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TALPHERA, INC.
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TALPHERA, INC.
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TALPHERA, INC.
Response Received
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TALPHERA, INC.
Response Received
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TALPHERA, INC.
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TALPHERA, INC.
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TALPHERA, INC.
Awaiting Response
0 company response(s)
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TALPHERA, INC.
Awaiting Response
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Medium
SEC wrote to company
2023-03-30
TALPHERA, INC.
Summary
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TALPHERA, INC.
Response Received
1 company response(s)
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TALPHERA, INC.
Response Received
3 company response(s)
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SEC wrote to company
2020-06-17
TALPHERA, INC.
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TALPHERA, INC.
Response Received
1 company response(s)
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SEC wrote to company
2020-04-14
TALPHERA, INC.
Summary
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TALPHERA, INC.
Awaiting Response
0 company response(s)
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SEC wrote to company
2019-11-25
TALPHERA, INC.
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TALPHERA, INC.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-06-12
TALPHERA, INC.
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TALPHERA, INC.
Response Received
1 company response(s)
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SEC wrote to company
2014-06-05
TALPHERA, INC.
Summary
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TALPHERA, INC.
Response Received
4 company response(s)
Medium - date proximity
SEC wrote to company
2010-12-08
TALPHERA, INC.
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| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-25 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2025-09-25 | SEC Comment Letter | TALPHERA, INC. | DE | 333-290454 | Read Filing View |
| 2025-05-09 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2025-05-08 | SEC Comment Letter | TALPHERA, INC. | DE | 333-286957 | Read Filing View |
| 2024-02-09 | SEC Comment Letter | TALPHERA, INC. | DE | 333-276898 | Read Filing View |
| 2024-02-09 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-11-29 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-11-29 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-08-07 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-08-07 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-04-11 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-04-11 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-03-30 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2022-11-21 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2022-11-21 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2020-07-07 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2020-07-06 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2020-07-06 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2020-06-17 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2020-04-22 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2020-04-14 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2019-11-25 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2019-11-07 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2019-10-25 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2017-06-13 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2017-06-12 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2014-06-11 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2014-06-05 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2011-02-04 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2011-02-04 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2011-02-01 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2011-02-01 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2010-12-08 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-25 | SEC Comment Letter | TALPHERA, INC. | DE | 333-290454 | Read Filing View |
| 2025-05-08 | SEC Comment Letter | TALPHERA, INC. | DE | 333-286957 | Read Filing View |
| 2024-02-09 | SEC Comment Letter | TALPHERA, INC. | DE | 333-276898 | Read Filing View |
| 2023-11-29 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-08-07 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-04-11 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-03-30 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2022-11-21 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2020-06-17 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2020-04-14 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2019-11-25 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2019-10-25 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2017-06-12 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2014-06-05 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2010-12-08 | SEC Comment Letter | TALPHERA, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-09-25 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2025-05-09 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2024-02-09 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-11-29 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-08-07 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2023-04-11 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2022-11-21 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2020-07-07 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2020-07-06 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2020-07-06 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2020-04-22 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2019-11-07 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2017-06-13 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2014-06-11 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2011-02-04 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2011-02-04 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2011-02-01 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
| 2011-02-01 | Company Response | TALPHERA, INC. | DE | N/A | Read Filing View |
2025-09-25 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm acrx20250925_corresp.htm TALPHERA, INC. 1850 Gateway Drive, Suite 175 San Mateo, CA 94404 September 25, 2025 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 RE: Talphera, Inc. Registration Statement on Form S-3 File No. 333-290454 Ladies and Gentlemen: Talphera, Inc. (the “ Registrant ”) hereby requests that the U.S. Securities and Exchange Commission (the “ Commission ”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on September 29, 2025, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes John T. McKenna of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with John T. McKenna of Cooley LLP, counsel to the Registrant, at (650) 843-5059. Very truly yours, Talphera, Inc. By: /s/ Vincent J. Angotti Name: Vincent J. Angotti Title: Chief Executive Officer cc: Raffi Asadorian, Talphera, Inc. John T. McKenna, Cooley LLP
2025-09-25 - UPLOAD - TALPHERA, INC. File: 333-290454
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> September 25, 2025 Vincent J. Angotti Chief Executive Officer Talphera, Inc. 1850 Gateway Drive, Suite 175 San Mateo, CA 94404 Re: Talphera, Inc. Registration Statement on Form S-3 Filed September 22, 2025 File No. 333-290454 Dear Vincent J. Angotti: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Joshua Gorsky at 202-551-7836 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: John T. McKenna </TEXT> </DOCUMENT>
2025-05-09 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm acrx20250509_corresp.htm TALPHERA, INC. 1850 Gateway Drive, Suite 175 San Mateo, CA 94404 May 9, 2025 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 RE: Talphera, Inc. Registration Statement on Form S-3 File No. 333-286957 Ladies and Gentlemen: Talphera, Inc. (the “ Registrant ”) hereby requests that the U.S. Securities and Exchange Commission (the “ Commission ”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on May 12, 2025, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes John T. McKenna of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with John T. McKenna of Cooley LLP, counsel to the Registrant, at (650) 843-5059. Very truly yours, Talphera, Inc. By: /s/ Vincent J. Angotti Name: Vincent J. Angotti Date: Chief Executive Officer cc: Raffi Asadorian, Talphera, Inc. John T. McKenna, Cooley LLP
2025-05-08 - UPLOAD - TALPHERA, INC. File: 333-286957
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 8, 2025 Vincent Angotti Chief Executive Officer Talphera, Inc. 1850 Gateway Drive, Suite 175 San Mateo, CA 94404 Re: Talphera, Inc. Registration Statement on Form S-3 Filed May 2, 2025 File No. 333-286957 Dear Vincent Angotti: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Jason Drory at 202-551-8342 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: John McKenna </TEXT> </DOCUMENT>
2024-02-09 - UPLOAD - TALPHERA, INC. File: 333-276898
United States securities and exchange commission logo
February 9, 2024
Vincent J. Angotti
Chief Executive Officer
Talphera, Inc.
1850 Gateway Drive, Suite 175
San Mateo, CA 94404
Re:Talphera, Inc.
Registration Statement on Form S-3
Filed February 6, 2024
File No. 333-276898
Dear Vincent J. Angotti:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: John T. McKenna, Esq.
2024-02-09 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm acrx20240209_corresp.htm February 9, 2024 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 RE: Talphera, Inc. Registration Statement on Form S-3 File No. 333-276898 Ladies and Gentlemen: Talphera, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on February 13, 2024, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes John T. McKenna of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with John T. McKenna of Cooley LLP, counsel to the Registrant, at (650) 843-5059. Very truly yours, TALPHERA, INC. By: /s/ Vincent J. Angotti Name: Vincent J. Angotti Title: Chief Executive Officer cc: Thomas P. McCracken, Talphera, Inc. John T. McKenna, Cooley LLP www.talphera.com 1850 Gateway Drive, Suite 175, San Mateo, CA 94404
2023-11-29 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm acrx20231129_corresp.htm November 29, 2023 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 RE: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-3 File No. 333-275721 Ladies and Gentlemen: AcelRx Pharmaceuticals, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on November 30, 2023, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes John T. McKenna of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with John T. McKenna of Cooley LLP, counsel to the Registrant, at (650) 843-5059. Very truly yours, ACELRX PHARMACEUTICALS, INC. By: /s/ Vincent J. Angotti Name: Vincent J. Angotti Title: Chief Executive Officer cc: Thomas P. McCracken, AcelRx Pharmaceuticals, Inc. John T. McKenna, Cooley LLP AcelRx Pharmaceuticals, Inc. 1850 Gateway Drive, Suite 175 San Mateo, CA 94404
2023-11-29 - UPLOAD - TALPHERA, INC.
United States securities and exchange commission logo
November 29, 2023
Vincent J. Angotti
Chief Executive Officer
AcelRx Pharmaceuticals, Inc.
1850 Gateway Drive, Suite 175
San Mateo, CA 94404
Re:AcelRx Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed November 22, 2023
File No. 333-275721
Dear Vincent J. Angotti:
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 Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: John T. McKenna, Esq.
2023-08-07 - UPLOAD - TALPHERA, INC.
United States securities and exchange commission logo
August 7, 2023
Vincent J. Angotti
Chief Executive Officer
AcelRx Pharmaceuticals, Inc.
25821 Industrial Boulevard, Suite 400
Hayward, CA 94545
Re:AcelRx Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed August 2, 2023
File No. 333-273589
Dear Vincent J. Angotti:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tyler Howes at 202-551-3370 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: John T. McKenna, Esq.
2023-08-07 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm acrx20230807_corresp.htm August 7, 2023 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 RE: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-3 File No. 333-273589 Ladies and Gentlemen: AcelRx Pharmaceuticals, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on August 9, 2023, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes John T. McKenna of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with John T. McKenna of Cooley LLP, counsel to the Registrant, at (650) 843-5059. Very truly yours, ACELRX PHARMACEUTICALS, INC. By: /s/ Vincent J. Angotti Name: Vincent J. Angotti Title: Chief Executive Officer cc: Thomas P. McCracken, AcelRx Pharmaceuticals, Inc. John T. McKenna, Cooley LLP
2023-04-11 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm acrx20230411_corresp.htm JOHN T. MCKENNA +1 650 843 5059 jmckenna@cooley.com April 11, 2023 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Kevin W. Vaughn RE: AcelRx Pharmaceuticals, Inc. Current Report on Form 8-K (File No. 001-35068) Filed March 30, 2023 Ladies and Gentlemen: On behalf of AcelRx Pharmaceuticals, Inc. (the “Company”), this letter is being transmitted in response to a comment received from the staff (the “Staff”) of the Securities and Exchange Commission, by letter dated March 30, 2023 (the “Comment Letter”), regarding the Company’s Current Report on Form 8-K, filed on March 30, 2023 (the “Form 8-K”). The text of the Staff’s comment has been included in this letter in italics for your convenience, and we have numbered the paragraph below to correspond to the numbering of the Comment Letter. Form 8-K filed March 30, 2023 Item 4.02. Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review, page 2 1. Please revise your disclosure to include a statement of whether the audit committee, or the board of directors in the absence of an audit committee, or authorized officer or officers, discussed with the registrant’s independent accountant the matters disclosed in the filing pursuant to Item 4.02(a)(3). The Company respectfully acknowledges the Staff’s comment and advises the Staff, that in Item 9B. “Other Information” to its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Commission on March 31, 2023 (the “Annual Report”), the Company included the information previously set forth in the Form 8-K and further disclosed: “On March 30, 2023, the Company’s management and the Audit Committee of the Company, in discussion with the Company’s independent registered accounting firm, WithumSmith+Brown PC, determined that the Company’s Prior Period Financial Statements for the Interim Periods, should no longer be relied upon because of the error in the earnings per share calculations. The Company’s management and the Audit Committee concluded that it is appropriate to restate the Prior Period Financial Statements for the Interim Periods noted above.” COOLEY LLP 3175 HANOVER STREET PALO ALTO, CA 94304-1130 T: (650) 843-5000 F: (650) 849-7400 COOLEY.COM U. S. Securities and Exchange Commission April 11, 2023 Page Two As the Annual Report was filed within the requisite four business days of the determination date of March 30, 2023, and one business day following the filing of the Form 8-K, the Company respectfully submits that it has provided the missing information with respect to Item 4.02(a)(3), and that an amendment of the Form 8-K is not necessary per General Instruction B.3. to Form 8-K, and upon the filing of the Annual Report and the separate and prominent presentation of the disclosure in Item 9B. “Other Information” investors were adequately advised of the discussions with the Company’s independent accountant with respect to the restatement. Should you have any questions regarding this matter, please feel free to contact me at (650) 843-5059. Sincerely, Cooley LLP /s/ John T. McKenna John T. McKenna cc: Raffi Asadorian – AcelRx Pharmaceuticals, Inc. Thomas McCracken – AcelRx Pharmaceuticals, Inc. COOLEY LLP 3175 HANOVER STREET PALO ALTO, CA 94304-1130 T: (650) 843-5000 F: (650) 849-7400 COOLEY.COM
2023-04-11 - UPLOAD - TALPHERA, INC.
United States securities and exchange commission logo
April 11, 2023
Raffi Asadorian
Chief Financial Officer
ACELRX PHARMACEUTICALS INC
25821 Industrial Boulevard
Suite 400
Hayward, CA 94545
Re:ACELRX PHARMACEUTICALS INC
Form 8-K filed March 30, 2023
Dear Raffi Asadorian:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2023-03-30 - UPLOAD - TALPHERA, INC.
United States securities and exchange commission logo
March 30, 2023
Raffi Asadorian
Chief Financial Officer
ACELRX PHARMACEUTICALS INC
25821 Industrial Boulevard
Suite 400
Hayward, CA 94545
Re:ACELRX PHARMACEUTICALS INC
Dear Raffi Asadorian:
We have reviewed your filing and have the following comment. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
Form 8-K filed March 30, 2023
Item 4.02. Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or
Completed Interim Review, page 2
1.Please revise your disclosure to include a statement of whether the audit committee, or the
board of directors in the absence of an audit committee, or authorized officer or officers,
discussed with the registrant’s independent accountant the matters disclosed in the filing
pursuant to Item 4.02(a)(3).
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
You may contact Kevin W. Vaughn at 202-551-3494 if you have questions regarding
comments on the financial statements and related matters.
FirstName LastNameRaffi Asadorian
Comapany NameACELRX PHARMACEUTICALS INC
March 30, 2023 Page 2
FirstName LastName
Raffi Asadorian
ACELRX PHARMACEUTICALS INC
March 30, 2023
Page 2
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-11-21 - UPLOAD - TALPHERA, INC.
United States securities and exchange commission logo
November 21, 2022
Vincent J. Angotti
Chief Executive Officer
AcelRx Pharmaceuticals Inc.
25821 Industrial Boulevard, Suite 400
Hayward, CA 94545
Re:AcelRx Pharmaceuticals Inc.
Registration Statement on Form S-3
Filed November 15, 2022
File No. 333-268396
Dear Vincent J. Angotti:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-11-21 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm acrx20221121_corresp.htm ACELRX PHARMACEUTICALS, INC. 25821 Industrial Boulevard, Suite 400 Hayward, CA 94545 November 21, 2022 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 RE: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-3 File No. 333-268396 Ladies and Gentlemen: AcelRx Pharmaceuticals, Inc. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3, as amended to become effective on November 22, 2022, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes each of John T. McKenna, Mark B. Weeks and David R. Ambler of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with John T. McKenna of Cooley LLP, counsel to the Registrant, at (650) 843-5059, or in his absence, Mark B. Weeks at (650) 843-5011 or David R. Ambler at (650) 843-5899. Very truly yours, ACELRX PHARMACEUTICALS, INC. By: /s/ Vincent J. Angotti Name: Vincent J. Angotti Title: Chief Executive Officer cc: Thomas McCracken, AcelRx Pharmaceuticals, Inc. John T. McKenna, Cooley LLP Mark B. Weeks, Cooley LLP David R. Ambler, Cooley LLP
2020-07-07 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm acrx20200707_corresp.htm AcelRx Pharmaceuticals, Inc. 351 Galveston Drive Redwood City, CA 94063 July 7, 2020 Via EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Paul Fischer RE: Withdrawal of Acceleration Request for AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed June 12, 2020 File Number: 333-239156 Ladies and Gentlemen: AcelRx Pharmaceuticals, Inc. (the “Registrant”) hereby respectfully requests that the Securities and Exchange Commission (the “Commission”) withdraw the Registrant’s request for acceleration, dated July 6, 2020 (with Accession Number 0001437749-20-014610), of the effective date of the Registrant’s Registration Statement on Form S-3 (File No. 333-239156) (the “Registration Statement”) which requested that the Commission cause such Registration Statement to become effective on July 9, 2020, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. Thank you for your assistance. If you should have any questions, please contact Robert Phillips at (415) 693-2020, or in his absence, David Ambler at (650) 843-5899. [Signature Page Follows] Very truly yours, AcelRx Pharmaceuticals, Inc. By: /s/ Raffi Asadorian Name: Raffi Asadorian Title: Chief Financial Officer cc: Ruben Garcia, AcelRx Pharmaceuticals, Inc. Mark B. Weeks, Cooley LLP Robert W. Phillips, Cooley LLP David R. Ambler, Cooley LLP
2020-07-06 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm acrx20200702_corresp.htm AcelRx Pharmaceuticals, Inc. 351 Galveston Drive Redwood City, CA 94063 July 6, 2020 Via EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Paul Fischer RE: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed June 12, 2020 File Number: 333-239156 Acceleration Request Requested Date: Wednesday, July 8, 2020 Requested Time: 4:00 p.m., Eastern Daylight Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, AcelRx Pharmaceuticals, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on July 8, 2020, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes each of Robert Phillips and David Ambler of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Robert Phillips at (415) 693-2020, or in his absence, David Ambler at (650) 843-5899. [Signature Page Follows] Very truly yours, AcelRx Pharmaceuticals, Inc. By: /s/ Raffi Asadorian Name: Raffi Asadorian Title: Chief Financial Officer cc: Ruben Garcia, AcelRx Pharmaceuticals, Inc. Mark B. Weeks, Cooley LLP Robert W. Phillips, Cooley LLP David R. Ambler, Cooley LLP
2020-07-06 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm acrx20200702_corresp.htm AcelRx Pharmaceuticals, Inc. 351 Galveston Drive Redwood City, CA 94063 July 6, 2020 Via EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Paul Fischer RE: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed June 12, 2020 File Number: 333-239156 Acceleration Request Requested Date: Thursday, June 9, 2020 Requested Time: 4:00 p.m., Eastern Daylight Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, AcelRx Pharmaceuticals, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 to become effective on July 9, 2020, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes each of Robert Phillips and David Ambler of Cooley LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Robert Phillips at (415) 693-2020, or in his absence, David Ambler at (650) 843-5899. [Signature Page Follows] Very truly yours, AcelRx Pharmaceuticals, Inc. By: /s/ Raffi Asadorian Name: Raffi Asadorian Title: Chief Financial Officer cc: Ruben Garcia, AcelRx Pharmaceuticals, Inc. Mark B. Weeks, Cooley LLP Robert W. Phillips, Cooley LLP David R. Ambler, Cooley LLP
2020-06-17 - UPLOAD - TALPHERA, INC.
United States securities and exchange commission logo
June 17, 2020
Vincent J. Angotti
Chief Executive Officer
Acelrx Pharmaceuticals Inc.
351 Galveston Drive
Redwood City, CA 94063
Re:Acelrx Pharmaceuticals Inc.
Registration Statement on Form S-3
Filed June 12, 2020
File No. 333-239156
Dear Mr. Angotti:
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 Paul Fischer at 202-551-3415 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Ambler, Esq.
2020-04-22 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm CORRESP April 22, 2020 VIA EDGAR Division of Corporation Finance Office of Manufacturing United States Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549-3628 Attention: Irene Paik Re: Request for Effectiveness for AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-4 (File No. 333-237584) Dear Ms. Paik: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the “Act”), AcelRx Pharmaceuticals, Inc. (the “Registrant”) hereby respectfully requests that the effectiveness of the above-referenced Registration Statement be accelerated to 4:00 p.m. Eastern Time, on Friday, April 24, 2020, or as soon thereafter as practicable. In making this acceleration request, the Registrant acknowledges that it is aware of its responsibilities under the Act. The Registrant respectfully requests that you notify Rama Padmanabhan of Cooley LLP at (858) 550-6024 or, in her absence, Nicole P. van de Leuv of Cooley LLP at (858) 550-6150 of such effectiveness and that such effectiveness also be confirmed in writing to the addresses listed on the cover page of the Registration Statement. If you have any questions or comments regarding the foregoing, please do not hesitate to contact Ms. Padmanabhan or Ms. van de Leuv at the telephone numbers above. Very truly yours, AcelRx Pharmaceuticals, Inc. By: /s/ Vincent J. Angotti Name: Vincent J. Angotti Title: Chief Executive Officer cc: Christopher D. Barnstable-Brown, Wilmer Cutler Pickering Hale and Dorr LLP Rama Padmanabhan, Cooley LLP AcelRx Pharmaceuticals, Inc • 351 Galveston Drive, Redwood City, CA 94063 • www.acelrx.com
2020-04-14 - UPLOAD - TALPHERA, INC.
April 13, 2020
Vincent J. Angotti
Chief Executive Officer
AcelRx Pharmaceuticals, Inc.
351 Galveston Drive
Redwood City, CA 94063
Re:AcelRx Pharmaceuticals, Inc.
Registration Statement on Form S-4
Filed April 6, 2020
File No. 333-237584
Dear Mr. Angotti:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Irene Paik at 202-551-6553 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Rama Padmanabhan - Cooley LLP
2019-11-25 - UPLOAD - TALPHERA, INC.
November 25, 2019
Raffi M. Asadorian
Chief Financial Officer
ACELRX PHARMACEUTICALS INC
351 Galveston Drive
Redwood City, CA 94063
Re:ACELRX PHARMACEUTICALS INC
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed March 7, 2019
File No. 001-35068
Dear Mr. Asadorian:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-11-07 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm acrx20191029_corresp.htm November 7, 2019 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences Attn: Sasha Parikh, Kevin Vaughn Washington, D.C. 20549 Re: AcelRx Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended December 31, 2018, as amended by that certain Form 10-K/A Filed March 7, 2019 and April 30, 2019, respectively File No. 001-35068 Ladies and Gentlemen: AcelRx Pharmaceuticals, Inc. (the “Company”) is providing this letter in response to comments (the “Comments”) received from the staff of the U.S. Securities and Exchange Commission’s Division of Corporation Finance (the “Staff”) by letter dated October 25, 2019 with respect to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018, filed on March 7, 2019, as amended by that certain Form 10-K/A for the fiscal year ended December 31, 2018, filed on April 30, 2019. Set forth below are the Company’s responses to the Comments. For your convenience, the Company has incorporated the Comments into this response letter. Form 10-K for the Fiscal Year Ended December 31, 2018, as amended by that certain Form 10-K/A for the Fiscal Year Ended December 31, 2018 Business Clinical Trials, page 8 1. Please address the following regarding your disclosure of certain serious adverse events (SAEs) experienced by patients in the clinical trials of certain product candidates: ● You disclose in a risk factor on page 34 that in the phase 3 active-comparator clinical trial (IAP309), double-blind, placebo-controlled, orthopedic surgery trial (IAP311) and phase 3 multi-center, open-label study (IAP312), patients experienced serious adverse events (SAEs) that were assessed as "possibly or probably related to the study drug." Please provide us proposed disclosure to be provided in future filings identifying each treatment related SAE "possibly or probably" related to Zalviso. ● Further on page 9, you disclose that in the IAP312 study “A total of 5 patients experienced serious adverse events, but all were considered unrelated to study drug by investigators.” This disclosure appears to contradict your disclosure on page 34. Please clarify for us whether the SAEs in the IAP312 study were related or unrelated to Zalviso. Revise such disclosure in future filings to reconcile the apparent contradiction. AcelRx Pharmaceuticals, Inc. 351 Galveston Drive Redwood City, CA 94063 Company Response: The Company respectfully acknowledges the Staff’s comment. The Company undertakes to identify serious adverse events (collectively, “SAEs”) “possibly or probably” related to Zalviso for the IAP309 and IAP311 trials in the risk factors section included in future filings, as applicable. The Company will also disclose such SAEs in any Clinical Trials section included in its annual reports on Form 10-K, if applicable. As it relates to the contradiction noted by the Staff in the second bullet of the Staff’s comment, the Company confirms that there were no SAEs “possibly or probably” related to Zalviso, the study drug in the IAP 312 trial. The Company undertakes to revise the referenced risk factor disclosure in future filings to eliminate the noted inconsistency. In addition, the Company will also revise the referenced risk factor to correct other information, including percentages and patient count. Below is the revised risk factor that the Company proposes to include in future filings, as applicable: “Zalviso may cause adverse effects or have other properties that could delay or prevent regulatory approval or limit the scope of any approved label or market acceptance. DSUVIA may cause adverse effects or have other properties that could limit market acceptance. Adverse events, or AEs, caused by Zalviso could cause us, other reviewing entities, clinical trial sites or regulatory authorities to interrupt, delay or halt any future FDA-required clinical trials and could result in the denial of regulatory approval. Phase 2 clinical trials we conducted with Zalviso did generate some AEs, but no serious adverse events, or SAEs, related to the trial drug. In our Phase 3 active-comparator clinical trial (IAP309), 8% of Zalviso-treated patients dropped out of the trial prematurely due to an AE (11% in the IV patient-controlled morphine group), and we observed three SAEs that were assessed as possibly or probably related to study drug (one – respiratory depression - in the Zalviso group and two – abdominal distension and ileus - in the IV patient-controlled morphine group). In our Phase 3, double-blind, placebo-controlled, abdominal surgery trial (IAP310), 6% of Zalviso-treated patients dropped out of the trial prematurely due to an AE (9% in placebo group). There were no SAEs determined to be related to study drug. In our Phase 3, double-blind, placebo-controlled, orthopedic surgery trial (IAP311), 7% of Zalviso-treated patients dropped out of the trial prematurely due to an AE (7% in placebo group). Four patients (three in the Zalviso group and one in the placebo group) experienced an SAE considered possibly or probably related to the trial drug by the investigator. The SAEs possibly or probably attributed to Zalviso were severe oxygen saturation decreased, sinus tachycardia and confusional state. In our Phase 3 multicenter, open-label study of Zalviso (IAP312), 3% of patients dropped out prematurely due to an AE. Five patients experienced treatment emergent SAEs in the IAP312 study and none of these were considered possibly or probably related to the study drug by the investigator. In our Phase 2 DSUVIA placebo-controlled bunionectomy study (SAP202), two patients in the DSUVIA 30 mcg group (5%) discontinued treatment due to an AE. There were no SAEs deemed related to DSUVIA. In our Phase 3 placebo-controlled abdominal surgery study (SAP301), one DSUVIA-treated patient (1%) dropped out of the trial prematurely due to an AE (4% in placebo group). There were two SAEs determined to be related to study drug in the placebo-treated group and no related SAEs in the DSUVIA group. In our Phase 3 open-label, single-arm emergency room study (SAP302), no DSUVIA-treated patients dropped out of the trial prematurely due to an AE. One patient had an SAE - angina pectoris - possibly related to study drug. In our post-operative study in patients aged 40 years or older (SAP303), 3% of DSUVIA-treated patients dropped out of the trial prematurely due to an AE. There were no SAEs deemed related to study drug. If DSUVIA or, if approved, Zalviso cause serious or unexpected side effects after receiving marketing approval, a number of potentially significant negative consequences could result, including: • regulatory authorities may withdraw their approval of the product or impose restrictions on its distribution in the form of a modified REMS program; • regulatory authorities may require the addition of labeling statements, such as warnings or contraindications; • we may be required to change the way the product is administered or conduct additional clinical trials; AcelRx Pharmaceuticals, Inc. 351 Galveston Drive Redwood City, CA 94063 • we could be sued and held liable for harm caused to patients; or, • our reputation may suffer. Any of these events could prevent us from achieving or maintaining market acceptance of DSUVIA or, if approved, Zalviso, and could substantially increase the costs of commercializing our products.” * * * Please contact Ruben A. Garcia at (650) 306-8252 with any questions or further comments regarding the Company’s responses to the Staff’s Comments. Sincerely, /s/ Raffi Asadorian Raffi Asadorian Chief Financial Officer cc: Raffi Asadorian, AcelRx Pharmaceuticals, Inc. Ruben A. Garcia, AcelRx Pharmaceuticals, Inc. Mark B. Weeks, Cooley LLP Robert W. Phillips, Cooley LLP David R. Ambler, Cooley LLP AcelRx Pharmaceuticals, Inc. 351 Galveston Drive Redwood City, CA 94063
2019-10-25 - UPLOAD - TALPHERA, INC.
October 25, 2019
Raffi M. Asadorian
Chief Financial Officer
ACELRX PHARMACEUTICALS INC
351 Galveston Drive
Redwood City, CA 94063
Re:ACELRX PHARMACEUTICALS INC
Form 10-K for the Fiscal Year Ended December 31, 2018
Filed March 7, 2019
File No. 001-35068
Dear Mr. Asadorian:
We have reviewed your filing and have the following comments. In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2018
Business
Clinical Trials, page 8
1.Please address the following regarding your disclosure of certain serious adverse events
(SAEs) experienced by patients in the clinical trials of certain product candidates:
•You disclose in a risk factor on page 34 that in the phase 3 active-comparator clinical
trial (IAP309), double-blind, placebo-controlled, orthopedic surgery trial (IAP311)
and phase 3 multi-center, open-label study (IAP312), patients experienced serious
adverse events (SAEs) that were assessed as "possibly or probably related to the
study drug." Please provide us proposed disclosure to be provided in future filings
identifying each treatment-related SAE "possibly or probably" related to Zalviso.
•Further on page 9, you disclose that in the IAP312 study “A total of 5 patients
experienced serious adverse events, but all were considered unrelated to study drug
FirstName LastNameRaffi M. Asadorian
Comapany NameACELRX PHARMACEUTICALS INC
October 25, 2019 Page 2
FirstName LastName
Raffi M. Asadorian
ACELRX PHARMACEUTICALS INC
October 25, 2019
Page 2
by investigators.” This disclosure appears to contradict your disclosure on page 34.
Please clarify for us whether the SAEs in the IAP312 study were related or unrelated
to Zalviso. Revise such disclosure in future filings to reconcile the apparent
contradiction.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
You may contact Sasha Parikh at 202-551-3627 or Kevin Vaughn at 202-551-3494 if you
have any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2017-06-13 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm acrx20170613_corresp.htm June 13, 2017 Via EDGAR United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Johnny Gharib RE: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed June 5, 2017 File Number: 333-218506 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (the “Filing”) to become effective at 4:00 p.m. Eastern Time on Wednesday, June 14, 2017, or as soon thereafter as is practicable. Very truly yours, AcelRx Pharmaceuticals, Inc. /s/ Jane Wright-Mitchell By: Jane Wright-Mitchell Chief Legal Officer cc: Mark B. Weeks Robert W. Phillips Cooley llp
2017-06-12 - UPLOAD - TALPHERA, INC.
June 12, 2017
Vincent Angotti
Chief Executive Officer
AcelRx Pharmaceuticals, Inc.
351 Galveston Drive
Redwood City, CA 94063
AcelRx Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed June 5, 2017
File No. 333-218506Re:
Dear Mr. Angotti:
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 Johnny Gharib at (202) 551-3170 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Robert W. Phillips, Esq.
2014-06-11 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm CORRESP June 11, 2014 VIA EDGAR United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Christina De Rosa Bryan J. Pitko RE: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed May 19, 2014 File Number: 333-196089 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-3 (the “Filing”) to become effective at 4:00 p.m. Eastern Time on Thursday, June 12, 2014, or as soon thereafter as is practicable. In connection with this request, the undersigned registrant hereby acknowledges that: • should the Commission or the staff of the Commission (the “Staff”), acting pursuant to delegated authority, declare the Filing effective, it does not foreclose the Commission from taking any action with respect to the Filing; • the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Filing effective, does not relieve the undersigned registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Filing; and • the undersigned registrant may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, AcelRx Pharmaceuticals, Inc. /s/ Timothy E. Morris By: Timothy E. Morris Chief Financial Officer cc: Mark B. Weeks Cooley LLP
2014-06-05 - UPLOAD - TALPHERA, INC.
June 4 , 2014 Via E -mail Richard A. King President and Chief Executive Officer AcelRx Pharmaceuticals, Inc. 351 Galveston Drive Redwood City, CA 94063 Re: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-3 Filed May 1 9, 2014 File No. 333-196089 Dear Mr. King : We have limited our review of your regist ration statement to the issue we hav e addressed in our comment . Please respond to this letter by amending your registration statement and providing the requested information . Where you do not believe our comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After revi ewing any amendment to your registration statement and the information you provide in response to this comment , we may have additional comments. Exhibit 5.1 1. We note that page 2 of the legal opinion filed as Exhibit 5.1 indicates that the opinion “as to the Debt Securities and the Warrants constituting valid and legally binding obligations of the Company…” is expressed “solely with respect to the laws of the State of New York.” As highlighted in Section II.B.1.e of the Division of Corporation Finance Staff Legal Bulletin No. 19, counsel must also consider the law of the jurisdiction under which the registrant is organized in order to provide the binding obligat ion opinion. Please revise your legal opinion to confirm that with respect to whether the Debt Securities and Warrants constitute valid and legally binding obligations of the Company, counsel considered the General Corporation Law of the State of Delaware in addition to the laws of the State of New York. Please file such revised opinion as an exhibit to an amended registration statement. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain th at the filing includes the information the Securities Act of 193 3 and Richard A. King AcelRx Pharmaceuticals, Inc. June 4, 2014 Page 2 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 accurac y 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 provide a written statement from the company acknowledging that: shou ld the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Christina De Rosa at (202) 551 -3577 , Bryan Pitko at (202) 551 -3203 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: Via E -mail Mark Weeks Cooley LLP 3175 Hanover Street Palo Alto, CA 94304
2011-02-04 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm Acceleration Request VIA FACSIMILE AND EDGAR February 4, 2011 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-4720 Attn: Jeffrey P. Riedler Christine Allen Lisa Vanjoske Dan Greenspan Sebastian Gomez Abero Re: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-1 (File No. 333-170594) Dear Mr. Riedler: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as the representative of the underwriters, hereby join AcelRx Pharmaceuticals, Inc. in requesting that the effective date of the above-referenced registration statement be accelerated to February 8, 2011, at 3:30 p.m., Eastern Time, or as soon thereafter as practicable. In connection with this acceleration request and pursuant to Rule 418(a)(7) and Rule 460 under the Act, please be advised that from January 20, 2011 through the date hereof, the undersigned effected the following approximate distribution of copies of the Preliminary Prospectus dated January 20, 2011: 0 to prospective underwriters; 250 to 250 institutional investors; 50 to 5 prospective dealers; and 25 to others. This is to further advise you that the underwriters have complied and will continue to comply with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, PIPER JAFFRAY & CO. By: PIPER JAFFRAY & CO. By: /s/ Christie Christina Christie Christina, Authorized Officer as representative of the several underwriters cc: Richard A. King, AcelRx Pharmaceuticals, Inc. Mark B. Weeks, Cooley LLP Chadwick L. Mills, Cooley LLP David W. Pollak, Morgan, Lewis & Bockius LLP Albert Lung, Esq., Morgan, Lewis & Bockius LLP
2011-02-04 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm Acceleration Request ACELRX PHARMACEUTICALS, INC. 575 Chesapeake Drive Redwood City, CA 94063 (650) 216-3500 February 4, 2011 VIA FACSIMILE AND EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attn: Jeffrey P. Riedler Christine Allen Lisa Vanjoske Dan Greenspan Sebastian Gomez Abero Re: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-1 (File No. 333-170594) Dear Mr. Riedler: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate actions to cause the above-referenced Registration Statement No. 333-170594 (the “Registration Statement”) to become effective on February 8, 2011, at 3:30 p.m., Eastern Time, or as soon thereafter as is practicable. This request for acceleration is subject, however, to your receiving a telephone call prior to such time from our legal counsel, Cooley LLP, confirming this request. The Registrant also hereby requests a copy of the written order verifying the effective date. In connection with this request, the Registrant acknowledges that: • should the Commission or the staff of the Commission (the “Staff”), acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Registrant may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Until such time as it becomes effective, the above-referenced Registration Statement will continue to be subject to the delaying amendment set forth therein. Very truly yours, ACELRX PHARMACEUTICALS, INC. /s/ Richard King Richard King President and Chief Executive Officer
2011-02-01 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm Acceleration Request VIA FACSIMILE AND EDGAR February 1, 2011 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549-4720 Attn: Jeffrey P. Riedler Christine Allen Lisa Vanjoske Dan Greenspan Sebastian Gomez Abero Re: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-1 (File No. 333-170594) Dear Mr. Riedler: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as the representative of the underwriters, hereby join AcelRx Pharmaceuticals, Inc. in requesting that the effective date of the above-referenced registration statement be accelerated to February 3, 2011, at 2:00 p.m., Eastern Time, or as soon thereafter as practicable. In connection with this acceleration request and pursuant to Rule 418(a)(7) and Rule 460 under the Act, please be advised that from January 20, 2011 through the date hereof, the undersigned effected the following approximate distribution of copies of the Preliminary Prospectus dated January 20, 2011: 0 to prospective underwriters; 250 to 250 institutional investors; 50 to 5 prospective dealers; and 25 to others. This is to further advise you that the underwriters have complied and will continue to comply with Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. [Remainder of Page Intentionally Left Blank] Very truly yours, PIPER JAFFRAY & CO. By: PIPER JAFFRAY & CO. By: /s/ Christie Christina Christie Christina, Authorized Officer as representative of the several underwriters cc: Richard A. King, AcelRx Pharmaceuticals, Inc. Mark B. Weeks, Cooley LLP Chadwick L. Mills, Cooley LLP David W. Pollak, Morgan, Lewis & Bockius LLP Albert Lung, Esq., Morgan, Lewis & Bockius LLP Signature Page to Acceleration Request Letter
2011-02-01 - CORRESP - TALPHERA, INC.
CORRESP 1 filename1.htm Acceleration Request ACELRX PHARMACEUTICALS, INC. 575 Chesapeake Drive Redwood City, CA 94063 (650) 216-3500 February 1, 2011 VIA FACSIMILE AND EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attn: Jeffrey P. Riedler Christine Allen Lisa Vanjoske Dan Greenspan Sebastian Gomez Abero Re: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S-1 (File No. 333-170594) Dear Mr. Riedler: Pursuant to Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate actions to cause the above-referenced Registration Statement No. 333-170594 (the “Registration Statement”) to become effective on February 3, 2011, at 2:00 p.m., Eastern Time, or as soon thereafter as is practicable. This request for acceleration is subject, however, to your receiving a telephone call prior to such time from our legal counsel, Cooley LLP, confirming this request. The Registrant also hereby requests a copy of the written order verifying the effective date. In connection with this request, the Registrant acknowledges that: • should the Commission or the staff of the Commission (the “Staff”), acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Registrant may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Until such time as it becomes effective, the above-referenced Registration Statement will continue to be subject to the delaying amendment set forth therein. Very truly yours, ACELRX PHARMACEUTICALS, INC. /s/ Richard King Richard King President and Chief Executive Officer
2010-12-08 - UPLOAD - TALPHERA, INC.
December 8, 2010 Richard King President and Chief Executive Officer AcelRx Pharmaceuticals, Inc. 575 Chesapeake Drive Redwood City, CA 94063 Re: AcelRx Pharmaceuticals, Inc. Registration Statement on Form S -1 Filed November 12, 2010 File No. 333 -170594 Dear Mr. King : We have reviewed your registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by am ending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. General 1. Please note that when you file a pre -effective amendment containing pricing -related information, we may ha ve additional comments. As you are likely aware, you must file this amendment prior to circulating the prospectus. 2. Please note that when you file a pre -effective amendment that includes your price range, it must be bone fide. We interpret this to mean th at your range may not exceed $2 if you price below $20 and 10% if you price above $20. 3. Please note that where we provide examples to illustrate what we mean by our comments, they are examples and not complete lists. If our comments are applicable to portions of the filing that we have not cited as examples, please make the appropriate changes in accordance with our comments. Richard King AcelRx Pharmaceuticals, Inc. December 8, 2010 Page 2 4. Please provide us proofs of all graphic, visual or photographic information you will provide in the printed prospectus prior to i ts use. 5. Please provide an explanation of the following terms where you first use them: • “bioadhesive excipient” • “high oral transmucosal uptake” Sufentanil Nano Tabs , page 1 6. You disclose in the last paragraph of this subsection that you have one issued patent in Europe. Please expand your disclosure in the Prospectus Summary section to disclose that this patent is currently subject to opposition by third parties . Risks Associated with Our Business, page 5 7. Please expand your bulleted list of risks to al so state that the design for the device component of your product candidates is still under development and may not be fully functional or commercially viable. Risk Factors, page 12 We might be unable to service our current debt…, page 14 8. Please expand your disclosure to describe the installment payment due dates, the current interest rate on the debt and amount of the installment payments, as well as the date when the outstanding $6.4 million will become due. Our product candidates may cause adverse effects… , page 16 9. Please quantify the frequency or number of AEs o bserved in your clinical studies, as compared to the subjects treated with placebo. We rely on limited sources of supply…, page 19 10. Please file copies of supplier agreements as exhibits an d describe the material terms of the agreements in your filing or, alternatively, please tell us why you are not substantially dependent on those suppliers. Our design for the device component of our product candidates …, page 20 11. Please expand you discl osure in the Business section to describe the stage of development for each of your devices. Richard King AcelRx Pharmaceuticals, Inc. December 8, 2010 Page 3 Our future success depends on our ability to retain key executives…, page 26 12. Please expand your risk factor to disclose that each of your executive officers is employed “at-will.” 13. This risk factor addresses two separate risks: (1) the risk of retaining key executives and other qualified personnel; and (2) the risk that consultant and avisors may be employeed by others and may have commitments under consulting or advisory contracts with other entities that may limit their availability to the company. Please separate the disclosure of these two risks under two appropriately titled risk factors. Business, page 66 ARX- 01 – Acute Post -Operative Pain, page 66 14. We note that you are using data from 2002 and 2003 for the percentage of errors resulting in patient deaths. Please update your disclosure with more recent data. Sufentanil NanoTab PCA System —ARX- 01 Clinical Program, page73 15. Please describe what you m ean by the “summed pain intensity difference” when you first use this phrase. Sufentanil/Triazolan NanoTab —ARX- 03 Clinical Program, page 82 16. Please describe what you mean by “Richmond Agitation -Sedation Scale” when you first use this phrase. Intellectu al Property, page 84 17. Please expand your disclosure to provide the expiration date of the European Patent you hold. Also, with respect to this European Patent and the rest of the patent applications, please disclose what these patent and p atent applicatio ns relate to. Executive Compensation, page 105 Cash Bonuses, page 111 18. We note that in connection with the hiring of Messrs. King and Welch the compensation committee approved annual cash bonus targets. To the extent these bonuses will be paid based o n the achievement of performance goals set in advance, please describe the performance goals. To the extent quantifiable, please quantify the performance metrics. Alternatively, if the bonuses will be awarded at the discretion of the board and no perform ance goals were set in advance, please disclose that fact. Richard King AcelRx Pharmaceuticals, Inc. December 8, 2010 Page 4 Long -Term Equity Incentive Awards, page 111 19. Please expand your disclosure to describe and quantify, to the extent quantifiable, the corporate milestones and financial milestones that will resu lt in the grant of an option covering 1% of the company for Mr. King and an option covering 100,000 shares for Mr. Welch. Please also disclose when the achievement of these milestones will be measured. Notes to Financial Statements, page F -8 Note 1. Organization and Summary of Significant Accounting Policies, page F -8 Liability Associated with Warrants to Purchase Convertible Preferred Stock, page F -12 20. You state that “changes in the estimated fair value of the convertible preferred stock during the period are recorded through other income…” Based on your other disclosures it appears that you are referring to your convertible preferred stock warrants. Please revise your disclosures to refer to the convertible preferred stock warrants or further advise us about why changes in the estimated fair value of the convertible preferred stock during the period are recorded in operations. Note 7. Warrants, page F -20 21. We note the fair values disclosed for the convertible preferred stock warrants at December 3 1, 2008 and 2009, and September 30, 2010. The total liabilities summed from the disclosures ($10,000+ 986,000+ 1,200,000 = $2,196,000) do not equal that stated on the balance sheet for September 30, 2010 of $2,219,000. Please revise your disclosures such that the total convertible preferred stock warrant liabilities are consistent with the balance sheet or further advise us about why these amounts do not equal. 22. With regards to valuing your 2010 warrants to purchase Series C convertible preferred stock, y ou disclose that you evaluated multiple potential outcomes using the intrinsic value or Black -Scholes value with multiple scenarios, and discounted the values back to September 30, 2010. Aside from the scenarios disclosed, please tell us what other scenarios were simulated in your evaluation of potential outcomes to determine a value for your warrants. Also tell us how you evaluated the various outcomes from the scenarios to arrive at your final estimate for the 2010 warrant. Additionally, please tell u s what accounting literature was relied upon in making your determination that using the intrinsic value was appropriate for valuing your warrants. Note 11. Net Loss Per Share of Common Stock, page F -32 23. Please revise your disclosures for total convert ible preferred stock warrants such that your quantitative disclosures and qualitative disclosures at note 7 for the total convertible Richard King AcelRx Pharmaceuticals, Inc. December 8, 2010 Page 5 preferred stock warrants are consistent. For example, at Note 5 and 7 you disclose that 10,000 convertible preferred stoc k warrants were issued in 2007 (Series A), 225,000 were issued in 2008 (Series B), and 913,056 were issued in 2009 (Series C). This disclosure is not consistent with your disclosures at page F -32 that 923,056 convertible preferred stock warrants were outs tanding at December 31, 2008 and 2009, and for the nine months ended September 30, 2009 and 2010. 24. Please revise your disclosure for the total “stock options to purchase common stock” outstanding at December 31, 2009 (2,657,500) to be consistent with the “ number of shares underlying outstanding options” at Note 10 Stock- Based Compensation (2,662,500) or further advise us about why these amounts should be different. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are r esponsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement please provide a written statement from the compa ny 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 t he declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Richard King AcelRx Pharmaceuticals, Inc. December 8, 2010 Page 6 You may contact Christine Allen at (202) 551 -3652 or Lisa Vanjoske at (202) 551- 3614 if you have questions regarding comments on the financial statements and related matters. Please contact Sebastian Gomez Abero at (202) 551- 3578 or Dan Greenspan at (202) 551 -3623 with any other questions. Sincerely, Jeffrey P. Riedler Assistant Director Cc: Mark B. Weeks Chadwick L. Mills Cooley LLP 3000 El Camino Real Palo Alto, CA 94306- 2155