahn Pharmaceuticals, Inc.
Mina Sooch, President and CEO, Ocuphire Pharma, Inc.
Asher M. Rubin, Hogan Lovells US LLP
Phillip D. Torrence, Honigman LLP
Jeffrey H. Kuras, Honigman LLP
Emily J. Johns, Honigman LLP
2020-09-30 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
Rexahn Pharmaceuticals, Inc.
15245 Shady Grove Road, Suite 455
Rockville, MD 20850
September 30, 2020
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F. Street, NE
Washington, D.C. 20549
Attention:
Abby Adams
Dorrie Yale
Re:
Rexahn Pharmaceuticals, Inc.
Registration Statement on Form S-4
File No. 333-239702
Acceleration Request
Requested Date:
October 2, 2020
Requested Time:
9:00 A.M. Eastern Time
Dear Ms. Adams and Ms. Yale:
Pursuant to Rule 461 under the Securities Act of 1933, as amended, Rexahn Pharmaceuticals, Inc. (the “Company”) hereby respectfully
requests that the above-referenced Registration Statement on Form S-4 (File No. 333-239702) (the “Registration Statement”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or
as soon as practicable thereafter, or at such later time as the Company or its counsel may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. The Company hereby authorizes
each of William Intner and Stephen Nicolai of Hogan Lovells US LLP, counsel to the Company, to make such request on its behalf.
Please confirm the effectiveness of the Registration Statement with William Intner of Hogan Lovells US LLP by telephone at (410) 659-2778 or, in his absence, Stephen Nicolai
of Hogan Lovells US LLP by telephone at (267) 675-4642.
Sincerely,
REXAHN PHARMACEUTICALS, INC.
/s/ Douglas J. Swirsky
Douglas J. Swirsky
President and Chief Executive Officer
cc: William Intner, Hogan Lovells US LLP
2020-09-24 - UPLOAD - Opus Genetics, Inc.
United States securities and exchange commission logo
September 24, 2020
Douglas Swirsky
President and Chief Executive Officer
Rexahn Pharmaceuticals, Inc.
15245 Shady Grove Road, Suite 455
Rockville, MD 20850
Re:Rexahn Pharmaceuticals, Inc.
Amendment No. 2 to Registration Statement on Form S-4
Filed September 16, 2020
File No. 333-239702
Dear Mr. Swirsky:
We have reviewed your amended registration statement and have the following
comment. Please respond to this letter by amending your registration statement and providing
the requested information. If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to our comment, we may have additional comments.
Amendment No. 2 to Registration Statement on Form S-4
Exhibits
1.In its consent filed as Exhibit 99.5, Oppenheimer & Co. Inc. disclaims that it comes within
the category of persons whose consent is required under Section 7 of the Securities Act of
1933. Please obtain and file a revised consent that does not include this disclaimer. Refer
to Securities Act Section 7(a) and Securities Act Rules CDI 233.01.
FirstName LastNameDouglas Swirsky
Comapany NameRexahn Pharmaceuticals, Inc.
September 24, 2020 Page 2
FirstName LastName
Douglas Swirsky
Rexahn Pharmaceuticals, Inc.
September 24, 2020
Page 2
You may contact Julie Sherman at (202) 551-3640 or Lynn Dicker at (202) 551-3616 if
you have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Dorrie Yale at (202) 551-8776 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: William I. Intner, Esq.
2020-09-15 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
Hogan Lovells US LLP
Harbor East
100 International Drive
Suite 2000
Baltimore, MD 21202
T +1 410 659 2700
F +1 410 659 2701
www.hoganlovells.com
September 15, 2020
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
Attention:
Abby Adams
Dorrie Yale
Re:
Rexahn Pharmaceuticals, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed August 27, 2020
File No. 333-239702
Dear Ms. Adams and Ms. Yale:
On behalf of Rexahn Pharmaceuticals, Inc. (“Rexahn”), this letter is in response to your letter dated September 10, 2020 (the “Comment Letter”) to Douglas J. Swirsky, relating to Rexahn’s Registration
Statement on Form S-4 (File No. 333-239702), initially filed with the Securities and Exchange Commission (the “Commission”) on July 6, 2020 and amended by Amendment No. 1 filed on August 27, 2020 (as amended, the “Registration Statement”).
Rexahn is concurrently filing Amendment No. 2 to the Registration Statement (“Amendment No. 2”). For your convenience, we have included the text of the applicable comment from the Comment Letter in bold immediately before our response. Except
as otherwise noted below, all page references contained in our responses below are to the pages of Amendment No. 2.
Amendment No. 1 to Form S-4 filed August 27, 2020
Cover Page
1.
We acknowledge your revised disclosures in response to prior comment 1 and that the Parent Cash Amount may vary significantly from the expected amount. Please further revise to prominently highlight that Rexahn
shareholders will not know at the time of the vote the percentage of shares they will hold in the combined company, that Rexahn may not be able to satisfy the requirement for a Parent Cash Amount of $0, and discuss the significance. Please
also limit your cover page disclosures to one page as required by Item 501(b) of Regulation S-K.
In response to the Staff’s comment, Rexahn has limited the disclosures on the cover page of Amendment No. 2 to one page and has revised the disclosures to emphasize that, at the time of the stockholder vote, Rexahn’s
stockholders will not know the percentage of shares they will hold in the combined company and that Rexahn may not be able to satisfy the requirement for a Parent Cash Amount of $0. Rexahn has also added similar language on pages 19, 20, 36, 152, 165
and 195 of Amendment No. 2.
Securities and Exchange Commission
- 2 -
September 15, 2020
Prospectus Summary
The Companies, page 12
2.
We note your response to prior comment 4 states that you have shortened the arrows for the last two rows of the pipeline table to the end of Phase 1, but the revised table still reflects arrows that are in the
midst of Phase 2. In addition, please ensure that dates in the "Anticipated Milestones" column and in the Business section correspond to your revised Summary narrative disclosures. Your disclosures also state that Ocuphire expects to launch a
Phase 2 trial for APX3330 in DR in the first quarter of 2021, and so please revise your table to illustrate that the Phase 2 trial is only with respect to DR and not DME or otherwise reconcile your disclosures.
In response to the Staff’s comment, Rexahn has replaced the pipeline tables on pages 13 and 228 of Amendment No. 2 and has revised the disclosure on pages 12 to 13, 227 to 228 and 260 of Amendment No. 2 to clarify that
Ocuphire expects to launch a Phase 2 trial for APX3330 in DR and DME in the first quarter of 2021.
Risk Factors
Risks Related to the Merger, page 35
3.
Please add a risk factor discussing to the extent true that the Oppenheimer opinion relied on financial projections that extended into 2040 and which made assumptions regarding FDA approval of Ocuphire's product
candidates but did not consider the possibility that such product candidates would not receive FDA approval. Please also highlight the different assumptions Oppenheimer used for its opinion, including that such assumptions did not account for
the effect of the post-closing dilutive issuances of Rexahn securities pursuant to the pre-merger financing.
In response to the Staff’s comment, Rexahn has added a new risk factor on page 45 of Amendment No. 2 disclosing that the Oppenheimer & Co. Inc. (“Oppenheimer”) opinion relied on Ocuphire Pharma, Inc.’s (“Ocuphire”)
financial projections that extended into 2040 (the “Ocuphire Projections”). The Ocuphire Projections included probability of success risk adjustments to account for the risk that a particular product candidate at a specific stage of development would
not continue to be developed and that a product candidate would not ultimately receive approval from the U.S. Food and Drug Administration (“FDA”). Oppenheimer considered the various risk-weighted probabilities of success attributed to each
individual product candidate assigned by Ocuphire management, which accounted for the possibility that product candidates may not receive FDA approval. Oppenheimer conducted a risk-adjusted analysis and therefore did not conduct any separate analyses
assuming the separate outcomes that Ocuphire’s product candidates either definitively do or do not receive FDA approval. Rexahn has also added a new risk factor on pages 45 and 46 highlighting the assumptions Oppenheimer used for its opinion,
including that such assumptions did not account for the effect of the post-closing dilutive issuances of Rexahn securities pursuant to the pre-merger financing.
Securities and Exchange Commission
- 3-
September 15, 2020
The Merger
Background of the Merger, page 111
4.
Refer to the last sentence of prior comment 15. You disclose the updated terms from Company A on February 19, 2020 on page 119, but Company's A's valuation of Rexahn had not changed since your board considered
Company A's proposal at its December 5, 2019 meeting, as you explain on 121. Revise to clarify what did change in the updated proposal.
In response to the Staff’s comment, Rexahn has revised the disclosure on page 120 of Amendment No. 2 to clarify the material changes between Company A’s proposal presented to Rexahn’s board of directors on December 5,
2019 and Company A’s updated indication of interest delivered on February 18, 2020.
Opinion of the Rexahn Financial Advisor, page 133
5.
We note your revised disclosures, including your discussion of the projections referenced by Oppenheimer. In the discussion regarding the discounted cash flow analysis, please revise to clearly explain that the
projected free cash flow used by Oppenheimer was based on various assumptions, including assumptions that FDA approval would be received for Nyxol in NVD, RM and presbyopia, and for APX3330 in DR, and assumed prices and market share for the
product candidates. In addition, to the extent true, please also revise to explain why Oppenheimer did not consider the separate possibility that the Ocuphire product candidates will not successfully complete clinical trials.
In response to the Staff’s comment, Rexahn has revised the disclosure on pages 139 to 140 of Amendment No. 2 to explain that the projected free cash flow used by Oppenheimer was based on various assumptions, including
assumptions that FDA approval would be received for Nyxol in NVD, RM and presbyopia, and for APX3330 in DR and DME, and assumed prices and market share for the product candidates. Rexahn also revised the disclosure on pages 139 to 140 of Amendment
No. 2 to explain that the probability of success risk adjustments applied a probability of achieving a favorable outcome at each of several key steps in the drug development process for each indication, including meeting clinical study endpoints and
FDA approval of NDAs, which then resulted in a cumulative probability of success for each program. Oppenheimer considered the various risk-weighted probabilities of success attributed to each individual product candidate assigned by Ocuphire
management, which accounted for the possibility that product candidates may not successfully complete clinical trials. Oppenheimer conducted a risk-adjusted analysis and therefore did not conduct any separate analyses assuming the separate outcomes
that Ocuphire’s product candidates either definitively do or do not receive FDA approval and/or successfully complete clinical trials.
6.
You refer to probability of success risk adjustments on page 139, and further state on page 143 that Ocuphire used a probability of success methodology and that Oppenheimer made some adjustments to these
probabilities. Please explain how these probabilities and further adjustments affected the cash flows for the indicated years.
In response to the Staff’s comment, Rexahn has revised the disclosure on page 144 of Amendment No. 2 to explain how the probability of success risk adjustments and Oppenheimer’s adjustments to Ocuphire’s projections
affected the cash flows for the indicated years.
Securities and Exchange Commission
- 4 -
September 15, 2020
Rexahn respectfully requests the Staff’s assistance in completing the review of the Registration Statement as soon as possible. Please advise us if we can provide any further information or assistance to facilitate your
review. If the Staff should have any questions, or would like further information, concerning any of the responses above, please do not hesitate to contact the undersigned at (410) 659-2778. We thank you in advance for your attention to the above.
Sincerely,
/s/ William I. Intner
William I. Intner
cc:
Douglas J. Swirsky, President and CEO, Rexahn Pharmaceuticals, Inc.
Mina Sooch, President and CEO, Ocuphire Pharma, Inc.
Asher M. Rubin, Hogan Lovells US LLP
Phillip D. Torrence, Honigman LLP
Jeffrey H. Kuras, Honigman LLP
Emily J. Johns, Honigman LLP
2020-09-10 - UPLOAD - Opus Genetics, Inc.
United States securities and exchange commission logo
September 10, 2020
Douglas Swirsky
President and Chief Executive Officer
Rexahn Pharmaceuticals, Inc.
15245 Shady Grove Road, Suite 455
Rockville, MD 20850
Re:Rexahn Pharmaceuticals, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed August 27, 2020
File No. 333-239702
Dear Mr. Swirsky:
We have reviewed your amended 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 amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Amendment No. 1 to Form S-4 filed August 27, 2020
Cover Page
1.We acknowledge your revised disclosures in response to prior comment 1 and that the
Parent Cash Amount may vary significantly from the expected amount. Please further
revise to prominently highlight that Rexahn shareholders will not know at the time of the
vote the percentage of shares they will hold in the combined company, that Rexahn may
not be able to satisfy the requirement for a Parent Cash Amount of $0, and discuss the
significance. Please also limit your cover page disclosures to one page as required by
Item 501(b) of Regulation S-K.
FirstName LastNameDouglas Swirsky
Comapany NameRexahn Pharmaceuticals, Inc.
September 10, 2020 Page 2
FirstName LastName
Douglas Swirsky
Rexahn Pharmaceuticals, Inc.
September 10, 2020
Page 2
Prospectus Summary
The Companies, page 12
2.We note your response to prior comment 4 states that you have shortened the arrows for
the last two rows of the pipeline table to the end of Phase 1, but the revised table still
reflects arrows that are in the midst of Phase 2. In addition, please ensure that dates in the
"Anticipated Milestones" column and in the Business section correspond to your revised
Summary narrative disclosures. Your disclosures also state that Ocuphire expects to
launch a Phase 2 trial for APX3330 in DR in the first quarter of 2021, and so please revise
your table to illustrate that the Phase 2 trial is only with respect to DR and not DME or
otherwise reconcile your disclosures.
Risk Factors
Risks Related to the Merger, page 35
3.Please add a risk factor discussing to the extent true that the Oppenheimer opinion relied
on financial projections that extended into 2040 and which made assumptions regarding
FDA approval of Ocuphire's product candidates but did not consider the possibility that
such product candidates would not receive FDA approval. Please also highlight the
different assumptions Oppenheimer used for its opinion, including that such assumptions
did not account for the effect of the post-closing dilutive issuances of Rexahn securities
pursuant to the pre-merger financing.
The Merger
Background of the Merger, page 111
4.Refer to the last sentence of prior comment 15. You disclose the updated terms from
Company A on February 19, 2020 on page 119, but Company's A's valuation of Rexahn
had not changed since your board considered Company A's proposal at its December 5,
2019 meeting, as you explain on 121. Revise to clarify what did change in the updated
proposal.
Opinion of the Rexahn Financial Advisor, page 133
5.We note your revised disclosures, including your discussion of the projections referenced
by Oppenheimer. In the discussion regarding the discounted cash flow analysis, please
revise to clearly explain that the projected free cash flow used by Oppenheimer was based
on various assumptions, including assumptions that FDA approval would be received for
Nyxol in NVD, RM and presbyopia, and for APX3330 in DR, and assumed prices and
market share for the product candidates. In addition, to the extent true, please also revise
to explain why Oppenheimer did not consider the separate possibility that the Ocuphire
product candidates will not successfully complete clinical trials.
6.You refer to probability of success risk adjustments on page 139, and further state on page
143 that Ocuphire used a probability of success methodology and that Oppenheimer made
FirstName LastNameDouglas Swirsky
Comapany NameRexahn Pharmaceuticals, Inc.
September 10, 2020 Page 3
FirstName LastName
Douglas Swirsky
Rexahn Pharmaceuticals, Inc.
September 10, 2020
Page 3
some adjustments to these probabilities. Please explain how these probabilities and further
adjustments affected the cash flows for the indicated years.
You may contact Julie Sherman at (202) 551-3640 or Lynn Dicker at (202) 551-3616 if
you have questions regarding the financial statements and related matters. Please contact Abby
Adams at (202) 551-6902 or Dorrie Yale at (202) 551-8776 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: William I. Intner, Esq.
2020-08-27 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
Hogan Lovells US LLP
Harbor East
100 International Drive
Suite 2000
Baltimore, MD 21202
T +1 410 659 2700
F +1 410 659 2701
www.hoganlovells.com
August 27, 2020
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
Attention:
Abby Adams
Dorrie Yale
Re:
Rexahn Pharmaceuticals, Inc.
Registration Statement on Form S-4
Filed July 6, 2020
File No. 333-239702
Dear Ms. Adams and Ms. Yale:
On behalf of Rexahn Pharmaceuticals, Inc. (“Rexahn”), this letter is in response to your letter dated August 2, 2020 (the “Comment Letter”) to Douglas J. Swirsky, relating to Rexahn’s Registration Statement
on Form S-4 (File No. 333-239702) (the “Registration Statement”) filed with the Securities and Exchange Commission (the “Commission”) on July 6, 2020. Rexahn is concurrently filing Amendment No. 1 to the Registration Statement (“Amendment
No. 1”). For your convenience, we have included the text of the applicable comment from the Comment Letter in bold immediately before our response. Except as otherwise noted below, all page references contained in our responses below are to the
pages of Amendment No. 1.
Registration Statement on Form S-4
Cover Page
1.
Revise your disclosure regarding the exchange ratio to more clearly explain that the percentage ownership in the combined company by Rexahn stockholders will be further decreased due to the issuances of
securities as part of the financing, and provide a sense of the significance of the further dilution.
In response to the Staff’s comment, Rexahn has revised the disclosure on the cover page of Amendment No. 1 to provide additional information regarding the potential that the percentage ownership in the combined company
by Rexahn stockholders will be further decreased due to the issuances of securities as part of the financing. Rexahn has also added similar language on pages 19, 36, 151, 164, and 195 of Amendment No. 1.
Securities and Exchange Commission
- 2 -
August 27, 2020
Questions and Answers About the Merger, page 1
2.
We note the scenarios provided on pages 2-3 and elsewhere in the registration statement. As there is a significant difference in effect on Rexahn shareholders based on the difference between trading prices at
$3.00 per share and $0.2861 per share addressed in Scenarios 2 and 3, tell us what consideration you have given to an additional scenario between those two amounts, or explain why you do not believe that information would materially add to
your disclosure.
In response to the Staff’s comment, Rexahn has revised the disclosure on pages 3, 37 to 38, and 192 of Amendment No. 1 to include an additional scenario based on a trading price at $1.50 per share.
Prospectus Summary
The Companies, page 12
3. Revise to explain the following terms at first use:
• pharmacologically-induced mydriasis;
• presbyopia;
• choroidal vascular disease;
• diabetic retinopathy;
• diabetic macular edema;
• vascular endothelial growth factors; and
• wet age-related macular degeneration.
In response to the Staff’s comment, Rexahn has revised the disclosure on pages 12 to 14 and 227 of Amendment No. 1 to explain the above-referenced terms at first use. Please note the diabetic retinopathy and diabetic
macular edema are each examples of retinal and choroidal vascular disease.
4.
Please revise the Ocuphire pipeline table here and in the Business section to shorten the arrows to the end of Phase 1 for the Nyxol trial for presbyopia and the APX 3330 trial for DR and DME as you state on
pages 12-13 that Ocuphire expects to initiate Phase 2 trials for these products in the second half of 2020. In addition, for the Nyxol trials, you state that the “Anticipated Milestone” is to initiate Phase 3 in the second half of 2020, but
we also note the statement on page 212 that Ocuphire plans to initiate a 6-month rabbit toxicology study in the second half of 2020 “[i]n preparation for at least one of the two Phase 3 registration trials,” and on page 70 that it plans to
complete a rabbit toxicology study over the next 12 to 18 months and that FDA regulations restrict Ocuphire from conducting trials of six months or more until it has completed a six-month toxicology. Revise to reconcile your disclosures, and
if the rabbit toxicology study is to precede either of the two Phase 3 trials, shorten the applicable arrow and update the “Anticipated Milestone.”
Securities and Exchange Commission
- 3 -
August 27, 2020
In response to the Staff’s comment, Rexahn has revised the disclosure on pages 13 and 228 of Amendment No. 1 to shorten the arrows to the end of Phase 1 for the Nyxol trial for presbyopia and the APX 3330 trial for DR
and DME. In addition, Rexahn has reconciled its disclosures on page 75 of Amendment No. 1 to clarify that Ocuphire Pharma, Inc. (“Ocuphire”) may conduct Phase 3 registration efficacy trials for Nyxol up to 28 days in duration for any acute
indication (MIRA-2) or chronic indications such as NVD (LYNX-1) based on its completed 28-day rabbit toxicology study. The 6-month rabbit toxicology study is only required to be completed prior to the conduct of any clinical trials of six months or
more. Therefore, the 6-month rabbit toxicology study must be completed prior to the planned 1 year Phase 3 safety exposure trial for chronic indications prior to filing its respective new drug application (“NDA”). Accordingly, Ocuphire did not
shorten any arrows for the MIRA-2 or LYNX-1 Phase 3 trials in the “Ocuphire Pipeline Indications” tables on pages 13 and 228, as these trials are not dependent on, and may begin prior to, the referenced rabbit toxicology studies. By way of
clarification, only the four planned Ocuphire-focused development trials are depicted in the “Ocuphire Pipeline Indications” tables on pages 13 and 228, while the additional studies and trials anticipated for NDA filing in one or more indications are
described in the section entitled “Ocuphire Business-Future Clinical Plans for Nyxol and APX3330” on page 261 of Amendment No. 1.
5.
We note the reference to APX2009 in Ocuphire’s pipeline table, as well as the last row of the table, which appears in gray. Given the early-stage development of APX2009, as well as the limited disclosures
regarding this candidate and using Nyxol for glaucoma, please explain why these programs are sufficiently material to the Ocuphire business to warrant inclusion in the pipeline table.
In response to the Staff’s comment, Rexahn has revised the pipeline table on pages 13 and 228 of Amendment No. 1 to include only the four planned Ocuphire-focused development trials. Rexahn has also revised the
disclosures on pages 235 and 251 of Amendment No. 1 to provide additional information regarding APX2009. In addition, Rexahn has revised the disclosures on page 81 of Amendment No. 1 to provide additional information regarding Ocuphire’s candidates
for potential glaucoma indications and to expand the disclosures regarding the planned inclusion of partner funding for this additional indication for Nyxol.
Opinion of the Rexahn Financial Advisor, page 16
6.
Revise the disclosure here and elsewhere where the Oppenheimer opinion is discussed to disclose that the Oppenheimer opinion was based on an presumed 4.3820 exchange ratio, $720,000 Parent Cash amount, and Rexahn
shareholders owning approximate 11.9% of the combined company on a fully diluted basis, as disclosed on page 130. In doing so, highlight that Oppenheimer did not take into consideration the potential dilution from the pre-merger financing.
Securities and Exchange Commission
- 4 -
August 27, 2020
In response to the Staff’s comment, Rexahn has revised the disclosure on pages 15, 17, and 129 to 130, of Amendment No. 1 to disclose that the Oppenheimer & Co. Inc. (“Oppenheimer”) opinion was based on a
presumed 4.3820 exchange ratio, $720,000 Parent Cash Amount (as defined in Amendment No. 1), and Rexahn shareholders owning approximately 11.9% of the combined company on a fully diluted basis. Rexahn has also highlighted on page 17 of Amendment No.
1 that Oppenheimer did not take into consideration any additional post-closing dilutive issuances of Rexahn securities pursuant to the pre-merger financing.
Risk Factors
Risks Related to the Merger, page 33
7.
In the first risk factor, you state that “it is reasonably likely” Rexahn will deliver significantly less than $3.2 million on the Anticipated Closing Date.” We also note certain of your disclosures based on an
assumption that the Parent Cash Amount is $0. To the extent Rexahn currently expects that the Parent Cash Amount will be approximately, or less than, $0, revise your disclosures to clarify any such expectation.
In response to the Staff’s comment, Rexahn has revised the disclosure on the cover page and pages 19, 32, 35, 150 to 151, 164, 195, and 331 of Amendment No. 1 to clarify Rexahn’s current expectations regarding the Parent
Cash Amount to be delivered on the anticipated closing date, assuming that the transaction closes before November 14, 2020, which is the outside date set forth in the Agreement and Plan of Merger and Reorganization, dated June 17, 2019, among Rexahn,
Razor Merger Sub, Inc. and Ocuphire, as amended by that certain First Amendment, dated June 29, 2020 (as amended, the “Merger Agreement”).
8.
Revise the assumptions on page 34 and elsewhere to explain the basis of the sample exchange ratio you used, including the Parent Cash Amount and explain the significance of the 85% calculation. Revise to
highlight material differences from the assumptions reflected in the fairness opinion.
In response to the Staff’s comment, Rexahn has revised the disclosure on pages 2, 36 to 37 and 191 of Amendment No. 1 to provide additional information regarding the assumptions underlying the sample exchange ratios and
the significance of the 85% calculation. Rexahn has also revised the disclosure on pages 2, 36 to 37 and 191 of Amendment No. 1 to highlight the material differences between the assumptions used in each of the scenarios on such pages and the
assumptions reflected in the fairness opinion.
Securities and Exchange Commission
- 5 -
August 27, 2020
9.
Expand the first risk factor on page 38 to discuss any covenants that would be applicable as a result of the Pre-Merger Financing and material to the combined company.
In response to the Staff’s comment, Rexahn has revised the disclosure on pages 41 to 42 of Amendment No. 1 to describe covenants that would be applicable as a result of the Pre-Merger Financing and material to the
combined company.
Risks Related to Rexahn, page 41
10.
We note on page 170 that, in the opinion of Hogan Lovells, the tax consequences of the issuance of the CVRs is uncertain. Expand on the risk factor relating to CVRs on page 42, including in the risk factor title,
to discuss the risks of uncertain tax treatment of the CVRs to shareholders and the possible outcomes, including that the reverse tax split and issuance of CVRs could be deemed a recapitalization.
In response to the Staff’s comment, Rexahn has added a new risk factor on pages 47 to 48 of Amendment No. 1 discussing the risks of uncertain tax treatment of the contingent value rights (“CVRs”) to shareholders
and the possible outcomes, including that the reverse stock split and issuance of CVRs could be deemed a recapitalization.
Risks Related to Ocuphire, page 62
11.
On pages 84 and 245 you disclose that Ocuphire has one overseas supplier for the drug used in Nyxol and one for APX3330, Ocuphire’s two main product candidates. You disclose on page 96 that COVID-19 pandemic
interruptions include the acceleration of a shipment of active pharmaceutical ingredient supply from overseas. Disclose the location of these overseas manufacturers or explain why that information is not material.
In response to the Staff’s comment, Rexahn has revised the disclosure on pages 89, 101 and 262 of Amendment No. 1 to include the locations of Ocuphire’s overseas suppliers.
12.
On pages 88 and 246 you disclose that five of Ocuphire’s patents related to Nyxol expire in 2020. To the extent the loss of these patents will have a material negative impact on the conduct of Ocuphire’s
business, revise to explain the impact. In addition, if true, revise to clarify that the patents for APX3330 do not include any covering composition of matter.
Because the expiring patents claim certain methods of use relating to Nyxol (but, for clarity, not the current Nyxol formulation) and do not cover the Nyxol composition of matter, Ocuphire believes the expiration of
these patents will not be material as Ocuphire has patent protection for Nyxol provided by U.S. Patents 9,795,560 and 10,278,918, expiring in year 2034, with composition of matter coverage for Ocuphire’s Nyxol Eye Drops. In response to the Staff’s
comment, Rexahn has revised the disclosure on pages 92 to 93 and 263 to 264 of Amendment No. 1 to clarify that such expiring patents do not cover the current clinical formulation for the Nyxol product. In response to the Staff’s comment, Rexahn has
also revised the disclosure on pages 93 and 263 to 264 of Amendment No. 1 to clarify that certain pending patent applications cover a combination therapy composition comprising an APE1/REF-1 inhibitor, such as APX3330, and a second therapeutic agent,
and methods of using such combination therapies.
Securities and Exchange Commission
- 6 -
August 27, 2020
13.
Expand your risk factor on page 93 regarding your dependence on the Apexian sublicense agreement to also cover the underlying license agreement with Eisai, and any material obligations under both license
agreements for which Ocuphire is responsible as a sublicensee and for which the breach thereof would have a material adverse impact on Ocuphire.
In response to the Staff’s comment, Rexahn has revised the disclosure on pages 98 to 99 of Amendment No. 1 to expand on Ocuphire’s dependence on the Apexian sublicense agreement and to address the material obligations
under each license agreement, if any, including as to whether a breach of such obligations by Ocuphire or Apexian could have a material adverse impact on Ocuphire.
The Merger
Background of the Merger, page 105
14.
Please substantially revise your disclosures in this section to provide additional information with respect to specific issues discussed during the negotiations between Rexahn and various parties, or considered
by the board, regarding the transaction, the merger agreement and related agreements, and the financing. As examples only, please expand upon your di
2020-08-03 - UPLOAD - Opus Genetics, Inc.
United States securities and exchange commission logo
August 2, 2020
Douglas Swirsky
President and Chief Executive Officer
Rexahn Pharmaceuticals, Inc.
15245 Shady Grove Road, Suite 455
Rockville, MD 20850
Re:Rexahn Pharmaceuticals, Inc.
Registration Statement on Form S-4
Filed July 6, 2020
File No. 333-239702
Dear Mr. Swirsky:
We have reviewed your 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 amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-4
Cover Page
1.Revise your disclosure regarding the exchange ratio to more clearly explain that the
percentage ownership in the combined company by Rexahn stockholders will be further
decreased due to the issuances of securities as part of the financing, and provide a sense of
the significance of the further dilution.
Questions and Answers About the Merger, page 1
2.We note the scenarios provided on pages 2-3 and elsewhere in the registration statement.
As there is a significant difference in effect on Rexahn shareholders based on the
difference between trading prices at $3.00 per share and $0.2861 per share addressed in
Scenarios 2 and 3, tell us what consideration you have given to an additional scenario
FirstName LastNameDouglas Swirsky
Comapany NameRexahn Pharmaceuticals, Inc.
August 2, 2020 Page 2
FirstName LastNameDouglas Swirsky
Rexahn Pharmaceuticals, Inc.
August 2, 2020
Page 2
between those two amounts, or explain why you do not believe that information would
materially add to your disclosure.
Prospectus Summary
The Companies, page 12
3.Revise to explain the following terms at first use:
•pharmacologically-induced mydriasis;
•presbyopia;
•choroidal vascular disease;
•diabetic retinopathy;
•diabetic macular edema;
•vascular endothelial growth factors; and
•wet age-related macular degeneration.
4.Please revise the Ocuphire pipeline table here and in the Business section to shorten the
arrows to the end of Phase 1 for the Nyxol trial for presbyopia and the APX 3330 trial for
DR and DME as you state on pages 12-13 that Ocuphire expects to initiate Phase 2 trials
for these products in the second half of 2020. In addition, for the Nyxol trials, you state
that the "Anticipated Milestone" is to initiate Phase 3 in the second half of 2020, but we
also note the statement on page 212 that Ocuphire plans to initiate a 6-month rabbit
toxicology study in the second half of 2020 "[i]n preparation for at least one of the two
Phase 3 registration trials," and on page 70 that it plans to complete a rabbit toxicology
study over the next 12 to 18 months and that FDA regulations restrict Ocuphire from
conducting trials of six months or more until it has completed a six-month toxicology.
Revise to reconcile your disclosures, and if the rabbit toxicology study is to precede either
of the two Phase 3 trials, shorten the applicable arrow and update the "Anticipated
Milestone."
5.We note the reference to APX2009 in Ocuphire's pipeline table, as well as the last row of
the table, which appears in gray. Given the early-stage development of APX2009, as well
as the limited disclosures regarding this candidate and using Nyxol for glaucoma, please
explain why these programs are sufficiently material to the Ocuphire business to warrant
inclusion in the pipeline table.
Opinion of the Rexahn Financial Advisor, page 16
6.Revise the disclosure here and elsewhere where the Oppenheimer opinion is discussed to
disclose that the Oppenheimer opinion was based on an presumed 4.3820 exchange
ratio, $720,000 Parent Cash amount, and Rexahn shareholders owning approximate 11.9%
of the combined company on a fully diluted basis, as disclosed on page 130. In doing so,
highlight that Oppenheimer did not take into consideration the potential dilution from the
pre-merger financing.
FirstName LastNameDouglas Swirsky
Comapany NameRexahn Pharmaceuticals, Inc.
August 2, 2020 Page 3
FirstName LastNameDouglas Swirsky
Rexahn Pharmaceuticals, Inc.
August 2, 2020
Page 3
Risk Factors
Risks Related to the Merger, page 33
7.In the first risk factor, you state that "it is reasonably likely" Rexahn will deliver
significantly less than $3.2 million on the Anticipated Closing Date." We also note certain
of your disclosures based on an assumption that the Parent Cash Amount is $0. To the
extent Rexahn currently expects that the Parent Cash Amount will be approximately, or
less than, $0, revise your disclosures to clarify any such expectation.
8.Revise the assumptions on page 34 and elsewhere to explain the basis of the sample
exchange ratio you used, including the Parent Cash Amount and explain the significance
of the 85% calculation. Revise to highlight material differences from the assumptions
reflected in the fairness opinion.
9.Expand the first risk factor on page 38 to discuss any covenants that would be applicable
as a result of the Pre-Merger Financing and material to the combined company.
Risks Related to Rexahn, page 41
10.We note on page 170 that, in the opinion of Hogan Lovells, the tax consequences of the
issuance of the CVRs is uncertain. Expand on the risk factor relating to CVRs on page 42,
including in the risk factor title, to discuss the risks of uncertain tax treatment of the CVRs
to shareholders and the possible outcomes, including that the reverse tax split and issuance
of CVRs could be deemed a recapitalization.
Risks Related to Ocuphire, page 62
11.On pages 84 and 245 you disclose that Ocuphire has one overseas supplier for the drug
used in Nyxol and one for APX3330, Ocuphire's two main product candidates. You
disclose on page 96 that COVID-19 pandemic interruptions include the acceleration of a
shipment of active pharmaceutical ingredient supply from overseas. Disclose the location
of these overseas manufacturers or explain why that information is not material.
12.On pages 88 and 246 you disclose that five of Ocuphire's patents related to Nyxol expire
in 2020. To the extent the loss of these patents will have a material negative impact on the
conduct of Ocuphire's business, revise to explain the impact. In addition, if true, revise to
clarify that the patents for APX3330 do not include any covering composition of matter.
13.Expand your risk factor on page 93 regarding your dependence on the Apexian sublicense
agreement to also cover the underlying license agreement with Eisai, and any material
obligations under both license agreements for which Ocuphire is responsible as a
sublicensee and for which the breach thereof would have a material adverse impact on
Ocuphire.
FirstName LastNameDouglas Swirsky
Comapany NameRexahn Pharmaceuticals, Inc.
August 2, 2020 Page 4
FirstName LastNameDouglas Swirsky
Rexahn Pharmaceuticals, Inc.
August 2, 2020
Page 4
The Merger
Background of the Merger, page 105
14.Please substantially revise your disclosures in this section to provide additional
information with respect to specific issues discussed during the negotiations between
Rexahn and various parties, or considered by the board, regarding the transaction, the
merger agreement and related agreements, and the financing. As examples only, please
expand upon your disclosure regarding the discussions between Rexahn and Ocuphire on
December 12, 2019, December 16, 2019, January 7, 2020, and February 14, 2020, as well
as the discussion regarding the pricing reset provisions and their impact on post-closing
allocation percentages between Mr. Swirsky and Ms. Sooch on February 27, 2020.
15.With respect to the initial indications of interest from Company A, Company B, and
Company C referenced on pages 106-107, please revise to disclose the assumed valuations
for each of Rexahn and the other company, and to provide the specific percentage
ownership split proposed by each company for the combined entity. Please also give
additional details regarding the changes proposed by Company A in its updated indication
of interest delivered on February 18, 2020.
16.You state on page 108 that the Strategic Alternative Committee concluded that Ocuphire,
Company A and Company B should proceed to the next stage of the review process
because they presented more "meaningful opportunities" for Rexahn stockholders than
other bidders. Please revise to provide additional information regarding the selection
criteria considered by the board.
17.You state that the issuance of CVRs was discussed with Ocuphire on December 10, 2019.
Revise to explain whether this was the first discussion regarding the issuance of CVRs,
and whether Rexahn had discussed the use of CVRs with any of the other parties
participating in the process at the time.
18.You state in "Rexahn Reasons for the Merger" on page 120 that the Rexahn board
considered the limited amount of cash expected to be left for distribution to Rexahn
stockholders in a potential dissolution and liquidation of Rexahn, and the risks, costs, and
timing of such a process. Please revise your Background section to include a discussion of
the board's consideration of these issues. You also disclose the board considered the
limited value given by the marketplace to Rexahn's product portfolio. Revise your
disclosure in the last paragraph on page 105 to explain the basis for this conclusion.
Opinion of the Rexahn Financial Advisor, page 124
19.We note your statement in the first bullet on page 125 that Oppenheimer reviewed certain
projected financial information. Please revise to disclose such projections and discuss all
material assumptions used to develop the projections, including, to the extent applicable,
details relating to the "probability of success risk adjustments" referenced on page 128,
such as which project candidates obtain FDA approval, when they receive FDA approval,
FirstName LastNameDouglas Swirsky
Comapany NameRexahn Pharmaceuticals, Inc.
August 2, 2020 Page 5
FirstName LastNameDouglas Swirsky
Rexahn Pharmaceuticals, Inc.
August 2, 2020
Page 5
when these products become commercially available, the assumed market for each such
product candidate, and any assumptions about competition. Additionally, discuss the
possible impact if the assumptions are incorrect.
20.With respect to the Selected Companies Analysis, you state that Oppenheimer selected the
companies "that it deemed relevant based on their business profiles and and financial
metrics." Please expand the disclosure to discuss how Oppenheimer used these measures
to select the companies.
21.Please revise the disclosure relating to the Selected Companies Analysis on page 127 to
clarify how Oppenheimer adjusted the implied median total enterprise value. Similarly
revise the disclosure relating to the Selected Transactions Analysis.
Interests of Rexahn Directors and Executive Officers in the Merger
Golden Parachute Compensation, page 134
22.We note that you have not included a separate advisory vote of shareholders regarding the
Regulation S-K Item 402(t) disclosure. Please advise why you have not done so, or revise
to include a resolution for such an advisory vote.
Agreements Related to the Merger
Material U.S. Federal Income Tax Consequences of the Receipt of CVRs, page 169
23.Shareholders are entitled to rely on the tax opinion. Delete the disclaimers here and in the
"Material U.S. Federal Income Tax Consequences of the Merger" section that the
discussions are "for information purposes only and [are] not tax advice." Please also
revise to remove language in these sections stating that "generally" certain tax
consequences will apply. See Staff Legal Bulletin No. 19.
Agreements Related to the Merger
Pre-Merger Financing, page 173
24.As the fairness opinion was based in part on Oppenheimer's consideration of the original
Securities Purchase Agreement, revise this section to describe the material differences
in terms of the Initial Securities Purchase Agreement and the Securities Purchase
Agreement.
Rexahn's Business
Collaboration and License Arrangements, page 209
25.You state that the royalty and release agreement with Next BT was amended to reinstate
the exclusive license to RX-0201 in Asia. Revise to clarify whether the reinstatement
terminated the potential royalty payments, which you state were put in place in exchange
for Next BT terminating its rights to RX-0201. Additionally, please file theh HaiChang
Agreement as an exhibit, or alternatively, explain why it is not required to be filed. Refer
to Item 21(a) of Form S-4 and Item 601(b)(10) of Regulation S-K.
FirstName LastNameDouglas Swirsky
Comapany NameRexahn Pharmaceuticals, Inc.
August 2, 2020 Page 6
FirstName LastNameDouglas Swirsky
Rexahn Pharmaceuticals, Inc.
August 2, 2020
Page 6
Ocuphire Business, page 212
26.We note the statements on page 213 and elsewhere that Ocuphire intends to pursue a
section 505(b)(2) regulatory pathway for Nyxol, and your reference that the active
pharmaceutical ingredient in Nyxol is in two FDA-approved drugs. Please clarify if
Ocuphire intends to rely on studies and results relating to both of those drugs, and disclose
whether there has been discussions with the FDA relating to the intended reliance for this
pathway.
27.Please revise your narrative disclosure of prior Nyxol trials to specify the specific primary
and secondary endpoints for the trial, and whether they were met. Additionally, clarify
when the presented measurements reflect non-statistically significant results, and explain
how statistical significance is relevant to the FDA's evidentiary standards for drug
approval. Please also explain the purpose of the referenced post-hoc analyses (e.g.,
Ocuphire is able to rely on such analyses for its NDA, or such analyses is used to
formulate future trials).
Unaudited Pro Forma Condensed Combined Financial Information
Note 2. Estimated Purchase Price, page 312
28.We note your disclosure that contingent consideration with respect to the CVRs has not
been recorded in the unaudited pro forma condensed combined financial statements since
the CVRs do not meet the requirements for derivative liability recognition. Rather, any
payments made pursuant to the CVR Agreement will be recognized to expense as IPR&D
only when the contingencies are resolved and any resultant consideration is paid or
becomes payable. Please further explain your accounting for the CVRs, including how
you determined that they do not qualify for derivative liability recognition and the
accounting guidance upon which you based your accounting.
Note 3. Pro Forma Adjustments, page 313
29.Reference is made to Note I where we see you have concluded that the Pre-Merger
Financing has been classified as equity for purposes of the pro formas but indicate that
may change. Please expand your discussion to specifically indicate why the accounting
may change and what, if any, impact there may be on the pro formas.
30.Reference is made to the pro forma adjustments to common stock. We see that you
accumulate several pro forma merger adjustments to equity and show the cumulative
amount of the adjustments in the pro forma balance sheet. So that we, and investors, may
better understand your accounting and the impact of each adjustment, please provide the
amount of each adjustment separately either on the pro forma balance sheet or as part of
your footnote disclosure in Note 3.
Principal Stockholders of the Combined Company, page 330
31.Please revise your disclosure to identify the natural persons who have voting and
FirstName LastNameDouglas Swirsky
Comapany NameRexahn Pharmaceuticals, Inc.
Aug
2019-10-07 - UPLOAD - Opus Genetics, Inc.
October 7, 2019
Douglas J. Swirsky
President, Chief Executive Officer and Director
REXAHN PHARMACEUTICALS, INC.
15245 Shady Grove Rd
Suite 455
Rockville, Maryland 20850
Re:REXAHN PHARMACEUTICALS, INC.
Form 10-K for Fiscal Year Ended December 31, 2018
Filed March 7, 2019
File No. 001-34079
Dear Mr. Swirsky:
We have completed our review of your filings. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-07-26 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
Hogan Lovells US LLP
Harbor East
100 International Drive
Suite 2000
Baltimore, MD 21202
T +1 410 659 2700
F +1 410 659 2701
www.hoganlovells.com
July 26, 2019
BY EDGAR
Andi Carpenter and Sharon Blume
Office of Healthcare and Insurance
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
Rexahn Pharmaceuticals, Inc.
Form 10-K for Fiscal Year Ended December 31, 2018
Filed March 7, 2019
Form 10-Q for Quarterly Period Ended March 31, 2019
Filed May 10, 2019
File No. 001-34079
Dear Ms. Carpenter and Ms. Blume:
On behalf of Rexahn Pharmaceuticals, Inc. (the “Company”), this letter is in response to your letter dated July 12, 2019 (the “Comment Letter”) to Mr. Douglas J. Swirsky, President, Chief Executive
Officer and Director of the Company, relating to the Company’s Annual Report on Form 10-K for the fiscal year December 31, 2018 and the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019. For ease of reference, each
of the Staff’s comments is set forth in italic type immediately before the corresponding response submitted on behalf of the Company, and the numbering below corresponds to the numbering in the Comment Letter.
Item 1 Description of Business
Our Pipeline Product Candidates, page 4
1.
We note your disclosures on pages 4-7 stating that your product candidates, including RX-3117, RX-5902, and RX-0201, "appeared to be safe." Further, we note your disclosure that RX-3117 "appeared to be
safe... with preliminary signs of efficacy." Safety and efficacy determinations are solely within the authority of the FDA. Please remove statements or inferences that your product candidates are or appeared to be safe and effective. You
may provide the objective results of the clinical trials with the stated endpoints and indicate whether the candidate was well tolerated.
Hogan Lovells US LLP is a limited liability partnership registered in the District of Columbia. “Hogan Lovells” is an international legal practice that includes Hogan Lovells US LLP and Hogan Lovells International LLP,
with offices in: Alicante Amsterdam Baltimore Beijing Birmingham Boston Brussels Colorado Springs Denver Dubai Dusseldorf Frankfurt Hamburg Hanoi Ho Chi Minh City Hong Kong Houston Johannesburg London Los Angeles Luxembourg
Madrid Mexico City Miami Milan Minneapolis Monterrey Moscow Munich New York Northern Virginia Paris Perth Philadelphia Rome San Francisco São Paulo Shanghai Silicon Valley Singapore Sydney Tokyo Warsaw Washington, D.C.
Associated Offices: Budapest Jakarta Riyadh Shanghai FTZ Ulaanbaatar Zagreb. Business Service Centers: Johannesburg Louisville. Legal Services Center: Berlin. For more information see www.hoganlovells.com.
Securities and Exchange Commission
- 2 -
July 26, 2019
The Company acknowledges the Staff’s comment and respectfully notes that its statements that its product candidates “appeared to be safe” or showed “preliminary signs of efficacy” are statements of
preliminary insight only and are not intended to imply that its product candidates are safe or effective or that the FDA has made or will make any determination that the product candidates are safe or effective. The Company believes that disclosure
of this information is helpful to investors to assess the current status of the product candidates and to help understand the Company’s rationale for moving forward. Nevertheless, in future filings, the Company will avoid statements that any of its
product candidates “appeared to be safe” or show “preliminary signs of efficacy” unless that has been determined by the FDA.
Notes to Financial Statements
14. Collaboration Agreements
Zhejiang Haichang Biotechnology Co., Ltd., page F-26
2.
On February 8, 2018, you entered into a research and development collaboration agreement with Zhejiang Haichang Biotechnology Co., Ltd ("Haichang") under which Haichang will develop RX-0301 using Haichang's
proprietary QTsome technology. You further indicate that Haichang will conduct certain preclinical and clinical activities through completion of Phase 2a proof of concept clinical trial in China. At that time, Haichang may obtain an
exclusive license to further develop and commercialize RX-0301 in China and will pay customary license fees, milestones and royalty payments to you.
Please address the following:
•
Tell us whether you gave any upfront consideration to Haichang for the preclinical and clinical activities it is to perform through completion of Phase 2a proof of concept clinical trial in China;
•
Tell us whether any licenses were exchanged upfront;
•
Explain to us how you are accounting for this agreement, including the specific accounting literature you relied upon when making such determination; and
•
Quantify and describe for us any related amounts recorded in your financial statements during the year ended December 31, 2018 and the quarter ended March 31, 2019.
The Company did not provide any upfront consideration to Haichang upon entering into the research and development collaboration agreement with Haichang, nor was any upfront consideration provided to
the Company by Haichang. Pursuant to the agreement, the Company granted Haichang an exclusive license under the Company’s intellectual property to conduct preclinical and clinical activities for nanoliposomal formulations of RX-0301 in China, Hong
Kong, Macau and Taiwan in accordance with an agreed research and development plan, and Haichang granted the Company a worldwide, exclusive and perpetual license under Haichang intellectual property to research, develop, commercialize and manufacture
nanoliposomal formulations of RX-0301.
Securities and Exchange Commission
- 3 -
July 26, 2019
Although the agreement is a research and development collaboration agreement, the Company is not required to be significantly involved in any joint development activities as the research and
development work under the agreed research and development plan is performed solely by Haichang. The Company’s contribution to the research and development collaboration is a license of intellectual property, which is consistent with the Company’s
ordinary business activities. As such, the Company accounts for this agreement as a contract with a customer that is within the scope of Accounting Standards Codification (“ASC”) No. 606, Revenue from Contracts with
Customers (ASC 606). The Company has determined that its sole performance obligation to Haichang as determined under ASC 606 is the license to intellectual property. The license of intellectual property granted to Haichang was determined to
be a right to use functional intellectual property, as the license has significant standalone functionality and is not dependent on continuing support of the license by the Company. The research and development collaboration agreement did not include
cash consideration or, as noted above, any up-front consideration. The Company will solely be compensated by Haichang in this arrangement through non-cash consideration in the form of the rights to the enhanced value of the licensed intellectual
property realized through the successful completion of research and development efforts by Haichang under this agreement. As the value of the non-cash consideration is dependent on the occurrence or non-occurrence of events that do not relate to the
form of the non-cash consideration, the transaction price in this agreement is variable. At the agreement’s outset, the Company determined that the transaction price should be fully constrained given the early-stage nature of the intellectual
property and uncertainty of the outcome of research and development activities to be completed by Haichang under the agreement. In addition, given the stage of the research and development efforts completed, the Company determined the value of the
variable consideration through December 31, 2018 and March 31, 2019 was de minimis and therefore should continue to be fully constrained. Accordingly, no amounts related to this agreement were recorded in the Company’s financial statements in either
period. The Company continues to re-evaluate its variable consideration constraint judgments on a periodic basis or when facts and circumstance indicate the factors impacting these judgments may change.
Form 10-Q for the Fiscal Quarter Ended March 31, 2019
Notes to Condensed Financial Statements
7 Collaboration Agreement, page 10
3.
On February 25, 2019, you entered into a collaboration agreement with BioSense Global LLC ("BioSense") to advance the development and commercialization of RX-3117 for pancreatic and other
cancers in certain territories. Please address the following:
•
Clarify for us whether you believe the granting of the exclusive license to develop and promise to supply RX-3117 are distinct performance obligations. If so, explain to us in further detail
how you made this determination;
•
Quantify for us the portion of the $3,000,000 transaction price that you will allocate to each performance obligation and describe when and how you expect to recognize the related revenue for
each (ex: at a point in time, over time); and
•
Describe and disaggregate for us further the $226,000,000 milestones the company is eligible to receive by development, regulatory, commercial categories and further disaggregate, if applicable, by
indication and geographic area. Considering the significant amount of potential milestones, tell us your consideration of disclosing an accounting policy that describes the factors you consider when determining whether milestones should
be constrained or included in the transaction price.
The Company has determined that the exclusive license of intellectual property and the supply of RX-3117 are distinct performance obligations. The Company notes the following factors in making this
determination:
•
The exclusive license of intellectual property was determined to be a right to use functional intellectual property as the license has significant standalone functionality and is not dependent on continuing support of the license by
the Company or the supply of RX-3117 in order for the customer to derive value. BioSense can benefit from the license on its own or with other resources readily available in the marketplace (contract manufacturing organizations and
contract research organizations, for example).
Securities and Exchange Commission
- 4 -
July 26, 2019
•
The supply of RX-3117 represents a distinct performance obligation as BioSense can benefit from the supply of RX-3117 separately from the license.
•
The license to intellectual property and the supply of RX-3117 are separately identifiable in the contract and the Company can fulfill its promise to transfer the license separately from fulfilling its promise to deliver the supply of
RX-3117.
•
The license of intellectual property and the supply of RX-3117 are not bundled to produce a combined output for the customer, do not significantly modify or customize one another and are not highly dependent on or highly interrelated
to one another.
The Company will allocate the $3,000,000 transaction price based on the relative standalone selling price of each performance obligation. The Company has determined the standalone selling price of
the license to intellectual property to be $3,000,000 using the adjusted market approach, which represents the price the market will bear based on the license rights granted and the state of the intellectual property. The Company has determined the
standalone selling price of the clinical supply of RX-3117 to be $0.6 million based on a cost plus a margin approach. Accordingly, the Company has allocated $2.5 million of the transaction price to the license of intellectual property and $0.5
million of the transaction price to the supply of RX-3117. The Company will recognize revenue for each performance obligation at the point in time when control of the licensed property or supply of RX-3117, respectively transfers to the customer.
Under the collaboration agreement with BioSense, the Company is eligible to receive (i) up to an aggregate of $126 million based on the achievement of development and regulatory milestones in China
and (ii) up to an aggregate of $100 million for the achievement of annual sales milestones in the Republic of Singapore, China, Hong Kong, Macau and Taiwan with respect to each pharmaceutical product containing RX-3117 as a single agent. The Company
accounts for the milestones in the contract using the most likely amount approach. At the contract outset, the Company had determined that all of the milestone fees should be fully constrained as it is not probable that a significant reversal of
revenue would not occur:
•
The milestone payments are earned based on the success of clinical development, regulatory approval activities and the successful commercialization of a product. Clinical development currently carries substantial risk and there is no
certainty of success. Regulatory approval is dependent on clinical development success and commercialization is dependent on clinical development success, regulatory approval and other factors. Accordingly, achievement of the milestones
is highly susceptible to factors outside of the Company’s control;
•
Uncertainty regarding the timing of milestone payments is not expected to be resolved for a significant period of time (more than one year for the first milestone and longer for subsequent milestones);
•
The Company does not have similar experiences or arrangements to consider in order to draw a conclusion on the likelihood of the milestones being achieved; and
•
The amounts present a broad range of possible consideration amounts when considered as a whole.
Furthermore, the Company notes that including one or more milestone payments could result in a significant reversal of revenue based on the magnitude of the reversal when compared to the upfront
consideration provided (the reversal amount would significantly exceed the upfront consideration). The Company will re-evaluate its variable consideration constraint judgments on a periodic basis or when facts and circumstance indicate the factors
impacting these judgments may change.
Securities and Exchange Commission
- 5 -
July 26, 2019
4.
Please file the collaboration agreement with BioSense
2019-07-12 - UPLOAD - Opus Genetics, Inc.
July 12, 2019
Douglas J. Swirsky
President, Chief Executive Officer and Director
REXAHN PHARMACEUTICALS, INC.
15245 Shady Grove Rd
Suite 455
Rockville, Maryland 20850
Re:REXAHN PHARMACEUTICALS, INC.
Form 10-K for Fiscal Year Ended December 31, 2018
Filed March 7, 2019
Form 10-Q for Quarterly Period Ended March 31, 2019
Filed May 10, 2019
File No. 001-34079
Dear Mr. Swirsky:
We have reviewed your filings and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2018
Item 1 Description of Business
Our Pipeline Product Candidates, page 4
1.We note your disclosures on pages 4-7 stating that your product candidates, including RX-
3117, RX-5902, and RX-0201, "appeared to be safe." Further, we note your disclosure
that RX-3117 "appeared to be safe... with preliminary signs of efficacy." Safety and
efficacy determinations are solely within the authority of the FDA. Please remove
statements or inferences that your product candidates are or appeared to be safe and
effective. You may provide the objective results of the clinical trials with the stated
endpoints and indicate whether the candidate was well tolerated.
FirstName LastNameDouglas J. Swirsky
Comapany NameREXAHN PHARMACEUTICALS, INC.
July 12, 2019 Page 2
FirstName LastNameDouglas J. Swirsky
REXAHN PHARMACEUTICALS, INC.
July 12, 2019
Page 2
Notes to Financial Statements
14. Collaboration Agreements
Zhejiang Haichang Biotechnology Co., Ltd., page F-26
2.On February 8, 2018, you entered into a research and development collaboration
agreement with Zhejiang Haichang Biotechnology Co., Ltd ("Haichang") under which
Haichang will develop RX-0301 using Haichang's proprietary QTsome technology. You
further indicate that Haichang will conduct certain preclinical and clinical activities
through completion of Phase 2a proof of concept clinical trial in China. At that time,
Haichang may obtain an exclusive license to further develop and commercialize RX-0301
in China and will pay customary license fees, milestones and royalty payments to you.
Please address the following:
•Tell us whether you gave any upfront consideration to Haichang for the preclinical and
clinical activities it is to perform through completion of Phase 2a proof of concept
clinical trial in China;
•Tell us whether any licenses were exchanged upfront;
•Explain to us how you are accounting for this agreement, including the specific
accounting literature you relied upon when making such determination; and
•Quantify and describe for us any related amounts recorded in your financial statements
during the year ended December 31, 2018 and the quarter ended March 31, 2019.
Form 10-Q for the Fiscal Quarter Ended March 31, 2019
Notes to Condensed Financial Statements
7 Collaboration Agreement, page 10
3.On February 25, 2019, you entered into a collaboration agreement with BioSense Global
LLC ("BioSense") to advance the development and commercialization of RX-3117 for
pancreatic and other cancers in certain territories. Please address the following:
•Clarify for us whether you believe the granting of the exclusive license to develop and
promise to supply RX-3117 are distinct performance obligations. If so, explain to us
in further detail how you made this determination;
•Quantify for us the portion of the $3,000,000 transaction price that you will allocate to
each performance obligation and describe when and how you expect to recognize the
related revenue for each (ex: at a point in time, over time); and
FirstName LastNameDouglas J. Swirsky
Comapany NameREXAHN PHARMACEUTICALS, INC.
July 12, 2019 Page 3
FirstName LastName
Douglas J. Swirsky
REXAHN PHARMACEUTICALS, INC.
July 12, 2019
Page 3
•Describe and disaggregate for us further the $226,000,000 milestones the company is
eligible to receive by development, regulatory, commercial categories and further
disaggregate, if applicable, by indication and geographic area. Considering the
significant amount of potential milestones, tell us your consideration of disclosing an
accounting policy that describes the factors you consider when determining whether
milestones should be constrained or included in the transaction price.
4.Please file the collaboration agreement with BioSense as an Exhibit or provide us with an
analysis supporting your determination that you are not substantially dependent on the
agreement.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
You may contact Andi Carpenter at 202-551-3645 or Sharon Blume at 202-551-3474
with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-07-19 - UPLOAD - Opus Genetics, Inc.
July 19, 2018
Douglas J. Swirsky
President and Chief Financial Officer
Rexahn Pharmaceuticals, Inc.
15245 Shady Grove Road, Suite 455
Rockville, MD 20850
Re:Rexahn Pharmaceuticals, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed July 9, 2018
File No. 001-34079
Dear Mr. Swirsky:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: William I. Intner, Esq.
2018-07-18 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
Hogan Lovells US LLP
Harbor East
100 International Drive
Suite 2000
Baltimore, MD 21202
T +1 410 659 2700
F +1 410 659 2701
www.hoganlovells.com
July 18, 2018
BY EDGAR
Ms. Irene Paik
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Re:
Rexahn Pharmaceuticals, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed July 9, 2018
File No. 001-34079
Dear Ms. Paik:
On behalf of Rexahn Pharmaceuticals, Inc. (the “Company”), this letter responds to a comment made by the staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) regarding the Company’s above referenced Preliminary Proxy Statement on Schedule 14A (“Proxy Statement”) in the Staff’s letter dated July 13, 2018.
Set forth below is the Staff’s comment in italic type, followed by the response submitted on behalf of the Company.
Proposal 1: Approval of an Amendment to the Company's Amended and
Restated Certificate of Incorporation..., page 8
1.
We note that if the shareholders approve the proposed amendment, the Board may cause the issuance of the additional shares of Common Stock without
further approval. Please revise your proxy statement to affirmatively disclose whether you have any specific plans, arrangements, understandings, etc. at this time to issue any of the newly authorized shares. If such plans exist,
please disclose all material information regarding the issuance.
In response to the Staff's comment, the Company will revise the first sentence in the third paragraph on page 8 under “Proposal 1:
Approval of an Amendment to the Company’s Amended and Restated Certificate of Incorporation to Increase the Number of Authorized Shares of Common Stock from 50,000,000 to 75,000,000” in its Definitive Proxy Statement on Schedule 14A to read as
follows (marked to show changes):
Hogan Lovells US LLP is a limited liability partnership registered in the District of Columbia. “Hogan Lovells” is an international legal
practice that includes Hogan Lovells US LLP and Hogan Lovells International LLP, with offices in: Alicante Amsterdam Baltimore Beijing Birmingham Boston Brussels Colorado Springs Denver Dubai Dusseldorf Frankfurt
Hamburg Hanoi Ho Chi Minh City Hong Kong Houston Johannesburg London Los Angeles Luxembourg Madrid Mexico City Miami Milan Minneapolis Monterrey Moscow Munich New York Northern Virginia Paris Perth
Philadelphia Rio de Janeiro Rome San Francisco São Paulo Shanghai Silicon Valley Singapore Sydney Tokyo Warsaw Washington DC Associated offices: Budapest Jakarta Shanghai FTZ Ulaanbaatar Zagreb. Business Service
Centers: Johannesburg Louisville. For more information see www.hoganlovells.com
Although at present there are no specific plans, arrangements or
understandings to issue any of the newly authorized shares, the The Board of Directors believes an increase in the number of authorized shares
of Common Stock is necessary because the availability of additional authorized but unissued shares will provide us with greater flexibility in considering actions that may be desirable or necessary to accomplish our business objectives and that
involve the issuance of our Common Stock. An increase in the number of authorized shares would allow us to issue Common Stock for a variety of corporate purposes, such as raising additional capital, without the delay associated with soliciting
shareholder approval and convening a special meeting of shareholders.
Thank you for your attention to this letter. If you have any questions with respect to the foregoing, please contact the undersigned at
(410) 659-2778. The Company would appreciate the Staff’s expeditious review of the Company’s Preliminary Proxy Statement. The Company expects to file its Definitive Proxy Statement on or about July 23, 2018.
Very truly yours,
/s/ William I. Intner
William I. Intner
cc:
Erin K. Jaskot, SEC Staff
Douglas J. Swirsky, Rexahn Pharmaceuticals, Inc.
2
2018-07-13 - UPLOAD - Opus Genetics, Inc.
July 13, 2018
Douglas J. Swirsky
President and Chief Financial Officer
Rexahn Pharmaceuticals, Inc.
15245 Shady Grove Road, Suite 455
Rockville, MD 20850
Re:Rexahn Pharmaceuticals, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed July 9, 2018
File No. 001-34079
Dear Mr. Swirsky:
We have limited our review of your proxy statement to those issues addressed in our
comment.
Please respond to this 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 this comment, we may have additional comments.
Preliminary Proxy Statement on Schedule 14A filed July 9, 2018
Proposal 1: Approval of an Amendment to the Company's Amended and Restated Certificate of
Incorporation..., page 8
1.We note that if the shareholders approve the proposed amendment, the Board may cause
the issuance of the additional shares of Common Stock without further approval. Please
revise your proxy statement to affirmatively disclose whether you have any specific plans,
arrangements, understandings, etc. at this time to issue any of the newly authorized
shares. If such plans exist, please disclose all material information regarding the
issuance.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
FirstName LastNameDouglas J. Swirsky
Comapany NameRexahn Pharmaceuticals, Inc.
July 13, 2018 Page 2
FirstName LastName
Douglas J. Swirsky
Rexahn Pharmaceuticals, Inc.
July 13, 2018
Page 2
Please contact Irene Paik at 202-551-6553 or Erin Jaskot at 202-551-3442 with any
questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: William I. Intner, Esq.
2017-07-07 - CORRESP - Opus Genetics, Inc.
CORRESP 1 filename1.htm Rexahn Pharmaceuticals, Inc. 15245 Shady Grove Road, Suite 455 Rockville, Maryland 20850 July 7, 2017 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Rexahn Pharmaceuticals, Inc. Registration Statement on Form S-3 (File No. 333-218285) Request for Acceleration of Effective Date Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Rexahn Pharmaceuticals, Inc. (the “Company”) hereby requests that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Registration Statement on Form S-3 and declare the Registration Statement effective as of 5:00 p.m., Eastern Daylight Time, on July 11, 2017, or as soon thereafter as possible. Please feel free to direct any questions or comments concerning this request to William Intner of Hogan Lovells US LLP at (410) 659-2778. Very truly yours, Rexahn Pharmaceuticals, Inc. /s/ Tae Heum Jeong By: Tae Heum Jeong Title: Senior Vice President and Chief Financial Officer
2017-06-02 - UPLOAD - Opus Genetics, Inc.
June 2, 2017
Peter Suzdak
Chief Executive Officer
Rexahn Pharmaceuticals, Inc.
15245 Shady Grove Road, Suite 455
Rockville, MD 20850
Rexahn Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed May 26, 2017
File No. 333-218285Re:
Dear Mr. Suzdak:
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.
Division of Corporation Finance
Office of Healthcare & Insurance
2016-11-15 - UPLOAD - Opus Genetics, Inc.
Mail Stop 4 546 November 15, 2016 Via E -mail Tae Heum Jeong Chief Financial Officer Rexahn Pharmaceuticals, Inc. 15245 Shady Grove Road, Suite 455 Rockville, MD 20850 Re: Rexahn Pharmaceuticals, Inc. Form 10 -K Filed March 14, 2016 File No. 001 -34079 Dear Mr. Jeong : We have completed our review of your filing . We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff . Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance
2016-10-14 - CORRESP - Opus Genetics, Inc.
CORRESP 1 filename1.htm October 14, 2016 Ms. Suzanne Hayes Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street, NE Washington, DC 20549 Re: Rexahn Pharmaceuticals, Inc. Form 10-K for the year ended December 31, 2015 Filed March 14, 2016 File No. 001-34079 Dear Ms. Hayes: On behalf of Rexahn Pharmaceuticals, Inc. (the “Company”), this letter responds to comments made by the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) regarding the Company’s above referenced Annual Report on Form 10-K for the year ended December 31, 2015 (“Form 10-K”) in the Staff’s letter dated September 30, 2016. Set forth below are the Staff’s comments in bold type, followed by our response. Staff’s Comments and Company’s Response Collaboration and License Agreements, page 20 1. Please provide us with proposed disclosure to be included in future filings that includes all material terms for your material collaboration and license agreements. In particular, please disclose the following information for your license agreement with Korea Research Institute of Chemical Technology and your collaboration agreement with Rexgene Biotech Co., Ltd., as appropriate: · Scope of the intellectual property transferred under the agreements; · Duration of the agreement; · Termination provisions; · Material payment provisions, such as aggregate amounts paid or received to date, future milestone payments to be paid or received, and royalty rates and royalty term. Please also file your material collaboration and license agreements as exhibits to your next Exchange Act report. RESPONSE: The Company proposes to include disclosure in its Annual Report on Form 10-K for the fiscal year ending December 31, 2016 regarding the Company’s collaboration agreement with Rexgene Biotech Co., Ltd. that is substantially consistent with the following: Rexgene Biotech Co., Ltd. (“Rexgene”) In February 2003, we entered into a research collaboration agreement with Rexgene, which is engaged in the development of pharmaceutical products in Asia. Rexgene has agreed to assist us with the research, development and clinical trials necessary for registration of Archexin in Asia. Under the agreement, we have granted Rexgene an exclusive license, with right to sublicense, to make, have made, use, sell and import Archexin in Asia. In accordance with the agreement, Rexgene paid us a one-time fee of $1,500,000 in 2003. Rexgene also agreed to pay us a royalty fee of 3% of net sales of licensed products related to Archexin on a country-by-country basis in all countries in Asia by Rexgene or any sublicensee of Rexgene. The agreement expires upon the last to expire of all U.S. and foreign patents presently or in the future issued that cover Archexin, which we currently expect to occur in 2025. The agreement is terminable by either party for the other party’s material breach, subject to a 90 day cure period. To date, the only amounts we have received under the agreement are from the initial one-time fee of $1,500,000 paid in 2003. The Company will incorporate by reference the previously-filed Rexgene agreement as an exhibit to its Form 10-Q for the quarterly period ended September 30, 2016. At this time, the Company does not consider any of its other collaboration and license agreements, including its agreement with Korea Research Institute of Chemical Technology (“KRICT”), to be material contracts under Item 601(b)(10) of Regulation S-K. The only pending obligation to be performed under the KRICT agreement, other than adherence to limited covenants, is a conditional obligation to pay an amount of money to KRICT in the event of an FDA approval. If FDA approval is obtained, and a drug is available to be marketed, the amount of money that would be payable would be immaterial in amount to the Company. Upon payment of that amount, there are no further obligations under the KRICT agreement, the KRICT agreement will terminate and the Company will hold all rights to the underlying technology. Intellectual Property, page 20 2. We note your statement that you hold U.S. and foreign patents for Archexin, RX-3117 and Supinoxin. Please provide us with proposed disclosure regarding your material patents to be included in future filings. Please ensure that the disclosure includes the following: · the specific product candidate to which the patent relates and the patent expiration date or expected expiration date for patent applications; · type of patent protection (e.g. composition of matter, use or process); and; · identification of the applicable jurisdictions where patents are granted or where patent applications are pending. 2 RESPONSE: The Company proposes to include disclosure in its Annual Report on Form 10-K for the fiscal year ending December 31, 2016 regarding the Company’s intellectual property that is substantially consistent with the following: Intellectual Property We generally seek proprietary patent and intellectual property (“IP”) protection for our drug candidates, processes, and other know-how. In addition to patent protection, we rely upon trade secrets, know-how, continuing technological innovation and licensing opportunities to develop and safeguard and maintain our IP. We hold U.S. and foreign patents for our drug candidates that expire from 2023 to 2034. In addition to these patents, we have issued or pending patents in other jurisdictions. The patent portfolios for our most advanced programs are summarized below: Archexin: The Archexin patent portfolio consists of a patent family that includes patents that have been issued in the United States, Europe, Japan and other jurisdictions. The patents in this family include composition of matter and use claims of varying scope, including picture claims to Archexin or a pharmaceutically acceptable salt thereof. The expiration date of these patents ranges from 2023 to 2025, not including any potential patent term extension or market exclusivity period. RX-3117: The RX-3117 patent portfolio consists of three patent families. The first family consists of patents that have been issued in the United States, Europe, Japan and other jurisdictions. The patents in this family include composition of matter, use, and process claims of varying scope, including picture claims to RX-3117 or a pharmaceutically acceptable salt thereof. The patents in this first family expire in 2025, not including any patent term extension or market exclusivity period that may apply. The second family consists of patents that have been issued in the United States, and are pending in Europe, Japan and other jurisdictions. The patents in the second family include process claims that generically cover RX-3117. The patents in this second family expire in 2034, not including any patent term extension or market exclusivity period that may apply. The third family consists of a patent that is pending in the United States. This patent would include use and process claims that generically cover RX-3117. This patent would expire in 2036, not including any patent term extension or market exclusivity period that may apply. 3 Supinoxin: The Supinxoin patent portfolio consists of three patent families. The first family consists of patents that have been issued in the United States and Europe, and are pending in Japan and other jurisdictions. The patents in the first family include composition of matter, use, and process claims of varying scope, including picture claims to Supinoxin or a pharmaceutically acceptable salt thereof. The patents in this first family expire in 2025, not including any patent term extension or market exclusivity period that may apply. The second family consists of patents that are pending in the United States, Europe, Japan and other jurisdictions. The patents in the second family include composition of matter, process and use claims that generically cover Supinoxin. The patents in this second family would expire in 2034, not including any patent term extension or market exclusivity period that may apply. The third family consists of a patent that is pending in the United States. The patent in the third family would include use and process claims that generically cover Supinoxin. This patent would expire in 2036, not including any patent term extension or market exclusivity period that may apply. Thank you for your attention to this letter. If you have any questions with respect to the foregoing, please contact the undersigned at (240) 268-5300. Very truly yours, /s/TAE HEUM JEONG Tae Heum Jeong Chief Financial Officer cc: Erin K. Jaskot, SEC Staff Tara Keating Brooks, SEC Staff William I. Intner, Hogan Lovells US LLP 4
2016-09-30 - UPLOAD - Opus Genetics, Inc.
Mail Stop 4546 September 30, 2016 Tae Heum Jeong Chief Financial Officer Rexahn Pharmaceuticals, Inc. 15245 Shady Grove Road, Suite 455 Rockville, MD 20850 Re: Rexahn Pharmaceuticals, Inc. Form 10-K Filed March 14, 2016 File No. 001-34079 Dear Mr. Jeong : We have reviewed your filing an d have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to these comments within ten busine ss days by providing the requested information or advis e us as soon as possible when you will respond. If you do not believe our comments apply to your facts and circumstances , please tell us why in your response. After reviewing your response to these comments, we may have additional comments. Collaboration and License Arrangements, page 20 1. Please provide us with proposed disclosure to be included in future fi lings that includes all material terms for your material collaboration and license agreements. In particular, please disclose the following information for your license agreement with Korea Research Institute of Chemical Technology and your collaboration agreement with Rexgene Biotech Co., Ltd., as appropriate: Scope of intellectual property transferred under the agreements; Duration of the agreement; Termination provisions; Material payment provisions, such as aggregate amounts paid or received to date, future milestone payments to be paid or received, and royalty rates and royalty term. Please also file your material collaboration and license agreements as exhibits to your next Exchange Act report. Tae Heum Jeong Rexahn Pharmaceuticals, Inc. September 30, 2016 Page 2 Intellectual Property, page 20 2. We note your statement t hat you hold U.S. and foreign patents for Archexin, RX -3117 and Supinoxin. Please provide us with proposed disclosure regarding your mat erial patents to be included in future filings. Please ensure that the disclosure includes the following: the specific product candidate to which the patent relates and the patent expiration date or expected expiration date for patent applications; type of patent protection (e.g. composition of matter, use, or process); and identification of the applicable jurisdictions w here patents are granted or where patent applications are pending. 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 Exchange Act of 1934 and all applicable Exchange 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 respo nding to our comments, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United Stat es. Please contact Tara Keating Brooks at (202) 551 -8336 or Erin Jaskot at (202) 551 -3442 with any other questions. Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance
2014-06-25 - CORRESP - Opus Genetics, Inc.
CORRESP 1 filename1.htm REXAHN PHARMACEUTICALS, INC. 15245 Shady Grove Road, Suite 455 Rockville, Maryland 20850 June 25, 2014 VIA EDGAR Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Attn: Jeffrey Riedler Re: Rexahn Pharmaceuticals, Inc. Shelf Registration Statement on Form S-3 (File No. 333-196255) Request for Acceleration of Effective Date Dear Mr. Riedler: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Rexahn Pharmaceuticals, Inc. (the “Company”) hereby requests that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the above-referenced Shelf Registration Statement on Form S-3 (as amended to date, the “Shelf Registration Statement”) and declare the Shelf Registration Statement effective as of 4:00 PM, Eastern Time, on June 26, 2014, or as soon thereafter as possible. In connection with this request for acceleration, the Company 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 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 defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, Rexahn Pharmaceuticals, Inc. /s/ Tae Heum Jeong By: Tae Heum Jeong Title: Senior Vice President and Chief Financial Officer
2014-06-05 - UPLOAD - Opus Genetics, Inc.
June 4, 2014 Via E -mail Peter D. Suzdak Chief Executive Officer Rexahn Pharmaceuticals, Inc. 15245 Shady Grove Road, Suite 455 Rockville, Maryland 20850 Re: Rexahn Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed May 23 , 2014 File No. 333-196255 Dear Dr. Suzdak : We have limited our review of your regist ration statement to the issue we hav e addressed in our comment . Please respond to this letter by amending your registration statement and providing the requested information . Where you do not believe our comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why i n 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. Exhibit 5.1 1. We note the language o n page 2 of the legal opinion filed as Exhibit 5.1 that “the opinions given in paragraphs (c) and (d) …” are expressed solely with respect to “the laws of the State of New York …” As hig hlighted in Section s II.B.1. f. of the Division of Corporation Finance Staff Legal Bulletin No. 19, counsel must consider the law of the jurisdiction under which th e registrant is organized in order to provide the binding obligation opinion with respect to warrants being offered under the registration stat ement. As such, p lease re vise the legal opinion with respect to whether the Preferred Stock Warrants and the Common Stock Wa rrants will constitute valid and binding obligations of the Company to confirm t hat such opinion is based on both Delaware General Corporation Law and the laws of the State of New York. 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 it s management are in Peter D. Suzdak Rexahn Pharmaceuticals, Inc. June 4, 2014 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 comment , in the event you request acceleration of the effective dat e of the pending registration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant t o 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 effect iveness 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 acceler ation of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Christina De Rosa at (202) 551 -3577 , Bryan Pitko at (202) 551 -3203 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: Via E -mail William Intner Hogan Lovells US LLP 100 International Drive, Suite 2000 Baltimore, Maryland 21202
2011-03-23 - UPLOAD - Opus Genetics, Inc.
March 23, 2011 Mr. Tae Heum Jeong Chief Financial Officer Rexahn Pharmaceuticals, Inc. 15245 Shady Grove Road, Suite 455 Rockville, MD 20850 Re: Rexahn Pharmaceuticals, Inc. Form 10-K for the year ended December 31, 2009 Filed March 31, 2010 Schedule 14A filed April 26, 2010 File No. 001-34079 Dear Mr. Jeong: We have completed our review of your fili ngs and do not have any further comments at this time. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant
2011-03-22 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
corresp.htm
2550 M Street NW
Washington DC 20037
(202) 457-6000
_________________
Facsimile (202) 457-6315
March 22, 2011
William H. Levay
202-457-5259
WLevay@pattonboggs.com
Mr. Mark Brunhofer
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Re: Rexahn Pharmaceuticals, Inc.
Form 10-K for the year ended December 31, 2010
Filed March 16, 2011
File No. 001-34079
Dear Mr. Brunhofer:
On behalf of Rexahn Pharmaceuticals, Inc. (the “Company”), this letter responds to oral comments made by the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) on March 22, 2011 regarding the Company’s response letter dated March 18, 2011 and the Company’s annual report on Form 10-K for the year ended December 31, 2010. Set forth below is a summary of the Staff’s oral comments in bold type, followed by our response.
Staff’s Comment and Company’s Response
1. Please provide proposed disclosure to be included in future periodic reports that identifies potential cash settlement obligations associated with the three publicly issued unit warrants. So in this regard, although these warrants appear to provide for a cashless exercise feature if a registration statement is not available, the US securities laws do not provide for an exemption in this instance and a cash settlement may be required because its unlikely that non-performance would be an acceptable alternative.
Mr. Mark Brunhofer
March 22, 2011
Page 2
Response:
The Company proposes to include the following disclosure in its future periodic reports with regard to the Company’s three publicly issued unit warrants:
"In addition, the public unit warrants contain a cashless exercise provision that is exercisable only in the event a registration statement is not effective, which provision may not be operative if an effective registration statement is not available because an exemption under the U.S. securities laws may not be available to issue unregistered shares. As a result, net cash settlement may be required."
In connection with responding to the foregoing comments, the Company hereby acknowledges that:
1.
the Company is responsible for the adequacy and accuracy of the disclosure in the filing;
2.
Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and
3.
the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
If you have any questions with respect to the foregoing, please contact Hwan Kim at (202) 457- 5615 or the undersigned at (202) 457-5259.
Thank you for your attention to this filing. We look forward to hearing from you shortly.
Very truly yours,
/s/ WILLIAM H. LEVAY
William H. Levay
cc: Tae Heum Jeong, Chief Financial Officer
2011-03-18 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
corresp.htm
2550 M Street NW
Washington DC 20037
(202) 457-6000
_____________
Facsimile (202) 457-6315
March 18, 2011
William H. Levay
202-457-5259
WLevay@pattonboggs.com
Mr. Mark Brunhofer
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Re:
Rexahn Pharmaceuticals, Inc.
Form 10-K for the year ended December 31, 2009
Filed March 31, 2010
File No. 001-34079
Dear Mr. Brunhofer:
On behalf of Rexahn Pharmaceuticals, Inc. (the “Company”), this letter responds to oral comments made by the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) on February 9, 2011 regarding the Company’s response letter dated January 19, 2011. Set forth below is a summary of the Staff’s oral comments in bold type, followed by our response.
Staff’s Comment and Company’s Response
1. Clarify the applicable period for the put/anti-dilution provisions in the Stock Purchase Agreements of December 2007 and March 2008. In Section 5.7 (Antidilution) of the Stock Purchase Agreement, the "put" provision survives for a 2 year period, but pursuant to Section 7.8 (Survival) of the Stock Purchase Agreement all of the representations, warranties, agreements and covenants contained in the Stock Purchase Agreement survive for only a one year period.
Response: The parties to the applicable Stock Purchase Agreements intended the “put” provision in Section 5.7 to survive for 2 years and the Company has treated this provision as being effective for the applicable two year period. The Section 7.8 survival provision should have included an exception for Section 5.7 indicating that this provision survived for 2 years.
Mr. Mark Brunhofer
March 18, 2011
Page 2
2. Provide details of how the liability associated with common stock “put” in the Stock Purchase Agreements of December 2007 and March 2008 were valued. The Company has previously used the Black Scholes method of valuation. The Staff recommended that there are more appropriate models to use such as the Lattice model.
Response: The make-whole provisions associated with the common stock, which were determined to be a freestanding put, and will be valued using a probability–weighting of put values provided by a Binomial Lattice model.
Additional value would result from the put upon an increase in the exercise price or upon decrease of the trading market price in the future. Since the exercise price is based on the actual sales price of the stock issued, it is not subject to adjustment unless there is an actual dilutive event. Therefore, the mechanism for determining the value of the put is to adjust the stock price input into the Binomial Lattice model based on the Company’s estimated future stock price. The methodology for valuing the put will provide for several different scenarios based upon these estimated future stock prices which will then be probability weighted. The model is based on management’s assumption that they will need to enter into a financing approximately every 6 months. We will use a Brownian motion technique to estimate the market price at several points in the future (e.g. at inception, 6 months, 12 months, 18 months and 24 months) over the term of the put to determine if the stock price will be expected to decrease over the related interval of time. Brownian motion is a continuous stochastic process that is widely used in financing for modeling random behavior that evolves over time. At each interval, the stochastic model will be run and the simulation will return the mean stock price (the “expected stock price).
Expected stock prices returned from the stochastic model will then be input into the Binomial Lattice model to provide a put value at each of the expected price and these values will be probability weighted to determine the overall fair value of the make-whole provision. The term will be based on the remaining term of the put (two years at inception) and the inputs for volatility and interest rate will be based on projected volatility and interest rate in the future over the remaining term.
3. In the Company's response letter of January 19th the tables do not include the latest warrants. Please revise the tables to include all warrants issued. Please explain or correct the variation in the dates for the Warrants between what was disclosed in the financial statements and the dates disclosed in the Company's prior response letters (eg. May 19th vs. June 5th; and October 19th versus October 23rd).
Mr. Mark Brunhofer
March 18, 2011
Page 3
Response: Please see the financial statements for the year ended December 31, 2010 and the quarters ended September 30, June 30, and March 31, respectively, in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010, filed with the Commission on March 16, 2011 (the “2010 10-K”), for inclusion of the latest warrants in the financial statements of the Company. The dates in the document have been conformed to June 5th and October 23rd, which is the date that the transactions were closed.
4. With respect to the Company's Materiality Analysis, the Staff does not believe that qualitative factors outweighs quantitative. The Staff recommends restating the 2009 10-K and the three 10-Qs for 2010.
Response: Pursuant to subsequent guidance from the Staff, the Company will include a restatement of certain portions of the Company’s (i) financial statements for the fiscal year ended December 31, 2009 and (ii) the quarters ended March 31, 2010, June 30, 2010, and September 30, 2010, within the 2010 10-K.
5. Provide the allocation of proceeds for each of the five unit offerings. On the day of issuance of warrants, proceeds are to be allocated to debt instruments first and then common stock.
Response: The Company has allocated the proceeds for each of the unit offerings first to debt instruments, and then to common stock. Please see footnote 12 of the annual financial statements included in the 2010 10-K and footnote 5 of the quarterly financials filed with the 2010 10-K where each unit offering is discussed, and an allocation is provided.
6. Provide draft disclosures of what the Company intends to file for the restatements of the 2009 10-K and the three 10-Qs for 2010.
Response: Please see the annual and quarterly financial statements in the 2010 10-K that include prior period adjustments of the 2009 annual and 2010 quarterly financials.
7. Provide the expected filing date for the Item 4.02 Current Report on Form 8-K.
Response: The Company filed a Current Report on 2010 8-K for Item 4.02 Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Report on March 16, 2011.
8. In connection with the restatement of the 2009 10-K, the Company must reassess the effectiveness of the Company disclosure controls and procedures and the Company's internal controls over financial reporting.
Mr. Mark Brunhofer
March 18, 2011
Page 4
Response: Please see Item 9A. Controls and Procedures and Management’s Report on Internal Control Over Financial Reporting in the 2010 10-K.
In connection with responding to the foregoing comments, the Company hereby acknowledges that:
1.
the Company is responsible for the adequacy and accuracy of the disclosure in the filing;
2.
Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and
3.
the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
If you have any questions with respect to the foregoing, please contact Hwan Kim at (202) 457- 5615 or the undersigned at (202) 457-5259.
Thank you for your attention to this filing. We look forward to hearing from you shortly.
Very truly yours,
/s/ WILLIAM H. LEVAY
William H. Levay
cc:
Tae Heum Jeong, Chief Financial Officer
2011-01-19 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
formcorresp.htm
January 19, 2011
Mr. Mark Brunhofer
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Re:
Rexahn Pharmaceuticals, Inc.
Form 10-K for the year ended December 31, 2009
Filed March 31, 2010
File No. 001-34079
Dear Mr. Brunhofer:
On behalf of Rexahn Pharmaceuticals, Inc. (the “Company”), this letter responds to comments made by the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in the Staff’s letter to Mr. Jeong dated December 21, 2010. Set forth below are the Staff’s comments in bold type, with each comment followed by the Company’s response.
Staff’s Comment and Company’s Response
Research and Development Projects, page 37
1. Please revise your disclosures as proposed in response to comment three to also quantify the research and development expenses that were incurred for the projects identified during each period that are presented in the financial statements.
The Company will add the following table to the disclosures:
Years Ended December 31,
Project Name
2009
2008
Cumulative from March 19, 2001 (Inception) to December 31, 2009
Clinical Candidates
Archexin
$
800,000
$
500,000
$
6,000,000
Serdaxin
200,000
400,000
1,000,000
Zoraxel
200,000
500,000
1,000,000
Preclinical Compounds
RX – 3117
250,000
50,000
300,000
Other Preclinical Compounds
200,000
250,000
1,250,000
$
1,650,000
$
1,700,000
$
13,300,000
Mr. Mark Brunhofer
January 19, 2011
Page 2
Financial Statements
Notes to the Financial Statements
9. Common Stock, page F-15
2. We acknowledge your response to our previous comment five and your separate assessment in your letter dated December 3, 2010. We are still evaluating your assessment that the anti-dilution rights associated with common stock should be accounted for as a liability under ASC 480-10-25-14. In your December 3, 2010 letter, you indicate that even if liability accounting under ASC Topic 480 is inappropriate, you would be required to account for this provision as a derivative liability under ASC Topic 815. In this regard, please explain to us why you believe this provision would be met settleable under ASC 815-10-15-83 and 15-99 through 15-139 when it appears that you must settle the provision gross by issuing shares.
In our December 3, 2010 letter, we addressed that the hierarchy of accounting considerations related to the classification and measurement of the financial instruments requires the application of ASC Topic 815 only if the financial instruments are not considered to be within the scope of ASC Topic 480. In our response, we concluded the anti-dilution put was within the scope of ASC Topic 480, so ASC Topic 815 was not applicable. Accordingly, we did not perform an analysis to determine whether the anti-dilution put would be a liability if ASC 815 had been considered applicable.
We did consider whether combination of the put and the common stock would be necessary under ASC Topic 815 as required within the guidance of ASC Paragraph 480-10-25-15, however, since this provision relates to the combination of two derivatives and the common stock was not considered a derivative, combination was not required.
2
Mr. Mark Brunhofer
January 19, 2011
Page 3
3. We acknowledge your representation in response to our previous comment five that the warrants should have been reclassified as liabilities at January 1, 2009 upon the adoption of the new guidance beginning at ASC 815-40-15-5. Please also provide us you analysis to support that these warrants should not have been reflected as liabilities upon issuance. Please reference the authoritative literature you relied upon to support your accounting.
After further consideration of the Fundamental Transaction provision in the warrant agreements, we have reassessed the conclusion that the warrants achieved equity classification at inception and determined that the warrants would require liability classification at inception.
The warrant agreements contain a provision in which the holders may request to receive cash equal to the Black-Scholes values of the remaining unexercised portion of the warrant if the Fundamental Transaction results in a rule “Rule 13e-3 transaction” in which the consideration issued consisted of principally of cash or stock in a non-public company. We first assessed whether the warrants were within the scope of ASC 480.
Since the warrant agreements give the holder the right to receive cash upon the occurrence of a Fundamental Transaction, we have determined that they would be considered liabilities at inception. ASC Paragraph 480-10-55-31 provides that warrants for shares that contain a written put option are liabilities under ASC Topic 480 because the warrants embody obligations to repurchase the issuers shares and may require a transfer of assets. ASC Topic 480-10-25-9 further clarifies that the phrase requires or may require encompasses instruments that either conditionally or unconditionally obligate the issuer to transfer assets. As such, warrants in which the transfer of assets is conditional on a defined contingency, such as a Fundamental Transaction, would require liability accounting.
The revised materiality analysis that considers liability classification at inception is included in Exhibit A attached hereto.
4. Your materiality assessment provided in your December 3, 2010 response on the warrants and the anti-dilution rights associated with common stock appears to indicate that the related errors are, at a minimum, quantitatively material to your financial statements.
·
Please revise your materiality assessment to separately quantify the financial impact of the error for your warrants and for the anti-dilution rights associated with common stock.
·
Please provide the impact for each error by quarter for 2009 and 2010.
·
Please revise your assessment to also include the impact on your total liabilities.
·
Assuming you can substantiate that the warrants should not have been accounted for as liabilities upon issuance, as requested in the preceding comment, please provide the fair values assigned to the warrants at issuance, upon the adoption of the provisions of EITF 07-5 on January 1, 2009 and at each quarterly balance sheet date starting at March 31, 2009.
3
Mr. Mark Brunhofer
January 19, 2011
Page 4
·
Please provide the fair values assigned to the anti-dilution rights associated with common stock upon issuance and for the following subsequent balance sheet dates:
o
December 31, 2007, 2008 and 2009
o
Each quarter end in 2009 and 2010.
The information requested in each of the five bullet points above are included in the exhibit attached to this response. For the fourth bullet point above, see response 3 above. As a result of that response, we have valued the warrants as liabilities as of issuance in Exhibit A attached hereto.
As a result of valuing the 2007 and 2008 warrants as of date issuance and determining that the 2009 warrants should be considered liabilities, the Company reviewed its materiality discussion contained in its December 3, 2010 response to the Commission. The Company still believes that the qualitative factors discussed in the response are still applicable.
·
Regarding the fair values assigned in the preceding two bullets, please explain to us how you computed the fair values. Please tell us what valuation models you used to determine fair values and provide the assumptions used in those models. To the extent you use the Black-Scholes option pricing model please explain to us why you use that model, instead of a binomial or lattice pricing model to value your warrants. In this regard the Black-Scholes model does not take into account the warrants’ down-round protection. It appears to us that the price adjustment feature would add value to the warrant for which the binomial or lattice models are better suited.
To compute the fair value of the warrants we utilized a Black-Scholes-Merton option model; however, the exercise price entered into the model was adjusted downward to incorporate the additional value associated with the down-round protection. The Black-Scholes-Merton option model comprises two components: intrinsic value and time value. We believe the down-round protection feature operates as a contingent put option on the enterprise value of the company. Lowering the exercise price for an estimate of the enterprise value put, on a per share basis, incorporates the value of the down-round protection into the Black-Scholes-Merton model. That is, the lowered exercise price has the effect of increasing the intrinsic value.
We assumed that a market participant would consider the probability of the occurrence of a future exercise price adjustment when determining the value to be assigned to warrants with down-round protection. Since anti-dilution risk is present when the trading market price is below or projected to be below the exercise price, it was assumed that a market participant would assign greater value to the down-round protection when the warrants are out of the money.
Inputs into the Black-Scholes-Merton model included the trading market price, the expected term, the risk free rate, stock price volatility and an exercise price which was adjusted downward to encompass the fair value of the down-round protection. Current accounting literature does not require a specific valuation model be used, rather, it expressly allows for the use of models that take into account all of the unique features of the instrument being valued. We believe that the use of a Black-Scholes-Merton option model, with an adjustment to the exercise price input, encompasses the fair value of the down-round protection provisions and provides a reliable estimate of the fair value of the warrants. Accordingly, we did not consider use of a binomial or lattice model to be necessary.
4
Mr. Mark Brunhofer
January 19, 2011
Page 5
5. We acknowledge your response to our previous comment six. Please explain to us why the provision identified in the first paragraph of page 15 of your October 15, 2010 letter that permits the holder to opt for cash settlement in the event of a Fundamental Transaction does not necessitate liability accounting under ASC 815-40-25-7 through 25-10 and ASC 815-40-55-2 through 55-6. In addition, please provide us the proposed revised disclosure you intend to include in future periodic reports that describes the anti-dilution provisions of these warrants.
As discussed in 3 above, we reconsidered the Fundamental Transaction provision in the warrant agreements and determined that they should be recorded as liabilities at inception under the scope of ASC Topic 480. Accordingly, consideration of the warrants under ASC Topic 815 was not considered applicable. We have revised our materiality analysis accordingly.
In future periodic reports, we will provide the following language to describe the anti-dilution provisions in the warrant agreements:
The warrants issued in December 2007, March 2008, June 2009 and October 2009 each have anti-dilutive protection provisions, which include customary terms providing for adjustment of the exercise price and the number of shares in the event of stock splits, stock dividends, and pro rata distributions. The warrants issued in December 2007 and March 2008 are also subject to down-round anti-dilution protection. Accordingly, if we sell common stock or common stock indexed financial instruments below the stated exercise price, the exercise price related to these warrants will adjust to that lower amount.
In addition, all the warrants mentioned above contain a provision for net cash settlement in the event that there is a fundamental transaction (contractually defined as a merger, sale of substantially all assets, tender offer or share exchange). If any fundamental transactions occurs in which the consideration issued consists principally of cash or stock in a non-public company, then the Holder has the option to receive cash, equal to the Black-Scholes value of the remaining unexercised portion of the warrant. Due to this contingent redemption provision, the warrants require liability classification in accordance with FASB ASC 480-10, Distinguishing Liabilities from Equity and must be recorded at fair value each reporting period.
5
Mr. Mark Brunhofer
January 19, 2011
Page 6
In connection with responding to the foregoing comments, the Company hereby acknowledges that:
(1)
the Company is responsible for the adequacy and accuracy of the disclosure in the filing;
(2)
Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and
(3)
the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
If you have any questions with respect to the foregoing, please contact the undersigned at (240) 268-5305.
Thank you for your attention to this filing. We look forward to hearing from you shortly.
Very truly yours,
/s/ TAE HEUM JEONG
Tae Heum Jeong
Chief Financial Officer
6
Exhibit A
REXAHN PHARMACEUTICALS, INC.
ANNUAL MATERIALITY ASSESSMENT
Year ended December 31, 2007 (in thousands)
Accumulated
Deficit
Total
Equity
Net income
(loss)
Total
Liabilities
Reported in 10K
$
(24,994
)
$
6,752
$
(4,304
)
$
(1,732
)
Financial impact of error:
Dec. 17, 2007 warrants
$
(435
)
$
(1,801
)
$
(435
)
$
(1,801
)
March 20, 2008 warrants
-
-
-
-
June 5, 2009 warrants
-
-
-
-
October 23, 2009 warrants
-
-
-
-
Total warrants
(435
)
(1,801
)
(435
)
(1,801
)
Anti-dilution rights
(3,157
)
(3,157
)
287
(3,157
)
Total impact of error
$
(3,592
)
$
(4,958
)
$
(148
)
$
(4,958
)
10K amount if adjusted:
$
(28,586
)
$
1,794
$
(4,452
)
$
(6,690
)
% impact:
Dec. 17, 2007 warrants
2
%
-27
%
10
%
104
%
March 20, 2008 warrants
0
%
0
%
0
%
0
%
June 5, 2009 warrants
0
%
0
%
0
%
0
%
October 23, 2009 warrants
0
%
0
%
0
%
0
%
Anti-dilution rights
13
%
-47
%
-7
%
182
%
Total % impact
15
%
-73
%
3
%
286
%
A-1
REXAHN PHARMACEUTICALS, INC.
ANNUAL MATERIALITY ASSESSMENT
Year ended December 31, 2008 (in thousands)
Accumulated
Deficit
Total
Equity
Net income (loss)
Total
Liabilities
Reported in 10K
$
(29,906
)
$
2,705
$
(4,912
)
$
(1,409
)
Financial impact of error:
Dec. 17, 2007 warrants
$
736
$
(630
)
$
1,171
$
(630
)
March 20, 2008 warrants
120
(76
)
120
(76
)
June 5, 2009 warrants
-
-
-
-
October 23, 2009 warrants
-
-
-
-
Total warrants
856
(706
)
1,291
(706
)
Anti-dilution rights
(644
)
(4,510
)
(931
)
(4,510
)
Total impact of error
$
212
$
(5,216
)
$
360
$
(5,216
)
10K amount if adjusted:
$
(29,694
)
$
(2,511
)
$
(4,552
)
$
(6,625
)
% impact:
Dec. 17, 2007 warrants
-2
%
-23
%
-24
%
45
%
March 20, 2008 warrants
0
%
-3
%
-2
%
5
%
June 5, 2009 warrants
0
%
0
%
0
%
0
%
October 23, 2009 warrants
0
%
0
%
0
%
0
%
Anti-dilution rights
2
%
-167
%
19
%
320
%
Total % impact
-1
%
-193
%
-7
%
370
%
A-2
REXAHN PHARMACEUTICALS, INC.
ANNUAL MATERIALITY ASSESSMENT
Year ended December 31, 2009 (in thousands)
Accumulated
Deficit
Total
Equity
Net income
(loss)
Total
Liabilities
Reported in 10K
$
(36,294
)
$
8,100
$
(6,387
)
$
(1,889
)
Financial impact of error:
Dec. 17, 2007 warrants
$
801
$
(565
)
$
990
$
(565
)
March 20, 2008 warrants
119
(72
)
120
(72
)
June 5, 2009 warrants
1,578
1,573
2,495
(1,263
)
October 23, 2009 warrants
39
(3,688
)
39
(882
)
Total warrants
2,537
(2,752
)
3,644
(2,782
)
Anti-dilution rights
1,331
(98
)
1,975
(98
)
Total impact of error
$
3,868
$
(2,850
)
$
5,620
$
(2,880
)
10
2011-01-06 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
formcorresp.htm
2550 M Street NW
Washington DC 20037
(202) 457-6000
Facsimile (202) 457-6315
January 6, 2011
Hwan Kim
202-457-8025
HKim@pattonboggs.com
Mr. Mark Brunhofer
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Re:
Rexahn Pharmaceuticals, Inc.
Form 10-K for the year ended December 31, 2009
Filed March 31, 2010
File No. 001-34079
Dear Mr. Brunhofer:
On behalf of Rexahn Pharmaceuticals, Inc. (the “Company”), we hereby request that the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) grant the Company an extension for filing its response to the Staff’s comments regarding the above referenced Annual Report on Form 10-K for the year ended December 31, 2009 (“Form 10-K”) contained in the Staff’s letter to Tae Heum Jeong dated December 21, 2010. The Company expects to file its response to the Staff’s comments on the Form 10-K on or before January 21, 2011.
The Company thanks you for your consideration of the requested extension and is available to answer any questions you may have.
Respectfully submitted,
/s/Hwan Kim
Hwan Kim
2010-12-22 - UPLOAD - Opus Genetics, Inc.
December 21, 2010 Mr. Tae Heum Jeong Chief Financial Officer Rexahn Pharmaceuticals, Inc. 15245 Shady Grove Road, Suite 455 Rockville, MD 20850 Re: Rexahn Pharmaceuticals, Inc. Form 10-K for the year ended December 31, 2009 Filed March 31, 2010 File No. 001-34079 Dear Mr. Jeong: We have reviewed your October 15, 2010 and December 3, 2010 responses to our September 17, 2010 letter and have the following comments. Please respond to this letter within te n business days by providing the requested information or by advising us when you will provid e the requested response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your responses to our comments. After reviewing your response to thes e comments, we may have additional comments. Research and Development Projects, page 37 1. Please revise your disclosures as proposed in response to comment th ree to also quantify the research and development expenses that were incurred for the projects identified during each period that are presen ted in the financial statements. Financial Statements Notes to the Financial Statements 9. Common Stock, page F-15 2. We acknowledge your response to our prev ious comment five and your separate assessment in your letter dated Decemb er 3, 2010. We are still evaluating your assessment that the anti-dilution rights a ssociated with common stock should be accounted for as a liability under ASC 480-10-25-14. In your December 3, 2010 letter, you indicate that even if lia bility accounting under ASC T opic 480 is inappropriate, you would be required to account for this provisi on as a derivative liability under ASC Topic 815. In this regard, please e xplain to us why you believe this provision would be net Mr. Tae Heum Jeong Rexahn Pharmaceuticals, Inc. December 21, 2010 Page 2 settleable under ASC 815-10-15-83 and 15-99 through 15-139 when it appears that you must settle the provision gross by issuing shares. 3. We acknowledge your representation in respons e to our previous comment five that the warrants should have been reclassified as liabilities at January 1, 2009 upon the adoption of the new guidance beginning at ASC 815-40-15- 5. Please also provide us your analysis to support that these warrants should not have been reflected as liabilities upon issuance. Please reference the authoritative literatu re you relied upon to support your accounting. 4. Your materiality assessment provided in your December 3, 2010 response on the warrants and the anti-dilution rights associated with common stock appears to indicate that the related errors are, at a minimum, quantitatively material to your financial statements. • Please revise your materiality assessment to separately quantify the financial impact of the error for your warrants and for the anti-dilution rights asso ciated with common stock. • Please provide the impact for each error by quarter for 2009 and 2010. • Please revise your assessment to also in clude the impact on your total liabilities. • Assuming you can substantiate that the warra nts should not have been accounted for as liabilities upon issuance, as requested in the preceding comment, please provide the fair values assigned to the warran ts at issuance, upon the adoption of the provisions of EITF 07-5 on January 1, 2009 a nd at each quarterly balance sheet date starting at March 31, 2009. • Please provide the fair values assigned to the anti-dilution rights associated with common stock upon issuance and for the followi ng subsequent balance sheet dates: o December 31, 2007, 2008 and 2009 o Each quarter end in 2009 and 2010. • Regarding the fair values assigned in the pr eceding two bullets, pl ease explain to us how you computed the fair values. Please te ll us what valuation models you used to determine fair values and provide the assu mptions used in those models. To the extent you use the Black-Scholes option pr icing model please explain to us why you use that model, instead of a binomial or la ttice pricing model to value your warrants. In this regard the Black-Scholes model does not take into account the warrants’ down-round protection. It appear s to us that the price ad justment feature would add value to the warrant for which the binomi al or lattice models are better suited. 5. We acknowledge your response to our previous comment six. Please explain to us why the provision identified in the first paragr aph of page 15 of your October 15, 2010 letter that permits the holder to opt for cash se ttlement in the event of a Fundamental Transaction does not necessitate liability accounting under ASC 815-40-25-7 through 25- 10 and ASC 815-40-55-2 through 55-6. In a ddition, please provide us the proposed revised disclosure you intend to include in futu re periodic reports th at describes the anti- dilution provisions of these warrants. Mr. Tae Heum Jeong Rexahn Pharmaceuticals, Inc. December 21, 2010 Page 3 Please contact Kei Nakada, Staff Accountan t, at (202) 551-3659 or Mark Brunhofer, Senior Staff Accountant, at ( 202) 551-3638, if you have questions regarding these comments. In this regard, do not hesitate to contact me, at (202) 551-3679. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant
2010-12-03 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
formcorresp.htm
December 3, 2010
Ms. Keira Nakada
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Re:
Rexahn Pharmaceuticals, Inc.
Form 10-K for the year ended December 31, 2009
Schedule 14A filed April 26, 2010
File No. 001-34079
Dear Ms. Nakada:
On behalf of Rexahn Pharmaceuticals, Inc. (the “Company,” “we,” “us” or “our”), this letter responds to the oral comments made by the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) on November 11, 2010 regarding Question 5 of the Staff’s letter to Dr. Chang Ahn dated September 17, 2010, and our response letter dated October 15, 2010. Set forth below is a summary of the Staff’s oral comments in bold type, followed by our response.
Staff’s Comment and Company’s Response
As it relates to Question 5 of the comment letter dated September 17, 2010 and the response dated October 15, 2010, please document why the right to receive additional shares are considered freestanding instruments, and can be accounted for separately from the common stock issued, and therefore, the stock issued should be classified as equity. Also, please do an analysis to determine whether Topic 480 or Topic 815 applies for the classification of the right to receive additional shares. If the conclusion is that Topic 815 does not apply, please illustrate this using the guidance in paragraphs 11a and 12 of FAS 133.
As we addressed in our response dated October 15, 2010, we concluded that the anti-dilution make whole provision (the “written put”) was considered a liability under ASC Topic 480. ASC Topic 480 is only applicable to freestanding financial instruments; hence, we were first required to determine whether the written put was considered a freestanding instrument.
In the hierarchy of accounting considerations related to the classification and measurement of the financial instruments, if the financial instruments are not considered to be within the scope of ASC Topic 480, then other accounting standards, such as ASC Topic 815, would apply. Accordingly, we first considered whether the financial instruments were within the scope of ASC Topic 480.
Ms. Keira Nakada
December 3, 2010
Page 2
As outlined in the Securities Purchase Agreement, the written put operates as follows:
If, at any time prior to the second anniversary of the Closing Date, the Company issues additional shares of stock at an effective price that is less than $1.40, as adjusted for stock dividends, combinations, splits and recapitalizations, then we are required to issue to the purchaser an additional number of shares of common stock equal to (i) the quotient of the purchase price divided by the diluted purchase price minus (ii) the initial shares, as adjusted by the Company for any stock dividend, combination, split, recapitalization.
Accordingly, if we enter into a dilutive issuance, the purchaser receives additional shares of common stock based on a formula which includes the number of initial shares; however, the initial shares do not change. In addition, according to the terms of the agreement, the purchaser, as defined in the Securities Purchase Agreement by name, is entitled to the additional shares of common stock issued upon a dilutive issuance. Therefore, even if the purchaser assigns their initial shares to a third party, the purchaser would be entitled to the additional shares to be issued upon a dilutive issuance by virtue of their right under the Securities Purchase Agreement.
As defined in the Glossary for ASC Topic 480, a freestanding instrument is a financial instrument that meets either of the following conditions:
(a)
It is entered into separately and apart from any of the entity’s other financial instruments or equity transactions
(b)
It is entered into in conjunction with some other transaction and is legally detachable and separately exercisable
We have concluded with the assistance of counsel that the anti-dilution rights granted in Section 5.7(a) of the Securities Purchase Agreements dated December 17, 2007 and March 20, 2008 are considered severable and freestanding from the shares of common stock issued pursuant to the agreements. The Securities Purchase Agreements were structured to provide the Purchasers with contractual rights to receive additional shares of Common Stock, upon the occurrence of a dilutive issuance, without regard to whether the Purchasers continue to own the initial shares of common stock so long as the agreements remain in effect. In making the determination that the anti-dilution provisions were legally detachable and separately exercisable, we considered the following:
1.
The anti-dilution provisions in Section 5.7(a) use a formula to calculate the Make-Whole Number which does not use or reference the Purchaser’s current holdings of common stock, but instead refers to the number of initial shares of common stock purchased by the purchaser, as adjusted for traditional anti-dilution provisions such as stock splits, dividends, recapitalizations and the like (the “initial adjusted shares”). Hence, during the period in which the anti-dilution provisions are effective, the number of shares that would be received by the purchaser is dependent on the number of initial adjusted shares and not their current holdings of common stock. This formula supports the determination that the anti-dilution right is a separate contractual right that exists separate and apart from the purchasers continued ownership of the common stock.
Ms. Keira Nakada
December 3, 2010
Page 3
2.
The Securities Purchase Agreement provides the Purchasers with the right to sell their shares of common stock to a third party once the sale is in compliance with the Securities Act of 1933; however, the transfer of the anti-dilution right requires the Company to affirmatively approve the transfer in accordance with Section 7.5 of the Agreement.
3.
The only connection between the anti-dilution right and the common stock issued pursuant to the Agreements is in the survival portion of Section 7.8 in which the representations, warranties and covenants (including the anti-dilution rights) cease to be effective once the Purchaser sells or transfers 50% or more of the shares of common stock purchased. Accordingly, a Purchaser could sell or transfer up to 49% of the shares of common stock issued pursuant to the Agreements and still receive the full Make Whole Number of shares as provided in Section 5.7 of the Agreement.
Pursuant to the terms of the Securities Purchase Agreements, the written put is legally detachable. In addition, any shares of common stock issued due to a dilutive issuance are payable to the initial purchaser; hence, the written put is considered separately exercisable since the purchaser could retain the shares paid in accordance with the written put even if they assign their initial shares of common stock to a third party. Accordingly, the common stock and the written put could be exercised separately. Since the written put was entered into in conjunction with the sale of common stock and it is legally detachable and separately exercisable, it meets the definition of a freestanding instrument under ASC Topic 480.
We also considered whether the written put should be accounted for separately or combined with the initial shares of common stock when determining the proper accounting for the instruments. ASC Paragraph 480-10-25-15 specifies that a freestanding financial instrument that is within the scope of ASC Topic 480 is prohibited from being combined with another freestanding financial instrument unless the combination is required under the provisions of ASC Topic 815. Rather, the instruments would be evaluated separately on a contract-by-contract basis for purpose of applying ASC Topic 480.
ASC Topic 815 generally does not provide for combination of separate financial instruments to be evaluated as a unit unless two or more derivative instruments have been entered into in lieu of a structured transaction in an effort to circumvent other applicable GAAP. In order to determine if ASC Topic 815 was applicable, we first considered whether the instruments met the definition of derivative instruments. The written put meets the definition of a derivative instrument because it contains an underlying variable, a notional amount, no initial net investment and it requires net settlement. An outstanding share of common stock, however, is not a derivative instrument. Accordingly, we determined the transaction was not within the scope of ASC Topic 815 because it involved only one derivative instrument, the written put, which was considered to be a freestanding instrument.
Ms. Keira Nakada
December 3, 2010
Page 4
In addition, ASC Topic 480 provides examples of certain instruments that are outside the scope of ASC Topic 480 including the issuance of puttable stock or a collar with an outstanding share of common stock. When a written put feature and an outstanding share of common stock are considered two separate freestanding instruments, then only the written put would be within the scope of ASC Topic 480 and the outstanding share would be outside the scope. ASC Paragraph 480-10-25-15 provides a specific example which we believe to be comparable to our transaction in which a freestanding written put option that is classified as a liability under ASC Topic 480 should not be combined with an outstanding equity share. Since our common stock is not puttable stock and the written put is a freestanding instrument, we analyzed the common stock and the written put separately rather than combining the two financial instruments as a unit.
After determining that the written put was a freestanding instrument, we analyzed the written put and the common stock separately under the guidance of ASC Topic 480 to determine if they required liability classification. ASC Paragraph 480-10-25-14 provides that a financial instrument, other than an outstanding share, that embodies a conditional obligation that the issuer may settle by issuing a variable number of its equity shares should be classified as a liability if at inception, the monetary value of the obligation is based solely or predominantly on one of three criteria. As outlined further in our response dated October 15, 2010, we concluded that the written put met the requirements for liability classification because it met two of the required criteria: 1) its value moves inversely with the value of the underlying common stock which, under ASC Topic 480, is not consistent with the general concepts or criterion for equity classified financial instruments and 2) the written put involved a fixed monetary amount known at inception. We analyzed the common stock separately and determined there were no terms or conditions associated with the common stock that warranted classification outside of stockholder’s equity pursuant to ASC Topic 480. Accordingly, the written put was required to be classified as a liability and recorded at fair value each reporting period, while the common stock achieved equity classification at inception.
As addressed in ASC Paragraph 815-40-15-3(e), the hierarchy of accounting considerations related to the classification and measurement of the financial instruments requires the application of ASC Topic 815, only if the financial instruments are not considered to be within the scope of ASC Topic 480. Since the written put was within the scope of ASC Topic 480, further analysis under ASC 815 is not applicable.
Ms. Keira Nakada
December 3, 2010
Page 5
In evaluating the materiality of the affects of accounting for both the anti-dilution features (“AD”) associated with the shares of common stock and the freestanding warrants as liabilities, the Company followed the guidance provided in Staff Accounting Bulletin No. 99-Materiality (“SAB 99”). Based upon the analysis detailed below, the Company has concluded that, in the aggregate, the affect of accounting for the AD features as a liability is both quantitatively and qualitatively immaterial and, as a result, the restatement its financial statements is not warranted.
Rexahn is a clinical stage biopharmaceutical company that falls within the guidance of ASC 915, “Development Stage Entities.” The Company’s core business is the development of its drug candidates. It has not generated any product revenues and has incurred negative cash flows from operations since its inception and expects to incur substantial losses in the future as a result of its emphasis on the development of it current and new drug candidates. It has been dependent on the private placement of its stock to fund its research and development efforts and has no debt on its balance sheet.
In coming to its conclusion, the Company has assessed both quantitative and qualitative factors.
The quantitative analysis below details the impact on, accumulated deficit, equity and net loss since the December 2007 common stock placement. The impact is variable due to the required mark-to-market adjustments at each period end, which results in swings (both positive and negative) in the amounts of the Company’s, accumulated deficit, equity and net loss.
The table below shows the impact on the results for the years ended December 31, 2007, 2008 and 2009 and for the nine months ended September 30, 2010. The impact is greatest in 2007 and becomes less significant in 2008 and 2009. By the third quarter of 2010, the impact was even less significant quantitatively. This was due to a combination of factors, which included a smaller mark-to-market adjustment and the fact that the AD features associated with both the December 2007 and March 2008 had expired prior to September 30, 2010. The warrants have a three-year exercise period. Some of the warrants were exercised in early 2010. The Company believes that because the AD features have expired and the remaining warrants will either be exercised or will expire within the next few months, the future impact will be minimal.
Ms. Keira Nakada
December 3, 2010
Page 6
December 31, 2007 ($000’s)
As Reported
If Adjusted
Dollar Impact
% Impact
Accumulated Deficit
$
(24,994
)
$
(28,151
)
$
(3,157
)
(13
%)
Total Equity
$
6,752
$
3,595
$
(3,157
)
(47
%)
Net Loss
$
(4,304
)
$
(7,461
)
$
(3,157
)
(73
%)
December 31, 2008 ($000’s)
As Reported
If Adjusted
Dollar Impact
% Impact
Accumulated Deficit
$
(29,906
)
$
(34,415
)
$
(4,509
)
(15
%)
Total Equity
$
2,705
$
(1,804
)
$
(4,509
)
(150
%)
Net Loss
$
(4,912
)
$
(6,264
)
$
(1,352
)
(28
%)
December 31, 2009 ($000’s)
As Reported
If Adjusted
Dollar Impact
% Impact
Accumulated Deficit
$
(36,294
)
$
(39,465
)
$
(3,171
)
(9
%)
Total Equity
$
8,100
$
7,364
$
(736
)
(9
%)
Net Loss
$
(6,387
)
$
(8,428
)
$
(2,041
)
(32
%)
Nine Months Ended September 30, 2010 ($000’s)
As Reported
If Adjusted
Dollar Impact
% Impact
Accumulated Deficit
$
(43,290
)
$
(46,984
)
$
(3,694
)
(9
%)
Total Equity
$
15,892
$
15,247
$
(645
)
(4
%)
Net Loss
$
(6,996
)
$
(7,518
)
$
(522
)
(7
%)
The Company considered the following qualitative factors in assessing the materiality of the financial statement misstatement:
1.
The Company discloses, in its filings with the Commission, that its core business, the development of drug candidates, is not currently profitable and may never become profitable. It also discloses that even if the Company is successful in developing and commercializing one or more of the drug candidates, it expects to incur substantial losses in the foreseeable future and may never become profitable.
2.
The Company has entered into several private placements of its stock over the last three years. The potential dilutive impact of the exercise of the AD features and the warrants contained in the December 2007 and March 2008 placements were disclosed as part of
2010-11-24 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
formcorresp.htm
2550 M Street NW
Washington DC 20037
(202) 457-6315
_____________
Facsimile (202) 457-6315
November 24, 2010
Hwan Kim
202-457-8025
HKim@pattonboggs.com
Ms. Keira Nakada
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Re: Rexahn Pharmaceuticals, Inc.
Form 10-K for the year ended December 31, 2009
Schedule 14A filed April 26, 2010
File No. 001-34079
Dear Ms. Nakada:
On behalf of Rexahn Pharmaceuticals, Inc. (the “Company”), we hereby request that the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) grant the Company an extension for filing its response to the Staff’s oral comments received on November 11, 2010 regarding Question 5 of the Staff’s letter to Dr. Chang Ahn dated September 17, 2010 and the Company’s response letter dated October 15, 2010. The Company expects to file its response to the Staff’s oral comments on or before December 3, 2010.
The Company thanks you for your consideration of the requested extension and is available to answer any questions you may have.
Respectfully submitted,
/s/Hwan Kim
Hwan Kim
2010-10-15 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
formcorresp.htm
October 15, 2010
Ms. Keira Nakada
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Re:
Rexahn Pharmaceuticals, Inc.
Form 10-K for the year ended December 31, 2009
Schedule 14A filed April 26, 2010
File No. 001-34079
Dear Ms. Nakada:
On behalf of Rexahn Pharmaceuticals, Inc. (the “Company”), this letter responds to comments made by the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) regarding the above referenced Annual Report on Form 10-K for the year ended December 31, 2009 (“Form 10-K”) and Schedule 14A filed on April 26, 2010 (“Schedule 14A”), in the Staff’s letter to Dr. Chang Ahn dated September 17, 2010. Set forth below are the Staff’s comments in bold type, with each comment followed by the Company’s response.
Form l0-K for the fiscal year ended December 31. 2009
Intellectual Property, page 18
1. Please provide proposed disclosure to be included in your Form 10-K for 2010 which includes the following information with regard to your intellectual property:
·
The number of material patents that you own;
·
The number of material patents that you have licensed;
·
The jurisdictions in which your material patents have been granted; and
·
The indication or product candidate to which each of your material patents relate.
RESPONSE:
The Company proposes to include the following disclosure in its Form 10-K for 2010 with regard to the Company’s intellectual property:
Ms. Keira Nakada
October 15, 2010
Page 2
Proprietary patent and intellectual property (IP) protection for our drug candidates, processes and know-how is important to our business. We diligently prosecute and defend our patents and proprietary technology. Rexahn has several U.S. and international patents issued for IP coverage of our drug candidates in cancer, CNS, behavioral and mood disorders, neuroprotection and sexual dysfunction, effective until 2020 to 2025. Additional U.S., Europe, and foreign patents are pending. We also rely upon trade secrets, know-how, continuing technological innovation and licensing opportunities to develop and maintain our competitive position.
In particular, Rexahn owns US patents for its Clinical and Pre-clinical candidates including US Patents related to RX-1792, RX-3117, Archexin and RX-0047. In addition, Rexahn owns patents in South Korea related to RX-1792, RX-3117, and in Switzerland, Germany, Spain, France, Great Britain, Italy, and Poland related to RX-3117. Additional US and/or foreign patent applications related to RX-3117, RX-8243, RX-5902, RX-21101 and RX-21202 are pending. Rexahn also owns pending US and foreign patent applications related to Zoraxel and Serdaxin.
In February 2005, we licensed-in CNS-related intellectual property from Revaax Pharmaceuticals, LLC. The intellectual property rights acquired cover use of certain compounds for anxiety, depression, aggression, cognition, Attention Deficit Hyperactivity Disorder, neuroprotection and sexual dysfunction. See "Collaboration and License Arrangements" in this Item for additional information.
Rexahn is the exclusive licensee of three US Patents, and patents in Australia, Mexico, New Zealand, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, the Netherlands and Sweden, related to Serdaxin. Rexahn is the exclusive licensee of one US Patent related to Zoraxel. Rexahn is also the exclusive licensee of additional pending US and/or foreign patent applications related to Zoraxel and/or Serdaxin.
Collaboration and License Arrangements, page 18
2. Please provide proposed disclosure to be included in your form 10-K for 2010 which includes the material terms of each of your material collaboration and license arrangements. In particular, for your license agreement with Revaax Pharmaceuticals LLC in relation to the licensing and development of certain compounds including Serdaxin and Zoraxel, please provide proposed disclosure which includes the following information:
·
Initial license fee;
·
Range of royalties (within a ten-percent range); and
Ms. Keira Nakada
October 15, 2010
Page 3
·
Aggregate potential milestone payments;
For your collaborative research agreement with Rexgene Biotech Co., Ltd. in relation to the development of Archexin, please provide proposed disclosure which· includes the termination provisions of the agreement.
RESPONSE:
The Company proposes to include the following disclosure in its Form 10-K for 2010 with regard to the Company’s collaboration and license arrangements:
Collaboration and License Arrangements
We have numerous collaborative research and development relationships with universities, research institutions and other organizations. A description of these material relationships is below.
Teva Pharmaceutical Industries (Teva). On September 21, 2009, we closed on licensing and stock purchase agreements with Teva for the development of our novel anti-cancer compound, RX-3117. RX-3117 is a small molecule, new chemical entity (NCE), nucleoside compound that has an anti-metabolite mechanism of action, and has therapeutic potential in a broad range of cancers including colon, lung and pancreatic cancer. The companies reached an agreement with respect to the commercialization and development of RX-3117, under which Teva purchased 3,102,837 shares of our common stock for $3.5 million. We will be eligible to receive additional development, regulatory and sales milestone payments. In addition, we will be eligible to receive royalties on net sales worldwide. Pursuant to the purchase agreement, Teva has the option to purchase additional shares of Rexahn’s common stock. If Teva exercises such option, it will acquire additional shares of common stock having a value of $750,000 plus such additional amount equal to the amount, if any, then anticipated to be required to complete the development of RX-3117. The price for any such common stock purchased by Teva will equal 120% of the closing price of the common stock on the last trading day prior to the date of purchase; provided, that if the number of shares subject to purchase by Teva would exceed 7% of the total outstanding common stock upon the completion of such purchase, then the aggregate purchase price shall remain the same, but the number of shares subject to purchase will be reduced so as not to exceed such amount.
TheraTarget, Inc. (TheraTarget). On December 14, 2009, Rexahn and TheraTarget, a developer of innovative polymer therapeutics for the treatment of cancer, formed a joint research collaboration agreement. Under the terms of the agreement, TheraTarget will synthesize and supply us with polymer-drug conjugate products, which are part of our polymer-based nanomedicine portfolio.
Korea Research Institute of Chemical Technology (KRICT). On July 13, 2009, we entered a licensing partnership with the Korea Research Institute of Chemical Technology (KRICT) to develop a synthetic process for Quinoxalines compounds. These compounds provide selective toxicity towards hypoxic cells – cells found in solid tumors and that are resistant to anticancer drugs and radiation therapy, making them a potential treatment for solid tumors.
Ms. Keira Nakada
October 15, 2010
Page 4
The University of Maryland Baltimore (UMB). On February 1, 2007, we entered into a Maryland Industrial Partnership Agreement with the UMB to collaborate with and sponsor the joint development of polymer-drug conjugates for cancer therapy, for the targeted delivery of cancer drugs. Intellectual property made or developed under this agreement is jointly owned by us and UMB. This project is currently on-going.
Revaax Pharmaceuticals LLC (Revaax). On February 10, 2005, we licensed on an exclusive basis, with the right to sublicense, all of the IP of Revaax, which includes four patents and multiple patent applications, with respect to certain chemical structures that have demonstrated in pre-clinical research the potential to treat certain behavioral disorders, such as anxiety, depression and cognitive disorders (the “Licensed Products”). This agreement expires upon the expiration of the royalty term for all Licensed Products in all countries, which is no earlier than August 2020 and could extend to August 2024. This agreement provides for an initial license fee and milestone payments based on the initiation of pivotal trials for disease treatment indication for licensed products.
Furthermore, we will pay Revaax a specified fee for each Licensed Product under the agreement upon receipt of the first approval by any federal, state or local regulatory, department, bureau or other governmental entity necessary prior to the commercial sale of the Licensed Product (“Marketing Approval”). Notwithstanding the milestone payment arrangement described above, we are not obligated to make any milestone payment with respect to milestone events for which we receive sublicense revenues and are obligated to pay Revaax a percentage of such sublicense revenues, as well as royalties for sales of Licensed Products based on net sales of the Licensed Products.
Under the agreement we agreed to pay Revaax an initial license fee of $375,000, payable in 8 installments of $46,875 each over a period of 2 years from February 10, 2005. In addition, we also agreed to pay Revaax a number of one time payments within 30 days of the first achievement of the following milestones, (a) $500,000 with respect to the dosing of the first patient in the first Phase III clinical trial or other controlled study in humans of the efficacy and safety with regards to any product the manufacture, use or sale of which is covered by a any claim of an issued and unexpired patent (the “Pivotal Trial”) within the Licensed Products, and $250,000 with respect to the dosing of the first patient, in the second, third, fourth and fifth Privotal Trial, and $125,000 with respect to the dosing of the first patient in any subsequent Pivotal Trial, (b) $5,000,000 with respect to the receipt of Marketing Approval, and $2,500,000 with respect to the receipt of the second, third, fourth and fifth Marketing Approval for a Licensed Product, and $1,250,000 with respect to any subsequent Marketing Approval. We are not under an obligation to make any payments with respect to milestone events for which we receive any non-creditable upfront fees or milestone payments received by us from any sublicense an in connection with the development and commercialization of a Licensed Product by such sublicense, less any license fees, milestone payments, or royalties payable by us to a third party under any technology acquisition agreement in connection with the development or commercialization of a Licensed Product, but specifically excluding any royalties revenues derived from any sublicense agreements. Also, at our option, we may elect to make up to 50% of any milestone payment in shares of our common stock with the number of shares determined by dividing the amount of the milestone portion by the fair market value of one share of common stock, as reasonably determined by our board of directors.
Ms. Keira Nakada
October 15, 2010
Page 5
We also agreed to pay Revaax royalty payments on all sales of the Licensed Product made to third parties. The royalties consist of (a) 4% of the portion of the aggregate net sales of the Licensed Product during a calendar year that is equal to or less than $250,000,000, (b) 5% of the portion of aggregate net sales of the Licensed Product in a calendar year that is greater than $250,000,000 but equal to or less than $500,000,000, (c) 6% of the aggregate sales of the Licensed Product during a calendar year that is greater than $500,000,000 but equal to or less than $750,000,000, and (d) 7% of the aggregate net sales of the Licensed Product during a calendar year exceeds $750,000,000. The royalty payment obligations will expire on the later of (a) expiration of any claim of an issued and unexpired patent within the Licensed Products which has not been held unenforceable or invalid and which has not been disclaimed or admitted to be invalid or unenforceable through reissue or otherwise (the “Valid Claim”) that, for the licenses granted under the Agreement, would be infringed by the sale of such Licensed Product, and (b) 10 years after the first commercial sale of the Licensed Product by us, our affiliates or sublicenses anywhere in the world.
Upon expiration of the Valid Claim for a particular Licensed Product in a particular country, each of the royalty fees will be reduced by 50% for the remainder of the term remaining on our royalty payment obligations, resulting in royalty fees of 2%, 2.5%, 3%, and 3.5%, as applicable.
Rexgene Biotech Co., Ltd. (Rexgene). On February 6, 2003 we entered into a Research Collaboration Agreement with Rexgene to collaborate in the development of a cancer treatment therapeutic compound denominated RX-0201(Archexin). We jointly agreed to develop a research and development plan for the purpose of registering RX-0201 for sale and use in the Republic of Korea and other Asian countries. The research and development plan would include clinical and animal trials to be conducted in the United States, clinical trials would be conducted in Korea and other Asian countries. We agreed to provide as its initial contribution to the joint development and research, a license to all technology related to RX-0201. Rexgene agreed to provide, as its initial contribution $1,500,000 to be used by us in further development of RX-0201. Rexgene agreed to pay us a royalty fee of 3% of net sales of all licenses technology related to RX-0201 in all countries in Asia by Rexgene or any sublicensee of Rexgene.
Ms. Keira Nakada
October 15, 2010
Page 6
The agreement was scheduled to expire upon the last to expire of all US and foreign patents presently or in the future issued that cover RX-0201, or if no licensed patent is issued within 20 years from the date of execution of the agreement. A breach of the agreement by either party will afford the non-breaching party the right to terminate the agreement upon 90 days written notice of termination specifying the obligations breached, provided that within said 90 days the breaching party does not remedy the breach.
Research and Development Projects, page 37
3. Please provide us proposed disclosure to be included in future filings of the research and development expenses incurred during each period presented by product.
RESPONSE:
The Company proposes to include the following disclosure in its future filings:
Research and Development Projects
Research and development expenses are expensed as incurred. Research and development expenses consist primarily of salaries and related personnel costs, costs to acquire pharmaceutical products and product rights for development and amounts paid to contract research organizations, hospitals and laboratories for the provision of services and materials for drug development and clinical trials. Costs incurred in obtaining the license rights to technology in the research and development stage and that have no alternative future uses are expensed as incurred. Our research and development programs are related to our three clinical stage lead drug candidates, Archexin, Serdaxin and Zoraxel and pre-clinical stage nano drug candidates, RX-0201-Nano, RX-0047-Nano and Nano-polymer Anticancer Drugs. Each of our lead drug candidates is in various stages of completion as described below. As we expand our clinical studies, we will enter into additional development agreements. Significant additional expenditures will be required if we complete our clinical trials, start new trials, apply for regulatory approvals, continue development of our technologies, expand our operations and bring our produc
2010-10-01 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
corresp.htm
2550 M Street NW
Washington DC 20037
(202) 457-6000
__________
Facsimile (202) 457-6315
October 1, 2010
Hwan Kim
202-457-8025
HKim@pattonboggs.com
Ms. Keira Nakada
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Re:
Rexahn Pharmaceuticals, Inc.
Form 10-K for the year ended December 31, 2009
Schedule 14A filed April 26, 2010
File No. 001-34079
Dear Ms. Nakada:
On behalf of Rexahn Pharmaceuticals, Inc. (the “Company”), we hereby request that the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) grant the Company an extension for filing its response to the Staff’s comments regarding the above referenced Annual Report on Form 10-K for the year ended December 31, 2009 (“Form 10-K”) and Schedule 14A filed on April 26, 2010 (“Schedule 14A”) contained in the Staff’s letter to Dr. Chang Ahn dated September 17, 2010. The Company expects to file its response to the Staff’s comments on the Form 10-K and Schedule 14A on or before October 15, 2010.
The Company thanks you for your consideration of the requested extension and is available to answer any questions you may have.
Respectfully submitted,
/s/Hwan Kim
Hwan Kim
2010-09-17 - UPLOAD - Opus Genetics, Inc.
September 17, 2010 Dr. Chang Ahn Chairman and Chief Executive Officer Rexahn Pharmaceuticals, Inc. 15245 Shady Grove Road, Suite 455 Rockville, MD 20850 Re: Rexahn Pharmaceuticals, Inc. Form 10-K for the year ended December 31, 2009 Schedule 14A filed April 26, 2010 File No. 001-34079 Dear Dr. Ahn: We have reviewed your filings and have th e following comments. In our comments, we ask you to provide us with information so we may better underst and your disclosure. Please respond to this letter within te n business days by providing the requested information, or by advising us when you will provide the requested response. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the fo rm type label CORRESP that keys your responses to our comment. After reviewing the information provided, we may have additional comments and/or request that you amend your filing. Form 10-K for the fiscal year ended December 31, 2009 Intellectual Property, page 18 1. Please provide proposed disclo sure to be incl uded in your Form 10-K for 2010 which includes the following information with re gard to your intellectual property: • The number of material patents that you own; • The number of material patents that you have licensed; • The jurisdictions in which your material patents have been granted; and • The indication or product candidate to which each of your material patents relate. Collaboration and License Arrangements, page 18 2. Please provide proposed disclo sure to be incl uded in your Form 10-K for 2010 which includes the material terms of each of your material collaboration and license arrangements. In particular, for your licen se agreement with Revaax Pharmaceuticals LLC in relation to the licensing and de velopment of certain compounds including Dr. Chang Ahn Rexahn Pharmaceuticals, Inc. September 17, 2010 Page 2 Serdaxin and Zoraxel, please provide proposed disclosure which includes the following information: • Initial license fee; • Range of royalties (within a ten-percent range); and • Aggregate potential milestone payments; For your collaborative research agreement w ith Rexgene Biotech Co., Ltd. in relation to the development of Archexin, please provi de proposed disclosure which includes the termination provisions of the agreement. Research and Development Projects, page 37 3. Please provide us proposed disclosure to be incl uded in future filings of the research and development expenses incurred during each period presented by product. Signatures, page 52 4. We note that your Form 10-K does not appear to have been signed by an individual identified as your controller or principal accounting officer. If an individual who has already signed your Form 10-K serves in this capacity, please advise us of this fact and confirm that your next Form 10-K will includ e this additional capaci ty in the signature block for this individual. If your principal accounting officer or controller has not signed your Form 10-K, your filing will need to be amended to include the signature of this individual as required u nder General Instruction D to Form 10-K. Financial Statements Notes to the Financial Statements 9. Common Stock, page F-15 5. It appears, based on your filed exhibits, th at the Securities Purchase Agreements and warrant agreements for your Decembe r 18, 2007 and March 20, 2008 unit offerings provide for anti-dilution protection whereby ad ditional shares and warrants, at a reduced exercise price, are issued if you issue equity instrument s at prices lower than the individual unit offering prices. Pl ease address the following comments: • Please explain to us why these anti-diluti on make-whole provisions associated with the common stock portion of these unit o fferings are not liabi lities under ASC Topic 480. • Please explain to us why these anti-diluti on provisions associat ed with the common stock warrants were not reclassified to li abilities on January 1, 2009 with the adoption of the new guidance starting at ASC 815-40-15-5. In this regard, it appears that the Subsequent Equity Sales provision in Secti ons 9d of these warra nt agreements is similar to Example 9 at ASC 815-40-55-33 and 55-34. Dr. Chang Ahn Rexahn Pharmaceuticals, Inc. September 17, 2010 Page 3 6. It appears that the warrants issued in c onjunction with your May 19, 2009 and October 19, 2009 unit offerings were made pursuant to shelf registration statements. It also appears that the June 30, 2010 unit offering identified in your June 30, 2010 Form 10-Q was also issued pursuant to a shelf registra tion statement. Please provide us proposed disclosure to include in your future filings to clarify the operation of the anti-dilution protection provisions associated with the warran ts in these units. In this regard, please address the following, as applicable , in your proposed disclosure: • Clarify how the provisions are structured to protect a holder’s position from being diluted based on a mathematical calculation; • Describe the inputs and how th ese inputs are used in the mathematical calculation of the provision; • Clarify whether the protection also applies to the common stock issued in the units; and • Confirm separately for us that these unit o fferings do not have the same provisions as your December 18, 2007 and March 20, 2008 unit whereby additional shares and warrants are issued if you issue equity instru ments at prices lower than the individual unit offering prices. Exhibits 31. Certifications Pursuant to Rule 13a-15(e) or Rule 15d-15(e) 7. Please provide us proposed disclosure to incl ude in your future filings to revise your certifications to be presented exactly as stipul ated in Item 601(b)(31) of Regulation S-K. In this regard, please remove the titles of your certifying of ficers and the name of your company from the introductory sentence. In addition, please change the rule reference for these exhibits in the E xhibit Index. You reference Rules 13a-15(e) and 15d-15(e) when the appropriate Rules are 13a-14(a) and 15d-14(a). The former rules define disclosure controls and pro cedures, the latter rules set the requirements for filing the certifications. Schedule Def 14A filed April 26, 2010 Executive Compensation and Other Matters, page 20 Summary Compensation Table, page 20 8. We note that the value of the option award gran ted to Mr. Soni in 2008 as reflected in the 2009 Summary Compensation Table is the same as the value for the option award as reflected in your 2008 Summary Compensation Table. As su ch, it appears that the 2009 Summary Compensation Table has not been re vised to properly valu e the option awards granted to named executive officers in acco rdance with FASB ASC Topic 718. Please advise. If the option awards have not been valued in accordance with FASB ASC Topic 718, your Form 10-K will need to be amended to revise your 2009 Summary Compensation Table accordingly. Dr. Chang Ahn Rexahn Pharmaceuticals, Inc. September 17, 2010 Page 4 We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. 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 responding to our comments, please provi de a written statement from the company acknowledging that: • the company is responsible for the adequacy an d accuracy of the disclo sure in the filing; • staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and • the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States. Please contact Kei Nakada, Staff Accountan t, at (202) 551-3659 or Mark Brunhofer, Senior Staff Accountant, at ( 202) 551-3638 if you have questions regarding the processing of your response as well as any questions regarding comments on the financial statements and related matters. You may contact Bryan Pitko, Staff Attorney at (202) 551-3203 with questions on any of the other comments. In this regard, do not hesitate to cont act me, at (202) 551-3679. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant
2009-03-02 - CORRESP - Opus Genetics, Inc.
CORRESP
1
filename1.htm
corresp.htm
March 2,
2009
Tabatha
Akins, Staff Accountant
Division
of Corporation Finance
Securities
and Exchange Commission
100 F
Street, N.E.
Washington,
DC 20549
Re: Rexahn
Pharmaceuticals, Inc.
Item 4.01 Form 8-K
Filed February 23m 2009
File No. 001-34079
Dear Ms.
Akins:
We are in
receipt of your letter dated February 25, 2009 providing comments on the
referenced filing for Rexahn Pharmaceuticals, Inc. (the “Company”).
We are
concurrently filing via EDGAR Amendment No. 1 to Form 8-K, and for the
convenience of the staff of the Securities and Exchange Commission (the
“Staff”), we are providing by overnight delivery copies of this letter and
marked copies of Amendment No. 1. Amendment No. 1 as filed via EDGAR
is marked as specified in Item 310 of Regulation S-T.
In this
letter, we have recited the comments from the Staff in bold type and have
followed each comment with the Company’s responses.
1.
With respect to paragraph (iv),
please amend your filing to filing to explicitly state whether during the
Company's two most recent fiscal years and all subsequent interim periods
through February 19, 2009 there were any disagreements with the former
accountant on any matter of accounting principles or practices, financial
statement disclosure, or auditing scope or procedure, which
disagreement(s), if not resolved to the satisfaction of the former
accountant, would have caused it to make reference to the subject matter
of the disagreement(s) in connection with its
report.
Per the
conversation you had with Monica Klein, the Company’s counsel, on February 27,
2009, we believe no change is necessary as the current disclosure includes the
subsequent interim periods through the resignation.
Tabatha
Akins
March 2,
2009
Page
2.
Please amend your filing to
make the following revisions to your
disclosure;
a.
Your
reference to the "including all subsequent interim periods" is too
vague. Please amend your filing to explicitly state whether,
during your past two fiscal years through the date of engagement (February
20, 2009), you consulted Parente Randolph, LLC regarding any of the
matters outlined in Item: 304(a)(2) of Regulation
S-K.
As
requested by the Staff, the Company has revised the disclosure.
b.
With
respect to the paragraph (i), please revise your disclosure to state "the
application of accounting principles to a specified transaction, either
completed or proposed".
As
requested by the Staff, the Company has revised the disclosure.
c.
With
respect to the paragraph (ii), please revise your disclosure to state "Any
matter that was either the subject of a disagreement (as defined in
paragraph 304(a)(1)(iv) and the related instructions to this item) or a
reportable event (as described in paragraph
304(a)(1)(v))".
As
requested by the Staff, the Company has revised the disclosure.
3.
Upon amending your filing,
please include, as Exhibit 16, an updated letter from your former
accountants, lazar Levine & Felix LLP, as required by Item 304(a)(3)
of Regulation S-K. Please ensure that your former accountants
date their letter.
The
Company has included an updated letter from the former
accountants.
Tabatha
Akins
March 2,
2009
Page
3
In
connection with responding to the Staff’s comments in the February 25, 2009
letter, the Company acknowledges and agrees that:
·
The
Company is responsible for the adequacy and accuracy of the disclosure in
the filing;
·
Staff
comments or changes to disclosure in response to staff comments do not
foreclose the Securities and Exchange Commission from taking any action
with respect to the filing; and
·
The
Company may not assert staff comments as a defense in any proceeding
initiated by the Securities and Exchange Commission or any person under
the federal securities laws of the United
States.
Please
acknowledge receipt of this letter and the enclosed materials by stamping the
enclosed duplicate of this letter and returning it to Monica Klein in the
envelope provided.
We
believe that the foregoing adequately responds to your correspondence and
questions. Please direct your questions or comments to Beth Hughes
(703/760-1649). In addition, we respectfully request that you provide
a facsimile of any additional comments you may have to Monica Klein’s attention
at 730/821-8949.
Very
truly yours,
/s/
Ted T.H. Jeong
Ted
T.H. Jeong
Chief
Financial Officer
Rexahn
Pharmaceuticals, Inc.
2009-03-02 - UPLOAD - Opus Genetics, Inc.
Via Facsimile and U.S. Mail Mail Stop 6010 March 2, 2009 Mr. Ted T.H. Jeong Rexahn Pharmaceuticals, Inc. Chief Financial Officer 9620 Medical Center Drive Rockville, Maryland 20850
Re: Rexahn Pharmaceuticals, Inc.
Item 4.01 Form 8-K
Filed March 2, 2009
File No. 001-34079
Dear Mr. Jeong:
We have completed our review of your Form 8-K and have no further comments
at this time.
S i n c e r e l y ,
T a b a t h a A k i n s
Staff Accountant
2009-02-25 - UPLOAD - Opus Genetics, Inc.
Via Facsimile and U.S. Mail Mail Stop 6010 February 25, 2009 Mr. Ted T.H. Jeong Rexahn Pharmaceuticals, Inc. Chief Financial Officer 9620 Medical Center Drive Rockville, Maryland 20850
Re: Rexahn Pharmaceuticals, Inc.
Item 4.01 Form 8-K
Filed February 23, 2009
File No. 001-34079
Dear Mr. Jeong:
We have reviewed your filing and have the following comments. Where
indicated, we think you should re vise your document in response to these comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary. Please be as deta iled as necessary in your explanation. In
some of our comments, we may ask you to provi de us with more information so we may
better understand your disclosure. After re viewing this information, we may raise
additional comments. Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
Item 4.01 Form 8-K
(1) Resignation of Former Accountant.
1. With respect to paragraph (iv), please amend your filing to filing to explicitly
state whether during the Company’s tw o most recent fiscal years and all
subsequent interim periods thr ough February 19, 2009 there were any
disagreements with the former accountant on any matter of accounting principles
Mr. Ted T.H. Jeong
Rexahn Pharmaceuticals, Inc. February 25, 2009 Page 2
or practices, financial statement disclosure , or auditing scope or procedure, which
disagreement(s), if not resolved to th e satisfaction of the former accountant,
would have caused it to make refe rence to the subject matter of the
disagreement(s) in connection with its report.
(2) Engagement of New Accountant
2. Please amend your filing to make the following revisions to your disclosure:
a. Your reference to the “inc luding all subsequent interi m periods” is too vague.
Please amend your filing to explicitly state whether, during your past two
fiscal years through the date of engagement (February 20, 2009), you consulted Parente Randolph, LLC regarding any of the matters outlined in Item 304(a)(2) of Regulation S-K.
b. With respect to the paragraph (i), please revise your disclosure to state “the
application of accounting principles to a specified transaction, either
completed or proposed”.
c. With respect to the paragraph (ii), please revise your disclosure to state “Any
matter that was either the subject of a disagreement (as defined in paragraph
304(a)(1)(iv) and the related instructions to th is item) or a reportable event (as
described in paragra ph 304(a)(1)(v)).”
3. Upon amending your filing, please include, as Exhibit 16, an updated letter from
your former accountants, Lazar Levine & Felix LLP, as required by Item 304(a)(3) of Regulation S-K. Please ensure that your former accountants date
their letter.
* * * *
As appropriate, please amend your filing and respond to these comments within
five business days or tell us when you will provide us with a response. You may wish to provide us with marked copies of the amendm ent to expedite our review. Please furnish
a cover letter with your amendment that keys your responses to our comments and
provides any requested information. Detailed co ver letters greatly faci litate our review.
Please understand that we may have addi tional comments after reviewing your
amendment and responses to our comments. We urge all persons who are responsi ble for the accuracy an d adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Exchange Act of 1934 and th at they have provided all information
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
Mr. Ted T.H. Jeong
Rexahn Pharmaceuticals, Inc. February 25, 2009 Page 3
In connection with responding to our comments, please provide, in writing, a
statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
If you have any questions, please do not hesitate to call me at (202) 551-3658.
S i n c e r e l y ,
T a b a t h a A k i n s S t a f f A c c o u n t a n t