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PALATIN TECHNOLOGIES INC
Response Received
18 company response(s)
Medium - date proximity
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PALATIN TECHNOLOGIES INC
Response Received
3 company response(s)
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PALATIN TECHNOLOGIES INC
Response Received
1 company response(s)
High - file number match
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PALATIN TECHNOLOGIES INC
Response Received
1 company response(s)
High - file number match
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PALATIN TECHNOLOGIES INC
Response Received
1 company response(s)
High - file number match
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PALATIN TECHNOLOGIES INC
Response Received
2 company response(s)
High - file number match
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Company responded
2018-08-23
PALATIN TECHNOLOGIES INC
Summary
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Company responded
2019-02-07
PALATIN TECHNOLOGIES INC
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PALATIN TECHNOLOGIES INC
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2015-08-07
PALATIN TECHNOLOGIES INC
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Company responded
2015-08-13
PALATIN TECHNOLOGIES INC
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PALATIN TECHNOLOGIES INC
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2015-08-07
PALATIN TECHNOLOGIES INC
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Company responded
2015-08-13
PALATIN TECHNOLOGIES INC
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PALATIN TECHNOLOGIES INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-05-11
PALATIN TECHNOLOGIES INC
Summary
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PALATIN TECHNOLOGIES INC
Response Received
6 company response(s)
High - file number match
SEC wrote to company
2005-05-23
PALATIN TECHNOLOGIES INC
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Company responded
2005-06-28
PALATIN TECHNOLOGIES INC
References: May 23, 2005
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Company responded
2006-03-24
PALATIN TECHNOLOGIES INC
References: March 16, 2006
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2006-03-28
PALATIN TECHNOLOGIES INC
References: March 16, 2006
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Company responded
2009-03-23
PALATIN TECHNOLOGIES INC
References: March 19, 2009
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Company responded
2011-03-04
PALATIN TECHNOLOGIES INC
References: February 18, 2011
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Company responded
2011-04-07
PALATIN TECHNOLOGIES INC
References: March 23, 2011
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PALATIN TECHNOLOGIES INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-03-23
PALATIN TECHNOLOGIES INC
References: March 4, 2011
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PALATIN TECHNOLOGIES INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-02-18
PALATIN TECHNOLOGIES INC
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PALATIN TECHNOLOGIES INC
Awaiting Response
0 company response(s)
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SEC wrote to company
2010-11-05
PALATIN TECHNOLOGIES INC
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PALATIN TECHNOLOGIES INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-03-31
PALATIN TECHNOLOGIES INC
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PALATIN TECHNOLOGIES INC
Awaiting Response
0 company response(s)
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SEC wrote to company
2009-03-19
PALATIN TECHNOLOGIES INC
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PALATIN TECHNOLOGIES INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2008-02-29
PALATIN TECHNOLOGIES INC
Summary
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PALATIN TECHNOLOGIES INC
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2008-02-04
PALATIN TECHNOLOGIES INC
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Company responded
2008-02-22
PALATIN TECHNOLOGIES INC
References: February 4, 2008
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PALATIN TECHNOLOGIES INC
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2007-10-12
PALATIN TECHNOLOGIES INC
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2007-11-26
PALATIN TECHNOLOGIES INC
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PALATIN TECHNOLOGIES INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2006-03-31
PALATIN TECHNOLOGIES INC
Summary
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PALATIN TECHNOLOGIES INC
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2006-03-22
PALATIN TECHNOLOGIES INC
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Company responded
2006-03-30
PALATIN TECHNOLOGIES INC
Summary
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PALATIN TECHNOLOGIES INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2006-03-16
PALATIN TECHNOLOGIES INC
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-02 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-05-02 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-15 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-15 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-10 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-10 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-10 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-10 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-07 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-07 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-07 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-07 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-02 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-02 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-02 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-02 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-03-31 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-03-31 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-03-11 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | 377-07769 | Read Filing View |
| 2024-10-25 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2024-08-20 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2024-08-20 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2024-07-31 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | 333-281007 | Read Filing View |
| 2024-03-27 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2024-03-19 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | 333-277934 | Read Filing View |
| 2023-12-14 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2023-12-06 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2022-09-23 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2022-02-10 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2019-02-07 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2018-08-23 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2018-08-22 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2015-08-13 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2015-08-13 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2015-08-07 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2015-08-07 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2011-05-11 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2011-04-07 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2011-03-23 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2011-03-04 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2011-02-18 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2010-11-05 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2009-03-31 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2009-03-23 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2009-03-19 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2008-02-29 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2008-02-22 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2008-02-04 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2007-11-26 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2007-10-12 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2006-03-31 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2006-03-30 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2006-03-28 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2006-03-24 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2006-03-22 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2006-03-16 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2005-06-28 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2005-05-23 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-11 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | 377-07769 | Read Filing View |
| 2024-07-31 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | 333-281007 | Read Filing View |
| 2024-03-19 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | 333-277934 | Read Filing View |
| 2023-12-06 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2022-02-10 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2018-08-22 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2015-08-07 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2015-08-07 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2011-05-11 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2011-03-23 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2011-02-18 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2010-11-05 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2009-03-31 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2009-03-19 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2008-02-29 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2008-02-04 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2007-10-12 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2006-03-31 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2006-03-22 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2006-03-16 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2005-05-23 | SEC Comment Letter | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-05-02 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-05-02 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-15 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-15 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-10 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-10 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-10 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-10 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-07 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-07 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-07 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-07 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-02 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-02 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-02 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-04-02 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-03-31 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2025-03-31 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2024-10-25 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2024-08-20 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2024-08-20 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2024-03-27 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2023-12-14 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2022-09-23 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2019-02-07 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2018-08-23 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2015-08-13 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2015-08-13 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2011-04-07 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2011-03-04 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2009-03-23 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2008-02-22 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2007-11-26 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2006-03-30 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2006-03-28 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2006-03-24 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
| 2005-06-28 | Company Response | PALATIN TECHNOLOGIES INC | NJ | N/A | Read Filing View |
2025-05-02 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm A.G.P. / Alliance Global Partners 590 Madison Ave., 28 th Floor New York, NY 10022 May 2, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. Registration Statement on Form S-1 File No. 333-286280 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), A.G.P. / Alliance Global Partners as Lead Placement Agent, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 5:00 p.m. Eastern Time on Monday, May 5, 2025 or as soon thereafter as practicable. Very truly yours, A.G.P / Alliance Global Partners By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2025-05-02 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm Palatin Technologies, Inc. 4B Cedar Brook Drive Cranbury, New Jersey 08512 May 2, 2025 VIA EDGAR SUBMISSION U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. (the “ Company ”) Registration Statement on Form S-1 (File No. 333-286280) (the “ Registration Statement ”) Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended , the Company hereby requests that the U.S. Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement to become effective on Monday, May 5, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable, unless the Company notifies you otherwise prior to such time. If you have any questions regarding this request, please contact our outside counsel, Faith L. Charles of Thompson Hine LLP, by telephone at (212) 908-3905 or via email at Faith.Charles@ThompsonHine.com. Please also call Faith L. Charles as soon as the Company’s Registration Statement has been declared effective. Thank you for your attention to this matter. Sincerely, PALATIN TECHNOLOGIES, INC. By: /s/ Carl Spana Name: Carl Spana, Ph.D. Title: President and Chief Executive Officer cc: Faith L. Charles, Esq., Thompson Hine LLP
2025-04-15 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm Palatin Technologies, Inc. 4B Cedar Brook Drive Cranbury, New Jersey 08512 April 15, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Manufacturing 100 F Street, N.E. Washington, D.C. 20549-3561 Re: Palatin Technologies, Inc. (the “Company”) Registration Statement on Form S-1 (the “Registration Statement”) Filed March 31, 2025 File No. 333 - 286280 Ladies and Gentlemen: Reference is made to the Company’s letter, filed as correspondence via EDGAR on April 10, 2025, in which the Company requested for acceleration of the effective date of the above-referenced Registration Statement for 5:00 p.m., Eastern Time, on April 14, 2025. The Company is no longer requesting that such Registration Statement be declared effective at such time, and we hereby formally withdraw our request for acceleration of the effective date of the Registration Statement at such time. Sincerely, PALATIN TECHNOLOGIES, INC. /s/ Carl Spana Carl Spana, Ph. D President and Chief Executive Officer
2025-04-15 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm A.G.P. / Alliance Global Partners 590 Madison Ave., 28 th Floor New York, NY 10022 April 15, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. Registration Statement on Form S-1 File No. 333-286280 Ladies and Gentlemen: Reference is made to our letter, filed as correspondence via EDGAR on April 10, 2025, in which we, as Lead Placement Agent for the proposed offering by Palatin Technologies, Inc. (the “Company”), joined the Company’s request for acceleration of the effective date of the above-referenced registration statement (the “Registration Statement”) for April 14, 2025 at 5:00 p.m., Eastern Time. We and the Company are no longer requesting that such Registration Statement be declared effective at that time, and we hereby formally withdraw our request for acceleration of the effective date of the Registration Statement at that time. Very truly yours, A.G.P./ALLIANCE GLOBAL PARTNERS By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2025-04-10 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm A.G.P. / Alliance Global Partners 590 Madison Ave., 28 th Floor New York, NY 10022 April 10, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. Registration Statement on Form S-1 File No. 333-286280 Ladies and Gentlemen: Reference is made to our letter, filed as correspondence via EDGAR on April 7, 2025, in which we, as Lead Placement Agent for the proposed offering by Palatin Technologies, Inc. (the “Company”), joined the Company’s request for acceleration of the effective date of the above-referenced registration statement (the “Registration Statement”) for April 8, 2025 at 5:00 p.m., Eastern Time. We and the Company are no longer requesting that such Registration Statement be declared effective at that time, and we hereby formally withdraw our request for acceleration of the effective date of the Registration Statement at that time. Very truly yours, A.G.P./ALLIANCE GLOBAL PARTNERS By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2025-04-10 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm A.G.P. / Alliance Global Partners 590 Madison Ave., 28 th Floor New York, NY 10022 April 10, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. Registration Statement on Form S-1 File No. 333-286280 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), A.G.P. / Alliance Global Partners as Lead Placement Agent, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 5:00 p.m. Eastern Time on Monday, April 14, 2025 or as soon thereafter as practicable. Very truly yours, A.G.P. / Alliance Global Partners By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2025-04-10 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm Palatin Technologies, Inc. 4B Cedar Brook Drive Cranbury, New Jersey 08512 April 10, 2025 VIA EDGAR SUBMISSION U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. (the “ Company ”) Registration Statement on Form S-1 (File No. 333-286280) (the “ Registration Statement ”) Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended , the Company hereby requests that the U.S. Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement to become effective on Monday, April 14, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable, unless the Company notifies you otherwise prior to such time. If you have any questions regarding this request, please contact our outside counsel, Faith L. Charles of Thompson Hine LLP, by telephone at (212) 908-3905 or via email at Faith.Charles@ThompsonHine.com. Please also call Faith L. Charles as soon as the Company’s Registration Statement has been declared effective. Thank you for your attention to this matter. Sincerely, PALATIN TECHNOLOGIES, INC. By: /s/ Carl Spana Name: Carl Spana, Ph.D. Title: President and Chief Executive Officer cc: Faith L. Charles, Esq., Thompson Hine LLP
2025-04-10 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm Palatin Technologies, Inc. 4B Cedar Brook Drive Cranbury, New Jersey 08512 April 10, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Manufacturing 100 F Street, N.E. Washington, D.C. 20549-3561 Re: Palatin Technologies, Inc. (the “Company”) Registration Statement on Form S-1 (the “Registration Statement”) Filed March 31, 2025 File No. 333 - 286280 Ladies and Gentlemen: Reference is made to the Company’s letter, filed as correspondence via EDGAR on April 7, 2025, in which the Company requested for acceleration of the effective date of the above-referenced Registration Statement for 5:00 p.m., Eastern Time, on April 8, 2025. The Company is no longer requesting that such Registration Statement be declared effective at such time, and we hereby formally withdraw our request for acceleration of the effective date of the Registration Statement at such time. Sincerely, PALATIN TECHNOLOGIES, INC. /s/ Carl Spana Carl Spana, Ph. D President and Chief Executive Officer
2025-04-07 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm A.G.P. / Alliance Global Partners 590 Madison Ave., 28 th Floor New York, NY 10022 April 7, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. Registration Statement on Form S-1 File No. 333-286280 Ladies and Gentlemen: Reference is made to our letter, filed as correspondence via EDGAR on April 2, 2025, in which we, as Lead Placement Agent for the proposed offering by Palatin Technologies, Inc. (the “Company”), joined the Company’s request for acceleration of the effective date of the above-referenced registration statement (the “Registration Statement”) for April 3, 2025 at 5:00 p.m., Eastern Time. We and the Company are no longer requesting that such Registration Statement be declared effective at that time, and we hereby formally withdraw our request for acceleration of the effective date of the Registration Statement at that time. Very truly yours, A.G.P./ALLIANCE GLOBAL PARTNERS By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2025-04-07 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm A.G.P. / Alliance Global Partners 590 Madison Ave., 28 th Floor New York, NY 10022 April 7, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. Registration Statement on Form S-1 File No. 333-286280 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), A.G.P / Alliance Global Partners as Lead Placement Agent, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 5:00 p.m. Eastern Time on Tuesday, April 8, 2025 or as soon thereafter as practicable. Very truly yours, A.G.P / Alliance Global Partners By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2025-04-07 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm Palatin Technologies, Inc. 4B Cedar Brook Drive Cranbury, New Jersey 08512 April 7, 2025 VIA EDGAR SUBMISSION U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. (the “ Company ”) Registration Statement on Form S-1 (File No. 333-286280) (the “ Registration Statement ”) Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended , the Company hereby requests that the U.S. Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement to become effective on Tuesday, April 8, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable, unless the Company notifies you otherwise prior to such time. If you have any questions regarding this request, please contact our outside counsel, Faith L. Charles of Thompson Hine LLP, by telephone at (212) 908-3905 or via email at Faith.Charles@ThompsonHine.com. Please also call Faith L. Charles as soon as the Company’s Registration Statement has been declared effective. Thank you for your attention to this matter. Sincerely, PALATIN TECHNOLOGIES, INC. By: /s/ Carl Spana Name: Carl Spana, Ph.D. Title: President and Chief Executive Officer cc: Faith L. Charles, Esq., Thompson Hine LLP
2025-04-07 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm Palatin Technologies, Inc. 4B Cedar Brook Drive Cranbury, New Jersey 08512 April 7, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Manufacturing 100 F Street, N.E. Washington, D.C. 20549-3561 Re: Palatin Technologies, Inc. (the “Company”) Registration Statement on Form S-1 (the “Registration Statement”) Filed March 31, 2025 File No. 333 - 286280 Ladies and Gentlemen: Reference is made to the Company’s letter, filed as correspondence via EDGAR on April 2, 2025, in which the Company requested for acceleration of the effective date of the above-referenced Registration Statement for 5:00 p.m., Eastern Time, on April 3, 2025. The Company is no longer requesting that such Registration Statement be declared effective at such time, and we hereby formally withdraw our request for acceleration of the effective date of the Registration Statement at such time. If you have any questions regarding this request, please contact our outside counsel, Faith L. Charles of Thompson Hine LLP, by telephone at (212) 908-3905 or via email at Faith.Charles@ThompsonHine.com. Thank you for your attention to this matter. Sincerely, PALATIN TECHNOLOGIES, INC. /s/ Carl Spana Carl Spana, Ph. D President and Chief Executive Officer Cc: Faith L. Charles, Esq., Thompson Hine LLP
2025-04-02 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm A.G.P. / Alliance Global Partners 590 Madison Ave., 28 th Floor New York, NY 10022 April 2, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. Registration Statement on Form S-1 File No. 333-286280 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), A.G.P./Alliance Global Partners as Lead Placement Agent, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 5:00 p.m. Eastern Time on Thursday, April 3, 2025 or as soon thereafter as practicable. Very truly yours, A.G.P / Alliance Global Partners By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2025-04-02 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm Palatin Technologies, Inc. 4B Cedar Brook Drive Cranbury, New Jersey 08512 April 2, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Manufacturing 100 F Street, N.E. Washington, D.C. 20549-3561 Re: Palatin Technologies, Inc. Registration Statement on Form S-1 (the “Registration Statement”) Filed March 31, 2025 File No. 333 - 286280 Ladies and Gentlemen: Reference is made to our letter, filed as correspondence via EDGAR on March 31, 2025, in which we requested for acceleration of the effective date of the above-referenced registration statement (the “ Registration Statement ”) for 5:00 p.m., Eastern Time, on April 2, 2025. We are no longer requesting that such Registration Statement be declared effective at this time, and we hereby formally withdraw our request for acceleration of the effective date of the Registration Statement. Sincerely, PALATIN TECHNOLOGIES, INC. /s/ Carl Spana Carl Spana, Ph. D President and Chief Executive Officer Cc: Faith L. Charles, Esq., Thompson Hine LLP
2025-04-02 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_rw.htm April 2, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. Registration Statement on Form S-1 File No. 333-286280 Ladies and Gentlemen: Reference is made to our letter, filed as correspondence via EDGAR on March 31, 2025, in which we, as Lead Placement Agent for the proposed offering by Palatin Technologies, Inc. (the “ Company ”), joined the Company’s request for acceleration of the effective date of the above-referenced registration statement (the “ Registration Statement ”) for April 2, 2025 at 5:00 p.m., Eastern Time. The Company is no longer requesting that such Registration Statement be declared effective at this time, and we hereby formally withdraw our request for acceleration of the effective date of the Registration Statement. Very truly yours, A.G.P./ALLIANCE GLOBAL PARTNERS By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2025-04-02 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm Palatin Technologies, Inc. 4B Cedar Brook Drive Cranbury, New Jersey 08512 April 2, 2025 VIA EDGAR SUBMISSION U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. (the “ Company ”) Registration Statement on Form S-1 (File No. 333-286280) (the “ Registration Statement ”) Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended , the Company hereby requests that the U.S. Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement to become effective on Thursday, April 3, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable, unless the Company notifies you otherwise prior to such time. If you have any questions regarding this request, please contact our outside counsel, Faith L. Charles of Thompson Hine LLP, by telephone at (212) 908-3905 or via email at Faith.Charles@ThompsonHine.com. Please also call Faith L. Charles as soon as the Company’s Registration Statement has been declared effective. Thank you for your attention to this matter. Sincerely, PALATIN TECHNOLOGIES, INC. By: /s/ Carl Spana Name: Carl Spana, Ph.D. Title: President and Chief Executive Officer cc: Faith L. Charles, Esq., Thompson Hine LLP
2025-03-31 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_coresp.htm A.G.P. / Alliance Global Partners 590 Madison Ave., 28 th Floor New York, NY 10022 March 31, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. Registration Statement on Form S-1 File No. 333-286280 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), A.G.P / Alliance Global Partners as Lead Placement Agent, hereby requests acceleration of the effective date of the above-referenced Registration Statement so that it will become effective at 5:00 p.m. Eastern Time on Wednesday, April 2, 2025 or as soon thereafter as practicable. Very truly yours, A.G.P / Alliance Global Partners By: /s/ Thomas J. Higgins Name: Thomas J. Higgins Title: Managing Director
2025-03-31 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp.htm Palatin Technologies, Inc. 4B Cedar Brook Drive Cranbury, New Jersey 08512 March 31, 2025 VIA EDGAR SUBMISSION U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. (the “ Company ”) Registration Statement on Form S-1 (File No. 333-286280) (the “ Registration Statement ”) Ladies and Gentlemen: Pursuant to Rule 461 of the Securities Act of 1933, as amended , the Company hereby requests that the U.S. Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement to become effective on Wednesday, April 2, 2025, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable, unless the Company notifies you otherwise prior to such time. If you have any questions regarding this request, please contact our outside counsel, Faith L. Charles of Thompson Hine LLP, by telephone at (212) 908-3905 or via email at Faith.Charles@ThompsonHine.com. Please also call Faith L. Charles as soon as the Company’s Registration Statement has been declared effective. Thank you for your attention to this matter. Sincerely, PALATIN TECHNOLOGIES, INC. By: /s/ Carl Spana Name: Carl Spana, Ph.D. Title: President and Chief Executive Officer cc: Faith L. Charles, Esq., Thompson Hine LLP
2025-03-11 - UPLOAD - PALATIN TECHNOLOGIES INC File: 377-07769
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 11, 2025 Carl Spana Chief Executive Officer Palatin Technologies, Inc. 4B Cedar Brook Drive Cranbury, NJ 08512 Re: Palatin Technologies, Inc. Draft Registration Statement on Form S-1 Submitted March 7, 2025 CIK No. 0000911216 Dear Carl Spana: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement no later than 48 hours prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Faith Charles, Esq. </TEXT> </DOCUMENT>
2024-10-25 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
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Palatin Technologies, Inc.
4B Cedar Brook Drive
Cranbury, New Jersey 08512
October 25, 2024
VIA EDGAR SUBMISSION
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Palatin Technologies, Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-281007) (the “Registration Statement”)
Ladies and Gentlemen:
Pursuant to Rule 461 of the Securities Act of 1933, as amended, the Company hereby requests that the U.S. Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement to become effective on Tuesday, October 29, 2024, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, unless the Company notifies you otherwise prior to such time.
If you have any questions regarding this request, please contact our outside counsel, Faith L. Charles of Thompson Hine LLP, by telephone at (212) 908-3905 or via email at Faith.Charles@ThompsonHine.com. Please also call Faith L. Charles as soon as the Company’s Registration Statement has been declared effective. Thank you for your attention to this matter.
Sincerely,
PALATIN TECHNOLOGIES, INC.
By: /s/ Carl Spana
Name:
Carl Spana, Ph.D.
Title: President and Chief Executive Officer
cc: Faith L. Charles, Esq., Thompson Hine LLP
2024-08-20 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
filename1.htm
ptn_corresp.htm
Palatin Technologies, Inc.
4B Cedar Brook Drive
Cranbury, New Jersey 08512
August 20, 2024
VIA EDGAR SUBMISSION
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Palatin Technologies, Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-281007) (the “Registration Statement”)
Ladies and Gentlemen:
Pursuant to Rule 461 of the Securities Act of 1933, as amended, the Company hereby requests that the U.S. Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement to become effective on Thursday, August 22, 2024, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, unless the Company notifies you otherwise prior to such time.
If you have any questions regarding this request, please contact our outside counsel, Faith L. Charles of Thompson Hine LLP, by telephone at (212) 908-3905 or via email at Faith.Charles@ThompsonHine.com. Please also call Faith L. Charles as soon as the Company’s Registration Statement has been declared effective. Thank you for your attention to this matter.
Sincerely,
PALATIN TECHNOLOGIES, INC.
By: /s/ Carl Spana
Name:
Carl Spana, Ph.D.
Title: President and Chief Executive Officer
cc: Faith L. Charles, Esq., Thompson Hine LLP
2024-08-20 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
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ptn_corresp.htm
Palatin Technologies, Inc.
4B Cedar Brook Drive
Cranbury, New Jersey 08512
August 20, 2024
VIA EDGAR SUBMISSION
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Palatin Technologies, Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-281007) (the “Registration Statement”)
Ladies and Gentlemen:
The Company hereby withdraws the request for acceleration, Accession Number 0001654954-24-010936, filed earlier today requesting that the above-referenced Registration Statement become effective on Thursday, August 22, 2024, at 4:00 p.m., Eastern Time, and requests that the Securities and Exchange Commission take no further action with regard to the request for acceleration.
If you have any questions regarding this request, please contact our outside counsel, Faith L. Charles of Thompson Hine LLP, by telephone at (212) 908-3905 or via email at Faith.Charles@ThompsonHine.com. Thank you for your attention to this matter.
Sincerely,
PALATIN TECHNOLOGIES, INC.
By:
/s/ Carl Spana
Name:
Carl Spana, Ph.D.
Title:
President and Chief Executive Officer
cc: Faith L. Charles, Esq., Thompson Hine LLP
2024-07-31 - UPLOAD - PALATIN TECHNOLOGIES INC File: 333-281007
July 31, 2024
Carl Spana
Chief Executive Officer
Palatin Technologies, Inc.
4B Cedar Brook Drive
Cranbury, NJ 08512
Re:Palatin Technologies, Inc.
Registration Statement on Form S-1
Filed July 25, 2024
File No. 333-281007
Dear Carl Spana:
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:Faith Charles
2024-03-27 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
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Palatin Technologies, Inc.
4B Cedar Brook Drive
Cranbury, New Jersey 08512
March 27, 2024
VIA EDGAR SUBMISSION
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Palatin Technologies, Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-277934) (the “Registration Statement”)
Ladies and Gentlemen:
Pursuant to Rule 461 of the Securities Act of 1933, as amended, the Company hereby requests that the U.S. Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement to become effective on Thursday, March 28, 2024, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, unless the Company notifies you otherwise prior to such time.
If you have any questions regarding this request, please contact our outside counsel, Faith L. Charles of Thompson Hine LLP, by telephone at (212) 908-3905 or via email at Faith.Charles@ThompsonHine.com. Please also call Faith L. Charles as soon as the Company’s Registration Statement has been declared effective. Thank you for your attention to this matter.
Sincerely,
Palatin Technologies, Inc.
By: /s/ Carl Spana
Name:
Carl Spana, Ph.D.
Title: President and Chief Executive Officer
cc: Faith L. Charles, Esq., Thompson Hine LLP
2024-03-19 - UPLOAD - PALATIN TECHNOLOGIES INC File: 333-277934
United States securities and exchange commission logo
March 19, 2024
Stephen T. Wills
Chief Financial Officer
Palatin Technologies, Inc.
4B Cedar Brook Drive
Cranbury, NJ 08512
Re:Palatin Technologies, Inc.
Registration Statement on Form S-1
Filed March 14, 2024
File No. 333-277934
Dear Stephen T. Wills:
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: Faith L. Charles, Esq.
2023-12-14 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
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Palatin Technologies, Inc.
4B Cedar Brook Drive
Cranbury, New Jersey 08512
December 14, 2023
VIA EDGAR SUBMISSION
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Palatin Technologies, Inc. (the “Company”)
Registration Statement on Form S-1 (File No. 333-275883) (the “Registration Statement”)
Ladies and Gentlemen:
Pursuant to Rule 461 of the Securities Act of 1933, as amended, the Company hereby requests that the U.S. Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement to become effective on Friday, December 15, 2023, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable, unless the Company notifies you otherwise prior to such time.
If you have any questions regarding this request, please contact our outside counsel, Faith L. Charles of Thompson Hine LLP, by telephone at (212) 908-3905 or via email at Faith.Charles@ThompsonHine.com. Please also call Faith L. Charles as soon as the Company’s Registration Statement has been declared effective. Thank you for your attention to this matter.
Sincerely,
Palatin Technologies, Inc.
By: /s/ Carl Spana
Name:
Carl Spana, Ph.D.
Title: President and Chief Executive Officer
cc: Faith L. Charles, Esq., Thompson Hine LLP
2023-12-06 - UPLOAD - PALATIN TECHNOLOGIES INC
United States securities and exchange commission logo
December 6, 2023
Stephen Wills
Chief Financial Officer and Chief Operating Officer
Palatin Technologies, Inc.
4B Cedar Brook Drive
Cranbury, NJ 08512
Re:Palatin Technologies, Inc.
Registration Statement on Form S-1
Filed December 4, 2023
File No. 333-275883
Dear Stephen Wills:
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: Faith Charles
2022-09-23 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm ptn_corresp [Letterhead of Palatin Technologies, Inc.] September 23, 2022 VIA EDGAR SUBMISSION U.S. Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 RE: Palatin Technologies, Inc. Registration Statement on Form S-3 (File No. 333-262555) Acceleration Request Ladies and Gentleman: Pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, Palatin Technologies, Inc. hereby respectfully requests acceleration of the effective date of its Registration Statement on Form S-3, as amended (File No. 333-262555) (the “Registration Statement”), so that the Registration Statement may become effective at 4:00 p.m. (Eastern Time) on Monday, September 26, 2022, or as soon thereafter as practicable. If you have any questions regarding this request, please contact our outside counsel, Faith Charles of Thompson Hine LLP, at (212) 908-3905 or Naveen Pogula of Thompson Hine LLP, at (404) 541-2913. Please also call either Faith Charles or Naveen Pogula as soon as the Registration Statement has been declared effective. Thank you for your attention to this matter. Very truly yours, Palatin Technologies, Inc. By: /s/ Stephen A. Slusher Name: Stephen A. Slusher Title: Chief Legal Officer cc: Faith Charles, Thompson Hine LLP Naveen Pogula, Thompson Hine LLP
2022-02-10 - UPLOAD - PALATIN TECHNOLOGIES INC
United States securities and exchange commission logo
February 10, 2022
Stephen T. Wills
Chief Financial Officer
Palatin Technologies, Inc
4B Cedar Brook Drive
Cranbury, New Jersey 08512
Re:Palatin Technologies, Inc.
Registration Statement on Form S-3
Filed February 7, 2022
File No. 333-262555
Dear Mr. Wills:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Faith L. Charles, Esq.
2019-02-07 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm Blueprint February 7, 2019 VIA EDGAR United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 RE: Palatin Technologies, Inc. Registration Statement on Form S-3 File No. 333-226905 Acceleration Request Ladies and Gentleman: Pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, Palatin Technologies, Inc. (the “Registrant”) hereby respectfully requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-226905) (the “Registration Statement”), so that it may become effective at 9:00 a.m. (Eastern Time) on Wednesday, February 13, 2019, or as soon thereafter as practicable. Please contact Faith L. Charles of Thompson Hine LLP at (212) 908-3905 with any comments or questions regarding the Registration Statement, this letter or related matters. Very truly yours, Palatin Technologies, Inc. By: /s/ Stephen A. Slusher Name: Stephen A. Slusher Title: Chief Legal Officer cc: Faith L. Charles, Thompson Hine LLP
2018-08-23 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP 1 filename1.htm Blueprint PALATIN TECHNOLOGIES, INC. 4-B CEDAR BROOK DRIVE CEDAR BROOK CORPORATE CENTER CRANBURY, NJ 08512 TEL: 609-495-2200 FAX: 609-495-2201 August 23, 2018 VIA EDGAR Irene Paik Division of Corporation Finance, Office of Healthcare & Insurance United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Palatin Technologies, Inc. Registration Statement on Form S-3 (File No. 333-226905) Dear Ms. Paik: On behalf of Palatin Technologies, Inc., a Delaware Corporation (the “Company”), this letter sets forth the Company’s response to the comment of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) set forth in your letter, dated August 22, 2018 (the “Staff Letter”), regarding Registration Statement on Form S-3 (the “Registration Statement”), filed by the Company with the Commission on August 17, 2018. For the convenience of the Staff, the comment from the Staff Letter corresponds to the numbered paragraph in the Staff Letter and is restated in italics prior to the response to such comment. Registration Statement on Form S-3 filed August 17, 2018 General 1. We note that you filed this registration statement more than 45 days after the end of your fiscal year. As you do not appear to meet the age of financial statement requirements of Rule 8-08(b) of Regulation S-X, you will need to include your audited financial statements or file and incorporate by reference your Form 10-K for fiscal year ended June 30, 2018 before we will accelerate the effective date of your registration statement. For additional guidance, please refer to Section 1220.3 of the Division's Financial Reporting Manual. Response: The Company respectfully advises the Staff that it intends to amend the Registration Statement to include audited financial statements, or will file and incorporate by reference the Company’s Form 10-K for fiscal year ended June 30, 2018, prior to requesting effectiveness of the Registration Statement. We appreciate the Staff’s comments and request the Staff contact our outside counsel, Faith L. Charles of Thompson Hine LLP, at (212) 908-3905 or the undersigned at (609) 495-2297 with any questions or comments regarding this letter. Very truly yours, PALATIN TECHNOLOGIES, INC. By: /s/ Stephen A. Slusher Name: Stephen A. Slusher Title: Chief Legal Officer cc: Carl Spana, Ph.D., President and Chief Executive Officer, Palatin Technologies, Inc. Faith Charles, Thompson Hine LLP
2018-08-22 - UPLOAD - PALATIN TECHNOLOGIES INC
August 22, 2018
Carl Spana, Ph.D.
President and Chief Executive Officer
Palatin Technologies, Inc.
4B Cedar Brook Drive
Cranbury, New Jersey 08512
Re:Palatin Technologies, Inc.
Registration Statement on Form S-3
Filed August 17, 2018
File No. 333-226905
Dear Dr. Spana:
We have limited our review of your registration statement to those issues we have
addressed in our 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 this comment, we may have additional comments.
Registration Statement on Form S-3 filed August 17, 2018
General
1.We note that you filed this registration statement more than 45 days after the end of your
fiscal year. As you do not appear to meet the age of financial statement requirements of
Rule 8-08(b) of Regulation S-X, you will need to include your audited financial
statements or file and incorporate by reference your Form 10-K for fiscal year ended June
30, 2018 before we will accelerate the effective date of your registration statement. For
additional guidance, please refer to Section 1220.3 of the Division's Financial Reporting
Manual.
FirstName LastNameCarl Spana, Ph.D.
Comapany NamePalatin Technologies, Inc.
August 22, 2018 Page 2
FirstName LastName
Carl Spana, Ph.D.
Palatin Technologies, Inc.
August 22, 2018
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 Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Faith L. Charles, Esq. - Thompson Hine LLP
2015-08-13 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
filename1.htm
ptn_corresp.htm
PALATIN
TECHNOLOGIES, INC.
4-B CEDAR BROOK DRIVE
CEDAR BROOK CORPORATE CENTER
CRANBURY, NJ 08512
TEL: 609-495-2200
FAX: 609-495-2201
August 13, 2015
By EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Alla Berenshteyn, Division of Corporation Finance
Jeffrey P. Riedler, Assistant Director
Re: Palatin Technologies, Inc. (the “Company”)
Registration Statement on Form S-3 (File No. 333-206003)
Dear Ladies and Gentlemen:
Pursuant to Rule 461 of the Securities Act of 1933, as amended (the “Act”), the Company hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on Tuesday, August 18, 2015, at 9:00 A.M., Eastern Time, or as soon thereafter as is practicable.
In connection with this acceleration request, the Company confirms that it is aware of its obligations under the Act. In addition, 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 a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
August 13, 2015
Page 2
If you have any questions regarding this request, please contact our outside counsel, Faith Charles of Thompson Hine LLP, at 212-908-3905 or the undersigned at 609-495-9197. Please also call Faith Charles as soon as the Company’s Registration Statement on Form S-3 has been declared effective. Thank you for your attention to this matter.
Sincerely,
PALATIN TECHNOLOGIES, INC.
By: /s/ Stephen A. Slusher
Name: Stephen A. Slusher
Title: Chief Legal Officer
cc: Faith Charles, Thompson Hine LLP
2015-08-13 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
filename1.htm
ptn_corresp.htm
PALATIN
TECHNOLOGIES, INC.
4-B CEDAR BROOK DRIVE
CEDAR BROOK CORPORATE CENTER
CRANBURY, NJ 08512
TEL: 609-495-2200
FAX: 609-495-2201
August 13, 2015
By EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Alla Berenshteyn, Division of Corporation Finance
Jeffrey P. Riedler, Assistant Director
Re: Palatin Technologies, Inc. (the “Company”)
Registration Statement on Form S-3 (File No. 333-206047)
Dear Ladies and Gentlemen:
Pursuant to Rule 461 of the Securities Act of 1933, as amended (the “Act”), the Company hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on Tuesday, August 18, 2015, at 9:00 A.M., Eastern Time, or as soon thereafter as is practicable.
In connection with this acceleration request, the Company confirms that it is aware of its obligations under the Act. In addition, 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 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 regarding this request, please contact our outside counsel, Faith Charles of Thompson Hine LLP, at 212-908-3905 or the undersigned at 609-495-9197. Please also call Faith Charles as soon as the Company’s Registration Statement on Form S-3 has been declared effective. Thank you for your attention to this matter.
Sincerely,
PALATIN TECHNOLOGIES, INC.
By: /s/ Stephen A. Slusher
Name: Stephen A. Slusher
Title: Chief Legal Officer
cc: Faith Charles, Thompson Hine LLP
2015-08-07 - UPLOAD - PALATIN TECHNOLOGIES INC
August 7 , 2015 Via E -mail Stephen A. Slusher Chief Legal Officer Palatin Technologies, Inc. 4B Cedar Brook Drive Cranbury, New Jersey 08512 Re: Palatin Technologies, Inc. Registration Statement on Form S -3 Filed August 3, 2015 File No. 333-206047 Dear Mr. Slusher : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of the effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action wit h respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in th e filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 4 61 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation Stephen A. Slusher Palatin Technologies, Inc. August 7 , 2015 Page 2 of the fact that those requesting acceleration are aware of their respective responsibilities u nder the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the registered securities . Please contact Alla Berenshteyn at (202) 551 -4325 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Via E -mail Faith L. Charles Thompson Hine LLP
2011-05-11 - UPLOAD - PALATIN TECHNOLOGIES INC
May 11, 2011
Carl Spana, Ph.D. President and Chief Executive Officer Palatin Technologies, Inc. 4C Cedar Brook Drive
Cranbury, New Jersey 08512
Re: Palatin Technologies, Inc. Form 10-K
Filed September 27, 2010 File No. 001-15543
Dear Mr. Spana:
We have completed our review of your f iling. We remind you that our comments or
changes to disclosure in res ponse to our comments do not for eclose the Commission from taking
any action with respect to the company or th e filing and the company may not assert staff
comments as a defense in any proceeding ini tiated by the Commission or any person under the
federal securities laws of the United States. We urge all pers ons who are responsible for the
accuracy and adequacy of the disclosure in the fi ling to be certain that the filing includes the
information the Securities Exchange Act of 1934 and all applicable rules require.
Sincerely,
Jeffrey Riedler
Assistant Director
2011-04-07 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
filename1.htm
response_040611.htm
[PALATIN TECHNOLOGIES, INC. LETTERHEAD]
April 7, 2011
Mr. Jeffrey Riedler
Assistant Director
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549
Re:
Palatin Technologies, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2010
Filed September 27, 2010
File No. 001-15543
Dear Mr. Riedler:
On behalf of Palatin Technologies, Inc., we respond as follows to the comments dated March 23, 2011 from the staff of the U.S. Securities and Exchange Commission (the “Commission”) relating to the above-captioned public filing (the “2010 10-K”). Please note that for your convenience, we have recited each of the staff’s comments and have provided our response to each comment immediately thereafter.
In the proposed disclosures provided below, changes from the 2010 10-K are shown with material to be deleted struck through and material to be added underlined.
Form 10-K, filed September 27, 2010
Patents and Proprietary Information, page 9
1.
We note your response to prior comment 2. In regard to the patent applications that are licensed to AstraZeneca, we also note your response that such patent applications are confidential, non-public documents until published as required under patent laws. However, we are not asking you to identify the specific patents that have been licensed to AstraZeneca or any confidential information contained within those patents. Rather, we are asking for information that clarifies the general scope of your patent coverage for your various product categories. Accordingly, please provide us with proposed disclosure for future filings that reflect the number of issued patent and pending patent applications, and the respective jurisdictions, relating to your compounds that target melanocortin receptors for the treatment of obesity, diabetes and related metabolic syndrome.
Response:
The requested disclosure will be made in the 2011 10-K. The disclosure will be made in the subsection corresponding to the subheading “Patent Protection”, which begins on page 9 of the 2010 10-K, and specifically the paragraph therein relating to AstraZeneca. Unless there has been a change in our business such that the statement is no longer material, and as otherwise required to update the disclosure, we will in substance provide disclosure as follows:
We own a number of United States and foreign patent applications that are licensed to AstraZeneca under our research collaboration and license agreement relating to our obesity program. Under the our research collaboration and license agreement with AstraZeneca, AstraZeneca is responsible for prosecution of these licensed patent applications and maintenance of issued patents in the United States and other countries. One patent application covering a class of compounds is pending in the United States, and if any patent issues, the presumptive term will be until 2029. Additionally, AstraZeneca is prosecuting a patent application under the Patent Cooperation Treaty and in the United States in its name resulting from its collaboration with us, on which our employees are inventors and for which royalties would be payable under our agreement with AstraZeneca if a compound covered by a claim of this application is developed for commercialization. AstraZeneca will be required to enter national stage prosecution on the Patent Cooperation Treaty application, including determining the countries in which AstraZeneca intends to seek patent protection, by November 2011. If any patent issues, the presumptive term will be until 2030. However, many Neither of these patent applications have not yet been examined, and we do not know the scope of patent claims that will be allowed, or whether any patents will issue. Additionally, until one or more compounds subject to the agreement with AstraZeneca are developed for commercialization, which may never occur, we cannot evaluate the duration of patents or their effect on the program any potential patent term extension under the Hatch-Waxman Amendments.
* * * * *
We hereby acknowledge 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.
You may contact me directly at (609) 495-9197 should you require additional information.
Very truly yours,
/s/ Stephen A. Slusher
Stephen A. Slusher
Chief Legal Officer
2011-03-23 - UPLOAD - PALATIN TECHNOLOGIES INC
March 23, 2011 Carl Spana, Ph.D. President and Chief Executive Officer Palatin Technologies, Inc. 4C Cedar Brook Drive Cranbury, New Jersey 08512 Re: Palatin Technologies, Inc. Form 10-K Filed September 27, 2010 File No. 001-15543 Dear Mr. Spana: We have reviewed your response letter dated March 4, 2011 and have the following comment. 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 our comment applies to your facts and circumstances, please tell us why in your response. After reviewing the information you provide in response to this comment, we may have additional comments. Form 10-K, filed September 27, 2010 Patents and Proprietary Information, page 9 1. We note your response to prior comment 2. In regard to the patent ap plications that are licensed to AstraZeneca, we also note your response that such pate nt applications are confidential, non-public documents until pub lished as required under patent laws. However, we are not asking you to identify the sp ecific patents that have been licensed to AstraZeneca or any confidential information contained within those patents. Rather, we are asking for information that clarifies the general scope of your patent coverage for your various product categories. Accordin gly, please provide us with proposed disclosure for future filings that reflects th e number of issued patents and pending patent applications, and the respective jurisdicti ons, related to your compounds that target melanocortin receptors for the treatment of obesity, diabetes and related metabolic syndrome. Carl Spana Ph.D. Palatin Technologies, Inc. March 23, 2011 Page 2 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 comment, please provide a written statement from the company acknowledging that: • the company is responsible for the adequacy and 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 Johnny Gharib at (202) 551-3170 or Daniel Greenspan at (202) 551-3623 with any questions. Sincerely, Jeffrey Riedler Assistant Director
2011-03-04 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
filename1.htm
response_030411.htm
[PALATIN TECHNOLOGIES, INC. LETTERHEAD]
March 4, 2011
Mr. Jeffrey Riedler
Assistant Director
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549
Re:
Palatin Technologies, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2010
Filed September 27, 2010
File No. 001-15543
Dear Mr. Riedler:
On behalf of Palatin Technologies, Inc., we respond as follows to the comments dated February 18, 2011 from the staff of the U.S. Securities and Exchange Commission (the “Commission”) relating to the above-captioned public filing (the “2010 10-K”). Please note that for your convenience, we have recited each of the staff’s comments and have provided our response to each comment immediately thereafter.
In the proposed disclosures provided below, changes from the 2010 10-K are shown with material to be deleted struck through and material to be added underlined.
Form 10-K, filed September 27, 2010
Melanocortin Receptor-Specific Programs, page 3
1.
Please provide proposed disclosure to be included in future filings regarding your collaboration and license agreement with AstraZeneca describing the duration of the agreement, termination provisions and the range of royalties you will be entitled to receive. An acceptable range of royalties is one of the following: single-digits,” “teens,” “twenties,” etc.
Response:
The requested disclosure will be made in our annual report on Form 10-K for the year ending June 30, 2011 (the “2011 10-K”). The disclosure will be made in the subsection corresponding to the subheading “Obesity”, which is on page 5 of the 2010 10-K, and in which the contractual arrangements with AstraZeneca are described in more detail. Unless there has been a change in our business such that the statement is no longer material, and as otherwise required to update the disclosure, we will in substance provide disclosure as follows:
Our agreement with AstraZeneca remains in effect as long as AstraZeneca is developing a compound covered by the agreement or commercializing a product for which a royalty is owed. The agreement may be terminated by AstraZeneca at any time upon notice to us, or by either party upon notice in the event of a material breach. Upon termination by AstraZeneca without cause or by us for cause, all rights and licenses we granted to AstraZeneca terminate, but AstraZeneca remains obligated to pay royalties and milestones on compounds developed during the collaboration portion of the agreement. In the event AstraZeneca terminates the agreement because we breached the agreement, rights and licenses we granted under the agreement become permanent, with financial terms, including royalties, to be determined by arbitration.
Pursuant to the terms of the research collaboration and license agreement with AstraZeneca, we We have received up-front and other licensing payments totaling $15 million from AstraZeneca under the agreement. We are eligible for milestone payments totaling up to $145 million, with up to $85 million contingent upon development and regulatory milestones and the balance on achievement of sales targets, plus mid to high single digit royalties on sales of approved products. AstraZeneca has responsibility for product commercialization, product discovery and development costs.
Patents and Proprietary Information, page 9
2.
We note that you own issued United States and foreign patent and patent applications pending the United States and other countries relating to various formulas. Please provide proposed disclosure for future filings specifying the number of patents and patent applications that you have associated with the respective product groups, the specific foreign jurisdictions in which your patents were granted or, in the case of patents pending, submitted. Please include in your discussion the patent applications that are licensed to AstraZeneca.
Response:
Under our collaboration and license agreement with AstraZeneca, we are required to keep certain non-public information confidential. See generally Article 13 of the Research Collaboration and License Agreement dated January 30, 2007, filed as Exhibit 10.2 to our quarterly report on Form 10-Q for the quarter ended December 31, 2006, filed with the
2
Commission on February 8, 2007. Under patent laws of the United States and other countries, patent applications are confidential, non-public documents until published as required under patent laws. Similarly, the fact of filing such applications, identity of inventors, identity of applicants and other similar facts is confidential information until such time as the applications publish. Accordingly, with respect to AstraZeneca we have only disclosed such patent applications as have been published, and have not made disclosure as to any patent application which is, under applicable substantive law, still confidential and hence subject to the confidentiality provisions of our collaboration and license agreement.
The requested disclosure will be made in the 2011 10-K. The disclosure will be made in the subsection corresponding to the subheading “Patent Protection”, which begins on page 9 of the 2010 10-K. Unless there has been a change in our business such that the statement is no longer material, and as otherwise required to update the disclosure, we will in substance provide disclosure as follows:
Patent protection. Our success will depend in substantial part on our ability to obtain, defend and enforce patents, maintain trade secrets and operate without infringing upon the proprietary rights of others, both in the United States and abroad. We own a number of issued United States patents and have pending United States patent applications, many with issued or pending counterpart patents in selected foreign countries. We seek patent protection for our technologies and products in the United States and those foreign countries where we believe patent protection is commercially important.
We own two issued United States and foreign patents claiming the bremelanotide substance; issued patents claiming the bremelanotide substance in Japan, Mexico, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Korea, Luxembourg, Monaco, Netherlands, Portugal, Spain, Sweden, Switzerland, United Kingdom, Italy, Australia and New Zealand; and pending patent applications claiming the bremelanotide substance in Brazil, Canada and Mexico. The issued United States patents have a term until 2020, which term may be subject to extension for a maximum period of up to five years as compensation for patent term lost during drug development and the FDA regulatory review process, pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Amendments). Whether we will be able to obtain patent term extensions under the Hatch-Waxman Amendments and the length of the extension to which we may be entitled cannot be determined until the FDA approves for marketing, if ever, a product in which bremelanotide is the active ingredient. In addition, the claims of issued patents covering bremelanotide may not provide meaningful protection. Further, third parties may challenge the validity or scope of any issued patent.
We also own an issued United States patent claiming non-oral administration of bremelanotide in combination with oral administration of a PDE-5 inhibitor. This patent has a term until 2025. However, this patent would apply only if we develop bremelanotide for use in combination therapy with a PDE-5 inhibitor. If we obtain regulatory approval for bremelanotide for use in combination therapy with a PDE-5
3
inhibitor, which may never occur, then the patent term may be subject to extension under the Hatch-Waxman Amendments, but we cannot presently evaluate the duration of any potential patent term extension.
We own patent applications on one class of alternative melanocortin receptor-specific peptides for treatment of sexual dysfunction which are pending in the United States, Australia, Brazil, Canada, China, India, Israel, Japan, Korea, Mexico and South Africa and before the European and Eurasian patent offices. If any patent issues in the United States, the presumptive term will be until 2029. We also own a patent application under the Patent Cooperation Treaty for a second class of alternative melanocortin receptor-specific peptides for treatment of sexual dysfunction. We will be required to enter national stage prosecution on this application, including filing the application in countries we select, by November 2011. If we enter national stage prosecution in the United States, and if any patent issues, the presumptive term will be until 2030. Until one or more product candidates covered by a claim of one of these patent applications are developed for commercialization, which may never occur, we cannot evaluate the duration of any potential patent term extension under the Hatch-Waxman Amendments.
We have patent applications pending in the United States and other countries own an issued United States patent claiming the PL-3994 substance and other natriuretic peptide receptor agonist compounds we have developed, which has a term until 2027, and two pending related United States patent applications, one claiming a precursor molecule and the other claiming related compounds. Patent applications claiming the PL-3994 substance and other compounds, including precursor molecules, are pending in Australia, Brazil, Canada, China, India, Israel, Japan, Korea, Mexico, Philippines and South Africa and before the European and Eurasian patent offices. One United States patent claiming PL-3994 has been issued, but other patent applications have not yet issued, and in any event we We do not know the full scope of patent coverage we will obtain, or whether any patents will issue other than the United States patent claiming PL-3994. The issued patent has a term until 2027, which term may be subject to extension for a maximum period of up to five years as compensation for patent term lost during drug development and the FDA regulatory review process, pursuant to the Hatch-Waxman Amendments. Whether we will be able to obtain patent term extensions under the Hatch-Waxman Amendments and the length of the extension to which we may be entitled cannot be determined until the FDA approves for marketing, if ever, a product in which PL-3994 is the active ingredient. Until one or more product candidates covered by a claim of the issued patent or one of these patent applications are developed for commercialization, which may never occur, we cannot evaluate the duration of any potential patent term extension under the Hatch-Waxman Amendments.
We additionally have filed twenty-five issued United States patents and thirteen patent applications, including six patent applications under the Patent Cooperation Treaty which have not yet entered national stage prosecution, on melanocortin receptor specific peptides and small molecules, but we are not actively developing any product candidate covered by a claim of one of these patents or applications. Most of the pending applications we are developing, but these
4
applications have not yet been examined. Until these applications are examined, and we do not know the scope of patent claims that will be allowed, or whether any patents will issue.
We own a number of United States and foreign patent applications that are licensed to AstraZeneca under our research collaboration and license agreement relating to our obesity program. Under the our research collaboration and license agreement with AstraZeneca, AstraZeneca is responsible for prosecution of these licensed patent applications and maintenance of issued patents in the United States and other countries. One licensed application has been published by relevant patent authorities in the United States. Additionally, AstraZeneca is prosecuting a patent application in its name resulting from its collaboration with us, on which our employees are inventors and for which royalties would be payable under our agreement with AstraZeneca if a compound covered by a claim of this application is developed for commercialization. This application has been published by relevant patent authorities in the United States and under the Patent Cooperation Treaty. However, many Neither of these patent applications have not yet been examined, and we do not know the scope of patent claims that will be allowed, or whether any patents will issue. Additionally, until one or more compounds subject to the agreement with AstraZeneca are developed for commercialization, which may never occur, we cannot evaluate the duration of patents or their effect on the program any potential patent term extension under the Hatch-Waxman Amendments.
In the event that a third party has also filed a patent application relating to an invention we claimed in a patent application, we may be required to participate in an interference proceeding adjudicated by the United States Patent and Trademark Office to determine priority of invention. The possibility of an interference proceeding could result in substantial uncertainties and cost, even if the eventual outcome is favorable to us. An adverse outcome could result in the loss of patent protection for the subject of the interference, subjecting us to significant liabilities to third parties, the need to obtain licenses from third parties at undetermined cost, or requiring us to cease using the technology.
* * * * *
We hereby acknowledge 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.
5
You may contact me directly at (609) 495-9197 should you require additional information.
Very truly yours,
/s/ Stephen A. Slusher
Stephen A. Slusher
Chief Legal Officer
6
2011-02-18 - UPLOAD - PALATIN TECHNOLOGIES INC
February 18, 2011 Carl Spana, Ph.D. President and Chief Executive Officer Palatin Technologies, Inc. 4C Cedar Brook Drive Cranbury, New Jersey 08512 Re: Palatin Technologies, Inc. Form 10-K Filed September 27, 2010 File No. 001-15543 Dear Mr. Spana: We have reviewed your filing 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 provide the requested response. If you do not believe our comments apply to your facts and circum stances, please tell us w hy in your response. After reviewing the information you provide in response to these comments, we may have additional comments. Form 10-K, filed September 27, 2010 Melanocortin Receptor-Specific Programs, page 3 1. Please provide proposed disclosu re to be included in fu ture filings regarding your collaboration and license agreement with AstraZeneca describing the duration of the agreement, termination provisions and the range of royalties you will be entitled to receive. An acceptable range of royalties is on e of the following: “single-digits,” “teens,” “twenties,” etc. Patents and Proprietary Information, page 9 2. We note that you own issued United States a nd foreign patents and patent applications pending in the United States and other countri es relating to various formulas. Please provide proposed disclosure for future filings specifying the number of patents and patent applications that you have associated with the respective product groups, the specific foreign jurisdictions in whic h your patents were granted or, in the case of patents pending, submitted. Please include in your disc ussion the patent applications that are licensed to AstraZeneca. Carl Spana Ph.D. Palatin Technologies, Inc. February 18, 2011 Page 2 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 and 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 Johnny Gharib at (202) 551-3170 or Daniel Greenspan at (202) 551-3623 with any questions. Sincerely, Jeffrey Riedler Assistant Director
2010-11-05 - UPLOAD - PALATIN TECHNOLOGIES INC
November 5, 2010
Steven T. Wills Chief Financial Officer Palatin Technologies, Inc. 4C Cedar Brook Drive
Cranbury, New Jersey 08512
Re: Palatin Technologies, Inc.
Registration Statement on Form S-1
Filed October 29, 2010
File No. 333-170227
Dear Mr. Wills:
We have limited our review of your registrati on statement to the issue we have 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 in your
response.
After reviewing any amendment to your re gistration statement and the information you
provide in response to this comment, we may have additional comments.
Form S-1
1. Please revise your prospectus to disclose the following in formation with regard to
your proposed offering:
• The total number of units to be sold in the offering;
• The number of shares of common stock underlying each warrant;
• The exercise price of the warrants;
• The expiration period for the warrants;
• The placement agent; and
• The placement agent fee.
If any of the terms identified above are dependent on the offering price of the units, please explain how the terms will be determined. To the extent that terms are to be determined based on a specific formula, please disclose the formula.
Steven T. Wills Palatin Technologies, Inc November 5, 2010 Page 2
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 incl udes the information the Securities Act of 1933 and
all applicable Securities Act rules require. Since the company and its management are in
possession of all facts relating to a company’s disc losure, 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 date
of the pending registration statement please pr ovide a written statement from the company
acknowledging that:
• should the Commission or the staff, acting purs uant to delegated authority, declare the
filing effective, it does not foreclose the Co mmission 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 a nd the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding re quests for acceleration. We will consider a
written request for acceleration of the effective date of the regi stration statement as confirmation
of the fact that those reques ting acceleration are aware of thei r respective responsibilities under
the Securities Act of 1933 and the Securities Excha nge Act of 1934 as they relate to the proposed
public offering of the securities specified in th e above registration stat ement. Please allow
adequate time for us to review any amendment prior to the requested effective date of the
registration statement.
Please contact Bryan Pitko at (202) 551-3203 with any questions. In this regard, please
also feel free to c ontact me at (202) 551-3715.
Sincerely,
Jeffrey Riedler
Assistant Director
cc: Faith L. Charles, Esq.
Thompson Hine LLP 335 Madison Avenue, 12th Floor New York, NY 10017
2009-03-31 - UPLOAD - PALATIN TECHNOLOGIES INC
Mail Stop 6010 March 31, 2009
Mr. Stephen T. Willis
Executive Vice President – Operations
and Chief Financial Officer
Palatin Technologies, Inc. 4C Cedar Brook Drive
Cranbury, NJ 08512
Re: Palatin Technologies, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed March 16, 2009
File No. 001-15543
Dear Mr. Willis:
We have completed our review of your preliminary proxy statement on
Schedule 14A and have no further comments at this time.
Sincerely,
J e f f r e y P . R i e d l e r A s s i s t a n t D i r e c t o r
2009-03-23 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
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Palatin Technologies, Inc. response to comment
[PALATIN TECHNOLOGIES, INC. LETTERHEAD]
March 23, 2009
Jeffrey P. Riedler
Assistant
Director
Mail Stop 6010
Division of Corporation Finance
Securities and Exchange
Commission
Washington, DC 20549
Re:
Palatin Technologies,
Inc.
Preliminary Proxy Statement on Schedule 14A
Filed March 16, 2009
File No. 001-15543
Dear Mr. Riedler:
We are responding to the Staff's comment dated
March 19, 2009, on the above-captioned filing (the "PRE 14A"). For the Staff's convenience, we have
recited the Staff's comment before our response.
PRE 14A
1.
We note that the
proposal to complete a reverse stock split of your outstanding shares will not affect the number of
common shares authorized in the restated certificate of incorporation. Please revise the discussion of
the proposed reverse stock split in your proxy statement to address whether the Company has any plans
to issue shares that will be newly available for issuance as a result of the reverse stock split.
Response: We propose amending
the fifth paragraph under Item Four, page 21, as appears below. Underlined material is to be added.
Raising capital. The reverse split would reduce
the number of shares of our common stock outstanding without reducing the total number of authorized
shares of common stock. As a result, we would have a larger number of authorized but unissued shares
from which to issue additional shares of common stock, or securities convertible or exercisable into
shares of common stock, in equity financing transactions. We currently have no plans for an equity
financing transaction or other transaction in which we would issue shares that will be newly available
for issuance as a result of the reverse stock split.
The foregoing will be included in the definitive
proxy statement to be filed based upon the PRE 14A, which we anticipate will be filed on March 30,
2009. Unless otherwise required, we will not file an amendment to the PRE 14A containing the foregoing.
We acknowledge 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.
Please contact me directly at (609) 495-9197 if
you require additional information.
Very truly yours,
/s/ STEPHEN A.
Slusher
Stephen A. Slusher
Executive Director, Legal & Intellectual Property Affairs
2009-03-19 - UPLOAD - PALATIN TECHNOLOGIES INC
Mail Stop 6010 March 19, 2009
Mr. Stephen T. Willis
Executive Vice President – Operations
and Chief Financial Officer
Palatin Technologies, Inc. 4C Cedar Brook Drive
Cranbury, NJ 08512
Re: Palatin Technologies, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed March 16, 2009
File No. 001-15543
Dear Mr. Willis:
This is to advise you that we have limited our review of the above-captioned filing to the
matters identified in the comments that follow.
Where indicated, we think you should revise your filing in response to our comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or a
revision is unnecessary. Please be as detailed as necessary in your explanation. After reviewing
this information, we may or may not raise additional comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requir ements 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 on any other aspe ct of our review. Feel free to call us at
the telephone numbers listed at the end of this letter.
PRE 14A
1. We note that the proposal to complete a re verse stock split of your outstanding common
shares will not affect the number of common sh ares authorized in the restated certificate
of incorporation. Please revi se the discussion of the proposed reverse stock plot in your
proxy statement to address whether the Compan y has any plans to is sue shares that will
be newly available for issuance as a result of the reverse stock split.
* * *
Mr. Stephen T. Willis
Palatin Technologies, Inc.
March 19, 2009
Page 2
As appropriate, please amend your filing and respond to these comments within 10
business days or tell us when you will provide us with a response. You may wish to provide us
with marked copies of the amendment to expedite our review. Please furn ish a cover letter with
your amendment that keys your responses to our comments and pr ovides any requested
information. Detailed cover lette rs greatly facilitate our review . Please understand that we may
have additional comments afte r reviewing your amendment and responses to our comments.
We urge all persons who are responsible fo r the accuracy and adequ acy of the disclosure
in the filing to be certain that the filing includes all information re quired under the Securities
Exchange Act of 1934 and that they have provi ded all information investors require for an
informed investment decision. Since the compa ny and its management are in possession of all
facts relating to a company’s disclosure, they are responsible for the acc uracy and adequacy of
the disclosures they have made.
In connection with responding to our comme nts, please provide, in writing, a statement
from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclo sure in the filing;
staff comments or changes to disclosure in re sponse 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 sta ff of the Division of Corporati on Finance in our review of your
filing or in response to our comments on your filing.
Please contact Daniel Greenspan, Special C ounsel, at (202) 551-3623 with any questions.
S i n c e r e l y , J e f f r e y P . R i e d l e r A s s i s t a n t D i r e c t o r
2008-02-29 - UPLOAD - PALATIN TECHNOLOGIES INC
Mail Stop 6010 February 29, 2008 Mr. Stephen T. Willis Executive Vice President – Operations and Chief Financial Officer Palatin Technologies, Inc. 4C Cedar Brook Drive Cranbury, NJ 08512 Re: Palatin Technologies, Inc. Form 10-K for Fiscal Year ended June 30, 2007 Filed September 13, 2007 File No. 1-15543 Dear Mr. Willis: We have completed our review of your Fo rm 10-K and related filings and have no further comments at this time. Sincerely, Jeffrey Riedler Assistant Director
2008-02-22 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
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[PALATIN TECHNOLOGIES, INC.
LETTERHEAD]
February 22, 2008
Mr. Jeffrey Riedler
Assistant
Director
Division of Corporation
Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549
Re:
Palatin Technologies, Inc.
Form 10-K for the Fiscal Year Ended June 30, 2007
Filed September 13, 2007
File No. 1-15543
Dear Mr. Riedler:
On behalf of Palatin
Technologies, Inc., we respond as follows to the comments dated February 4, 2008 from the
staff of the U.S. Securities and Exchange Commission (the “Commission”) relating
to the above-captioned public filing (the “2007 10-K”). Please note that
for your convenience, we have recited each of the staff’s comments and have provided
our response to each comment immediately thereafter.
Form 10-K for the year
ended June 30, 2007
Item 1. Business
Patents and Proprietary
Information, page 6
1.
We note your disclosure that you own issued patents relating to Bremelanotide
and NeutroSpec, and that you license certain patents relating to
compounds and methods of treatment for sexual dysfunction. Please expand your
disclosure to describe the nature of these patents and their duration,
as required by Item 101 (c)(1)(iv) of Regulation S-K.
Response:
With respect to bremelanotide, the
relevant sentence on page 6 of the 2007 10-K states: “We own issued United States and
foreign patents covering bremelanotide, and additionally have pending United States and
foreign applications.” Unless there has been a change in our business such that the
statement is no longer material, we will insert sentences stating in substance the
following in our annual report on Form 10-K for the year ending June 30, 2008:
1
The issued United States patents claim the bremelanotide substance and use of bremelanotide
for stimulating sexual response. The issued United States patents have a term until 2020,
which term may be subject to extension for a maximum period of up to five years as
compensation for patent term lost during drug development and the FDA regulatory review
process, pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984,
referred to as the Hatch-Waxman Amendments. Whether we will be able to obtain patent term
extensions under the Hatch-Waxman Amendments and the length of the extension to which we
may be entitled cannot be determined until approval for marketing, if it is ever obtained,
by the FDA of a product in which bremelanotide is the active ingredient.
With respect to NeutroSpec®, the
relevant sentence on page 6 of the 2007 10-K states: “We own patents relating to
certain aspects of NeutroSpec, but the claims of those patents would not be effective in
preventing others from developing competing products.” We believe that this
disclosure is sufficient, since disclosure under any of paragraphs (c)(1)(i) through (x)
of Item 101 of Regulation S-K is required only “[t]o the extent material to an
understanding of the registrant’s business taken as a whole.” Because we
disclose that the patents will not be effective in preventing others from developing
competing products, it is not material to an understanding of our business to further
understand the “duration and effect” of the patents.
Additionally, we had withdrawn
NeutroSpec from the market in December 2006. On page 5 of the 2007 10-K, we disclose that
“[a]ll ongoing clinical trials and plans for future clinical trials and regulatory
approvals of NeutroSpec have been suspended and no final decision concerning future
activities involving NeutroSpec have been made.” If we decide to proceed with
development of NeutroSpec, we will reconsider whether additional disclosure on the nature
and terms of the patents is warranted.
With respect to the license to
certain patents relating to compounds and methods of treatment for sexual dysfunction, the
relevant sentence on page 6 of the 2007 10-K states: “We also license certain patents
relating to compounds and methods of treatment for sexual dysfunction, and believe these
patents have value but are not required to commercialize bremelanotide.” This
sentence referred to certain patents that were the subject of a license agreement with
Competitive Technologies, Inc. (“CTI”). The license agreement did not apply to
bremelanotide, primarily because bremelanotide was not disclosed or claimed in any of the
patents included in the license agreement. The utility of the patents was predominately
defensive, and secondarily provided a potential alternative product. In either instance
the license agreement and patents licensed under the license agreement were not required
for any product we were developing, and therefore not material to an understanding of our
business taken as a whole. We described the license agreement in order to provide
continuity with previous reports which described that agreement, including disclosure of
litigation between CTI and us.
2
As we disclosed in our report on Form
8-K filed on January 23, 2008, and in Part II, Item 1 of our report on Form 10-Q for the
quarterly period ended December 31, 2007 filed on February 8, 2008, the license agreement
was terminated effective January 21, 2008 pursuant to a settlement agreement and release
with CTI, resolving all outstanding disputes with CTI. Because the license agreement with
CTI has been terminated, we will delete the sentence relating to the license of certain
patents quoted above from our next annual report on Form 10-K.
Item 15. Exhibits and
Financial Statement Schedules
2.
We
note the following agreements have been described but not filed as exhibits:
•
Exclusive
license agreement with The Wistar Institute of Biology and Anatomy;
•
License
agreement with Competitive Technologies, Inc.
Please
file these agreements as exhibits or provide us with an analysis supporting your
determination that the agreements are not required to be filed pursuant to Item
601 (b)(10) of Regulation S-K. Please note that if these agreements were filed
previously, you may amend your Form 10-K to incorporate the previously-filed agreement by
reference.
Response:
With respect to the license
agreements with The Wistar Institute of Biology and Anatomy (“Wistar”) and with
CTI, we do not believe that revised disclosure is necessary. We described these two
agreements, even though they were not material contracts as defined in Item 601 (b)(10) of
Regulation S-K, in order to provide continuity with previous reports which described them.
The license agreement with Wistar is
for rights to the cell line which produces the monoclonal antibody used in NeutroSpec, as
generally disclosed on page 6 of the 2007 10-K. As explained above in our response to the
first comment, we withdrew NeutroSpec from the market in December 2006 and suspended
development. Unless we decide to proceed with development of NeutroSpec, the agreement is
not material. In the event that we proceed with development of NeutroSpec, including
seeking or obtaining approval to market NeutroSpec, we will determine at that time whether
the agreement is required to be filed pursuant to Item 601 (b)(10).
The license agreement with CTI was
for rights to a peptide called variously MT-II or PT-14. We had ceased developing that
peptide in 2000. As explained above in our response to the first comment, the license
agreement did not apply to bremelanotide (the product we were and are developing), and was
not material to an understanding of our business taken as a whole.
3
As we have described above in our
response to the first comment, our license agreement with CTI has been terminated pursuant
to a settlement agreement. CTI retained all rights to MT-II/PT-14, and we expressly
relinquished all claims to any contractual or intellectual property rights to that peptide
or any patents licensed under the terminated license agreement. We retained all rights to
bremelanotide, and CTI expressly relinquished all claims to any contractual or
intellectual property rights to bremelanotide, including any claim that making, using or
selling bremelanotide infringes any patents licensed under the terminated license
agreement. Because the license agreement with CTI has been terminated, for this additional
reason it should not be filed as an exhibit.
* * * * *
We hereby acknowledge 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.
You may contact me directly at (609)
495-2200 extension 2222 should you require additional information.
Very truly yours,
/s/ STEPHEN T. WILLS
Stephen T. Wills
Executive Vice President - Operations and
Chief Financial
Officer
4
2008-02-04 - UPLOAD - PALATIN TECHNOLOGIES INC
Mail Stop 6010 February 4, 2008 Mr. Carl Spana, Ph.D. President and Chief Executive Officer Palatin Technologies, Inc. 4C Cedar Brook Drive Cranbury, NJ 08512 Re: Palatin Technologies, Inc. Form 10-K for Fiscal Year ended June 30, 2007 Filed September 13, 2007 File No. 1-15543 Dear Mr. Spana: We have reviewed your filing and have the following comments. In our comments, we ask you to provide us with information to better understand your disclosure. Where a comment requests you to revise disclosure, the information you provide should show us what the revised disc losure will look like and identify the annual or quarterly filing, as appli cable, in which you intend to first include it. If you do not believe that revised disclosure is necessary, explain the reason in your response. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing. 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. Form 10-K for the year ended June 30, 2007 Item 1. Business Patents and Proprietary Information, page 6 Mr. Carl Spana Palatin Technologies, Inc. February 4, 2008 Page 2 1. We note your disclosure that you own issu ed patents relating to Bremelanotide and NeutroSpec, and that you license cer tain patents relating to compounds and methods of treatment for sexual dysfuncti on. Please expand your disclosure to describe the nature of these patents an d their duration, as required by Item 101 (c)(1)(iv) of Regulation S-K. Item 15. Exhibits and Financial Statement Schedules 2. We note the following agreements have been described but not filed as exhibits: • Exclusive license agreement with Th e Wistar Institute of Biology and Anatomy; • License agreement with Competitive Technologies, Inc. Please file these agreements as exhibits or provide us with an analysis supporting your determination that the agreements ar e not required to be filed pursuant to Item 601 (b)(10) of Regulation S-K. Please note that if these agreements were filed previously, you may amend your Form 10-K to incorporate the previously- filed agreement by reference. * * * * * Please respond to these comments within 10 business days or tell us when you will provide us with a response. Please provide us any requested information. Detailed cover letters greatly facilitate our review. Please file the letter on EDGAR under the form type label CORRESP. 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. 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 Mr. Carl Spana Palatin Technologies, Inc. February 4, 2008 Page 3 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. Please do not hesitate to contact Rose Zukin at (202) 551-3239 or me at (202) 551-3715 if you have questions regarding th e comments and related matters. Sincerely, Jeffrey Riedler Assistant Director
2007-11-26 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
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Palatin Technologies, Inc. acceleration request
[PALATIN TECHNOLOGIES, INC. LETTERHEAD]
November 26, 2007
via EDGAR
Securities and Exchange Commission
450 Fifth Street, N.W.
Washington, D.C. 20549
Attention:
Jeffrey Riedler, Mail Stop 60-10
Assistant Director, Division of Corporate
Finance
Re:
Acceleration Request for Palatin Technologies,
Inc.
Registration Statement on Form
S-3, Filed September 28, 2007
File No. 333-146392
Ladies and gentlemen:
We respectfully request
acceleration of the effective date of our above-captioned registration statement on Form S-3 under the Securities Act of 1933, to
9:00 a.m. Eastern Time on Tuesday, November 27, 2007 or as soon after that as practicable. We also acknowledge the following:
•
should the Commission or the staff, acting
pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action
with respect to the filing;
•
the action of the Commission or the staff, acting
pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full
responsibility for the adequacy and accuracy of the disclosures in the filing; and
•
the company may not assert this action as a
defense in any proceeding by the Commission or any person under the federal securities laws of the United States.
PALATIN TECHNOLOGIES, INC.
By:
s/ STEPHEN A.
SLUSHER
Stephen A. Slusher
Executive Director, Legal & Intellectual
Property Affairs
2007-10-12 - UPLOAD - PALATIN TECHNOLOGIES INC
1
Mail Stop 6010 October 12, 2007 Stephen T. Willis Chief Financial Officer Palatin Technologies, Inc. 4C Cedar Brook Drive Cranbury, NJ 08512
Re: Palatin Technologies, Inc.
Registration Statement on Form S-3 Filed on September 28, 2007 File Number 333-146392
Dear Mr. Willis:
We have reviewed your filing and have th e following comments. Where indicated, we
think you should revise your document in response to these comments. If you disagree, we will
consider your explanation as to why our commen t is inapplicable or a revision is unnecessary.
Please be as detailed as nece ssary in your explanation.
Form S-3
1. Please file forms of your indentures as exhi bits to the registration statement prior to
requesting effectiveness. As you may be aw are, the Trust Indenture Act of 1939 requires
that an indenture be qualified at the time of registration.
* * *
We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filings reviewed by the staff to be certain that they have provided all information investors
require for an informed decision. Since the comp any and its management are in possession of all
facts relating to a company’s disclosure, they are responsible for the acc uracy and adequacy of
the disclosures they have made. Notwithstanding our comments, in the even t the company requests acceleration of the
effective date of the pending registration statement, it should furnish a letter, at the time of such
request, acknowledging that:
2
• should the Commission or the staff, acting purs uant to delegated authority, declare the
filing effective, it does not foreclose the Co mmission 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 this action 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 advi sed that the Division of En forcement has access to all
information you provide to the staff of the Divisi on of Corporation Finance in connection with
our review of your filing or in re sponse to our comments on your filing.
We will consider a written request for acceleration of the effective date of the registration statement as a confirmation of the fact that those requesting accelerat ion are aware of their
respective responsibilitie s under the Securities Act of 1933 and the Securities Exchange Act of
1934 as they relate to the proposed public offeri ng of the securities specified in the above
registration statement. We w ill act on the request and, pursuant to delegated authority, grant
acceleration of the effective date.
Please contact Rose Zukin at (202) 5 51-3239 or me at (202) 551-3715 with any
questions. S i n c e r e l y ,
J e f f r e y P . R i e d l e r
A s s i s t a n t D i r e c t o r cc: Faith L. Charles, Esq. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. 666 Third Avenue New York, NY 10017
2006-03-31 - UPLOAD - PALATIN TECHNOLOGIES INC
Via Facsimile and U.S. Mail
Mail Stop 6010
March 31, 2006
Carl Spana, Ph. D.
President and Chief Executive Officer
Palatin Technologies, Inc.
4C Cedarbrook Drive
Cranbury, NJ 08512
Re: Palatin Technologies, Inc.
Form 10-K for Fiscal Year Ended June 30, 2005
File No. 1-15543
Dear Dr. Spana:
We have completed our review of your Form 10-K and have no further comments
at this time.
S i n c e r e l y ,
Kevin Woody
B r a n c h C h i e f
2006-03-30 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
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Palatin Technologies, Inc. acceleration request
[PALATIN TECHNOLOGIES, INC. LETTERHEAD]
March 30, 2006
via EDGAR
Securities and Exchange Commission
450 Fifth Street, N.W.
Washington, D.C. 20549
Attention:
Jeffrey Riedler, Mail Stop 0309
Assistant Director, Division of Corporate
Finance
Re:
Acceleration Request for
Palatin Technologies, Inc.
Registration Statement on Form
S-3
File No. 333-132369 Filed March 13, 2006
Ladies and gentlemen:
We respectfully request
acceleration of the effective date of our above-captioned registration statement on Form S-3 under the Securities Act of 1933, to
2:00 p.m. EST on Friday, March 31, 2006, or as soon after that as practicable. We also acknowledge the following:
•
should the Commission or the staff, acting
pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action
with respect to the filing;
•
the action of the Commission or the staff, acting
pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full
responsibility for the adequacy and accuracy of the disclosures in the filing; and
•
the company may not assert this action as a
defense in any proceeding by the Commission or any person under the federal securities laws of the United States.
PALATIN TECHNOLOGIES, INC.
By:
s/ STEPHEN T.
WILLS
Stephen T. Wills
Executive Vice President and
Chief Financial Officer
2006-03-28 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
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Response to staff comment letter dated March 16, 2006
[PALATIN TECHNOLOGIES, INC. LETTERHEAD]
March 28, 2006
James Rosenberg
Senior Assistant Chief Accountant
Securities and Exchange Commission
Mail Stop 3-9
Washington, DC 20549
Re:
Palatin Technologies, Inc.
Form
10-K for the Fiscal Year Ended June 30, 2005
File No. 001-15543
Dear Mr. Rosenberg:
On behalf of Palatin
Technologies, Inc. (the “Company”), we respond as follows to the
Staff’s comments dated March 16, 2006 relating to the above-captioned public filings.
Please note that for the Staff’s convenience, we have recited each of the
Staff’s comments and provided our response to each comment immediately thereafter.
Form 10-K for the Fiscal
Year Ended June 30, 2005
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of
Operations, page 15
We believe your disclosure
regarding research and development projects could be improved. Please refer to the
Division of Corporation Finance “Current Issues and Rulemaking Projects Quarterly
Update” under section VIII – Industry Specific Issues – Accounting and
Disclosure by Companies Engaged in Research and Development Activities. You can find it at
the following website address:
http://www.sec.gov/divisions/corpfin/cfcrq032001.htm#secviii.
Please provide us the following
information in a disclosure-type format for each of your major research and development
projects:
a)
The costs incurred during each period presented and to
date on the project;
b)
The nature, timing and estimated costs of the efforts
necessary to complete the project;
c)
The anticipated completion dates;
d)
The risks and uncertainties associated with completing
development on schedule, and the consequences to operations, financial position and liquidity if the project is not completed
timely; and,
e)
The period in which material net cash inflows from
significant projects are expected to commence.
Regarding b. and c. disclose the
amount or range of estimated costs and timing to complete the phase in process and each
future phase. To the extent information
1
requested above is not estimable, disclose those
facts and circumstances indicating the uncertainties that preclude you from making a
reasonable estimate.
In an amendment to our Form S-3 (File
No. 333-132369), we will revise our discussion of expected future losses beginning on page
7 under “Risk Factors” as attached to include information regarding costs
incurred, current status and significant uncertainties in each of our major development
programs. We have changed references to “PT-141” to “bremelanotide”
its new generic name approved in February 2006.
We will include substantially similar
disclosures in future periodic reports filed with the Commission on Form 10-K and Form
10-Q.
Item 8. Financial
Statements, page 28
Note 2: Summary of
Significant Accounting Policies, page 35
Other assets, page 36
You disclose that you capitalized
certain license payments related to PT-141. Please explain to us your basis for
capitalizing costs for PT-141 prior to FDA approval. Please cite authoritative literature
you relied upon to support your accounting. In your response, please compare and contrast
the capitalization of these costs versus your decision to expense NeutroSpec raw materials
and finished goods prior to FDA approval.
We have a license agreement for
certain patent rights related to certain compounds and methods of treatment for sexual
dysfunction. The agreement requires us to make fixed, annual payments and additional
payments based on certain upfront fees we receive from any sublicense.
In August 2004, upon the closing of a
collaborative development and marketing agreement, we received a total of $20,000,000 from
King for certain rights to bremelanotide (formerly known as PT-141) and shares of our
common stock and warrants. The agreement included a sublicense of the patent rights
described above. During the fiscal year ended June 30, 2005, we paid a total of $2,017,900
to the licensor in cash and stock as their share of the consideration received from King.
Of the $20,000,000 received from
King, $3,606,672 was recorded as an equity contribution and $16,393,328 was recorded as an
up-front license fee, which was deferred and is being recognized over the expected term of
the development program related to the agreement, pursuant to guidance in SAB 104. Because
the $2,017,900 paid to our licensor was directly related to the license revenue from King,
we have treated the related sublicense fee as an incremental direct cost of the King
license fee, to be charged over the same period as the related deferred revenue, in
accordance with SAB 104 and by analogy to paragraph 4 of Technical Bulletin 90-1. Fixed
annual payments due under the license agreement are expensed as incurred.
2
In contrast, in the absence of
directly associated contract revenue, NeutroSpec costs were charged to research and
development expenses as incurred because they were not recoverable prior to FDA approval
in July 2004.
In future periodic reports filed with
the Commission on Form 10-K and Form 10-Q, we will cite in our footnote disclosures the
authoritative literature we used to support our accounting for the contingent license
payment.
Note 8: Commitments and
Contingencies, page 40
You disclose in the footnote to
your contractual obligation table that your license agreements include royalty and other
contingent payment obligations. Please tell us in a disclosure-type format the aggregate
amount of contingent payment obligations under each material license agreement and the
conditions under which you would be required to pay.
In response to the first comment
above, in an amendment to our Form S-3 (File No. 333-132369), we will revise our
discussion of expected future losses beginning on page 7 under “Risk Factors” as
attached to include information regarding costs incurred, current status and significant
uncertainties in each of our major development programs.
In the discussion of our NeutroSpec
program, we have disclosed the aggregate amount of our contingent payment obligations
under license agreements pertaining to NeutroSpec and a description of the conditions
under which we would be required to pay. We have also disclosed that we do not reasonably
expect to make any such contingent payments in the next twelve months.
In the discussion of our other
research and development programs, we have disclosed the nature of our contingent payment
obligations under a license agreement for patent rights related to certain compounds and
method of treatment for sexual dysfunction. We have also disclosed that we do not
reasonably expect to sublicense such rights or make any such contingent payments in the
next twelve months.
We will include substantially similar
disclosures in future periodic reports filed with the Commission on Form 10-K and Form
10-Q.
We acknowledge 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 actions 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.
3
You may contact me directly at (609)
495-2200 extension 2222 should you require additional information.
Very truly yours,
s/ Stephen T. Wills
Stephen T. WillsChief
Financial
Officer
Attachment
Insert to Form S-3 (File No.
333-132369) “Risk Factors. We expect to continue to incur substantial losses over the
next few years and we may never become profitable.”
We have never been profitable and we
may never become profitable. As of December 31, 2005, we had an accumulated deficit of
$145.0 million and a net loss for the six months then ended of $13.5 million. We have
voluntarily suspended sales and marketing of NeutroSpec, our only approved product. We
will incur additional losses as we develop bremelanotide and MIDAS and determine whether
to continue our development of NeutroSpec, including testing for other indications. Unless
and until we receive approval from the FDA or other regulatory authorities for our product
candidates, we cannot sell our products and will not have product revenues from them.
Therefore, for the foreseeable future, we will have to fund all of our operations and
capital expenditures from license and other contract revenue under our existing
collaborative development agreements and from cash, cash equivalents and investments on
hand. We will need to seek additional sources of financing, which may not be available on
acceptable terms, if at all. If we do not succeed in raising additional funds on
acceptable terms, we may be unable to complete planned pre-clinical and clinical trials or
obtain approval of our product candidates from the FDA or other regulatory authorities. In
addition, we could be forced to discontinue product development, reduce or forego sales
and marketing efforts and forego attractive business opportunities, which would have a
material adverse effect on our business.
We
have summarized below the costs to date and current status of our major development
programs.
Bremelanotide
– In the years ended June 30, 2005, 2004 and 2003 and cumulatively to date, we have
incurred approximately $18.3 million, $11.7 million, $9.0 million and $52.1 million,
respectively, in research and development (“R&D”) expenses, including an
allocated portion of general R&D expenses. Spending to date has been primarily related
to formulation, manufacturing, preclinical and clinical activities. As of June 30, 2005,
we had two Phase 2B clinical trials ongoing for ED and we initiated a Phase 2B study for
FSD in our fiscal year ended June 30, 2006 (“fiscal 2006”). We expect spending
after June 30, 2005 to amount to $30 million to $40 million of direct costs on
bremelanotide to conduct these and other clinical studies for ED and FSD and continue
related process and development activities prior to initiating a Phase 3 clinical trial. A
significant portion of the additional direct costs will be reimbursed by our collaboration
partner, King. The amount of such spending is dependent on a number of factors, including
patient enrollment in clinical studies, the results of research activities and discussions
with King. Assuming positive results from our current studies and related activities, we
expect development efforts related to bremelanotide to continue for several years. Due to
the uncertainties inherent in development activities, including whether bremelanotide will
sustain a product profile competitive with current therapies and results of manufacturing
scale-up, Phase 3 clinical trials, and regulatory adherence, we cannot reasonably predict
when, if ever, we will be able to submit a new drug application (“NDA”) to the
FDA.
Attachment Page 1
NeutroSpec
– In the years ended June 30, 2005, 2004 and 2003 and cumulatively to date, we have
incurred approximately $3.1 million, $8.2 million, $5.4 million and $51.9 million,
respectively, in R&D expenses, including an allocated portion of general R&D
expenses. Spending to date has been primarily related to an initial indication of imaging
equivocal appendicitis, for which we received FDA approval in July 2004. In December 2005,
the Company and Mallinckrodt, our collaboration partner, voluntarily suspended the sales,
marketing and distribution of NeutroSpec and recalled all existing customer inventories.
All ongoing clinical trials and regulatory approvals of NeutroSpec have been suspended
pending a review of the relationship between NeutroSpec use and observed serious adverse
events and an FDA Advisory Committee meeting expected to be held in 2006. We expect to
spend approximately $1 million to $2 million of direct costs on NeutroSpec during fiscal
2006 to perform certain FDA-required post-marketing studies, review the safety of
NeutroSpec and explore other indications, a significant portion of which will be
reimbursed by our collaboration partner, Mallinckrodt. The amount of such spending and the
nature of future development activities are dependent on a number of factors, including
primarily the review of NeutroSpec safety and discussions with both the FDA and
Mallinckrodt.
Our
license agreements related to NeutroSpec require royalty payments on commercial net sales
and payments of up to $2.25 million contingent on the achievement of specified cumulative
net margins on sales by Mallinckrodt. No contingent amounts will be payable related to
NeutroSpec unless we recommence sales and marketing of NeutroSpec. We do not reasonably
expect to make any such contingent payments during the next twelve months.
Other
Research and Development – In the years ended June 30, 2005, 2004 and 2003 and
cumulatively to date, we have incurred approximately $3.7 million, $3.4 million, $3.0
million and $16.8 million, respectively, in R&D expenses, including an allocated
portion of general R&D expenses. Spending to date has been primarily related to the
identification of lead compounds for various therapeutic indications, primarily a
melanocortin therapeutic small molecule for treatment of obesity and a natriuretic
compound for treatment of congestive heart failure. We expect to spend approximately $3
million to $4 million of direct costs in fiscal 2006 to continue laboratory research on
various compounds in preparation for filing an Investigational New Drug Application and
commencing clinical trials. The amount of such spending and the nature of future
development activities are dependent on a number of factors, including primarily the
success of our discovery programs, preclinical studies, our ability to progress a compound
into human clinical trials and discussions with potential development partners.
We
have a license agreement for patent rights related to certain compounds and methods of
treatment for sexual dysfunction. The license agreement requires contingent payments based
on certain upfront fees we receive as a result of a sublicense. We do not reasonably
expect to sublicense such rights or make any material contingent payments during the next
twelve months.
Due
to factors described elsewhere in our filing, including the difficulty in currently
estimating the costs and timing of future Phase 1 clinical trials and large-scale Phase 2
and Phase 3 clinical trials for any product under development, we cannot predict with
reasonable certainty when, if ever, a program will advance to the next stage of
Attachment Page 2
development or be successfully completed, or when, if ever, significant
related net cash inflows will be generated.
We
monitor our cash balances and periodic spending on an ongoing basis. If we fail to
successfully complete our planned development activities for any products on a timely
basis, we may increase development spending, adjust development plans for other products
and/or require additional funding.
Attachment Page 3
2006-03-24 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
filename1.htm
Response to staff comment letter dated March 16, 2006
[PALATIN TECHNOLOGIES, INC. LETTERHEAD]
James Rosenberg
Senior Assistant Chief Accountant
Securities and Exchange Commission
Mail Stop 3-9
Washington, DC 20549
Re:
Palatin Technologies, Inc.
Form
10-K for the Fiscal Year Ended June 30, 2005
File No. 001-15543
Dear Mr. Rosenberg:
On behalf of Palatin
Technologies, Inc. (the “Company”), we respond as follows to the
Staff’s comments dated March 16, 2006 relating to the above-captioned public
filings. Please note that for the Staff’s convenience, we have recited each of the
Staff’s comments and provided our response to each comment immediately thereafter.
Form 10-K for the Fiscal
Year Ended June 30, 2005
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of
Operations, page 15
We believe your disclosure
regarding research and development projects could be improved. Please refer to the
Division of Corporation Finance “Current Issues and Rulemaking Projects Quarterly
Update” under section VIII – Industry Specific Issues – Accounting and
Disclosure by Companies Engaged in Research and Development Activities. You can find it at
the following website address: http://www.sec.gov/divisions/corpfin/cfcrq032001.htm#secviii.
Please provide us the following
information in a disclosure-type format for each of your major research and development
projects:
a)
The costs incurred during each period presented and to
date on the project;
b)
The nature, timing and estimated costs of the efforts
necessary to complete the project;
c)
The anticipated completion dates;
d)
The risks and uncertainties associated with completing
development on schedule, and the consequences to operations, financial position and liquidity if the project is not completed
timely; and,
e)
The period in which material net cash inflows from
significant projects are expected to commence.
Regarding b. and c. disclose the
amount or range of estimated costs and timing to complete the phase in process and each
future phase. To the extent information requested above is not estimable, disclose those
facts and circumstances indicating the uncertainties that preclude you from making a
reasonable estimate.
We have summarized below the costs to
date and current status of our major development programs.
PT-141 – In the years ended June 30,
2005, 2004 and 2003 and cumulatively to date, we have incurred approximately $18.3
million, $11.7 million, $9.0 million and $52.1 million, respectively, in research and
development (“R&D”) expenses, including an allocated portion of general
R&D expenses. Spending to date has been primarily related to formulation,
manufacturing, preclinical and clinical activities. As of June 30, 2005, we had two Phase
2B clinical trials ongoing for Erectile Dysfunction (ED) and initiated a Phase 2B study
for Female Sexual Dysfunction (FSD) later in fiscal 2006. We expect to spend an additional
$30
1
million to $40 million of direct costs on PT-141 to conduct these and other
clinical studies for ED and FSD and continue related process and development activities prior to initiating a Phase 3 clinical
trial. A significant portion of the additional direct costs will be reimbursed by our collaboration partner, King Pharmaceuticals,
Inc.(“King”) The amount of such spending is dependent on a number of factors, including patient enrollment in clinical
studies, the results of research activities and discussions with King. Assuming positive results from our current studies and
related activities, we expect development efforts related to PT-141 to continue for several years. Due to the uncertainties
inherent in development activities, including whether PT-141 will sustain a product profile competitive with current therapies and
results of manufacturing scale-up, Phase 3 clinical trials, and regulatory adherence, we cannot reasonably predict when, if ever,
we will be able to submit an NDA to the FDA.
NeutroSpec – In the years ended
June 30, 2005, 2004 and 2003 and cumulatively to date, we have incurred approximately $3.1
million, $8.2 million, $5.4 million and $51.9 million, respectively, in R&D expenses,
including an allocated portion of general R&D expenses. Spending to date has been
primarily related to an initial indication of imaging equivocal appendicitis, for which we
received FDA approval in July 2004. In December 2005, the Company and Mallinckrodt Imaging
(“Mallinckrodt”), our collaboration partner, voluntarily suspended the sales,
marketing and distribution of NeutroSpec and recalled all existing customer inventories.
All ongoing clinical trials and regulatory approvals of NeutroSpec have been suspended
pending a review of the relationship between NeutroSpec use and observed serious adverse
events and an FDA Advisory Committee meeting expected to be held in 2006. We expect to
spend approximately $1 million to $2 million of direct costs on NeutroSpec during fiscal
2006 to perform certain FDA-required post-marketing studies, review the safety of
NeutroSpec and explore other indications, a significant portion of which will be
reimbursed by our collaboration partner, Mallinckrodt. The amount of such spending and the
nature of future development activities are dependent on a number of factors, including
primarily the review of NeutroSpec safety and discussions with both the FDA and
Mallinckrodt.
Other Research and Development –
In the years ended June 30, 2005, 2004 and 2003 and cumulatively to date, we have incurred
approximately $3.7 million, $3.4 million, $3.0 million and $16.8 million, respectively, in
R&D expenses, including an allocated portion of general R&D expenses. Spending to
date has been primarily related to the identification of lead compounds for various
therapeutic indications, primarily a melanocortin therapeutic small molecule for treatment
of obesity and a natriuretic compound for treatment of congestive heart failure. We expect
to spend approximately $3 million to $4 million of direct costs in fiscal 2006 to continue
laboratory research on various compounds in preparation for filing an IND application and
commencing clinical trials. The amount of such spending and the nature of future
development activities are dependent on a number of factors, including primarily the
success of our discovery programs, preclinical studies, our ability to progress a compound
into human clinical trials and discussions with potential development partners.
Due to factors described elsewhere in
our filing, including the difficulty in currently estimating the costs and
timing of future Phase 1 clinical trials and large-scale Phase 2 and Phase 3 clinical
trials for any product under development, we cannot predict with reasonable certainty
when, if ever, a program will advance to the next stage of development or be successfully
completed, or when, if ever, significant related net cash inflows will be generated.
We monitor our cash balances and
periodic spending on an ongoing basis. If we fail to successfully complete our planned
development activities for any products on a timely basis, we may increase development
spending, adjust development plans for other products and/or require additional funding.
Item 8. Financial
Statements, page 28
Note 2: Summary of
Significant Accounting Policies, page 35
Other assets, page 36
You disclose that you capitalized
certain license payments related to PT-141. Please explain to us your basis for
capitalizing costs for PT-141 prior to FDA approval. Please cite authoritative
2
literature
you relied upon to support your accounting. In your response, please compare and contrast
the capitalization of these costs versus your decision to expense NeutroSpec raw materials
and finished goods prior to FDA approval.
We have a license agreement for
certain patent rights related to certain compounds and methods of treatment for sexual
dysfunction. The agreement requires us to make fixed, annual payments and additional
payments based on certain upfront fees we receive from any sublicense.
In August 2004, upon the closing of a
collaborative development and marketing agreement, we received a total of $20,000,000 from
King for certain rights to PT-141 and shares of our common stock and warrants. The
agreement included a sublicense of the patent rights described above. During the fiscal
year ended June 30, 2005, we paid a total of $2,017,900 to the licensor in cash and stock
as their share of the consideration received from King.
Of the $20,000,000 received from
King, $3,606,672 was recorded as an equity contribution and $16,393,328 was recorded as an
up-front license fee, which was deferred and is being recognized over the expected term of
the development program related to the agreement under SAB 104. We have treated the
related sublicense fee as an incremental direct cost of the King license fee, to be
charged over the same period as the related deferred revenue, in accordance with SAB 104
and by analogy to paragraph 4 of Technical Bulletin 90-1. Fixed annual payments due under
the license agreement are expensed as incurred.
In contrast, in the absence of
directly associated contract revenue, NeutroSpec costs were charged to research and
development expenses as incurred because they were not recoverable prior to FDA approval
in July 2004.
Note 8: Commitments and
Contingencies, page 40
You disclose in the footnote to
your contractual obligation table that your license agreements include royalty and other
contingent payment obligations. Please tell us in a disclosure-type format the aggregate
amount of contingent payment obligations under each material license agreement and the
conditions under which you would be required to pay.
The license agreements related to
NeutroSpec require royalty payments on commercial net sales and payments of up to
$2,250,000 contingent on specified milestone events, primarily based on the achievement of
certain sales thresholds. No contingent amounts will be payable related to NeutroSpec
unless we recommence sales and marketing of NeutroSpec. We do not expect to make any
payments based on milestone events during fiscal 2006.
Our license agreement for patent
rights related to certain compounds and methods of treatment for sexual dysfunction
requires minimum payments of $150,000 per year. We are not currently developing any
products subject to the license agreement that would require the payment of royalties. The
license agreement requires contingent payments based on certain upfront fees we receive as
a result of a sublicense, which contingent payment has been paid with respect to the
sublicense to King. We do not expect to make any contingent payments during fiscal 2006.
We acknowledge 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 actions 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.
You may contact me directly at (609)
495-2200 extension 2222 should you require additional information.
Very truly yours,
s/ Stephen T. Wills
Stephen T. Wills
Chief Financial
Officer
3
2006-03-22 - UPLOAD - PALATIN TECHNOLOGIES INC
<DOCUMENT> <TYPE>LETTER <SEQUENCE>1 <FILENAME>filename1.txt <TEXT> Mail Stop 6010 March 22, 2006 Stephen T. Wills Chief Financial Officer Palatin Technologies, Inc. 4C Cedar Brook Drive Cranbury, New Jersey 08512 Re: Palatin Technologies, Inc. Registration Statement on Form S-3 Filed March 13, 2006 File No. 333-132369 Dear Mr. Wills: We have limited our review of your filing to the following matters: resolution of your pending confidential treatment request and resolution of the outstanding comments on your Form 10-K. After any issues that arise during our examination of the confidentiality request have been satisfied, and after the outstanding comments on your Form 10-K are resolved, we will consider your request for acceleration of the effective date of the registration statement. Please understand that the purpose of our review 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. Feel free to call us at the telephone numbers listed at the end of this letter. 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 all information required under the Securities Act of 1933 and that they have provided all information investors require for an informed investment decision. Since the company and its management are in possession of all facts relating to a company`s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event the company requests acceleration of the effective date of the pending registration statement, it should furnish a letter, at the time of such request, acknowledging that: * should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; * the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and * the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. In addition, please be advised that the Division of Enforcement has access to all information you provide to the staff of the Division of Corporation Finance in connection with our review of your filing or in response to our comments on your filing. We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. We will act on the request and, pursuant to delegated authority, grant acceleration of the effective date. We direct your attention to Rules 460 and 461 regarding requesting acceleration of a registration statement. Please allow adequate time after the filing of any amendment for further review before submitting a request for acceleration. Please provide this request at least two business days in advance of the requested effective date. Please contact Mary K. Fraser at (202) 551-3609 or me at (202) 551-3715 with any questions. Sincerely, Jeffrey P. Riedler Assistant Director cc: Peter A. Lodwick, Esq. Thompson & Knight LLP 1700 Pacific Avenue - Suite 3300 Dallas, Texas 75201 ?? ?? ?? ?? Stephen T. Wills Palatin Technologies, Inc. March 22, 2006 Page 1 </TEXT> </DOCUMENT>
2006-03-16 - UPLOAD - PALATIN TECHNOLOGIES INC
Via Facsimile and U.S. Mail
Mail Stop 6010
March 16, 2006
Carl Spana, Ph. D.
President and Chief Executive Officer
Palatin Technologies, Inc.
4C Cedarbrook Drive
Cranbury, NJ 08512
Re: Palatin Technologies, Inc.
Form 10-K for Fiscal Year Ended June 30, 2005
File No. 1-15543
Dear Dr. Spana:
We have limited our review of your filing to those issues we have addressed in
our comments. In our comments, we ask you to provide us with more information so we
may better understand your disclosure. After reviewing this inform ation, 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 filings. 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.
Form 10-K for the year ended June 30, 2005
Item 7. Management’s Discussion and Analys is of Financial Condition and Results of
Operations, page 15
1. We believe your disclosure regarding rese arch and development projects could be
improved. Please refer to the Division of Co rporation Finance “Current Issues and
Rulemaking Projects Quarterly Update” under section VIII – Industry Specific
Issues – Accounting and Disclosure by Companies Engaged in Research and
Development Activities. You can find it at the following website address:
http://www.sec.gov/divisions/c orpfin/cfcrq032001.htm#secviii
Carl Spana, Ph. D.
Palatin Technologies, Inc.
March 16, 2006
Page 2
Please provide us the following information in a disclosure-type format for each
of your major research and development projects:
a) The costs incurred during each period presented and to date on the project;
b) The nature, timing and estimated costs of the efforts necessary to complete the
project;
c) The anticipated completion dates;
d) The risks and uncertainties associated with completing development on schedule, and the consequences to oper ations, financial position and liquidity
if the project is not completed timely; and,
e) The period in which material net cash in flows from significant projects are
expected to commence.
Regarding b. and c., disclose the amount or range of estimated costs and timing to
complete the phase in process and each future phase. To the extent that
information requested above is not estimable, disclose those facts and
circumstances indicating the uncertain ties that preclude you from making a
reasonable estimate.
Item 8. Financial Statements, page 28
Note 2: Summary of Significant Accounting Policies, page 35
Other Assets, page 36
2. You disclose that you capita lized certain license paym ents related to PT-141.
Please explain to us your basis for cap italizing costs for PT -141 prior to FDA
approval. Please cite the authoritative litera ture you relied upon to support your
accounting. In your response, please compare and contra st the capitalization of
these costs versus your decision to expense NeutroSpec raw materials and
finished goods prior to FDA approval.
Note 8: Commitments and Contingencies, page 40
3. You disclose in the footnote to your cont ractual obligation tabl e that your license
agreements include royalty and other con tingent payment obligations. Please tell
us in a disclosure-type format the aggregate amount of contingent payment
obligations under each material license ag reement and the conditions under which
you would be required to pay.
Please respond to these comments within 10 business days or tell us when you
will provide us with a response. Please furnish a letter that keys your responses to our
Carl Spana, Ph. D.
Palatin Technologies, Inc.
March 16, 2006
Page 3
comments and provide the requested information. Detailed letters gr eatly facilitate our
review. Please file your letter on EDGA R under the form type label CORRESP.
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 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.
In connection with responding to our co mments, please provide, in your letter, 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 contact Mark Brunhofer, Staff Accountant, at
(202) 551-3638 or Donald Abbott, Senior Staff Accountant, at (202) 551-3608. In this
regard, do not hesitate to contact me, at (202) 551-3679.
Sincerely,
Jim B. Rosenberg
Senior Assistant Chief
Accountant
2005-06-28 - CORRESP - PALATIN TECHNOLOGIES INC
CORRESP
1
filename1.htm
response letter date June 28, 2005
[PALATIN LETTERHEAD]
June 28, 2005
James Rosenberg
Senior Assistant
Chief Accountant
Securities and Exchange Commission
Mail Stop 3-9
Washington, DC 20549
Re:
Palatin Technologies,
Inc.
Form 10-K for the Fiscal Year Ended June 30, 2004
Form 10-Q for the Quarter Ended March 31,
2005
File No. 001-15543
Dear Mr. Rosenberg:
On behalf of Palatin
Technologies, Inc. (the “Company”), we respond as follows to the
Staff’s legal comments dated May 23, 2005 relating to the
above-captioned public filings. Captions and page references herein correspond to
those set forth in the draft Form 10-Q/A for the quarter ended March 31, 2005, the
enclosed copy of which has been marked with the changes from the initial filing. Please
note that for the Staff’s convenience, we have recited each of the Staff’s
comments and provided our response to each comment immediately thereafter.
Form 10-K for the Fiscal
Year Ended June 30, 2004
Management’s
Discussion and Analysis
Critical Accounting
Policies, page 21
For each critical accounting policy
we do not see any disclosure about the factors and assumptions and reasonably likely
effects that changes could have, nor do we see disclosure quantifying what your actual
changes in estimates have been and what caused those changes. Please provide us your
analysis to support why that disclosure is not in the filing.
The Company’s most
significant accounting estimate is its estimate of the period over which it will perform
development activities under collaborative agreements. This estimate is used for the
purposes of recognizing revenue on up-front payments received under such agreements in
accordance with Staff Accounting Bulletin No. 104.
During fiscal years 2000 through
2004, the Company recognized a total of $1.3 million of revenue from up-front payments
received under its collaboration agreement with Mallinckrodt, including $0.5 million under
its initial agreement in 1999 and $0.8 million under an amendment entered into in 2002.
The Company’s performance period ended in June 2004 and the subject product was
approved by the FDA in July 2004. Accordingly, as of June 30, 2004, the Company had no
remaining performance obligation and no related deferred revenue balance subject to
significant uncertainty.
In August 2004, the Company
entered into a collaboration agreement with King Pharmaceuticals for the development of a
different product. In its proposed Form 10-Q/A for the quarter ended March 31, 2005, the
Company has included a discussion in MD&A on page 11 of the factors, assumptions and
reasonably likely effects of changes in assumptions related to that agreement. The Company
has also expanded its discussion to provide more information regarding its other critical
accounting policies.
Financial Statements
Revenue Recognition, page
57
Please explain more specifically to
us the revenue recognition basis for each revenue stream (e.g. grant and contract revenues
and up front fees), including the criteria you use in determining when the earnings
process is complete, the nature of facts and circumstances underlying adjustments to your
performance period estimate and the factors used to determine substantive progress toward
completion under the contract. As it relates to Mallinckrodt, explain the relationship
between cash payments of $3.2 million, revenue of $2 million and deferred revenue of
$242,000 in 2004.
License fees and
royalties:
License fees and royalties consist
of the up-front fees received from Mallinckrodt under a 1999 collaboration agreement for
the development of a pharmaceutical product. The agreement required the Company to perform
development activities during an initial development phase of the collaboration.
Accordingly, the up-front fees were deferred and amortized to revenue over the estimated
performance period for those activities. Specific performance periods were not stated in
the agreement and were estimated by management based on detailed development programs
agreed to by the parties. Management monitored the progress and results of these
development activities and adjusted its estimated performance period accordingly. Due to
the uncertainty inherent in its development programs, including the possibility that a
program could be terminated prior to completion without a payment obligation on the part
of the Company, the Company recognized such revenue on a straight-line basis, as it
believed that no other basis was more reflective of the pattern over which such revenue
was earned. At the inception of the collaboration in 1999, the Company estimated that its
performance period would end in the fourth quarter of fiscal year 2002. In 2002, the FDA
reviewed the biologics license application for the product and determined that additional
manufacturing and process validation data were required. Accordingly, in the fourth
quarter of fiscal year 2002, the performance period was adjusted prospectively and
thereafter from time to time to the date of FDA approval in July 2004.
Of the $3,200,000 received from
Mallinckrodt under a May 2002 amendment to its collaboration agreement, $800,000 was
received as an up-front payment in 2002, of which $61,538, $584,611 and $153,851 was
recognized as revenue during the fiscal years ended June 30, 2002, 2003 and 2004,
respectively.
Grants and contracts:
Grants and contracts consist of
research and development funding, including amounts received from Mallinckrodt under its
collaboration agreement based on the attainment of specified development milestones.
Under its collaboration agreement
with Mallinckrodt, the Company earned revenue from achieving development milestones. The
contractual milestones pertain primarily to manufacturing tasks and regulatory filings
that are discrete tasks or events representing substantive achievements toward completion
of the development program. These milestones are recorded as revenue upon objective
completion of the task.
Of the $3,200,000 received from
Mallinckrodt under the amendment to its collaboration agreement, $400,000 and $2,000,000
was received and recognized as revenue during fiscal years 2003 and 2004, respectively.
Independent of the funding
provided under its collaboration agreement, the Company also received payments from
Mallinckrodt for the performance of other studies. These payments are recorded as revenue
as work on the studies is completed by the Company. At June 30, 2004, the Company has a
deferred revenue liability of $242,000, representing payments received from Mallinckrodt
in advance of performance.
Grant revenue earned under
contracts with the Department of Health and Human Services is earned and recognized as
monies are spent by the Company for employee time and out-of-pocket expenses incurred in
accordance with the terms of the grant.
Note 6.
Stockholders’ Equity, page 63
Please provide the references to the
technical literature that served as the basis for your accounting for the downward
adjustment in 2003 of the exercise price of certain previously issued and outstanding
warrants, which was presented as a deemed dividend in computing net loss attributable to
common stockholders. Demonstrate how the amount charged to expense in 2003 complies with
GAAP.
The sale of common stock and
warrants in July 2002, November 2002 and March 2003 triggered downward adjustments in the
exercise prices of certain of the Company’s outstanding warrants. At the date of each
related stock issuance, using the approach provided under Statement of Financial
Accounting Standards No. 123 for modifications of options and warrants issued for goods or
services, the value transferred to the warrant-holders at the time of reset was determined
by comparing the fair value of the warrants before the reset with the fair value of the
warrants after the reset, as calculated by the application of the Black Scholes model. The
transferred value was treated as a deemed dividend for earnings per share purposes by
analogizing to circumstances described in EITF Issue No. 98-5, EITF Issue No. 00-27 and
Statement of Financial Accounting Standards No. 128.
Form 10-Q for the
quarter ended March 31, 2005
Please amend the filing to provide
the following disclosures in MD&A or as indicated:
•
Disaggregate product sales from
royalty revenue on the face of the statement of operations.
We have amended our Consolidated Statements of Operations
on page 3 to disaggregate product sales from royalty revenue.
•
Disclose the payment terms for product sales and royalties.
We have revised our discussion in MD&A on pages 14 and
16 to provide a discussion of payment terms.
•
Clarify in your accounting policy note to the financial
statements when royalties are recognized.
We have revised our note on page 7 to clarify when we
record royalty revenue.
•
Explain why product and royalty revenue decreased to $466,000
in the quarter ended March 31, 2005 from $1.5 million in the quarter ended December 31, 2004.
The discussion of product sales in MD&A on page 14 has
been revised to provide a discussion of the variation in quarterly sales.
•
Quantify the amount of product sales that do not have a
related cost of products sold since the cost of the product sold was previously expensed as research and development expense
prior to FDA approval.
Disclosure has been added to the Cost of Sales discussion
in MD&A on page 15 to indicate that the active drug product for all units sold to date was previously expensed.
•
Explain what is included in cost of sales if the cost of
product sold was previously expensed as research and development expense.
Disclosure has been added to the Cost of Sales discussion
in MD&A on page 14 to indicate that recorded costs of sales includes primarily packaging and other materials.
•
Disclose the period over which the $20 million up front
payment from King is being recognized and how that period was determined.
We have amended our discussion in MD&A on page 11 to
state the estimated performance period and provide more information concerning how the period was determined.
•
In MD&A, disaggregate the amount of each material
component of license, grant and contract revenue so that a reader can understand the nature and amount of each revenue
stream.
The Company’s discussion of license, grant and
contract revenue in MD&A on page 14 has been amended to identify each component of revenue.
•
Disclose the components of accounts receivable at March 31,
2005 explaining the high level of receivables as compared to revenue in the quarter ended March 31, 2005.
The Company has amended its discussion in MD&A on page
16 and its notes to financial statements on page 6 to include the components of the March 31, 2005 receivables
balance and an indication that a significant portion of the Company’s quarterly revenues are received after
quarter-end by the terms of its collaboration agreements.
We acknowledge that:
•
The Company is responsible for the adequacy and accuracy of
the disclosure in the filings;
•
Staff comments or changes to disclosure in response to staff
comments in the filings reviewed by the staff do not foreclose the Commission from taking any actions 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.
We will file the amended Form 10-Q upon completion of your review. You
may contact me directly at (609) 495-2200 extension 2222 should you require additional information.
Very truly yours,
/s/ Stephen T. Wills
Stephen T. WillsChief
Financial
Officer
2005-05-23 - UPLOAD - PALATIN TECHNOLOGIES INC
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 03-09
Via Facsimile and U.S. Mail
May 23, 2005
Mr. Carl Spana
President and Chief Executive Officer
Palatin Technologies, Inc.
4C Cedarbrook Drive
Cranbury, NJ 08512
RE: Palatin Technologies, Inc.
Form 10-K for the fiscal year ended June 30, 2004
Filed September 13, 2004
Form 10-Q for quarter ended March 31, 2005
Filed May 10, 2005
File No. 001-15543
Dear Mr. Spana:
We have reviewed your filings and have the following
comments. We have limited our review of the above referenced
filings
to only those issues addressed. Where our comments call for
disclosure, we think you should amend your March 31, 2005 Form 10-
Q
in response to these comments. In some of our comments, we ask
you
to provide us with supplemental information so we may better
understand your disclosure. Please amend your Form 10-Q filing
for
March 31, 2005 and respond to these comments within 15 business
days
or tell us when you will provide us with a response prior to the
expiration of the 15-day period. If we have requested additional
information as well as an amendment, or if you disagree with any
comment that calls for disclosure, please provide this letter
prior
to your amendment. You may wish to provide us with marked copies
of
the amendment to expedite our review. Detailed letters greatly
facilitate our review. Please file your letter on EDGAR under the
form type label CORRESP. Please understand that we may have
additional comments after reviewing your responses to our
comments.
Please understand that the purpose of our review 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 on any other
aspect
of our review. Feel free to call us at the telephone numbers
listed
at the end of this letter.
Form 10-K for the fiscal year ended June 30, 2004
Managements Discussion and Analysis
Critical Accounting Policies, page 21
1. For each critical accounting policy we do not see any
disclosure
about the factors and assumptions and the reasonably likely
effects
that changes could have, nor do we see disclosure quantifying what
your actual changes in estimates have been and what caused those
changes. Please provide us your analysis to support why that
disclosure is not in the filing.
Financial Statements
Note 2. Summary of Significant Accounting Policies
Revenue Recognition, page 57
2. Please explain more specifically to us the revenue recognition
basis for each revenue stream (e.g. grant and contract revenues
and
up front fees), including the criteria you use in determining when
the earnings process is complete, the nature of facts and
circumstances underlying adjustments to your performance period
estimate and the factors used to determine substantive progress
towards completion under the contract. As it relates to
Mallinckrodt,
explain the relationship between cash payments of $3.2 million,
revenue of $2 million and deferred revenue of $242,000 in 2004.
Note 6. Stockholders` Equity, page 63
3. Please provide the references to the technical literature that
served as the basis for your accounting for the downward
adjustment
in 2003 of the exercise price of certain previously issued and
outstanding warrants, which was presented as a deemed dividend in
computing net loss attributable to common stockholders.
Demonstrate
how the amount charged to expense in 2003 complies with GAAP.
Form 10-Q for the quarter ended March 31, 2005
4. Please amend the filing to provide the following disclosures in
MD&A or as indicated:
* Disaggregate product sales from royalty revenue on the face of
the
statement of operations.
* Disclose the payment terms for product sales and royalties.
* Clarify in your accounting policy note to the financial
statements
when royalties are recognized.
* Explain why product and royalty revenue decreased to $466,000 in
the quarter ended March 31, 2005 from $1.5 million in the quarter
ended December 31, 2004.
* Quantify the amount of product sales that do not have a related
cost of product sold since the cost of the product sold was
previously expensed as research and development expense prior to
FDA
approval.
* Explain what is included in cost of sales if the cost of product
sold was previously expensed as research and development expense.
* Disclose the period over which the $20 million upfront payment
from
King is being recognized and how that period was determined.
* In MD&A, disaggregate the amount of each material component of
license, grant and contract revenue so that a reader can
understand
the nature and amount of each revenue stream.
* Disclose the components of accounts receivable at March 31, 2005
explaining the high level of receivables as compared to revenue in
the quarter ended March 31, 2005.
* * * * *
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filings reviewed by the staff to
be
certain that they have provided all information investors require.
Since the company and its management are in possession of all the
facts relating to a company`s disclosure, they are responsible for
the accuracy and adequacy of the disclosures they have made.
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 filings;
* Staff comments or changes to disclosure in response to staff
comments in the filings reviewed by the staff 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 advised that the Division of
Enforcement
has access to all information you provide to the staff of the
Division of Corporation Finance in our review of your filings or
in
response to our comments on your filings.
You may contact Frank Wyman, Staff Accountant at (202) 551-
3660
or Lisa Vanjoske, Assistant Chief Accountant, at (202) 551-3614,
if
you have questions regarding the comments. In this regard, do not
hesitate to contact me at (202) 551-3679.
Sincerely,
Jim B. Rosenberg
Senior Assistant Chief Accountant
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Mr. Carl Spana
Palatin Technologies, Inc.
Page 3
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